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 .
Applicants are informed that the rejections of the previous Office action not stated below have been withdrawn from consideration in view of the Applicant’s arguments and/or amendments.
Claims 14-22 are pending and are examined 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.
(Prior Rejection Maintained) Claims 14-22 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 pre-AIA the inventories), at the time the application was filed, had possession of the claimed invention.
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 requirements 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 BU 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.
Claims 14-22 are rejected as lacking adequate descriptive support for a possession of a nucleic acid molecule encoding one or more synthetic antibodies, wherein the nucleic acid molecule comprises at least one selected from the group consisting of:
a) a nucleotide sequence encoding an anti-Middle East Respiratory Syncytial Coronavrus (MERS-CoV) synthetic antibody; and
b) a nucleotide sequence encoding a fragment of an anti-MERS-CoV synthetic antibody.
The one or more antibodies bind to a MERS-CoV antigen selected from spike, RNA polymerase, nucleocapsid protein, envelope protein, matrix protein, any fragment thereof and any combination thereof.
The nucleotide sequence also has a cleavage domain, and a leader sequence. The nucleic acid molecule comprises an expression vector and the nucleic acid molecule can be part of a composition that can comprise a pharmaceutically acceptable excipient.
The nucleotide sequence encodes an amino acid sequence at least 85% identity to SEQ ID NO: 2 and is at least 85% identity to SEQ ID NO: 3; or an amino acid sequence at least 85% identity to SEQ ID NO:s 5 and 7.
In support of the claimed genus of a “nucleic acid sequence encoding an anti-MERS-CoV synthetic antibody or fragment thereof” the specification in Example 2 details 1 anti-MERS-CoV antibody, which comprises SEQ ID NO: 2 and is encoded by SEQ ID NO: 3 or comprises SEQ ID NO:s 5 and 7. While the claims and the specification contemplate that homologous amino acid and nucleic acid sequences relative to SEQ ID NO:s 2 and 3 or comprises SEQ ID NO:s 5 and 7, no derivatives or variants or mutants thereof are disclosed that can bind to a MERS-CoV antigen, such as spike, RNA polymerase, nucleocapsid protein, envelope protein, matrix protein, any fragment thereof and any combination thereof. Thus, the application fails to provide examples of any species within the claimed genus. Moreover, the decision arrived at in Amgen v. Sanofi, 598 US 594 (2023) supports expanded analysis of whether a claim drawn to an antibody being specific for an epitope, even a specific epitope, permits an applicant to pursue all possible antibodies that are capable of being produced against such an epitope. Presently, the claimed nucleic acid sequence does not require that specific structures are encoded (i.e., amino acid sequences for each CDR of the antibody). In view of the fact patterns detailed in Amgen v. Sanofi, applicants are in possession of the nucleic acid encoded anti-MERS-CoV antibody of SEQ ID NO: 2 and encoded by SEQ ID NO: 3 or the anti-MERS-CoV comprises SEQ ID NO:s 5 and 7.
In view of this uncertainty and the lack of a representative number of examples of the claimed genus, the claims are rejected for lack of adequate written description support.
Response to arguments:
Applicants arguments have been fully considered but are not persuasive:
The present invention requires a nucleotide sequence that encodes an antibody with at least 85% identity to SEQ ID NO: 2 or a nucleotide sequence that encodes an antibody comprising heavy and light chains having at least 85% identity to SEQ ID NO:s 5 and 7, respectively. The Complementary Determining Regions (CDRs) of the antibody have not been identified by applicant. In addition, the length of SEQ ID NO:s 2, 5 and 7 are 737, 474 and 234 amino acids, respectively. Based on the claim percent identity and the amino acid length of SEQ ID NO:s 2, 5 and 7, that amount of variation permitted by the claims allows for 100, 71 and 35 amino acids, respectively, to be mutated in these sequences. This degree of permittable variation and without knowing where CDRs are located in the variable domains of the claimed antibody, the mutations can occur in the CDRs which would impact the ability of the antibody to bind to a MERS coronavirus. As stated in the previous Office action and above, applicants have reduced to practice one antibody that comprises the claimed amino acids sequences. Therefore, in view of applicant’s disclosure, the functional importance of CDRs in epitope binding and the findings of the Amgen v. Sanofi, 598 US 594 (2023), applicants are not in possession of a nucleic acid sequence that encodes an amino acid sequence at least 85% identity to SEQ ID NO: 2 and is at least 85% identity to SEQ ID NO: 3; or an amino acid sequence at least 85% identity to SEQ ID NO:s 5 and 7; wherein the antibody binds to a MERS coronavirus, such as a MERS-CoV antigen selected from spike, RNA polymerase, nucleocapsid protein, envelope protein, matrix protein, any fragment thereof and any combination thereof.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a jomt research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AJA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/ATA/25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto- processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD- info-L jsp.
(Prior Rejection Maintained) Claims 14-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,230,592.
The patented invention is drawn to an antibody that binds to MERS-CoV and it comprises either SEQ ID NO: 2 or both SEQ ID NO:s 5 and 7. The antibody is encoded by a nucleotide sequence with at least 90% identity to SEQ ID NO: 3. SEQ ID NO: 2 comprises SEQ ID NO:s 5 and 7. Therefore, these antibodies are interpreted to be “homologous” to SEQ ID NO: 2 and encoded by a nucleic acid sequence “homologous” to SEQ ID NO: 3.
(Prior Rejection Maintained) Claims 14-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11981724 in view of Graham et al. (WO/16/138160).
The patented invention is drawn to a method administering a nucleotide sequence with at least 90% identity to SEQ ID NO: 3. SEQ ID NO: 2 comprises SEQ ID NO:s 5 and 7. While the patented invention is drawn to a method of using this antibody, it is identified in claim 1 as an “anti-Middle East Respiratory Syncytial Coronavirus” antibody.
Graham et al. teach isolating monoclonal antibodies and antigen binding fragments thereof that bind to MERS-CoV S protein (spike protein). [see page 34] They also teach nucleic acid molecules that encode the antibodies and antigen binding fragments thereof, host cells that express the antibodies and that expression vectors can be created that include the nucleic acid sequences. [see page 34, lines 9-20] Graham et al. teach that a leader sequence is present in the nucleic acid sequences, [see page 93, line 19]; a cleavage site can be included in a linker between the variable heavy and light chains [see page 93, lines 26-27]; and a pharmaceutically acceptable carrier or auxiliary substances that can suspend the different MERS-CoV specific products taught by Graham et al. (including nucleic acid sequences that encode antibodies). [see page 98, lines 16-20] Graham et al. provide specific examples of anti-MERS-CoV antibodies and the DNA that encodes these antibodies in Example 2, such as JC57-13 and JC57-11.One of ordinary skill in the art having read Graham et al. (see teachings summarized above) would be motivated to employ the antibody of ‘724 to treat a MERS-CoV infection in a subject. Therefore, the instant invention is rendered prima facie obvious to one of ordinary skill in the art.
Response to arguments:
Applicant presents the following arguments in traversal of the rejection:
Applicants request that the nonstatutory double patenting rejection be placed in abeyance until claims have actually issued or are deemed allowable in this application.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached on M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671