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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. PCTCN2021128243, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. A claim by claim analysis indicated a lack of support for the compounds: from the second row of compounds on instant claim page 24 through page 27. These compounds lacked support in the priority document PCTCN2021128243. Thus claim 49 received a priority date of 09/05/2022. The rest of the claims received a priority date of 11/02/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/05/2024, 06/18/2024, and 08/21/2025 are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – The "Sequence Listing" has not been entered into the application because the required statement of no new matter is missing. See 37 CFR 1.825(a)(4) or 1.825(b)(5).
Required response – Applicant must provide:
A proper statement of no new matter.
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.
Claim 51 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while possibly being enabling for treating coronavirus infection with some of the compounds of table 2 1-115 (pages 101-103), does not reasonably provide enablement for preventing coronavirus infection with any compound or treating coronavirus infection with any compound of claim 1. 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.
Applicants are not enabled for preventing any coronavirus infection. The only established prophylactics are vaccines not the compounds such as presently claimed. In addition, it is presumed that “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit the symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted. “The factors to be considered [in making an enablement rejection] have been summarized as a) the quantity of experimentation necessary, b) the amount of direction or guidance presented, c) the presence or absence of working examples, d) the nature of the invention, e) the state of the prior art, f) the relative skill of those in that art, g) the predictability or unpredictability of the art, h) and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. a) As discussed above, preventing diseases required identifying those patients who will acquire the disease before the disease occurs. This would require extensive and potentially open-ended clinical research on healthy subjects. B) The specification states that the disease to be prevented is SARS-CoV-2. C) There are no working examples of such preventive procedure in a man or animal in the specification. D) The claims rejected are drawn to the medical prevention and are therefore physiological in nature. E) The state of the art is that no general procedure is art-recognized for determining which patients generally will become afflicted with disease before the fact [Boyle, Patrick, Are some people immune to COVID-19?, AAMCNews, Jan. 19, 2023] F) The artisan using Applicant’s invention would be a board certified physician who specializes in treating diseases. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of diseases generally. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of the practitioners in that art, Genetech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent diseases generally. That is, the skill is so low that no compound effective generally against diseases has ever been found let alone one that can prevent such conditions. G) It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved”, and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 214 (CCPA 1970). H) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases and on the multitude of compounds embraced by formula (I).
The Examiner suggests deletion of the word “prevention”.
Claim 51 is to a method of “treating or preventing a coronavirus infection in a patient”, with a compound of claim 1. The scope of claim 1 is very broad and claim 1’s Formula (I) which includes variable groups such as heteroaryl, heterocycloalkyl, aryl, cycloalkyl, all of which can be “optionally substituted” which is further defined with an expansive scope including cycloalkyl, aryl, heteroaryl, heterocycloalkyl, etc.
The nature of the claimed invention is to treating or preventing a coronavirus infection in a patient. Although the level of skill in the art is very high, the level of predictability in the art is very low. In fact, the courts have made a distinction between mechanical elements, which function the same in different circumstances, yielding predictable results, and chemical and biological compounds, which often react unpredictably under different circumstances. Nationwide Chem. Corp. v. Wright, 458 F. supp. 828, 839, 192 USPQ 95, 105(M.D. Fla. 1976); Aff’d 584 F.2d 714, 200 USPQ 257 (5th Cir. 1978); In re Fischer, 427 F.2d 833, 839, 166 USPQ 10, 24(CCPA 1970). Thus, the physiological activity of a chemical or biological compound is considered to be an unpredictable art.
The specification provides very little guidance with respect to support for the methods of claims 51. Although the Specification has in vitro biological examples on page 100-104
of Compounds 1-115, these compounds are all very similar in structure and do not represent the large structural variations encompassed by claim 1’s Formula (I) which includes variable groups such as heteroaryl, heterocycloalkyl, aryl, cycloalkyl, all of which can be “optionally substituted” which is further defined as including an expansive scope including cycloalkyl, aryl, heteroaryl, heterocycloalkyl, etc. In addition, while there are in vivo studies with a small subset of the above in vitro compounds, none of the studies relate to efficacy for treating or preventing SARS-CoV-2 infection in a patient or an in vivo method of inhibiting a protease of SARS-CoV-2, but are instead only In vitro studies. Furthermore, there are no working examples provided in the disclosure with respect to the methods of claim 51. Additionally, the instant specification provides evidence that not all compounds of formula I can be predictably used for the method of claim 51 because table 2 indicates that several of the example compounds have IC50 greater than 10,000 nM meaning they are unlikely to inhibit SARS-CoV-2 Mpro at any useful treatment range without further undue experimentation or modification to improve the treatment.
As stated in the Specification on page 1, viable treatments remain elusive for SARS-CoV-2. Thus, one of skill in the art would need to synthesize and screen each of the species within the broad scope of claim 1 and furthermore test each candidate with an in vivo model for efficacy which would be an enormous burden.
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that every instantly claimed compound of formula (I) could be predictably used for the treatment of or preventing a coronavirus infection as inferred by the claims and contemplated by the specification. Accordingly, the instant claims 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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection 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.
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.
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.
Claim(s) 1, 5, 13, 15, 19, 21, 26, 27, 30, 31, 36, 38, 40, 42, 45, 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over RYDER ( RYDER et al., WO 2010151799 A2, 2010-12-29, IDS) in view of (Barillari et al., Classical Bioisosteres, Bioisosteres in Medicinal Chemistry, First Edition. Edited by Nathan Brown, 2012, pages 15-29 (Year: 2012)).
.
The reference RYDER teaches the following compound(Figure 1, page 102), wherein R1=H, R2=Cl, p=0, A=aryl,R3=OCH3, n=1, R5=CH3, B=heteroaryl, R7=H, R8=aryl substituted with 2 CH3, q=2, m=0 for the purpose of for treating and preventing disorders associated with parasitic infections and inflammatory disorders(abstract). The reference also teaches “A pharmaceutical composition comprising a therapeutically effective amount of a compound of Figure 1, and a pharmaceutically acceptable carrier”(reference claim 29).
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This helps to teach claims 1, 5, 13, 15, 19, 21, 26, 27, 30, 31, 36, 38, 40, 42, 45, 50.
The reference RYDER does not teach wherein R1=halogen (all claims) or R6=CH3 (claim 38).
The reference Barillari teaches(page 15):
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The reference Barillari teaches(page 17):
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This helps to teach claims 1, 5, 13, 19, 21, 26, 27, 30, 31, 36, 38, 40, 42, 45, 50.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified RYDER with Barillari because RYDER teaches compounds for pharmaceutical purposes and Barillari teaches common methods to improve drug candidate properties by replacing functional group with different bioisosteres. One would have been motivated to do so because these modifications can lead to improved properties such as such as pharmacological activity, selectivity, and pharmacokinetics. For example, Due to the high strength of the C-F bond, fluorine is often introduced to achieve metabolic stability. One would have a reasonable expectation of success due to of the strong bond strength and because this is a very common method for isosteric replacement, meaning that often times such substitutions have a reason expectation of success. Further, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963). It is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the H group for a Me. 2144.08(II)(A)(4)(c). One would have a reasonable expectation of success because it is also a bioisosteres.
Claim(s) 1, 15, 26, 27, 30, 31, 36, 40, 42, 38, 50 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable e over WANG (WANG et al., WO 2022119756 A1, effective filing date 2020-12-04, IDS) in view of (Barillari et al., Classical Bioisosteres, Bioisosteres in Medicinal Chemistry, First Edition. Edited by Nathan Brown, 2012, pages 15-29 (Year: 2012)).
The reference WANG teaches the following compound (page 69), wherein R1=R2=Cl, p=0, A=aryl, R3=aryl, n=1, B=heteroaryl, m=0, R7=H, R8=C2 alkyl substituted with R8a=aryl.
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This helps to teach claims 1, 15, 26, 27, 30, 31, 36, 40, 42, 38.
The reference WANG teaches “This invention is in the field of medicinal chemistry and relates to a new class of small-molecules having a methyl-acetamido-propanamide structure (e.g..,; Formula I) which function as inhibitors of the SARS-CoV-2 main protease (Mpro), which function as therapeutics for the treatment of viral infection characterized with Mpro protease activity and/or expression (e.g., COVID-19), and which function as therapeutics for the treatment of other conditions characterized with Mpro protease activity and/or expression”(abstract) and “The method of claim 9, wherein the pharmaceutical composition is dispersed in a pharmaceutically acceptable carrier”(reference claim 12).
This helps to teach claims 50 and 51.
The reference WANG does not teach wherein R5=methyl (all claims) or R6=CH3 (claim 38).
The reference Barillari teaches(page 15):
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The reference Barillari teaches(page 17):
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This helps to teach claims 1, 15, 26, 27, 30, 31, 36, 40, 42, 38, 50 and 51.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified WANG with Barillari because WANG teaches compounds for pharmaceutical purposes and Barillari teaches common methods to improve drug candidate properties by replacing functional group with different bioisosteres. One would have been motivated to do so because these modifications can lead to improved properties such as such as pharmacological activity, selectivity, and pharmacokinetics. Further, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963). It is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the H group for a Me. 2144.08(II)(A)(4)(c). One would have a reasonable expectation of success because it is also a bioisosteres.
Claim(s) 1, 5, 6, 10, 13, 15, 19, 21, 26-27, 30-31, 36, 38, 40, 42, 45, 49-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over ZAVORONKOVS (ZAVORONKOVS et al., WO 2021219089 A1, publication date 2021-11-04, effective filing date 2020-04-30, IDS).
The reference ZAVORONKOVS teaches the following general formula [006] for the purpose of treating coronavirus infection(title).
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The reference ZAVORONKOVS teaches that in some embodiments R5 is methyl[0078].
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ZAVORONKOVS teaches this lead compound (above)(page 78). This is nearly the same as the instant compound on page 25(below) of the instant claims expect for the methyl group at R5 and the rotation of the 5-membered ring. The reference teaches R11 of the general formula as being thiazole without a specific orientation[0098].
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This helps to teach claims 1, 5, 6, 10, 13, 15, 19, 21, 26-27, 30-31, 36, 38, 40, 42, 45, 49, 51.
The reference ZAVORONKOVS teaches(reference claim 67):
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This helps to teach claim 50.
The reference ZAVORONKOVS does not teach a specific compound of instant claim 49 but instant requires picking and choosing several variables, the same is true for claims all claims.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified ZAVORONKOVS to achieve a compound of the instant invention because all necessary changes are suggested by embodiments under the general formula of the reference. For instance, the instant compound shown above only requires two changes to be made from the lead compound on reference page 78; an addition of a methyl which is suggested by paragraph [0078] and the rotation of the 5-membered ring suggested by page [0098]. One would be motivated to do so since the compound of the general formula of the reference are suggested for treating coronavirus infection and such slight modifications may keep the same overall activity but improve performance. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and 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). One would have a reasonable expectation of success because these changes are suggested by the reference.
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Claim(s) 1, 5, 10, 15, 27, 30, 31, 40, 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wu (Wu et al., Novel synthesis of pseudopeptides bearing a difluoromethyl group by Ugi reaction and desulfanylation, 08 August 2011) in view of (Barillari et al., Classical Bioisosteres, Bioisosteres in Medicinal Chemistry, First Edition. Edited by Nathan Brown, 2012, pages 15-29 (Year: 2012)).
The reference Wu teaches the following compound (4l table 1, page 1073), as a pseudopeptide which may be potentially useful in pharmaceutical and agrochemical fields(page 1070). Wherein, R1=R2=F, P=0, A= phenyl, B=phenyl, R8= phenyl, R7=H, n=m=q=0.
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This helps to teach claim 1, 5, 10, 15, 27, 30, 31, 40, 42.
The reference Wu does not teach wherein R5=methyl (all claims).
The reference Barillari teaches(page 15):
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The reference Barillari teaches(page 17):
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This helps to teach claims 1, 15, 26, 27, 30, 31, 36, 40, 42, 38, 50 and 51.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Wu with Barillari because Wu teaches compounds for pharmaceutical purposes and Barillari teaches common methods to improve drug candidate properties by replacing functional group with different bioisosteres. One would have been motivated to do so because these modifications can lead to improved properties such as such as pharmacological activity, selectivity, and pharmacokinetics. Further, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963). It is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the H group for a Me. 2144.08(II)(A)(4)(c). One would have a reasonable expectation of success because it is also a bioisosteres.
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, 5-6, 10, 13, 15, 19, 21, 26-27, 30, 31, 36, 38, 40, 42, 45, 49-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11731944 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent ‘944 claims:
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258
300
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542
249
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853
577
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839
565
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844
592
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874
576
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854
595
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857
667
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788
618
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This anticipates claims 1, 5-6, 10, 13, 15, 19, 21, 26-27, 30, 31, 36, 38, 40, 42, 45, 49-51.
Claims 1, 5, 6, 10, 13, 15, 19, 21, 26-27, 30, 31, 36, 38, 40, 42, 45, 49-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-54 of copending Application No. 19/522,024 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The application ‘024 claims:
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430
777
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562
655
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This anticipates claims 1, 5, 6, 10, 13, 15, 19, 21, 26-27, 30, 31, 36, 38, 40, 42, 45, 49-51.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 5-6, 10, 13, 15, 19, 21, 26-27, 30, 31, 36, 38, 40, 42, 45, 49-51 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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