DETAILED ACTION
Non-Final Rejection
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions (Amended)
2. Applicant’s election of Group I claims 1-6 and 15-18 in the reply filed on 10/28/2025 is acknowledged. Applicant’s election of species SEQ ID NO: 28 (Group A) is acknowledged.
Applicant elected a non-immunoglobulin-binding protein, a genus for Group B.
Applicant was required to elect a final species for Group B and however, applicant in response to restriction/election made a remark by reciting “In the event that additional specificity is required with respect to Species Group B, applicant hereby elects the non-Immunoglobulin-binding protein of SEQ ID NO: 14, more particularly a multimer thereof (e.g., a monomer, dimer, trimer, or tetramer thereof), even more particularly a trimer thereof such as that found in instant SEQ ID NO: 30 (i.e., SEQ ID NO: 30 has the structure SEQ ID NO: 28 - SEQ ID NO: 14 – SEQ ID NO: 14 - SEQ ID NO: 14)”.
Applicant did not amend the claims on which the elected Group B final species comprising the elected “SEQ ID NO: 14, 28, and 30” read on. Without reciting the elected Group B species SEQ ID NOs in the claims it would not be possible to examine the affected claims.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Withdrawn Species Election
For compact prosecution, the examiner has withdrawn species election for the SEQ ID NOs: 1, 27, 28, and 65 as claimed in instant claim 1, and SEQ ID NOs: 63 or 64 as claimed in instant claim 5, and all the claimed sequences were searched for the prior art.
The examiner has also searched SEQ ID NO: 14, and SEQ ID NO: 30 for the prior art in response to applicant remarks filed in the reply on 10/28/2025 regarding a species of a non-immunoglobulin binding protein. The SEQ IDs were free of the prior art.
Status of Claims
3. Claims 1-7, 9, 11, and 13-18 as filed on 12/22/2022 are pending.
4. Claims 7, 9, 11, and 13-14 are withdrawn from consideration in response to Restriction/Election 10/28/2025.
5. Elected claims 1-6 and 15-18 (Restriction/Election 10/28/2025) are under examination in this office action.
Priority
6. The instant application is a United States National Stage Application of PCT International Patent Application Serial No. PCT/EP2021/067257, filed June 23, 2021, which itself claims the benefit of the following European Patent Applications: EP 20181725.1, filed June 23, 2020; EP 20186603.5, filed July 17, 2020; EP 20188821.1, filed July 31, 2020; and EP 2021357.9, filed October 12, 2020.
Information Disclosure Statement
7. Applicant did not file an information disclosure statement (IDS).
Drawings
8. Drawings filed on 12/22/2022 are considered and are accepted.
Claim Interpretation
9. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
The instant claims 1-6 and 15-18 are directed to a binding protein that specifically bind to Spike protein or S1 protein or RBD of SARS-CoV-2 virus. The binding protein require at least 80% amino acid identity to SEQ ID NO: 28 (claim 1) and or SEQ ID NOs: 63 or 64 (claim 5) and the binding protein binds to spike of SARS CoV-2 virus with a binding affinity of less than 500 nM. The claims 3-5 comprise dimers and multimers of the claimed binding protein. Claims 15 and 17 comprise the binding protein with a higher binding affinity of 100 nM. The claim 1 and dependent claims 2-5 and 15-18 are interpreted to comprise a composition of a genus of a binding protein with a 20% amino acid variation or substitution of amino acids and still maintaining the binding affinity lower than 500 nM to the Spike protein or S1 protein or RBD of SARS-CoV-2 virus.
Claim Rejections - 35 USC § 112(a) Written Description
10. 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.
The instant claims 1-6 and 15-18 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.
Claim 1 recites a binding protein for the spike protein of severe acute respiratory syndrome corona virus 2 (SARS-Cov-2) comprising an amino acid sequence with at least 80 % sequence identity to any one of SEQ ID NOs: 1, 27, 28, and 65 (elected SEQ ID NO: 28), wherein the binding protein has a binding affinity of less than 500 nM for the spike protein or domains thereof.
Each of the claims 1-6 and 15-18 is drawn, inherently or explicitly, to any binding protein for the spike protein of severe acute respiratory syndrome corona virus 2 (SARS-Cov-2) comprising an amino acid sequence with at least 80 % sequence identity to any one of SEQ ID NOs: 1, 27, 28, and 65 (elected SEQ ID NO: 28), wherein the binding protein has a binding affinity of less than 500 nM for the spike protein or domains thereof. The instant claim 5 comprises SEQ ID NO: 63 or 64 SEQ ID NO: 28 (or at least 80 % identical thereto) linked to each other in head-to-tail orientation (see SEQ ID NO: 64 and SEQ ID NO: 63, respectively), See, specification pages 10-11 (formula on specification page 11 line 16, and page 15).
Thus, the claims are drawn to compositions comprising a genus of any binding protein for the spike protein of severe acute respiratory syndrome corona virus 2 (SARS-Cov-2) comprising an amino acid sequence with at least 80 % sequence identity to any one of SEQ ID NOs: 1, 27, 28, and 65 (elected SEQ ID NO: 28), wherein the binding protein has a binding affinity of less than 500 nM for the spike protein or domains thereof.
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.
In the context of claimed invention, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) recently decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which concerned adequate written description for claims drawn to antibodies (reads on a binding protein of SARS CoV-2 Spike protein). The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called "newly characterized antigen" test should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the "newly characterized antigen" test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of a newly characterized antigen (e.g. Spike protein of SARS CoV-2 virus) alone is not considered adequate written description of a claimed antibody (reads on a binding protein of SARS CoV-2 Spike protein) to that newly characterized antigen, even when preparation of such an antibody is routine and conventional. Id.
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 specification teaches: amino acid sequences of monomers and dimers as binding proteins for SARS-CoV-2 spike protein (Figure 1 A-B); wherein binding protein for the spike protein or domains thereof" or “affinity ligand for the spike protein or domains thereof describes a protein that is capable to bind to the spike protein and/or the S1 domain of the spike glycoprotein and/or the RBD (Specification, page 7 and elsewhere) expression of such proteins (Specification, Example 2, page 29-31); wherein specific ligand 21243
showed binding (Figures 3-4, page 20, Table 2), Example 6 (page 35).
However, it is well known within the prior art that even the most minor differences in binding protein structure (e.g. deleting/substitution of one or more amino acids) can have significant effects on antigen binding ability. The art relating to antibodies for examples recognizes that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity that is characteristic of the parent immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff et al 1982. (Proc Natl Acad Sci USA 79:1979-1983). Rudikoff et al 1982 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. In the instant claims 1 (and dependent claims 2-6 and 15-18) for the elected SEQ ID NO: 28 and for claim 5 SEQ ID NO: 63 or 64 there would be 2 amino acid mismatch for every 10 amino acids (at least 80% identity). It is noted that the unpredictability of binding proteins (immunoglobulin as well as non-immunoglobulin) affinity to their respective receptors are both structurally and conformationally sensitive.
Thus, while the specification as indicated above identifies specific SEQ ID NOs that bind
to spike protein of severe acute respiratory syndrome corona virus 2 (SARS-Cov-2), it does not identify a representative sample of any binding proteins that bind to spike protein of severe acute respiratory syndrome corona virus 2 (SARS-Cov-2) comprising an amino acid sequence with at least 80 % sequence identity to any one of SEQ ID NOs: 1, 27, 28, and 65 (elected SEQ ID NO: 28), wherein the binding protein has a binding affinity of less than 500 nM for the spike protein or domains thereof clearly within the breadth of the claimed genus.
There is no apparent common conserved structure to the different binding proteins that distinguishes those that bind to spike protein of severe acute respiratory syndrome corona virus 2 (SARS-Cov-2) comprising an amino acid sequence with at least 80 % sequence identity to any one of SEQ ID NOs: 1, 27, 28, and 65 (elected SEQ ID NO: 28), wherein the binding protein has a binding affinity of less than 500 nM for the spike protein or domains thereof from those that do not. There is therefore a high level of uncertainty as to which binding proteins comprising an amino acid sequence with at least 80 % sequence identity to any one of SEQ ID NOs: 1, 27, 28, and 65 (elected SEQ ID NO: 28), wherein the binding protein has a binding affinity of less than 500 nM for the spike protein or domains thereof fall within the scope of the claimed genus (SEQ ID NO: 8).
Further, the specification has identified binding proteins only by function: the ability to comprise an amino acid sequence with at least 80% sequence identity to any one of SEQ ID NOs: 1, 27, 28, and 65 (elected SEQ ID NO: 28), and show binding affinity of less than 500 nM for the spike protein or domains thereof. The specification does not provide a specific structure of binding proteins comprising an amino acid sequence with at least 80 % sequence identity to any one of SEQ ID NOs: 1, 27, 28, and 65 (elected SEQ ID NO: 28), within the genus that correlates with the required function. Because there is no identification of structures common to each binding proteins, nor sufficient representative examples of the binding protein by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of binding proteins through identification of a structure and function. While the binding proteins for the spike protein of severe acute respiratory syndrome corona virus 2 (SARS-Cov-2) must comprise an amino acid sequence with at least 80 % sequence identity to any one of SEQ ID NOs: 1, 27, 28, and 65 (elected SEQ ID NO: 28),show binding affinity of less than 500 nM for the spike protein or domains thereof, this is not alone sufficient structure to correlate with the function. This is because the mere presence of the claimed percent identity and binding affinity as claimed does not demonstrate that any binding protein with the claimed percent sequence identity would be able to show binding affinity of less than 500 nM for the spike protein or domains thereof.
The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004).
In this case, the only factor present in the claims is a genus “binding protein” to a “Spike protein of SARS-CoV-2 virus” and a function binding without claiming a single species of a binding protein and disclosure of a specific complete or partial structure for a species of a binding protein. EliLily, 119 F.3 at 1568, 43 USPQ2d at 1406. The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, 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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not clearly allow persons of ordinary skill in the art to recognize that the inventors invented what is claimed. As discussed above, the skilled artisan cannot envision the detailed chemical structure encompassed by a genus “binding molecule” capable of carrying out the claimed function of binding to Spike protein of SARS-CoV-2 virus. Given that the specification has only described the function of a component, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph. The applicant/inventor needs to show that they have truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, the applicant/inventor has only a research plan, leaving it to others to explore and figure out the unknown contours of the claimed genus." AbbVie Deutsch/and GmbH & Co. v. Janssen Biotech, 759 F.3d 1285, 1300 (Fed. Cir. 2014). "In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad, 598 F.3d at 1351.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated: “A written description of an invention involving a chemical genus, like a description of a chemical species requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or sub-combinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representatives, the Courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
For the reasons above, and in view of the uncertainty as to which binding proteins would comprise an amino acid sequence with at least 80 % sequence identity to any one pf SEQ ID NOs: 1, 27, 28, and 65 (elected SEQ ID NO: 28), and show binding affinity of less than 500 nM for the spike protein or domains thereof, the applicant has not provided sufficient written description support for the genus of binding proteins identified in claims 1 and 5. The application therefore fails to provide adequate support for the claimed genus of binding proteins.
Claim Rejections - 35 USC § 112(a) Enablement Requirement
11. The instant claims 1-6 and 15-18 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 enablement requirement. The claims 1-6 and 15-18 contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C.1988). Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including the nature of the invention, the state of the prior art, the breadth of the claims, the amount of guidance in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, and the quantity of experimentation necessary. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention. The claims 1-6 and 15-18 are directed to a binding protein that specifically bind to Spike protein of SARS-CoV-2 virus, the binding protein require at least 80% amino acid identity to SEQ ID NO: 28 (claim 1) and or SEQ ID NOs: 63 or 64 (claim 5) and the binding protein binds to spike of SARS CoV-2 virus with a binding affinity of less than 500 nM. The claims 3-5 comprise dimers and multimers of the claimed binding protein. Claims 15 and 17 comprise the binding protein with a higher binding affinity of 100 nM.
Working Examples. The specification does not disclose even a single working example with a binding protein claimed as SEQ ID NO: 28 that comprise an amino acid sequence variations up to at least 80% identity and binding of the variant protein to spike protein of SARS-CoV-2 virus. The specification does not disclose data and figures generated by experimental studies for a working example indicating the applicant/inventors did not perform the experiments with variant binding protein having 80% sequence identity with SEQ ID NO: 28 (claim 1) and or SEQ ID NOs: 63 or 64 (claim 5).
The amount of experimentation necessary. One skilled in the art would require to perform many permutations and combinations of amino acid sequence variations to arrive at the inventions of broad generic claims 1-6 and 15-18 that comprise a binding protein with at least 80% amino acid sequence identity to SEQ ID NO: 28 (claim 1) and or SEQ ID NOs: 63 or 64 (claim 5) and binds to spike of SARS CoV-2 virus with a binding affinity of less than 500 nM. It would require undue experimentation to cover the breadth of the claims that requires identifying the specific amino acid positions and amino acid residues (claimed at least 80% amino acid identity) to enable the claimed binding affinity of less than 500 nM to the spike protein of SARS-CoV-2 virus. The ordinary skills in the art would be burdened with planning, executing the optimization experiments and developing the binding molecule(s) to arrive at the claimed invention. Many numbers of experiments will be required to generate repeatable and statistically significant data to encompass the full scope and breadth of the claimed invention. There will be undue experimentation burden on the ordinary skills in the art.
Level of predictability in the art. The specificity and binding affinity (nM) of the claimed binding protein with at least 80% amino acid identity to SEQ ID NO: 28 (claim 1) and or SEQ ID NOs: 63 or 64 (claim 5) and binds to spike of SARS CoV-2 virus with a binding affinity of less than 500 nM is unpredictable to achieve. For the reasons discussed above, it would have required undue experimentation for one skilled in the art before the effective filing date of the claimed invention to practice the full scope of the invention claimed. This is particularly true given the nature of the invention, the state of the prior art, the breadth of the claims, the amount of experimentation necessary, the level of skill which is high, the working examples provided and scarcity of guidance in the specification, and the unpredictable nature of the art. The enablement inquiry for claims that include functional requirements (e.g. specific binding between viral antigen or epitope and antibodies (antibodies reads on the claimed binding protein) and there is unpredictability of the art and guidance in specification fall short is addressed in “Amgen v. Sanofi, Aventisub LLC, 987 F.3d 1080, 1086 (Fed. Cir. 2021)”.
Breadth of claims. The claims 1-6 and 15-18 are directed to a binding protein that specifically bind to Spike protein of SARS-CoV-2 virus, the binding protein require at least 80% amino acid identity to SEQ ID NO: 28 (claim 1) and or SEQ ID NOs: 63 or 64 (claim 5) and the binding protein binds to spike of SARS CoV-2 virus with a binding affinity of less than 500 nM. It would require undue experimentation to cover the breadth of the claims.
Additionally, in the recently decided Amgen v. Sanofi (590 U.S. 594; 143 S.Ct. 1243 May 18, 2023) Supreme Court decision addressing enablement, the Court held that enablement of an unpredictably broad functional claim (e.g. functionally specific analogous antibodies or the instant claimed binding protein that specifically bind to Spike protein of SARS-CoV-2 virus) requires sufficient disclosure in light of the state of the prior art as to how to enable the making (e.g. protocols) and use for the full range of the claimed invention without unreasonable or undue experimentation.
For the reasons discussed above, it would have required an undue experimentation for one skilled in the art before the effective filing date of the claimed invention to practice over the full scope of the invention claimed. This is particularly true given the nature of the invention, the state of the prior art, the breadth of the claims, the amount of experimentation necessary, the level of skill which is high, the working examples provided and scarcity of guidance in the specification, and the unpredictable nature of the art. The enablement inquiry for claims that include functional requirements and there is unpredictability of the art and guidance in specification fall short is addressed in “Amgen v. Sanofi, Aventisub LLC, 987 F.3d 1080, 1086 (Fed. Cir. 2021)”.
Claim Rejections - 35 USC § 112 (b)
12. 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.
The instant claims 1-6 and 15-18 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 1: The instant claim 1 recites “a binding protein for the spike protein of severe acute respiratory syndrome corona virus 2 (SARS-Cov-2) comprising an amino acid sequence with at least 80 % sequence identity to any one of… ”. It is not clear whether the claimed binding protein or spike protein comprises “an amino acid sequence with at least 80 % sequence identity to any one of…”.
Claim 3: For the instant claim 3, it is not clear whether the claim intends to recite “further wherein 2, 3, 4, 5 or 6 additional binding proteins … are linked to each other” or not.
Claim 5: For the instant claim 4, it is not clear whether the claim intends to recite “further wherein the binding proteins … to SEQ ID NO: 63 or 64” or not.
Claim 6: For the instant claim 6, it is not clear to which “further” molecule the claimed binding protein is fused to?
13: Claimed subject matter that is free of prior art:
The SEQ ID NOs: 1, 27, 28, and 65 as claimed in instant claim 1, and SEQ ID NOs: 63 or 64 as claimed in instant claim 5 are free of prior art. Because the search of the claimed sequences (instant claim 1 and claim 5) for the prior art using USPTO ABSS resource did not yield hit for at least 80% amino acid sequence identity to the claimed full-length sequences of the claimed binding protein(s).
Applicant has claimed the SEQ ID NOs: 1, 27, 28, and 65 (as claimed in instant claim 1), and SEQ ID NOs: 63 or 64 (as claimed in instant claim 5) as genus of a binding protein amino sequences requiring at least 80% amino acid sequence identity to the claimed full-length sequences of the claimed binding protein(s) allowing a 20% amino acid variability in the amino acid sequence for the claimed SEQ ID NOs. The applicant did not claim a final single species (a single amino acid sequence species) of the claimed binding protein(s). Additional sequence search would be required when the applicant elects a final single species of the claimed amino acid sequence of the binding protein as a response to the 35 U.S.C. 112 rejection in this office action.
Conclusion
14. No claim is allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMADHAN J JADHAO whose telephone number is (703)756-1223. The examiner can normally be reached M-F 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMADHAN JAISING JADHAO/Examiner, Art Unit 1672
/BENNETT M CELSA/Quality Assurance Specialist, Art Unit 1600