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 .
Status of the Claims
Claims 1 – 8 and 10 – 11 are pending.
Claims 1 – 8 are rejected.
Claims 10 – 11 are withdrawn.
Election/Restriction
Applicant’s election with traverse of Group I, claims 1 – 8, in the reply filed on March 31, 2026 is acknowledged.
The traversal is on the ground(s) that claims 1 – 8 and 10 explicitly require the feature of “adding water to the nitration mixture”, which is not disclosed in WO 2019/162149 A1. On page 1, 2nd paragraph – page 2, 3rd paragraph, Applicant states the differences between the process as disclosed in ‘149 and the process as claimed in the instant application. Applicant assert that those skilled in the art could not have found the presently claimed invention obvious in view of ‘149 publication, and as such, claims 1 – 8 and 10 should be examined together. Emphasis added. Further, claim 11 recites, in part, “a chemical purity > 99%, and a content of the dimeric impurity, which is also not disclosed or suggested in ‘149 publication. Thus, claim 11 should be examined with claims 1 – 8 and 10.
However, the requirement for Unity of Invention is whether a group of inventions are linked as to form a single general inventive concept. As disclosed on point 6, page 4 of the Restriction required dated February 2, 2026, the inventions of the groups require the technical feature of hexanoic acid, 6-(nitrooxy)-, (1S,2E)-3-[(1R,2R,3S,5R)-2-[(2Z)-7-(ethylamino)-7-oxo-2-hepten- 1-yl]-3,5-dihydroxycyclopentyl]-1-(2-phenylethyl)-2-propen-1-yl ester and the process for the preparation of said compound. This technical feature is not a special technical feature because it does not make a contribution over Almirante WO 2019/162149 A1, which teaches the compound, hexanoic acid, 6-(nitrooxy)-, (1S,2E)-3-[(1R,2R,3S,5R)-2-[(2Z)-7-(ethylamino)-7-oxo-2-hepten- 1-yl]-3,5-dihydroxycyclopentyl]-1-(2-phenylethyl)-2-propen-1-yl ester, and the process for the preparation of said compound. See, e.g., paragraphs [0014] – [0016]. Thus, the inventions do not form a single general inventive concept under PCT Rule 13.1. Applicant’s remarks are not persuasive, the requirement is still deemed proper and is therefore made FINAL.
Examination: Applicant’s elected invention of Group I, claims 1 – 8, is not allowable. Claims 10 – 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
PNG
media_image1.png
46
386
media_image1.png
Greyscale
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 2, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1 – 2 are objected to because of the following informalities:
Claim 1:
Page 3, lines 9-10: The limitation “… solved selected from methanol, ethanol or isopropanol…” is grammatically correct because it does not recite the proper language for the group of alternatives. In order to overcome the objection, Applicant may amend as follows: “… solved selected from methanol, ethanol and
Page 4, lines 7 – 9: The limitation “… slurring the solid with a mixture… ratio of 3:1 to 5:1 and water in an amount of 0.3 - 1 mole of water for mole of ε-caprolactone” is grammatically incorrect because the sentence is wordy and does not recite proper punctuation. In order to overcome the objection, Applicant may amend to insert a comma (,) as follows: “… slurring the solid with a mixture… ratio of 3:1 to 5:1, and water in an amount of 0.3 - 1 mole of water for mole of ε-caprolactone”.
Page 4, lines 20-22: Insert the terms “of formula” as follows: “… preparation of hexanoic acid, 6-(nitrooxy)-, (1 S,2E)-3-[(1 R,2R,3S,5R)-2-[(2Z)-7-(ethylamino)-7-oxo-2-hepten-1-yl]-3,5-dihydroxycyclopentyl]-1-(2-phenylethyl)-2-propen-1-yl ester of formula (I) comprising the following steps”.
Page 5, line 8: Insert the terms “of formula” as follows: “… purifying the crude compound of formula (I) by column chromatography”.
Claim 2:
Lines 1 – 3 of the claim: The limitation “… in step 1a) the inorganic base is KOH and the solvent is methanol and the reaction is carried out at the reflux temperature of methanol” is grammatically incorrect because the sentence is wordy and does not recite proper punctuation. Emphasis added. In order to overcome the objection, Applicant may amend to replace the term “and” with a comma (,) as follows: “… in step 1a) the inorganic base is KOH,
Lines 1 – 3 of the claim: The claim is incomplete because it is missing a period (.) at the end of the sentence. In order to overcome the objection, Applicant may insert a period (.) after the phrase “… temperature of methanol”.
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.
Claims 1 – 8 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 recites the limitation “… preparation of the 6-(nitrooxy)hexanoyl chloride (VIIIb)”. Emphasis added. See, page 3, line 6. A structure nor a limitation for 6-(nitrooxy) hexanoyl chloride (VIIIb) has been previously recited in the claim. There is insufficient antecedent basis for this limitation in the claim. Dependent claims 2 – 8 do not remedy the issue and are also considered indefinite.
In order to overcome the rejection, Applicant may amend as follows:
The limitation “… preparation of
Insert a structure of 6-(nitrooxy)hexanoyl chloride (VIIIb) after the limitation “… preparation of 6-(nitrooxy)hexanoyl chloride (VIIIb) by:”
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.
Claim 1 – 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 8, 11 – 13 and 16 of copending Application No. 17/631,559 (U.S. Publication 2022/0274924 A1). As of April 17, 2026, the claims in US ‘559 have been allowed but a patent number has not been issued yet. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 in US ‘559 claims a process:
PNG
media_image2.png
121
1006
media_image2.png
Greyscale
PNG
media_image3.png
295
365
media_image3.png
Greyscale
Claim 1 further recites the steps, in-part:
PNG
media_image4.png
416
362
media_image4.png
Greyscale
PNG
media_image5.png
458
1004
media_image5.png
Greyscale
PNG
media_image6.png
766
635
media_image6.png
Greyscale
The process of preparing the compound of formula (I) in US ‘559 is obtained by the instantly claimed process. The scope of the claims overlap and encompass similar methods. Thus, the claims in US ‘559 render the instant claims unpatentable for anticipatory-type double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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, Amy L. Clark can be reached at (571) 272-1310. 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.
/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
Prosecution Insights