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 .
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 9/9/2024; 12/9/2024; 4/10/2025; and 6/18/2026 have been considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in paragraphs [0049 and 0086] of the instant published application, USPgPub 2024/0423926. 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.
Claim Objections
Claim 25 is objected to because of the following informalities: the claim lacks a period. Appropriate correction is required.
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 joint 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 AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /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/apply/applying-online/eterminal-disclaimer.
Claims 21-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,083,228.
Claims 1 and 16 of ‘228 are drawn to a method of reducing exacerbations of chronic obstructive pulmonary disease (COPD) in a human subject comprising administering a about 0.03% to about 0.05% of a non-ionic detergent and an RSV F glycoprotein, anticipating instant claims 21-24. Claim 10 of ‘228 recites that the molar ratio of the non-ionic detergent to viral glycoprotein is about 30:1 to about 60:1, anticipating instant claim 25. Claim 8 of ‘228 anticipates the nonionic detergent is selected from PS20, PS40, PS60, PS65, and PS80, anticipating instant claim 26. Claims 15 and 16 of ‘228 recites that the non-ionic detergent is PS80, anticipating instant claim 27. Claim 12 of ‘228 anticipates claim 28, that the vaccine is substantially free of another detergent. Claim 2 of ‘228 states that the exacerbation is caused by an environmental insult, as required by instant claim 29 and claims 4 and 5 of ‘228 state that the environmental insult is selected from influenza or RSV, anticipating claim 30. Claim 6 of ‘228 anticipates instant claim 31, requiring the incidence of exacerbations is reduced by about 50% as determined by hospitalization rate. Claim 7 of ‘228 requires that the human is at least 60 years old, anticipating instant claim 32. Claim 9 of ‘228 states that the vaccine further comprises at least one of an influenza HA and NA protein, anticipating claim 33. Claim 11 of ‘228 recites the RSV F protein comprises a deletion of 1to 10 amino acids corresponding to amino acids 137-146 of SEQ ID NO:2 and an inactivated primary furin cleavage site corresponding to amino acids 131 to 136 of SEQ ID NO:2, wherein the primary furin cleavage site is inactivated by mutation, anticipating instant claim 34, and claims 13 and 17 of ‘228 state that the RSV F protein is selected from the group consisting of SEQ ID NOS: 2-13 and variants of SEQ ID NOS: 2-13 lacking part or all of the N- terminal signal peptide, as required by instant claim 35. Claim 14 of ‘228 requires that the RSV F protein consists of SEQ ID NO: 19, anticipating instant claim 36.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
De Serres et al. (Journal of Clinical Virology. 2009; 46: 129-133) discuss exacerbations of COPD caused by viral and bacterial infections, see Tables 1 and 2.
Zwaans et al. (Journal of Clinical Virology. 2014; 61: 181-188) provide a review of studies correlating various respiratory virus infections and COPD exacerbations, see Figure 1 and Tables 3 and 4.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671
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