DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 Dec. 2025 has been entered.
Claims 1-4, 6, 10, 11 and 13-18 are currently pending.
Claims 1-4, 6, 10, 11 and 13 are withdrawn as being drawn to a nonelected invention.
Claims 14-18 are considered here.
Any objection/rejection not reiterated herein has been withdrawn.
Response to Arguments
Applicant's arguments filed 22 Dec. 2025 have been fully considered but they are not persuasive.
Applicant argues that the written description rejection improperly requires additional examples to support the disclosure. This is not persuasive because the rejection as written below does not state that examples are required, but rather only that Applicant must show possession of the genus by providing sufficient distinguishing identifying characteristics such that one of ordinary skill in the art could identify species within the genus. The instant specification discloses only a single sequence and does not provide any additional disclosure that would allow one of ordinary skill to identify other polypeptides falling within the genus. As such, the specification does not evidence possession of the full scope of the claimed genus.
Applicant further argues that the recitation of a base sequence (SEQ ID 1) and a function (production of Gly-Glu-Arg) is sufficient to satisfy written description. This is not persuasive because the specification does not provide any teachings, guidance or other disclosure that would allow one of ordinary skill to identify additional species within the genus – e.g., a structure-function correlation that describes which residues/portions of the SEQ ID 1 are responsible for the substrate specificity characteristics corresponding to the claimed Gly-Glu-Arg producing ability. In the case of a chemical invention such as a polypeptide, written description requires a precise definition, such as by structure, formula, chemical name, or physical properties (MPEP 2163).
Applicant further argues that disclosure in the specification regarding various percentage identities to SEQ ID 1 and the number of residues that can be substituted or deleted are sufficient to support the claims. This is not persuasive because the above-cited disclosures are merely generic statements regarding the scope of the claims that do not provide any information that would allow one of ordinary skill to identify additional species within the genus.
Applicant further argues that the claimed enzyme “is characterized in that it provides a high yield of Gly-Glu-Arg that is a functional peptide”, and that descriptions at [0088] and [0099]-[0116] of the specification “collectively define the characteristic substrate specificity and application profile that the ‘present enzyme’ (SEQ ID NO: 1 + >90% identity variants) must exhibit” “including optimal temperature, temperature stability, optimal pH & pH stability, and low-temperature reactivity.” (Response, p. 5, last ¶ to p. 6, 1st ¶). This is not persuasive because the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The instant claims require only 90% identity to SEQ ID 1 and the ability to produce Gly-Glu-Arg.
Applicant further argues that Tian et al. evidences that enzymes are classified the same when they share 90% or more sequence identity and exhibit similar behavior. This is not persuasive because enzyme classification is not at issue (i.e. whether the 90% limitation distinguishes collagenases vs. other types of enzymes).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 14-18 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
New claim 14 recites a method of producing a collagen tripeptide comprising Gly-Glu-Arg by allowing a collagenase having 90% or more sequence identity to SEQ ID 1 to act on collagen or gelatin. The claims thus encompass a genus of collagenase enzymes having the claimed function of producing Gly-Glu-Arg. Since SEQ ID 1 is 987 amino acids in length, the 90% or more sequence identity limitation defines a large genus of polypeptides (allowing for nearly 100 mismatches at any point along the sequence). To show possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus, which in the case of a chemical invention requires a precise definition, such as by structure, formula, chemical name, or physical properties (MPEP 2163). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species sufficient to show the applicant was in possession of the claimed genus; A “representative number of species” means that the species which are adequately described are representative of the entire genus (MPEP 2163).
The instant specification discloses only the sequence of SEQ ID 1 (and SEQ ID 2 which comprises SEQ ID 1 and a signal peptide). The specification measures Gly-Glu-Arg production for the collagenase of SEQ ID 1 in Example 7 and Fig. 7, and shows greater production with the enzyme of SEQ ID 1 than for a comparative Streptomyces-derived collagenase. However, the specification does not provide any additional examples of such Gly-Glu-Arg producing ability for variants of SEQ ID 1 that could be considered a representative number of species supporting the claimed genus. The specification also fails to provide any structure-function relationship or other teachings/guidance that would allow one of ordinary skill to identify variants within the claimed genus (e.g., which portions of the enzyme can be modified and/or which portions are responsible for the claimed functionality). Thus, the instant specification does not evidence possession of the claimed collagenase having a collagen tripeptide producing ability for Gly-Glu-Arg for the entire scope of the claimed genus of at least 90% (claim 14) or 99% (claim 16) identity to SEQ ID 1 (see MPEP 2163 - A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed). The recitation in claim 15 that the collagenase is “derived from Lysinibacillus fusiformis” is construed herein to mean only that the collagenase originates from L. fusiformis and would encompass variants of native L. fusiformis enzymes. Moreover, the specification discloses only a single L. fusiformis-derived collagenase of SEQ ID 1, whereas Kamon and A0A1H9AG47 (previously cited) evidence the existence of multiple sequence variants of L. fusiformis-derived collagenases which are not described/supported by the specification as filed (see OTDP rejection below for sequence comparison of instant SEQ ID 1 and the collagenase of Kamon).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 14-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 18694444 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘444 App teach a collagenase derived from L. fusiformis and having an amino acid sequence greater than 99% identical to that of SEQ ID 1 (see alignment attached with Non-Final office action of 1 April 2025) which is useful for making collagen tripeptide from beef gelatin (and would be useful for tenderizing meat), and it would have been obvious to use such enzyme in a method for its intended activity. The ‘444 specification further evidences that the ‘444 collagenase has Gly-Glu-Arg producing ability, which is greater than Streptomyces-derived collagen (‘444, Figs. 7-8).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
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/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657