DETAILED ACTION
Claims 1, 3, 9, 12, 21, 22, 27, 29, 31, 34, 35, 37, 40, 50, 52, 58-60, 63, 65, and 66 are currently pending in the instant application. Claims 3, 34, 60, 63, and 66 are withdrawn from consideration as being for non-elected subject matter. Claim 58 is objected. Claims 1, 9, 12, 21, 22, 27, 29, 31, 35, 37, 40, 50, 52, 58, 59, and 65 are rejected.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to products of formula (I) and the species of compound 180:
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in the reply filed on 16 January 2026 is acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species appears allowable. Therefore, the search and examination has been extended to the compounds:
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and
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which are not allowable.
Claims 1, 9, 12, 21, 22, 27, 29, 31, 35, 37, 40, 50, 52, 58, 59, and 65 have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned compounds.
Specification
The disclosure is objected to because of the following informalities:
The Preliminary Amendment filed 21 March 2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “which is incorporated by reference in its entirety.”
MPEP 211.02 and MPEP 201.06(c)(IV) state the following in regard to “Incorporation by Reference” and PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to International applications:
MPEP 211.02, in-part
For applications filed on or after September 21, 2004, a claim under 35 U.S.C. 119(e) or 120 and 37 CFR 1.78 for benefit of a prior-filed provisional application, nonprovisional application, international application designating the United States, or international design application designating the United States that was present on the filing date of the continuation or divisional application, or the nonprovisional application claiming benefit of a prior-filed provisional application, is considered an incorporation by reference of the prior-filed application as to inadvertently omitted material, subject to the conditions and requirements of 37 CFR 1.57(b). The purpose of 37 CFR 1.57(b) is to provide a safeguard for applicants when all or a portion of the specification and/or drawing(s) is (are) inadvertently omitted from an application. See MPEP § 201.06 and 217. However, applicants are encouraged to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed under 35 U.S.C. 119(e) or 120 if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material pursuant to 37 CFR 1.57(b). See 37 CFR 1.57(c). See also MPEP §§ 217 and MPEP § 608.01(p).
When a benefit claim is submitted after the filing of an application, and the later-filed application as filed did not incorporate the prior-filed application by reference, applicant cannot add an incorporation by reference statement of the prior application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)). See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980). See also 37 CFR 1.57(b).
MPEP 201.06(c)(IV), in-part
201.06(c) 37 CFR 1.53(b) and 37 CFR 1.63(d) Divisional-Continuation Procedure [R-07.2015]
IV. INCORPORATION BY REFERENCE
An applicant may incorporate by reference the prior application by including, in the continuing application-as-filed, an explicit statement that such specifically enumerated prior application or applications are “hereby incorporated by reference.” The statement must appear in the specification. See 37 CFR 1.57(c) and MPEP § 608.01(p). The inclusion of this incorporation by reference statement will permit an applicant to amend the continuing application to include subject matter from the prior application(s), without the need for a petition provided the continuing application is entitled to a filing date notwithstanding the incorporation by reference. For applications filed prior to September 21, 2004, the incorporation by reference statement may appear in the transmittal letter or in the specification. Note that for applications filed prior to September 21, 2004, if applicants used a former version of the transmittal letter form provided by the USPTO, the incorporation by reference statement could only be relied upon to add inadvertently omitted material to the continuation or divisional application.
An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)). If an incorporation by reference statement is included in an amendment to the specification to add a benefit claim under 35 U.S.C. 120 after the filing date of the application, the amendment would not be proper. When a benefit claim under 35 U.S.C. 120 is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980).
20.6 Confirmation of Incorporation by Reference of Elements and Parts
(a) The applicant may submit to the receiving Office, within the applicable time limit under Rule 20.7 , a written notice confirming that an element or part is incorporated by reference in the international application under Rule 4.18 , accompanied by:
(i) a sheet or sheets embodying the entire element as contained in the earlier application or embodying the part concerned;
(ii) where the applicant has not already complied with Rule 17.1(a) , (b) or (b-bis) in relation to the priority document, a copy of the earlier application as filed;
(iii) where the earlier application is not in the language in which the international application is filed, a translation of the earlier application into that language or, where a translation of the international application is required under Rule 12.3(a) or 12.4(a) , a translation of the earlier application into both the language in which the international application is filed and the language of that translation; and
(iv) in the case of a part of the description, claims or drawings, an indication as to where that part is contained in the earlier application and, where applicable, in any translation referred to in item (iii).
(b) Where the receiving Office finds that the requirements of Rule 4.18 and paragraph (a) have been complied with and that the element or part referred to in paragraph (a) is completely contained in the earlier application concerned, that element or part shall be considered to have been contained in the purported international application on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(c) Where the receiving Office finds that a requirement under Rule 4.18 or paragraph (a) has not been complied with or that the element or part referred to in paragraph (a) is not completely contained in the earlier application concerned, the receiving Office shall proceed as provided for in Rule 20.3(b)(i) , 20.5(b) , 20.5(c) , 20.5bis(b) or 20.5bis(c) , as the case may be.
20.7 Time Limit
(a) The applicable time limit referred to in Rules 20.3(a) and (b) , 20.4 , 20.5(a) , (b) and (c) , 20.5bis(a) , (b) and (c) , and 20.6(a) shall be:
(i) where an invitation under Rule 20.3(a) , 20.5(a) or 20.5bis(a) , as applicable, was sent to the applicant, two months from the date of the invitation;
(ii) where no such invitation was sent to the applicant, two months from the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(b) Where neither a correction under Article 11(2) nor a notice under Rule 20.6(a) confirming the incorporation by reference of an element referred to in Article 11(1)(iii)(d) or (e) is received by the receiving Office prior to the expiration of the applicable time limit under paragraph (a), any such correction or notice received by that Office after the expiration of that time limit but before it sends a notification to the applicant under Rule 20.4(i) shall be considered to have been received within that time limit.
4.18 Statement of Incorporation by Reference
Where the international application, on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office, claims the priority of an earlier application, the request may contain a statement that, where an element of the international application referred to in Article 11(1)(iii)(d) or (e) , or a part of the description, claims or drawings referred to in Rule 20.5(a) , or an element or part of the description, claims or drawings referred to in Rule 20.5bis(a) is not otherwise contained in the international application but is completely contained in the earlier application, that element or part is, subject to confirmation under Rule 20.6 , incorporated by reference in the international application for the purposes of Rule 20.6 . Such a statement, if not contained in the request on that date, may be added to the request if, and only if, it was otherwise contained in, or submitted with, the international application on that date.
The instant application is a 371 application which has an International filing date of 22 September 2021. The incorporation by reference statement is being added by way of a Preliminary Amendment filed 21 March 2023, which is after the instant application's International filing date of 22 September 2021. Therefore, the “incorporation by reference” statement being added to the instant specification by way of the Preliminary Amendment is deemed new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 58 is objected to because of the following informalities: Many of the structures in claim 58 are unclear or the text is too small which prevents the atoms and bonds from being seen clearly. See for example structure
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and
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It is suggested that applicant provide clear structures for each compound in claim 58. Appropriate correction is required.
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, 9, 12, 21, 22, 27, 29, 31, 35, 37, 40, 50, 52, 58, 59, and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9-12 of U.S. Patent No. 12479856. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are claiming compounds of the formula, for example, formula (XIV):
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(conflicting claim 1) wherein X7 is O (conflicting claim 3), wherein R1 and R2 are both hydrogen (conflicting claim 4), wherein R3 and R4 are both hydrogen (conflicting claim 5), and wherein R7 and R11 are each hydrogen (conflicting claim 6). A specific compound claimed is the compound on column 565, 1st compound:
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which corresponds to applicant’s instant formula (I):
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wherein, for example, n is 1; Z is C(O); X1 is S; X2 is a bond; X3 is C(R17); R17 is H; X4 is N; X5 is C; X6 is
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; R13’ is H; R19 and R20 are H; R1, R2, R3, R4, R5, R6, R7, R8, R12, and R13 are each hydrogen; R9 and R11 are taken together with the atoms to which they are attached to form a 3 membered carbocycle; R10 is C1 alkyl; two of R14, R15 and R16 are H and the other is -OR30 wherein R30 is aryl (instant claim 1). The conflicting claims correspond to instant claim 9 wherein R5 and R6 is H. The conflicting claim corresponds to instant claim 12, at least when X1 is S. The conflicting claims correspond to instant claim 21 when X6 is
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. The conflicting claims correspond to instant claim 22 as X7 is limited in claim 22, however, X7 is not required to be present on the compound of instant claim 1. The conflicting claims correspond to instant claim 27 as R1 and R2 are both hydrogen and R3 and R4 are both hydrogen. The conflicting claims correspond to instant claim 29 wherein R9 and R11 together with the atoms to which they are attached form:
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. The conflicting claims correspond to instant claim 31 wherein R10 is C1-C6 alkyl. The conflicting claims correspond to instant claim 35 at least wherein R12 is hydrogen. The conflicting claims correspond to instant claim 37 at least wherein R13, R19 and R20 are hydrogen. The conflicting claims correspond to instant claim 40 wherein at least two of R14, 15 and R16 are hydrogen. The conflicting claims correspond to instant claim 50 as R21, while being limited in claim 50, is not required to be present on the compound of instant claim 1. The conflicting claims correspond to instant claim 52 as R22, while being limited in claim 52, is not required to be present on the compound of instant claim 1. The conflicting claims correspond to a compound which differs only by a hydrogen versus a methyl to instant claim 58 which claims the compound:
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However, it is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity. The conflicting claim 10 corresponds to the pharmaceutical composition of instant claim 59 and 65.
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 1 and its dependent claims 9, 12, 21, 22, 27, 29, 31, 35, 37, 40, 50, 52 and 59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the compounds of formula (I), or a pharmaceutically acceptable salt, prodrug, enantiomer, mixtures of enantiomers, diastereomers, tautomers, racemates, or rotamer thereof, does not reasonably provide enablement for any isomer or isolated isomer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The nature of the invention
The nature of the invention is a compound of formula (I) or a pharmaceutically acceptable salt, prodrug, or isolated isomer thereof.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that an isomer is any compound having the same composition, including constitutional isomers, which are compounds whose atoms are connected differently. Constitutional isomers can contain different functional groups in varying positions.
The amount of direction or guidance present and the presence or absence of working examples
The only direction or guidance present in the instant specification is for enantiomers, mixtures of enantiomers, diastereomers, tautomers, racemates, or rotamer thereof, see page 26 of the specification. There is no data present in the instant specification for the preparation or utility of constitutional isomers.
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure, specifically, the instant claims include any isolated isomer, i.e. any isolated compound with the same number of each atom.
The quantity or experimentation needed and the level of skill in the art
While the level of the skill in the pharmaceutical arts is high, it would require undue experimentation of one of ordinary skill in the art to prepare any isolated isomer as instantly claimed since an isomer of the compounds need only have the same composition of atoms, not necessarily the same order of atoms and can have varying functional groups in varying positions. Therefore, the claims lack enablement for all isolated isomers.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 9, 12, 21, 22, 27, 35, 37, 40, 50, 52, and 59 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Registry No. 301189-34-4.
Registry No. 301189-34-4 is:
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. Registry No. 301189-34-4 corresponds to instant claim 1 formula (I):
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wherein, for example, n is 1; Z is C(O); X1 is S; X2 is a bond; X3 is C(R17); R17 is H; X4 is N; X5 is C; X6 is
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; R13’ is H; R19 and R20 are H; R1, R2, R3, R4, R5, R6, R7, R8, R9, R10, R11, R12, and R13 are each hydrogen; two of R14, R15 and R16 are H and the other is -C(O)R31 wherein R31 is aryl. Registry No. 301189-34-4 corresponds to instant claim 9 wherein R5 and R6 is H. Registry No. 301189-34-4 corresponds to instant claim 12, at least when X1 is S. Registry No. 301189-34-4 corresponds to instant claim 21 when X6 is
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. Registry No. 301189-34-4 corresponds to instant claim 22 as X7 is limited in claim 22, however, X7 is not required to be present on the compound of instant claim 1. Registry No. 301189-34-4 corresponds to instant claim 27 as R1 and R2 are both hydrogen and R3 and R4 are both hydrogen. Registry No. 301189-34-4 corresponds to instant claim 35 at least wherein R12 is hydrogen. Registry No. 301189-34-4 corresponds to instant claim 37 at least wherein R13, R19 and R20 are hydrogen. Registry No. 301189-34-4 corresponds to instant claim 40 wherein at least two of R14, 15 and R16 are hydrogen. Registry No. 301189-34-4 corresponds to instant claim 50 as R21, while being limited in claim 50, is not required to be present on the compound of instant claim 1. Registry No. 301189-34-4 corresponds to instant claim 52 as R22, while being limited in claim 52, is not required to be present on the compound of instant claim 1. Regarding the composition of claim 59, comprising the anticipatory compounds and a carrier, the Registry entry for Registry no. 301189-34-4 discloses a mass solubility in unbuffered water at pH 7.00. This teaching in of water anticipates the claimed composition, wherein the compounds are present with a pharmaceutically acceptable carrier (i.e., water).
Registry number 301189-34-4 is available as prior art as of 03 November 2000 the date it was indexed into the CAplus database.
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compound anticipates the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
(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) 1, 9, 12, 21, 22, 27, 29, 31, 35, 37, 40, 50, 52, and 59 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Patent No. 12479856.
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
US Patent No. 12,479,856 provides compound
(XIV):
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in claim 1 and column 22 wherein X7 is O (claim 3), wherein R1 and R2 are both hydrogen (claim 4), wherein R3 and R4 are both hydrogen (claim 5), and wherein R7 and R11 are each hydrogen (claim 6). A specific compound claimed is the compound on column 565, 1st compound:
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which corresponds to applicant’s instant formula (I):
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wherein, for example, n is 1; Z is C(O); X1 is S; X2 is a bond; X3 is C(R17); R17 is H; X4 is N; X5 is C; X6 is
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; R13’ is H; R19 and R20 are H; R1, R2, R3, R4, R5, R6, R7, R8, R12, and R13 are each hydrogen; R9 and R11 are taken together with the atoms to which they are attached to form a 3 membered carbocycle; R10 is C1 alkyl; two of R14, R15 and R16 are H and the other is -OR30 wherein R30 is aryl (instant claim 1). The compound of the ‘856 patent corresponds to instant claim 9 wherein R5 and R6 is H. The compound of the ‘856 patent corresponds to instant claim 12, at least when X1 is S. The compound of the ‘856 patent corresponds to instant claim 21 when X6 is
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. The compound of the ‘856 patent corresponds to instant claim 22 as X7 is limited in claim 22, however, X7 is not required to be present on the compound of instant claim 1. The compound of the ‘856 patent corresponds to instant claim 27 as R1 and R2 are both hydrogen and R3 and R4 are both hydrogen. The compound of the ‘856 patent corresponds to instant claim 29 wherein R9 and R11 together with the atoms to which they are attached form:
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. The compound of the ‘856 patent corresponds to instant claim 31 wherein R10 is C1-C6 alkyl. The compound of the ‘856 patent corresponds to instant claim 35 at least wherein R12 is hydrogen. The compound of the ‘856 patent corresponds to instant claim 37 at least wherein R13, R19 and R20 are hydrogen. The compound of the ‘856 patent corresponds to instant claim 40 wherein at least two of R14, 15 and R16 are hydrogen. The compound of the ‘856 patent corresponds to instant claim 50 as R21, while being limited in claim 50, is not required to be present on the compound of instant claim 1. The compound of the ‘856 patent corresponds to instant claim 52 as R22, while being limited in claim 52, is not required to be present on the compound of instant claim 1. The compound of the ‘856 patent along with claim 10 of the ‘856 patent corresponds to the pharmaceutical composition of instant claim 59.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 58 and 65 is/are rejected under 35 U.S.C. 103 as being obvious over US Patent No. 12479856.
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
US Patent No. 12,479,856 provides compound
(XIV):
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in claim 1 and column 22 wherein X7 is O (claim 3), wherein R1 and R2 are both hydrogen (claim 4), wherein R3 and R4 are both hydrogen (claim 5), and wherein R7 and R11 are each hydrogen (claim 6). A specific compound claimed is the compound on column 565, 1st compound:
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which corresponds to a compound which differs only by a hydrogen versus a methyl to instant claim 58 which claims the compound:
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However, it is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity. The ‘856 patent claim 10 corresponds to the pharmaceutical composition of instant claim 65.
Conclusion
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 8 May 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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