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 .
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See paragraph at bottom of page 10.
Claim Objections
Claims 14 and 20 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claims 14 and 20 are not been further treated on the merits.
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 1-9, 11-13, and 15-19 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 require AP205 with at least 90% identity to SEQ ID# 7 and 26.
The Court has indicated in Amgen Inc vs Sanofi ( 2017-1480, Fed Cir, 2017) that “an adequate written description must contain enough information about the actual makeup of the claim products – a precise definition such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other material,” which may be present in “function “terminology “when the art has established a correlation between structure and function” (page 17, 1st paragraph).
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by 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 genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, the genus of sequence that is 90% identical to AP205 of SEQ ID# 5 or 26 that can function as AP205.
The specification does not disclose the genus of sequence that is 90% identical to AP205 of SEQ ID# 5 or 26 that can function as AP205. The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[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.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
The Board in Ex Parte Kubin further stated on page 16 that:
Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that:
[F]or purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
The specification does disclose the range of sequences 90% identical to SEQ ID# 7 or 26 that can function as AP205. There is no teaching of residues that can be changed or what must be maintained.
Thus, the specification does not provide an adequate written description of the genus of sequence that is 90% identical to AP205 of SEQ ID# 5 or 26 that can function as AP205 that is required to practice the claimed invention. Applicants have not described the genus of at least 90% identity to SEQ ID# 7 or 26 sufficiently to show they had possession of the claimed genus.
Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
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.
Claims 1-9, 11-13, and 15-19 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.
Claims 1 and 15 (and claims 3-4, 6-9, 11-13, and 16-19 that depend from them) recite "at least 90%” and refer to AP205. It is not clear how any percent identity can be determined since there is no requisite context (specified sequence) for comparison. Claims 2 and 5 recite a sequence identifier but it is not clear if it is specifically at least 90% of SEQ ID# 26 or 7. For claim 1, 2, 5, and 15, it would be clear if written as (for example) …AP205 with at least 90% identity to SEQ ID No: XX.
Claim 4 is unclear as to what is selected. The claim recites a and b, c. The standard language would be selected from the group consisting of: a, b, and c. It appears applicant intends “a, b, and c” and is treated as such
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6-8, 11-13, and 15 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Chackerian et al. (US20190201540A1).
For claims 1, 2, 6-7, and 15, Chackerian et al. teach …VLPs displaying full-length mature ApoC3 (SEQ ID NO:3) were constructed by genetically inserting the ApoC3 gene at the C-terminal of a single-chain dimer version of the AP205 coat protein. In this conformation, each recombinant VLP displays 90 copies of the ApoC3 protein.” (para 16) as well as in the same paragraph “Displaying a target antigen on the surface of a virus-like particle (VLP) can increase the immunogenicity of the antigen. VLP display can elicit strong antibody responses against self-antigens, which are normally poorly immunogenic. For claim 7, the “consisting” is interpreted as limiting in that the fusion to the elements recited in claim 1 and no extra elements in the fusion.
For claim 8 ApoC3 is a self molecule.
For claim 11, the AP205 construct can be a pharmaceutical composition (para 25).
For claim 12-13, the AP205 construct can be administered to immunize or treat (abstract).
Thus, Chackerian et al. anticipate the claimed invention.
Claim Rejections - 35 USC § 103
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.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chackerian et al. (US20190201540A1) as applied to claims 1, 2, 6-8, 11-13, and 15 above, and further in view of Carrillo Molina et al. (20190315807).
Chackerian et al. is discussed above.
Chackerian et al. is silent on linkers.
Linkers are well known in the art and routinely used in fusion proteins and include GGGS as used in a fusion protein in a VLP, see Carrillo Molina et al. paragraph 228.
One of ordinary skill in the art before the effective date of filing would be motivated to use linkers to improve flexibility for protein folding and movement so VLPs can form and antigens be expressed on the surface as taught by Chackerian et al. One of ordinary skill in the art before the effective date of filing would have the expectation of success as linkers are routinely used in fusion proteins.
Thus, it would have been prima facie obvious before the effective time of filing to modify the AP205 to use GGS linkers as taught by Carrillo Molina et al.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chackerian et al. (US20190201540A1) as applied to claims 1, 2, 6-8, 11-13, and 15 above, and further in view of Steyaert et al. (20210206880).
Chackerian et al. is discussed above.
Chackerian et al. is silent on the sequence of the single chain AP205 dimer.
Steyaert et al. teach a AP205 dimer that has a sequence at least 90% identical to instant SEQ ID# 7 (the individual AP205 in the prior art are at least 90% to SEQ ID# 26 in the dimer), see comparison sheet.
One of ordinary skill in the art before the effective date of filing would be able to choose any AP205 dimer sequence taught that can be used to display antigens. One of ordinary skill in the art before the effective date of filing would have the expectation of success as the sequence is used to display peptides on the surface.
Thus, it would have been prima facie obvious before the effective time of filing to modify the AP205 to use the sequence taught by Steyaert et al.
Claim(s) 9, and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chackerian et al. (US20190201540A1) as applied to claims 1, 2, 6-8, 11-13, and 15 above, and further in view of Wang (11112412).
Chackerian et al. is discussed above.
Chackerian et al. does not teach SSARS-CoV-2 RBM SEQ ID# 95.
For claims 9, and 16-7, Wang teaches SEQ 14 as the RBM (col 4, line 41) and this is identical to instant SEQ ID# 95 and this can detect neutralizing antibodies (patent claim 1).
For claims 18-19, one of ordinary skill in the art before the effective date of filing would have been motivated to use the modified AP205 VLP displaying SEQ ID# 95 to treat or immunize against SARS-CoV-2 as the VLPs are taught to be immunogenic by Chackerian et al.
One of ordinary skill in the art before the effective date of filing would know the RBM would be useful to make neutralizing antibodies that can be used to treat or prevent a SARS-CoV-1 infection and be motivated to use it as a vaccine antigen. One of ordinary skill in the art before the effective date of filing would have the expectation of success knowing it binds neutralizing antibodies.
Thus, it would have been prima facie obvious before the effective time of filing to modify the AP205 of Chackerian et al. to display the SARS-CoV-2 RBM of Wang and use to treat or immunize.
Allowable Subject Matter
Claim 10 is 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon-Fri.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/ Examiner, Art Unit 1671
/Shanon A. Foley/ Primary Examiner, Art Unit 1671