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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/20/2026 has been entered.
Claim Status
Claims 1-4 were amended, claims 5-7, 9, and 15-29 were canceled, and claims 30-44 were newly added in the response filed 1/20/2026. Claims 1-4 and 30-44 are currently pending and under examination.
Priority/Specification/35 USC 112(a) New Matter
The Application was filed on 8/27/2023 and claims the benefit of priority to:
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See filing receipt dated 9/7/2023. Due to the amendments filed on 1/20/2026, all claims appear to be able to claim the benefit of the earliest effective filing date. See a discussion of previous issues on p. 4-22 of the OA dated 7/31/2025. Accordingly, the objection to the specification (p. 10); the 35 USC 112(a) new matter rejections of record (p. 10-22); the 35 USC 112(a) written description rejections of record (p. 36-41); the 35 USC 112(a) scope of enablement rejections of record (p. 41-46); and the 35 USC 102 rejection over the PGPUB of the parent application (US 2021/0198191) of record (p. 46-48) are all withdrawn. Also see discussion on p. 8-10 of the response filed 1/20/2026.
Claim Objections
Unless repeated below, the claim objections on p. 23-24 of the OA dated 7/31/2025 are withdrawn.
Claims 2, 3, and 34 are objected to because of the following informalities:
In line 3 of claim 2, the definite article “the” should be inserted before the word “protected”.
In line 2 of claim 3, the definite article “the” should be inserted before the word “diazoketone”.
In line 2 of step (vi) in claim 34, the indefinite article “a” should be inserted before the word “bicyclic”.
In line 1 of step (vii) in claim 34, the definite article “the” should be inserted before the word “bicyclic”.
In line 1 of step (viii) in claim 34, the definite article “the” should be inserted before the word “dienone”.
In line 2 of step (b) in claim 34, there is an error. The end of the limitation reads “to obtain;”, which does not make sense. There are words missing here. However, the limitation is not considered to be indefinite because the claimed steps (separating a racemic diol by preparative chiral chromatography) clearly provide separated stereoisomers.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
Unless repeated below, the 35 USC 112(b) rejections of record on p. 24-36 of the OA dated 7/31/2025 are withdrawn.
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 31-33 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.
Claims 31-33 depend from canceled claims 6 and 9. Therefore, the claims are indefinite. They claim limitations do not appear to further limit any of the steps of claim 1, therefore, they are not treated further on the merits.
Claim Rejections - 35 USC § 112
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.
Claim 41 is 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 41 does not further limit step (a)(vii) of claim 34, from which it depends.
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.
Withdrawn Prior Art Rejections
The Applicant’s amendments are persuasive to overcome the 35 USC 102 rejection of record of claim(s) 1-5 as being anticipated by McMorris (“Total Synthesis of hydroxymethylacylfulvene, an antitumor derivative of illudin S” Chem Commun, 1997, p. 315, of record) on p. 48-50 of the OA dated 7/31/2025. The Applicant has significantly narrowed the scope of the claims to that of the examples on p. 13-24 of the specification as filed. Therefore, McMorris no longer anticipates the claimed processes and the rejection is withdrawn. Also see p. 10 of the response filed 1/20/2026.
The same reasoning applies to the 35 USC 103 rejection of record of claim(s) 1-7, 9, and 15 as being unpatentable over McMorris in view of Kelner (US 2008/0306147, published on 12/11/2008, of record) on p. 52-58 of the OA dated 7/31/2025. Therefore, this rejection is also withdrawn.
Allowable Subject Matter
Claims 1, 4, and 30 are allowed. Claims 2, 3, 34-40 and 42-44 are objected to but otherwise appear to be free from the prior art.
The closest prior art to the claimed invention is the McMorris reference of record. McMorris teaches a different process for producing acylfulvene and hydroxyureamethylacylfulvene than that claimed. See Scheme on p. 315, which includes the following reactions:
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Compound (6) of McMorris corresponds to racemic 4-hydroxy-5-methylcyclopent-2-en--1-one produced in instant step (b) of claim 1 and step (a)(ii) of claim 34. The process of Morris generally follows that claimed, with minor differences in reactants and protecting groups, up until instant step (e) of claim 1 and step (a)(v) of claim 34. McMorris teaches that cycloadduct (9) (corresponding to the product of instant step (d) in claim 1 and step (a)(iv) of claim 34), is treated with KOH-MeOH (iii) to produce a cyclopentenone product which is then transformed in step (iv) to diol compound (11) upon treatment with OsO4 and NMO. Diol compound (11) must be further protected in step (v) before being methylated in step (vi) to produce compound (13) and compound (13) is reduced in step (vii) and deprotected to produce intermediate (15). Another five steps are then required to obtain acylfulvene (19). Thus, the process of McMorris requires thirteen steps to obtain acylfulvene (19) starting from compound (6).
In contrast, the instantly claimed process carries out a methylation step (instant step (e) in claim 1 and step (a)(v) of claim 34) followed by diol formation, reduction, and oxidation to obtain acylfulvene in four steps. Thus, the instantly claimed process requires seven steps to obtain acylfulvene (19) starting from instant step (c). The instantly claimed process is more efficient than the prior art process and such major modifications to the process of McMorris to arrive at that instantly claimed would not have been obvious to the skilled artisan. Therefore, the claimed processes appear to be free from the prior art.
Conclusion
Claims 1, 4, and 30 are allowed. Claims 2, 3, 34-40 and 42-44 are objected to but otherwise appear to be free from the prior art. Claims 31-33 are rejected under 35 USC 112(b) and claim 41 is rejected under 35 USC 112(d).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY C BONAPARTE whose telephone number is (571)272-7307. The examiner can normally be reached 11-7.
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/AMY C BONAPARTE/ Primary Examiner, Art Unit 1692