DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/31/25 has been entered.
Disposition of Claims
Claims 1-2, 4, 6-8, 11, 13-15, and 17-25 remain pending. No amendments to pending claims have been presented. Claims 1-2, 4, 6-8, 11, 13-15, and 17-25 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 US20230277655A1, Published 09/07/2023.
Response to Arguments
Applicant's arguments filed 12/31/2025 regarding the previous Office action dated 10/02/2025 have been fully considered and are addressed herein.
Terminal Disclaimer
The terminal disclaimer filed on 06/10/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 11,524,069 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The terminal disclaimer filed on 06/10/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of 11,207,403 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
The claim interpretation was presented in an earlier Office action and will not be repeated herein.
Double Patenting
The text regarding nonstatutory double patenting was presented in a previous Office action.
(Rejection withdrawn.) The provisional rejection of claims 1-2, 4, 6-8, 11, 13-15, and 17-25 on the ground of nonstatutory double patenting as being unpatentable over claims 19-38 of copending Application No. 19/020,003 (reference application) in view of Rigaut (US20170360923A1; CITED ART OF RECORD) is withdrawn in light of the new rejection infra.
(New rejection.) Claims 1-2, 4, 6-8, 11, 13-15, and 17-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-38 of copending Application No. 19/020,003 (reference application) in view of Rigaut (US20170360923A1; CITED ART OF RECORD) and Burakova et. al. (Burakova Y, et. al. Viral Immunol. 2018 Jan/Feb;31(1):11-22. Epub 2017 Jun 15.; hereafter “Burakova”.)
The applied reference (Rigaut) has a common Assignee (Sanofi Pasteur) and inventor (Jean Haensler) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Although the claims at issue are not identical, they are not patentably distinct from each other because both are claiming immunogenic compositions comprising HCMV antigens, namely HCMV gB and HCMV pentameric complex antigens (complex comprising UL128/UL130/UL131/gH/gL). Both claim the composition comprises a Th1-inducing adjuvant. Both claim mutations to the endoproteolytic cleavage site in gB, both claim the use of gB and/or gH which lacks the transmembrane domain. Both claim the use of the ectodomain of the full length gH encoded by the UL75 gene. Both claim the use of the immunogenic composition as a vaccine, wherein said vaccine increases neutralizing antibody levels and/or persistence of anti-HCMV neutralizing antibodies. Both claim identical sequences for HCMV gB.
The main difference between the instant claims and the ‘003 claims is the Th1-inducing adjuvant, as the instant claims provide that said adjuvant is a TLR-4 agonist, while the ‘003 claims are drawn to the use of a linear or branched polyacrylic acid polymer salt with an average molecular weight (MW) in the range of 350 to 650 kDa. However, switching out one adjuvant which has a similar mechanism of immune stimulation for another would be a common optimization or functional analysis for vaccine compositions for a skilled artisan, and Th1-inducing adjuvants, such as the TLR-4 agonist GLA or a linear or branched polyacrylic acid polymer such as CARBOPOL ®, PAA20, or PAA225000, would be obvious to a skilled artisan, especially given the teachings of Rigaut and Burakova. Rigaut teaches immunological and vaccine formulations comprising a newly applied non-crosslinked polyacrylic acid polymer adjuvant (entire document; see abstract), wherein said adjuvant is a linear or branched polyacrylic acid polymer for use as an adjuvant in a vaccine composition, characterized in that said polyacrylic acid (PAA) polymer salt has a weight average molecular weight Mw in the range of 350 to 650 kDa (entire document; see reference claim 1). Said higher MW PAA were not as reproducible in their adjuvanting effects (¶[0004-0008]), and the lower MW PAA appeared to be safer and produce more reproducible immunogenic results, especially strong Th1 responses (¶[0009-0030]). A skilled artisan would be aware that TLR4 agonists on the market, such as GLA or 3D-MPL, could be used as adjuvants and induce a Th1-balanced response. The data provided by Rigaut (see e.g. ¶[0289-0292]) would suggest the novel PAA adjuvants would induce similar Th1 immune response results as the TLR4 agonists of the instant claims, and substitution of PAA for a TL4 agonist (or vice-versa) would be a substitution of one known element with another to test the effects of these adjuvants on the HCMV composition, especially since Rigaut tests the adjuvanting effects of these PAA on HCMV antigens such as gB (¶[0255-0309]; Figs. 2-5). Additionally, Burakova details the use of polyacrylic acid polymers (carbomers) such as CARBOPOL® in veterinary medicine, and shows that these adjuvants can induce IFN-gamma production and T-cell differentiation in pigs after vaccination with modified live porcine reproductive and respiratory syndrome (PRRS) virus vaccine, as well as improving the efficacy of a DNA vaccine against equine herpes virus. Burakova notes that the exact mechanism of carbomer-mediated adjuvanticity has yet to be elucidated. Previous studies proposed the ability of these crosslinked polymers to entrap and slowly release antigenic molecules stimulating immune cells, while recent research findings suggest that polyacrylic acid polymer can promote Th1 cell responses through improved uptake of antigens by antigen-presenting cells (APCs) without the activation of pattern recognition receptors (PRRs)(p. 16, rt. Col., ¶2). Burakova teaches that TLR4 agonists, such as lipopolysaccharide-based adjuvants (e.g. MPLA, AS04, etc.), elicit Th1 activation and have been utilized extensively in human vaccines (p. 4, ¶ bridging cols.)
Therefore, given what was known in the prior art at the time of filing regarding Th1-inducing adjuvants, the differences between the adjuvants used in the instant claims and the ‘003 claims would be obvious, and the substitution for one known element for another would be obvious for a skilled artisan given the teachings of Rigaut and Burakova. For at least these reasons, the instant claims and the ‘003 claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to arguments
Applicant's arguments filed 06/10/2025 have been fully considered but they are not entirely persuasive.
Applicant provides extensive arguments citing case law, namely Allergan USA, Inc. v. MSN Lab ‘ys Priv. Ltd, 111 F.4th 1358, 1367 (Fed. Cir. 2024)(hereafter “Allergan”). The Applicant argues that the Federal Circuit reversed a lower court’s invalidation of a patent based upon a later-filed, later-issued, earlier-expiring patent in the same family with the same effective filing date, concluding that it would not serve as a proper reference against the claims on appeal for purposes of non-statutory double patenting regardless of any concern possibility of multiple suits against an accused infringer by different assignees of patents (p. 1 of “Remarks” from 12/31/2025). First, it should be noted that the fact pattern in the instant claims and the Allergan claims is different (as even noted by Applicant in their arguments); one important distinction is that neither the instant claims nor the ‘003 claims have yet been patented and are both still copending. Therefore, due to the pending nature alone of the ‘003 patent claims and the fact that it is in the same patent family with the same disclosure, it is unclear how the claims in the ‘003 application will be amended over the course of prosecution. Applicant argues that the instant claims cannot be improperly extended because of the terminal disclaimers already filed over the ‘069 and ‘403 patents, and therefore it is unnecessary to require a terminal disclaimer over the ‘003 reference claims. Again, as ‘003 is still pending, and the ‘003 disclosure is a CON of the instant disclosure and the ‘069 patent disclosure, said claims could be amended in that application to be identical to either the instant claims or the ‘069 claims. Said claims in ‘003 could also be amended to be patentably distinct from not only the instant claims, but also the ‘069 and ‘403 patents. The Examiner has not yet been assigned in the ‘003 application, and could allow claims without properly raising the NSDP rejections necessary in the ‘003 application. The Office cannot predict how the ‘003 claims will be amended by the Applicant or prosecuted by the Office. To further clarify, the issue of shielding does not apply in the instant fact pattern as no restriction was ever set forth in this patent family. The rules of the USPTO as laid out in the MPEP require a terminal disclaimer over those copending claims as they are obvious variants of the instant claims and are not patentably distinct, and because both applications are pending and have the same effective filing date.
The MPEP very clearly sets forth what is required of the Office in such an instance. MPEP 804.I.B.1.b.(ii):
“(ii) Application under examination has the same patent term filing date
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.”
Again, referring to MPEP 804:
“The doctrine of nonstatutory double patenting also seeks to prevent 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) (citing Chisum, Patents, § 9.04(2)(b) (1981) ). A terminal disclaimer, submitted in compliance with 37 CFR 1.321(c) or (d) to overcome a double patenting rejection, includes a provision that the patent or any patent issuing from the application is only enforceable for and during such period that it is owned by the same party (or parties) that owns the other patents or applications, identified in the terminal disclaimer, that claim obvious variations of one invention. Van Ornum, 686 F.2d at 944-45, 214 USPQ at 767 (citing Chisum, Patents, § 9.04(2)(b) (1981)).”
It is also of note that the Federal Circuit has conflicting case law on this matter (e.g. In re Cellect; LLC, 81 F.4th 1216 (Fed. Cir. 2023)), and Applicant is also directed to recent PTAB hearing findings regarding NSDP (Ex Parte Baurin, Appeal 2024-002920, Application No. 17/135,529 (PTAB Nov. 6, 2024); recent PTAB decision in 17/409,019). Therefore, as the Examiner as a representative of the Office is tied to following the instructions for prosecution outlined in the MPEP for the fact pattern of their particular case, and as the MPEP states that the terminal disclaimers are required over copending claims in Applicant-related applications with the same effective filing date if the claims are patentably indistinct, the Office maintains that it is proper to maintain the rejection until the appropriate terminal disclaimers are filed or until the claims are amended in such a way to be patentably distinct. Therefore, this line of argument is not persuasive.
Applicant argues that the test for obviousness was not properly performed, in that the analysis was “turned around” (p. 4 of “Remarks”). The Office disagrees. As MPEP 804.II.B.4 notes, the one-way test for distinctness applies if the patent term filing date of the application under examination is the same or later than that of a reference application or patent, only a one-way determination of distinctness is needed in resolving the issue of double patenting, i.e., whether the invention claimed in the application would have been anticipated by, or an obvious variation of, the invention claimed in the reference application or patent. See, e.g., In re Berg, 140 F.3d 1428, 1435, 46 USPQ2d 1226, 1231-32 (Fed. Cir. 1998). Therefore, the proper analysis is whether the instant claims are an obvious variation of the reference claims. The Office showed that the TLR-4 agonists, such as MPL, are biological adjuvant equivalents to those PAAs of Rigaut. The analysis is not that the instant claims are making an improvement over the ‘003 claims, but are substituting one known element (PAA adjuvant) with another (MPL). To further highlight that these adjuvants are biological equivalents, the additional teachings of Burakova have been included to show that PAA adjuvants, while around in veterinary medicine for quite some time, were not as well documented for use in humans, and an equivalent Th1-inducing adjuvant, such as the TLR-4 agonist MPL or derivatives thereof, which have been well-studied in the art with respect to human clinical trials, could be substituted in place of the PAA to aid in the induction of similar immune responses as PAA in humans (which would be especially pertinent to HCMV as this virus has limited host tropism and only generates disease in humans.)
Additionally, as this NSDP rejection is an obviousness-type rejection, MPEP 2144.06.II. is further relevant in that the prior art, as evidenced by Burakova, recognizes the functional equivalence of PAA and TLR-4 agonists as adjuvanting agents. Even further, MPEP 2144.06.I, as both the instant and reference claims are drawn to compositions which are “comprising” components, this open-ended claim language would allow for the addition of unrecited elements, and, as found in In re Kerkhoven, “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). As TLR-4 agonists and PAAs are shown in the art to be Th1-inducing adjuvants, as evidenced by both Burakova and Rigaut, the combination of the two adjuvants in the HCMV gB/pentamer complex immunogenic compositions of the instant and reference claims would be obvious modifications. Therefore, this line of argument is not persuasive.
For at least these reasons, the claims still stand as being rejected.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
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/RACHEL B GILL/
Primary Examiner, Art Unit 1671