Distribution of Manuscript With No Legal Obligation to Keep Confidential is Not a Printed Publication ""[w]here professional and behavioral norms entitle a party to a reasonable expectation" that information will not be copied or further distributed"

CORDIS CORPORATION,
v.
BOSTON SCIENTIFIC CORPORATION
and SCIMED LIFE SYSTEMS, INC., (FEDERAL CIRCUIT)

In the ongoing stent battle, Cordis and Boston Scientific appealed another case to the Federal Circuit. The issue most interesting is where the court further explained what constitutes a printed publication under 35 U.S.C. § 102(b). The facts are as follows:

• In 1980 the inventor of the ’762 patent, Dr. Palmaz, prepared a ten-page paper describing his work on stents. This paper is the “1980 monograph.” At that time he was a resident at a hospital in California. His name was not on the paper.
• He gave copies of the paper to approximately six of his teachers at an oral presentation of his work to these physicians and several other colleagues.
• Pursuant to agreements, Palmaz later gave copies of the monograph to two companies (Vascor, Inc., and Shiley, Inc.) while attempting to commercialize his stent technology.
• Neither agreement required confidentiality, and the Shiley agreement specifically stated that Shiley “shall not be committed to keep secret any idea or material submitted.”
• In 1983 Dr. Palmaz revised the paper; the revised paper became the “1983 monograph.”
  In 1983 he also gave a copy of both monographs to Werner Schultz, a technician from whom Dr. Palmaz was seeking fabrication assistance.
• When Dr. Palmaz joined the faculty in 1983 at the University of Texas, San Antonio, he gave a copy of the 1983 monograph to a doctor there (who then gave it to the technician setting up Dr. Palmaz’s laboratory) and to the university as part of a research proposal. Dr. Palmaz applied for the patent that became the ’762 patent in 1985.

The court explained the different scenarios that have been evaluated previously:

A document is publicly accessible if it “has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it and recognize and comprehend therefrom the essentials of the claimed invention without need of further research or experimentation.” In re Wyer, 655 F.2d 221, 226 (CCPA 1981) quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743 (S.D.N.Y.1966)). In general, “[a]ccessibility goes to the issue of whether interested members of the relevant public could obtain the information if they wanted to.” Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1569 (Fed. Cir. 1988). Many of our cases in this area have concerned publications available in libraries, and the question has been whether the publication has been sufficiently indexed to be publicly accessible. See, e.g., In re Cronyn, 890 , 655 F.2d at 226. Other cases have involved widespread distribution so that the public could easily obtain copies of the publication. , 545 F.3d 1340, 1350-51 (Fed. Cir. 2008). F.2d 1158, 1161 (Fed. Cir. 1989); In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986); In re WyerSee, e.g., Kyocera Wireless Corp. v. Int’l Trade Comm’n

The Issue here was framed this way:

Here we have a somewhat different question: whether the distribution to a limited number of entities without a legal obligation of confidentiality renders the monographs printed publications under § 102(b).

We have held that where a distribution is made to a limited number of entities, a binding agreement of confidentiality may defeat a finding of public accessibility. But we have also held that such a binding legal obligation is not essential. Klopfenstein, 380 F.3d at 1351. We have noted that “[w]here professional and behavioral norms entitle a party to a reasonable expectation” that information will not be copied or further distributed, “we are more reluctant to find something a ‘printed
publication.’” Id. at 1350-51.

The court found that the norms here were biased towards confidentiality:

The record here contains clear evidence that such academic norms gave rise to an expectation that disclosures will remain confidential…Therefore, the distribution to the academics did not render the monographs as printed publications under 35 U.S.C. § 102(b).

Boston Scientific urged that, "even if the academic and hospital distributions did not create public accessibility, the distribution of monographs to two commercial entities did so. "

The court noted:

"There is no claim here that the two commercial entities provided any express agreement to keep the document confidential; indeed, one entity’s disclosure agreement did not discuss the entity’s confidentiality obligations, and the other entity’s disclosure agreement specifically disclaimed such obligations (most likely to avoid a lawsuit resulting from inadvertent disclosure)."

Boston Scientific argue[d] that under the decision of our predecessor court, the Court of Claims, in Garrett Corp. v. United States, “[w]hile distribution [of a government report] to government agencies and personnel alone may not constitute publication, distribution to commercial companies without restriction on use clearly does.” 422 F.2d 874, 878 (Ct. Cl. 1970) (citation omitted).

However, [according to the court] "the evidence here was sufficient to support a conclusion that there was an expectation of confidentiality between Dr. Palmaz and each of the two commercial entities."

While the Shiley legal agreement executed before development discussions disclaimed a confidentiality requirement, Dr. Palmaz testified that he requested confidentiality during subsequent discussions and was “surprise[d]” when he was shown the language of the Shiley agreement. J.A. at 8517; id. at 19,354. There is no suggestion that the request for confidentiality was not, in fact, honored. Dr. Palmaz confirmed that the entities kept their copies of the monograph confidential, whether or not they were legally obligated to do so. J.A. at 8502. The district court noted that “there is no evidence that [the commercial entities] would have distributed, or in fact did distribute, the 1980 Monograph outside of the company.” Cordis Corp. v. Boston Scientific Corp., Civ. No. 03-027-SLR, 2005 WL 1331172, at *4 (D. Del. June 3, 2005). There was no showing that similar documents in the past became available to the public as a result of disclosure by these or similar commercial entities, that these or similar commercial entities typically would make the existence of such documents known and would honor requests for public access, or that these or similar commercial entities had an incentive to make the document available, etc. The mere fact that there was no legal obligation of confidentiality—all that was shown here—is not in and of itself sufficient to show that Dr. Palmaz’s expectation of confidentiality was not reasonable."

Other issues in the case involved claim construction, obviousness, or anticipation but were generally ordinary.

The full opinion can be found here.

A list that fails to disclose a species can anticipates the species if that species is "at once envisaged"?

IN RE MARTIN GLEAVE (Fed. Cir. March 26, 2009)
Claims at Issue:

1. A bispecific antisense oligodeoxynucleotide, wherein substantially all of the oligodeoxynucleotide is complementary to a portion of a gene encoding human IGFBP-2 and substantially all of the oligodeoxynucleotide is also complementary to a gene encoding human IGFBP-5, and wherein the oligodeoxynucleotide is of sufficient length to act as an antisense inhibitor of human IGFBP-2 and human IGFBP-5.

4. The antisense oligodeoxynucleotide according to claim 1, wherein the oligodeoxynucleotide consists essentially of a series of bases as set forth in any of Seq. ID. Nos. 3 through 7. [Those sequences range from eighteen to twenty-two DNA bases in length and SEQ ID NO: 5 is a 20mer.]

The claims were rejected as anticipated by Wraight.

"In Wraight, the applicants listed every fifteen-base-long sense oligodeoxynucleotide in the IGFBP-2 gene. The list includes more than 1400 sequences. Wraight also disclosed the general concepts that antisense oligonucleotides are preferably between fifteen and twenty-five bases in length, and that some antisense oligonucleotides may be bispecific (i.e., capable of inhibiting “an IGFBP such as IGFBP-2 and/or IGFBP-3”). Finally, Wraight states that “[a]ntisense oligonucleotides to IGFBP-2 may be selected from molecules capable of interacting with one or more” of the sense oligonucleotides described in the long list. "

The court explained what constitutes a proper 102(b) rejection

A reference is anticipatory under § 102(b) when it satisfies particular requirements. First, the reference must disclose each and every element of the claimed invention, whether it does so explicitly or inherently. Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1375 (Fed. Cir. 2006). While those elements must be “arranged or
combined in the same way as in the claim,” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008), the reference need not satisfy an ipsissimis , 545 F.3d 1312, 1314 (Fed. Cir. 2008); , 339 F.3d 1373, 1380–81 (Fed. Cir. 2003); verbis test, In re Bond, 910 F.2d 831, 832–33 (Fed. Cir. 1990). Second, the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” Impax Labs., Inc. v. Aventis Pharms. Inc.see In re LeGrice, 301 F.2d 929, 940–44 (CCPA 1962). As long as the reference discloses all of the claim limitations and enables the “subject matter that falls within the scope of the claims at issue,” the reference anticipates—no “actual creation or reduction to practice” is required. Schering Corp. v. Geneva Pharms., Inc.see In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985).

Gleave (the appellant) argued that

“Wraight does not describe any particular individual antisense species,” because Wraight merely gives the public “ink, formed into strings of letters, without inventive thought and without placing the public in possession of anything new. There is no guidance to make particular selections, and no understanding of which of the targets would be useful, and what the properties of the related antisense would be.”

The Federal Circuit, however, stated that the enablement requirement of 102 is not how to use for a composition, just how to make.

"A thorough reading of our case law, however, makes clear that a reference need disclose no independent use or utility to anticipate a claim under § 102. E.g., Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005)"

The court explained that any confusion about utility or use comes from case law related to method claims. The court explained to enable a method you have to be able to use it not make it.

"Gleave’s claims are to compositions of matter—oligonucleotides—and therefore a reference satisfies the enablement requirement of § 102(b) by showing that one of skill in the art would know how to make the relevant sequences disclosed in Wraight. "…"Thus, the fact that Wraight provides “no understanding of which of the targets would be useful” is of no import, because Gleave admits that it is well within the skill of an ordinary person in the art to make any oligodeoxynucleotide sequence. See Appellant’s Br. 10. As such, Wraight is an enabling disclosure sufficient to anticipate Gleave’s invention under § 102(b). "

Applicant also argued that the prior art did not teach any oligo with antisense activity. The appellant's lawyer even admitted this even with the following phrase "sufficient length to act as an antisense inhibitor " in the claim. Therefore, they viewed the antisense inhibitor limitation as an intended use and not relevant for 102 analysis. "Certainly where the claims themselves do not require a particular activity, we have no call to require something more from the anticipating reference. "

Gleave argued that a long list should not be anticipatory and should be treated more like a generic statement. Court explained that lists and generic terms have always been treated differently except when a genus can anticipate a species when:

compounds that falls within the genus is so limited that a person of ordinary skill in the art can “at once envisage each member of this limited class.” Eli
Lilly, 471 F.3d at 1376. In that limited circumstance, a reference describing the genus anticipates every species within the genus. See Perricone, 432 F.3d at 1377.

The court explained this argument regarding the two types of claims fails for two reasons:

First, Wraight expressly lists every possible fifteen-base-long oligodeoxynucleotide sequence in IGFBP-2, and under our precedent, this list anticipates Gleave’s claims. Second, even if we were to accept Gleave’s invitation to treat Wraight as equivalent to the statement that one “could make antisense that targets IGFBP-2,”4 which we decline to do, a person of ordinary skill in the art equipped with an IGFBP sequence is admittedly capable of envisioning how to make any antisense sequence. Thus, even
if we were to adopt Gleave’s policy position, Gleave’s claims would not be entitled to a patent over Wraight.

The explained that at most Gleave has invented a method of use not a claim for the composition itself.

What wasn't explained is why the claims to the specific sequences were anticipated since only 15mers were disclosed in Wraight and those in claim 4 were from 18-22 and the elected species was a 20mer. The only explanation that I can think of is that Wraigh said an antisense oligo that is from 15-25 can be made and therefore all oligos 18-22 could be at once envisaged? Thoughts?

The full opinion can be found here.

"Public use bar applies to obvious variants of the demonstrated public use"

In CLOCK SPRING v WRAPMASTER (Fed. Cir., March 25, 2009) the federal circuit invalidated a a claim due to a public use under 35 U.S.C. § 102(b). The claim at issue was:

A method for repairing a pipe
adapted to carry an internal load directed radially outward therefrom, said
pipe having a defective region defined by at least one cavity extending from
an outer surface of said pipe toward the center of said pipe but not extending
completely through the wall of said pipe, said method comprising the steps of:

providing a filler
material having a workable uncured
state and a rigid cured state,

filling said cavity to at
least said outer surface of said pipe with said filler material in said workable
state,

providing at least one band
having a plurality of elastic convolutions of high tensile strength material,

while said filler material is
in said workable state, wrapping said
plurality of convolutions of said high tensile strength material about said pipe
to form a coil overlying stud filler material[,]

tightening said coil about said
pipe so that said filler material completely fills that portion of said cavity
underlying said coil[,]

securing at least one of said convolutions to
an adjacent one of said convolutions, and

permitting said filler material to cure to said rigid
state, whereby a load carried by said pipe is
transferred substantially instantaneously from said pipe to said coil.

“[A] public use includes any public use of the claimed invention by a person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor.” Adenta, 501 F.3d at 1371 . "In order for a use to be public within the meaning of § 102(b), there must be a public use with all of the claim limitations. "

There was no dispute that the use was public and there was no control over the people demonstrating the use or observing it. "(“An invention is in public use if it is shown to or used by an individual other than the inventor under no limitation, restriction, or obligation of confidentiality.”). They found that the filling cavaties would have been obvious in view of the demonstration. Therefore, even though the exact limitation may not have been in public use it still qualified because, as the Federal Circuit stated: "We have held that the public use bar applies to obvious variants of the demonstrated public use. Netscape Commc’ns Corp. v. Konrad, 295 F.3d 1315, 1321 (Fed. Cir. 2002)."

They further found that all other elements were part of the demonstration and therefore it was barred under 102(b). Patentee also tried to argue that it was an experimental use. The Federal Circuit found that there was no control, which although not dispositive indicates that it may not be experimental. "A use may be experimental only if it is designed to (1) test claimed features of the invention or (2) to determine whether an invention will work for its intended purpose—itself a requirement of patentability. " The patentee argued that the demonstration was done to determine the durability of the method and end product but there was no evidence of record indicating that this was indeed true. "Clock Spring’s problem, however, is that no report in the record states, or in any way suggests, that the 1989 demonstration was designed to test durability for the purposes of the patent application to the PTO. " Rather there was evidence that durability was for the end user rather than for patentability.

Interestingly, the district court had decided that there was an issue of material fact regarding the public use and found the claims invalid for being obvious. The CAFC reversed the public use decision and did not decide obviousness.

The case can be found here.

It is unnecessary for the Specification to provide a description of proteins which are already known in the prior art.

Ex parte ALA FISHMAN et al.
Appeal 2009-1258
Application 10/096,840
Technology Center 1600
Decided: March 20, 2009

Claims at issue:
22. A chimeric protein for therapy of allergic responses by targeted elimination of FCεRI expressing cells wherein the chimeric protein comprises a cell targeting moiety consisting of an Fc region of an IgE molecule genetically fused to a cell killing moiety.

29. A pharmaceutical composition comprising the chimeric protein of claim 22, wherein said composition is in a form suitable for injection, intra-nasal, intra-thecal, intra-dermal, trans-dermal, inhalation, topical application, oral administration, sustained release, or ethereal administration.

43. A chimeric protein for therapy of allergic responses by targeted elimination of FCεRI expressing cells wherein the chimeric protein comprises a cell targeting moiety consisting of an Fc region of an IgE molecule genetically fused to a cell killing moiety, and the chimeric protein does not cause degranulation of target cells.

Examiner rejected claims as lacking written description because the specification "does not reasonably provide a written description of any and all chimeric protein comprising any cell targeting moiety consisting of an Fc region of any IgE molecule genetically fused to any cell killing moiety as set forth in claims." The Board following Capon v. Eshhar and Falkner v. Inglis reversed the Examiner.

"Simply stated, there is no evidence on this record to support a conclusion that the cell killing and cell targeting moieties set forth in Appellants’ claims were not known to those of ordinary skill in this art at the time the invention was made. It is unnecessary for the Specification to provide a description of proteins which are already known in the prior art. Capon, 418 F.3d at 1357-58."

The Board affirmed that the claims were obvious, in part, because the appellants mischaracterized the prior art (according to the Board) and, therefore, the contention was not persuasive.

Case can be found here

X-ray Powder Diffraction Pattern is Relevant for Obviousness Analysis regardless of whether or not the compound has unexpected properties. (BPAI)

Ex parte MANNE SATYANARAYANA REDDY et al (BPAI)
Appeal 2008-4197
Application 10/651,306
Technology Center 1600
Decided: March 18, 2009

Claims at issue:
1. A hydrous compound of the formula …

42. Hydrous (S)-5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole magnesium in the form of an amorphous solid made by a process comprising:…

44. A solid pharmaceutical composition comprising a hydrous (S)-5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole magnesium in the form of an amorphous solid, wherein the esomeprazole magnesium has substantially the same X-ray powder diffraction pattern as shown in Figure 1, and a pharmaceutically acceptable carrier.

45. A method for reducing gastric acid secretion in a subject which comprises administering to the subject a solid pharmaceutical composition comprising an amount of the compound of claim 1 effective to reduce gastric acid secretion by said subject.

The Examiner rejected claim 42 under 112, second paragraph for the use of product-by-process claim language. The Examiner argued that since they could describe the product as evidence by claim 1, product by process claims are improper. The Board reversed citing, SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1315 (Fed. Cir. 2006), citing that rule the Examiner was using is not the correct standard.

The Examiner rejected claims 44 and 45 for lack of written description and enablement. The Board emphasized that written description and enablement are distinct and noted that the Examiner did not provide any argument regarding written description and therefore reversed that rejection. With regards to enablement the Examiner was concerned that the form claimed could transform in the solid form and therefore the claim was not enabled for some reason. Appellants pointed out that if there was a transformation that changed the x-ray diffraction pattern then it would be outside the scope of the claim and thus not part of the claim. Appellants also supplied evidence stating that conversion from one form to another is "so slow as to be negligible" and that even if it was converted it does not impact the activity of the compound. Examiner never responded to these arguments and therefore they reversed.

The claims were also rejected as obvious. The Examiner cited references describing related compounds that disclosed that some drugs may exist in amorphous forms but do not refer to the claimed compound. The Examiner also stated that an X-ray diffraction pattern although a property is not enough to overcome obviousness unless the X-ray form has an advantage or unexpected results. The prior art references failed to show any compound with a similar X-ray powder diffraction pattern. Therefore, the Board found that the claims were not obvious and reversed the Examiner.

Case can be found here.

BPAI holds that "paving the way" to the claimed invention does not enable the entire scope

Ex parte WENDELL LIM, JOHN DUEBER, and BRIAN YEH (BPAI)
Appeal 2008-3676
Application 10/613,380
Technology Center 1600
Decided: March 18, 2009

The claim at issue:

1. An autoregulated fusion protein comprising an output domain and a plurality of input domains, wherein at least one of the input domains is heterologous to the output domain, and the input domains interact with each other to allosterically and external ligand-dependently regulate the output domain.

The Applicants provided one working example and described how one of skill in the art would use their techniques to screen other "output domain" (catalytic domains) and "input domain" (regulatory domains, i.e. SH3 domain) to create the autoregulated fusion protein. The Examiner, which the Board agreed with, found that the specification did not provide a person to "predictably produce" a desired fusion protein and that an "extremely large amount of experimentation would be required." The Board instead characterized the specification as "an interesting avenue of further research." The Board explained:

They, may have even paved the way for further research
(see e.g., App. Br. 6). What they have not done is provide an enabling
description of the claimed invention that would allow a person of ordinary skill
in the art to practice the claimed invention without undue
experimentation. Other than the recommendation that one do the screens and
figure it out for yourself, Appellants have provided no guidance on how to
successfully select the appropriate plurality of input domains that can be
fused, with or without a linker, to an output domain to successfully obtain a
fusion protein with the properties one would desire.

Applicants had submitted a declaration stating that “[t]hose skilled in the art have recognized that the invention is not limited to a single embodiment, but that Applicants’ teachings ‘…pave the way for creating new signal-response elements by protein design[’]” The Board found this unconvincing because "providing an interesting avenue for further research (e.g., paving the way) is not the same as providing a disclosure that enables a person of ordinary skill in the art to practice the claimed invention without undue experimentation."

Case can be found here.

An abbreviation in a claim need not be spelled out when it would be understood when read in light of the specification

Ex parte BRUCE KERWIN, BYEONG CHANG, and LEI SHI
Appeal 2008-4371
Application 10/461,839
Technology Center 1600
Decided: March 9, 2009

Claim at issue:
1. A stable pharmaceutical formulation comprising at least 45 mg/ml PEGsTNF-R1, at least one tonicity modifier that is not NaCl, a surfactant and a buffer, wherein said pharmaceutical formulation is between pH 4.0 and 5.5 and wherein the viscosity is less than 400 cP.

The claim used the term "PEGsTNF-R1". The Examiner acknowledges that Appellants’ Specification defines PEGsTNF-R1 but insists that “the acronym ‘PEGsTNF-R1’ as recited in the claims should be spelled out and/or defined the first time it is recited in the claims." The Examiner acknowledges on this record that a person of ordinary skill in the art would understand the bounds of the claimed invention when read in light of the Specification. The Examiner argued that looking to the specification to define PEGsTNF-R1 would be adding an extraneous limitation. The Examiner relied upon In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993), to find that “[a]lthough the claims are interpreted in light of the specification, limitations from the specification are not read into the claims” (Ans. 7). The Board disagreed holding that “[I]t is entirely proper to use the specification to interpret what the patentee meant by a word or phrase in the claim.” In re Paulsen, 30 F.3d at 1480." Therefore, the claim was definite.

The claims were found to be obvious for standard reasons such as overlapping ranges and optimization of dosages requiring nothing more than routine experimentation.

Case can be found here

Bilski applied to kill another patent application

In Re Ferguson (Federal Circuit, March 6, 2009)

The Federal Circuit made another decision applying Bilski, this time from an appeal from the PTO's BPAI. Here, there were two claims at issue:

A method of marketing a product, comprising:
developing a shared marketing force, said shared
marketing force including at least marketing channels, which enable marketing a
number of related products;

using said shared marketing force to market a
plurality of different products that are made by a plurality of different
autonomous producing company, so that different autonomous companies, having
different ownerships, respectively produce said related products;

obtaining a share of total profits from each of said
plurality of different autonomous producing companies in return for said using;
and

obtaining an exclusive right to market each of said
plurality of products in return for said using.

A paradigm for marketing software, comprising:
a marketing company that markets software from a
plurality of different independent and autonomous software companies, and
carries out and pays for operations associated with marketing of software for
all of said different independent and autonomous software companies, in return
for a contingent share of a total income stream from marketing of the software
from all of said software companies, while allowing all of said software
companies to retain their autonomy.

The BPAI reversed the Examiner's 102 and 103 rejection and entered a new ground of rejection under 101 applying Bilski. The Federal Circuit held that the method claim although a process failed the machine or transformation test laid out in Bilski. The stated, that the method claim is "not tied to any particular machine or apparatus." The Federal Circuit defined what counts as a machine relying upon In re Nujiten, "As this court recently stated in In re Nuijten, 500 F.3d 1346 (Fed. Cir. 2007), a machine is a “‘concrete thing, consisting of parts, or of certain devices and combination of devices.’ This ‘includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result." The court explained, "Applicants’ method claims are not tied to any concrete parts, devices, or combination of devices."

"Nor do Applicants’ methods, as claimed, transform any article into a different state or thing. At best it can be said that Applicants’ methods are directed to organizing business or legal relationships in the structuring of a sales force (or marketing company). But as this court stated in Bilski, “[p]urported transformations or manipulations simply of public or private legal obligations or relationships, business risks, or other such abstractions cannot meet the test because they are not physical objects or substances, and they are not representative of physical objects or substances.” 545 F.3d at 963."

Applicants argued that their "paradigm" claim is a company and as such is "analagous to a machine." The Federal Circuit rejected this argument. "But the paradigm claims do not recite “a concrete thing, consisting of parts, or of certain devices and combination of devices,” Nuijten, 500 F.3d at 1355, and as Applicants conceded during oral argument, “you cannot touch the company.” The called the "paradigm" an abstract idea--"a business model for an intangible marketing company."

Newman concurred in the judgment in that she would have affirmed the Examiner's 103 rejection. Newman is concerned about the policy effects of the way Bilski is being used to strike down innovation. She would have found the paradigm to satisfy 101 because it is concrete and limited but found them invalid under 103. Newman remarked:

"This court’s retreat into the methods of the past is
unworthy of our responsibility to support innovation in the future. Major
adjustment in established law should be based on changing industrial or
intellectual or equitable needs – of which no evidence is before this court. The only need of
which I am aware is that of the current harsh economic times, when the need is
of enhanced incentives to innovation and investment in new things and new
industries, not reduction in the existing incentives."

Case can be found here

Post-filing art can be used to show that there is no reasonable expectation of success (BPAI)

Ex parte ATUL VARADHACHARY

Appeal 2008-3921

Application 10/732,429

Technology Center 1600

Decided: March 5, 2009

The claims at issue were

1. A method of treating tissue or organ transplant rejection in a recipient comprising the step of orally administering to the recipient an effective amount of a lactoferrin composition to attenuate the tissue or organ transplant rejection.

34. A method of modulating the immune response against an organ or tissue transplant in a recipient comprising the step of orally administering to the recipient an effective amount of a lactoferrin composition to modulate the response against the organ or tissue transplant.

Claim 1 was rejected as being inherently anticipated by a single reference; claims 1 and 34 were rejected as allegedly obvious. A prior art reference taught the administration of lactoferrin in organ transplant patients and immunocompromised patients. However, the reference only taught that it could be used to prevent infections not to attenuate rejection or modulate the response against the organ transplant. The case nicely summarizes inherent anticipation

"To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Thus, "[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent." Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001). "Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient." In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations and internal quotation marks omitted). Therefore, the Examiner cannot establish inherency merely by demonstrating that the asserted limitation is probable or possible. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). However, "'[i]n general, a limitation or the entire invention is inherent and in the public domain if it is the 'natural result flowing from' the explicit disclosure of the prior art.'" Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005) (quoting Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1379 (Fed. Cir. 2003). Therefore, "when considering a prior art method, the anticipation doctrine examines the natural and inherent results in that method without regard to the full recognition of those benefits or characteristics within the art field at the time of the prior art disclosure." Perricone, 432 F.3d at 1378.

The Examiner appeared to be arguing that since the compound was used in organ transplant cases it was necessarily and always being used to prevent rejection. The Board noted that some transplant patients will not have rejection and only infection and therefore the result will not always necessarily result from the prior art. "No evidence has been put forward by the Examiner that all, or even substantially all, transplant patients with infection are also experiencing rejection" Therefore, no anticipation.

With regards to obviousness the Examiner found a reference that discussed the oral administration of lactoferrin. However, the applicant submitted a post-filing reference that stated "[i]t has been reported in the literature that oral lactoferrin is not absorbed systemically through the mature gut to any significant degree." The Board when stating the law regarding obviousness stated, "An obviousness analysis requires that the prior art both suggest the claimed subject matter and reveal a reasonable expectation of success to one reasonably skilled in the art. In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991)." Here, the BPAI found no reasonable expectation of success because of the post-filing reference. The Board concluded: "Thus, while [the primary reference] teaches that oral administration may be contemplated, the prior art at the time Appellants' claimed invention was made establishes that a person of ordinary skill in the art would have no expectation of successfully using orally administered lactoferrin in [the primary reference's] method." Therefore, "A person of ordinary skill in the art would not have a reasonable expectation of successfully practicing the claimed invention in view of the combination of" the cited references.

Case can be found here

No Abuse of Discretion When an Appointed Neutral Expert Testifies; Section 103 requires an inquiry regarding "whether the improvement is more than the predictable use of prior-art elements according to their established function"

MONOLITHIC POWER SYSTEMS, INC. (MPS), v. O2 MICRO INTERNATIONAL LIMITED (Fed. Cir. March 5, 2009)
District Court Did Not Abuse Its Discretion When it Appointed a Neutral Expert to Testify; and "Section 103 of Title 35 requires this court to inquire “whether the improvement is more than the predictable use of prior-art elements according to their established functions.”

This was a DJ action and the patentee is 02 Micro.

The district court was struggling with the technical complexities of the case. At a case management conference the judge stated the following:

On the technical issues here . . . I find this extremely difficult to
understand. And the notion that a jury is going to understand it, to me, is
foolishness. You can talk for months and the jury isn’t really going to
understand this in the sense of being able to make a reasoned, rational decision
about it.They will make a decision, we hope. Maybe they will hang
because they’ll say that we can’t possibly understand this, but in my
experience, they make a decision. But what is it based on? . . . It is kind of
trial by ordeal or by sort of a champion, like a jousting contest rather than on
the actual scientific merits of who is right and who is wrong.

Over the objection of 02 Micro the district court ordered the parties to confer on a Rule 706 expert, which was eventually appointed and who testified. The court-appointed expert, Dr. Santi, offered testimony largely consistent with MPS’s theory of the case, including MPS’s position that it did not infringe O2 Micro’s asserted claims. The district court instructed the jury that the appointed expert was “an independent witness retained by the parties jointly at the court’s direction to assist in explaining the technology at issue in this case.” The Federal Rules of Evidence allow a court to appoint an expert either “on its own motion or on the motion of any party.” Fed. R. Evid. 706(a). It is reviewed under circuit law and this was in the ninth circuit.

The Federal circuit noted that "While commentators have observed that district courts rarely make Rule 706 appointments . . . this court acknowledges that the Federal Rules do authorize those appointments." O2 Micro argued that it violated its 7th amendment rights to a jury trial because it was taking issues out of the jury's hands. The Federal Circuit that this was not the case because the parties agreed on an expert, the jury instructions were proper, and they could call their own experts to attack, support, or supplement the 706(a) appointed expert. The district court instructed the jury in the following manner:

You should not give any greater weight to Professor Santi’s opinion testimony than to the testimony of any other witness simply because the court ordered the parties to retain an independent witness. In evaluating his opinion, you should carefully assess the nature of and basis for Professor Santi’s opinion just as you would do with any other witness’ opinion.

The Federal Circuit noted that the jury's verdict did not track the expert's testimony. For example the CAFC stated, "Whereas Dr. Santi opined that only claim 12 of the ’722 patent was obvious, the jury found all claims obvious." The Federal Circuit ultimately held that O2's argument is a policy argument and it was rejected by Congress.

The Federal Circuit did not like the rule but followed it, they stated, " The predicaments inherent in court appointment of an independent expert and revelations to the jury about the expert’s neutral status trouble this court to some extent," but found that it did not violate the Ninth Circuit's liberal interpretation of circumstances of when the rule can be used.

The claims were also found to be obvious and this was upheld by the Federal Circuit. The CAFC found that the elements were known and there was motivation to make the combination. In framing whether the invention was obvious the court stated, "Section 103 of Title 35 requires this court to inquire “whether the improvement is more than the predictable use of prior-art elements according to their established functions.” KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1740 (2007)." They found that the combination was nothing more than a predictable use.

Case can be found here

An individual who provides an insignificant contribution that is the element recited in a dependent claim is generally not an inventor

NARTRON CORPORATION v. SCHUKRA U.S.A., (Fed. Cir. March 5, 2009)

The District court granted summary judgment of dismissal of the infringement suit for failure of the patentee to join an alleged co-inventor on the patent being asserted. The CAFC reversed because "the alleged co-inventor, provided only an insignificant contribution to the invention of claim 11 of the ’748 patent." Claim 1 and claim 7 of the patent were being asserted. Claim 11 the defendant alleged was also invented by an individual who was not listed as an inventor. The listed inventors admit that they did not "invent the lumbar support adjustor including an extender recited in claim 11." Benson, who is the alleged unlisted inventor, claimed to have provided the listed inventors with the idea of the extender. Benson admitted that the extender was part of the prior art in an automobile seat. The district court held that Benson was a co-inventor because Benson "had conceived of the extender element of claim 11, and, as a co-inventor, he was required to have been joined as a plaintiff in any infringement suit." Therefore, the case was dismissed.

The patentee argued that the extender element was in the prior art and therefore could not have supported a claim of co-inventorship. The patentee argued that the invention related to the controller of the seat not the lumbar support or the extender. The patentee also argued that regardless of whether the element was in the prior art the contribution was insignificant to the invention. The alleged infringer argued that because the combination was patentable Benson should be listed. The defendant also argued that an aspect of a claim cannot be insignificant simply because it appears in a dependent claim.

The Federal Circuit reversed the District court. The Court held "Any contribution Benson made to the invention described in claim 11 by contributing an extender was insignificant and therefore prevents Benson from attaining the status of a co-inventor." “One who simply provides the inventor with well-known principles or explains the state of the art without ever having a firm and definite idea of the claimed combination as a whole does not qualify as a joint inventor.” Ethicon, 135 F.3d at 1460. Moreover, a joint inventor must “contribute in some significant manner to the conception or reduction to practice of the invention [and] make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention.” Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir. 1998); see Caterpillar, 387 F.3d at 1377 (quoting Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997)). The court held that Benson's contribution was no more than "the exercise of ordinary skill in the art."

The court also looked at the specification and noted that the specification focused on the controller not the elements of the seat. They also pointed out, "The specification mentions the extender only once in a twenty-column patent." and it was discussing the background upon which the controller was built, implying that the number of times and where an element is stated may impact whether it is significant or not. The court further explained, "Benson’s contribution of the extender amounted to “nothing more than explaining to the inventors what the then state of the art was and supplying a product to them for use in their invention.”

The court did limit the holding to facts such as these. The court stated, "This is not a case in which a person claims to be an inventor because he has suggested a non-obvious combination of prior art elements to the named inventors. Such an individual may be a co-inventor. There is not, and could not be, any claim that the addition of the extender here was anything but obvious. Benson’s contribution therefore does not make him a co-inventor of the subject matter of claim 11."

Case can be found here.

"Conclusive Evidence" showing possession is not required for Written Description; "Mere Assertions" not enough to show lack of enablement (BPAI)

Ex parte SAMUEL LOCKWOOD et al. (BPAI)
Appeal 2008-5693
Application 10/793,676
Technology Center 1600
Decided: March 2, 2009

Claim:
A method of reducing C-reactive protein (CRP) levels in a subject comprising administering to a subject who would benefit from such treatment, an effective amount of a pharmaceutically acceptable formulation to reduce the level of circulating CRP in the subject, said pharmaceutically acceptable formulation comprising a non naturally occurring carotenoid analog or derivative; wherein the synthetic carotenoid analog or derivative has the structure …

The Examiner rejected the claims as lacking written description and lacking enablement. The Examiner alleged that the specification "fails to disclose any treatable diseases caused by increased C-reactive protein (CRP), and how reducing CRP is the same as treating the diseases” and characterized the claims as reach through claims, which according to the Examiner are unpatentable. Applicants countered showing that there is a correlation with CRP and certain known diseases.

The Board stated reversed the Examiner. The Board found that the "specification provides direct descriptive support of an association between many ischemic disease states and reperfusion injury (FF 1-2). The Specification directly teaches that levels of C-reactive protein are associated with reperfusion injury and that treatment of these conditions with carotenoids “is expected to inhibit and/or ameliorate . . . disease conditions” (Spec. 7, ll. 2-5; FF 3-4). The Specification also teaches possession of a large number of specific carotenoids (FF 5)." The Examiner had argued that there was no "no conclusive evidence that reduction of circulating CRP is ‘a powerful anti-inflammatory therapeutic modality’ and/or ‘a strong therapeutic modality’” The Board held that for written description this standard is incorrect you only have to show possession of the invention, not conclusive evidence of a link.

The claims were also rejected as being non-enabled. The Examiner did not provide any evidence other than opinion that the claims were not enabled. The Examiner seemed to rely upon the step of detecting and diagnosing CRP to perform the claim. The Board noted that this is routine and not undue. The Examiner also argued that it is not known all diseases arising from CRP are known. The Board held that it is not a requirement and there can be some inoperative embodiments. The Examiner argued that there could be some mutations that cause constituve expression of CRP rather than heart injury. But this argument was not supported by any evidence just Examiner opinion.

The Board Concluded: "The Examiner has not provided the required evidence or scientific reasoning to show that one of ordinary skill in the art would find that reduction of CRP levels in a patient would have required “undue experimentation”. The Examiner's mere assertions to that effect are not sufficient for establishing a prima facie case of lack of enablement. Balancing the factors in the Wands analysis, upon which the rejection is based, demonstrates that there is no prima facie case of lack of enablement.

The claims were rejected for being indefinite but the Examiner failed to say why and thus the rejection was reversed. The claims were also rejected for containing new matter because an R group was not in the specification. This was a new ground of rejection and was remanded to the Examiner for further prosecution.

Case can be found here