DETAILED ACTION
Claims 31-39, 41-48 and 51-62 are currently pending in the instant application. Claims 31-34, 36, 37, 41-43, and 52 are rejected. Claims 35, 38-39, 44-48, 51 and 53-62 are withdrawn from consideration as being for non-elected subject matter.
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 .
Election/Restrictions
Applicant's election with traverse of Group I and the species:
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in the reply filed on 30 April 2025 has been previously acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species is not allowable (see the following non-statutory double patenting rejection). However, in order to expedite prosecution, the search and examination has been extended to the compound:
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which is not allowable.
Claims 31-34, 36, 37, 41-43, and 52 have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned compound.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 5 September 2025 have been fully considered and entered into the instant application.
In regards to the non-statutory double patenting rejection over US Patent No. 11,254,640, Applicant’s argues that the examiner did not identify the differences between the claims and why a person of ordinary skill in the art would consider those differences to be an obvious variant over the reference claims. Applicant states that the examiner did not identify any difference between the instant claims and the claims of the reference ’640 patent. In the instant case, the examiner required an election of species according to MPEP 803.02. Applicants elected the species
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to which the search and examination was limited to along with the expansion to the compound
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. The examiner provided that the conflicting claims claimed the compound,
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and directed to conflicting claims 1, 9, 17 and 25, See for example, conflicting claim 9:
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which is the same compound as the elected species of
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. Applicant states that the examiner provided that the claims are drawn to products and methods of use of species, allegedly including the instant elected species. The instant elected species is:
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. The conflicting claims do include the elected species, see conflicting claim 1:
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column 122, lines 25-30, see conflicting claim 9 as provided above, see conflicting claim 17 column 126, lines 25-30:
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and conflicting claim 25:
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. The conflicting claims specifically claim the compound
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which is the instant elected species
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. Therefore, the conflicting claims anticipate applicant’s instantly claimed invention which provides the basis for non-statutory double patenting. Please see MPEP 804 II. B. (emphasis added):
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 determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate. To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences. Then the examiner should determine whether those differences render the claims patentably distinct using an anticipation analysis and/or an obviousness analysis. See Pfizer, Inc. v. Teva Pharms. USA, Inc., 518 F.3d 1353, 1363, 86 USPQ2d 1001, 1008 (Fed. Cir. 2008).
Applicant references Ex Parte Whalen, 89 USPQ2d 1078, 1081 (BPAI 2008) where the conflicting claims differed as the claims in Whalen were drawn to compositions with a specific viscosity wherein the reference claims recited a composition having a biocompatible polymer, but the specification of the related patent did not describe the claimed viscosity, so the Board in Whalen found there was no evidence of inherency. This is not the same fact pattern as the instant case. In the instant case, the elected species is
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, which is specifically claimed in the conflicting claims, see for example conflicting claim 9:
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. Applicant’s elected species is anticipated by the conflicting claims as the conflicting claims have the elected species compound specifically claimed. The instant double patenting rejection does not lack sufficient reasoning as the elected species is
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, and the conflicting claims claim the same compound
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. The nonstatutory double patenting rejection is therefore maintained. Applicant’s amendment to claim 31 has overcome the 35 USC 112(a) rejection of claims 31 and 52. Applicant’s amendment to claim 43 has overcome the 35 USC 112(d) rejection.
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.
Claims 31-34, 36, 37, 41-43, and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 12-16, 17, and 25 of U.S. Patent No. 11,254,640. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to products and methods of use of species, including the instant elected species:
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, see conflicting claims 1, 9, 17 and 25.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 31 and 52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Registry No. 885479-51-6.
Registry No. 885479-51-6 is
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. This compound corresponds to the formula (I) of the instant claims:
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wherein, for example, R1a is C1 alkyl; R1b is C1 alkyl; R1c is C1 alkyl; L is C1 alkyl; R2 is halogen; X is CR3; R3 is C6 cycloalkyl; R4 is hydrogen; R5 is hydrogen; R6 is -C(O)OR8b; R8b is C1 alkyl; and R7 is hydrogen. Please see page 13 of the specification, paragraph [0034] which defines “alkyl” and states that Alkyl groups can be substituted or unsubstituted. In the instant case, the C1 alkyl of each of R1a, R1b, and R1c is substituted in the Registry No. 885479-51-6 with an oxo group and with an alkoxy group.
Registry No. 885479-51-6 is available as prior art as of 24 May 2006, the date it was indexed into the CAplus database.
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compound anticipates the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Regarding the pharmaceutical composition of claim 52 comprising the anticipatory compounds and a pharmaceutically acceptable excipient, the Registry entry for Registry No. 885479-51-6 discloses a mass solubility in unbuffered water. This teaching in of water anticipates the claimed composition, wherein the compounds are present with a carrier (i.e., water).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 6 January 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600