"Examiner must articulate "a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does."

BPAI CASE
Ex parte FRANCIS X. HURSEY
Appeal 2009-003346
Application 10/939,687
Technology Center 1600
Decided: June 11, 2009

Claim at issue:
1. A composition for promoting the formation of clots in blood, said composition comprising: a binder; a zeolite disposed in said binder, said zeolite having an adjusted calcium content via the addition of a calcium-containing compound to said zeolite, said calcium content being between about 75 wt.% to about 83 wt.%, said composition being operable to reduce a heat of hydration when exposed to blood.

Examiner had found two references that described combining a zeolite with a binder and zeolite with calcium oxide. The prior art did not teach the exact percentage or that it would lead to a reduced heat of hydration. The Board found that reducing the heat of hydration is in contrast to what the prior art taught. The Examiner argued that it was obvious because it was just about optimization of the amount of calcium and that would it would have been obvious to optimize it. The Examiner then contended that the reduced heat of hydration would have been an inherent property in the optimized composition. The Board disagreed that it would have been obvious.

The Board stated:

In order to support such a conclusion the Examiner must articulate “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR, 550 U.S. at 418. The Examiner has failed to articulate such a reason on this record. More particularly, the Examiner has failed to explain why a person of ordinary skill in the art would optimize the calcium content to a weight percentage that reduces the heat of hydration when the evidence the Examiner relies upon expressly teaches that it is advantageous to utilize a zeolite that generates heat as it absorbs moisture (FF 6). Simply stated the evidence relied upon by the Examiner directs one of ordinary skill in this art away from Appellant’s claimed invention.

The rejection was reversed. 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.

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.

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

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.

Prior art must teach all the elements for obviousness

Ex parte ROGER B. QUINCY, III and JOHN G. MACDONALD (BPAI)
Appeal 2009-0441
Application 10/328,730
Technology Center 1600
Decided: February 26, 2009

25. A substrate that contains an odor control composition in an amount of from about 0.5 wt.% to about 25 wt.% of the substrate, wherein said odor control composition comprises a silicon oxide compound and a transition metal that constitutes from about 0.2 wt.% to about 10 wt.% of said odor control composition,

wherein said silicon oxide compound is formed from a silicon source and a cyclodextrin template.

The Examiner argued that a composition with a chelating agent is the same as a metal ion because it can chelate metal. The Board thankfully disagreed. The reference “[s]uitable odor control agents also include chelating agents typically suitable to chelate metal ions like iron and manganese.” (FF3.) [The reference] did not say that metal ions are odor control agents. [The Reference] taught making an odor control composition with a chelating agent, but did not teach making a composition with the metal ion a chelating agent could bind. [The reference] also did not teach using a “chelate” of agent and metal as the Examiner argues..."Put another way, the cited prior art did not contain all the elements of the claimed composition. The Office’s case for obviousness did not account for the differences."

Case can be found here

Just because the group of obvious variants may be large does not make the use of any [one] any less obvious.

Ex parte JACQUES DEGELAEN et al. (BPAI)

Appeal 2008-5883 

Application 10/702,507 

Technology Center 1600 

Decided: February 25, 2009 

The claim at issue was an assay kit for detecting one or more antibiotics containing a β-lactam ring in a liquid dairy product.  The prior taught a similar assay but with a different receptor for recognizing the antibiotic.  The Examiner found the claim to be obvious.  The Board affirmed.  The applicant argued that there were a large number of bacterial receptors to choose from and no guidance to pick the one they chose and there was no expectation of success.  The Board disagreed and sided with the Examiner.  The Board stated:

"We recognize that there are a large number of bacteria from which beta-lactam receptors may be obtained, but just because the group of obvious variants may be large does not make the use of any specific-binding protein for a beta-lactam antibiotic any less obvious."

With regards to the expectation of success the Board stated that the applicant had not provided any scientific or other evidence to show that there would not have been a reasonable expectation of success. The Board once again reiterated that arguments of counsel are not sufficient.  

Case can be found here

The resulting, and desired, [effect] from the combination would have been entirely predictable and grounded in common sense.

In BALL AEROSOL  v. LIMITED BRANDS, INC., (DECIDED: February 9, 2009) the prior art contained all the elements to prevent a candle from scorching the surface on which it is placed.  The invention claimed a cover to a candle that could then be used as a seat for the candle preventing the heat from being transferred to where the candle is being used (i.e. a table).  The district court sua sponte held the patent valid because Limited did not give a reason to combine the references.  Even when KSR was issued the district court maintained the ruling noting that KSR requires the reason to combine to be explicit and found that Limited used only conclusory statements.  The Federal Circuit reversed.  They found that the scorching problem was well known and the elements were also known and all that was needed was to combine the elements.  "The resulting, and desired, decreased heat transfer between the candle holder and the supporting surface from the combination would have been entirely predictable and grounded in common sense."

The Federal Circuit, more importantly, reprimanded the court for requiring an explicit motivation to combine references. In reviewing the KSR decision the Federal Circuit stated, "the analysis that "should be made explicit" refers not to the teachings in the prior art of a motivation to combine, but to the court's analysis."  

As to whether Limited's candles infringed the patent the district court found infringement because Limited candle "is reasonably capable of being configured in such a way that its holder is supported by the cover when the cover is placed open end down on a surface." The Federal Circuit reversed.  The standard is not "reasonably capable" instead "infringement requires "specific instances of direct infringement or that the accused device necessarily infringes the patent in suit.""  Since the plaintiff did not provide any evidence of direct infringement the Federal Circuit reversed and remanded with instructions for finding non-infringement.  

Case can be found here

Ex parte ROELOF JOHANNES HENDRIK KRUISINGA

Ex parte ROELOF JOHANNES HENDRIK KRUISINGA
Appeal 2008-5626
Application 10/472,029
Technology Center 1600
Decided: February 4, 2009
BPAI
Claim at issue was:
6. A method of treating sleep latency in ADHD disorder in a human comprising administering to a human in need thereof, a therapeutically effective amount of at least one member of the group consisting of melatonin or a pharmaceutically acceptable salt of melatonin.

According to BPAI the prior art taught melatonin for sleep issues in any mammal. Another reference stated that patients with ADHD on the drugs have sleep problems. Therefore, it would have been obvious to use melatonin to treat sleep latency. The applicant had attempted to argue that "“Flaugh is directed to the use of a variety of melatonin related compounds to treat sleeping disorders in humans with DIMS disorders such insomnia and not treating sleep latency, let alone in ADHD disorder patients”Appellant contends that the “Stein reference is directed to a study of sleep problems in stimulant treated and untreated children with ADHD . . . It had nothing to do with teaching the treatment of sleep latency in ADHD patients” The Board disregarded the applicant's arguments saying the facts were such that it would have been obvious and predicted to have success.

The case can be found here.