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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Feb. 12th, 2026 has been entered.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The specification lacks a Detailed Description of the drawings. A detailed description of the invention and drawings follows the general statement of invention and brief description of the drawings. This detailed description, required by 37 CFR 1.71, MPEP §§ 608.01, 2161, and 2162, must be in such particularity as to enable any person skilled in the pertinent art or science to make and use the invention without involving extensive experimentation and must clearly convey enough information about the invention to show that applicant invented the subject matter that is claimed.
The disclosure is objected to because of the following informalities: In page 157, “Talbe 8” should read “Table 8”. – Applicant is required to check the entire specification for typos and spelling errors.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show labels for the X and Y axes, as described in the specification (particularly Figures 1-7). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Status of the Claims
Claims 1, 12, 16, 18, 21, 23, 25, 27, 30, 34-38, and 43-45 are pending in this application. Claims 2-11, 13-15, 17, 19-20, 22, 24, 26, 28-29, 31-33, and 39-42 have been cancelled by Applicant.
Claim Objections
Claims 1, 16, 18, and 43 is objected to because of the following informalities:
Claim 1 is objected because, if A3 is always absent in the structure of Formula II-1, then why include it in the structure? For simplicity and clarity, Applicant should submit a new structure for Formula II-1 wherein the A3 variable has been removed. The same goes for L1 and L2, which are always a bond; and A1-2, 4-6 which are limited to a single option each.
The entire claim should be revised to correct many spacing issues of entries following commas, for example:
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- missing space after the comma.
Claims 1, 16, and 18, in the definition for ring E, claim reads: “wherein the … heteroaryl comprising…” Claim should read: “wherein the … heteroaryl comprises…” Similar issue is found in the definitions for ring D in claim 18.
Claim 43 reads: treatment of disease in a subject, which method comprising” The claim should read: “treatment of a disease in a subject in need thereof, the method comprising…”
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 1, 12, 16, 18, 21, 23, 25, 27, 30, 34-38, and 43-45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is directed to the compounds of Formula II-1, or a stereoisomer, tautomer, pharmaceutically acceptable salt, prodrug, chelate, non-covalent complex, or solvate thereof, however, the specification provides no support for ‘chelates or non-covalent complexes’.
The purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 920 (Fed. Cir. 2004), (quoting Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000)). To determine whether there is adequate written description support for the genus of methods and means of achieving the claimed properties, the Specification is reviewed for species that achieve the claimed results. "[T]he specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Ariad, 94 USPQ2d at 1170-1171.
In the present case, in the specification, Applicant has not shown possession of the full scope of claim 1, as it pertains specifically to chelates or non-covalent complexes of the instant compounds of Formula II-1.
Claims 12, 16, 18, 21, 23, 25, 27, 30, 34-38, and 43-45 are rejected for depending upon the limitations of claim 1 without remedying the deficiencies of claim 1.
Further regarding claim 43, the claim language broadly encompasses ‘treatment of disease’, which could be any disease (any cancer, viral infections, fibrosis, osteoarthritis, or metabolic conditions, etc.). However, the specification does not reference every possible disease that can be treated with the present compounds, and provides no data to support the treatment of any disease beyond cancers or hyperproliferative disorders, particularly colon cancer, gastric cancer, thyroid cancer, lung cancer, leukemia, pancreatic cancer, melanoma, multiple melanoma, brain cancer, renal cancer, liver cancer, squamous cancer, gastrointestinal cancer, mesothelioma, prostate cancer, ovarian cancer, or breast cancer (para. bridging pages 58-59).
"[T]he specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Ariad, 94 USPQ2d at 1170-1171.
Claim 43 is 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 the treatment of the cancers listed in claim 44, it does not reasonably provide enablement for any and all disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make us of the invention commensurate in scope with these claims.
The applicant’s attention is drawn to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998), where the court set forth eight factors to considers 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 examples; and (8) the quantity of experimentation necessary.
Breadth of Claims
Claim 43 broadly encompasses a method of treating any disease (any cancer, viral infections, fibrosis, osteoarthritis, or metabolic conditions, etc.), in any subject in need thereof, comprising administration of any of the compounds of Formula II-1, or stereoisomers, tautomers, pharmaceutically acceptable salts, prodrugs, chelates, non-covalent complexes, or solvates thereof.
The term “subject” was not defined in the specification. Accordingly, the broadest reasonable interpretation of the term “subject” is taken to be any animal (humans, other primates, dogs, cats, squid, etc.).
Nature of the invention/ State of the Prior Art/ Predictability in the Art
Fu et al. (Sig Transduct Target Ther, 2022, 7, 376) discloses the Hippo pathway is crucial in the regulation of numerous biological processes; such as cell proliferation and differentiation, organ growth, embryogenesis, and tissue regeneration/wound healing. However, dysregulation of the Hippo pathway can cause a variety of diseases, including cancer, eye diseases, cardiac diseases, pulmonary diseases, renal diseases, hepatic diseases, and immune dysfunction (abstract). Fu discloses that substantial efforts have been made to understand the upstream and downstream signals that influence the activity of the Hippo pathway (abstract) – thus, while Hippo pathway (upstream or downstream) might be associated in some way with a wide range of diseases, its inhibition does not guarantee treatment of all diseases.
Wei et al. (Med Comm. 2023; 4: e340, 42 pages) discloses YAP/TAZ influences the expressions of downstream genes and proteins as well as enzyme activity in metabolic cycles, cell proliferation, inflammatory factor expression, and the trans differentiation of fibroblasts into myofibroblasts. YAP/TAZ can also be regulated through epigenetic regulation and posttranslational modifications. Consequently, the regulatory function of these mechanisms implicates YAP/TAZ in the pathogenesis of metabolism-related diseases, atherosclerosis, fibrosis, and the delicate equilibrium between cancer progression and organ regeneration (abstract). Again, while YAP/TAZ regulation might have an effect on a range of conditions, its regulation does not necessarily translate to treatment of all diseases, as claimed.
Finally, the medical arts are also generally considered to be unpredictable making the goal of achieving prevention in this case even less likely. See Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970) (“In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involve.”).
Level of One of Ordinary Skill
The level of one of ordinary skill in the art would be high, likely an M.D. or Ph.D. in the medical arts (e.g., studying treatment of cancers and viral infections, etc.). See Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376 at 1381–82 (Fed. Cir. 1983) (Factors that may be considered in determining level of ordinary skill in the art include: … type of problems encountered in the art …”).
Guidance/Working Examples
The specification provides some EC50 data for TEAD-YAP/TAZ inhibition in vitro with some of the claimed compounds (see page 153-154 of the specification); then provides examples of proliferation inhibition potency (IC50) of some compounds in NCI-H226 cells, which are derived from a human non-small cell lung carcinoma (NSCLC), specifically squamous cell carcinoma – See Table 7 of the spec. (page 156-157) – it is noted that none of the compounds of this table (Table 7) are encompassed by amended claim 1, therefore, there is no evidence that the claimed compounds will behave like the compounds shown in the table, since they have a different bicyclic core – Table 7 is reproduced below for convenience. The same is seen with the experiments reported in Table 9 (page 159), wherein none of the instantly claimed compounds were tested.
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Applicant also discloses some pharmacokinetics data of the claimed compounds in plasma following PO cassette dosing in mice (see page 157-157) – see Table 8 of the spec.
Degree of Experimentation
To practice the invention as claimed, the skilled artisan would have to screen each of the many compounds encompassed by Formula II-1, stereoisomers, tautomers, pharmaceutically acceptable salts, prodrugs, chelates, non-covalent complexes, or solvates thereof in order to determine whether the compounds meet the functional limitations of the claim for the treatment any disease. In addition, the skilled artisan would need to determine which subjects would benefit from treatment these diseases (humans, other primates, cats, dogs, squid, etc.) by administering the instantly claimed compounds to a statistically significant pool of subjects from each species. Thus, the quantity of experimentation in this area would be extremely large, since there are a significant number of parameters that would have to be studied beyond in vitro data disclosed for TEAD-YAP/TAZ inhibition and pharmacological studies with the claimed compounds. Furthermore, the ultimate outcome of such experimentation is completely unpredictable.
In sum, taking into consideration the Wands factors outlined above, an undue amount of experimentation would be required here to make and use the full scope of the claimed invention.
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.
Claims 1, 12, 16, 18, 21, 23, 25, 27, 34-36, 38, and 43 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Liao et al. (US 2018/0222904 A1) (“Liao”).
Regarding claims 1, 12, 16, 18, 21, 23, 25, 27, 34-36, Liao discloses their compounds of Formula I, and their preferred embodiment 250 (page 112; and Liao’s claim 1) below, which anticipates the instant compounds when ring D is a heterocycle (
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); R4 is
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, wherein L3 is a bond, and R5-7 are H; ring E is phenyl; and R2 is -C(O)Ra, wherein Ra is a heterocycle comprising 2 heteroatoms (N and O).
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(I)
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(250)
Applicant is advised that a recitation of the intended use of the claimed invention, such as “wherein the compound inhibits protein protein interaction of YAP/TAZ and TEAD” in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02. Furthermore, products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 38, Liao discloses an assay with their compound 250 above (see Table on page 124), then in para. [0211] states that compounds to be assayed were dissolved in DMSO (thus anticipating a pharmaceutical composition comprising their compound and a carrier). Liao also claims a pharmaceutical composition comprising their compounds of claim 1 (Liao’s claim 8).
Regarding claim 43, Liao claims a method of treating an autoimmune disease comprising administering a therapeutically effective amount of their compounds to a subject in need thereof (Liao’s claim 8).
Claim Rejections - 35 USC § 103
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.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Liao et al. (US 2018/0222904 A1) (“Liao”); as applied to claims 1, 12, 16, 18, 21, 23, 25, 27, 34-36, 38, and 43.
The teachings of Liao are disclosed in the 102-section above and incorporated herein.
Regarding claim 37, Liao discloses the compounds of Formula I (Liao’s claim 1), which reads on the instant compounds when A is N or CR1, wherein R1 (corresponding to instant R1) can be H, etc.; B-D can be N or CH; R2 (corresponding to instant ring E-(R2)m) can be one of
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, wherein X can be a bond and E, can be H, a saturated carbocycle, etc.; and R3 (corresponding to instant ring D-R4) can be
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, wherein Y can be -C(O)-; and R6-8 can be H, halogen, alkyl, alkyl-phenyl, etc. (Liao’s claim 3).
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Therefore, regarding claim 37, particularly regarding the compound below, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Chen’s disclosed formula; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds Btk inhibitors for the treatment of cancers (see abstract) disclosed by Chen. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
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Claims 1, 12, 16, 21, 23, 25, 27, 30, 34, 36, 38, and 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2019/0144451 A1) (“Chen”).
Regarding claims 1, 12, 16, 21, 23, 25, 27, 30, 34, 36, and 45, Chen discloses their compounds of Formula I and their preferred embodiment compound 1 (pages 1 and 25) as Bkt inhibitors for the treatment of cancers – which is the same intended use of the instant invention. Chen discloses, in their compounds of Formula I, in the -C(O)NHR9 group (corresponding to instant R2), R9 can be substituted or unsubstituted heteroaryl; R10 (corresponding to instant Ra in L3) can be H or alkyl; R6-8 can be L-J-W, V-Q-W, or X-A-W, respectively, wherein L, J, V, Q, X, and A can be absent, alkylene, or heterocycle, etc., and W can be H or NR25R26, wherein R25-26 can be H, alkyl, cycloalkyl, etc.
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(Formula I)
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Chen’s compound 1 reads on the instant invention when instant ring D is aryl (phenyl); R4 is
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, wherein L3 is -N(C1 alkyl)-, R5-7 are H; ring E is phenyl; R2 is -C(O)NRaRb, wherein Ra and Rb- are H and heteroaryl (pyridine), respectively; and R1 is -NRdRe, wherein Rd and Re are H. While the instant claims require Re to be C1-6 alkyl, etc. (not H, as in Chen’s compounds), Applicant is advised that H vs. Me is considered an obvious modification in the absence of superior, unexpected results. Note In re Wood 199 USPQ 137; In re Lohr 187 USPQ 548 and In re Bowers 149 USPQ 573. Note also In re Fauque 121 USPQ 425 in which differences were 2H’s vs 2 methyl groups. Also see MPEP 2144.09. Therefore, the instant compounds, wherein R1 is -NHMe, are obvious in view of Chen. Furthermore, regarding claim 45, Chen teaches their R6-8 groups can be H or alkyl – when L, J, V, Q, X, and A are alkylene and W is H – and further teaches their R9 group can be H (reading on instant Ra-b being selected from H and alkyl). Therefore, Chen discloses a relatively narrow subgenus of compounds, which is encompassed by the instantly claimed genus.
Therefore, regarding claims 1, 12, 16, 21, 23, 25, 27, 30, 34, 36, and 45, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Chen’s disclosed formula; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds Btk inhibitors for the treatment of cancers (see abstract) disclosed by Chen. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Applicant is advised that a recitation of the intended use of the claimed invention, such as “wherein the compound inhibits protein protein interaction of YAP/TAZ and TEAD” in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Further regarding claim 30, Chen discloses their R8 (corresponding to instant R5) can be X-A-W, wherein X and A can be alkelene or heterocycle, etc. and W can be H, (corresponding to instant R5 being -C1-6 alkylene-Rc., wherein Rc is a heterocycle ([0017] and [0020]).
Regarding claim 38, Chen discloses pharmaceutical compositions comprising their compounds and excipients ([0030]).
Regarding claims 43-44, Chen discloses their compounds in methods for the treatment of cancers like pancreatic cancer [0064], leukemia [0193], etc.
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.
Claims 1, 12, 16, 18, 21, 23, 25, 27, 30, 34-38, and 43-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-27 and 30-36 of copending Application No. 18/839,000 (Copending ‘000).
Regarding claims 1, 12, 16, 18, 21, 23, 25, 27, 30, 34-38, and 43-45, Copending ‘000 claims a pharmaceutical composition comprising the compounds of Formula I below, which anticipates the instant compounds:
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Claim 37 is rejected for claiming the compound above: 1-(1-(2-fluoroacryloyl)azetidin-3-yl)-3-(4-(trifluoromethyl)phenyl)-1,3-dihydro-2H-imidazo[4,5-b]pyrazin-2-one (compound 229).
Regarding claim 38, Copending ‘000 speaks to a pharmaceutical composition comprising their compounds and acceptable carriers (Copending ‘000 claims 1-8).
Regarding claims 43-44, Copending ‘000 speaks to a method of treating cancers like lung, prostate, rectal, and colon cancers etc. (Copending ‘000 claims 14-15).
Applicant is reminded that one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by the disclosed formula. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Copending ‘000. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the instant claims.
Furthermore, applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pages 42-45, filed 01/20/2026, with respect to the rejection(s) of the claim(s) under 35 USC § 103 over Liu in view of Morita; Taunton Jr. in view of Morita; and Goldstein, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Liao et al. or Chen et al., as presented in this action.
Applicant is reminded that a recitation of the intended use of the claimed invention, such as “wherein the compound inhibits protein protein interaction of YAP/TAZ and TEAD” in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Double Patenting
While applicant failed to acknowledge the provisional non-statutory double patenting rejections of record, Applicant is advised that, upon reconsideration, the provisional NSDP rejection over Copending App. No. 18/009,362 (Copending ‘362) has been withdrawn. However, claims stand rejected over Copending App. No. 18/839,000 (Copending ‘000).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights