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
2. The election filed 08/05/2026 in response to the Office Action of 05/18/2026 is acknowledged and has been entered.
Applicant has elected species: a) HAS binding polypeptide: SEQ ID NOs: 127 (loop 2) and 180 (loop 4); and b) PD-L1 binding polypeptide: SEQ ID NOs: 25 (loop 2) and 60 (loop 4).
Because applicant did not distinctly and specifically point out any supposed errors in the restriction requirement, the election has been treated as an election without traverse. See MPEP 818.03(a).
3. Claims 1, 3-10, 13, 16-22, 24-25 and 31 are pending and currently under prosecution.
Priority
4. Applicant’s claim under 35 U.S.C. §§ 119(e) and 365(c) for benefit of the earlier filing date of application, is acknowledged.
Claim Rejections - 35 USC § 112
5. 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.
6. 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.
7. Claims 1, 3-10, 13, 16-22, 24-25 and 31 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.
This is a “written description” rejection.
The considerations that are made in determining whether a claimed invention is supported by an adequate written description are outlined by the published Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, para. 1, ``Written Description'' Requirement (Federal Register; Vol. 66, No. 4, January 5, 2001; The 2015 Written Description Workshop materials; hereinafter “Guidelines”).
These guidelines state that rejection of a claim for lack of written description, where the claim recites the language of an original claim should be rare. Nevertheless, these guidelines further state, “the issue of a lack of written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant has possession of the claimed invention” (Id. at 1105). The “Guidelines” continue:
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. This problem may arise 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 lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.
With further regard to the proposition that, as original claims, the claims themselves provide in haec verba support sufficient to satisfy the written description requirement, the Federal Circuit has explained that in ipsis verbis support for the claims in the specification does not per se establish compliance with the written description requirement:
Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). See also: University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 1892 (CA FC 2004).
Thus, an original claim may provide written description for itself, but it must still be an adequate written description, which establishes that the inventor was in possession of the invention.
In this instance, claim 1 is drawn to a fusion protein comprising a human serum albumin (HSA) binding variant polypeptide and a PD-L1 binding polypeptide.
Claims 5-10 and 16-22 are drawn to a fusion protein comprises an amino acid sequence having at least 80%, at least 85%, at least 90%, or at least 95% sequence identity to SEQ ID NOs: 277-287 and 290-291.
Thus, the claims are drawn to a genus of fusion proteins comprising a HSA binding variant polypeptide, and a genus of fusion proteins comprises an amino acid sequence having at least 80%, 85%, 90%, or 95% identical to SEQ ID NOs: 277-287 and 290-291.
Although the specification teaches the HSA binding polypeptide SEQ ID NOs: 86-191 (see Table 2), and SEQ ID NO: 277-287 and 290-291 (see Table 7); however, the specification does not teach the claimed HSA binding variant polypeptide, and an amino acid sequence having at least 80%, 85%, 90%, or 95% identical to SEQ ID NOs: 277-287 and 290-291 would have or retain the activity or function of the HSA binding polypeptide, and SEQ ID NOs: 277-287 and 290-291.
Given the fact that the claims are drawn to a genus of fusion proteins comprising a HSA binding variant polypeptide, and a genus of fusion proteins comprises an amino acid sequence having at least 80%, 85%, 90%, or 95% identical to SEQ ID NOs: 277-287 and 290-291, which have no particular function or activity, there is no correlation between any one particularly identifying structural feature and any one particularly identifying functional feature. Consequently, it is submitted that the skilled artisan could not immediately envision, recognize or distinguish at least a substantial number of a HSA binding variant polypeptide, and an amino acid sequence having at least 80%, 85%, 90%, or 95% identical to SEQ ID NOs: 277-287 and 290-291, to which the claims are directed.
Although the specification teaches the HSA binding polypeptide (SEQ ID NOs: 86-191), and SEQ ID NO: 277-287 and 290-291; however, the HSA binding polypeptide and the SEQ ID NOs are not reasonably representative of the plurality of HSA binding variant polypeptide, and an amino acid sequence having at least 80%, 85%, 90%, or 95% identical to SEQ ID NOs: 277-287 and 290-291. This is largely because each HSA binding variant polypeptide, and an amino acid sequence having at least 80%, 85%, 90%, or 95% identical to SEQ ID NOs: 277-287 and 290-291 has substantially varying structure and need not have any particular function or activity.
Guidelines states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was ‘ready for patenting’ such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” (Id. at 1104). “Guidelines” further states, “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus” (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. Moreover, because the claims encompass a genus of fusion proteins comprising a HSA binding variant polypeptide, and a genus of fusion proteins comprises an amino acid sequence having at least 80%, 85%, 90%, or 95% identical to SEQ ID NOs: 277-287 and 290-291, which vary both structurally and functionally, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. In this instance, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; Applicant has not shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; and Applicant has not described distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention at the time the application was filed.
Thus, it is submitted that the instant claims, and the disclosure describing the claimed subject matter, fails to satisfy the written description requirement set forth under 35 U.S.C. § 112, first paragraph.
8. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
9. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
10. Claims 1, 13, 24-25 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keyt et al. (US 20190185570, published on 06/20/2019).
Claims 1, 13, 24-25 and 31 are herein drawn to a fusion protein comprising a human serum albumin (HSA) binding polypeptide and a PD-L1 binding polypeptide.
Keyt et al. teach an anti-PD-L1 antibody fusion with HSA binding scFv; see entire document, e.g., Example 7. Keyt et al. teach binding affinity; see [0080-0081].
For claim 13, Keyt et al. teach the fusion is via a peptide linker; see [0016], [0121], claim 18.
For claims 24 and 31, Keyt et al. teach a pharmaceutical composition for the treatment of cancer, wherein the pharmaceutical composition comprises an effective amount of the binding molecule and a pharmaceutically acceptable carrier; see [0020].
For claim 25, Keyt et al. teach the nucleic acid encoding the binding polypeptide; see [0066].
Double Patenting
11. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
12. Claims 1, 3-10, 13, 16-22, 24-25 and 31 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-62 of copending Application No. 18/698634. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1, 3-10, 13, 16-22, 24-25 and 31 are herein drawn to a fusion protein comprising a human serum albumin (HSA) binding polypeptide and a PD-L1 binding polypeptide.
Claims 1-62 of copending Application No. 18/698634 are drawn to a fusion protein comprising: (a) a PD-L1 binding polypeptide that binds to PD-L1 with a Kd of 1×10−6 M or less; and (b) a human serum albumin (HSA) binding polypeptide that binds to HSA with a Kd of 1×10−6 M or less.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
13. No claims are allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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