Prosecution Insights
Last updated: September 17, 2026
Application No. 18/572,134

INHIBITORS OF TRANSGLUTAMINASES

Non-Final OA §112§DOUBLEPATENT
Filed
Dec 19, 2023
Priority
Jun 30, 2021 — EU 21182956.9 +5 more
Examiner
MCMILLIAN, KARA RENITA
Art Unit
1623
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Zedira GmbH
OA Round
1 (Non-Final)
30%
Grant Probability
At Risk
1-2
OA Rounds
11m
Est. Remaining
68%
With Interview

Examiner Intelligence

Grants only 30% of cases
30%
Career Allowance Rate
296 granted / 970 resolved
-29.5% vs TC avg
Strong +38% interview lift
Without
With
+37.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
52 currently pending
Career history
1041
Total Applications
across all art units

Statute-Specific Performance

§101
2.2%
-37.8% vs TC avg
§103
47.6%
+7.6% vs TC avg
§102
10.2%
-29.8% vs TC avg
§112
17.8%
-22.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 970 resolved cases

Office Action

§112 §DOUBLEPATENT
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 This application is a national stage entry of PCT/EP2022/068217 filed on 06/30/2022 which claims priority to U.S. Provisional Application No. 63/217,783 filed on 07/02/2021. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Europe: EP 21183316.5 on 07/01/2021; EP 21182956.9 on 06/30/2021; PCTEP2021086674 on 12/17/2021; and PCTEP2022065435 on 06/07/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Election/Restrictions Applicant's election with traverse of Group I (claims 1-10, 12-14, 16 and 17) drawn to a compound of general formula (I) and compositions thereof in the reply filed on July 7, 2026 is acknowledged. The traversal is on the ground(s) that Hils WO 2018/122419 does not teach compounds within the scope of claim 1 of the instant application. This is not found persuasive because as detailed on pages 5-7 of the prior office action, the technical feature is the common structure shared between all alternatives. In the instant case, R2, L, R3, R6 and R7 are highly variable and thus the common structure shared between all alternatives is PNG media_image1.png 170 164 media_image1.png Greyscale . This common structure which serves as the technical feature is not a special technical feature because does not constitute a structurally distinctive portion in view of Hils et al. WO 2018/122419 (Provided on IDS). Hils et al. discloses a compound having the same core structure as the compounds of Group I (page 112). As such, no special technical feature exists among the different groups of inventions because the technical feature fails to make a contribution over the prior art due to a corresponding lack of novelty and thus there is a lack of unity of inventions as the different groups of inventions do not relate to, and are not so linked as to form a single general inventive concept. The requirement is still deemed proper and is therefore made FINAL. It is noted that claims 12-14, 16 and 17 have been currently amended and now are not drawn to a compound of general formula (I) as previously. Claims 12-14, 16 and 17 are now drawn to a method of using a compound of general formula (I). Newly amended claims 12-14, 16 and 17 are directed to an invention that lacks unity with the invention originally claimed for the following reasons: Since claims 12-14, 16 and 17 are now drawn to a method of using the compounds of general formula (I) and not drawn to a compound of general formula (I), claims 12-14, 16 and 17 lack unity of invention for the same reasons as detailed on pages 5-7 of the prior restriction requirement. Therefore, this invention of claims 12-14, 16 and 17 has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 12-14, 16 and 17 are withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03. To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. Claims 12-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Claims 1-10 are currently presented for examination. 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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-10 of copending Application No. 18/394,766 (U.S. Publication No. 2024/0270715). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of copending ‘766 are substantially overlapping in scope and mutually obvious for the reasons detailed below. Claims 1-10 of the instant application claim a compound of formula (I) having the following structure: PNG media_image2.png 182 368 media_image2.png Greyscale such as PNG media_image3.png 148 326 media_image3.png Greyscale and compositions thereof. Claims 5-10 of copending ‘766 claim a compound of formula (II) having the following structure PNG media_image4.png 202 354 media_image4.png Greyscale wherein L2 is -NRN1, RN1 is H, and R3 is 1-adamantyl PNG media_image5.png 98 86 media_image5.png Greyscale and R2 is selected from PNG media_image6.png 104 388 media_image6.png Greyscale . Claim 6 of copending ‘766 specifically claims formula (II-a) having the following structure: PNG media_image7.png 156 286 media_image7.png Greyscale (Ra-Re may be selected as H). The differences between the claims of copending ‘766 and Applicant’s elected species is the substituent at R2, wherein R2 in copending ‘766 is imidazole; and methyl instead of ethyl is attached to the NH of PNG media_image8.png 88 92 media_image8.png Greyscale of Applicant’s elected species. However, since claim 1 of the instant application claims that R2 may be substituted for the same imidazole rings as claimed in the cited claims of copending ‘766, the cited claims of the instant application are not patentably distinct from the cited claims of copending ‘766. With respect to ethyl instead of methyl attached to the NH of PNG media_image8.png 88 92 media_image8.png Greyscale , a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and/or similar utilities. “An obviousness rejection based on similarity in chemical structure and/or function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Thus adjacent Homologs are considered to be obvious absent unexpected results. Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. Structural similarities of chemical compounds have been found to support a prima facie case of obviousness. See, e.g., Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1900-02, In re Merck & Co., 800 F.2d 1091, 1096-97, 231 USPQ 375, 378-79 (Fed. Cir. 1986)In re May, 574 F.2d 1082, 1093-95, 197 USPQ 601, 610-11 (CCPA 1978) (stereoisomers); In re Wilder, 563 F.2d 457, 460, 195 USPQ 426, 429 (CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428 F.2d 1341, 1344, 166 USPQ 406, 409 (CCPA 1970) (acid and ethyl ester); In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41 (CCPA 1963) (omission of methyl group from pyrazole ring). Thus the cited claims of the instant application and the cited claims of copending ‘766 are mutually obvious and not patentably distinct. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-10 of copending Application No. 18/572,114 (U.S. Publication No. 2024/0376055 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of copending ‘114 are substantially overlapping in scope and mutually obvious for the reasons detailed below. Claims 1-10 of the instant application claim a compound of formula (I) having the following structure: PNG media_image2.png 182 368 media_image2.png Greyscale such as PNG media_image3.png 148 326 media_image3.png Greyscale and compositions thereof. Claims 1-4 and 6-10 of copending ‘114 claim a compound of formula (I) having the following structure: PNG media_image2.png 182 368 media_image2.png Greyscale and compositions thereof, wherein R2 may be selected as PNG media_image9.png 98 144 media_image9.png Greyscale (R12-R14 are H and R10 is CH3); R1 is PNG media_image10.png 98 94 media_image10.png Greyscale R4 is NR6R7 wherein R6 is -CH2CH3 and R7 is H; L may be selected as L1L2 wherein L1 is CH2CO and L2 is -NRN1 and RN1 is H; and R3 is adamantyl. Thus, the only difference between the cited claims of the instant application and the cited claims of copending ‘114 is that R6 in the instant claims as in the elected species is methyl whereas R6 in copending ‘114 is ethyl. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and/or similar utilities. “An obviousness rejection based on similarity in chemical structure and/or function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Thus adjacent Homologs are considered to be obvious absent unexpected results. Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties. Structural similarities of chemical compounds have been found to support a prima facie case of obviousness. See, e.g., Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1900-02, In re Merck & Co., 800 F.2d 1091, 1096-97, 231 USPQ 375, 378-79 (Fed. Cir. 1986)In re May, 574 F.2d 1082, 1093-95, 197 USPQ 601, 610-11 (CCPA 1978) (stereoisomers); In re Wilder, 563 F.2d 457, 460, 195 USPQ 426, 429 (CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428 F.2d 1341, 1344, 166 USPQ 406, 409 (CCPA 1970) (acid and ethyl ester); In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41 (CCPA 1963) (omission of methyl group from pyrazole ring). Thus the cited claims of the instant application and the cited claims of copending ‘114 are mutually obvious and not patentably distinct. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim Rejections - 35 USC § 112(b) 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 1-8 and 10 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. Regarding claim 1, on pages 2 and 7, and claim 2 on page 14, and claim 3 on page 16, the word "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the word are part of the claimed invention. See MPEP § 2173.05(d). In addition, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 on page 2 recites the broad recitation L represents -L1 or -L1L2, and the claim also recites preferably -L1L2, which is the narrower statement of the range/limitation. In the present instance, claim 1 on page 7 recites the broad recitation wherein the unsubstituted bicyclic residues can be substituted with 1 to 5 of the substituents R9 - R¹⁴ and RN, and the claim also recites preferably with 1 to 3 of the substituents R¹¹ - R¹³ which is the narrower statement of the range/limitation. In the present instance, claims 2 and 3 on pages 14 and 16 recite the broad recitation wherein the unsubstituted bicyclic residues can be substituted with 1 to 5 of the substituents R9 - R¹⁴ and RN, and the claim also recites preferably with 1 to 3 of the substituents R¹¹ - R¹³ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Thus claims 1-3 and all claims dependent upon claims 1-3 which do not remedy the issue are rejected. Claim Rejections - 35 USC § 112(a) 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 1-8 and 10 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention. Claims 1-8 and 10 of the instant application claim compounds of general formula (I) or a diastereomer, an enantiomer, a mixture of diastereomers, a mixture of enantiomers, a racemate, a solvate, a hydrate, or a pharmaceutically acceptable salt thereof. While there is adequate written description for compounds of general formula (I) as well as a diastereomer, an enantiomer, a mixture of diastereomers, a mixture of enantiomers, a racemate, or a pharmaceutically acceptable salt thereof, there is inadequate written description for any hydrate or solvate thereof. In the present case, the important factors leading to a conclusion of inadequate written description is the broad scope of the claims, the absence of any working example of a formed solvate or hydrate, and the lack of predictability in the art. The breadth of the claims includes all of the compounds of general formula (I) or a diastereomer, an enantiomer, a mixture of diastereomers, a mixture of enantiomers, a racemate, a hydrate, or a pharmaceutically acceptable salt thereof, as well as the presently unknown list of solvents embraced by the term "solvate". Thus, the scope is broad. Applicants have not taught in the instant specification what is meant by solvate, including how to prepare a solvate with appropriate solvents used to prepare the solvates. Applicants have not provided at least one working example showing the preparation of a solvate or a hydrate. Thus the specification does not enable any person skilled in the art of synthetic organic chemistry to make the invention commensurate in scope with these claims. Although the claims are drawn to solvates or hydrates, the numerous examples presented all fail to produce a single solvate or hydrate. These cannot be simply willed into existence. As was stated in Morton International Inc. v. Cardinal Chemical Co, 28 USPQ2d 1190 "The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity. However...there is no evidence that such compounds exist...the examples of the '881 patent do not produce the postulated compounds...there is ... no evidence that such compounds even exist." The same circumstances appear to be true here. There is no evidence that solvates or hydrates of the instantly claimed compounds actually exist; if they did, they would have been formed. Hence, applicants must show that solvates and hydrates can be made, or limit the claims accordingly. In addition, the claims are directed to encompass "solvates thereof” which only corresponds in some undefined way to specific instantly disclosed chemicals. None of these meet the written description provision of 35 USC 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompasses a myriad of possibilities. To the extent that no structure function data is disclosed in connection with these functionally described compounds to correlate, or there is no disclosed correlation established between these functional drugs and the contemplated desired therapeutic effect to be achieved in practicing the instant invention, the specification provides insufficient written description to support the genus encompassed by the claims. Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed solvates or hydrates regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, lnc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966(1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.") Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966. The state of the art is that it is not predictable whether solvates will form or what their composition will be. In the language of the physical chemist, a solvate of an organic molecule is an interstitial solid solution. This phrase is defined in the second paragraph on page 358 of West (Solid State Chemistry). West, Anthony R., "Solid State Chemistry and its Application, Wiley, New York, 1988, pages 358 & 365. The solvent molecule is a species introduced into the crystal and no part of the organic host molecule is left out or replaced. In the first paragraph on page 365, West says, "it is not usually possible to predict whether solid solution will form, or if they do form, what is their compositional extent". Thus, in the absence of experimentation, one cannot predict if a particular solvent will solvate any particular crystal. One cannot predict the stoichiometry of the formed solvate, i.e. if one, two or a half of a molecule of solvent added per molecule of host. In the same paragraph on page 365, West explains that it is possible to make meta--stable non-equilibrium solvates, further clouding what Applicants mean by the word solvate. Compared with polymorphs, there is an additional degree of freedom to solvates, which means a different solvent or even the moisture of the air that might change the stable region of the solvate. Furthermore the formation of hydrates and solvates is unpredictable since predicting the formation of solvates or hydrates of a compound and the number of molecules of water or solvent incorporated into the crystal lattice of a compound is complex and difficult (see page 18 of Vippagunta et al. 2001, Advanced Drug Delivery Reviews, Volume 48, pages 3-26). Each solid compound responds uniquely to the possible formation of solvates or hydrates and hence generalizations cannot be made for a series of related compounds (page 18). It is estimated that approximately one-third of the pharmaceutically active substances are capable of forming crystalline hydrates which behave similar to solvates that are formed when a pure organic solvent or a mixture of solvents is used as the solvent instead of water for crystallizing the compound (page 15). The mere presence of water in a system is not a sufficient reason to expect hydrate formation, because some compounds, though they are soluble in water, do not form hydrates (page 15). It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that the recitation encompasses solvates of the claimed compounds. Thus, the skilled artisan would view the preparation of any solvate or hydrate of the claimed compounds that are encompassed by the claims, as highly unpredictable in light of the state of the art with regard to the formation of solvates and hydrates for drug compounds. Moreover, one of skill in the art would recognize that it is highly unpredictable in regard to therapeutic effects, side effects and toxicity generated by administering any solvate or hydrate of the compounds encompassed by the claims. Thus since Applicants have not described in adequate detail how to prepare a solvate or hydrate and furthermore have not provided any evidence that solvates or hydrates of the claimed compounds can actually be formed and the state of the art with respect to solvate preparation is unpredictable, an ordinary skilled artisan could not completely envisage Applicants’ invention and moreover, an ordinary skilled artisan could not practice Applicants’ invention without undue experimentation. Furthermore, since Applicants have not adequately described what specific compounds encompass the claimed pharmaceutically acceptable solvates and hydrates thereof, an ordinary skilled artisan could not completely envisage Applicant's invention. Conclusion Claims 1-10 are rejected. Claim 11 is cancelled. Claims 12-17 are withdrawn. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM. 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, Adam C. Milligan can be reached at (571)270-7674. 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. /KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623 KRM
Read full office action

Prosecution Timeline

Dec 19, 2023
Application Filed
Apr 14, 2026
Response after Non-Final Action
Aug 12, 2026
Non-Final Rejection mailed — §112, §DOUBLEPATENT (current)

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Prosecution Projections

1-2
Expected OA Rounds
30%
Grant Probability
68%
With Interview (+37.9%)
3y 8m (~11m remaining)
Median Time to Grant
Low
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