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
1. Claims 1-34 are pending in the current application.
Priority
2. This application is a CIP of 17/950,898 09/22/2022; 17/950,898 is a CIP of 17/520,287 11/05/2021 PAT 11746119; 17/520,287 is a CON of 17/191,214 03/03/2021 PAT 11643424; 17/191,214 is a CON of 16/452,858 06/26/2019 PAT 10975111; 16/452,858 has PRO 62/690,196 06/26/2018.Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/690,196 17/191,214, 17/520,287, 17/950,898 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The genus of claim 1 has new definitions of the variables R5 and R6 as N(R7)2, and N(R8)2 . In the priority applications the genus is defined as follows:
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The new definitions of R5 and R6 are unsupported. The compounds in claim 3 do not appear in any of the priority documents, except for one the 5th one. 17/950,898 is drawn only to the 5th structure in claim 3. Based upon the foregoing the priority date afforded the instant claims is August 28, 2023, the filing date of the instant application.
Response to Restriction Election
3. Applicant’s election of group I and the species,
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in the reply filed on February 12, 2026 is acknowledged. The election was made with traverse and the examiner find the arguments unpersuasive. According to the arguments there is no search burden, however there is substantial search burden as outlined in the restriction requirement of December 29, 2025 at 5. Applicants’ representative does not explain which claims read on the elected species; however the examiner has determined that claims 1-4, 11-16 read on the elected species.
Drawings
4. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
5. Claim 1 and 11 are objected to for the following informality: In the R³ definition there is a bond missing between X and R⁵. Appropriate correction is required.
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.
6. Claims 2, 11-16 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 and 11 recites the broad recitation R4 is a H or pharmaceutically acceptable cation, and the claim also recites R4 is H, Li, Na, K, Mg, Ca, Zn, Cs, ammonium or tetraalkylammonium which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
7. Claim 16 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claim 16 defines a composition by “reduces or eliminates one or more of a cardiac channelopathy or a condition resulting from the irregularity or alteration in the cardiac pattern caused by the active agent used to treat a disease; is administered in an amount per unit dose of between about 1 mg and about 1 gram;” ‘Reduces or eliminates”, “used to treat a disease” and “administered” lack antecedent basis in the claim from which they depend. A description of administration or a method step of treating a disease does not make sense in this context. Compounds cannot comprise administration steps. See also MPEP § 2112 - MPEP § 2112.02. This is grounded in the statutory distinction, between a physical product and activities that constitute a process (which may include a new “use” of a known invention). Otherwise these composition claims would mutate into method claims.
8. Claim 3, 12 is 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. The compounds in claim 3 and 12 are not charged balanced and are missing a cation. The oxygen is positively charged with no counterion. The structure is incomplete. Claim 3 and 12 also states “the compound is selected from at least one of:”. The compound can only be selected once, selecting two or more makes a composition. MPEP § 2173.05(h), states “A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196.”
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.
9. Claims 4, 13 and 16 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 4, 13 and 16 state that the “compound is a single entity, a solvate, hydrate, a crystal, an amorphous solid, a liquid or an oil”. While the physical forms, a crystal, an amorphous solid, a liquid or an oil could be thought of as inherent manifestations of the compound, both solvates and hydrates lie outside the scope of claim 1 and 11 as they comprise different molecules outside of claim 1. 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.
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 claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 1-4, 11-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 17/950,898 (issue fee paid April 3, 2026, no issue notification as of this writing April 21, 2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound in copending claim 1 and 10 is the 5th compound in claim 3 and 12 of the instant application. While broader and drawn to additional embodiments the instant claims 1-4 are drawn to the same compound. Claims 11-16 are drawn to the same compositions with the same secondary ingredients.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
11. Claims 1-2, 4, 11, 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,746,119. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of the patent claims read on the genus of the instant claims where R4 is Mg, X is a direct linkage, R5 is alkyl (C3), Y is a direct linkage and R6 is alkyl (C3), R1 is C13H27, R2 is C13H27. The composition claims correspond in the same or similar manner with various cardiopathy inducing agents, with excipients and binders and formulated for various delivery routes.
12. Claims 1-2, 4, 11, 13-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,975,111. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of the patent claim 3 read on the genus of the instant claims where R4 is Na, Mg, Ca, X is O or a direct linkage, R5 is alkyl, Y is a direct linkage or O and R6 is alkyl, R1 is C13H27, R2 is C13H27. The genus of claim 1 is the same when R3 is the first selection differing only when X and Y may also be CH2, and where R5 and R6 are species of the N(R7)2, N(R8)2, i.e. NH2, NHMe. The composition claims correspond in the same or similar manner with various cardiopathy inducing agents, with excipients and binders and formulated for various delivery routes.
13. Claims 1-4, 11-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 9, 13, 15-20, 23, 27, 29-31, 33-34, 37, 41, 43-46 of copending Application No. 18/260,012. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds in copending method claims are the same. The methods could not be practiced without the claimed compounds. The genus of claim 1 is the same when R3 is the first selection differing only when X and Y may also be CH2, and where R5 and R6 are species of the N(R7)2, N(R8)2, i.e. NH2, NHMe. The compounds of the copending claim 5 read on the genus of the instant claims where R4 is Na, Mg, Ca, X is O or a direct linkage, R5 is alkyl, Y is a direct linkage or O and R6 is alkyl, R1 is C13H27, R2 is C13H27. Claim 13 includes various compounds that cause cardiopathy inducing agents.
This is a provisional nonstatutory double patenting rejection because the patentably
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
14. Claim(s) 1-2, 4, 11, 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McChesney US 2019/0389888 A1 (cited on the IDS). McChesney on page 3 column 2 ff. teaches various compounds that read on the genus of the instant claims where R4 is Na, Mg, Ca, X is a direct linkage, R5 is alkyl, Y is a direct linkage and R6 is alkyl, R1 is C13H27, R2 is C13H27, all of the compounds will page 7 except those with a dioxolane ring. The genus of claim 1 is the same that of page 11 of McChesney where the R5 is the first selection and differs only when X and Y may also be CH2, and where R5 and R6 are species of the N(R7)2, N(R8)2, i.e. NH2, NHMe. The composition claims correspond in the same or similar manner with various cardiopathy inducing agents, with excipients and binders and formulated for various delivery routes. These compositions are disclosed on page 20ff.
15. Claims 1-4, 11-16 is/are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by McChesney US 2023/0042703 A1 (cited on the IDS). McChesney teaches the compound which is the 5th compound in claim 4 in the abstract and various places:
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This species reads on the genus of the instant claims where R4 is anything, X is a direct linkage, R5 is alkyl (C2) substituted with amino, Y is a direct linkage and R6 is alkyl (C2) substituted with amino, R1 is C13H27, R2 is C13H27. The composition claims correspond in the same manner with those disclosed on page 2 ff. with various cardiopathy inducing agents, with excipients and binders and formulated for various delivery routes. Addiitonal salt form such as an HCl salt are disclosed on page 15 and 16. The claims also describe the same compositions.
16. Claim(s) 1-2, 4, 11, 13, 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 106188169 A (cited on the IDS). Page 12 teaches the following compound:
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This compound reads on claim 1 where R1 and R2 are C17 hydrocarbons, R4 is Na, R3 is the first selection, where X is a “direct linkage” and R5 is C2 hydrocarbon, Y is a “direct linkage” and R6 is a C2 hydrocarbon, both C2 hydrocarbons possessing 1 double bond. The compound was in a solution in water as per paragraph 147 “ the contents of the dialysis bag were lyophilized to obtain AC-DSPG.” This is a composition, a solution of claim 16. Indicating the material was also isolated as a solid and about a 100 mg was made. There is also mention on paragraph [0151] of other compounds “where 2-methacryloyl chloride (MAC) and 2-butenoyl chloride (BC) have similar solubility properties and reactivity to acryloyl chloride (AC) under the above system, so we use the same reaction conditions and use the same The MAC-DSPG, MAC-DPPG, MAC-DMPG, BC-DPPG, BC-DOPG, and BC-DMPG”, which would be compounds of the instant claims as discussed above with alternative esters on R5 and R6, where MC is used a 3 carbon branched hydrocarbon and where BC is used a 3 carbon branched hydrocarbon.
Conclusion
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID K O'DELL/Primary Examiner, Art Unit 1621
Prosecution Insights