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 amendment filed 06/25/2026 is acknowledged and has been entered.
Claims 1, 4-6 and 10 have been amended. Claims 3 and 7-9 have been cancelled.
3. Claims 1-2, 4-6 and 10-20 are pending in the application. Claims 15-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/29/2026.
4. Claims 1-2, 4-6 and 10-14 have been examined.
Grounds of Objection and Rejection Withdrawn
5. Unless specifically reiterated below, Applicant’s amendment and/or arguments have obviated or rendered moot the grounds of objection and rejection set forth in the previous Office action mailed 03/25/2026.
Grounds of Rejection Maintained
Claim Rejections - 35 USC § 112
6. 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.
7. 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.
8. Claims 1-2, 4-6 and 10-14 remain/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.
Claims 1-2, 4-6 and 10-14 are drawn to a nucleotide sequence encodes an anti-HBsAg antibody comprising a sequence having at least 90%, or 95% identity to SEQ ID NO: 2, and a nucleotide sequence having at least 80%, 90%, 95% identity to SEQ ID NO: 1.
Thus, the claims are drawn to a genus of antibodies comprise a sequence having at least 90% or 95% identity to SEQ ID NO: 2, or 80%, 90%, 95% identity to SEQ ID NO: 1.
The specification teaches SEQ ID NOs: 1-2; see Example 2. The specification does not teach that an antibody comprises a sequence having at least 80%, 90% or 95% identity to SEQ ID NO: 1 or 2 would have or retain the activity or function of SEQ ID NO: 1 or 2.
Given the fact that the claims are drawn to a genus of antibodies comprise a sequence having at least 80%, 90% or 95% identity to SEQ ID NO: 1 or 2, 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 the genus of antibodies comprise a sequence having at least 80%, 90%, or 95% identity to SEQ ID NO: 1 or 2 to which the claims are directed.
Although the specification teaches SEQ ID NO: 1 or 2, SEQ ID NO: 1 or 2 is not reasonably representative of the genus of antibodies comprise a sequence having at least 80%, 90%, or 95% identity to SEQ ID NO: 1 or 2. This is largely because each sequence having at least 80%, 90%, or 95% identity to SEQ ID NO: 1 or 2 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 antibodies comprise a sequence having at least 80%, 90%, or 95% identity to SEQ ID NO: 1 or 2, 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.
The Applicant’s arguments:
The Specification adequately describes a nucleic acid molecule comprising at least one selected from the group consisting of: a) a nucleotide sequence encoding an anti-Hepatitis B surface antigen (HBsAg) synthetic antibody comprising a sequence having at least 90% identity to SEQ ID NO:2; and b) a nucleotide sequence encoding a fragment of an anti-HBsAg synthetic antibody comprising at least 90% of the full length of SEQ ID NO:2, at least on pages 9, 15, 16, and 17 of the Specification as-filed. Further, the as-filed Specification elaborates on criteria for identifying fragments and variants of antibodies that retain biological activity which can be easily inferred by those skilled in the art, at least on pages 9 and 14.
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
Pages 9 and 14 of the specification only general state “substitution of amino acids having similar hydrophilicity values can result in peptides retaining biological activity” (see page 14 of the instant specification); however, the specification does not specifically point out which residue of SEQ ID NO: 1 or 2 can been substituted and would retain biological activity as SEQ ID NO: 1 or 2.
Because the claims encompass a genus of antibodies comprise a sequence having at least 80%, 90%, or 95% identity to SEQ ID NO: 1 or 2, 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. Therefore, the rejection is maintained for the reasons of record.
Conclusion
9. No claim is allowed.
10. THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
11. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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