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 .
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/20/2026 has been entered.
Claims 2-4, 11, 12, 14-16, 23, 26, and 27 have been cancelled. Claims 1, 13, and 17 have been amended.
Claims 1, 5-10, 13, 17-22, 24, and 25 are pending and under examination.
2. The objection to claim 17 is withdrawn in response to the amendment filed on 01/20/2026.
The rejection of claims 1, 5-10, 13, 17-22, 24, and 25 under 35 U.S.C. 103 as being unpatentable over Gardner et al. (PGPUB 2016/0340405), in view of all Cummings et al. (PGPEB 2002/0026033), Ramamurthi et al. (Thesis, April 2017), and Muthumani et al. (Vaccine, 2008, 26: 5128-5134) is withdrawn in response to the amendment limiting claims 1 and 13 to human and mouse subjects. The claimed SEQ ID NO: 2 or 4 are the nucleic acids encoding rhesus and human eCD4-Ig, respectively, optimized for expression in both mouse and human subjects. The prior art of record does not teach SEQ ID NO: 2 or 4, nor does the prior art render obvious arriving at SEQ ID NO: 2 or 4.
Claim Rejections - 35 USC § 112(a)
3. 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.
4. Claims 10 and 22 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.
Adequate written description requires more than a mere statement that it is part of the invention. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC1993). The Guidelines for the Examination of Patent Application Under the 35 U.S.C.112, 1"Written Description Requirement" makes it clear that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species disclosures of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, 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 (Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see especially page 1106 3rd column). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail such that the Artisan can reasonably conclude the inventors had possession of the claimed invention. Such possession may be demonstrated by describing the claimed invention with all its limitations using such descriptive means as words, structures, figures, diagrams, and/or formulae that fully set forth the claimed invention. Possession may be shown by an actual reduction to practice, showing that the invention was "ready for patenting", or by describing distinguishing identifying characteristics sufficient to show that the Applicants were in possession of the claimed invention (January 5, 2001, Fed. Reg., Vol. 66, No. 4, pp.1099-11). In analyzing whether the written description requirement is met for the genus claims, it is determined whether representative numbers of species have been described by their complete structure and functional characteristics.
Claims 10 and 22 are drawn to a genus of polypeptides having eCD4-Ig activity, wherein the polypeptides have an amino acid sequence at least 90% identical to SEQ ID NO: 1 or 3. The applicant has disclosed and reduced to practice the codon-optimized SEQ ID NOs: 2 and 4, which encode the wild-type rhesus and human eCD4-Ig set forth by SEQ ID NOs: 1 and 3, respectively.
The parent claims 1 and 13 recite an eCD4-Ig encoded by a nucleic acid at least 96% homologous to SEQ ID NOs: 2 and 4. When the claims are analyzed in view of the specification, these changes must result in a protein with eCD4-Ig activity. Thus, claims 1 and 13 allow for a 4% variability, as long as activity is preserved. The 4% variability encompasses synonymous and non-synonymous changes. If the changes are mostly synonymous, the protein identity remains high and the encoded protein is likely to exhibit eCD4-Ig activity. However, if a higher proportion of the 4% changes in SEQ ID NO: 2 and 4 are non-synonymous, the protein identity will drop. Non-synonymous changes would impact protein amino acid sequence and could impact functionality. It is well known that minor structural differences among even structurally related compounds can result in substantially different biology. For example, Seffernick et al. (J Bacteriol, 2001, 183: 2405-2410) teach that proteins that are 98% identical could have distinct activities (see Abstract). Witkowski et al. (Biochemistry, 1999, 38: 11643-11650) teach that a change of a single amino acid can result in a different function (see Abstract). Although the applicant is relying upon biological activity and the disclosure of the wild-type amino acid sequence to support an entire genus, one of skill in the art would know that a change of even one amino acid residue in the claimed sequence could render an inactive protein or a protein with a different activity. Therefore, one of skill in the art would not recognize the applicant to be in possession of the entire claimed genus.
Claim Rejections - 35 USC § 112(b)
5. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claim 24 and 25 are rejected 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 which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites the limitation "the one” nucleic acid. This recitation renders the claim unclear because the parent claim 13 recites a first and a second nucleic acid, and thus, the recitation of “the one” and “said flow diverter” in the dependent claim 24 makes it uncertain which of the nucleic acids is intended.
Claim 25 is rejected for being dependent from the rejected claim 24 and also for failing to further clarify the basis of the rejection.
Claim Rejections - 35 USC § 112(d)
7. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
8. Claims 8, 10, 20, 22, 24, and 25 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 8 and 20 recite that the synthetic protein is an antigen, antibody or immunoadhesin. This recitation broadens the subject matter of the parent claims 1 and 13, which are limited to a specific immunoadhesin, i.e., eCD4-Ig having a sequence at least 96% identical to SEQ ID NO: 2 or 4.
Claims 10 and 22 recite that eCD4-Ig has a sequence at least 90% homologous to SEQ ID NO: 1 or 3. However, the parent claims 9 and 21 are limited to the wild-type eCD4-Ig (i.e., set forth by SEQ ID NO: 1 or 3). Thus, claims 10 and 22 broaden the subject matter of the parent claims 9 and 21 because it encompasses sequences other than sequences other than the wild-type SEQ ID NO: 1 and 3.
Claims 24 recite and 25 (via its dependence upon claim 24) recite “the one or more nucleic acid molecules”. This recitation broadens the subject matter of the parent claim 13, which is limited to two nucleic acids.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
9. Claims 1, 5-7, 13, and 17-19 are allowed. Claims 8, 10, 20, 22, 24, and 25 are rejected.
Claims 9 and 21 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.
The following amendments to claims 9 and 21 are suggested:
Claim 9
The method of claim 1, wherein the first recombinant nucleic acid sequence is set forth by SEQ ID NO: 2 or 4.
Claim 21
The method of claim 13, wherein the first recombinant nucleic acid sequence is set forth by SEQ ID NO: 2 or 4.
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/ILEANA POPA/Primary Examiner, Art Unit 1633