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

Written Description Requires Specification to be Read as a Whole (BPAI)

Ex parte FREDERICK KHACHIK (BPAI)
Appeal 2009-25571
Application 11/702,486
Technology Center 1600
Decided: February 20, 2009

21. A lutein composition suitable for human consumption which
comprises:
(a) at least about 90% lutein having been extracted and purified from plant extracts which contain 10% or less of non-lutein carotenoids,

(b) no traces of toxic chemicals that would render the lutein composition unsuitable for human consumption, and
(c) significantly less than about 10% of non-lutein carotenoids obtained by purification of said plant extracts.

The examiner rejected the claim for lacking written description. The Examiner alleges that the specification would be understood to only include a limitation of at least 97%, not 90%. The patent disclosed two statements that are relevant:

1. "after recrystallization, the purity of “the resulting lutein is usually greater than 90%, most often greater than 97%." with two working examples of greater than 97%.

2. The specification also disclosed “[w]hile 70% pure lutein may be acceptable for use in animal feed, further purification of this compound may be employed to produce lutein with purity greater than 97% for human consumption”

The examiner relied upon the second to state that specification only described greater than 97% while ignoring the first statement. The Board disagreed finding that read as a whole the specification adequately described the 90% limitation. The Board stated that the second phrase only says that further purification may be employed, "but [the specification] does not say that only lutein compositions with 97% purity are suitable for human consumption." Therefore, the claim satisfied the written description requirement.

Case can be found here

A correlation step is an element for anticipation purposes (BPAI)

Ex parte FLORIAN KRONENBERG (BPAI)
Appeal 2008-4087
Application 10/485,039
Technology Center 1600
Decided: February 13, 2009

The claims below were ultimately found to be anticipated and obvious based upon other references than the one I describe below but I have seen a rejection in a case I am working on where the correlation or diagnosing step is ignored when determining whether something is anticipated. The definiteness issue is also helpful because it slaps the Examiner for making an illogical argument.

19. A method of diagnosing early stage renal impairment in humans, comprising:
measuring an amount of apoA-IV in a plasma sample or a serum sample of a human;
comparing the measured amount of apoA-IV with a reference value; and
diagnosing early stage renal impairment based on the comparison of the measured amount of apoA-IV with the reference value.

50. A method of diagnosing coronary heart disease in humans who suffer from renal impairment comprising:
measuring the amount of apoA-IV in a plasma sample or a serum sample of a human;
comparing the measured amount of apoA-IV with a reference value; and
diagnosing coronary heart disease in humans who suffer from renal impairment based on the comparison of the measured amount of apoA-IV with the reference value.

The Examiner alleged that claims 19 and 50 were indefinite because "the interrelationships of the steps are not clear because it is not clear in what or for what diagnosing is being made or how diagnosing is “based on” the comparison. There are no limitations found in the claims limiting the human (patient) population, defining “early stage” from any other renal impairment, or other, condition wherein a patient has an elevated apoA-IV level, or even setting forth that the diagnosis is for the condition in the human providing the sample."

The Board reversed finding when read in light of the specification the terms were clear. In part, the Board stated: "We disagree with the Examiner’s finding that “it is not clear in which humans or human, or in what manner, one is to diagnose the condition with the measurement comparison”"…"That manner of diagnosis in either of claim 19 or claim 50 would be any manner that would measure the amount of apoA-IV in a plasma or serum sample of a human."

The Examiner also rejected a kit claim as being indefinite because it included a calibration curve. The Examiner found that “[c]laim 49 provides no further limitation of the components of the kit. The curve, essentially printed matter, merely relates to the intended use for the components of the kit” The Board reversed holding: A person of ordinary skill in this art understands what is meant by the term “calibration curve.” Further, we know of no prohibition against the inclusion of language relating to the intended use of article of manufacture (e.g., a kit). Accordingly, the term is not indefinite even if it represents printed matter and relates to the intended use of the kit’s components.

The Examiner also rejected the claims as anticipated. The Examiner found a reference that disclosed the measuring steps but did not include the diagnosing step and because there is nothing "other than a mental step setting forth an intended result, or a characterization of the results, from the active measuring and comparing steps." the claim was anticipated. The Board reversed and agreed with the Appellant finding that the reference did not disclose the diagnosing step. The Board stated, "There is no evidence on this record that [the reference] correlated apoA-IV levels to early stage renal impairment or coronary heart disease in humans who suffer from renal impairment is diagnosed. The fact that [the reference] teaches an ELISA for detecting apoA-IV is not sufficient to anticipate Appellant’s method claims."

Case can be found here

Enablement requires both how to use and how to make-BPAI

Ex parte SAMUELSON (BPAI)
Appeal 2008-5927
Application 10/958,452
Technology Center 1600
Decided: February 10, 2009

16. A method of modulating the conformation of DNA (deoxyribonucleotides) double helix which is bound to polyaniline in a complex, comprising changing the oxidation state of the polyaniline.

The claim was rejected for not being enabled. The Examiner did not reject it on how to make but rather on "how to use." The Examiner found that it would require undue experimentation to use the invention. The Board looked to the specification for the uses and agreed. Therefore, although the "use" was not in the claim it was read into the claim for purposes of determining whether the claim was enabled.

The Examiner reasoned "the specification does not provide any example or other form of enabling guidance as to how the changes in oxidation state of polyaniline-dsDNA is to be used in a method that has utility, and no declaration has been filed which would show that appellants have been able to use the invention in the manner disclosed, using the guidance provided. This lack of showing, and the teachings of Zhang et al., some 9 years post effective filing date, all point to the instant disclosure as not being enabling for the claimed invention."

The Board summarized the law as follows:
The Court has explained that “‘the how to use prong of section 112 incorporates as a matter of law the requirement of 35 U.S.C. § 101 that the specification disclose as a matter of fact a practical utility for the invention.’” In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999), quoting In re Ziegler, 992 F.2d 1197, 1200 (Fed. Cir. 1993). “Patent protection is granted in return for an enabling disclosure . . . , not for vague intimations of general ideas that may or may not be workable.”

The Board held: Balancing the Wands factors, we agree with the Examiner that undue experimentation would have been required to use the claimed invention. With a Specification that only teaches methods of making the DNA-polyaniline complex (FF 2-8), with no guidance as to how modulating the DNA-polyaniline complexes results in a practical, real world use, such as use as a biosensor (FF 9-11), the significant experimentation required for use the polyaniline-DNA complex in the claimed method, and the unpredictibilty of the prior art, we conclude that it would require an undue amount of experimentation to use the polyaniline-DNA complex in a method of modulating conformation as set forth in the claim 16.

Case can be found here

Enablement requires more than "mere plausibility'--BPAI

Ex parte JACQUES DUMAS (Bayer Corporation)
Appeal 2008-3379
Application 09/838,286
Technology Center 1600
Decided: February 10, 2009

Claim at issue:
50. A method of treating a disease mediated by p38 within a host, said method comprising administering to said host a compound of Formula I.

The Examiner rejected claims 50 and 52-56 under 35 U.S.C. § 112, first paragraph as enabled for treating rheumatoid arthritis, osteoarthritis and septic arthritis with the compound of formula I but not reasonably enabled for “a method of treating a disease mediated by p38 within a host” with the compound of formula I.

Appellants contend “[n]o evidence has been presented which even suggests that any compounds of this invention, as inhibitors of p38, would not be effective in treating the diseases defined by the functional language. Furthermore, no evidence has been presented of the ‘undue experimentation,’ allegedly necessary to practice the invention commensurate in scope with the claims” (App. Br. 3). Appellants contend that “one of ordinary skill in the art, by performing the same or similar tests, can, by routine experimentation, determine the activity levels of each of the claimed compounds in treating various p38 mediated diseases”

The Board found that "The art cited by the Examiner provides extensive evidence of the unpredictability of p38 inhibitors in treating diseases, including diseases expressly listed in the Specification" and affirmed the holding that the claims were not enabled for the entire scope. The Board affirmed the Examiner stating: "The Specification only teaches methods of making the compounds of formula I with no teaching or examples of specific diseases on which the compounds are predicted to function (FF 1-4)." The found that there was significant unpredictability in the art.

“If mere plausibility were the test for enablement under section 112, applicants would obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the ‘inventor’ would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis.” Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318. The Appellants argued that they did not have to enable every species but the Board stated "while a claim may encompass some inoperable subject matter, it must encompass some operable matter."--Almost seeming to indicate that any method isn't enabled but they did defer to the Examiner on the 3 conditions that are mentioned above.

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

"The conclusion that something can be done is not a reason that would have prompted a person of ordinary skill to combine prior art elements."

Ex parte SUN-WING TONG and YI-WEI TANG (BPAI)

Appeal 2008-5634

Application 10/923,444

Decided: February 6, 2009

Case can be found here

In Ex Parte Tong, the Board held that the Examiner had erred in finding specific claims obvious because there must be "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."  (citing KSR).  The claims were as follows:

1. A method of collecting and testing nasopharyngeal

specimens comprising the steps of: 1) positioning the patient

with his or her face pointing upwards, 2) dropping at least a

single drop of a sterile solution into each eye at a time and

then holding head erect and blinking several times, 3)

repeating step 2 until about 2-5mL of solution has been used

up, 4) having the patient spit out the collected fluid in the

back of the throat into a specimen container, and 5) testing

the collected fluid for a disease or disorder selected from the

group consisting of viral upper respiratory infections,

malignancies of the nasal, nasopharyngeal, and

oropharyngeal regions, gene alteration, certain chemicals,

biological abnormalities, and combinations thereof.

5. The method of claim 1, wherein the viral upper

respiratory infection is SARS coronavirus infection,

influenza A virus infection, influenza B virus infection,

parainfluenza virus infection, coronavirus upper respiratory

infection, adenovirus upper respiratory infection, rhinovirus

upper respiratory infection, respiratory syncytial virus

infection, metapneumovirus infection, or other emerging

viral infections.

6. The method of claim 1, wherein the malignancy of the

nasopharyngeal region is nasopharyngeal cancer.

The Board affirmed that claim 1 was obvious because of the use of the term "certain chemicals." The prior art had taught that if you drop chemicals in the eyes they can be collected in the back of the throat.  The Board, however, held that claims 5 and 6 were not obvious because the prior art did not suggest to use the collection for a disease or disorder.  The Board found that the prior art "provides no reason to instill a sterile solution into patients' eyes in order to test for diseases or disorders such as those found in claims 5 and 6."  In KSR, the court noted that an invention "composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art." KSR, 127 S. Ct. at 1741. There must be "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." Id.

"The Examiner does not provide a reason to test samples derived from liquid instilled into the lacrimal duct. Rather, the Examiner concludes that "[t]hese specimens can be tested for the presence of virus or cancerous cells"The conclusion that something can be done is not a reason that would have prompted a person of ordinary skill to combine prior art elements."

Ex parte MATHAI MAMMEN and DAVID OARE

Ex parte MATHAI MAMMEN and DAVID OARE
Appeal 2008-5874 (BPAI)
Application 10/426,364
Decided: February 4, 2009

Claim at issue was a composition claim. The Office alleged that the claim was not entitled to priority to the priority documents. The BPAI agreed holding that the priority documents did not contain enough "blaze marks" that would have identified the sub-genus based upon the genus that was disclosed in the priority document. "In order to obtain benefit of priority for Appellants’ claim . . ., the skilled artisan would have been required to make a large number of specific selections." They explained "the Specification does not provide the clear blaze marks which would have lead to the genus which is now claimed."

The explained "The skilled artisan would have had to select formula (a) from among the nine formulas disclosed as muscarinic receptor antagonists (FF 1-2). Following that selection, the skilled artisan would have had to select NH for
the B” group (FF 3) from among at least six different possibilities (FF 4-5) where –O- and not NH, is indicated as preferred (FF 6). Among the 662 compounds expressly made in U.S. Application 09/456,170, none of them
selected NH for the B” group (FF 7). The skilled artisan would also have had to select a particular group of
six compounds for the B group (FF 8) with the N in the B group linking to the X group (see claim 52). However, U.S. Application 09/456,170 does not require that the N in the B group function as a linker, though it does teach
that linkage (FF 9-12). Additionally, U.S. Application 09/456,170 teaches a significantly larger genus as possible preferred B groups (FF 12). The skilled artisan would also have been required to select a K” group
as a bond, which is indicated as preferred (FF 13-14) and select the R2 group as formula (iii) from four possible choices (FF 15-16)."

This was too much in view of the Examiner and the BPAI

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.

Ex parte ALLEN

Ex parte THERESA M. ALLEN, PAUL USTER, FRANCIS J. MARTIN, and SAMUEL ZALIPSKY
Appeal 2008-5030
Application 11/049,848
Technology Center 1600
Decided: February 4, 2009

The claim at issue was the following:
A targeting conjugate consisting essentially of (i) a lipid having a polar head group and a hydrophobic tail, (ii) a hydrophilic polymer having a proximal end and a distal end, said polymer attached at its proximal end to the head group of the lipid, and (iii) a targeting ligand attached to the distal end of the polymer, said targeting conjugate in dried form.

The Examiner argued that the claim was anticipated by the prior art because it involved a drying step; The appellant argued that the prior art included byproducts that were present in the dried form and the presence of the term "consisting essentially of" put the prior art outside the scope of the pending claim. The Board affirmed the Examiner.

The Board explained:
“By using the term ‘consisting essentially of,’ the drafter signals that the invention necessarily includes the listed ingredients and is open to unlisted ingredients that do not materially affect the basic and novel properties of the invention.” PPG Indus. Inc. v. Guardian Indus. Corp, 156 F.3d 1351, 1354 (Fed. Cir. 1998)."

The term "consisting essentially of" applied to the conjugate and not any other by-products present in the composition.
They stated: "Appellants have not shown that any by-products that would be present with the conjugate in the lipid pellet would materially affect the basic and novel properties of the conjugate." "Thus, the phrase “consisting essentially of” does not exclude unlisted elements from being in the same reaction product as the conjugate. Instead, it excludes from the conjugate itself unlisted elements that materially affect its basic and novel properties."

Thus, without them showing anything to show that the by-products would affect the conjugate the claim is anticipated. Case can be found here

Ex parte GERHARD JAEHNE

Ex parte GERHARD JAEHNE 

Appeal 2008-4548 

Application 10/463,789 

Technology Center 1600 

BPAI

__________ 

Decided:1 February 2, 2009 

This case had claims to a pharmaceutical composition and a method of using.  The Examiner rejected the claims for lack of written description and not being enabled.  The BPAI reversed the enablement rejection because the Examiner only found that the claim was broad but did not find that any of the other Wands factors tended toward a showing of lack of enablement.  The written description was satisfied because although there was no ipsis verbis support one of skill in the art would have recognized possession because the term that was being used was inherently needed for the composition to even exist.  "The Specification "provides adequate direction which reasonably leads persons skilled in the art to the later claimed compound."

Case can be found here: