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 .
Election/Restrictions
Applicant's election with traverse of Group 2 (claims 1-2, 28, 30, and 34) in the reply filed on 1/09/2026 is acknowledged. The traversal is on the ground(s) that all claims recite the same sequences for enzymes involved in synthesis.
The traversal has been considered but is found unpersuasive because the instant application is a national stage application under 35 U.S.C. 371. As set forth in the last office action, Groups 1-3 vs. Group 4 lack unity of invention as they do not share the same technical feature. Although Groups 1-3 form a combination of categories, they do not have unity of invention a priori since the shared technical feature is not a special technical feature in view of Kovalic US 2004/0216190 A1). The restriction requirement is therefore maintained as proper and hereby made FINAL.
Claims 7-12, 20, 22, 26, 29, 31, 35-36, and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
The instant application is a national stage entry of PCT/EP2021/087323 (filed on 12/22/2021), which claims foreign priority under 35 U.S.C. 119(a)-(d) based on applications GB2116554.3 and GB2020623.1 (filed on 11/17/2021 and 12/24/2020, respectively, in the United Kingdom of Great Britain). Certified copies of the foreign priority documents are on file.
Claim Objections
Claims 1-2 are objected to because of the following informalities: the term “UDP-4-keto, 6-deoxy-D-glucose” in step (i)(b) of claim 1 and step (iv)(b) of claim 2 should be amended to “UDP-4-keto-6-deoxy-D-glucose”. Appropriate correction is required.
Claim 2 is also objected since there should be no space after the beta symbol in “UDP-β -L-rhamnose” in step (v).
Claim 28 lists sequence identifiers, some of which are preceded by “SEQ ID No.” or “SEQ ID No” in line 4. To maintain consistency with the rest of the claims, they should be reformatted to “SEQ ID NO”.
Claim Interpretation
The claimed invention is drawn to a method of making QA-FRX(X/A) or QA-Mono-FRX(X/A), QA-Di-FRX(X/A), and/or QA-Tri(X/R)-FRX(X/A), wherein FRX(X/A) is added at the C-28 position of quillaic acid (QA) using either the recited enzyme or “an enzyme with a sequence with at least 70% identity”. The latter phrase is interpreted to mean “an enzyme sharing at least 70% identity” with the enzyme recited in the same step.
Claim Rejections - 35 USC § 112
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 1-2, 28, 30, and 34 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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 at the time the application was filed, had possession of the claimed invention.
Applicant’s method uses either: (i) the specified enzymes (ex. Qs-28-O-FucT having the sequence of SEQ ID NO 2, Qs-28-O-RhaT having the sequence if SEQ ID NO 4, Qs-28-O-XylT3 having the sequence of SEQ ID NO 6); or (ii) enzymes having sequences that are at least 70% (or 45%) identical relative to the specified enzymes.
To satisfy the written description aspect of 35 U.S.C. 112(a) for a claimed genus of a chemical or biological material, it must be clear that: (1) the identifying characteristics of the claimed material have been disclosed, e.g., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed cor-relation between function and structure, or by a com-bination of such identifying characteristics; and (2) a representative number of species within the genus must be disclosed. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
In this case, the specification fails to provide sufficient identifying characteristics of “an enzyme with a sequence of at least with at least 70% sequence identity” or “an enzyme with a sequence of at least with at least 45% sequence identity” (% sequence identity is relative to the recited enzymes; see Claim Interpretation section above). There is no description for a plurality of enzymes having sequences that share at least 70% (or 45%) identity with SEQ ID NOs. 2, 4, 6, 8, 10, 12, 14, 26, 28, 30, 32, 34, 36, 38, 40, 48, 50, 52, or 54. Applicant has not identified particular structures (i.e., amino acid residues) which must be shared by all substantially equivalent enzymes and impart the functional properties. Thus, a person with ordinary skill in the art would not immediately envisage all enzymes encompassed by the claims.
Review of the specification also fails to show disclosure of a representative number of species within the claimed genus. The number of enzymes which can be considered at least 70% (or 45%) identical to the specified enzymes, which comprise 457 to 713 amino acids, is extraordinarily great. In the absence of identified and exemplified enzymes, the specification is considered to only show reduction of practice of a single species for each recited enzyme (ex. Qs-28-O-FucT per se) that falls within the scope of the claims. There is no actual reduction to practice all possible species of the various enzymes. Disclosure of a single species does not constitute a representative number for such a broad genus as is encompassed by the breadth of “an enzyme with a sequence of at least with at least 70% sequence identity” or “an enzyme with a sequence of at least with at least 45% sequence identity”. Hence, the specification does not disclose a representative number of species, as required to support the written description requirement.
Applicant’s disclosure therefore fails to provide sufficient written description to support the breadth of the claims.
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 1-2, 28, 30, and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of co-pending Application No. 18/751380.
The co-pending application is directed to a method of producing QA, a QA derivative, UDP-fucose, S-2-methylbutyryl CoA, or UDP-arabinofuranose. Although the claims at issue are not identical, they are not patentably distinct from each other because some embodiments produce QA derivatives comprising a fucose, rhamnose, xylose, and a second xylose/apiose at the C-28 position of QA using the same glycosylation enzymes. For example, the FucT used to produce a C-28 glycosylated QA derivative includes QsFucT according to SEQ ID NO: 93, which is 100% identical to applicant’s Qs-28-O-FucT having the sequence of SEQ ID NO: 2 (see results of Sequence-to-Sequence Alignments against 18/751380).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Osbourn et al. (WO 2019/122259 A1) provides methods for biosynthesis of QA in a host comprising nucleotide sequences that encode enzymes that catalyze formation of QA (Abstract). However, it does not teach methods of making QA intermediates or derivatives that are glycosylated at the C-28 position of QA.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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