DETAILED ACTION
Claims 1-3, 13, 15, 20, 28-31, 37, 39, 45, 62, 95, and 104-108 are currently pending in the instant application. Claims 1, 30, 31, 45, 62, 104 and 106-108 are rejected. Claims 2, 3, 13, 15, 20, 28, 29, 37, 39, 95, and 105 are withdrawn from consideration as being for non-elected subject matter.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 without traverse of Group I and the species:
PNG
media_image1.png
128
388
media_image1.png
Greyscale
in the reply filed on 22 September 2025 has been previously acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species appears allowable. Therefore, the search and examination has now been extended to the compounds:
PNG
media_image2.png
202
282
media_image2.png
Greyscale
,
PNG
media_image3.png
154
236
media_image3.png
Greyscale
, and
PNG
media_image4.png
138
200
media_image4.png
Greyscale
which are not allowable.
Claims 1, 30, 31, 45, 62, 104 and 106-108 have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned compounds. Claims 37 and 39 are now withdrawn claims as the elected species corresponds to claim 30 wherein R30 is alkyl substituted with triarylphosphoniumalkylamido and instant claim 37 has R30 substituted with triarylphosphonium not triarylphosphoniumalkylamido. Instant claim 39 has R30 substituted with P+(Ph)3 not P+(PH)3alkylamido.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 23 January 2026 have been fully considered and entered into the instant application. Applicant’s amendment has overcome the objection to the abstract as the legal phraseology has been removed. Applicant’s amendment to claim 45 has overcome the objection as duplicate species have been removed. As claim 30 has been made independent and claim 39 has been amended, the 35 USC 112(d) rejection has been overcome in regards to claims 30, 31, 37, and 39. As claim 45 still includes compounds outside the scope of the parent claim, claim 45 is still rejected under 35 USC 112(d). The 35 USC 102(a)(1) rejection of claims 1, 30, 31, 45, and 62 as being anticipated by Registry No. 3612-80-4 is withdrawn as claim 1 contains the proviso:
PNG
media_image5.png
58
668
media_image5.png
Greyscale
. The 35 USC 102(a)(1) rejection of claims 1, 30, 31, 37, 39, 45, and 62 as being anticipated by Kasukhin et al. has been overcome as the compound:
PNG
media_image6.png
246
302
media_image6.png
Greyscale
has been provided out of the instant claims by the proviso:
PNG
media_image7.png
134
668
media_image7.png
Greyscale
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 1 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of copending Application No. 19/170,296 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting Application No. 19/170,296 claims the compound
PNG
media_image3.png
154
236
media_image3.png
Greyscale
in conflicting claim 28. This compound corresponds to instant claim 1 formula (VI):
PNG
media_image8.png
98
194
media_image8.png
Greyscale
wherein Q is absent; X is O; L is C2alkyl substituted with NHC(O)Rb; Rb is C3alkyl; Y is -P(R7)3; R7 is unsubstituted aryl. This compound corresponds to instant claim 30 formula (VIb):
PNG
media_image9.png
132
162
media_image9.png
Greyscale
wherein X30 is O and R30 is alkyl substituted with triarylphosphoniumalkylamido.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 30 and its dependent claims 31, 45, 104, 106, 107, and 108 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Specifically, claim 30 is drawn to a compound having a structure represented by formula VIb:
PNG
media_image10.png
132
146
media_image10.png
Greyscale
which does not include “or a pharmaceutically acceptable salt thereof” or a “G.” However, claim 30 excludes by proviso the compound
PNG
media_image11.png
152
524
media_image11.png
Greyscale
which has a “G” and is a pharmaceutically acceptable salt of the formula VIb. It is unclear how the compound
PNG
media_image12.png
130
174
media_image12.png
Greyscale
is excluded from the formula VIb as the formula VIb does not include a “G” and does not include pharmaceutically acceptable salts thereof. Dependent claims 31, 104, 106 and 107 do not resolve the issue at hand and are therefore also rejected. Claims 45 and 108 limit the formula VIb of claim 30 to specific pharmaceutically acceptable salts with a “G” which is unlear as claim 30 is drawn only to formula VIb and not to pharmaceutically acceptable salts thereof of compounds with a “G” variable.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 45 and 108 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 45 provides species which fail to limit parent claim 30. For example, the compound:
PNG
media_image13.png
126
254
media_image13.png
Greyscale
has deuterium on the pyridine ring, which is hydrogen in parent claim 30. Additionally, all other compounds in claim 45 are pharmaceutically acceptable salts of the formula IVb which contain a “G” variable. However, claim 30 is not drawn to pharmaceutically acceptable salts and does not have a “G” variable as claim 30 is only drawn to compounds of formula VIb. Please check each species in claim 45 is properly dependent upon claim 30. Instant claim 108 is claiming a salt with G as a pharmaceutically acceptable salt, however, parent claim 30 is only drawn to compounds of formula VIb and does not include pharmaceutically acceptable slats thereof or have a “G” variable.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1 and 62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Registry No. by 1452-63-7.
Registry No. 1452-63-7 is:
PNG
media_image4.png
138
200
media_image4.png
Greyscale
. Registry No. 1452-63-7 corresponds to applicant’s instant formula (VI):
PNG
media_image14.png
86
202
media_image14.png
Greyscale
wherein Q is absent; X is NH; L is a bond; and Y is NH2.
Registry number 1452-63-7 is available as prior art as of 16 November 1984 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:
PNG
media_image15.png
99
480
media_image15.png
Greyscale
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 compositions of claim 62 comprising the anticipatory compounds and a carrier, the Registry entry for Registry no. 1452-63-7 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).
Claim(s) 1, 30, 31, and 106 /are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Registry No. 789460-22-6. Registry No. 789460-22-6 is:
PNG
media_image16.png
214
330
media_image16.png
Greyscale
This compound corresponds to claim 1, to the formula (VI):
PNG
media_image14.png
86
202
media_image14.png
Greyscale
wherein Q is absent, X is NH; L is C1alkyl; and Y is -P(R7)3; wherein R7 is aryl. The compound corresponds to formula VIb of instant claims 30, 31, and 106
PNG
media_image17.png
146
168
media_image17.png
Greyscale
wherein X30 is NR34; R34 is H; and R30 alkyl substituted with triarylphosphonium. While the instant claims exclude the compound
PNG
media_image12.png
130
174
media_image12.png
Greyscale
by proviso, it is noted that the provided out compound is not the formula (VI) but is a pharmaceutically acceptable salt of the formula (VI) provided out which also contains a “G” variable. Registry No. 789460-22-6 corresponds to the formula (VI), not a pharmaceutically acceptable salt thereof and does not contain a “G” variable.
Registry number 789460-22-6 is available as prior art as of 26 November 2004 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:
PNG
media_image15.png
99
480
media_image15.png
Greyscale
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.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. 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 ____________________ 5 June 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
Prosecution Insights