DETAILED ACTION
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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/09/2026 has been entered.
Claims 25-26, 28-54 are pending. Claims 1-24 and 27 have been cancelled,
The following rejections are maintained with response to arguments following.
This action is FINAL.
Withdrawn Rejections
The 35 USC 103(a) rejection made in the previous office action is withdrawn based upon amendments to the claims.
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 25-26, 28-54 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.
The claims are drawn to a variant of a TdT comprising a substitution of alanine, valine, isoleucine, leucine, asparagine, cysteine, or glycine at amino acid position 336 wherein the numbering of amino acid positions is determined by alignment with the sequence of SEQ ID No. 1, wherein the sequence of the variant has at least 95% identity with SEQ ID No. 1 and is capable of synthesizing a nucleic acid in absence of a template strand.
When the claims are analyzed in light of the specification, the instant invention encompasses an enormous group of amino acid fragments. The specification does not describe which amino acids are critical to the functionality of capable of synthesizing a nucleic acid in absence of a template strand. The claims are drawn to 95% identity with SEQ ID No. 1, however, the specification does not describe which changes would provide the functionality.
The specification does not provide an adequate written description of the claimed genus of polypeptides as the claims are broadly written. In particular, although there is specific descriptions of amino acid changes in position 336, 454, and 457 and functionality, the specification does not describe any other possible changes to the structure that would be encompassed and how these changes would affect functionality.
In analysis of the claims for compliance with the written description requirement of 35 U.S.C. 112, first paragraph, the written description guidelines note regarding genus/species situations that “Satisfactory disclosure of a ``representative number'' depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed.” (See: Federal Register: December 21, 1999 (Volume 64, Number 244), revised guidelines for written description.) In the instant case, the specification fails to teach the necessary common attributes or features of the genus of encompassed amino acids in view of the species disclosed. As such, one of skill in the art would not recognize that applicant was in possession of the detection of ANY amino acid sequence at least 90% identical to SEQ ID No. 1 and the functionality.
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.” (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 page 1116).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude, "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966.
An adequate written description of a DNA, such as the cDNA of the recombinant plasmids and microorganisms of the '525 patent, "requires a precise definition, such as by structure, formula, chemical name, or physical properties," not a mere wish or plan for obtaining the claimed chemical invention. Fiers v. Revel , 984 F.2d 1164, 1171, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). Accordingly, "an adequate written description of a DNA requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the DNA itself." Id. at 1170, 25 USPQ2d at 1606.
The claims do not meet the written description provision of 35 USC 112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision. (See page 1115.)
Response to Arguments
The reply traverses the rejection. A summary of the arguments is made below with response to arguments following. The reply asserts that in paragraph 11 the specification relates to engineered DNA polX polymerase variants and that the mutations of these variants may further includes the volume of the catalytic activity, increase 3OH modified nucleotides or confer flexibility (p. 8). The reply points to the examples and the figures to provide support for the functionality (p. 8-9).
These arguments have been reviewed but have not been found persuasive.
In particular the claims encompass more variants that the two recited variants and the variations in figure 5, examples. The claims encompass any variant at any position such that the structure is 95% identical to SEQ ID No. 1. The specification, rather, only provides specific positions that are substitutions. The specification does not provide an adequate written description of the claimed genus of polypeptides as the claims are broadly written. In particular, although there is specific descriptions of amino acid changes in position 336, 454, and 457 and functionality, the specification does not describe any other possible changes to the structure that would be encompassed and how these changes would affect functionality. As noted above the specific variants provided the functionality, however, the specification does not provide guidance to any of the other potential variants in any location of SEQ ID No. 1 and functionality.
Conclusion
No claims are allowed. In order to provide compact prosecution it is noted that “a variant comprises SEQ ID No. 1 wherein at positions 336 there is a substitution of alanine, valine, isoleucine, leucine, asparagine, cysteine or glycine” appears to be free of the art.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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