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 Group I, claims 1, 2, 4-6, 8, 11, 13-15, and 19 and species: antibody or antigen-binding fragment thereof, therapeutic moiety, monomethyl auristatin E (MMAE), and gastric cancer in the reply filed on 08/28/2025 is acknowledged. The traversal is on the ground(s) that the reference used to break unity of invention does not anticipate the antibody of the instant claims. This is not found persuasive because the instant claims refer to a table to reference sequences and do not claim the sequences within the instant claims. The instant claims are required to be self-containing. As such, the broadest reasonable interpretation of the claims without reading into the specification for the contents of Table 1 do not require any specific sequence other than an antibody that binds to ALPPL2 and/or ALPP, thus making the reference used in breaking unity appropriate based on the instant claims.
Claims 22-23 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 08/28/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-2, 6, 8, 13-15, 19, and new claims 37-38 are under consideration in the instant Office Action.
Claims 4-5 and 11 are cancelled.
Claims 22-23 remain withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims
Withdrawn Objections
Objections to claims 1-2, 5, 8, 13-15, and 19 due to minor informalities are hereby withdrawn in view of amendments to the claims.
Withdrawn Rejections
Rejections of claims 1-2, 5, 8, 11, 13-15, 19 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paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter are hereby withdrawn in view of amendments to the claims.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.
Claim 13 is 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.”
Claim 13 calls for a chimeric molecule comprising an antigen-binding molecule and a “heterologous moiety”. The recited “heterologous moiety” encompasses a broad, vast category of moieties that Applicant does not provide sufficient written description for. There is no specific structural requirements for the heterologous moiety beyond the required function. Claim 14 calls for a slightly narrower list of heterologous moieties, wherein the heterologous moiety is a detectable moiety, a half-life extending moiety, or a therapeutic moiety. According to instant claim 13, the required identity of the heterologous moiety can be achieved in any form, no specific structure is required, as long as they are different than the chimeric molecule it is attached to. 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 linked to its function. Instant claim 13 does not require any specific heterologous moiety or that they possess any particular conserved structure or other disclosed distinguishing features. Therefore, the genera are merely defined by generic identity and the instant specification fails to describe the full genera of the possible products that are encompassed by these claims.
There are a few specific examples of heterologous moiety in the instant specification, but there is no support provided that the Applicants have envisioned all of the possible variants encompasses by the generic requirements of the instant claims. Further, the instant claims 13-14 do not require that the claimed heterologous moiety possess any particular conserved structure or other disclosed distinguishing feature. The scope of the terms of the “heterologous moiety” is so broad and reads on so many possible genera and the instant specification fails to describe any and/or all of the possible heterologous moiety types that are encompassed by this term. The term “heterologous moiety” encompasses any moiety that has the required characteristic of differing from the chimeric molecules of the instant claims, but the instant specification fails to teach all the possible structures encompassed by the possible moieties in the instant claims. The claims do not require that the “heterologous moiety” possess any particular conserved structure or other disclosed distinguishing feature. The term “heterologous moiety” encompasses many species across many genera including FcRn binding moieties, (XTEN polypeptides, albumin, albumin binding polypeptide or fatty acid, the C-terminal peptide (CTP) of the 13 subunit of human chorionic gonadotropin, PAS; HAP; transferrin; polyethylene glycol (PEG); hydroxyethyl starch (HES), polysialic acids (PSAs), etc., see page 37 of the instant specification, as long as they achieve the required function. Thus the claims are drawn to multiple genera of molecules that are defined only by their function as a heterologous moiety. Therefore, the genus is merely defined by function and the instant specification fails to describe the full genus of molecules 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 claimed heterologous moiety 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 “heterologous moieties”.
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 heterologous moieties, 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).
Therefore, claim 13 is rejected as failing to satisfy the written description requirement.
Response to Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
Applicant argues that the instant claims 1-2, 5-6, 8, 11, 13-15, and 19 have been amended to recite antigen-binding molecules fully defined in the specification and this obviates the instant rejection. This is not found persuasive.
While Applicant has amended the claims sufficiently to describe the antigen-binding molecules, the written description issues regarding the heterologous moiety still remain as the terminology encompasses a broad category of undefined species that Applicant has not provided the necessary disclosure for. See modified rejection above, which focuses on the lack of proper written description in the disclosure for the broad category of heterologous moieties that are claimed.
Thus, the rejection is maintained.
Allowable Subject Matter
Claims 1-2, 6, 8, 19, and new claims 37-38 are considered allowable.
Claims 14-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675