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 .
DETAILED ACTION
Claims 21-30 are pending in the application. Claims 21 and 23-30 are rejected. Claim 22 is objected to.
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. 119(e) 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. 62/868,117, 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. Provisional Application No. 62/868,117 discloses the following generic structure in the claims and the broadest disclosure in the specification (page 1):
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The generic structure fails to provide for the possibility for the instant variable R1 to be hydrogen and for the R3 position to be methyl. The provisional application fails to provide a generic structure for intermediates corresponding to instant claim 21; however, none of the disclosed intermediates support the broadened scope of the instant claims. For this reason, none of the claims under examination are supported by the ‘117 priority document.
The disclosure of the prior-filed application, Application No. 62/904,906, 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. Provisional Application No. 62/904,906 discloses the following generic structure in the claims and the broadest disclosure in the specification (page 1):
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The generic structure fails to provide for the possibility for the instant variable R3 to be hydrogen and for the R2 position to be F. The corresponding structure for an intermediate is disclosed on page 8 of the provisional application with analogous scope to the structure above. For this reason, claims 21 and 23-29 are not supported by the ‘906 application. Claim 22, however, is supported by the ‘906 application.
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. 120 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. 18/194,155 (and similarly 16/906,063), 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.
Instant claim 25 recites a method for manufacturing a composition having a particular formula. The claim further recites “wherein the method includes utilizing the compound according to claim 21.” The parent applications generally disclose preparation of a compound of instant claim 21 (recited as compound formula 13) on pages 13 and 14. The parent applications, however, only disclose specific methods of using the intermediate of 13 going forward. The parent applications disclose the following scheme:
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All examples similarly apply the same approach in Preparations 24, 25, 27, 28 and 29. There is no disclosure or suggestion that intermediate compound 13 should be applied in any other approaches of generating the formula depicted in instant claim 25. The instant claim 25 is rejected as indefinite but only minimally requires “utilizing” the intermediate compound 13 that would include approaches not even remotely suggested by the parent application such as burning the compound of formula 13, capturing the resultant carbon dioxide in biomass and using the resultant biomass to prepare an intermediate that could then be converted to a compound of the formula depicted in claim 25. The instant claim 25 would further appear to embrace methods that would directly conflict with the method disclosed by the parent application, such as by using a free acid of the compound of formula 15 such that a mixture of products would be obtained due to multiple available free carboxylic acids in the mixture. The parent application fails to disclose or reasonably suggest that the compound of formula 13 could be applied in any conceivable manner in which it could be converted to the formula of instant claim 25. Dependent claims 26-30 are similarly not supported for the same reasons.
The instant claims therefore have the following earliest effective filing dates:
Claims 25-30: September 9th, 2024.
Claims 21, 23 and 24: June 19th, 2020.
Claims 22: September 24th, 2019.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on January 15th, 2025.
Claim Objections
In claims 25-30, references to “a composition” or “the composition” should be replaced with “a compound” or “the compound”, respectively.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 25-30 are rejected as indefinite since parent claim 25 recites a method “wherein the method includes utilizing the compound according to claim 21.” This limitation does not amount to an active step since it does not define or limit how the compound is actually involved in the method. The preamble of “for manufacturing a composition of the formula:” is considered an intended use that does not actually require a separate manipulation. MPEP 2173.05(q) states: “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” The instant claims are distinguished from the case discussed in MPEP 2173.05(q)(II) since there is no nexus between the preamble and limitation of “utilizing” to require any particular manipulation.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 29 and 30 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The fee worksheet filed September 24th, 2024 states that only one independent claim is pending following the preliminary amendment where instant claim 21 is the only claim that does not refer to another claim. Claim 29, however, is a product-by-product dependent upon a method. Since the product-by-product by process is not limited to a method of production, claims 29 and 30 embrace subject matter that is not necessarily embraced by claim 21, from which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 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.
Claim(s) 21 is rejected under 35 U.S.C. 102(a)(2) and claims 25-28 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent PGPub No. 2021/0171499 A1 by Ammann et al., which claims priority to Provisional Application No. 62/926,270, which was filed October 25th, 2019.
Amman et al. teach the following compound on page 223:
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The compound is embraced by instant claim 21 where R1 is H, R2 is H and R3 is H. Support can be found on page 80 of the ‘270 provisional application together with Example 2 on page 81 that teaches a corresponding fluorine substituted compound prepared according to the same method.
Regarding instant claim 25, this claim is rejected as indefinite; however, the preamble of “for manufacturing” is considered an intended use that does not materially limit any actual method steps. Claim 25 only requires “utilizing the compound according to claim 21,” which only appears to require that the compound of claim 21 exist. The same rationale applies to claims 26-28 that only refer to the composition of the preamble.
Claim(s) 29 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent PGPub No. 2020/0325121 A1 by Zhong et al., which claims priority to PCT/CN2019/082381, which was filed April 12th, 2019.
The prior art teaches the following compound on page 36:
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The compound is embraced by the formula of instant claim 25 where one of R1 and R2 is hydrogen and the other is F and R3 is hydrogen. Support can be found on page 177 of the priority document. Instant claim 29 is drafted as product-by-process claim; however, MPEP 2113(I) notes: ‘"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).’
Claim(s) 29 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent PGPub No. 2021/0171499 A1 A1 by Ammann et al., which claims priority to U.S. Provisional Application No. 63/028,187, which was filed May 21st, 2020 and U.S. Provisional Application No. 62/926,270, which was filed October 25th, 2019.
Amman et al. teach the following compound on page 35:
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The compound is embraced by the formula of instant claim 25 where one of R1 and R2 is hydrogen and the other is F and R3 is hydrogen. Support can be found on page 37 of the ‘270 priority document. The prior art further teaches the following compound on page 128:
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The compound is embraced by the formula of instant claim 25 where R1 and R2 are F and R3 is hydrogen. Support can be found on page 93 of the ‘187 priority document. Instant claim 29 is drafted as product-by-process claim; however, MPEP 2113(I) notes: ‘"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).’
Claim(s) 25-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent PGPub No. 2020/0407347 A1 by Coates et al.
The prior art teaches Preparation 18 on page 12 where a compound of the formula of instant claim 21 is prepared, which compound is embraced by the variables where R1 is F, R2 is H and R3 is -CH3. The prior art further teaches preparation of a compound having the structure of instant claims 25, 26, 27 (first structure) and 28 (first structure) on pages 13 and 14 as Preparations 25 and Example 2. The compound prepared is further embraced by instant claims 29 and 30, which are product-by-process claims.
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.
Claim 21 and 23-30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent PGPub No. 2020/0325121 A1 by Zhong et al., which was filed June 16th, 2020.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches compounds of the following general formula (abstract) as GLP-1R agonists:
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As an example of the prior art genus, the prior art teaches the following compound on page 36:
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The compound is embraced by the formula of instant claim 25 where one of R1 and R2 is hydrogen and the other is F and R3 is hydrogen. The prior art further teaches the following compound on page 38:
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Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art is deemed to anticipate instant claim 29, which is recited as a product-by-process that does not distinguish from the first compound cited above. Instant claim 30 recites a similar product-by-process that differs based on replacement of hydrogen with methyl on compound 84 of the prior art at the instant R3 position. Instant claim 29 further encompasses a compound where R2 is considered F and R3 is -CH3, which also differs by replacement of hydrogen with methyl. Instant claims 21, 23 and 24 embrace intermediates leading to either compound 84 (embraced by instant claim 21) or the compounds differing by replacement of hydrogen with methyl (embraced by instant claims 21, 23 and 24 (first and third compounds)). Instant claims 25-28 further embrace a method of utilizing said intermediates to prepare the compound 84 or the compounds differing by replacement of hydrogen with methyl. Compound 84 meets the structural limitations of instant claims 25 and 26 and the corresponding compounds where compound 84 contains a methyl group at the instant R3 position meet the structural limitations of instant claims 25, 26, 27 (first and third structures) and 28 (first and third structures).
Instant claims 21, 25, 26, 29 and 30 additionally encompass analogous subject matter discussed above relative to compound 95 of the prior art where hydrogen is replaced with methyl at the instantly claimed R3 position.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
Regarding replacement of hydrogen with methyl, it is first noted that the prior art generally teaches that the corresponding ring can be substituted by alkyl groups. See definition of R3 on page 4, paragraph [0050]. Furthermore, the prior art teaches that compounds 84 and 95 possess properties in the most desirable range on page 31. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its
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homologs because
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often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
The issue of patentability over the replacement of alkyl groups for hydrogen has arisen many times. For instance, the replacement of a methylene group with a dialkyl-substituted methylene group was determined to be prima facie obvious on the ground that “one skilled in the art would have been, prima facie, motivated to make the claimed compounds in the expectation that they, too, would possess antimicrobial activity." (In re Wood 199 USPQ 137). In the instant case, a person having ordinary skill in the art at the time the invention was made would have been motivated to synthesize the instantly claimed homologs with the reasonable expectation that they would have the same utility as the closest structurally related compounds taught by the prior art and with the motivation of obtaining additional useful compounds.
Instant claims 29 and 30 are drafted as product-by-process claims. MPEP 2113(I) notes: ‘"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).’ Accordingly, the prior art would render these claims obvious irrespective of how they were synthesized.
Regarding instant claims 21 and 23-28 that are directed to intermediates or methods of making, Zhang et al. teach in paragraph [0251] on page 24: “The compounds of any one of the formulae described above, may be prepared by the general and specific methods described below, using the common general knowledge of one skilled in the art of synthetic organic chemistry.” Zhang et al. teach that one particular method was used to prepare compounds 84 and 95 on pages 32-38 where the linkage between the benzimidazole and phenyl ring is formed before the bond between the pyridine and phenyl ring. Zhang et al., however, teach an additional method on pages 56 and 57 where the corresponding bonds are formed in a different order:
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The intermediate 6 of the prior art possesses an analogous backbone to the structure of instant claim 21 where if the general approach of page 56 were taken to generate compound 84 of the prior art or the homologs discussed above, intermediates embraced by instant claims 21, 23 and 24 would be obtained. Furthermore, converting the intermediates to the corresponding final products would be embraced by instant claims 25-28. At least in the interest of determining which particular bond forming sequences taught by the prior art would be optimum for the individual compounds being synthesized in terms of yield, cost, purity, etc., a person having ordinary skill in the art would have been motivated to test the disclosed sequences taught by Zhang et al. Such screening would have led to intermediates and methods instantly claimed when preparing either compound 84 or the homologs discussed above.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 29 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,655,242. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of the patent recites the compound recited in instant claim 30. Instant claims 29 and 30 are drafted as product-by-process claims; however, MPEP 2113(I) notes: ‘"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).’
Claims 21 and 23-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,473,267. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 14 of the patent recites a compound of instant claim 21 where R1 is F, R2 is H and R3 is CH3, which is embraced by instant claims 21, 23 and 24 (first compound). Regarding instant claims 25-28, claim 16 of the patent recites further steps to prepare a compound embraced by the formula of claims 25, 26, 27 (first structure) and 28 (first structure). Instant claims 29 and 30 are drafted as product-by-process claims. Regardless, MPEP 2113(I) notes: ‘"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).’
Allowable Subject Matter
Claim 22 is 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.
Claim 22 encompasses subject found to be obvious under 35 USC 103. Regardless of Applicant’s potential traversal of the rejection above as it stands, the reference by Zhang et al. claims its earliest priority date to PCT/CN2019/082381, which was filed April 12th, 2019. The ‘381 disclosure only provides for a preparation analogous to the sequence disclosed on pages 32 and 33 of the primary reference (See page 171 of the ‘203 document). There is no disclosure in the ‘381 application corresponding to the sequence disclosed on pages 56 and 57 of the primary reference, which the Examiner finds is necessary to support a rejection under 35 USC 103. For this reason, the 103 rejection is not made over claim 22, which has an earliest effective filing date of September 24th, 2019, which predates the next earliest priority claim of Zhang et al. (April 10th, 2020).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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