Prosecution Insights
Last updated: August 06, 2026
Application No. 18/567,468

PARP7 INHIBITOR AND USE THEREOF

Final Rejection §112
Filed
Dec 06, 2023
Priority
Apr 01, 2022 — CN 202210339089.9 +1 more
Examiner
BARSKY, JARED
Art Unit
1628
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Novostar Pharmaceuticals Ltd.
OA Round
2 (Final)
50%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
73%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allowance Rate
469 granted / 933 resolved
-9.7% vs TC avg
Strong +23% interview lift
Without
With
+23.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
77 currently pending
Career history
1015
Total Applications
across all art units

Statute-Specific Performance

§101
2.2%
-37.8% vs TC avg
§103
49.4%
+9.4% vs TC avg
§102
8.5%
-31.5% vs TC avg
§112
16.5%
-23.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 933 resolved cases

Office Action

§112
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Response to Amendments Applicant’s amendments to the claims of June 4, 2026, in response to the Office Action of March 10, 2026 are acknowledged. Response to Arguments The § 103 rejections are withdrawn in view of the amendments to the claims. Further, the Scope of Enablement Rejection and Written Description Rejections are withdrawn with respect to the product claims. The traversal of the rejections with regard to method claims 16 and 18 are responded to below. Applicant argues that the correlation between PARP7 activity and broad-spectrum tumor indications is known. Further, Applicant argues that the correlation between PARP7 activity autoimmune and inflammatory diseases has been confirmed. The examiner notes that while there may be a relationship between PARP7 overexpression, claim 16 is directed to any condition affected by PARP7 activity. This does not mean overexpression. Further, to treat a condition of the CNS, the an agent must be established to cross the blood brain barrier. There is no indication that the claimed agent can treat brain tumors or conditions of the CNS. As such, it is not clear that brain cancer, malignant glioma, or other CNS tumors can be treated with a PARP7 inhibitor. The examiner also notes that conditions associated with PARP7 include stroke and viral infections, among others. References are cited below to show the state of the art. According to Qiu et al., “PARP7:anEmergingTherapeuticTarget-InsightsintoBiological Functions and Advances in Small-Molecule Inhibitor Development,” J. Med. Chem 2025, 68, 19846-19870, “PARP7 is associated with various diseases, including viral infections, cancers, and stroke.” Abstract. According to Jeltema et al., “PARP7 protects the lung epithelial barrier from diverse environmental threats,” PNAS 2026 Vol. 123 No. 10, PARP7 protects the lung during pulmonary diseases. “Loss of PARP7 in mice increases susceptibility to chemically induced diffuse alveolar hemorrhaging (DAH) and pristane-induced lupus.” PARP7 inhibition in human bronchial epithelial cells in air–liquid interface culture leads to increased barrier permeability after cigarette smoke challenge or bacterial infection. Failure to maintain barrier integrity within the airways underlies or contributes to various pulmonary diseases including acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD), asthma, cystic fibrosis (CF), and idiopathic pulmonary fibrosis (IPF) (2, 3). These are each conditions that are “regulated by or affected by PARP7” and it would further appear from Jeltema, e.g., that inhibiting PARP7 in these inflammatory or autoimmune conditions would contribute to the pathology of these conditions. “PARP7 Protects Against Lupus-Associated Autoantibodies and Lung Inflammation.” Page 2, 2nd full par. According to Dima et al., “Glioblastoma and PARP inhibitors: the important of patient selection to maximize therapeutic benefits. A critical review,” Frontiers in Oncology March 31, 2026, “The choice of PARPi with optimal trapping and blood-brain barrier penetration capacity, together with molecular stratification based on genomic and expression profiles, appears crucial for the effective use of these agents in glioblastoma.” To date, available trials on PARPi in GBM showed limited clinical efficacy of these agents. Nonetheless, PARPi have very different blood-brain barrier (BBB) penetrance and trapping properties.” See p2, 3rd full par. It is not clear that the claimed agents will treat the scope of conditions claimed including crossing the BBB and treating conditions including those associated with airway barrier integrity, e.g. It is further unclear which conditions were contemplated at the time of filing to be treatable and are considered: “regulated by or affected by PARP7 activity or involves PARP7 activity or overexpression….” The phrase affected by PARP7 activity includes conditions associated with low and high PARP activity. Claim of Foreign Priority Applicant’s claim of foreign priority has been perfected with the submission of a foreign translation on June 4, 2026. Status of the Claims Claims 1, 3, 4, 6-8, 12-16, 18, and 22 are pending and examined. Allowable Subject Matter Claims 1, 3, 4, 6-8, 12-15 and 22 are allowed. Suggestions for Allowance of claims 16 and 18: limit claim 16 to those conditions in which PARP7 is overexpressed; show that the claimed agent can cross the BBB in concentrations sufficient to treat claimed conditions; and remove at least those conditions recognized as being associated with a loss of airway barrier integrity that is known to contribute to various pulmonary diseases including acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD), asthma, cystic fibrosis (CF), and idiopathic pulmonary fibrosis (IPF). 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 16 and 18 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for inhibiting PARP7 with specific compounds of claim 14, e.g., with different degrees of in vitro potency and those conditions known to be represented by such model, are not considered enabled for treatment of all hyperproliferative diseases, autoimmune and inflammatory diseases. 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. Treatment of all hyperproliferative diseases, autoimmune and inflammatory diseases is not enabled. The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below 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.” In the instant case, the claimed invention pertains to compounds of Formula (I-1), which are alleged by the Specification to prevent and treat all forms of cancer, autoimmune disorders, and others. The State of the Prior Art and the Relative Skill of those 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.” Rodriguez et al., “High PARP7 Expression is Associated with Higher Estrogen Response and Immune Suppression but Less Cell Proliferation and Better Survival in Breast Cancer,” Annals of Surgical Oncology October 28, 2025, teaches: “High PARP7 expression is associated with estrogen and androgen response, but also with better overall survival and lower cell proliferation.” See Conclusion of Abstract. As discussed above, the instantly claimed invention pertains to compounds of Formula (I-1), which are alleged by the Specification to treat conditions as an inhibitor of PARP7. At the time the instant application was filed, it would have been known by those of ordinary skill in the art that - compounds, in the vast majority of cases, demonstrate a remarkably high correlation between their structure, specificity and ability to produce a pharmacological effect. At the same time, it would have also been generally assumed that two compounds with similar chemical properties would exhibit similar biological effects. Thus, given a series of compounds that are shown to exert an activity of interest (or given a target of interest), the ordinarily skilled artisan would have expected that a limited genus of related compounds (e.g., compounds exhibiting near equal molecular shapes and volumes, approximately the same distribution of electrons, and similar physical properties such as hydrophobicity, etc.) would interact with the given target to elicit a related biological response. Accordingly, at the time the invention was made, the relative skill of those in the art tasked with identifying compounds exerting an activity of interest would have been high, as the ordinarily skilled artisan would have had, at minimum, a Ph.D. and experience with screening techniques including computer assisted virtual screening techniques such as ligand-based and structure-based design methods. Deciding which technique to use would have been determined by the skilled artisan’s knowledge regarding the compound and target of interest. Ligand based drug design relies on knowledge of a compound or compounds of interest (i.e., ligands) to derive new compounds that will, in theory, similarly interact with the target of interest to elicit the activity of interest. Conversely, structure based drug design relies on knowledge of the three dimensional structure of the target of interest (i.e., receptor, ion channel, or enzyme) to derive new compounds that will, in theory, interact with the target of interest to elicit the activity of interest. In either case, the compounds derived from these techniques (applied alone or in combination) are then subjected to in vitro testing for validation. The Level of Predictability in the Art: Once a compound has been identified by ligand based and/or structure based drug design methods as potentially binding to the target molecule, it must be evaluated. However, as discussed by Anderson (Chem and Biol 10:787-797, 2003), “it is important to consider that the ranking assigned by the scoring function is not always indicative of a true binding constant, since the model of the target:ligand interaction is inherently an approximation. Usually, several molecules which scored well during the docking run are evaluated in further tests since even the top scoring molecule could fail in vitro assays… Finally, leads are brought into the wet lab for biochemical evaluation” (Page 794, Column 1). By that point, as noted by Thiel (Nature Biotechnol 2:513-519, 2004), “libraries are small and hit rates are on the order of one in ten” (Page 517, Column 2). This low level of predictability is not surprising considering that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific receptor or enzyme. Indeed, modifying even a single atom in a compound can dramatically change the compound’s overall structure and - even though complementarity in one portion of the compound might be improved by the chemical revision - the overall binding or activity might be severely compromised. This is certainly true in the case. For example, comparing the structures of those compounds of claim 14, they appear relatively similar. However, the in vitro IC50 PARP-7 inhibitory data show substantial differences in in vitro efficacy. Thus, each change in structure must be evaluated for drastic changes in efficacy. The Amount of Direction Provided by the Inventor / Existence of Working Examples: The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. In the instant case, the Specification discloses 87 compounds species encompassed by Formula (I) that shows activity for in vitro PARP-7 inhibitor IC50. See Specification p226. The variability in results is substantial ranging from low to high and this includes for almost identical compounds. Moreover, data is only provided for 16 compounds. Further, Table 2 provides data for approximately 23 compounds shown IC50 values for a single type of cancer cell, being NCI-H1373 cells, which appears to be a lung adenocarcinoma cell for NSCLC. This is the only data provided for the 87 compounds shown in the Specification. In fact, approximately 64/87 compounds have no data at all. There is not a single example of another disease treated or an in vivo model in which the claimed compounds have been tested. There is no showing of crossing the BBB. Scope or Breadth of the Claims: As stated in MPEP 2164.01(c), “when a compound or composition claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient to preclude a rejection for nonenablement based on how to use” (emphasis added). Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). Indeed, the Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557 (Fed. Cir. 1993) (emphasis added). At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt, 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner, 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art. Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims". Amgen, Inc., v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. See also Ak Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore, 439 F.2d 1232 (CCPA 1971). As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation”. As to the first inquiry, as discussed above, the claims are drawn to compounds of Formula (I), which are alleged by the Specification as inhibitors of ERAP1. Considering that the conditions claimed includes thousands of distinct cancers, immune conditions, autoimmune conditions, infections, viruses, and more, it is evident that the claims are broad. Yet, as discussed above, the instant Specification discloses only 87 similarly structured compound species encompassed by Formula (I) and the slight deviations in structure of those 87 compounds is substantial- yet such structural deviations pale in comparison to the drastic breadth of the claimed compounds, including their metabolites, deuterated forms, and prodrugs. Despite the variability in efficacy and the lack of an any in vivo assay, there instant claims are directed to treating and preventing all forms of cancer, inflammatory disorders, immune conditions, infections and others. As such, the claim is extremely broad with respect to the disclosure. The second inquiry is discussed in detail below. With respect to a subject population, there is not a single example of a disease treated or an in vivo model in which the claimed compounds have been tested. Amount of Experimentation Necessary: 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 invention as claimed. As discussed above, the claims are drawn to compounds of Formula (I-1), which are alleged by the Specification to inhibit PARP7. Since identifying any compound which is capable of modulating the activity of a specific receptor, ion channel, or enzyme is extremely complex, the nature of the instant invention considered to be one of extreme complexity. In the instant case, this complexity is exacerbated by the broadness of Formula (I) with respect to the disclosure since Formula (I) encompasses thousands of compound species, whereas the instant Specification discloses only 87 such compound species low and high in vitro IC50 inhibitory activity. Although the relative skill of those in the art to which the invention pertains is high, the state of the art and unpredictability within the art is such that even the most talented artisan (armed with screening techniques including computer assisted virtual screening techniques such as ligand-based and structure-based design methods) could not reasonably predict which of the hundreds of millions of compounds encompassed by Formula (I) would exert the alleged activity based on the limited disclosure of 87 compounds comprising discrepancies in activity. Although the skilled artisan would have known that certain chemical modifications to the disclosed compounds may predictably provide structurally related compounds having similarly activity, the skilled artisan would have also known that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific receptor or enzyme. The quantity of experimentation needed The quantity of experimentation needed is undue experimentation. One of skill in the art would need to definitively determine the specific population of individuals who would need to be treated and would furthermore have to determine which of the claimed compounds would provide for the prevention and treatment of neurodegenerative conditions. To prevent and treat cancer and immune conditions in any patient population, as the instant claims are drawn to, would require undue experimentation to both develop an animal model which would reasonably correlate with all forms of neurodegenerative and also to identify the portion of the population in which the instantly claimed compounds would need to necessarily be administered. Thus, factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instantly claimed methods. In view of the breadth of the claim, the chemical nature of the invention, and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims. The court in Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001, states that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.” Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated or prevented by the compound encompassed in the instant claims, with no assurance of success. To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure. Claim Rejections - 35 USC § 112 (Written Description) Claim 16 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Following reasons apply: Claim 16 is directed to a compound or method using a compound of Formula (I) that can treat a disorder wherein the condition is “regulated by or affected by PARP7 activity or involves PARP7 activity or overexpression….” The examiner notes that this language include conditions not contemplated and can include lower expression of PARP7 in a subject, and other conditions with a tangential role for PARP7, e.g. See claim 16. It is not entirely clear which persons or conditions are: regulated by or affected by PARP7 activity or involves PARP7 activity or overexpression. In other words, it is not clear that Applicant contemplated the extent and/or specificity of subject populations claimed. It is further not clear which metabolites, prodrugs, etc., were contemplated as not a single example of any of these categories of agents, including metabolites have necessarily been identified nor described in the Specification. The instant Specification tests approximately 23 compounds of the 87 actually shown. The variability in potency for PARP7 inhibition is substantial. The Specification does not describe other nor test nor contemplate any other specific compounds. Claimed invention is not fully described in the specification. The written description requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of claimed invention. 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, and demonstrate that by disclosure in the specification of the patent. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003). Written description requirement, serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed. A patentee can lawfully claim only what he has invented and described, and if he claims more his patent is void. See MPEP 2163.01-02) for General principles governing compliance with the written description requirement applications. 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention The written description requirement has several policy objectives. “[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed.” In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term. Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable". Whenever the issue of written description arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). MPEP 2163.02). Whether the written description requirement is satisfied is a fact-based inquiry that will depend on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed. The written description requirement is not satisfied by the appearance of mere indistinct words in a specification or a claim, even an original claim. . A description of what a material does, rather than of what it is, usually does not suffice." Enzo, 323 F.3d at 968 (citing Eli Lilly, 119 F.3d at 1568); see Rochester, 358 F.3d at 926 ("[G]eneralized language may not suffice if it does not convey the detailed identity of an invention."). The function of description requirement is to ensure that the inventor had possession, as of filing date of the application relied on, the specific subject matter claimed by him. See Genentech, 108 F 3d 1361, 1365 (Fed. Cir. at 1366, 78, 1999). Written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate written support. Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. Where the specification provides only constructive examples in lieu of working examples, it must still "describe the claimed subject matter in terms that establish that the applicant was in possession of the claimed invention, including all of the elements and limitations. It is suggested to amend the claims to represent the embodiments in the Specification that were possessed at the time of filing. Conclusion THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JARED BARSKY/Primary Examiner, Art Unit 1628
Read full office action

Prosecution Timeline

Dec 06, 2023
Application Filed
Mar 10, 2026
Non-Final Rejection mailed — §112
Jun 04, 2026
Response Filed
Jul 30, 2026
Final Rejection mailed — §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
50%
Grant Probability
73%
With Interview (+23.1%)
2y 7m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 933 resolved cases by this examiner. Grant probability derived from career allowance rate.

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