DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
A new claim set was not filed in the instant RCE.
Amended claims
Newly canceled claims
Newly added claims
Previously canceled claims
2, 4, 24-40
Previously withdrawn claims
Claims under instant examination
1, 3, 5-23
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/12/26 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on 3/12/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Nos. 10,226,458 and 9,034,867 and US Patent Application No. 18/498,553 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Claim /Rejections
The obviousness-type double patenting rejection of claims 1, 3 and 5-23 as being unpatentable over claims 1-29 of U.S. Patent No. 9,034,867; claims 1-21 of U.S. Patent No. 10,226,458; and Claims 48-51 of U.S. Application No. 18/498,553 are hereby withdrawn due to a terminal disclaimer filed on 3/12/26.
Partially 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 1, 3 and 5-23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over:
Claims 1-24 of U.S. Patent No. 9,452,131;
Claims 7-13 of U.S. Patent No. 11,097,006;
Claims 1-16 of U.S. Patent No. 9,526,726;
Claims 1-29 of U.S. Patent No. 10,085,980;
Claims 1-36 of U.S. Patent No. 10,238,651;
Claims 1-15 of U.S. Patent No. 10,813,928;
Claims 7-8 and 16-17 of U.S. Patent No. 10,342,877;
Claims 1-19 of U.S. Patent No. 10,639,376; and
Claims 1-6 of U.S. Patent No. 11,406,632.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising compound A-7, sorbitan laurate, polysorbate 20 and an aqueous carrier. The difference is that the patented claim a method of using such composition. However, it would have been obvious to one of ordinary skill in the art to have the composition if it has already been used, for example, to treat a disorder. Thus, the instant claims and the application claims are obvious variants.
Claims 1, 3 and 5-23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over:
Claims 1-6 and 14-15 of U.S. Patent No. 11,097,006; and
Claims 9-10 of U.S. Patent No. 9,193,685.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising compound A-7, sorbitan laurate, polysorbate 20 and an aqueous carrier. It is noted that the ‘685 and ’867 compositions represent a species (with regards to the amount of each ingredient) within the scope of the instantly claimed genus. Thus, the instant claims and the application claims are obvious variants.
Response to Arguments
No arguments were presented in the instant RCE. The Examiner reiterates its position in the arguments presented in the After Final which was filed on 1/28/26; such is identical except for the inclusion of the instantly withdrawn double patenting rejections:
Applicants’ arguments have been considered but were not found persuasive.
With regards to the double patenting rejections over US Patent Nos. 9,452,131; 11,097,006; 9,526,726; 10,085,980; 10,238,651; 10,813,928; 10,342,877; 10,639,376; and 11,406,632, Applicants argue that while the reference patent claims had an earlier issue date than the patent against, they were applied, the reference patent claims had a later filing date and therefore, the reference patents would expire after expiration of the patent(s) in question (Remarks: p. 7). Applicants refer to Allergan USA, Inc. v. MSN Lab’ys Priv. Ltd., 111 F.4th 1358, 1369 (Fed. Cir. 2024), which states “[T]he purpose of the ODP doctrine…is to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter.” Applicants also direct attention to Ex Parte Baurin (App No. 17/135,529), in which the Board concluded that “the…patent claims [from a second, later-filed application that was earlier-issued] cannot serve as reference claims against the claims on appeal”. Applicants refer to these same arguments for the double patenting rejections over 11,097,006; 9,526,726; 10,085,980; 10,238,651; 10,813,928; 10,342,877; 10,639,376; and 11,406,632 (Remarks: p. 9-13).
With regards to the ODP over US Patent No. 9,452,131 patent, Applicants argue that the ‘131 patent cannot serve as a reference for ODP purposes because the ‘131 patent has both a later patent term filing date (3/19/15), whereas the instant application has a patent term filing date three years prior (3/19/12) (Remarks: p. 8).
This is not found persuasive. In response, the Examiner notes the following:
The instant scenario and that in In re Allergan do not present the same fact pattern. For example, the instant application and ‘131 patent do not have a common priority date, whereas the question posed in In re Allergan was “can a first-filed, first-issued, later-expiring claim be invalidated by a later-filed, later issued, earlier-expiring reference claim having a common priority date? We hold that it cannot.” Furthermore, this decision concerned double patenting between claims in issued patents, which do not reflect the instant double patenting rejections between claims in a pending application and claims in an issued patent. Applicants’ argument, therefore, improperly broadens the decision in Allergan.
The patent term adjustment (PTA) has not been calculated and/or determined in the instant application. This is a distinction from the facts in the Allergan case, in which the PTA had already been determined. As indicated in MPEP 2733: “The Office has revised 37 CFR 1.705 to implement the statutory changes to The Office has revised 37 CFR 1.705 to implement the statutory changes to 35 U.S.C. 154(b)(3)(B)(i). The amendment to the statute provides that the Office shall transmit a determination of the patent term adjustment no later than the date of issuance of the patent. Accordingly, the Office is no longer required to transmit a determination at the time of the mailing of the notice of allowance which occurs before all of the guarantees of the statute could be calculated.”
The MPEP 804.02(VI) states: “There are at least two reasons for insisting upon a terminal disclaimer to overcome a nonstatutory double patenting rejection in an application subject to a 20-year term under 35 U.S.C. 154(a)(2). First, 35 U.S.C. 154(b) includes provisions for patent term adjustment based upon prosecution delays during the application process…. Second, 37 CFR 1.321(c)(3) requires that a terminal disclaimer filed to obviate a nonstatutory double patenting rejection based on commonly owned conflicting claims include a provision that any patent granted on that application be enforceable only for and during the period that the patent is commonly owned with the application or patent which formed the basis for the rejection.”
Furthermore, the Examiner directs attention to Ex parte Baumeister (from US Patent Application 17/409,019; 11/21/25) and In re Fallaux, 564 F.3d 1313,1316 (Fed. Cir. 2009).
In re Fallaux [1318] states:
“The application under examination was also filed post-URAA, and thus, any patent issued from the application would expire before the reference patents expired. Yet, the Federal Circuit upheld the Board's decision, affirming the NSDP rejection of the pending claims over the reference patents with later patent term filing dates and later expiration dates because "there is a second justification for obviousness-type double patenting-harassment by multiple assignees." Fallaux, 564 F.3d at 1318. As explained below, that justification remains relevant to the instant facts.”
Ex parte Baumeister [p.8] states:
“Fallaux remains good law. Indeed, the Federal Circuit cited Fallaux as recent as in Allergan. See Allergan, 111 F.4th at 1367 (citing Fallaux, 564 F.3d at 1318). Thus, under Fallaux, which is binding on us, we are not persuaded by Appellant's argument that the reference patents do not qualify as NSDP references because they each have a later patent term filing date compared to the instant application and expires later than any patent issuing from the instant application.”
Such is pertinent to the instant scenario.
And finally, although Applicants have not challenged the distinctness issue, the Examiner has provided a proper obviousness type rationale in the instant double patenting rejections for why the conflicting claims are not patentably distinct from each other. Specifically, the difference between the instant claims and the reference claim is that the reference claims are directed to a method of using the composition that is claimed in the instant claims; however, it would have been obvious to one of ordinary skill in the art to have the composition if it has already been used, for example, to treat a disorder.
With regards to double patenting rejections over US Patent No. 9,193,685, Applicants indicated that terminal disclaimers have been submitted (Remarks: 12-13). However, no filing has occurred.
Conclusion
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached on Monday-Friday 8:00-5:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617