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 .
Response to Amendment
The amendment filed 29 August 2025 in which claims 67, 71, 73-76, 79, 82, and 84-87 were amended has been entered.
Claims 67-87 are under examination on the merits.
Specification
(Previous objection, withdrawn). Applicant’s amendments to the Specification submitted on 29 August 2025 have overcome the objection previously set forth in the Non-Final Office Action mailed on 29 April 2025.
Drawings
(Previous objection, withdrawn). Applicant’s amendments to the Drawings submitted on 29 August 2025 have overcome the objection previously set forth in the Non-Final Office Action mailed on 29 April 2025.
Claim Objections
(Previous objections, withdrawn as to claim 67). Applicant’s amendments to claim 67 have overcome previous objections to claim 67.
(Previous objections, withdrawn as to claims 73-76 and 84-87). Applicant’s amendments to claim 67 have overcome previous objections to claim 67.
Claim Rejections - 35 USC § 112
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.
(Previous rejection, withdrawn as to claims 71 and 82). Claims 71 and 82 were 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 joint inventor (or for application subject to pre-AIA 25 U.S.C. 112, the applicant), regards as the invention.
See claims 71 and 82 as submitted on 29 August 2025.
Applicant’s amendments to claims 71 and 82 have overcome previous rejection to the instant claims.
(Previous rejection, withdrawn as to claim 79). Claim 79 was 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 joint inventor (or for application subject to pre-AIA 25 U.S.C. 112, the applicant), regards as the invention.
Applicant’s amendment to claim 79 has overcome previous rejection to the instant claims.
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.
(New rejection, necessitated by amendment to claims 71 and 82). Claims 71 and 82 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.
Neither the instant specification nor the originally filed claims appear to provide support for the phrase “an oil-in-water emulsion adjuvant containing squalene”. A trademark/tradename (e.g. MF-59) only defines the source of the product—not the product itself. As such, the disclosure of “MF-59” in Specification does not provide support for “an oil-in-water emulsion adjuvant containing squalene,” rather, only a specific source of an oil-in-water emulsion adjuvant containing squalene.
Thus, such a phrase constitutes NEW MATTER. In response to this rejection, Applicant is required to point to support for the phrase or to cancel the new matter
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(Previous rejection, maintained as to claims 67-69). Claims 67-69 were rejected under 35 U.S.C. 103 as being prima facie obvious over Kugelman et al, Tegally et al, Xia and Arashkia et al.
(Previous rejection, maintained as to claims 70-72 and 77-78). Claims 70-72 and 77-78 were rejected under 35 U.S.C. 103 as being prima facie obvious over Kugelman et al, Tegally et al, Xia, Arashkia et al, and Starry et al.
(Previous rejection, maintained as to claims 73-76). Claims 73-76 were rejected under 35 U.S.C. 103 as being prima facie obvious over Kugelman et al, Tegally et al, Xia, Arashkia et al, Starry et al, and Morein et al.
(Previous rejection, maintained as to claims 79-83). Claims 79-83 were rejected under 35 U.S.C. 103 as being prima facie obvious over Kugelman et al, Tegally et al, Xia, Arashkia et al, Starry et al, and Vogel et al (Prior Art of Record).
(Previous rejection, maintained as to claims 84-87). Claims 84-87 were rejected under 35 U.S.C. 103 as being prima facie obvious over Kugelman et al, Tegally et al, Xia, Arashkia et al, Starry et al, Vogel et al, and Morein (Prior Art of Record).
Arguments
Applicant’s arguments filed 29 August 2025 have been fully considered but they are not persuasive.
Applicant contends on pages 10-11 of the Remarks submitted on 29 August 2025:
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In response: The Declaration under 37 CFR 1.130(b) submitted on 29 August 2025 was fully considered, but was found insufficient to disqualify Arashkia as prior art under the 35 U.S.C. 102(b)(1)(B) exception. One of the inventors, Gale Smith, asserts in the Declaration that he is a named author on Tian, which is a prior public disclosure, but does not assert that he actually invented the relevant subject matter, which is required under Rule 1.130(b).
It is noted that the Tian reference currently constitutes prior art under at least 35 USC 102(a)(1). While the paper was published within one year of the instant application filing date and has all three named inventors of the instant application listed as authors, so are 27 additional individuals who are not inventors on the instant application. See § MPEP 2153.01: if application names fewer joint inventors than a publication (e.g., the application names as joint inventors A and B, and the publication names as authors A, B and C), it would not be readily apparent from the publication that it is an inventor-originated disclosure and the publication would be treated as prior art under AIA 35 U.S.C. 102(a)(1) unless there is evidence of record that an exception under AIA 35 U.S.C. 102(b)(1) applies.
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.
(Previous rejection, withdrawn as to claims 67-78). Claims 67-78 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 58-68 and 70-75 of copending Application No. 17795337. Applicant’s arguments, see pgs. 11-12, filed 29 August 2025, with respect to claims 67-78 have been fully considered and are persuasive.
(Previous rejection, withdrawn as to claims 79-87). Claims 79-87 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 58, 68, and 72-75 of copending Application No. 17795337 in view of Stary et al. Applicant’s arguments, see pgs. 11-12, filed 29 August 2025, with respect to claims 67-78 have been fully considered and are persuasive.
(Previous rejection, maintained as to claims 67 and 70-73). Claims 67 and 70-73 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46 and 58 of copending Application No. 18715010.
(Previous rejection, maintained as to claims 68, 69, 77, and 78). Claims 68, 69, 77, and 78 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46 and 58 of copending Application No. 18715010 in view of Kugelman et al, Tegally et al, Xia, and Arashkia et al.
(Previous rejection, maintained as to claims 74-76). Claims 74-76 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 58 of copending Application No. 18715010 in view of Morein et al.
(Previous rejection, maintained as to claims 79-84). Claims 79-84 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46 and 58 of copending Application No. 18715010 in view of Kugelman et al, Tegally et al, Xia, Arashkia et al, Stary et al, and Vogel et al.
(Previous rejection, maintained as to claims 85-87). Claims 85-87 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 58 of copending Application No. 18715010 in view of Kugelman et al, Tegally et al, Xia, Arashkia et al, Stary et al, and Vogel et al, and Morein et al.
Arguments
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Applicant contends on pages 12-13 of the Remarks submitted on 29 August 2025:
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In response:
It is well established that a nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy so as to prevent the unjustified or improper timewise extension of the right to exclude granted by a patent. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). However, a double patenting rejection also serves public policy interests by preventing the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982). These are two coequal considerations, i.e., an unjustified or improper timewise extension is not a condition precedent that must be satisfied before consideration can be given to possible harassment by multiple assignees.
Moreover, the decision in Allergen was limited to the proposition that a first-filed, first-issued patent that expires later due to patent term adjustment (PTA) is not subject to an obviousness-type double patenting (ODP) challenge over a later-filed, later-issued patent in the same family. Here, neither the instant application nor the conflicting application have issued, and are not members of the same family. Given that prosecution is ongoing in both applications, the final determination of which application would actually expire first, if issued—or even when any issued patent would expire—cannot be determined at least because PTA covered delays by Applicant and/or the Office can still occur.
Ex Parte Baurin is currently on rehearing so its applicability and precedential value to the instant application action have yet to be resolved. See Appeals Review Panel Order, issued 03/05/2026.
Applicant contends on pages 13-14 of the Remarks submitted on 29 August 2025:
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In response: As discussed above in detail above, the Declaration, while fully considered, was found insufficient to disqualify Arashkia as prior art under the 35 U.S.C. 102(b)(1)(B) exception.
Conclusion
NO CLAIMS ARE ALLOWED
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 Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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, 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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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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