DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
The listing of claims filed 3 August 2023 has been examined.
Claims 26–50 are pending and new. Claims 1–25 are canceled.
Priority
The instant application was filed 3 August 2023; is a national stage application of PCT/GB2022/050310, filed 7 February 2022, and claims priority to China 202110166985.5, filed 7 February 2021, and United Kingdom 2101715.7, filed 8 February 2021.
Acknowledgment is made of applicant’s claim for foreign priority and a copy of the priority documents have been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 September 2023 is acknowledged and has been considered.
Objections to the Specification
The title of the invention is objected to because it is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The abstract of the disclosure is objected to because it recites language referring to the purported merits (“novel”) and phrases that can be implied (“The invention relates to”).
Appropriate correction is required.
For guidelines for the preparation of patent abstracts, see MPEP § 608.01(b) (Explaining: The abstract should be in narrative form and avoid legal phraseology (e.g., means, said), terms referring to purported merits of the invention (e.g., new, novel), and phrases that can be implied (e.g., The disclosure concerns, The disclosure defined by this invention). The language should be clear and concise, and not repeat information given in the title. It should not compare the invention with the prior art. The abstract is generally limited to a single paragraph within the range of 50 to 150 words in length.).
Claim Rejections - 35 U.S.C. § 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 MPEP explains the purposes of the definiteness requirement relate to clarity:
The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what the inventor or a joint inventor regards as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability.
MPEP § 2173.02 (emphasis added).
The Federal Circuit has stated the patent drafter is in the best position to improve clarity by resolving any ambiguities in a claim during prosecution:
We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
Halliburton v. M-I LLC, 514 F.3d 1244, 1249 (Fed. Cir. 2008).
Claims 32, 34, 36–39, 41, 43, 45–49 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claim 32 recites: “A compound obtainable from the process as defined in claim 31.”
Claim 31 is directed to a process of preparing a compound of formula (IB) through a series of 14 steps, in which intermediate compounds of formulae (III)–(XX) are obtained. Because 14 different compounds are obtainable in the process of claim 31, and claim 32 does not identify any particular compound, claim 32 is ambiguous because it could refer to the compound of formula (IB) or any of the intermediate compounds. Accordingly, a meaningful search and examination cannot happen.
Claims 37 and 38 are directed to a composition and method, respectively, comprising “the compound of formula (I) according to claim 32.” The claims inherit without curing the indefiniteness of claim 32.
Appropriate correction is required.
For the purpose of searching prior art, claim 32 will be interpreted as being directed to a compound of Formula (I) (claim 33) or Formula (IB) (claim 35).
(ii) Claims 34 and 36, in step (i), recite “an XRPD pattern substantially as shown in Figure [1 or 4].” The term “substantially” is a term of degree, as it could refer to an XRPD pattern that is 80%, 90%, 100%, etc. identical to the pattern shown in Figure 1 or 4, and the specification does not provide a standard for ascertaining the requisite degree. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the claimed invention.
Appropriate correction is required.
Examiner recommends deleting the term.
(iii) Claims 34 and 36, in step (iii), recite “major peaks.” The term “major” is a relative term, as it implies there are “minor” or other peaks, and the specification does not provide a standard for ascertaining meaning of the term. Thus, the term renders the claim ambiguous because it is not known how many or which peaks are included or excluded by the term.
Appropriate correction is required.
Examiner recommends deleting the term and specifying the peaks intended to be claimed.
(iv) Claims 41 and 45–48 recite “suitable” in the context of a catalyst, ligand, oxidant, or acid. The term “suitable” is a term of degree, as one embodiment may work better (i.e., be more suitable) for the catalyst, ligand, oxidant, or acid than another embodiment, and the specification does not provide a standard for ascertaining which embodiments would or would not be suitable. Due to the ambiguity, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Appropriate correction is required.
Examiner recommends deleting the term
(v) Claims 43 and 49 are directed to processes of preparing a compound of formula (XIII) and formula (II), respectively, comprising “the use of a compound” without setting forth any affirmative steps involved in the process. Accordingly, the claims are directed to improper processes and are indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112(a)
The following is a quotation 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.
Claim 38 is rejected under 35 U.S.C. § 112(a) because 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 the claims.
MPEP § 2164.01(a) explains how enablement for the claimed invention can be analyzed:
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.” . . . These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The Wands factors are analyzed with respect to the claimed invention in turn below.
The breadth of the claim is broad in scope, as it extends to treating or preventing (“prophylaxis” is synonymous with prevention) any and/or all diseases.
The nature of the invention generally relates to the pharmaceutical art and more specifically to a compound of formulae (I) and (IB), pharmaceutical compositions thereof, methods of making the compounds, and methods of administering the compound to a subject. The compounds appear to target DNA polymerase Ɵ (PolƟ) activity for the purpose of treating cancer. (Spec., 1:36–2:14) (page:line). Thus, the nature of the invention is sophisticated.
The state of the prior art appears to be in its infancy. A publication by Stockley et al., J. Med. Chem. (2022), 65, 13879–13891 (“Stockley”) explains that small molecule inhibitors of PolƟ have been studied and exhibited promising results. (Stockley, p.13879). Stockley states, “PolƟ inhibitors thus have considerable potential to provide major clinical benefit to cancer patients alone or in combination with PARP inhibitors.” (Id., p.13880). Stockley does not suggest the state of the art is mature.
Generally, in order to treat a disease, one of skill in the art must identify a biological target for affecting the disease, demonstrate a first drug candidate some way modulates the normal processes of the biological target, and demonstrate that a subject would benefit from such modulation without detrimental side effects. Typically, the process includes in vitro laboratory screening, in vivo testing, and clinical testing. Once that process has been successfully completed by the first drug candidate, subsequent drug candidates can benefit from the established proof of concept if a substantial correlation can be established between the first drug candidate and the subsequent drug candidates.
In order to prevent a disease, one of skill in the art would need to identify the subjects likely to acquire such as disease, carry out the claimed invention (e.g., administer the claimed compound/composition), and demonstrate the subject did not have any cells infected by the pathogen and/or demonstrate the subject did not develop the disease as a result of the administration of the compound/composition.
Examiner is unaware of evidence from the prior art that supports a claim for preventing a disease (e.g., cancer) with a PolƟ inhibitor. Thus, the state of the prior art is in its infancy.
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
The level of predictability in the art is generally unpredictable. The relevant art requires each potential drug candidate to be assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18, 24 (CCPA 1970). The more unpredictable an area is the more specific disclosure is necessary to satisfy the statutory requirement. MPEP § 2164.02(II) explains that a correlation between the claimed invention and the evidence provided in an application, along with a correlation between the evidence and the models recognized in the art, are required:
“Correlation” as used herein refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use. An in vitro or in vivo animal model example in the specification, in effect, constitutes a “working example” if that example “correlates” with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute “working examples.” In this regard, the issue of “correlation” is also dependent on the state of the prior art. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate. Even with such evidence, the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition. In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995) (reversing a USPTO decision based on finding that in vitro data did not support in vivo applications).
Further, treatments may be effective for some subjects and ineffective for other subjects. Thus, each candidate for pharmaceutical medicine must be evaluated on its own even when a nexus to an existing drug or class of drugs has been established.
The amount of direction provided by the inventor is limited to a general discussion of PolƟ inhibitors, compositions thereof, administration routes, dosage, schedule, and use in combination with other therapeutic agents. (Spec.,19:18–25:16; 32:11–46:7).
The existence of working examples are limited to synthetic processes. There are no examples relevant to the claimed method.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure is extensive, as it includes in vitro and in vivo screening for each specific disease or disorder encompassed by the claims. As claimed, the indefinite scope of such diseases is essentially unbound.
Scope of Enablement Conclusion
In view of the Wands factors discussed above, the disclosure of the instant application does not reasonably enable a person having ordinary skill in the art to use the full scope of the claimed invention. The breadth of the claims is broad in scope; the nature of the invention is sophisticated; the state of the prior art is in its infancy; the level of skill in the art is high; the pharmaceutical art is unpredictable; the direction provided by the inventor is limited to general guidance; there are no working examples relevant to the claimed method; and the quantify of experimentation needed to practice the claimed invention is extensive. Thus, when the evidence is considered as a whole, undue experimentation would be required to practice the full scope of the claimed invention.
Examiner recommends amending the claim: delete prophylaxis and define the disease.
Claim Rejections - 35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 32, 33, and 37–39 are rejected under 35 U.S.C. §§ 102(a)(1) and (a)(2) as being anticipated by WO2021/028670 (“Blencowe”).
Blencowe discloses (2S,3S,4S)-N-(5-chloro-2,4-difluorophenyl)-3,4-dihydroxy-N-(methyl-d3)-1-(6-methyl-4-(trifluoromethyl)pyridin-2-yl)-5-oxopyrrolidine-2-carboxamide. (Blencowe, 3:7–11).
Blencowe discloses pharmaceutical compositions of the active compound. (Id., 16:22–23:12).
Blencowe discloses administering the compounds/compositions in combination with another therapeutic agent, including an anticancer agent. (Id., 25:26–37:11).
Claim Rejections - 35 U.S.C. § 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.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966); MPEP § 2141(II).
Claims 26–29 are rejected under 35 U.S.C. § 103 as being unpatentable over Blencowe; and Claims 40 and 41 are rejected under 35 U.S.C. § 103 as being unpatentable over Blencowe in view of Forero-Cortes et al., Org. Process Res. Dev. (2019), 23, 1478–1483 (“Forero”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Regarding claims 26–29, Blencowe discloses a process of treating a compound of formula (XX) with a Lewis acid (BCl3). (Blencowe, pp.39–44, step p).
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Regarding claims 40 and 41, Blencowe discloses a process of preparing a compound of formula (XX) comprising reacting a compound similar to formula (XVIII) with a compound of formula (XIX). (Id., 7:4–23) (shown below).
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Blencowe discloses the reaction of a compound similar to formula (XVIII) with a compound of formula (XIX) can occur “in the presence of suitable catalysts and ligands.”) (Id.). The catalyst and ligands can be, for example, Pd2(dba)3. (Id.).
Forero discloses the Buchwald-Hartwig amination reaction, which is a method of making a nitrogen-carbon bond via palladium-catalyzed coupling. Forero discloses the reaction involves and amine and an aryl halide. (Forero, p.1478). The halide can be, inter alia, chloride or bromide, as shown in the examples in Scheme 5. (Id., p.1480).
Ascertaining the differences between the prior art and the claims at issue
Regarding claims 26–29, Blencowe does not disclose the use of a scavenging agent, such as a diol; and Blencowe does not disclose BF3 as the Lewis acid.
Regarding claims 40 and 41, the compound of formula (IV) includes a chloro-substituent, whereas the claimed formula (XVIII) includes a bromo-substituent in the corresponding position.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application does not include evidence demonstrating an unexpected result for the claimed process compared to the process in Blencowe.
The question of obviousness
Regarding claims 26–29: Based on the above factors, it would have been obvious for a person having ordinary skill in the art prior to the filing of the instant application to modify the teachings of Blencowe to arrive at the claimed method because the substrate, product, and conditions of the reaction were known: the same acetal is converted to the same diol using an acid (to deprotect the acetal). And, there is no evidence in the specification suggesting the use of a different Lewis acid and a scavenging agent are critical to the reaction. See, e.g., In re Aller, 220 F.2d 454, 456 (CCPA 1955) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”); see also In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); MPEP § 2144.056(II). Considering the substantial similarity between the claimed process and the process disclosed in Blencowe, and the high level of ordinary skill in the art, there would have been a reasonable expectation of success at arriving at the claimed invention.
Regarding claims 40 and 41: Based on the above factors, it would have been obvious for a person having ordinary skill in the art prior to the filing of the instant application to modify the teachings of Blencowe to arrive at the claimed method because a substrate, the product, and conditions of the reaction were known; and the difference between a chloro-pyridine and bromo-pyridine in the palladium-catalyzed coupling reaction is a substitution of known equivalents. Indeed, there is no evidence in the specification suggesting the difference in aryl halide is critical to the reaction. Accordingly, one of ordinary skill in the art would have been a reasonable expectation of success at arriving at the claimed invention.
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 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993); In re Longi, 759 F.2d 887 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937 (CCPA 1982); In re Vogel, 422 F.2d 438 (CCPA 1970); In re Thorington, 418 F.2d 528 (CCPA 1969).
Please note the following information regarding terminal disclaimers:
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(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 32, 33, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Pat. No. 12,258,886 (reference claims).
18/264,079
12,258,886
32. A compound obtainable from the process as defined in claim 31.
33. The compound according to claim 32, which is (2S,3S,4S)-N-(5-chloro-2,4-difluorophenyl)-3,4-dihydroxy-N-(methyl-d3)-1-(6-methyl-4-(trifluoromethyl)pyridin-2-yl)-5-oxopyrrolidine-2-carboxamide.
35. The compound according to claim 32, which is (2S,3S,4S)-N-(5-chloro-2,4-difluorophenyl)-3,4-dihydroxy-N-(methyl-d3)-1-(6-methyl-4-(trifluoromethyl)pyridin-2-yl)-5-oxopyrrolidine-2-carboxamide hemihydrate.
17. A compound selected from
. . .
(2S,3S,4S)-N-(5-chloro-2,4-difluorophenyl)-3,4-dihydroxy-N-(methyl-d3)-1-(6-methyl-4-(trifluoromethyl)pyridin-2-yl)-5-oxopyrrolidine-2-carboxamide
. . .
or a pharmaceutically acceptable salt or solvate thereof.
Although the claims at issue are not identical, they are not patentably distinct from each other because they cover the same compounds. While reference claim 17 does not specifically recite a hemihydrate, it does encompass solvates of the base compound. Accordingly, an infringer of a patent granted based on the instant claims would also be an infringer of the reference claim.
Allowable Subject Matter
Claims 30, 31, and 42 are allowable.
Claims 44 and 50 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623