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 19 November 2025 has been received and entered. Claims 1-5 and 7-9 were pending. Claims 2 and 8 have been amended. Claim 6 was cancelled. No new claims were 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 19 November 2025 regarding the previous Office action dated 19 August 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 If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn.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arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Information Disclosure Statement
The information disclosure statements (IDSes) submitted on 10 February 2022, 11 November 2022, 16 March 2023, 29 July 2024, 24 October 2024, 13 March 2025, 14 July 2025, and 11 November 2025 have been considered, as a whole, by the examiner. Any individual references with strikethroughs, however, have not been considered if the references in question lack dates, for example.
Claim Objections
(Objection withdrawn) – The objection to Claim 8 for containing minor informalities is withdrawn in light of the amendments to the claim.
(New Objection – necessitated by amendment) – Claims 1-2 are objected to for the following reason: Applicant is advised that should claim 1 be found allowable, claim 2 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
(New Rejection) – Claims 1 and 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 “wherein the method induces an immune response against at least one symptom associated with RSV lower respiratory tract infection (LRTI)”. Immune responses are induced against an antigen. It is unclear how an immune response can be induced against a symptom. This lack of clarity renders the claims indefinite. It is suggested that the claims be amended to instead recite “wherein the method induces an immune response against the RSV F protein”, but Applicant is free to amend the claims as they deem necessary.
Furthermore, regarding Claims 1 and 2, they both recite the limitation “wherein the method induces an immune response against at least one symptom associated with RSV lower respiratory tract infection (LRTI)”. It is unclear what is meant by the term “associated with” and no definition is provided in the instant Specification. This term can be interpreted as meaning a symptom directly caused by the virus. Another interpretation is that those infected with RSV are more prone to exhibiting certain symptoms not as a direct result of infection with RSV, but perhaps through another means, such as a secondary infection with another infectious agent commonly acquired by those infected with RSV. This lack of clarity renders the claims indefinite. The claim language causes multiple interpretations. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
It is suggested that the phrase “associated with” be replaced with “caused by”, as long as such an amendment is supported by the originally-filed disclosure, 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 and 2 are rejected on the grounds of being indefinite. Claims 3-5 and 7-9 are also rejected since they depend upon Claim 1, but do not remedy the deficiencies of Claim 1.
Regarding Claims 1 and 2, they recite the limitation “a respiratory syncytial virus (RSV) F protein having a deletion of 1 to 10 amino acids corresponding to amino acids 137-146 of SEQ ID NO: 2”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 2 recite the broad limitation “a deletion of 1 to 10 amino acids corresponding to amino acids 137-146 of SEQ ID NO: 2”, and the claim also recites the deletion of amino acids 137-146, which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claims, and therefore not required, or (b) a required feature of the claims. Currently, it is unclear if the phrase “corresponding to” gives only an example of the deletion or is required by the claims. Said another way, the claims could be interpreted to require deletion of all of 137-146 of SEQ ID NO: 2 in all embodiments or only 1-10 residues thereof. The presence of multiple structural interpretations renders the claims indefinite.
Additionally, Claims 1 and 2 also recite the limitation “an inactivated primary furin cleavage site corresponding to amino acids 131 to 136 of SEQ ID NO: 2, the primary furin cleavage site being inactivated by mutation”. It is unclear based on the claim language used if the recited amino acids, 131-136 of SEQ ID NO: 2, are already mutated or if they can be further mutated. Furthermore, it is unclear if regions upstream and/or downstream can be mutated. The lack of clarity in the claims leads to multiple possible interpretations. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 1 and 2 are rejected on the grounds of being indefinite. Claims 3-5 and 7-9 are also rejected since they depend upon Claim 1, but do not remedy the deficiencies of Claim 1.
Regarding Claim 4, it recites the limitation “wherein the composition comprises a nanoparticle comprising a non-ionic detergent core and the RSV F protein, wherein the RSV F protein is associated with the core and the detergent of the non-ionic detergent core is present at about 0.03% to about 0.05%”. It is unclear what the term “associated with” means in this context and no definition is provided in the instant Specification. One interpretation is that the F protein is physically bound to the core, such as through a linker of some kind. Another interpretation is that the F protein is interacting with the core through noncovalent bonds or electrostatic interactions. This lack of clarity renders the claim indefinite. It is suggested that the claim be amended by clarifying exactly how the F protein interacts with the core, as long as said amendment is supported by the originally-filed disclosure, but Applicant is free to amend the claim as they deem necessary. Also, it is unclear from the claim exactly what the claimed percentages are referring to. One interpretation is that it is referring to mass/volume. Another interpretation is that it is referring to mass/mass. The presence of multiple interpretations renders the claim indefinite. It is suggested that the claim be amended to specify how the percentages should be interpreted without use of parentheses and for both values, as long as said amendment is supported by the originally-filed disclosure, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 4 is rejected on the grounds of being indefinite. Claim 5 is also rejected since it depends upon Claim 4, but does not remedy the deficiencies of Claim 4.
Many issues above are owed to multiple interpretations. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
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.
(New Rejection) – Claims 1-5 and 7-9 are rejected 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) (cited in a previous Office Action), and Pushko et al. (U.S. Patent 8,715, 692 B2, Issued 06 May 2014) (cited in a previous Office Action).
Steff et al. teach a method for protecting infants against disease caused by RSV through maternal immunization using recombinant RSV antigens to reduce the incidence or severity of RSV infection in young infants (see Abstract). Steff et al. also teach wherein said method comprises administering an immunogenic composition comprising a recombinant RSV F protein analog induces a humoral immune response, wherein the maternal antibodies generated are transferred to the gestational infant via the placenta, thereby conferring protection against infection and/or disease caused by RSV (see Paragraphs 018-020). Additionally, Steff et al. teach wherein said immunogenic composition further comprises an adjuvant, such as alum (see Paragraph 031). Finally, Steff et al. teach that said immunogenic composition comprising the RSV F protein analog can be administered during the third trimester of pregnancy, such as between 28 and 34 weeks of gestation (see Paragraphs 032-033, 073). The method of maternal immunization disclosed by Steff et al. would have been effective at protecting a gestational infant from RSV infection because, as disclosed by Steff et al., the “timing of maternal immunization is designed to allow generation of maternal antibodies and transfer of the maternal antibodies to the fetus. Thus, favorably sufficient time elapses between immunization and birth to allow optimum transfer of maternal antibodies across the placenta. Antibody transfer starts in humans generally at about 25 weeks of gestation, increasing up 28 weeks and becoming and remaining optimal from about 30 weeks of gestation. A minimum of two to four weeks is believed to be needed between maternal immunization as described herein and birth to allow effective transfer of maternal antibodies against RSV F protein” (see Paragraph 073). Steff et al. then state that “maternal immunization can take place any time after 25 weeks of gestation” and that favorable “maternal immunization is carried out between 26 and 38 weeks, such as between 28 and 34 weeks of gestation” (see Paragraph 073) and “at least two or at least three or at least four or at least five or at least six weeks prior to the expected delivery date of the infant and that the timing “of administration may need to be adjusted in the case of a pregnant female who is at risk of an early delivery, in order to provide sufficient time for generation of antibodies and transfer to the fetus” (see Paragraph 074).
They do not teach a vaccine composition comprising a nanoparticle comprising a non-ionic detergent core and a viral glycoprotein, wherein said viral glycoprotein is an RSV F protein comprising a deletion of 1 to 10 amino acids and wherein said detergent is selected from the group consisting of PS-20, PS-40, PS-60, and PS-80 and is present at about 0.03% to about 0.05%. Steff et al. also do not teach an RSV F protein comprising any of SEQ ID NOs: 3-12 or 19.
This deficiency is remedied by Smith and Pushko.
Smith et al. teach a vaccine composition comprising a nanoparticle comprising a non-ionic detergent core and a viral glycoprotein, wherein said viral glycoprotein is associated with the core and the detergent is present at about 0.03% to about 0.05%, wherein the non-ionic detergent is selected from the group consisting of PS-20, PS-40, PS-60, and PS-80, and wherein said viral glycoprotein is an RSV F protein comprising a deletion of 1 to 10 amino acids corresponding to amino acids 137-146 of SEQ ID NO: 2 and an inactivated primary furin cleavage site, wherein the primary furin cleavage site is inactivated by mutation (see Claims 1-2, 4). Smith et al. also teach wherein said vaccine composition comprises an alum adjuvant and wherein said RSV F protein comprises reference SEQ ID NO: 19, which is 100% identical to instant SEQ ID NO: 19 (see Sequence Listing; Claims 7-8, 24-25). Finally, Smith et al. teach a method of administering said vaccine composition to a pregnant female adult (see Paragraphs 0014-0015; Claims 19, 23).
Pushko et al. teach a vaccine composition comprising alum as an adjuvant and an RSV F protein comprising patented SEQ ID NO: 8, which is 100% identical to instant SEQ ID NO: 8 (see Sequence Listing; Claims 1, 8, 12-17). It is noted that SEQ ID NO. 8 meets the structural requirements of the genus of Smith and so would be obvious to use in the method of Smith above, meeting said requirements making it predictably functional therein.
A person having ordinary skill in the art would have been motivated to modify the teachings of Steff et al. with those of Smith et al. and Pushko et al. in order to develop a method of maternal immunization comprising administering a composition comprising an RSV F protein and an adjuvant to a pregnant woman. It would have been obvious to a skilled artisan to use composition disclosed by Smith et al. in the method taught by Steff et al. as the nanoparticle structure promotes immunogenicity via enhanced epitope presentation and inhibits degradation of the antigen via improved stability, as disclosed by Smith et al. (see Paragraphs 0003 and 0008). It would have been obvious to a skilled artisan to use the RSV F protein disclosed by Pushko et al. in the method taught by Steff et al. because the Pushko sequence contains a deletion in the N-terminal half of the fusion domain and inactivation via mutation of one of the two furin cleavage sites. As disclosed by Pushko et al., the inactivated furin cleavage site is adjacent to a fusion peptide and cleavage at both sites is needed for membrane fusion (Column 2, Lines 36-43) as the fusion peptide associates with the host cell membrane and promotes fusion of the membrane of the virus or an infected cell with the target cell membrane. The combination of these traits would have made the immunogenic composition of Steff et al. safer and more effective at eliciting an immune response. One of ordinary skill in this art would have recognized these advantages based on the teachings of the prior art and so the claims above are obvious. Furthermore, all the compositions of Steff, Smith, and Pushko are related and used to vaccinate against RSV. Thus, they have the same art accepted purpose. It is therefore obvious to combine them into one method of vaccination for that same purpose. Therefore, a method using all immunogens from RSV discussed above for the purpose of Steff is obvious here. “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).
It is noted that the wherein clauses of the claims rejected above are simply intended results of the method steps positively recited. They are therefore not given weight; however, even if they were, the steps are present in the obvious method above and so the results will necessarily occur. The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. > See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative steps”). < In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id.
Response to Arguments
Applicant's arguments filed 14 July 2025 and 19 November 2025 have been fully considered but they are not persuasive.
In their Response field on 14 July 2025, Applicant argued that the Novavax reference cited by Examiner was not enabling for what it supposedly taught. As the Novavax reference has not been utilized in this new rejection, the arguments presented against it have been rendered moot. Any deficiencies present in the Smith et al. and Pushko et al. references have been cured by the inclusion of the Steff et al. reference, which teaches maternal immunization during the same period of gestation as the instant claims. As such, a person having ordinary skill in the art would have had a reasonable expectation of success and of having the same or similar results as provided by the instant application. Additionally, Steff et al. teach that there’s an optimal window and time for maternal immunization and this optimal window is essentially the same as the instantly claimed window for maternal immunization and it has been held that in cases “where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” and that “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close” (see MPEP 2144.05(I)). Furthermore, it has also been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (see MPEP 2144.05(I)). 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.
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.
(Rejection withdrawn) – The provisional rejection of Claims 1, 3-5, 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 (reference application) in view of Dormitzer (US 20140044751 A1), Smith et al. (US 20170202948 A1), and Pushko et al. (U.S. Patent No. 8,715,692 B2) is withdrawn.
(New Rejection) – Claims 1-5 and 7-9 are provisionally rejected 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) (cited in a previous Office Action), and Pushko et al. (U.S. Patent 8,715, 692 B2, Issued 06 May 2014) (cited in a previous Office Action).
Both claim sets are drawn to an RSV F protein comprising an F1 domain, an F2 domain, and p27, wherein the F protein comprises a deletion of 1-10 amino acids corresponding to amino acids 137-146 and an inactivated primary cleavage site. Both claim sets are also drawn to a composition comprising said RSV F protein, wherein the composition comprises a nanoparticle with a detergent core, the RSV F protein, and an adjuvant, wherein the detergent is selected from PS-20, PS-40, PS-60, PS-65, and PS-80. The main differences between the instant claims and the reference claims are that the instant claims are drawn to a method of maternal immunization comprising administering said composition to a pregnant woman who is about 28 weeks to about 33 weeks pregnant, while the reference claims are drawn to the RSV F protein itself comprising specific sequences for the inactivated furin cleavage site as well as additional modifications and an immunogenic composition comprising said F protein and a pharmaceutically acceptable buffer. Although the instant claims are method claims, they recite a method of using the F protein of the reference claims and it would have been obvious to a person having ordinary skill in the art to use the reference product in the method of the instant claims.
The previous teachings of Steff et al., Smith et al., and Pushko et al. have been summarized above.
A person having ordinary skill in the art would have been motivated to modify the teachings of the reference claims with those of Steff et al., Smith et al., and Pushko et al. in order to develop a method of maternal immunization comprising administering a composition comprising an RSV F protein and an adjuvant to a pregnant woman. It would have been obvious to a skilled artisan to use composition disclosed by Smith et al. in the method taught by Steff et al. as the nanoparticle structure promotes immunogenicity via enhanced epitope presentation and inhibits degradation of the antigen via improved stability, as disclosed by Smith et al. (see Paragraphs 0003 and 0008). It would have been obvious to a skilled artisan to use the RSV F protein disclosed by Pushko et al. in the method taught by Steff et al. because the Pushko sequence contains a deletion in the N-terminal half of the fusion domain and inactivation via mutation of one of the two furin cleavage sites. As disclosed by Pushko et al., the inactivated furin cleavage site is adjacent to a fusion peptide and cleavage at both sites is needed for membrane fusion (Column 2, Lines 36-43) as the fusion peptide associates with the host cell membrane and promotes fusion of the membrane of the virus or an infected cell with the target cell membrane. The combination of these traits would have made the immunogenic composition of Steff et al. safer and more effective at eliciting an immune response. One of ordinary skill in this art would have recognized these advantages based on the teachings of the prior art and so the claims above are obvious. Furthermore, all the compositions of Steff, Smith, and Pushko are related and used to vaccinate against RSV. Thus, they have the same art accepted purpose. It is therefore obvious to combine them into one method of vaccination for that same purpose. Therefore, a method using all immunogens from RSV discussed above for the purpose of Steff is obvious here. “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).
It is noted that the wherein clauses of the claims rejected above are simply intended results of the method steps positively recited. They are therefore not given weight; however, even if they were, the steps are present in the obvious method above and so the results will necessarily occur. The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. > See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative steps”). < In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 19 November 2025 have been fully considered but they are not persuasive.
In their Response, Applicant argues that the “present patent application was filed on August 25, 2021, and has an earliest non-provisional filing date (PCT/US2020/019721) of February 25, 2020” and the copending “application no. 19/153,322 was filed on August 2, 2025, with an earliest non-provisional filing date (PCT/US2024/014509) of February 5, 2024, which is later than the earliest non-provisional filing date of the presently pending application” (see Page 2 of Remarks, First Paragraph). Applicant also argues that in “Allergan, the court held that a first-filed, first-issued claim cannot be invalidated under nonstatutory double patenting by a later-filed, later-issued claim, even if the first-issued claim expires later than the later-issued claim due to PTA” and that the PTAB confirmed in Appeal #2024-002920 “that Allergan similarly applies in a case where co-pending applications do not share a priority date” (see Page 2, Paragraph 2). Applicant then argues that the “same fact pattern as in Appeal #2024-002920 applies to the present application and the 19/153,322 copending application” and that said “copending application cannot be prior art for nonstatutory double patenting over the present application, which is earlier-filed” (see Page 2, Paragraph 2). While Examiner agrees with the arguments presented overall, an important aspect of the argument presented by Applicant is that said provisional nonstatutory double patenting rejection, in order to be withdrawn, must be the only rejection remaining in the earlier-filed application. See MPEP 804(I)(B)(1)(b)(i). This was the case in the previous Office Action mailed on 19 August 2025. This is no longer the case, however. As such, instant Claims 1-5 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 103-105 and 118-121 of the reference application in view of Steff et al., Smith et al., and Pushko et al.
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:
Smith et al. (US 2016/0000902 A1, Published 07 January 2016)
Smith et al. disclose a combination composition comprising an RSV component and 1-4 influenza components and methods using said combination composition for inducing immune responses against both viruses at the same time. This reference has not been utilized, as rejection would have been redundant to those set forth above.
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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671