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
Acknowledgment is made of applicant's claim for foreign priority based on the application EP22216126.7 filed in on 12 December, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 4, 2026, is acknowledged and has been considered.
Status of Claims and Non-Compliance Issues
Acknowledgement is made of claims submitted on August 4, 2026. However, Examiner notes there are non-compliance issues with the amended set of claims as follows:
Claim 15 presented in the set of claims submitted on 08/04/2026 differs from claim 15 previously submitted in the amended claims set dated 12/18/2023, which was considered in the first Office Action. The amendments made to the said claim fail to include proper markings as outlined in 37 CFR 1.121. Amendments to a claim must be made by rewriting the entire claim with all changes reflected by appropriate markings to indicate additions or deletions made. Accordingly, the amended claim 15 in the claim set date 08/04/2026 is non-compliant with 37 CFR 1.121.
Claim 16 is presented in the amended in set of claims submitted on 08/04/2026. However, claim 16 was previously canceled in the amended set of claims set submitted 12/18/2023. Pursuant to 37 CFR 1.121 (c)(5), a previously canceled claim may be reinstated only by adding the claim as a new claim with a new claim number. Accordingly, the presently submitted amendment is not in compliance with 37 CFR 1.121 (c)(5). Claim 16 should have remained canceled and the newly presented claim, currently numbered as claim 16 has been renumbered as claim 17 and marked as New by the Examiner.
Accordingly, the status of the claims in the instant application is; claim 1-8,14 and 16 are canceled; claims 9-13 and 15 are amended and claim 17 is new. Thus, claims 9-13, 15 and 17 are pending in the Application.
Response to Amendments
The amendments filed on August 4, 2026, have been entered. With respect to the Applicant remarks that claims 1-16 were pending in the application, examiner referencing the amended claims submitted on 12/18/2023, notes that claims 1-13 and 15 were pending in the application as claims 14 and 16 were canceled.
Therefore, as discussed under the claims status above, claims 9-13, 15 and 17 are currently pending in application.
Applicants amendments to the specification have overcome objections previously set forth in the Non-Final Office action mailed on 05/05/2026. Applicant’s amendments to claim 9 overcomes the 35 U.S.C. § 102(a)(2) rejection for as being anticipated by Veal for claims 1-5, 7-12 and 15 as previously set in the Office Action mailed on 05/05/2026. Applicant’s cancelation of the generic claims and amendments to the claim 9 overcomes the 35 U.S.C. § 103 rejection for as being obvious over Veal in view of Wermuth for claims 1-5, 7-12 and 15 as previously set in the Office Action mailed on 05/05/2026. Claims 1-8 are canceled and claims 9-13, 15 and 17 are examined on merits herein.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
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.
Claims 15 and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment cancer, fibrotic diseases, neurodegenerative disease, atherosclerosis, infectious disease or chronic kidney disease modulated by QPCT and QPCTL activity, it does not reasonably provide enablement for every and all types of cancer or fibrotic diseases or neurodegenerative diseases as broadly claimed in the instant claims 15 and 17. 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.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558,1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the nature of the invention,
2- the breadth of the claims,
3- the state of the prior art,
4- the predictability of the art,
5- the relative skill of those in the art,
6- the amount of direction or guidance provided,
7- the presence or absence of working examples and
8- the quantity of experimentation necessary to make or use the invention.
.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Undue experimentation is required by one skilled in the art to determine enablement of the instant disclosure as claimed due to the following:
The nature of the invention (1) and the breath of the claims (2):
Compound of the claimed invention are disclosed as inhibitors of glutaminyl-peptide cyclotransferase (QPCT) and glutaminyl-peptide cyclotransferase-like protein (QPTCL).
With regards to the nature of the invention and breath of the claims, the instant claims (15 and 17) are drawn to a method for treatment of cancer or fibrotic disease and conditions associated with these diseases (claim 15) and a method for the treatment of cancer, fibrotic diseases, neurodegenerative diseases, atherosclerosis, infectious diseases or chronic kidney diseases (claim 17).
The breath of the claims is directed to every and all types of cancers, fibrotic diseases, neurodegenerative diseases, atherosclerosis, infectious disease or chronic kidney diseases. The breadth of the claims is substantial in view of the broad patient population scope encompassing the recited diseases.
The state of the prior art (3), predictability in the art (4) or lack thereof and relative skill level (5):
Regarding the state of the prior art and predictability or lack thereof; examiner picked cancer and Alzheimer’s disease as examples on the discussion pertaining to the state of the art. A review by Zugazagoitia et al., 2016 (Zugazagoitia et al., Current challenges in Cancer treatment, Clinical Therapeutics, Vol. 38, No.7, page 1551-1566; Published July 2016), hereon after, Zugazagoitia, provides an overview of the state of the art in cancer therapy using lung cancer as an example – as of 2016 (abstract). The reference highlights that while major revolutions have changed cancer treatment paradigms namely onco-gene-driven cancer and immune-oncology there are still many challenges in the field of cancer therapy for example due to tumor heterogeneity and acquired resistance. Zugazagoitia discusses different targets that have been used in lung cancer treatments e.g. EGFR (targeted by EGFR tyrosine kinase inhibitors), ALK, MEK, ROS-1, HER, FGFR1, 2,3, among others, each with wide selection of drugs/ compounds for treatment (Table 1- page 1554 & 1560). The reference further demonstrates, different immune-suppressing treatments that act through different immune inhibitory checkpoints such as PD-1/L1 and CTL4 – again each with different selection of drugs/ compounds for treatment (Table II – page 1556). For each of these approaches, different challenges are encountered for example tumor mutations and intratumor heterogeneity, emergence of resistant clones on drug pressure and patient selection for clinical trials, among others (page 1558-1560).
Additionally, Dokholyan et al., 2022 (Dokholyan et al., Challenges and progress in research, diagnostics and therapeutics in Alzheimer’s disease and related dementias. Alzheimer’s Dementia: Translational Research & Clinical Interventions, 2022;8:e12330 page 1-5; Published 1 August 2022) hereon after Dokholyan, provides a discussion on the Alzheimer’s a neurodegenerative disease. Dokholyan points out that the principle challenge in identifying curative therapeutics is the etiology of the disease (page 1). The reference indicates that Alzheimer’s disease has multiple risk factors and complex pathology therefore the path to effective treatment is quite uncertain. Notably, Dokholyan points out that similar to other chronic diseases AD has a complex pathophysiology and this complexity makes treatment more difficult than is the case for some infectious diseases. Furthermore, the reference states that it is not fully know whether Aβ and tau proteins are the sole significant early molecular events that lead to downstream processes in AD (page 2).
Therefore, as evidenced by the state of the art, diseases such as cancer and Alzheimer’s are multifactorial in nature, modulated through different pathways and in some cases there are genetic complexities. Hence, different treatments have been implemented using different pathways or targeted approaches.
Accordingly, while QPCT/ QPCTL inhibitors are being investigated for their therapeutic potential in certain cancers and other QC-mediated diseases / conditions, prior art does not demonstrate therapeutic efficacy, for example, across the broad spectrum of all types of cancers or the diseases / conditions encompassed by the instant claims.
The relative skill of those in art is high, that is an MD or PhD. However, that factor is outweighed by the unpredictable nature of the art as illustrated in the prior art discussed above. There is no absolute predictability even in view of the seemingly high level of skill in the art. Prior art demonstrates that to be enabled to treat for example different cancer types would require approaches that involve screening in vitro and in vivo to determine if the compound exhibits the desired pharmacological activities.
Accordingly, one of ordinary skill in the art would be faced with a high degree of unpredictability, in determining which patient populations inside of the enormous disease scope represented by instant claims 15 and 17 would actually benefit from administering the compounds of claimed invention.
The amount of direction or guidance provided (6), presence or absence of working examples (7) and quantity of experimentation necessary (8):
Regarding the amount of direction or guidance provided; With respect to disease treatment scope, the specification provides a long speculative list of diseases - pages 63-65 - “Method of treatment”. While the specification lists numerous diseases, it does not provide any actual evidence of the treatment of those diseases in a human subject.
The working examples in the specification relate to evaluation of inhibitory activity on QPCT/L - Assay A (page 47); SIRPα signalling assay – using Raji or A549 cells (Assay B) (page 51), and CACO-2 permeability (Assay C) (page 56). In addition, there are microsomal and hepatocyte clearance tests (pages 59-60) and evaluation of plasm protein binding (page 61). There are no in vivo cancer treatment outcomes and there are no working examples relevant to the treatment of any other claimed disease (e.g. neurodegenerative disease, fibrotic disease, atherosclerosis, infectious disease, etc.).
The specification itself describes that the structural difference between the compounds in the instant application and prior art, “unexpectedly” lead to (i) potent inhibition of QPCT and QPCTL, (ii) potent inhibition of QPCT/L in cells relevant to lung disease or cancer and (iii) appropriate membrane permeability and a low in vitro efflux (Specification – page 9). Therefore, applicant’s own characterization shows that the results of administering the claimed compounds to particular cell types could not have been predicted from the prior art and, by extension, the generalizability of this surprising result across different pathologies relating to different cell types cannot be predicted from the limited data presented.
Regarding the quantity of experimentation necessary; The quantity of experimentation needed is undue experimentation. One of skill in the art would need to test each untested patient population (e.g. patients having specific cancer types, specific neurodegenerative diseases, specific fibrotic diseases, etc.) and assess if there is a benefit for that patient population after administering the claimed compounds. Each patient population would need to be independently tested, with no assurance that an actual improvement would be observed. Furthermore, recited diseases have diverse pathogenesis, affected by different genetic complexities, environmental factors and other risk factors. Thus, for the varying types of diseases claimed where it is currently unknown if QPCT/L activity drives the disease, the artisan would first need to determine if that is the case and further identify if administration of the claimed compounds actually provides a benefit in a subject.
Accordingly, the instant claims 15 and 17 as broadly claimed do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success. As such, in view of the factors discussed above, claims 15 and 17 are rejected as failing to comply with the full scope of the claim enablement requirement.
Maintained / Modified Rejection
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9-12, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Veal (WO 2024/020517, cited in IDS) in view of Wermuth et al., 2008, ( “The Practice of Medicinal Chemistry” (Fourth Edition) Chapter 8: Molecular Variations Based on Isosteric Replacements. Pg. 181-241 and Chapter 13: Substituent Groups . pg. 319-357, Academic Press, 2008, ISBN 978-0-12-417205-0), hereon after, Wermuth and Meanwell 2011, (Meanwell NA, Synopsis of some recent tactic Application of Bioisosteres in Drug Design, Journal of Medicinal Chemistry, 2011, 54, page 2529-2591; Published March 17, 2011), hereon after, Meanwell.
Veal discloses an embodiment, example 34 (pg. 43, & pg. 151 [00438]) as shown.
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Instant claim 9 discloses the compound -
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as shown (claims page 12). Veal’s example 34 differs from instant claimed compound, wherein a H in Veal’s compound is modified to a F for the compound in instant claim 9. This is an obvious modification to pursue optimization of a bioactive compound in view of Wermuth and Meanwell.
Wermuth teaching on fluorine-hydrogen isosterism reveals fluorine mimics hydrogen because it is considerable smaller than other halogens; fluorine being the most electronegative halogen particularly forms very stable bonds with carbon; it is rarely ionized or displaced and in addition it has no d-orbitals. Wermuth teaches the chemical inertia of fluorine explains why fluoro derivatives are more resistant to metabolic degradation and thus, the F-H isosterism serves to give analogues that have improved properties and more resistant to metabolic degradation (Wermuth et. al 2008, pages 226-227).
Meanwell teaching on isosteres of H, indicates the unique properties of fluorine have led to its widespread application in drug design and cites numerous examples in the reference that differ only by a –F for –H (3.1.5 - page 2531). Meanwell’s review classifies H/F exchange as classical bioisosteres and provides a variety of molecular scaffolds and the different potencies, and other properties exhibited upon H/F exchange. For example; (i) increase in lipophilicity, (ii) modulation of metabolism (page 2531) (iii) the high electronegativity of F shown to reduce the basicity of proximal amines and increase acidity of acids (page 2532), (iv) substitution of H by F used as a strategy for influencing conformation (page 2533), and (v) F/H exchange found to influence membrane permeability and modulate potency (page 2534).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(D), a prima facie case of obviousness exists for applying a known technique to a known method or product ready for improvement to yield predictable results. Based on the teachings of Wermuth and Meanwell the structural modification between the compound disclosed by Veal and H-F exchange in the claimed invention would have been obvious given that substituent exchange between hydrogen and fluorine falls within the same classical grouping of bioisosteric groups and such replacements are part of the standard “toolbox” of molecular drug design.
It would have been obvious to substitute H on Veal’s compound for F to arrive at the instantly claimed compound because prior art teaches such a substitution improves compound properties, for example stability, lipophilicity or permeability.
Furthermore, it is well-within the ordinary skill in art to incorporate F in lieu of H. Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Likewise, Veal teaches the following compound, (Ex. 120, pg. 59, [00597], pg. 202);
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The instant claim 9 discloses a compound where the OH is replaced with a methoxy group – OCH3 (Instant claims – page 5).
Veil teaches a sub-genus compound of formula IC ([00156] -page 35),
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wherein, one of the embodiments containing Y1, Y2, Y3 and Y4 is further disclosed as,
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([00160]- pg. 35), wherein R5 is defined as independently H or ORa, among others, ([00135] – pg. 31) and Ra is defined as independently selected from H, C1-C6alkyl, among others, ([0028], pg. 5).
Applicant’s claimed invention reads on Veal’s subgenus wherein, ORa, with Ra selected from C1alkyl, is a methoxy group (–OCH3) as claimed in the instant invention.
Veal further teaches exemplified embodiments at a different ring position, that serves as evidence that –OH can be substituted with –OCH3 (Table 1 pg. 36-37, [00326], pg.114 & [00340], pg. 118).
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Veal et al. Ex. 3 –
page 36 & [00326]
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Ex. 7 –
page 37 & [00340]
Furthermore, Wermuth teaches replacement of a hydrogen in hydroxy (OH) for a methyl (OMe) is a known modification and represents “a common practice in medicinal chemistry” (page 319). Wermuth teaches methyl group modifications in –OH to –OCH3, in a compound affect pharmacological properties for any of the following reasons (i) can help increase lipophilicity which can drastically modify the bioavailability of a drug and thus its efficacy, for example in the case of morphine derivatives and their CNS activities (Box 13.1 – page 321). (ii) the methyl group can affect hydrophobic interactions at receptor sites, (iii) the steric hinderance by the methyl affects conformation enhance favorable or unfavorable for ligand-receptor interactions, (iv) there are electronic effects due to the methyl group and (v) seen from a metabolic point of view, the methyl group plays an important role because it can be oxidized, shifted or can serve as a blocking group (page 320-325). Additionally, Wermuth illustrates an example where two –OH groups substituted with –OCH3, resulted in a 5-fold potency increase due to the modification of its pharmacokinetic properties, and the methylation provided a more lipophilic drug with better blood-brain barrier (BBB) crossing (page 321).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.08(II)(A)(4)(c), the closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 1904 (and cases cited therein). This includes H vs Me (CH3), In re Druey, 319 F.2d 237, 240, 138 USPQ 39, 41 (CCPA 1963) (omission of methyl group from pyrazole ring).
Given the same utility of Veal and instant compounds, substituting OH for OCH3, at a different position of the pyridine ring would be obvious to one skilled in the art. Additionally, Veal suggests substitution of OCH3 at the same position of the ring as claimed in the instant invention. See also § 2144.08(II)(A)(4)(d), “It is the properties and utilities that provide real world motivation for a person of ordinary skill to make species structurally similar to those in the prior art. Dillon, 919 F.2d at 697, 16 USPQ2d at 1905; In re Stemniski, 444 F.2d 581, 586, 170 USPQ 343, 348 (CCPA 1971).”
Applicant’s claimed invention is not patentable over Veal and in view of the teachings of Wermuth because (i) the structural modifications between the compound disclosed by Veal and the instant claimed invention would have been obvious given that Veal suggests such a modification in a subgenus, (ii) exemplifies such a modification in a different position of the ring and (iii) the H to CH3 replacement, in OH to OCH3, is part of the standard “toolbox” of molecular drug design used to improve the pharmacological properties of a compound. Furthermore, it is well-within the ordinary skill in art to incorporate CH3 in lieu of H to obtain OCH3. Thus, an artisan would arrive at the same invention as presently claimed.
Response to Applicant’s Arguments
Applicant's arguments filed 08/04/2026 regarding 35 U.S.C. 103 rejection have been fully considered but they are not persuasive.
In response to Applicant’s arguments that cite, Veal describes a genus encompassing thousands if not hundreds of thousands of compounds; nothing in Veal et al., provides any suggestion or motivation to make or use the compounds recited in the amended claim 9 and Wermuth teaches H-F substitution nothing in Wermuth.
teaches or suggests any other modification to the genus of the compounds in Veal.
Examiner reiterates the following (a) Veal disclosure is related compounds that can inhibit or modulate QPCT and QPCTL , or their pharmaceutically acceptable salt and /or solvate thereof and methods for treating disorders related to QPCT/L such as neurological disorders, cancer and inflammation; (b) besides the broad genus, Veal exemplifies embodiments and method of making Ex. 34 (pgs. 43 & 151) and Ex. 120 (pgs. 59 & 202)
Regarding the –OH to –OMe substitution, Veal teaches a subgenus compound that suggest a methoxy group at the meta-position of the pyridine ring as claimed in the instant invention and further exemplifies a similar substitution at a different position of the pyridine ring as discussed in the 35 U.S.C 103 rejection above.
Regarding the H to F replacement, such substitutions are well known in the field of medicinal chemistry as taught by Wermuth and Meanwell. H and F fall within the same classical grouping of bioisosteric group, part of the standard “toolbox” of molecular drug design to impart potential improvement in pharmacological properties of a compound as discussed in the 35 U.S.C 103 rejection above.
Per MPEP § 2144 (I), the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art, or it may be reasoned from knowledge generally available to one of ordinary skill in the art and established scientific principles. See In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988).
Therefore, Examiner maintains the rejection of claim 9-12, 15 and 17 over Veal in view of Wermuth and Meanwell as described in the 35 U.S.C. 103 Rejection.
Conclusion
Claims 9-12, 15 and 17 are rejected.
Claim 13 is objected to.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/P.O./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
