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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-46) and species i) SEQ ID NO: 15, ii) SEQ ID NO: 2 the RBC-binding moiety B6 scFv, iii) flexible linker SEQ ID NO: 23, iv) first domain at the N-terminus and second domain at the C-terminus, v) SEQ ID NOs: 15, 23 and 2, vi) whole blood, and vii) claim 40 in the reply filed on 5/21/2026 is acknowledged. Applicant provided no arguments for the traversal.
Applicant’s request for reconsideration of the non-elected claims is denied because search burden is not considered for restrictions under 35 U.S.C. § 121 and 372 and under PCT Rule 13.1 371.
Accordingly, the requirement is still deemed proper and is therefore made FINAL.
Status of the Claims
Claims 47-87 have been withdraw as being directed to a non-elected invention. Claims 5, 10, 12-14, 17, 19-20, 23, 26, 29-32, 37-39, and 41 have been withdrawn as being directed to a non-elected species. Claims 1-4, 6-9, 11, 15-16, 18, 21-22, 24-25, 27-28, 33-36, 40, 42-46 are under examination at this time.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “an infectious bronchitis virus” twice. Appropriate correction is required.
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 1-4, 6-9, 11, 15-16, 18, 22, 24-25, 33-36, 40 and 42-46 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 directed, inter alia, a recombinant polypeptide comprising: a first domain, wherein the first domain comprises an epitope of a coronavirus; a linker; and a second domain, wherein the second domain is a moiety that is capable of specifically binding an antigen on the surface of a red blood cell.
For the first domain, applicant has identified the RBD as an epitope that can function in the agglutination assay. The RBD was chosen because of its small size and stable folding, as well as the fact that the RBD is the target of the majority of neutralizing antibodies. Applicant has not identified other coronavirus epitopes that can be used as a first domain. The claims encompass coronavirus epitopes (from any coronavirus protein) that are structurally and biologically different from the RBD. For example, it is not clear if other S protein epitopes or epitopes from other coronavirus proteins will behave the same as the RBD in the agglutination assay.
For the second domain, applicant has identified singe chain variable fragment (scFv) antibodies (e.g., 10F7 and B6) as agents that can bind a red blood cell antigen in the agglutination assay. However, applicant’s claims encompass agents that can bind RBCs and that are structurally and biologically different from the identified scFVs 10F7 and B6.
The written description rejection is made because the claims are interpreted as being drawn to a polypeptide comprising a genus of second domains which possess the function of binding to an antigen on the surface of RBCs. 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). To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the specification is the function of the second domain (binding to an antigen on the surface of RBCs). There is no disclosure of sufficient characteristics of the claimed genus of second domains to allow persons of ordinary skill in the art to recognize that applicant was in possess of the claimed genus.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of second domains. A definition by function alone is not sufficient because it is only an indication of what a thing does, rather than what it is. 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 distinguishing, identifying characteristics of the encompassed genus of second domains.
While the specification and claims recite various agents that can possibly be the second domain, there are no examples or teachings demonstrating that such agents, when joined to a coronavirus epitope via a linker, can function in the claimed agglutination assay and detect anti-coronavirus antibodies (see, for example, claim 35). Likewise, while the specification and claims recite various sources for coronavirus epitopes (see, for example, claims 2 and 3) that can possibly be the first domain, there are no examples or teachings demonstrating that coronavirus epitopes (other than the RBD), when joined to a scFV via a linker, can function in the claimed agglutination assay and detect anti-coronavirus antibodies (see, for example, claim 35).
Given that the specification has only described the function of the second domain, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
Allowable Subject Matter
Claims 21 (as it reads on the elected species of SEQ ID NOs: 15, 23 and 2), claim 27 and claim 28 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.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/ Primary Examiner, Art Unit 1672
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