Office Action Predictor
Last updated: April 17, 2026
Application No. 18/254,511

HETEROCYCLIC COMPOUND AS DIACYLGLYCEROL KINASE INHIBITOR AND USE THEREOF

Non-Final OA §103§112
Filed
May 25, 2023
Examiner
LEE, CHIHYI NMN
Art Unit
1628
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
LG chem Ltd.
OA Round
1 (Non-Final)
34%
Grant Probability
At Risk
1-2
OA Rounds
3y 2m
To Grant
99%
With Interview

Examiner Intelligence

Grants only 34% of cases
34%
Career Allow Rate
26 granted / 77 resolved
-26.2% vs TC avg
Strong +65% interview lift
Without
With
+65.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
57 currently pending
Career history
134
Total Applications
across all art units

Statute-Specific Performance

§101
2.7%
-37.3% vs TC avg
§103
35.3%
-4.7% vs TC avg
§102
14.2%
-25.8% vs TC avg
§112
28.5%
-11.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 77 resolved cases

Office Action

§103 §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. Priority The instant application 18 / 254 , 511 filed on May 2 5 , 202 3 is a 371 of PCT/KR2021/017518 filed on November 25, 20 21 , which claims priority to, and the benefits of Foreign Application No. KR10-2020-0161547 filed on November 2 6 , 20 20 . Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statements (IDS) submitted on 05/25/2023, 01/22/2024 and 10/28/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Status of Claims Claims 1 -6 are pending and under examination. Claim Interpretation Instant claim 1 recites chemical structures with an arrow ( ) shown below: “ ” , when reasonably construed in light of the compound species recite in claim 3, said arrow refers to a point of connection to the nitrogen atom of the piperidinyl ring ( ). Regarding the limitation of “for the prevention or treatment of diseases associated with diacylglycerol kinases (DGKs)” in claim 4 , the limitation of “wherein the disease associated with diacylglycerol kinases (DGKs) is cancer” in claim 5 and the limitation of “wherein the cancer is selected from the group consisting of gastrointestinal cancer, pancreatic cancer, breast cancer, colon cancer, retinoblastoma, liver cancer, lung cancer, ovarian cancer, cervical cancer, endometrial cancer, brain tumor, testicular cancer, laryngeal cancer, prostate cancer, neuroblastoma, kidney cancer, thyroid cancer, esophageal cancer, skin cancer, osteosarcoma and bladder cancer” in claim 6 , each of these limitations is reasonably construed by the Examiner as being drawn to the intended use of the pharmaceutical composition set forth in claim 4 , and these limitation s do not create a structural difference to the pharmaceutical composition. Claim Objections Claims 2- 4 are objected to because of the following informalities: Regarding claims 2-4, the recitation of “a pharmaceutically acceptable salt or stereoisomer thereof” should read –pharmaceutically acceptable salt or stereoisomer thereof— , such that the article “a” proceeding the phrase “pharmaceutically acceptable salt” is deleted, because said article is often used to refer to a subject matter that has not been mentioned before . T herefore, said article can cause confusion with respect to whether the “pharmaceutically acceptable salt” recites therein is referring to the same pharmaceutically acceptable salt set forth in claim 1 or a distinct pharmaceutically acceptable salt that has not yet been introduced in c laim 1. Regarding claim 3, the recitation of “wherein the compound of Formula 1 is selected from the following group” should read –wherein the compound of Formula 1 is selected from the group consisting of – , because the claim language is not being consistent with the Markush claim language. Please note a “Markush” claim recites a list of alternatively useable members. In re Harnisch, 631 F.2d 716, 719-20, 206 USPQ 300, 302-304 (CCPA 1980); Ex parte Markush , 1925 Dec. Comm'r Pat. 126, 127 (1924). The listing of specified alternatives within a Markush claim is referred to as a Markush group or Markush grouping. Abbott Labs v. Baxter Pharmaceutical Products, Inc ., 334 F.3d 1274, 1280-81, 67 USPQ2d 1191, 1196-97 (Fed. Cir. 2003). Claim language defined by a Markush grouping requires selection from a closed group “consisting of” the alternative members. Id. at 1280, 67 USPQ2d at 1196. See MPEP § 2111.03, subsection II, for a discussion of the term “consisting of” in the context of Markush groupings . Appropriate correction is required. Claim Rejections - 35 USC § 112 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 4-6 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 breast cancer, cervical cancer, brain tumor and skin cancer , does not reasonably provide enablement for preventing or treating the entire scope of diseases associated with diacylglycerol kinases . 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. Attention is directed to In re Wands , 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman , 230 USPQ 546 ( BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and, (8) the quantity of experimentation necessary. All of the Wands factors have been considered and discussed below: (1, 5) The breadth of the claims and the Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.” Claim 4 recites “[a] pharmaceutical composition for the prevention or treatment of disease s associated with diacylglycerol kinases (DGKs) comprising the compound of Formula 1, or a pharmaceutically acceptable salt or stereoisomer thereof according to claim 1 as an active ingredient, together with a pharmaceutically acceptable carrier ”. Please note that a ccording to page 16, 1 st paragraph of the specification, “[t]he compound of Formula 1 according to the present invention exhibits inhibitory activity against diacylglycerol kinases (DGKs)” , and its inhibitory effect against DGK enzyme is specifically disclosed in Table 1 of the specification. Therefore, the breadth of the claim covers preventing or treating each and every disease species associated with diacylglycerol kinases , including the disease subgenus and species set forth in claims 5-6. (2, 3, 4) The state of the prior art, the level of skill in the art, and the predictability or lack thereof in the art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.” As discussed above, the claimed invention pertains to a pharmaceutical composition comprising any compound species of Formula 1 or pharmaceutically acceptable salt or stereoisomer thereof with the intention to prevent or treat each and every disease species associated with diacylglycerol kinases . At the time the application was filed, one skilled in the art would have known that DGKα selective inhibitors , R59022 and R59949 , inhibit the proliferation of glioblastoma, melanoma, breast cancer, and cervical cancer cells in the in vitro studies (see e.g., Figure 6); and they also demonstrate efficacy in delaying tumor growth , decreas ing angiogenesis and increasing mouse survival in glioblastoma and melanoma xenograft treatment models (see e.g., abstract), as evidenced by Dominguez et al. ( Cancer Discov , 2013 . Vol. 3(7): 782-797 ). According to Liu et al. ( Int J Mol Sci , 2024 . Vol. 25(23):13207 ), mammalian DGK isoforms are classified into five subtypes based on functional domains (see e.g., Figure 3) ; and each isoforms are linked to distinct DGK-related diseases based on their unique function shown below: (see e.g., Table 2). Specifically, DGKα is known to promot e T-cell anergy and plays an essential role in the programmed cell death-1/ligand-1 (PD-1/PD-L1) axis, significantly limiting the Ras/extracellular signal-regulated kinase (ERK) pathway, which is crucial for activator protein-1 (AP-1) activation (see e.g., p. 6, “ 5. Physiological Functions of DGKs ” section). In other words, while the cited reference demonstrates that DGKη has shown connection to bipolar disorder, the art with respect to treating the entire scope of DGK-related diseases , includ ing bipolar disorder , using a small molecule that inhibits DGK α (the compound of Formula I, or pharmaceutically acceptable salt or stereoisomer of the claimed invention) is still underdeveloped , because different DGK isoforms are known in the art to play distinct roles in various signaling pathways. At the time the application was filed , the relative skill of those in the art tasked with identifying compounds exerting an inhibitory activity against DGK enzyme would have been high, as the ordinarily skilled artisan would have had an experience with screening techniques such as performing an in-silico molecular comparison method to calculate molecular similarity of target substance to reference compounds that are known to selectivity inhibit DGK ( 2D-similarity-based virtual screening) (see e.g., p. 379 , “ 2.1. In silico drug discovery ” section), as evidenced by Velnati et al. ( European Journal of Medicinal Chemistry , 2019. Vol. 164 : 378 - 390 ). Even though the compound of Formula 1 or a pharmaceutically acceptable salt or stereoisomer thereof , which exhibits inhibitory effect against DGK enzyme , may play a role in treating breast cancer, cervical cancer, brain tumor and skin cancer by inhibiting the DGK enzyme , it is uncertain whether the pharmaceutical composition comprising any compound species the compound of Formula 1 or a pharmaceutically acceptable salt or stereoisomer thereof can be used for treating or preventing the entire scope of disease s associated with diacylglycerol kinases for the reasons set forth herein. (6, 7, 8) The amount of guidance given, the presence of working example and the quantitation of experimentation required: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the claimed invention . In the present case, the specification discloses the DGK enzyme inhibitory effect of the compound of Example 1-67 (see e.g., Table 1); However, their biological activities against the entire scope of disease s associated with diacylglycerol kinases have not been disclosed. Therefore, one of the relative skill in the art armed with screening techniques could not reasonably predict which disease species associated with diacylglycerol kinases encompassed by the claim could be treated or prevented by the compound of Formula 1 , or pharmaceutically acceptable salt or stereoisomer thereof based on the limited disclosure provided. As a result, it would require an undue experimentation as it is highly unpredictable that the pharmaceutical composition comprising any compound species of Formula 1 , or pharmaceutically acceptable salt or stereoisomer would, in fact, be usable across the entire scope of disease s associated with diacylglycerol kinases with the intention to prevent or treat. Accordingly, the pharmaceutical composition comprising any compound species of F ormula 1 , or pharmaceutically acceptable salt or stereoisomer, with the intended use that covers preventing or treating the entire scope of disease s associated with diacylglycerol kinases is not enabled by the instant specification. To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure. Claim s 4-6 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch , 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi , 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph). The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: Claim 4 is drawn to “[ a ] pharmaceutical composition for the prevention or treatment of disease associated with diacylglycerol kinases (DGKs) comprising the compound of Formula 1, or a pharmaceutically acceptable salt or stereoisomer thereof according to claim 1 as an active ingredient, together with a pharmaceutically acceptable carrier”. The claimed term “prevention”, when given its broadest reasonable interpretation, is taken to include subjects (i.e., a patient population) that have not yet developed a disease associated with diacylglycerol kinases. The claimed term “treatment”, when given its broadest reasonable interpretation, is taken to include only those subjects (i.e., a patient population) that have developed detectable symptoms of a disease associated with diacylglycerol kinases. The Markush grouping “prevention” and “treatment” do not share a common use, and is therefore improper, because the patient populations to which each species is directed do not overlap in scope. In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided). In order to overcome this rejection, a pplicant should amend the above claim 4 by deleting the word “ prevention ” in order that the species recited in the Markush Group ing share a common use, "treatment" . Accordingly, claims 5-6 are rejected based on their dependency on a rejected base claim. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1-2 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Tulshian et al. (WO 20000 / 06545 A1) , in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176) . Tulshian et al. teaches a compound having the structure of: is a compound of formula I and an ORL-1 agonist (see e.g., abstract; Table 7, p.54, 2 nd last compound) (referred to herein as Compound 1 ) . Tulshian et al. further teaches the compound of formula I : , wherein X 1 is ; R 11 is independently selected from the group consisting of , inter alia , H or R 5 -(C 1 -C 6 )alkyl ; and R 5 is 1 to 3 substituents independently selected from the group consisting of, inter alia , H (see e.g., claim 1). Tulshian et al. further teaches a pharmaceutical composition comprising a therapeutically effective amount of the compound of formula I in combination with a pharmaceutically acceptable carrier (see e.g., claim 10; p. 7, line 20-22). Tulshian et al. does not teach the claimed compound of Formula I. Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g., “introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical, wherein the classical bioisosteres are a series of replacements defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (see e.g., p. 3148-3149). Patani et al. further teaches hydrogen and methyl is one of the classical bioisosteres based on Grimm’s Hydride Displacement Law (see e.g., p. 3152; Figure 14). Patani et al. further exemplified said replacement shown below: (see e.g., p. 3153, right column, Figure 14 and Table 12). Patani et al. further teaches benzene, thiophene and pyridine are also classical bioisosteres resulted in analogues with retention of biological activity within different series of pharmacological agents (see e.g., p. 3158, left column, “E. Ring Equivalents” section, 1 st paragraph). In the present case, the difference between the compound 1 of Tulshian et al. and the claimed compound of Formula 1 lies on the lies on R 11 and the benzene moiety of shown below (see shaded): . It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select compound 1 of Tulshian et al. and then modify the compound by replacing the hydrogen with a methyl at the R 11 position and replacing the benzene with a pyridine based on the Grimm’s Hydride Displacement Law taught by Patani et al. One would have been motivated to do so, because Patani et al. the replacement of hydrogen with methyl, and the replacement of benzene with pyridine are bioisosteric replacement technique s based on Grimm’s Hydride Displacement Law , and they can be interchanged in medicinal chemistry to arrive compound with similar properties. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the modified compound 1 of Tulshian et al. would successfully exhibits ORL-1 agonist activity ; and therefore, said modified compound would successfully incorporate into a pharmaceutical composition with a pharmaceutically acceptable carrier without any appreciable loss of activity. Regarding the limitation of “for the prevention or treatment of diseases associated with diacylglycerol kinases (DGKs)” in claim 4 , the limitation of “wherein the disease associated with diacylglycerol kinases (DGKs) is cancer” in claim 5 and the limitation of “wherein the cancer is selected from the group consisting of gastrointestinal cancer, pancreatic cancer, breast cancer, colon cancer, retinoblastoma, liver cancer, lung cancer, ovarian cancer, cervical cancer, endometrial cancer, brain tumor, testicular cancer, laryngeal cancer, prostate cancer, neuroblastoma, kidney cancer, thyroid cancer, esophageal cancer, skin cancer, osteosarcoma and bladder cancer” in claim 6 , these limitations are drawn to the intended use of the pharmaceutical composition instantly claimed. The intended use of the claimed pharmaceutical composition does not patentably distinguish the pharmaceutical composition, per s e, since such undisclosed use would naturally flow from the fact that the claimed pharmaceutical composition is obvious over the teachings of prior arts. In order to be limiting, the intended use must create a structural difference between the claimed pharmaceutical composition and the pharmaceutical composition taught by Tulshian et al. in view of Patani et al. In the present case, the pharmaceutical composition comprising the modified compound 1 of Tulshian et al. and a pharmaceutically acceptable carrier renders obvious the limitation instantly claimed. P lease note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether a pplicant’s claimed compound is different and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the a pplicant. Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary. Claim s 1-2 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Baba et al. ( WO 2008/089201 A2 ). Baba et al. teaches a compound Ref No. 66 having the structure of: is a compound of formula (II) that exhibit s binding affinity to the opioid receptor-like ( ORL- 1) receptor useful for treat ing or prevent ing acute or chronic pain , including, inter alia , cancer pain (see e.g., claim 19; Table 2, Ref No. 66; p. 3, lines 13-14; p. 160, line 21 to p . 161, line 3). Bab a et al. further teaches the compound of formula (II): , wherein Q is selected from naphthaleno or pyridino ; R 3 is selected from, inter alia , -H or -(C 1 -C 6 alkyl); and Z is -[(C 1 -C 10 )alkyl optionally substituted by R 1 ] h -, wherein h is 0 or 1 (see e.g., claim 2 ) . Bab a et al. further teaches when h is 0, Z is a bond (see e.g., p. 124, line 2-4). Baba et al. further teaches "-(C 1 -C 10 )alkyl ” means a straight chain or branched non-cyclic hydrocarbon having from 1 to 10 carbon atoms , including a - CH 2 - group (see e.g., p. 112, line 13-17). Bab a et al. further teaches the phrase “ pyridino ”, when used in connection with the Q group, means (see e.g., p. 126, line 11-13). Baba et al. further teaches i n another embodiment , R 3 is methyl, ethyl, n-propyl or iso-propyl (see e.g., p. 97, line 7). Baba et al. further teaches a composition comprising an effective amount of the compound or a pharmaceutically acceptable derivative of the compound and a pharmaceutically acceptable carrier or excipient (see e.g., claim 21). In the present case, the difference between the compound Ref No. 66 of Baba et al. and the claimed compound of Formula 1 lies on the Z moiety , the R 3 , and the position of nitrogen atom of the pyridino moiety taught by Baba et al. shown below (see shaded) : . It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select the compound Ref No. 66 of Baba et al. and then modify said compound by ( i ) changing the position of nitrogen atom of the pyridino moiety , in this case, from to , (ii) replacing the bond with -CH 2 - at the Z moiety , and (iii) replacing -H with methyl at the R 3 according to the formula (II) taught by said prior art. One would have been motivated to do so, because Baba et al. clearly teaches the Q ring can be pyridino , such as and ; the Z moiety can be a bond or -(C 1 -C 10 )alkyl optionally substituted by R 1 - , including -CH 2 - ; and R 3 can be -H or methyl to arrive a compound of formula (II) with binding affinity to the ORL-1 receptor . One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by the modified compound Ref No. 66 of Baba et al. would have successfully arrive a compound of formula (II) that exhibits binding affinity to ORL-1 receptor ; and therefore, said modified compound would successfully incorporate into a pharmaceutical composition with a pharmaceutically acceptable carrier without any appreciable loss of activity. Regarding the limitation of “for the prevention or treatment of diseases associated with diacylglycerol kinases (DGKs)” in claim 4 , the limitation of “wherein the disease associated with diacylglycerol kinases (DGKs) is cancer” in claim 5 and the limitation of “wherein the cancer is selected from the group consisting of gastrointestinal cancer, pancreatic cancer, breast cancer, colon cancer, retinoblastoma, liver cancer, lung cancer, ovarian cancer, cervical cancer, endometrial cancer, brain tumor, testicular cancer, laryngeal cancer, prostate cancer, neuroblastoma, kidney cancer, thyroid cancer, esophageal cancer, skin cancer, osteosarcoma and bladder cancer” in claim 6 , these limitations are drawn to the intended use of the pharmaceutical composition instantly claimed. The intended use of the claimed pharmaceutical composition does not patentably distinguish the pharmaceutical composition, per s e, since such undisclosed use would naturally flow from the fact that the claimed pharmaceutical composition is obvious over the teachings of prior art. In order to be limiting, the intended use must create a structural difference between the claimed pharmaceutical composition and the pharmaceutical composition taught by Baba et al. In the present case, the pharmaceutical composition comprising the modified compound Ref No. 66 of Baba et al. and a pharmaceutically acceptable carrier renders obvious the limitation instantly claimed. P lease note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether a pplicant’s claimed compound is different and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the a pplicant. Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary. Free of the Art Claim 3 is free of the art . Conclusion Claims 1-2 and 4-6 are not allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Chihyi Lee whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0663 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 8:30 am - 5:00 pm 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, FILLIN "SPE Name?" \* MERGEFORMAT Amy L. Clark can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (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. 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. /CHIHYI LEE/ Examiner, Art Unit 1628 /JEAN P CORNET/ Primary Examiner, Art Unit 1628
Read full office action

Prosecution Timeline

May 25, 2023
Application Filed
Sep 02, 2025
Non-Final Rejection — §103, §112
Apr 15, 2026
Response after Non-Final Action

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12576048
ANTI-CANCER ACTIVITY OF ADAMANTANE DERIVATIVES
2y 5m to grant Granted Mar 17, 2026
Patent 12551478
QUINOLINE DERIVATIVE HAVING INDOLEAMINE-2,3-DIOXYGENASE INHIBITORY ACTIVITY
2y 5m to grant Granted Feb 17, 2026
Patent 12534451
SMALL MOLECULE MODULATORS OF PANK
2y 5m to grant Granted Jan 27, 2026
Patent 12522590
Brefeldin A Derivatives, Preparation Method and Use thereof
2y 5m to grant Granted Jan 13, 2026
Patent 12521357
INTRAVENOUS DOFETILIDE TO CONVERT ATRIAL FIBRILLATION/FLUTTER
2y 5m to grant Granted Jan 13, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
34%
Grant Probability
99%
With Interview (+65.2%)
3y 2m
Median Time to Grant
Low
PTA Risk
Based on 77 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in for Full Analysis

Enter your email to receive a magic link. No password needed.

Free tier: 3 strategy analyses per month