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 .
DETAILED ACTION
Claims 1-4, 8-18, 20 and 22-28 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I,
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in the reply filed on January 29, 2026 was acknowledged in the previous Office Action. The requirement was deemed proper and therefore made FINAL in the previous Office Action.
Claims 10-18, 20, 22 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on
January 29, 2026.
Response to Arguments
Applicant’s arguments filed August 10, 2026 have been fully considered. Applicant argues that withdrawn claims 10-18, 20, 22 and 23 should be rejoined because claims 10-18, 20, 22 and 23 depend directly or indirectly from independent claim 1.
In response, Applicant has requested rejoinder of non-elected and withdrawn inventions of Groups II-IV. In accordance with M.P.E.P. §1893.03(d) and §821.04 and In re Ochiai, 71 F.3d 1565, 37 USPQ 1127 (Fed. Cir. 1995), rejoinder of product claims with process claims commensurate in scope with the allowed product claims will occur following a finding that the product claims are allowable. Until, such time, a restriction between product claims and process claims is deemed proper. Therefore, Applicant’s argument is not persuasive.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 10, 2026 was filed after the mailing date of the non-final Office Action on
May 8, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Rejections and objections made in the previous Office Action that do not appear below have been overcome by Applicant’s amendments to the claims. Therefore, arguments pertaining to these rejections and objections will not be addressed.
As a result of the current amendments to the claims per the Amendment filed August 10, 2026, the following rejections and objections apply.
Claim Interpretation
The interpretation of specific tabulated compounds (i.e., Compound 1, Compound 2, Compound 18, etc.) in the claims (such as in instant claims 8 and 26) is that the specific compound is as disclosed in the instant specification, which compound is in a specific salt form. For instance, “Compound 1” is disclosed on page 90 of the instant specification and is defined as follows:
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Duplicate Claims, Warning
Applicant is advised that should claim 8 be found allowable, claim 27 will be objected to under
37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP §608.01(m).
Applicant is also advised that should claim 26 be found allowable, claim 28 will be objected to under
37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP §608.01(m).
Claim Objections
Claims 8 and 24-28 are objected to because of the following informalities:
in Compound 44 in claim 8 on page 6, “1,4-Ph” should have been “1,3-Ph” as found in Figure 3B (Sheet 5/12);
in Compound 49 in claim 8 on page 6, “Thiophene” is misspelled;
in claim 24, the last line of the claim, an additional “R’” should not have been added (line 2 of page 10);
in claim 25, an “and” should have been added before Compound 52 for proper Markush language format (page 13);
in claim 26, an “and” should have been added before Compound 27 for proper Markush language format (page 13);
in claim 26, a period should have been added at the end of the claim (page 13);
in claim 27, an “and” should have been added before Compound 53 for proper Markush language format (page 18);
in claim 27, a period should have been added at the end of the claim (page 18);
in claim 28, an “and” should have been added before Compound 27 for proper Markush language format (page 19); and
in claim 28, a period should have been added at the end of the claim (page 19).
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.
Claims 8, 25 and 27 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.
Currently amended dependent claim 8 is unclear for several reasons. Although claim 8 has been amended to add tables from various figures/drawings, Applicant did not add the accompanying formulae from the various figures/drawings. Further, a few of the variables listed in the headings of the added tables in claim 8 do not correspond to the variables defined in independent claim 1. See the table heading on page 5 in claim 8 for compounds of option (ii) definitions in claim 1 (reproduced below),
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and the table heading on page 6 in claim 8 for compounds of option (iii) definitions in claim 1 (reproduced below),
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Therefore, claim 8 is indefinite.
In claim 8, Compound 41 is confusing since it is unclear how the y’ variables can represent “1/0” (page 6). Therefore, claim 8 is indefinite.
Claim 8 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 for Compound 53,
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, in claim 8 (page 7). Note the definition of “alkyl” in paragraph [65] on page 14 of the instant specification wherein the term “alkyl” embraces “partially unsaturated hydrocarbons”. See claim 27 for same. Therefore, claims 8 and 27 are indefinite.
Claim 25 is unclear because the nomenclature for Compound 21 is not found in the claim (page 12). Therefore, claim 25 is indefinite.
Claim 27 is unclear because the nomenclature for Compound 21 is not found in the claim (page 15). Therefore, claim 27 is indefinite.
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 8 and 27 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.
Claims 8 and 27 each fail to further limit claim 1 because claim 8 and claim 27 are each broader in scope than claim 1 due to Compound 53 claimed in claims 8 and 27.
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 1-4, 8, 9 and 24-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable:
over claims 20-39 of copending Application No. 19/099,414 (reference application); and
over claims 24-53 of copending Application No. 19/743,407 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because copending Application No. 19/099,414 claims methods of using compounds, which compounds anticipate the instant claimed products of formula I in instant claim 1 (see especially the compound in claim 25 in the copending application). Copending Application No. 19/743,407 claims products which anticipate the instant claimed products of formula I in instant claim 1 (see especially the compound in claim 27 in the copending application).
The instant application shares common inventors with each of the above cited copending applications. Copending Application No. 19/099,414 is not related to the instant application. Copending Application No. 19/743,407 is a continuation of the instant application. Thus, no 35 USC 121 shield exists here. See MPEP §804.01. Therefore, the claims in each of the above cited copending applications anticipate and/or render obvious the instant claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 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 1-4, 9 and 24 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by Ivarsson et al. {US Patent 10,624,909}.
Ivarsson et al. disclose, for instance, Compound (IV f) in column 12,
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{a compound of instant formula I,
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wherein
R1 = OPO32-;
R3 = OPO32-;
R7 = OPO32-;
R11 = OPO32-;
R5 = -O(Alkyl)nX
where
n = 3,
each “Alkyl” = methyl or ethyl linked by heteroatom
(the term “alkyl” can extend to alkyl groups
linked or bridged by hetero atoms [such as
oxygen] per the definition in the instant
specification on page 14, paragraph [65]); and
X = H;
R9 = -O(Alkyl)nX
where n = 3,
each “Alkyl” = methyl or ethyl linked by heteroatom
(the term “alkyl” can extend to alkyl groups
linked or bridged by hetero atoms [such as
oxygen] per the definition in the instant
specification on page 14, paragraph [65]); and
X = H}.
Ivarsson et al. disclose that his compounds “may be present in any form commonly used in pharmaceutical technology” and lists sodium salt (column 17, lines 29-37). Ivarsson et al. disclose formulations comprising his compounds together with pharmaceutically acceptable carriers and/or excipients (column 16, lines 8-28). Therefore, Ivarsson et al. anticipate the instant claimed invention.
Response to Arguments
Applicant’s arguments filed August 10, 2026 have been fully considered. Applicant argues that the compounds disclosed in Ivarsson et al. are not encompassed by the formulae of amended claims 1 and 24 due to the amended definition of variable “n” in the instant claims.
In response, Applicant’s attention is directed to the definition of the term “alkyl” in the instant specification on page 14, paragraph [65], which definition is reproduced below,
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As a result of the definition of the term “alkyl”, the instant R5 and R9 can each represent the substituent
-O(Alkyl)nX where n can represent, for instance, three (3); each “Alkyl” can represent, for instance, methyl or ethyl linked by a heteroatom (such as oxygen); and each X can represent, for instance, hydrogen. Therefore, it is disagreed that the compounds disclosed in Ivarsson et al. {such as Compound (IV f) in column 12} are not encompassed by currently amended independent claims 1 and 24. The anticipation rejection is deemed proper and therefore, the anticipation rejection is maintained.
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.
This application contains claims 10-18, 20, 22 and 23 drawn to an invention nonelected with traverse in the reply filed on January 29, 2026. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP §821.01.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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 acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. 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.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
September 22, 2026Book XXVII, page 89
