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 .
Amendments
In the reply filed 3/09/2026, Applicant has amended Claim 40, and cancelled Claim 41.
Claims 37-38 and 40 are under consideration.
Withdrawn 35 USC § 112(b)
The prior rejection of Claim 40 under 35 U.S.C. § 112(b) pre-AIA 2nd paragraph as being indefinite is withdrawn in light of Applicant’s amendments of instant claim to describe the composition.
Declaration under 37 CFR 1.132
The declaration under 37 CFR 1.132 filed by Dr. Daniel Grant on 3/09/2026 is insufficient to overcome the rejection of instant claims based upon 35 U.S.C 103 as set forth in the last Office action for the reasons set forth below.
Maintained 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 37-38 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Passini et al., (US Patent 11,911,440, patented 2/27/2024, filed 11/10/2022, which is a CON of 16/794,031 filed 2/18/2020, which is a CON of 16/449,221 filed 6/21/2019, which is a CON of 15/160,949 filed 5/20/2016, which is a CON of 13/287,583 filed 11/2/2011, which is a CON of PCT/US2010/001239, filed 4/27/2010), in view of Wolfe et al. (US 2013/0317089, filed 11/10/2011) and Gao et al. (WO2011/133874, published 10/27/2011, filed 4/22/2011)
With respect to claims 37 and 38, Passini claims a method of treating spinal muscular atrophy (SMA) comprising intrathecal injection of a recombinant self-complementary (sc)AAV9 capsid containing vector comprising a 5’ AAV2 ITR, a CMV enhancer/chicken-beta actin promoter, a SMN1 coding DNA, and a 3’AAV2 ITR (patented claim 1 of Passini).
Furthermore, in regard to claim 37, Passini teaches the AAV vector further comprises a bovine growth hormone polyadenylation (BGH polyA) sequence in order to prolong expression of the SMN1 coding DNA and act as a termination signal (col 19, 3rd para.,col 21, 2nd para.)
In regard to claim 40, Passini teaches the method uses the AAV vector in a pharmaceutically acceptably carrier (col 27, 3rd to col 28, 2nd para.)
However, in regard to claim 37, Passini is silent to the AAV vector further comprising a SV40 intron.
Nevertheless, Wolfe et al., teaches an AAV vector for the transduction of neurons that comprises 5’ and 3’ ITRs, promoter, transgene, BGH polyA and the SV40 intron [0047].
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to practice the method of treating SMA comprising intrathecal injection of a recombinant scAAV9 capsid containing vector comprising a 5’ AAV2 ITR, a CMV enhancer/CBA promoter, a SMN1 coding DNA, a BGH pA and a 3’AAV2 ITR as taught by Passini and combine an SV40 intron as taught by Wolfe with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by the in vivo success of Wolfe in using AAV vectors comprising SV40 introns to transduce neurons.
However, although Passini has patented a scAAV9 with a CBA promoter, they disclose in their working example that because of the limited packaging size of the scAAV they chose the smaller GUSB promoter instead of the larger 1.6 kb CBA promoter for a working example (col 34, last para).
[AltContent: textbox ([img-media_image1.png])] Nevertheless, Gao et al discloses a mini-CBA promoter with BGH polyA for use in scAAV (p. 32, EXAMPLES section, Nucleic acid constructs, Examples 3 & 4, see excerpt of Fig. 3 adjacent). Specifically, Gao teaches the combination of CMV enhancer of 286 nt (SEQ ID NO:3), Chicken Beta-actin promoter of 265 nt (SEQ ID NO:4), and sv40 Intron of 172 nt (SEQ ID NO:5), and BGH poly A of 196 nt (SEQ ID NO:7), which is a total of 919 nt for the mini-CBA with polyA (see p.40 of SEQUENCES section of Gao).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to practice the method of treating SMA comprising intrathecal injection of a recombinant scAAV9-SMN1 vector comprising a CMV enhancer/CBA promoter as claimed by Passini and substitute the mini-CBA promoter with SV40 intron as taught by Gao with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so for several reasons. First, as stated supra, Passini has explicitly claimed a scAAV with a CMV enhancer/CBA promoter, and it would have been predictably obvious to turn to a CBA promoter that could have been successfully used in scAAV vectors. Furthermore, the successful cloning and sequencing of a DNA sequence encoding a known gene is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the DNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. Ex parte Kubin, 83 U.S.P.Q.2d (BNA) 1410 (B.P.A.I. 2007), aff'd, 561 F.3d 1351 (Fed. Cir. 2009). In instant case, the patented claims of Passini provide the suggestion or motivation to use the CBA promoter in a scAAV9 vector, while Gao provides an enabling disclosure for a mini-CBA promoter to be used in scAAV vectors.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 3/09/2026 are acknowledged.
First, Applicant again argues that Passini contemplates a genus of 9 possible AAV serotypes, and does not provide any prophetic examples or working examples of gene therapy with the AAV9 serotype (p. 4 of Remarks).
Second, Applicant again argues that Passini does not provide a reasonable expectation of success for using the larger 1.6 kb CBA promoter in a scAAV vector (pgs. 4 of Remarks). Furthermore, Applicant argues that although Gao teaches a miniCBA promoter that can be used in a scAAV, it is unpredictable to switch components of a scAAV9 vector and unknown whether intrathecal administration would be therapeutically effective to treat SMA. Applicant argues that the publication of Passini in JCI (2010) comparing the rAAV to the scAAV supports that a switch of promoter would not automatically have the same effect and does not support a reasonable expectation of success.
Third, Applicant again argues that Passini teaches away from the CBA promoter in a scAAV vector because the packaging size constraints of the scAAV vector, the smaller 0.4 kb GUSB promoter was chosen in the working example (pgs. 4-5 of Remarks).
Finally, Applicant argues and Dr. Grant declares there were unexpected results with the claimed method. Specifically, Applicant and Dr. Grant cites the post-filing art of Finkel et al. (2023) demonstrating that the intrathecal administration of the claimed the AAV, known as “onasemnogene abeparvovec” was safe and well tolerated in a Phase I clinical study, and that the administration of a medium dose increased the HFMSE scores in human SMN patients 24-60 months in age, which is the gold standard for SMA-specific assessment of motor ability and disease progression. In addition, Applicant argues and Dr. Grant declares that the post-filing art disclosed in the Novartis press release (2024), which was later published in Proud et al. (2025), demonstrated the claimed method using “onasemnogene abeparvovec” significantly increased HFMSE scores in all human SMN patients aged 2-18 years in a Phase 3, randomized controlled trial.
Importantly, Applicant argues and Dr. Grant swears that the cited AAV vector of “onasemnogene abeparvovec” (formally known as AVXS-101) is an example of the scAAV9-CBA-SMN vector disclosed in the specification of instant application comprising a scAAV9 vector with a CMV enhancer/chicken beta actin hybrid promoter operably linked to a human SMN transgene. Furthermore, Dr. Grant declares that it was unexpected that a single low-dose intrathecal injection of the recited scAAV was effective in older and heavier SMA human patients. Furthermore, Dr. Grant swears that the FDA approval of the recited scAAV meets an unmet need because it offers a fixed dose that reduces systemic viral vector exposure, making a potential one-time treatment for a broad range of patients regardless of age or weight.
Applicant's arguments and Dr. Grant’s declaration have been fully considered but are not found persuasive.
[AltContent: textbox ([img-media_image2.png])]In regard to Applicant’s first argument regarding the choosing of scAAV9 for SMN gene therapy, as stated in the response to argument in the non-final Office action, although Passini does not provide a preferred embodiment of a method of scAAV9-SMN gene therapy, Passini explicitly claims a method of treating SMA comprising intrathecally administering a scAAV9 vector encoding SMN protein with a CBA promoter (see adjacent patented claim 1), furthermore Passini also provides enabling disclosures for treating SMN with scAAV8 and delivery by intrathecal injections (Examples 2 and 4). The MPEP 2123 (I) states that patents are relevant as prior art for all they contain, and that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. In instant case, the method steps (i.e., intrathecal administration) and reagents (i.e., scAAV9) to be included in the SMN gene therapy method as taught by Passini are typical agents found in the gene therapy art and appear both in the specification and in the claims. Furthermore in regard to choosing AAV9, as stated supra, Passini only claims two serotypes (i.e., AAV8 or AAV9), and the fact that the prior art teaches/claims these elements within a list of known options does not render their selection any less obvious. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“That the ʼ813 patent discloses a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose.”); see also In re Susi, 440 F.2d 442, 445 (CCPA 1971) (obviousness rejection affirmed where the disclosure of the prior art was “huge, but it undeniably include[d] at least some of the compounds recited in appellant’s generic claims and [was] of a class of chemicals to be used for the same purpose as appellant’s additives”); In re Kubin, 561 F.3d 1351, 1359 (Fed. Cir. 2009) (“[W]here a skilled artisan merely pursues ‘known options’ from a ‘finite number of identified, predictable solutions,’ obviousness under § 103 arises.” (quoting KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)).
In response to Applicant's second arguments in regard to the reasonable expectation of success in substituting the CBA promoter of Passini, as a first matter, the simple substitution of one CBA promoter for another CBA promoter to obtain predictable results was well within the skill of the ordinary artisan. Furthermore, Gao had already established that the miniCBA could be use with scAAV vectors for the successful expression of transgenes in cells, thereby supporting such a substitution was reasonably predictable. In regard to the success of intrathecal delivery, although Passini does not provide a preferred embodiment using the AAV9-SMN vector, they do demonstrate that ICV and lumbar injections of scAAV8-SMN improved survival in SMA mutant mice (Example 4). Thus, at the time of filing, Passini provided a reasonable expectation of success, that delivery of an AAV-SMN vector to the intrathecal space would treat SMA.
By contrast, it must be noted that Applicant’s disclosure at the time of filing provides only contemplative working examples and there is no reduction to practice of the claimed method in any subject. Although the MPEP is clear that an applicant can rely on an affidavit or declaration under 37 CFR 1.132 to establish non-obviousness even if the specification as filed lacks specific working examples, any arguments against the enablement of Passini’s 11,911,440 patent could just as easily be applied to instant application. Moreover, must like in instant case, during prosecution of Passini’s application 18/054,500, Passini also provide post-filing evidence of the unexpected results when using the scAAV9-CBA vector nearly a decade before Applicant. Importantly, in order to complete the art of record and rebut Applicant’s arguments, the post-filing evidence of Passini et al. (US 10,821,154, filed 5/01/2013, patented 11/03/2020) demonstrates that the scAAV9-CBA-hSMN1 vector claimed in US 11,911,440 by Passini was enabled and robustly targeted motor neurons when delivered intrathecally to a pig or non-human primate (Figures 7-14, of 10,821,154 patent). Moreover, in regard to the argued un-met need of SMN gene therapy, the fact that Passini perused the method of intrathecal delivery of the scAAV9-CBA-SMN vector in a non-human primate mode (i.e., the gold standard for pre-clinical trials), evidences that Passini’s US 11,911,440 is not merely a “blocking patent”.
In response to Applicant's second arguments in regard to Passini teaching away from the 1.6 kb CBA promoter in a scAAV9 vector because it is too large and could not be combined with a scAAV with reasonable expectation of success, as stated in the non-final Office action, Passini has explicitly claimed a scAAV with a CMV enhancer/CBA promoter, and US Patents are presumed operable and enabled (see MPEP 2121, Section I), thus making and using of the patented product would have been understood as being within the level of skill of the ordinary artisan. Furthermore, because alternative CBA promoters with a smaller size to fit in an scAAV were known as taught by Gao, and it would have been predictably obvious to turn to a CBA promoter that has been successfully used in scAAV vectors. In other words, Passini does not discourage or discredit the CBA promoter in general, but only the 1.6 kb CBA promoter. Furthermore, as stated in the non-final Office action, Passini has explicitly claimed a scAAV with a CMV enhancer/CBA promoter, thus any allegations of a teaching away must be tempered with novelty and significance of a patented invention.
Finally, in response to Applicant's third argument that the Applicant’s claimed invention has yielded unexpected results as evidenced by the declaration of Dr. Grant swearing that the results published in Finkel (2023) and Proud (2025) using onasemnogene abeparvovec (alias OAV101 or formally AVXS-101 from AveXis, Inc), are in fact the same methods and an example of the vector as claimed, as a first matter, the Examiner acknowledges Dr. Grant’s affidavit swearing that onasemnogene abeparvovec is “an example” of the claimed scAAV9 comprising a chicken beta-actin promoter with CMV enhancer, an SV40 intron, a SMN transgene, and a bovine growth hormone polyadenylation signal (Section 7 of the Grant declaration). However, Dr. Grant has chosen to use the descriptor of “an example” to characterize the scAAV reagent used in clinical studies, and this point is further detailed in the 2018 Novartis press release stating that AVXS-101 is a “proprietary” gene therapy product (p. 3, “About AVXS-101”). Thus, in contrast to Applicant’s arguments, which indicated that the type of CBA promoter is a critical element of the scAAV, neither the Grant declaration, the prior art, the press releases from Applicant’s licensees, nor the instant claims indicate what type of CBA promoter is used. In other words, the CBA promoter is claimed by Applicant with such a high degree of generality, it encompasses the CBA promoter not only found in onasemnogene abeparvovec, but also the CBA promoter claimed by Passini.
Furthermore, neither Dr. Grant nor Applicant have furnished any evidence that the SV40 intron or the BGHpA (which are the only elements in the claimed method and vector that differentiate it from the patent scAAV9-CBA-SMN of Passini) in any way contributes to the purported unexpected results. In other words, the claimed method is almost exactly the same as the patent method of Passini, with the exception of an SV40 intron and BGHpA, which are obvious additions in light of the teaching of Passini as a whole. Therefore, in the absence of evidence of the criticality of these distinguishing characteristics, the ordinary artisan practicing the patented method of Passini would have also reached the same unexpected result.
In an attempt to differentiated the two methods Dr. Grant’s declaration cites the studies of Finkel and Proud as establishing a dose 1 x1014 gc of the scAAV-CBA-SMN vector that when used in the claim-recited methods results in a safe and effective lower dose of the claim-recited scAAV vector (Section 11). However, it must also be noted that the unclaimed dose 1 x1014 gc of the scAAV-CBA-SMN vector, is squarely in the range claimed by Passini of 106 to 1015 (see patented claim 13 of Passini 11,911,440). Accordingly the patent method of Passini, would also have resulted in a safe and effective lower dose in a human patient. It must also be noted that instant claims do not recite the dose that Dr. Grant swears yielded the unexpected results, nor do the instant claims limit the method to humans, or even a human SMN1 transgene.
With that in mind, it appears that the cited post-filing results are not commensurate in scope with instant invention.
As stated above in the non-final Office action, Passini demonstrates in a mouse model of SMA that any AAV8 vector that delivers SMN to the brain (albeit scAAV vector have increased uptake and correlate better with longevity after treatment) can improve symptoms of SMA. Furthermore, Passini provides post-filing evidence nearly a decade before Applicant that the scAA9 vector with a CBA promoter results in robust transgene expression after intrathecal delivery to a non-human primate. Thus, the success of the animal models of AAV-SMN gene therapy reasonably predicted that there would have been some beneficial effect in the human disease.
With that in mind, it appears that the cited post-filing results are merely an affirmation that the claim invention worked as intended.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Maintained 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 37-38, and 40 stand rejected on the grounds of nonstatutory double patenting over claims 34-40, and 44-53 of U.S. Patent No. 12,168,777 (Kaspar et al., Patented 12/17/2024) in view of Wang et al. (Gene Therapy, 2003, 10:2105-2111, see IDS filed 1/19/2023)
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the method of treating SMA in a particular patient comprising intrathecal administration of a composition comprising a AAV9 vector of cited patent makes obvious the method of instant application. It is clear that the elements of the cited patent claims are to be found in instant claims. The difference between the cited patent claims and the instant claims lies in the fact that the cited patent claims do not recite that the AAV vector is a self-complementary AAV.
Nevertheless, Wang et al. (2003) teaches that scAAV vectors were well known in the art, and that they avoided the rate-limiting step of second strand synthesis for transgene expression (Abstract, Introduction).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have claimed a method of treating SMA comprising intrathecal administration of a AAV9-SMN as in the cited patent and choose a scAAV as taught by Wang with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Wang because scAAVs avoid the slow onset of transgene expression, especially in vivo, where a few weeks are often required to achieve significant transgene expression after conventional AAV vector delivery (Introduction, 1st para.).
Since the instant application claims are made obvious by cited patent claims in view of Wang, said claims are not patentably distinct.
Provisional Double Patenting
Claims 37-38, and 40 stand provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 222-236, 254, 256-265 of copending Application No. 18/940,967
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method of treating SMA in a particular patient by intrathecal injection of an scAAV9 vector comprising AAV2 ITRs, CBA promoter, SV40, BGH pA encoding SMN of cited application anticipates the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific to the subject.
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Claims 37-38, and 40 stand provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 119, 121-122, and 124, and 126-128 of copending Application No. 17/309,403
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method of treating SMA in a particular patient by intrathecal injection of a specific dose of an scAAV9 composition encoding SMN of cited application anticipates the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific to the dose of AAV9.
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 3/09/2026 are acknowledged.
Applicant again argues that the obvious-type nonstatuatory double patenting rejection is improper because 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. Applicant argues that instant application has a patent term date extending back to 7/31/2013, while cited patent US 12,168,777, as well as cited application 18/940,967 (which is a CON of US 12,168,777) were filed with patent term dates of 11/01/2018 with an expiration date of 7/25/2039. Since instant application has the earlier patent term date ending 7/31/2033, Applicant argues the obvious type double patenting with cited patent and cited copending application should be withdrawn because the cited patent will expire after the patent term of instant application once patented.
Applicant argues while the Federal Circuit has not addressed the exact situation, In Allegen, (Allergan USA Inc. v. MSN Laboratories Private LTD. 114 F. 4h 1358 (Fed. Gire. 2024), the Federal Circuit reasoned that the first-filed patent did not extend any period of exclusivity on the claimed subject matter and therefore should not be subjected to non-statutory double patenting based on the later-filed reference patent. This logic should apply in the present application because the reference patent (the '777 patent) is a later-filed and later-expiring patent.
In Ex Parte Baurin (Appeal 224-002920, Nov. 8, 2024), the Patent and Trademark Appeal Board (PTAB), by analogy to the Allergan decision, stated that a patent having a later filing date compared to an application at issue, which expires later than any patent claims that would issue from the application at issue is not a proper reference patent to establish non-statutory double patenting.
Furthermore, Applicant’ argues that the patent application is also exclusively licensed to Novartis AG, so the risk of a defendant being harassed by multiple assignees is very unlikely.
Applicant's arguments have been fully considered but they are not persuasive.
While the Examiner agrees that the provisional obvious double patenting (ODP) rejections over applications 18/940,967, as well as 17/309,403, would be withdrawn if they were the only rejections remaining, MPEP 804 I.1.(a) indicates that the terminal disclaimer does not just affect patent term but is also to prevent possible harassment by multiple assignees (see ¶8.33 Heading for Nonstatutory Double Patenting). In other words, terminal disclaimers can ensure:
Common Ownership: The disclaimer binds the patent to the reference patent for its entire term, requiring that both patents remain under common ownership for the disclaimer to be valid.
Enforceability: A terminal disclaimer often includes a condition that the patent is only enforceable if it is commonly owned or enforced with the reference patent.
Licensing Constraints: The limitation to common ownership means that selling or exclusively licensing the patent separately from the reference patent can render it unenforceable.
Combined Risk: Because of the common ownership requirement, if one patent in the chain is found to be invalid, it can complicate the enforcement of the others.
Furthermore, there is established legal precedent for ODP as not being limited to patent applications filed later than the reference patent. The Federal Circuit has repeatedly sustained ODP rejections where the reference patent has a later priority and patent-term filing date than the application under examination. The cases look not to the relative filing dates of the patents, but to whether the claims are patentably indistinct and whether the relationship between the patents creates the risks ODP exists to prevent. For example, In re Fallaux, 564 F.3d 1313 (Fed. Cir. 2009), the application on appeal was a continuation filed in 2003, with a priority and patent-term filing date of 1997. Id. at 1315. The ODP reference patents had later priority and patent-term filing dates (1998 and 1999) and issued in 2002, before the continuation was filed. The Federal Circuit affirmed the Board's ODP rejection based on these later-priority reference patents. Id. at 1319. The court acknowledged that "the unjustified patent term extension justification for obviousness-type double patenting has limited force in this case," but it identified a "second justification for obviousness-type double patenting-harassment by multiple assignees." Id. at 1318-19 (citing In re Van Ornum, 686 F.2d 937, 944-48 (C.C.P.A. 1982)). This problem could not be cured by a terminal disclaimer because the patents were not commonly owned. Id. at 1319. The Federal Circuit affirmed a similar ODP rejection in In re Hubbell, 709 F.3d 1140 (Fed. Cir. 2013). There, the reference patent also had a later priority and patent-term filing date than the application under examination. See id. at 1142 (citing U.S. Patent No. 7,601,685 (reference patent, with priority and effective patent-term filing date of Aug. 27, 1998); U.S. Patent Application No. 10/650,509 (application at issue, claiming priority to 1997, with patent-term filing date of Apr. 2, 1998)). The Federal Circuit again affirmed the ODP rejection, stating that "the multiple assignee harassment justification adopted in Van Ornum and reaffirmed in Fallaux.”
As in those cases, the reference patent here has later priority dates and later expiration dates than the application under examination. As in those cases, the application and reference patents share common inventors. And as in those cases, the applicant could have sought the claims at issue earlier but chose not to do so for over 5 years.
In regard to the Federal Circuit's 2024 decision in Allergan USA, Inc. v. MSN
Laboratories Private Ltd., 111 F.4th 1358 (Fed. Cir. 2024), addressed a materially
different question than the one presented in this application. It held that "a first-filed,
first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued,
earlier-expiring reference claim having a common priority date." Id. at 1369.
The facts of Allergan bear little resemblance to this application. In Allergan, the
challenged patent was the first-filed application in a priority chain, so that the later filed
continuations were derivative of the very patent they were being used to attack.
111 F.4th at 1369. Here, the reference patents arise from separate application families and do not share a common priority date with the application in examination. In
Allergan, the challenged patent was the first to issue. Id. Here, the reference patents
issued before the application has even resulted in a patent.
Allergan's reasoning reinforces this narrow scope. The Federal Circuit
emphasized that "[t]o hold otherwise-that a first-filed, first-issued parent patent
having duly received PTA can be invalidated by a later-filed, later-issued child
patent with less, if any, PTA-would ... effectively abrogate the benefit Congress
intended to bestow on patentees when codifying PTA." Id. at 1371. That concern
arises only when the challenged patent is the first to establish exclusivity over the
claimed subject matter and the only difference in expiration dates results from PTA.
Where, as here, the reference patents have entirely independent filing dates and
claim entirely different priority chains, invalidating the earlier-filed application does
not "abrogate" any PTA benefit-it addresses the classic double patenting concern
of preventing proliferation of patentably indistinct claims across independent patent
families.
In regard to the Baurin panel reversed the examiner's ODP rejections on the ground that the reference patents had later filing dates and later expiration dates than the application on appeal, without citation to Fallaux or Hubbell. Ex parte Baurin, No. 2024-002920 (P.T.A.B. Nov. 6, 2024). In denying rehearing, the panel reaffirmed
this holding and attempted to distinguish Fallaux and Hubbell on the ground that the
applicants in those cases did not specifically challenge whether the reference patents
were proper ODP references. Ex parte Baurin, No. 2024-002920, at 17-21 (P.T.A.B.
Dec. 17, 2025). The panel also referred to the Federal Circuit's anti-harassment
justification for ODP as "dicta at best." Id. at 22. But as explained above, in both
precedents, the Federal Circuit recognized that the ODP rejections based on a laterfiled, later-expiring patent were proper, and it explicitly grounded these decisions in
an anti-harassment rationale. Treating this rationale as dicta would require
concluding that the Federal Circuit affirmed these ODP rejections on no ground at
all.
The Baumeister panel, confronting materially identical facts, reached the
opposite conclusion and correctly recognized that "Fallaux remains good law" and
that "the Federal Circuit cited Fallaux as recent[ly] as in Allergan." Ex parte
Baumeister, No. 2026-000193, at 8 (P.T.A.B. Nov. 20, 2025). Applying Fallaux,
Hubbell, and Cellect, the Baumeister panel recognized that the anti-harassment
rationale independently supports ODP rejections where reference patents have later
filing dates and later expiration dates, because the risk of divided ownership persists.
As the Federal Circuit recognized in Cellect, even a patent owner's promise not to
divide ownership does not "suffice[] to abrogate the potential future risk of multiple owners." In re Cellect, LLC, 81 F.4th 1216, 1230 (Fed. Cir. 2023).
Indeed, the anti-harassment rationale applies with particular force when, as
here, patentably indistinct patents arise from separate application families with
different priority dates. There is less inherent structural reason for such patents to
remain commonly owned, increasing the risk that the patents end up in different
hands. Adopting the Baurin panel's reading would immunize earlier-filed
applications from ODP based on later-filed reference patents regardless of whether
the patents share a common priority chain, increasing the risk of the harassment that
ODP is designed to prevent.
Conclusion
ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
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/ARTHUR S LEONARD/ Examiner, Art Unit 1631
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