Office Action Predictor
Last updated: April 15, 2026
Application No. 18/043,620

ANTITUMORAL ASCORBIC ACID ESTERS

Non-Final OA §112
Filed
Mar 01, 2023
Examiner
RAO, PADMAJA S
Art Unit
1627
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Suigeneris Farmacosmetics, S.L.
OA Round
1 (Non-Final)
71%
Grant Probability
Favorable
1-2
OA Rounds
2y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allow Rate
84 granted / 118 resolved
+11.2% vs TC avg
Strong +40% interview lift
Without
With
+40.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
61 currently pending
Career history
179
Total Applications
across all art units

Statute-Specific Performance

§101
2.2%
-37.8% vs TC avg
§103
32.8%
-7.2% vs TC avg
§102
17.2%
-22.8% vs TC avg
§112
25.5%
-14.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 118 resolved cases

Office Action

§112
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 Application Claims 1-8 and 10-14 are pending in the application as of the preliminary amendment submitted 03/01/2023. Claim 9 is cancelled. Claims 1-8 and 10-14 are examined herein. Claims 1-8 and 13-14 are allowable. Claims 10-12 are rejected under 35 U.S.C. 112(a) as discussed below. Priority This application is a 371 of PCT/EP2021/075104 filed 09/13/2021 and claims foreign priority to EP 20382804.1 filed 09/14/2020. The effective filing date of instant claims 1-8 and 10-14 is 09/14/2020, since the subject matter of the claims are supported by the foreign priority application. Information Disclosure Statement The information disclosure statement submitted on 03/01/2023 has been considered. The submission is in compliance with the provisions of 37 CFR 1.97. Claim Rejections - 35 USC § 112 - Enablement The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 10-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for treating or preventing pancreatic cancer, melanoma, colon cancer, gastric cancer, and lung cancer in a subject in need thereof, does not reasonably provide enablement for the broad recitation of treating or preventing a neoplastic disease in a subject in need thereof. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection. To be enabling, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright , 999 F.2d 1557, 1561 (Fed. Cir. 1993). The determination that "undue experimentation” would have been needed to practice the claimed invention in full scope is not a single, simple factual determination. As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." In re Wands , 8 USPQe2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. Keeping that in mind, the Wands factors are relevant to the instant application for the following reasons: The breadth of the claims/The nature of the invention The claims recite a method of treating or preventing a neoplastic disease, the method comprising administering to a subject in need thereof a therapeutically effective amount of the compound of instant claim 1. The instant specification defines “neoplastic disease” to encompass cancers of any kind and origin and precursor stages thereof and further includes both primary and metastatic tumors (Pg. 13, fourth full paragraph). The specification does not provide a limiting definition of the limitation “ neoplastic disease “. The refore, the scope of the conditions being treated by the method claims is extensive, and encompass each and every type of cancer. The state of the prior art/The level of predictability in the art Lovly et al. (Tumor Heterogeneity and Therapeutic Resistance, 2016, hereinafter Lovly). Lovly teaches tumor heterogeneity encompasses more than just the clinical picture and can represent both intratumor and intertumor differences (Abstract). Lovly teaches tumor heterogeneity is not one distinct term but rather encompasses several facets – within a disease, within a patient and within a tumor itself - that render tumors unique (Pg. e585, first column, last paragraph; Pg. e591, second column, first full paragraph). Lovly teaches ongoing challenges include the accurate and timely assessment of genetic changes as well as the development of resistance and the resultant compensatory mechanisms (Abstract; Pg. e586, second column, second full paragraph). Lovly, highlights the complexity of tumor heterogeneity in clinical decision making (e589-e590, case studies) and emphasizes that the need to understand the underlying causes of this heterogeneity and development of resistance, to effect better treatment outcomes (Pg. e591, second column, first full paragraph; Pg. e590, first column, first paragraph). Therefore, it is clear that the significant variability found within and between tumors is a major contributor to treatment failure and cancer recurrence in patients. It is unclear how the instantly claimed method would achieve treatment/prevention of any and all types of cancers encompassed by “neoplastic diseases”, considering that different types of cancers have different etiologies with unique genetic/proteomic profiles requiring targeted therapies. The level of one of ordinary skill in the art The relative level of skill in the art is high, such as, an oncologist or molecular biologist with advanced educational degrees (e.g., M.D. and/or Ph.D.). Additionally there is significant unpredictability in the art regarding the development of therapies, due to the heterogenous nature of cancers. The amount of direction provided by the inventor/The existence of working examples The specification at pages 29-30 and figures 1-13 indicate the inhibitory effect of a subset of compounds , Ia, Ib and Ic, towards the growth of different cancer cell lines including, melanoma, colon cancer, gastric cancer, lung cancer and pancreatic cancer cell lines. However, the disclosure does not indicate how the disclosed data correlates with the treatment of all neoplastic conditions being claimed. There is lack of direction or guidance regarding, how the administration of the disclosed compounds are capable of treating all types of neoplastic conditions. One of ordinary skilled in the art would not be able to practice the method of the claims to achieve the intended result of treating or preventing all neoplastic diseases, as instantly claimed. The quantity of experimentation needed Considering the state of the art as discussed above, particularly with regards to the high degree of unpredictability in the art with respect to treating various tumors and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in scope with the claims. Reasons for Allowance (claims 1-8 and 13-14) The compounds of formula (I) as in claim 1 are free of prior art. The following is an examiner’s statement of reasons for allowance: The instant claims relate to compounds of formula (I) as in claim 1, with variables as defined in claim 1, a pharmaceutical composition thereof, and a process for the preparation of a compound of formula (I) as in claim 1. The closest prior art of record is Yang et al. (CN106139151 A, 23 November 2011, in the IDS) and Tang et al. (US 2012/0115897 A1, 10 May 2012). Yang et al. teaches a medicine for treating malignant tumors, in particular an L-palmitoyl ascorbate antitumor medicine (Abstract). Yang et al. teaches compounds of the generic formula shown below (Para. [0007]). Tang et al. teaches ascorbyl ester derivatives of aryl (ethanoic) propanoic acid, for use in the treatment of certain cancers, among other conditions (Abstract; Para. [0006]; Para. [0022]) and pharmaceutical compositions thereof (Para. [0023]). Tang et al. teaches the following exemplary compound in an embodiment (Para. [0027]). The novelty of the instantly claimed compound of formula (I) lies in the cyclohexyl ring attached to the alkyl carbon chain of the ester functional group, which is not taught or suggested by the prior art. Therefore, the compounds of the instant invention are novel and non-obvious variants of the compounds taught by the prior art. The process of preparation of said compounds of formula (I) are novel and non-obvious. Conclusion Claims 10-12 are rejected. Claims 1-8 and 13-14 are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT PADMAJA S RAO whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9918 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 9:00-5:30 pm EDT . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kortney L Klinkel can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-5239 . 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. /P.S.R./ Examiner, Art Unit 1627 /Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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Prosecution Timeline

Mar 01, 2023
Application Filed
Dec 05, 2025
Non-Final Rejection — §112
Mar 20, 2026
Response Filed

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
71%
Grant Probability
99%
With Interview (+40.4%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 118 resolved cases by this examiner. Grant probability derived from career allow rate.

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