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/Disposition of Claims
Applicant’s Amendment filed on 31 March 2026 has been received and entered. Claims 1-5 and 7-9 were pending. Claims 1-2 and 4 have been amended. Claim 6 has been cancelled. No new claims have been added.
Accordingly, Claims 1-5 and 7-9 are currently pending and will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2022/0133875 A1, Published 05 May 2022. Applicant’s amended Specifications as presented on 23 December 2024 and 25 August 2021 are acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Response to Arguments
Applicant's arguments filed 31 March 2026 regarding the previous Office action dated 31 December 2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Claim Objections
Withdrawn Objections
(Objection Withdrawn) – The objection to Claims 1-2 for being substantial duplicates of each other is withdrawn in light of the amendments to the claims.
New Objections
(New Objection) – Claims 1-2 are objected to because of the following informalities: in both claims, it is suggested that they say “…wherein the method reduces the risk of…” instead of “…wherein the method reduces risk of…”.
Also, in Claims 1-2, it is suggested that they say “…in a fusion domain within the sequence…” instead of “…in a fusion domain within a sequence…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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.
Withdrawn Rejections
(Rejection Withdrawn) – The rejection of Claims 1-2, and dependent claims 3-5 and 7-9 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection Withdrawn) – The rejection of Claim 4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
New Rejections
(New Rejection – necessitated by amendment) – Claims 1-2, and dependent claims 3-5 and 7-9 thereof, 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.
Regarding Claims 1 and 2, they both recite the limitation “comprising a respiratory syncytial virus (RSV) F protein having a deletion of 1 to 10 amino acids in a fusion domain within a sequence corresponding to amino acids 137-146 of SEQ ID NO: 2”. The use of the phrase “a fusion domain” renders the claims indefinite because the wording of the claim implies that there are multiple fusion domains present and only one is being chosen. If there is only one fusion domain present, however, then the claims should reflect that. It is suggested that the claims be amended to recite “the fusion domain”, if only one such domain is present, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 1-2 are rejected on the grounds of being indefinite. Claims 3-5 and 7-9 are also rejected, since they depend on Claim 1 but do not remedy the deficiencies of Claim 1.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
For the purpose of examining these claims on their merits, Claim 4 will be interpreted such that the limitation “wherein the RSV F protein is anchored in the core” means that the protein is in the core and not anchored to the core. This means that there is a trans-detergent portion present.
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.
(Rejection Maintained) – The rejection of Claims 1-5 and 7-9 under 35 U.S.C. 103 as being unpatentable over Steff et al. (WO 2014/024026 A1, Published 13 February 2014) (cited on IDS filed on 11 November 2025), Smith et al. (US 2017/0202948 A1, Published 20 July 2017), and Pushko et al. (U.S. Patent No. 8,715,692 B2, Issued 06 May 2014) is maintained.
Response to Arguments
Applicant's arguments filed with respect to the rejection of Claims 1-5 and 7-9 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
In their Response, Applicant argues that “Steff teaches that a vaccine with an RSV F protein is only protective when used in combination with a B. pertussis antigen” (see Page 3 of Remarks, Paragraph 2) and “that immunizing with an RSV F antigen in the absence of a B. pertussis antigen, even in the presence of an adjuvant, failed to protect offspring born to immunized mothers from RSV challenge” (see Page 3, Paragraph 3). Applicant also argues that “Examiner has provided no further rationale for why a person having ordinary skill in the art might have been motivated to modify Steff with Smith and Pushko” and that therefore there “is no reasonable rationale for modifying Steff with Smith and Pushko” (see Page 3, Paragraph 3). Applicant then argues that the “specification of the present application describes results from the phase 3 clinical trial at paragraphs 98-100” (see Page 4, Paragraph 2), which Applicant alleges are surprising and unexpected, and that the combination of references “fails to lead a person having ordinary skill in the art to expect success at protecting offspring born to pregnant mothers specifically vaccinated between 28 and 33 weeks” (see Page 3, Last Paragraph and Page 4, First Paragraph).
Examiner finds the Arguments presented unpersuasive. Regarding the teachings of Steff et al., Examiner acknowledges that Steff et al. uses an additional antigen to see protection against RSV challenge. The instant claims, however, do not exclude the use of multiple antigens or specifically the use of a B. pertussis antigen. The instant claims recite a composition comprising the claimed RSV F protein, an aluminum-based adjuvant, and a non-ionic detergent core, but the instant composition can have additional components because “comprising” is open-ended. Thus, it is open to containing additional antigens, whether they are from RSV, a different respiratory virus, or a different kind of pathogenic microorganism altogether, the last of which is the case for Steff et al. If Applicant’s desire is for the only antigen present to be the instant RSV F protein, then the instant claims should be amended to explicitly recite that.
With regard to Applicant’s argument about the lack of rationale and motivation to modify Steff with Smith and Pushko, Examiner provided that in the rejection itself. As noted previously, the composition taught by Smith et al. promotes immunogenicity via enhanced epitope presentation and inhibits degradation of the antigen via improved stability, that the RSV F protein with the inactivated furin cleavage site would prevent the F protein from initiating fusion with the target cell membrane, and that the combination of the traits of Smith et al. and Pushko et al. would have made the composition of Steff et al. safer and more effective at eliciting an immune response. Additionally, all of the compositions of Steff et al., Smith et al., and Pushko et al. are related to and used to vaccinate or immunize against RSV, meaning that they have the same art-accepted purpose. It would therefore be obvious to combine them into one method of vaccination or immunization for that same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Regarding the alleged surprising and unexpected results presented by Applicant and that the combination of references would not lead to a PHOSITA vaccinating a pregnant woman between 28 and 33 weeks, Applicant is reminded that Affidavit evidence must be statistically significant: MPEP 716.02b: The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c). While Applicant has demonstrated practical significance, they have failed to demonstrate statistical evidence, which is needed. From the data provided, it is unclear if there is a change in efficacy. Even assuming arguendo that there is a pattern, i.e., statistical significance, there would still be a question of whether or not the prior art already knows that it is optimal. Steff et al. teach that there is an optimal window and time for maternal immunization and this optimal window is essentially the same as the instantly claimed window for maternal immunization. As such, it would have been obvious to a skilled artisan or practitioner to administer the vaccine to the pregnant woman during the optimal window and at a time which would allow for the best protection for the gestational infant in order to optimize the efficacy of the administered vaccine for both the mother and the infant. Therefore, for at least these reasons, the rejection of Claims 1-5 and 7-9 under 35 U.S.C. 103 as being unpatentable over is maintained.
Double Patenting
(Rejection Maintained) – The provisional rejection of Claims 1-5 and 7-9 on the ground of nonstatutory double patenting as being unpatentable over claims 103-105 and 118-121 of copending Application No. 19/153,322 in view of Steff et al. (WO 2014/024026 A1, Published 13 February 2014) (cited on IDS filed on 11 November 2025), Smith et al. (US 2017/0202948 A1, Published 20 July 2017), and Pushko et al. (U.S. Patent No. 8,715,692 B2, Issued 06 May 2014) is maintained.
Response to Arguments
Applicant's arguments filed with respect to the provisional rejection of Claims 1-5 and 7-9 on the ground of nonstatutory double patenting have been fully considered but they are not persuasive.
In their Response, Applicant argues “that the 19/153,322 copending application cannot be prior art for nonstatutory double patenting over the present application, which is earlier-filed” and that “the combination of Steff, Smith, and Pushko, fails to render the presently pending claims obvious” (see Page 5 of Remarks, Paragraph 2).
Examiner does not find these Arguments persuasive. With regard to the combination of the prior art references not rendering the instant claims obvious, that argument has been rebutted above in the context of the 103 rejection and will not be reiterated here. With regard to the copending application not being able to serve as prior art for a nonstatutory double patenting over the instant application if the instant application is the earlier-filed of the two, this argument is not persuasive. A copending application does not have to qualify as prior art in order to be used as the basis for raising a nonstatutory double patenting rejection over the application being examined. Any supporting references used for making the nonstatutory double patenting rejection must qualify as prior art, however, as is the case for the rejection in question. As stated in the heading for nonstatutory double patenting (see the previous Office Action), 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).” There also has to be at least some overlap between the inventive entities between the two applications. There is no mention, however, of when either application has been filed. Such information only becomes a consideration when the nonstatutory double patenting rejection is the only rejection outstanding for the instant application. See MPEP 804(I)(B)(1)(b)(i). Therefore, the provisional rejection of Claims 1-5 and 7-9 on the ground of nonstatutory double patenting as being unpatentable over the reference claims in view of Steff et al., Smith et al., and Pushko et al. is maintained.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below:
Pushko et al. (US 2014/0294879 A1, Published 02 October 2014)
Pushko et al. teach immunogenic compositions comprising modified RSV F proteins. This reference has not been utilized, as rejection would have been redundant those set forth above.
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 CAREY A STUART whose telephone number is (703)756-4668. The examiner can normally be reached Monday - Friday, 7:30 AM - 4:30 PM EST.
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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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