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New Reasoning by Board Is Not “New Ground of Rejection” Reopening Reexamination – Past “Informative” PTAB Decisions

November 16, 2020by Jacob Doughty

Ex parte Sami Chems. & Extracts, Ltd., is a 2009 decision of the Board of Patent Appeals and Interferences (BPAI) that is listed among the Patent Trial and Appeal Board’s (PTAB) informative decisions. Ex parte Sami Chems. & Extracts, Ltd., is indicated by the PTAB to be informative as to “[n]ew grounds of rejection… claim construction.”

According to the PTAB’s Standard Operating Procedure, “[i]nformative decisions set forth Board norms that should be followed in most cases, absent justification, although an informative decision is not binding authority on the Board.”

In Ex parte Sami Chems. & Extracts, Ltd., the BPAI considered a request for rehearing on the issue of whether patentee was entitled to remand to the examiner – and thus a further opportunity to engage in prosecution in a reexamination proceeding – because the BPAI relied on a different claim construction than the examiner in upholding the examiner’s anticipation and obviousness rejections.

Independent claim 1 is an exemplary claim at issue:

A method of promoting lean body mass in a human individual in need thereof, comprising administering to the individual a lean body mass promoting effective amount of forskohlin.

In its decision affirming the examiner, the BPAI construed “promoting” as meaning “to help bring into being,” and concluded that the language “[a] method of promoting lean body mass,” was unambiguous.  Patentee argued that during prosecution, patentee and examiner had a common understanding that the term “promoting” meant “increasing,” under which construction, the rejected claims were patentable. Patentee argued that, in view of this difference in construction, it was entitled to “remand of the case to the Examiner, so that Appellants may amend the claims and otherwise respond to the outstanding rejections in a manner consistent with the new claim construction adopted by the Board.”

As explained by the BPAI, the criterion of whether a rejection is considered “new” in a decision on appeal is whether the appellant has had a fair opportunity to react to the thrust of the rejection. The BPAI acknowledged that it did not use the “same words” as the examiner in construing the claims, but noted that the BPAI and the examiner had considered the same prior art and evidence provided by patentee, and the “basic thrust of the rejection by the Examiner and the Board was the same.”

The BPAI further noted that, although the examiner did not explicitly construe the term “promoting” in the same manner as the BPAI, it could be inferred from the examiner’s reasoning – particularly with respect to anticipation – that the examiner viewed the claim in the same manner as the BPAI. The BPAI thus concluded that patentee had a fair opportunity to react to the rejections affirmed on appeal.

Patentee appealed to the Court of Appeals for the Federal Circuit (CAFC). The BPAI’s decisions were affirmed in a Rule 36 affirmance, and a reexamination certificate cancelling all claims was issued.

Takeaway: This case demonstrates: (i) the importance of presenting all amendments and evidence and reaching agreement with the examiner at the earliest opportunity in a reexamination proceeding, and (ii) the difficulty in relying on “procedural” arguments to carry the day before the PTAB. Reexamination proceedings are procedurally limited compared to ex parte prosecution. After an adverse decision from the PTAB in regular prosecution, applicant will have further opportunities to amend or present evidence (e.g., by filing a Request for Continued Examination or continuation application). Not so in a reexamination proceeding – only appeal to the CAFC will prevent issuance of an adverse reexamination certificate. While patentee’s attempt to reopen prosecution by asserting a new ground of rejection was understandable, something more than differences in the degree or manner of explanation between the examiner and the BPAI would have been necessary to prevail.

Judges: Spiegel, Delmendo, Grimes

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Disclosure of cDNA Anticipates Isolated Polypeptide – Past “Informative” PTAB Decisions

October 27, 2020by Jacob Doughty

Ex parte Chuang is a 2008 decision of the Board of Patent Appeals and Interferences (BPAI) that is listed among the Patent Trial and Appeal Board’s (PTAB) informative decisions. Ex parte Chuang is indicated by the PTAB to be informative as to “Anticipation – 35 U.S.C. § 102… cDNA.”

According to the PTAB’s Standard Operating Procedure, “[i]nformative decisions set forth Board norms that should be followed in most cases, absent justification, although an informative decision is not binding authority on the Board.”

In Ex parte Chuang, the BPAI considered whether a claim reciting an isolated polypeptide was properly rejected as anticipated by prior art disclosing a cDNA encoding the recited polypeptide.

Independent claim 4 was at issue:

An isolated polypeptide, comprising the amino acid sequence of SEQ ID NO: 1.

In rejecting the claim, the examiner relied on prior art that disclosed isolation of a polynucleotide that encoded a polypeptide having 100% homology to SEQ ID NO: 1. While applicant conceded that, in the prior art, “[o]ne of the myriad cDNAs encodes an amino acid sequence identical to SEQ ID NO: 1,” it was undisputed that the claimed proteins were not physically created in the prior art. Relying on a prior BPAI decision (Lee v. Dryja, 79 U.S.P.Q.2d 1614 (B.P.A.I. 2005)), applicant asserted that disclosure of the cDNA at best rendered its encoded protein obvious – “the fact that a novel product can be readily made does not render the product not novel.”

The BPAI disagreed, stating that an invention need not have been actually made in the prior art for disclosure of such invention to be enabling. The BPAI noted that applicant did not dispute that the prior art was enabling for expression of the claimed polypeptide, and further distinguished over its prior decision in Lee v. Dryja. The BPAI pointed out that, in Lee v. Dryja, the issue was whether a party was in possession of a single enabled embodiment and, further, there was evidence in Lee v. Dryja that the disclosed nucleotide sequence did not, in fact, express the protein at issue.

The BPAI affirmed the examiner’s anticipation rejections and noted that there is no “generic rule that cDNAs cannot anticipate proteins.”

Takeaway: This case provides insight into how the USPTO has viewed the relationship between nucleotide sequences and the polypeptides they encode in the context of identifying enabling prior art. It is apparent that the BPAI would have required some evidence of obstacles preventing a skilled artisan from navigating from the disclosed cDNA to the claimed isolated polypeptide to reverse the examiner’s rejections. Of course, this case predates the Supreme Court’s recent eligibility jurisprudence, including Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), which likely would have even further complicated applicant’s quest for enforceable patent rights.

Judges: Grimes, Lebovitz, Fredman

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Written Description for Generic Sequence Claims – Past “Informative” PTAB Decisions

October 5, 2020by Jacob Doughty

Ex parte Porro is a 2008 decision of the Board of Patent Appeals and Interferences (BPAI) that is listed among the Patent Trial and Appeal Board’s (PTAB) informative decisions. Ex parte Porro is indicated by the PTAB to be informative as to “Specification and claim requirements – 35 U.S.C. § 112… Written description… species-genus.”

According to the PTAB’s Standard Operating Procedure, “[i]nformative decisions set forth Board norms that should be followed in most cases, absent justification, although an informative decision is not binding authority on the Board.”

In Ex parte Porro, the BPAI considered whether a claim defining a recombinant yeast as having a coding region encoding an enzyme having “at least about 90% identity with SEQ ID NO: 11” was properly rejected for failing to comply with the written description requirement of 35 USC 112.

Independent claim 13 was at issue:

A method of generating ascorbic acid, comprising:

a) obtaining a recombinant yeast capable of converting an ascorbic acid precursor into ascorbic acid, wherein the yeast is functionally transformed with a coding region encoding L-galactose dehydrogenase (LGDH) enzyme having at least about 90% identity with SEQ ID NO: 11,

b) culturing the recombinant yeast in a medium comprising an ascorbic acid precursor, thereby forming ascorbic acid, and

c) isolating the ascorbic acid.

In rejecting the claim, the examiner asserted that the claim encompassed a set of coding regions/amino acids (90% identity with SEQ ID NO: 11) defined by the function of the encoded protein (LGDH). Applicant acknowledged that “90% identity with SEQ ID NO: 11” included approximately 3.4 x 1041 variants. The examiner found that the specification disclosed only a single LGDH sequence, derived from Arabidopsis thaliana. The examiner further noted a teaching in the prior art that an LGDH discovered in A. thaliana was, “as far as we know, the only plant dehydrogenase acting on a non-phosphorylated sugar.” The examiner concluded that, in view of the size of the genus and the lack of guidance in the specification and the prior art, a skilled artisan “would not have been able to envision a sufficient number of specific embodiments that meet the functional limitations of the claims.”

The BPAI agreed with the examiner. The BPAI noted particularly that the specification did not provide guidance regarding what structural features were responsible for the enzymatic activity of LGDH or describe what amino acid changes could be made in the wild-type sequence without affecting the enzymatic activity of the protein. The BPAI conceded that a skilled artisan could make libraries of SEQ ID NO: 11 variants and screen them to identify specific proteins that are at least 90% identical to SEQ ID NO: 11 and that have LGDH enzymatic activity – however, this was not sufficient to demonstrate possession of the claimed invention.

The BPAI indicated that the applicant could have described a representative number of functional variants, or it could have described structural features that are common to functional variants that distinguish them from the rest of the genus. But neither was done in this case. The BPAI noted that different inventions can be described in different ways, but a chemical genus must be described in some way that demonstrates to those of skill in the art that the applicant was in possession of the claimed genus at the time the application was filed.

The result in Ex parte Porro is reflected in Example 11 of the USPTO’s Written Description Training Materials. It should be noted, however, that the USPTO has indicated in its Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials that such materials are being revised at the time of this post.

Takeaway: When claiming a genus of structures defined by a nucleic acid or amino acid sequence, it is not necessary to describe any particular number of specific sequences. However, it must be apparent (e.g., to the examiner) that the inventor(s) grasped the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. This can be achieved through disclosure of sufficient number of species that are representative of the full scope of the genus or disclosure/demonstration of a structure-function correlation common to members of the genus. Of course, this is easier to do when drafting an application than when responding to a rejection.

Judges: Scheiner, Mills, Grimes

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Enablement and Definiteness of Broad, Generic Chemical Formulae – Past “Informative” PTAB Decisions

September 14, 2020by Jacob Doughty

Ex parte Hicks is a 2007 decision of the Board of Patent Appeals and Interferences (BPAI) that is listed among the Patent Trial and Appeal Board’s (PTAB) informative decisions. Ex parte Hicks is indicated by the PTAB to be informative as to “Specification and claim requirements – 35 U.S.C. § 112… Enablement… Indefiniteness… scope.”

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Revisiting “Informative” Board Decisions: Indefiniteness and Parameter Patents

July 13, 2020by Jacob Doughty

Ex parte Bobrowski is a 2008 decision of the Board of Patent Appeals and Interferences (BPAI) that is listed among the Patent Trial and Appeal Board’s (PTAB) informative decisions. Ex parte Bobrowski is indicated by the PTAB to be informative as to “35 U.S.C. § 112 – indefiniteness – In re Steele.”

The BPAI considered whether claims reciting particular parameters were indefinite and, thus, unpatentable under pre-AIA 35 USC § 112, second paragraph (which, like AIA 35 USC § 112(b), requires one or more claims “particularly pointing out and distinctly claiming the subject matter [regarded as the] invention”).

While the decision focused entirely on indefiniteness, the appeal was, in fact, an appeal of prior art rejections. However, the BPAI found the claims to be insufficiently clear and definite – even after consulting the specification – to allow comparison with the prior art. In framing its analysis, the BPAI cited In re Steele, 305 F.2d 859 (CCPA 1962), for the proposition that it is erroneous to analyze claims based on “speculation as to the meaning of the terms employed and assumptions” as to their scope (In re Steele is also cited for this proposition in MPEP 2143.03 and 2173.06).

A representative claim, as separated into its constituent parts by the BPAI, recited:

An extract of plant material from family Euphorbaciae and species Croton

(1) that reduces at least one opioid-induced complication selected from the group consisting of[:] nausea, emesis, retching and itch,

(2) the extract at a concentration of 1mg/mL of 50% (v/v) ethanol/water having reduced UV absorbency of about at least 4.3 between the range of 390 nm and 430 nm relative to the absorbency within the same range for unextracted plant material.

The BPAI first construed the terms “extract” and “plant material” in the preamble of the claim. Consulting the specification, the BPAI found that it was clear that the application dealt with a solvent extraction process, so the term “extract” was construed to mean a solvent extracted portion of plant material from Croton. The BPAI construed “plant material” to mean any part of a plant. The BPAI then addressed “ambiguities” in feature (2).

During examination, the examiner found that feature (2) should be given no patentable weight, because it did not make clear the amount of Croton relative to the claimed composition. The BPAI disagreed, noting that feature (2) – though ambiguous – was intended to characterize UV absorbency (a parameter), which could properly define the recited extract.

The BPAI looked to the specification in its consideration of how a skilled artisan would interpret and apply feature (2). The specification described an extraction process in which latex or sap from Croton was mixed with an organic solvent in a 1:1 proportion and, separately, the specification described a relative absorbency of a “concentration of 1 mg of extracted latex to 1 mL of water.”  The specification further described the comparative UV absorbency of proanthocyanidin between the “parent latex” and the extract, noting that “the reduced proanthocyanidin content is quantifiable spectrophotometrically.”

The BPAI noted that, even with the benefit of such description, the claim did not tell a skilled artisan what the baseline should be for comparison of the extract’s UV absorbency. While the specification discussed comparison with a “latex,” the claim referred without antecedent basis to “unextracted plant material,” which could be any plant material. The BPAI noted that applicant presumably intended something broader than “latex,” when it selected the term “unextracted plant material” for its claim and, thus, refused to import a limitation from the specification. In the absence of specificity as to the baseline for comparison, the BPAI concluded that it was not possible to compare the claimed invention with the prior art.

While the ambiguity as to baseline was fatal, the BPAI also noted that, even if the baseline was limited to a “latex,” neither the claim nor the specification described the amount, concentration, or method of preparation of the “unextracted plant material.”

Further, the BPAI stated that the “reduced UV absorbency of about at least 4.3… relative to the absorbency… for unextracted plant material,” was unclear because no units for “4.3” were provided. The BPAI noted that, while the specification described a 4.3 “fold” reduction in absorbance, absorbency was also described in in terms of “absorbance units” or “AU” in the art.

Thus, the BPAI concluded that the claim was so unclear that it could not be interpreted to resolve issues raised on appeal with respect to the examiner’s prior art rejections.

 Takeaway: Claims reciting new or unconventional parameters can be useful tools for protecting new discoveries and improvements in existing technologies. Also, it can be difficult for competitors to quickly confirm freedom-to-operate/practice when confronted with claims reciting new or unconventional parameters. However, clarity in defining how new or unconventional parameters are measured is essential – both in the specification and the claims themselves. Extra, pre-filing review of parameter claim language is recommended, particularly when a US application is a translation of a prior application in a language other than English.

Judges: Torczon, Lane, Moore

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