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 .
DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Q311M, L309Y, IgG, an antibody including the Fc variant, and a monoclonal antibody in the reply filed on 07/15/2025 is acknowledged. The traversal is on the ground(s) that claims 5, 10, 15, and 16 are all dependent on claim 1, which recites the specific Fc variant and this Fc variant is the common special technical feature shared by all of these claims. This is not found persuasive because the restriction requirement is not separating the invention into distinct groups of invention. Rather, it is requiring the selection of particular species from the list claimed by the Applicant. This helps narrow the invention to a preferred embodiment for the sake of examination, which will be interpreted in light of the claims it depends on.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-16 are withdrawn from consideration pursuant to 37 CFR1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 07/15/2025.
Upon further consideration, the Examiner is withdrawing the election requirement for the amino acid substitutions at positions 309 and 311. All species of amino acid substitutions at those positions will now be under examination.
Claims 1, 5-14, 17-18 are now under consideration in the instant Office Action.
Withdrawn Claim Objections
Claim Objections
Objections of claims 6 and 7 due to minor informalities are hereby withdrawn in view of amendments to the claims that corrected them.
Withdrawn Rejections
Rejections of claims 1-14 and 17-18 under 35 U.S.C. 103 as being unpatentable over Igawa et al. (US 2013/131319 A1, in instant PTO-892), in view of KR101573883 B1, hereinafter ‘883 (in IDS filed 07/29/2022) are hereby withdrawn in view of amendments to the claims to include sequences not found in the prior art.
Rejections of claims 1-14, and 17-18 as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 9, 10, 11-14, and 16-18 of copending Application No. 18/702,227, hereinafter ‘227, in view of Igawa et al. (see above) are hereby withdrawn in view of amendments to the claim to include sequences not found in the copending application.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5-14, and 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 5-14, and 17-18 use the transitional term “having the amino acid sequence of”. This term is problematic because the recitation of these terms in instant claims 1, 5-14, and 17-18 does not satisfy the written description requirement as it is unclear what is encompassed by “having” the amino acid sequences. Applicant has not conveyed that they are in possession of all the antibodies that are included in the broad term “having the sequence of”. It is not immediately clear whether open or closed claim language is intended, Crystal Semiconductor Corp. v. Trilech Microelectronics Int’l Inc., 246 F.3d 1336, 1348, 57 USPQ2d 1953, 1959 (Fed. Cir. 2001) (term “having” in transitional phrase "does not create a presumption that the body of the claim is open"); Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1573, 43 USPQ2d 1398, 1410 (Fed. Cir. 1997) (in the context of a cDNA having a sequence coding for human PI, the term “having” still permitted inclusion of other moieties), see MPEP 2111.03. Applicant is encouraged to use transitional phrases “comprising of” or “consisting of” to define the scope of a claim with respect to what unrecited additional components, if any, are excluded from the scope of the claims.
Modified Rejections Necessitated by Amendment
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 10-11 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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.
See MPEP §2163(I)(A) which states: "The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
Instant claims 10-11 and 18 are drawn to an antibody including an Fc variant with a functional requirement of having an increased in vivo half-life when compared to a wild-type. There is no specific structural requirement for the antibody including an Fc variant beyond the required function. Further, instant claims 10-11 and 18 read on any generic antibody with no specificity to a particular antigen and the recited antibody lacks structural details such as sequences for the heavy and light chain CDR sequences or heavy and light chain variable region sequences. The required function of the antibody can be achieved in any form, no specific structure is required, as long as they comprise the Fc variant of claim 1. The scope of the claim is so broad and reads on so many possible genera that it is clear that the specification fails to describe all of the possible means of achieving the response of an increased in vivo half-life when compared to a wild-type linked to its function. The claims do not require that the antibody including the Fc variant possess any particular conserved structure or other disclosed distinguishing features. Therefore, the genera are merely defined by function and the instant specification fails to describe the full genera of the possible methods that are encompassed by these claims.
There are a few specific examples of antibodies in the instant specification on page 5 describing the use of the antibody “trastuzumab” with an Fc variant, but there is no support provided that the Applicant has envisioned all of the possible variants encompassed by these functional requirements of the instant claims. Further, the instant claims does not require that the claimed antibody possess any particular conserved structure or other disclosed distinguishing feature. The scope of the term “Fc variant” and “antibody including an Fc variant” is so broad and reads on so many possible genera and the instant specification fails to describe any of the possible antibodies that are encompassed by this term. The “antibody including an Fc variant” encompasses any antibody that has the required function but the instant specification fails to teach all the possible antibodies encompassed by the “antibody” in the instant claim. The claims do not require that the “Fc variant” or “antibody” possess any particular conserved structure or other disclosed distinguishing feature. Therefore, the genus is merely defined by function and the instant specification fails to describe the full genus of antibodies that are encompassed by this claim.
To provide adequate written description and evidence of possession of claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of prospective activity or function. There is not even identification of any particular portion of the structure that must be conserved for said activity except its function. The specification does not provide a complete structure of all possible forms of the claims agents and variants and fails to provide a representative number of species for any genera. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genera of antibodies with Fc variants.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that they invented what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed structure of the encompassed agents, fragments and variants, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
Applicant argues “appropriate corrections have been made to the claims” and that the rejection be withdrawn. This is not persuasive.
While the Examiner acknowledges that some of the amendments to the claims resolve written description issue raised in the previous Office Action, there are still remaining written description issues in certain claims as described above. As such, the Examiner has excluded the claims that no longer fail to satisfy the written description requirement. The instant Office Action instead hones in on outstanding written description issues, which remain in the instant claims.
Therefore, the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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