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 .
Priority
The instant application, filed 01/20/2023, is a Continuation of PCT/US21/42644, filed 07/21/2021, which claims domestic priority to U.S. Application No. 63/054,767, filed 07/21/2020.
Amendments and Claim Status
The following amendment filed on 04/08/2026 is acknowledged and entered.
Claims 119, 121, 125, 126 are amended;
Claim 130 is cancelled;
Claims 120-124, 127, 129, 131, 132, and 134-13 are withdrawn according to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species;
Claims 119-129 and 131-138 are pending and are under prosecution.
Information Disclosure Statement
The Information Disclosure Statement filed on 04/08/2026 is acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statement is considered.
Telephonic communication
A phone call was placed by Examiner to Applicant’s agent of record, Trevor Lohrey, with final communication on 06/23/2026. A series of examiner’s amendment was proposed to claims in order to place them in condition for allowance. However, Applicant’s agent was unable to receive a timely approval from Applicant, and requested an office action.
Response to arguments
Applicant’s arguments filed 04/08/26 with respect to the claim objections and claim rejections under 35 U.S.C. § 103, and the nonstatutory double patenting rejection have been fully considered.
With respect to the rejection of claims 119, 125, 126, 130, and 133 are rejected under 35 U.S.C. § 103 as being unpatentable over Saiah et al. (WO 2019241789 A1, published December 19, 2025, cited on applicant IDS dated 05/19/2023) the cancellation of claim 130 is sufficient to render the rejection against said claim moot. Applicant’s arguments are herein addressed as follows.
Applicant disagrees with the grounds for rejection, but places no arguments on the record. The rejected compound 439 is stricken from consideration according to the amendment of the instant claims filed 04/08/2026. Due to the striking of compound 439, Applicant argues that the instant claims are in condition for allowance.
Applicant’s argument is unconvincing because, pursuant to MPEP § 803.02, the search has been extended to include an additional species, which hereby stands rejected. As such, the rejection on the grounds of obviousness under 35 USC § 103 is amended, and hereby maintained.
With respect to the rejection of claims 119, 125, 126, 130, and 133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-15, and 17 of U.S. Patent No. US 11603377 B2, (cited on applicant IDS dated 05/19/2023), the cancellation of claim 130 is sufficient to render the rejection against said claim moot. Applicant’s arguments are herein addressed as follows.
Applicant argues that the nonstatutory patenting rejection is based only on species 439, which is stricken from consideration according to the amendment of the instant claims filed 04/08/2026. Therefore, due to the striking of compound 439, Applicant argues that the instant claims are in condition for allowance.
Applicant’s argument is unconvincing because, pursuant to MPEP § 803.02, the search has been extended to include an additional species, which hereby stands rejected. As such, the nonstatutory double patenting rejection is hereby maintained.
Status of Claims
Claims 119-129 and 131-138 are pending in the instant application. In the response to restriction/election requirement, filed 10/10/2025 Applicant elected compound 457 as a specific species of Formula (III-C), which is encompassed by claims 119, 125, and 133. Upon examination, the elected species had been found to be free of the prior art of record. Accordingly, in the previous office action, filed 01/09/2026 the search was expanded pursuant to MPEP § 803.02 to include an additional species, compound 439—encompassed by claims 119, 125, 126, 130, and 133. As such, claims 120-124, 127-129, 131, 132, and 134-138 were withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 119, 125, 126, 130, and 133 read on an elected invention and species subject to examination and were under consideration. In the most recent amendment to the claims filed 04/08/2026, Applicant has stricken compound 439 from consideration in the instant claims. Accordingly, the search is hereby further expanded pursuant to MPEP § 803.02 to include an additional species, compound 427—encompassed by claims 119, 125, 126, 128, and 133. As such, claims 120-124, 127, 129, 131, 132, and 134-138 are hereby withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 119, 125, 126, 128, and 133 read on an elected invention and species subject to examination and are therefore under consideration in the instant application, and examined on the merits as such.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 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.
Claims 119, 125, 126, 128, and 133 are rejected under 35 U.S.C. § 103 as being unpatentable over Saiah et al. (WO 2019241789 A1, published December 19, 2019, cited on applicant IDS dated 05/19/2023),
The instant claims are drawn to a compound of Formula (III-C), specifically examined as compound number 427 in accordance with MPEP § 803.02: as the compound to which the Markush-type claim has been extended, and a pharmaceutically composition thereof.
Saiah teaches a compound of Formula (III) (claim 12), wherein R1 is a C4 hydrocarbon wherein one of the methylene units are replaced by -O- (claim 1). Saiah further teaches a composition comprising a pharmaceutically acceptable carrier (claim 17).
Regarding wherein R1 of compound 427 differs from the CH2CH2OH by a single methylene unit, the courts have determined that such differences result in homologous structures, which have been determined to be obvious over one another. The courts have stated:
[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious) (see MPEP § 2144.09).
Figure 2. Structural comparison of instantly claimed Formula (III-C) and prior art compound
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Figure 2. a) Instantly claimed Formula (III-C); b) Prior Art Formula (III); c) Instantly claimed species
Thus, the compounds taught by the prior art would result in compounds of sufficiently close in structure. The courts have further stated:
similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close' structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP § 2144.08(d)).
Therefore, the compound of the prior art renders obvious compound 427, due to its structural similarity and obvious modifications using a single CH2 unit to arrive at the compound instantly claimed.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. However, it would have been prima facie obvious to make the combination since all the claimed elements were explicitly taught within the prior art and a person having ordinary skill in the art would have been motivated to combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yields nothing more than predictable results (see MPEP § 2143 (I)(A)).
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.
Figure 3. Structural comparison of instantly claimed Formula (III-C) and patented Formula (X)
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Figure 3. a) Instantly claimed Formula (III-C); b) Patented Formula (X); c) Instantly claimed species
Claims 119, 125, 126, 128, and 133 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-15, 17, and 18 of U.S. Patent No. US 11603377 B2, (cited on applicant IDS dated 05/19/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims drawn to a compound of Formula (X) renders obvious the instantly claimed compound no. 439 (see Figure 3) wherein,
Wherein L is C2 alkylene
R1 is OH
R2 and R3 are C1 alkoxy
R4 is
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(see patented claims 1, 14, 15, 17, and 18)
R5 is OH
R6 and R7 come together to form a carbonyl
Regarding claim 7, R25 of R4 is substituted C2 alkyl
Regarding claims 8 and 9, R25 is substituted OH
Regarding claim 10, D is -O-, G is -O-, y is 1-3, and V is hydrogen
Regarding claim 11, R25 is -D-(CH2-CH2-G)y-V, D is -O-, G is -O-, y is 1, and V is hydrogen
Regarding claim 12, R′ and R″ are hydrogen
Regarding claim 13, z is 2
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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