DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's amendment and remarks, filed 10/10/25, are acknowledged.
Claims 1, 4, 6-8, 14, 16, and19 have been amended.
Claims 1, 4-14, 16-17, and 19 are pending and are under examination.
In view of Applicant’s claim amendments, the previous grounds of rejection are withdrawn. The following are new grounds of rejection necessitated by Applicant’s claim amendments.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1, 4-14, 16-17, and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
An antibody or fragment thereof that specifically binds to Siglec-9, wherein the antibody or fragment thereof comprises a heavy chain (HC) CDR1 sequence of SEQ ID NO: 1, a HC CDR2 sequence of SEQ ID NO:2, a HC CDR3 sequence of SEQ ID NO:3, a light chain (LC) CDR1 sequence of SEQ ID NO:4, a LC CDR2 sequence of SEQ ID NO:5, and a LC CDR3 sequence of SEQ ID NO:6;
does not reasonably provide enablement for:
An antibody or fragment thereof that specifically binds to a sialic acid-binding receptor, wherein the antibody or fragment thereof comprises a heavy chain (HC) CDR1 sequence of SEQ ID NO: 1, a HC CDR2 sequence of SEQ ID NO:2, a HC CDR3 sequence of SEQ ID NO:3, a light chain (LC) CDR1 sequence of SEQ ID NO:4, a LC CDR2 sequence of SEQ ID NO:5, and a LC CDR3 sequence of SEQ ID NO:6.
The specification disclosure is insufficient to enable one skilled in the art to practice the invention as claimed without an undue amount of experimentation. Undue experimentation must be considered in light of factors including: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill in the art, the level of predictability of the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention, in re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
“The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling (MPEP 2164.03)” The MPEP further states that physiological activity can be considered inherently unpredictable.
Claim 1, as amended is directed to an antibody or fragment thereof defined by 6 VH and VL CDRs, wherein the antibody functions to bind to any “sialic acid-binding receptor”. This encompass an antibody that binds to a genus of sialic binding receptor (i.e. Siglec-1, -2, -3, -4, -5, -6, -7, - 8, -9, -10, -11, -12, -14, -15 or -16). The state of the art is such that the 6 CDRs of an antibody are critically involved in antigen binding, (see Hall, 1992, and Rabia, 2018, of record). Thus, making a using a genus of antibodies having defined CDRs that can bind to any sialic acid binding receptor, including structurally and functionally distinct receptors such as Siglec-1, -2, -3, -4, -5, -6, -7, - 8, -10, -11, -12, -14, -15 or -16, would be highly unpredictable.
Thus, based on the breadth of the claims and the unpredictability of the art, the instant specification must provide a sufficient and enabling disclosure, commensurate in scope with the instant claims. The instant specification discloses a single antibody that binds to Siglec-9 having VH and VL of SEQ ID NO: 7 and 8 (and CDRS 1-6). No guidance is provided regarding any antibodies having said CDRs for binding to any other Siglecs, such as Siglec 1, Siglec, 2, Siglec 3, etc.
Thus, based on the unpredictability of the art, the breadth of the claims, and the lack of guidance provided by the instant specification, it would require undue experimentation to make and use antibodies as broadly claimed.
Amendment to the claim to recite that the antibody or fragment thereof specifically binds to Siglec-9, would be remedial.
Claims 1, 4-14, 16-17, and 19 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is insufficient written description to demonstrate that applicant was in possession of the claimed genus of antibodies or fragments thereof comprising CDRs of SEQ ID NO; 1-6, and that bind to “a sialic-binding receptor”.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See MPEP 2163.
The claims encompass an antibody or fragment thereof defined by the CDRs of SEQ ID NO: 1-6, that functions to bind to a genus of sialic binding receptor (i.e. Siglec-1, -2, -3, -4, -5, -6, -7, - 8, -9, -10, -11, -12, -14, -15 or -16). The state of the art is such that the 6 CDRs of an antibody are critically involved in antigen binding (see Hall, 1992, and Rabia, 2018). The specification does not disclose a correlation between structure and function of binding the genus of different siglec antigens of the present claims, nor does it disclose a representative number of species. The specification discloses a single Siglec-9 binding antibody having the CDRs of SEQ ID NO: 1-6, or VH and VL of SEQ ID NO: 7-8. This is not sufficiently representative of the broad genus of different antibodies and antibody fragments encompassed by the present claims, which can bind to any sialic acid binding receptor, including a genus of structurally and functionally distinct receptors such as Siglec-1, -2, -3, -4, -5, -6, -7, - 8, -10, -11, -12, -14, -15 or -16.
The instant application has not provided a sufficient description showing possession of the necessary functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus of antibodies and inhibitors encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. §112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe Inc, 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002).
In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear 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 [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning – i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3. Note the following Court Decisions regarding the written description of antibodies in the context of the current claims.
Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
Amendment to recite that the antibody or fragment thereof specifically binds to Siglec-9 would be remedial.
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, 4-14, 16-17, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 40-59 of copending Application No. 18/699,081 in view of WO2018027203 and US 20190002560.
The ‘081 application claims an antibody that binds to Siglec-9, comprising, for example, SEQ ID NO: 2, which comprises CDRs identical to SEQ ID NO: 1-6 of the instant application, and also comprises SEQ ID NO: 7 and 8 of the instant application. The ‘081 application claims nucleic acid molecules encoding said antibody, and pharmaceutical compositions. The ‘081 application claims a composition comprising said antibody and an adjuvant. The ‘081 application claims methods of treating cancer, infectious disease, or increasing natural killer said function in a subject comprising administering said antibody. Although not specifically claimed in the ‘081 application, selecting from the known codons to encode the 12 amino acid CDR of SEQ ID NO: 4, for example, would involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSR International Co. V. Telefex Inc 82 USPQ2d 1385). Said SEQ ID NO: 12 would also be “a sequence” having 100% identity to a nucleotide sequence of SEQ ID NO: 16, as recited in claim 7. Furthermore, it would also be obvious to include in the antibody compositions a vaccine according to WO2018027203 (see above) in order to enhance cancer treatment. Furthermore, using an expression vector as taught in US 20190002560 for expressing the nucleic acids claimed in the ‘081 application would be obvious and routine and well within the purview of the ordinary artisan.
This is a provisional nonstatutory double patenting rejection.
Applicant argues that the claims of the ‘081 application do not recite an antibody comprise SEQ ID NO: 1-6. However, as noted above, the ‘081 application claims an antibody comprising SEQ ID NO: 2, and SEQ ID NO: 2 comprises identical CDRs of the instant claims. The ‘081 application also claims nucleic acid encoding said antibody.
It is noted that the instant application has an earlier patent term filing date than the ‘081 application. If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner will withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent. The rejection is maintained since the double patenting rejection is not the only rejection remaining, but the rejection will be withdrawn once it is the only rejection remaining.
No claim is allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker, can be reached at telephone number 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644