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 1-4, 11-16, 35-44 are pending in the current application. Applicant is reminded claim amendments are governed by 37 C.F.R. 1.121. The current amended claims do not comply with since the manner of making the amendment is not pointed out, i.e. claim while a bracket was provided to show deletion of C1 in both the R5 and R6 definitions, the insertion of C3 as the lower bound of the alkyl range was not indicated. As per section (C) (2) “When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived.” These errors could be properly held as non-responsive, however in the interest of advancing prosecution the examiner has not held them non-responsive. Any future failure to comply with Rule § 1.121 “Manner of making amendments in applications.” may be held non-responsive.
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 as N(R7)2, and N(R8)2 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. Applicants’ arguments regarding the priority claim are unpersuasive.
Claim Rejections/Objections Withdrawn
3. The objection to claim 1 and 11 for the drawing informality with a bond missing between X and R⁵ is withdrawn based upon the amendments. The rejection of claim 16 under 35 U.S.C. 112, second paragraph, is withdrawn based upon the amendments. The rejection of claim 3, 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn based upon the amendments. The rejection of claims 4, 13 and 16 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn based upon the amendments. The rejections of claims 1-4, 11-16 on the grounds of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 17/950,898, over claims 1-12 of U.S. Patent No. 11,746,119, over claims 1-16 of U.S. Patent No. 10,975,111 and 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 are withdrawn in view of the timely filed approved terminal disclaimers. The rejection of claims 1-2, 4, 11, 13-16 under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by McChesney US 2023/0042703 A1 is withdrawn based upon the amendments.
The rejection of claim(s) 1-2, 4, 11, 13, 16, under 35 U.S.C. 102(a)(1) as being anticipated by CN 106188169 A is withdrawn based upon the amendments.
Claim Rejections/Objections Maintained/ New Grounds of Rejection
4. The rejection of claims 2, 11-16 and new claims 40-44 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for a broad range or limitation together with a narrow range or limitation is maintained. Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive.
The rejection of claim(s) 1-2, 4, 11, 13-16 and new claims 35-44 under 35 U.S.C. 102(a)(1) as being anticipated by McChesney US 2019/0389888 A1 (cited on the IDS). Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive. According to the applicants’ representative, McChesney US ‘888 is not prior art based upon the priority claim, however based upon the discussion above the priority date afforded the instant claims is August 28, 2023, the filing date of the instant application.
The rejection of claims 3, 12, 16, under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by McChesney US 2023/0042703 A1 is maintained. Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive. According to the applicants’ representative, McChesney US ‘703 is not prior art based upon the priority claim, however based upon the discussion above the priority date afforded the instant claims is August 28, 2023, the filing date of the instant application.
A new rejections under 112 (d) is made below.
Response to Restriction Election
5. 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.
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, 40-44 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.
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.
7. Claims 3 and 12 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. Many of the compounds require both R5 and R6 to be C2 alkyl which has been deleted as a possibility from claim 1. For example both the 4th and 5th compounds require ethyl substituted by -OH or -NH2, respectively. Many other compounds have a C2 group. 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
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.
8. Claim(s) 1-2, 4, 11, 13-16, 35-44 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 on page 7 except those with a dioxolane ring, including those with 3 or 4 carbon alkyls, compound 7, 8, 9 for example. 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.
9. Claims 3, 12, 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. Additional salt form such as an HCl salt are disclosed on page 15 and 16. The claims also describe the same compositions.
Conclusion
10. 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 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
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