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
1. Claims 1, 16 are amended. Claims 9-15, 25-27 are withdrawn. Claims 1-8, 16-24 are under consideration.
2. Due to the new rejections below, this Action is a Non-Final Action.
Claim Rejections - 35 USC § 112
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.
3. (new rejection) Claims 1-8, 16-24 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.
See claims 1-8, 16-24 as submitted 2/2/2026.
As to claims 1, 16, the claims recite “S1 protein binding domain polypeptide” and “S1 protein receptor binding domain polypeptide”. It is not clear if the polypeptide is S1 (S1 domain) and binds to proteins (such as ACE2, receptor) or if the protein binding domain (or protein receptor binding domain) polypeptide binds to S1 (binding domain to S1 protein or protein receptor).
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. (new rejection) Claims 1, 4, 6, 8, 16-20, 22, 24 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.
See claims 1, 4, 6, 8, 16-20, 22, 24 as submitted 2/2/2026.
See also the 35 U.S.C. 112(b) rejection above. In view of the uncertainty the term “S1 protein binding domain poypeptide” is interpreted as a binding domain of S1 protein (for binding to ACE2)(see specification, p. 1).
Each of the claims is drawn, inherently or explicitly, to any recombinant polypeptide consisting of a SARS-CoV-2 S1 protein binding domain polypeptide and a GM-CSF polypeptide, wherein S1 protein binding domain polypeptide reads on any binding domain of S1 protein. Thus, the claims are drawn to compositions comprising a genus of binding domains of S1 protein.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
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 Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the application teaches: SEQ ID NO: 1; SEQ ID NOs: 6, 7.
However, it is known in the art that antigen specificity is a complex interaction involving multiple components. Even the most minor differences can have significant effects on binding ability. For example, Lucchese et al. (“How a single amino acid change may alter the immunological information of a peptide,” Frontiers in Bioscience E4: 1843-1852 (2012))(See PTO-892: Notice of References Cited) teaches: a single amino acid change may alter the immunological information of a peptide (title). Further, Wong et al. ("Comparative Analysis of the CDR Loops of Antigen Receptors," Front. Immunol. 10:2454 (2019))(See PTO-892: Notice of References Cited) teaches: the structural variability in TCR loops is higher than in antibodies, suggesting TCR CDRs are more flexible (abstract); there are three in the TCRa chain and three in the TCR b chain; the structural complementarity between the binding sites of the antigen receptor and their cognate antigen governs the binding interactions; as the CDRs form the majority of the binding site, their conformations are critical to the binding (p. 2). Further, even minor changes in the amino acid sequences may dramatically affect antigen-binding function as evidenced by Rudikoff et al. ("Single amino acid substitution altering antigen-binding specificity," Proc Natl Acad Sci USA 79:1979-1983 (1982))(See 892-Notice of References Cited). Rudikoff et al. teaches that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function.
Domains are variable and unpredictable with respect to binding, so a structure-function relationship cannot be established based upon sequence homology alone (such as recited in claims 4, 6, 22).
Therefore, in light of the knowledge in the art, broad scope of the claims, which reads
upon a genus of binding domains as claimed, and the limited teachings in the specification, there is still a high level of uncertainty as to which binding domains fall within the scope of the indicated genus and show binding activity.
However, while the specification as indicated above identifies SEQ ID NOs: 1, 6, 7, in view of challenges known in the art as indicated above, it does not identify a representative sample of binding domains of S1 protein especially in view of the breadth of the claims. Thus, the application does not identify a representative sample of binding domains of S1 protein within the breadth of the claimed genus.
There is no apparent common conserved structure to the different binding domains of S1 protein that distinguishes those that bind as compared to those that do not. There is therefore a high level of uncertainty as to which binding domains of S1 protein fall within the scope of the indicated genus.
Further, the specification has identified binding domains of S1 protein only by function: the ability to bind. The specification does not provide a specific structure of any binding domains of S1 protein within the genus that correlates with the required function. Because there is no identification of structures common to each binding domains of S1 protein, nor sufficient representative examples of the binding domains of S1 protein by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of binding domains of S1 protein through identification of a structure and function. While the binding domains of S1 protein are required to bind, this is not alone sufficient structure to correlate with the function. This is because the mere presence of a domain does not demonstrate that a polypeptide would be able to bind.
For the reasons above, the application has not provided sufficient written description support for the genus of binding domains of S1 protein identified in claims 1, 4, 6, 8, 16-20, 22, 24. The application therefore fails to provide adequate support for methods of using this genus of binding domains of S1 protein.
Claim Rejections - 35 USC § 103
5. (previous rejection, withdrawn) Claims 1, 2 were rejected under 35 U.S.C. 103 as being unpatentable over Swartz et al. (US20110129438)(cited in applicant's IDS submitted 11/14/2022) in view of Wu et al. ("A new coronavirus associated with human respiratory disease in China," Nature, Vol. 579: 265-269 (2020)) (cited in applicant's IDS submitted 11/14/2022).
Applicant contends: claim 1 has been amended; the invention described in Swartz et al. includes a bacterial immunity protein and an antigen; the claims exclude a recombinant polypeptide of Swartz et al.; Wu et al. does not overcome the deficiencies.
In view of applicant’s amendments, the rejection is withdrawn.
6. (previous rejection, withdrawn) Claims 3, 4 were rejected under 35 U.S.C. 103 as being unpatentable over Swartz et al. in view of Wu et al. as applied to claims 1, 2 above, and further in view of Kruse et al. (WO2021222772; previously cited).
In view of the withdrawal of the rejection over Swartz et al. in view of Wu et al. on which the instant rejection depends, the instant rejection is also withdrawn.
7. (previous rejection, withdrawn) Claims 5, 6 were rejected under 35 U.S.C. 103 as being unpatentable over Swartz et al. in view of Wu et al. as applied to claims 1, 2 above, and further in view of Escriou et al. (WO2021160850A1; previously cited).
In view of the withdrawal of the rejection over Swartz et al. in view of Wu et al. on which the instant rejection depends, the instant rejection is also withdrawn.
8. (previous rejection, withdrawn) Claims 7, 8 were rejected under 35 U.S.C. 103 as being unpatentable over Swartz et al. in view of Wu et al. as applied to claims 1, 2 above, and further in view of Novak et al. (WO0053761A2; previously cited).
In view of the withdrawal of the rejection over Swartz et al. in view of Wu et al. on which the instant rejection depends, the instant rejection is also withdrawn.
9. (previous rejection, withdrawn) Claims 16-19 were rejected under 35 U.S.C. 103 as being unpatentable over Selvaraj et al. (US20150071987; previously cited) in view of Swartz et al. (US20110129438)(cited above) in view of Wu et al. ("A new coronavirus associated with human respiratory disease in China," Nature, Vol. 579: 265-269 (2020))(cited above).
In view of the withdrawal of the rejection over Swartz et al. in view of Wu et al. on which the instant rejection depends, the instant rejection is also withdrawn.
10. (previous rejection, withdrawn) Claim 20 was rejected under 35 U.S.C. 103 as being unpatentable over Selvaraj et al. in view of Swartz et al. in view of Wu et al. as applied to claims 16-19 above, and further in view of Alsharifi et al. (U.S. Patent No. 10251947; previously cited).
In view of the withdrawal of the rejection over Swartz et al. in view of Wu et al. on which the instant rejection depends, the instant rejection is also withdrawn.
11. (previous rejection, withdrawn) Claims 21, 22 were rejected under 35 U.S.C. 103 as being unpatentable over Selvaraj et al. in view of Swartz et al. in view of Wu et al. as applied to claims 16-19 above, and further in view of Kruse et al. (WO2021222772; previously cited).
In view of the withdrawal of the rejection over Swartz et al. in view of Wu et al. on which the instant rejection depends, the instant rejection is also withdrawn.
12. (previous rejection, withdrawn) Claims 23, 24 were rejected under 35 U.S.C. 103 as being unpatentable over Selvaraj et al. in view of Swartz et al. in view of Wu et al. as applied to claims 16-19 above, and further in view of Novak et al. (WO0053761A2; previously cited).
In view of the withdrawal of the rejection over Swartz et al. in view of Wu et al. on which the instant rejection depends, the instant rejection is also withdrawn.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
13. (new rejection) Claims 1, 2 are rejected under 35 U.S.C. 103 as being unpatentable over Dimitrov et al. (WO2005010034A)(See PTO-892: Notice of References Cited) in view of Wu et al. ("A new coronavirus associated with human respiratory disease in China," Nature, Vol. 579: 265-269 (2020)) (cited in applicant's IDS submitted 11/14/2022).
See claims 1, 2 as submitted 2/2/2026.
Dimitrov et al. teaches: SARS-CoV spike (p. 1); spike protein; constructs that encode the spike protein, polypeptides and peptide fragments of the spike protein; coupled proteins that include spike protein or portion thereof (abstract); peptide fragment coupled to adjuvant (p. 19); wherein composition can include adjuvant and polypeptide, peptide fragment, coupled protein of any combination thereof (p. 29); wherein adjuvant is chemically linked to a polypeptide, peptide fragment (p. 30); wherein GM-CSF may be used as adjuvant (p. 18); soluble S1 (Example 4); wherein coupled proteins have carrier protein coupled to a polypeptide or peptide fragment; carrier may be used to increase immunogenicity (p. 21); carrier protein may be coupled to a polypeptide or peptide fragment by creation of a fusion protein through use of recombinant methods (p. 22).
Dimitrov et al. does not teach SARS-CoV-2 S1 protein binding domain.
Wu et al. teaches: SARS-CoV-2 S1 domain (p. 266).
One of ordinary skill in the art would have been motivated to use SARS-CoV-2 S1 domain of Wu et al. with the protein of Dimitrov et al. Dimitrov et al. teaches spike protein constructs and use of SARS-CoV S1 domain, and Wu et al. teaches such a known SARS-CoV S1 domain (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using domain of Wu et al. with the protein of Dimitrov et al. There would have been a
reasonable expectation of success given the underlying materials (binding site domains as taught
by Dimitrov et al. and Wu et al.) and methods are known, successfully demonstrated, and
commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one
of ordinary skill in the art before the effective filing date of the claimed invention.
14. (new rejection) Claims 3, 4 are rejected under 35 U.S.C. 103 as being unpatentable over Dimitrov et al. in view of Wu et al. as applied to claims 1, 2 above, and further in view of Kruse et al. (WO2021222772; previously cited).
See claims 3, 4 as submitted 2/2/2026.
See the teachings of Dimitrov et al. in view of Wu et al. above.
Dimitrov et al. in view of Wu et al. does not teach: wherein the SARS-CoV-2 S1 protein
binding domain polypeptide comprises SEQ ID NO:1; wherein the SARS-CoV-2 S1 protein
binding domain polypeptide comprises a sequence at least 80% identical to SEQ ID NO:1.
Kruse et al. teaches: SARS-CoV-2 spike protein RBD SEQ ID NO: 15, which has 100%
identity with instant SEQ ID NO: 1 (See Result 30 of STIC Sequence Search Result
20250925_192003_us-17-925-179-1.rag in Supplemental Content Tab).
One of ordinary skill in the art would have been motivated to use binding domain as
taught by Kruse et al. with the construct as taught by Dimitrov et al. in view of Wu et al. Dimitrov et al. in view of Wu et al. teaches use of SARS-CoV-2 binding domain, and Kruse et al. teaches such a binding domain (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using binding domain as taught by Kruse et al. with the construct as taught by Dimitrov et al. in view of Wu et al. There would have been a reasonable expectation of success given the
underlying materials (binding domains as taught by Kruse et al. and Dimitrov et al. in view of Wu et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
15. (new rejection) Claims 5, 6 are rejected under 35 U.S.C. 103 as being unpatentable over Dimitrov et al. in view of Wu et al. as applied to claims 1, 2 above, and further in view of Escriou et al. (WO2021160850A1; previously cited).
See claims 5, 6 as submitted 2/2/2026.
See the teachings of Swartz et al. in view of Wu et al. above.
Swartz et al. in view of Wu et al. does not teach: wherein the SARS-CoV-2 S1 protein
binding domain polypeptide comprises SEQ ID NO:6; wherein the SARS-CoV-2 S1 protein
binding domain polypeptide comprises a sequence at least 80% identical to SEQ ID NO:6.
Escriou et al. teaches: 2019-nCov S protein SEQ ID NO: 3, which has 100% identity with
instant SEQ ID NO: 6 (See Duplicate 69 of Result 40 of STIC Sequence Search Result
20250925_192003_us-17-925-179-6.rag in Supplemental Content Tab).
One of ordinary skill in the art would have been motivated to use protein as taught by
Escriou et al. with the construct as taught by Dimitrov et al. in view of Wu et al. Dimitrov et al. in view of Wu et al. teaches use of SARS-CoV-2 protein, and Escriou et al. teaches such a protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using protein as taught by Escriou et al. with the construct as taught by Dimitrov et al. in view of Wu et al. There would have been a reasonable expectation of success given the underlying
materials (binding domains as taught by Escriou et al. and Dimitrov et al. in view of Wu et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
16. (new rejection) Claims 7, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Dimitrov et al. in view of Wu et al. as applied to claims 1, 2 above, and further in view of Novak et al. (WO0053761A2; previously cited).
See claims 7, 8 as submitted 2/2/2026.
See the teachings of Swartz et al. in view of Wu et al. above.
Swartz et al. in view of Wu et al. does not teach: wherein the GM-CSF polypeptide
comprises SEQ ID NO:2; wherein the GM-CSF polypeptide is at least 80% identical to SEQ ID
NO:2.
Novak et al. teaches: known GMCSF protein with 100% identity with instant SEQ ID
NO: 2 (See Result 1 of STIC Sequence Search Result 20250925_192003_us-17-925-179-2.rag in
Supplemental Content Tab).
One of ordinary skill in the art would have been motivated to use GMCSF protein as
taught by Novak et al. with the construct as taught by Dimitrov et al. in view of Wu et al. Dimitrov et al. in view of Wu et al. teaches use of GM-CSF protein, and Novak et al. teaches such a protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using GMCSF protein as taught by Novak et al. with the construct as taught by Dimitrov et al. in view of Wu et al. There would have been a reasonable expectation of success given the
underlying materials (GMCSF protein as taught by Novak et al. and Dimitrov et al. in view of Wu et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
17. (new rejection) Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Selvaraj et al. (US20150071987; previously cited) in view of Dimitrov et al. (AU2004259750A1; cited above) in view of Wu et al. ("A new coronavirus associated with human respiratory disease in China," Nature, Vol. 579: 265-269 (2020))(cited above).
See claims 16-19 as submitted 2/2/2026.
Selvaraj et al. teaches: influenza VLPs [0079](as recited in claim 19); GPI anchored
immunostimulatory molecules (abstract); VLPs modified to express immunostimulatory
molecules by protein transfer with GPI anchored cytokines and immunostimulatory molecules;
vaccines and therapeutic compositions can be used for preventing or treating viral diseases
[0038]; including viral protein [0015]; antigens such as TAA onto envelope VLPs using
anchoring for protein transfer [0040]; wherein antigens are anchored onto exterior of particles,
using GPI anchor [0068]; further including adjuvant including IL-12 [0008](as recited in claims
17, 18).
Selvaraj et al. does not teach: wherein the GPI-recombinant polypeptide consists of
SARS-CoV-2 S1 protein receptor binding domain polypeptide and a GM-CSF polypeptide (GPI-
RBD-GM-CSF polypeptide).
See the teachings of Dimitrov et al. in view of Wu et al. above.
One of ordinary skill in the art would have been motivated to use protein as taught by
Dimitrov et al. in view of Wu et al. with the VLP as taught by Selvaraj et al. Selvaraj et al. teaches use of viral protein, and Swartz et al. in view of Wu et al. teaches such a protein (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using protein as taught by Dimitrov et al. in view of Wu et al. with the VLP as taught by Selvaraj et al. There would have been a reasonable expectation of success given the underlying materials
(viral proteins as taught by Selvaraj et al. and Dimitrov et al. in view of Wu et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
18. (new rejection) Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. as applied to claims 16-19 above, and further in view of Alsharifi et al. (U.S. Patent No. 10251947; previously cited).
See claim 20 as submitted 2/2/2026.
See the teachings of Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. above.
Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. does not teach: A/PR8.
Alsharifi et al. teaches: influenza strain A/PR8 (Example 2).
One of ordinary skill in the art would have been motivated to use influenza strain as
taught by Alsharifi et al. with the construct as taught by Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. teaches use of
influenza strain and Alsharifi et al. teaches such a strain (See MPEP 2144.06: Substituting
equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using influenza strain as taught by Alsharifi et al. with the construct as taught by Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. There would have been a reasonable expectation of
success given the underlying materials (influenza as taught by Alsharifi et al. and Selvaraj et al. in view of Dimitrov et al. in view of Wu et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention
19. (new rejection) Claims 21, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. as applied to claims 16-19 above, and further in view of Kruse et al. (WO2021222772; previously cited).
See claims 21, 22 as submitted 2/2/2026.
See the teachings of Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. above.
Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. does not teach: wherein the
SARS-CoV-2 S1 protein binding domain polypeptide comprises SEQ ID NO:1; wherein the
SARS-CoV-2 S1 protein binding domain polypeptide comprises a sequence at least 80%
identical to SEQ ID NO:1.
See the teachings of Kruse et al. above.
One of ordinary skill in the art would have been motivated to use binding domain as
taught by Kruse et al. with the construct as taught by Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. teaches use of
SARS-CoV-2 binding domain, and Kruse et al. teaches such a binding domain (See MPEP
2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using binding domain as taught by Kruse et al. with the construct as taught by Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. There would have been a reasonable expectation of
success given the underlying materials (binding domains as taught by Kruse et al. and Selvaraj et al. in view of Dimitrov et al. in view of Wu et al.) and methods are known, successfully
demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
20. (new rejection) Claims 23, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. as applied to claims 16-19 above, and further in view of Novak et al. (WO0053761A2; previously cited).
See claims 23, 44 as submitted 2/2/2026.
See the teachings of Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. above.
Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. does not teach: wherein the
GM-CSF polypeptide comprises SEQ ID NO:2; wherein the GM-CSF polypeptide is at least
80% identical to SEQ ID NO:2.
See the teachings of Novak et al. above.
One of ordinary skill in the art would have been motivated to use GMCSF protein as
taught by Novak et al. with the construct as taught by Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. teaches use of GM-CSF protein, and Novak et al. teaches such a protein (See MPEP 2144.06: Substituting
equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using GMCSF protein as taught by Novak et al. with the construct as taught by Selvaraj et al. in view of Dimitrov et al. in view of Wu et al. There would have been a reasonable expectation of
success given the underlying materials (GMCSF protein as taught by Novak et al. and Selvaraj et al. in view of Dimitrov et al. in view of Wu et al.) and methods are known, successfully
demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
21. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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