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 .
Claim Status
Claims 1-16 are pending.
Claims 1, 2, 7 and 8 are examined herein.
Claims 3-6 and 9-16 are withdrawn (see restriction/election below).
Priority
This application is filed 12/20/2023 and claims the benefit of domestic priority as below:
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Information Disclosure Statements
Two IDS(s) received on 03/18/2024 and 06/12/2024 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant elects Group I, claims 1-8, is drawn to a compound having a structure represented by Formula I, and salts and compositions thereof, with traverse in the reply field on 06/25/2026 is acknowledged. Claims 9-16 (Group II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of use, there being no allowable generic or linking claim.
Applicants argue that the restriction is improper because the restriction between Groups I and II because the method claims of Group II cannot be practiced with a materially different product Under MPEP § 806.05(h), a product and its process of use are distinct if the process can be practiced with a materially different product. In addition, Applicants further argue that the restriction is legally insufficient because Group II cannot be practiced with Atezolizumab, Gemcitabine, or another materially different product, and the specification does not disclose the compounds of Formula I as diagnostic agents. Therefore, based on a restriction requirement under MPEP § 806.05, the Applicants request that the restriction between Groups I and II be reconsidered and withdrawn, and that all Claims 1-16 be examined together.
This argument has been considered but does not persuasive. MPEP 806.05(h) states that “A product and a process of using the product can be shown to be distinct inventions if either or both of the following can be shown: (A) the process of using as claimed can be practiced with another materially different product; or (B) the product as claimed can be used in a materially different process. The burden is on the examiner to provide an example, but the example need not be documented”
In this case, the claims of Group I and Group II remain district because Group I is directed to the product/composition itself, whereas Group II is directed to a particular therapeutic method of using the product. The claimed product is not limited solely to the recited cancer treatment method, and the product may be used in a materially different process of using that product. In addition, the examples of Atezolizumab, Gemcitabine, or diagnostic use were provided to show that the product claims and the process of use claims are not coextensive and that the claimed product is not inseparably tied to only one process of use. Atezolizumab and Gemcitabine illustrate materially different process in which a compound may be used. Thus, the examples collectively demonstrate the distinctness of the product invention and the process of use invention under MPEP 806.05(h).
Applicant’s argument improperly treats the examples as though they must themselves literally satisfy every limitation of the Group II method claims. That is not the standard for maintain a product/process of use restriction. The relevant inquiry under MPEP 806.05(h) is whether the product and the process of using the product are distinct, including whether there is a materially different product or materially different process of use. The cited examples show that the claimed pharmaceutical composition and the claimed therapeutic method present separate statutory and examination issues.
Further, even if Applicant disputes whether Atezolizumab and Gemcitabine would practice the Group II claims, the restriction remains proper under the second prong of MPEP 806.05(h). The claimed product of Group I is not limited on its face to use only in the cancer treatment method of Group II. The product may be considered separately from that particular therapeutic method, including in a materially different process of use, such as diagnostic use. MPEP 806.5(h) does not require the examiner’s example to be documented, and Applicant has not shown by evidence or convincing argument that such an alternative use is impossible.
Lastly, it is not the sole basis for the restriction requirement, and the principal issue is whether the claimed groups are distinct and whether their examination together would impose a serious search and/or examination burden. In this case, the serious search and examination burden is present. The compound and composition claims require searching and examining chemical structures, substituent variations, genus and species scope, compositions, chemical obviousness, written description, enablement, and utility. The method of treatment claims require separate searching and examination directed to therapeutic use, disease indications, administration, dosing, patient populations, mechanism of action, and treatment efficacy. These inquiries involve different search fields and different patentability issues.
Accordingly, the restriction requirement is deemed proper and is made FINAL.
Applicant elects 5-(2-fluoro-6-hydroxy-4-(((6-methylpyrazin-2-yl)amino)methyl)phenyl)-1,2,5-thiadiazolidin-3-one 1,1-dioxide in example 16 as the species, with traverse in the reply field on 06/25/2026 is acknowledged.
The claims 1, 2, and 5-8 in Group I are readable on the elected species.
If the elected specie is not identified in the prior arts, the elected specie would be allowable if
an independent claim were drafted with that specie alone. (see MPEP 802.03)
The elected specie was not identified in the prior art. Further, the Examiner expanded the search to alternative species within the genus of Formula (I) and/or compounds in claim 7, and subsequent examination is based on alternative species expansion. (see 35 USC 102 below and MPEP 818)
Accordingly, claims 1, 2, 7, and 8 read on the alternative species, and will be examined on their merits. Claims 3-6 in Group I are withdrawn that are not readable on the alternative species.
With respect to the expanded species, the art is rejected under 35 USC 102, 35 USC 103, and double patenting below.
Claim Objections
Claims 1, 2 and 7 are objected to because of the following informalities:
Claims 1 and 2 are objected to because the relationship among the listed limitations is unclear because the claim language does not include a conjunction (i.e., and/or) or other linking language indicating whether the listed limitations are intended to be accumulative requirements or alternatives.
Claim 7 is objected to because the compound, “5-(4-(((5-chloropyridin-3-yl)amino)methyl)-2-fluoro-6-hydroxyphenyl)-1,2,5-thiadiazolidin-3-one 1,1-dioxide”, is duplicated.
Claim Rejections - 35 USC § 112
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.
Claim 1 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “alkyl”, and the claim also recites “ethyl” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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)(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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 7 and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Liu et al., (U.S. Patent 12,162,848 B2, effectively filed date 01/31/2022).
The applied reference has a common assignee and inventor 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.
Liu discloses PTPN2 inhibitors for treating cancer. The compound disclosed in example 79 (see col. 135) by Liu anticipates the instant claims 1, 2 and 7 when R1/R3/R4 are -C(R7)=/-C(R9)=/-C(R10)= wherein R7/R9/R10 are hydrogen, R2 is -C(R8)= wherein R8 is cyano, R5 is -N=, and R6 is hydrogen in the instant compounds of formula (I). Also, the example 79 compound is identical to the instant example 4 compound recited in claim 7. Liu further teaches a pharmaceutical composition comprising a compound of Formula (I) according to claim 1, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier in claim 17, as required to the instant claim 8.
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Instant Formula (I) Liu’s example 79
Claim(s) 1 and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mu et al., (U.S. Patent US 2024/0180886 A1, effectively filed date 11/09/2022).
The applied reference has a common assignee and inventor 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.
Mu discloses PTPN2 inhibitors for treating cancer. The compound disclosed in example 32 (see table 1) by Mu anticipates the instant claims 1 when R1 is -C(R7)= wherein R7 is cyano, R2 is -C(R8)= wherein R8 is alkyl, R3/R5 are -C(R9)=/-C(R11)= wherein R9/R11 are hydrogen, R4 is -N=, and R6 is hydrogen in the instant compounds of Formula (I). Mu further teaches a pharmaceutical composition comprising a compound of Formula (I) according to claim 1, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier in claim 10, as required to the instant claim 8.
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Instant Formula (I) Mu’s example 32
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 1, 2, 7 and 8 is/are rejected under 35 U.S.C. 103 as being obvious over Liu et al., (U.S. Patent 12,162,848 B2, effectively filed date 01/31/2022) in view of Mu et al., (U.S. Patent US 2024/0180886 A1, effectively filed date 11/09/2022).
This rejection under 35 U.S.C. 103 is made in the alternative; to the extent claims 1, 2, 7, and 8 are not anticipated, they are obvious in view of Liu and Mu.
As discussed above with respect to the rejection under 35 USC 102, Liu disclose PTPN2 inhibitors for treating cancer, and example 79 compound.
Liu fails to teach the specific compound derivatives in claim 7, except example 79 compound.
Mu discloses PTPN2 inhibitor compounds containing substituted six membered heteroaryl rings, including pyridyl, substituted pyridyl, cyano pyridyl, pyrimidinyl, pyrazinyl, and related aza-heteroaryl analogs (abstract and table 1). Moreover, the instant example 7 compound in claim 7 is a positional isomer of the examples 2 and 3 compound of Mu in claim 9. Thus, Mu teaches that the heteroaryl portion of the PTPN2 inhibitor scaffold may be varied among closely related pyridyl and diazine analogs while retaining the same therapeutic purpose.
The claimed compounds differ from the example 79 compound primarily by routine heteroaryl variation, including positional variation of the pyridyl nitrogen and/or cyano substituent, replacement or addition of common pyridyl substituents such as methyl, cyclopropyl, chloro, trifluoromethyl, methoxy, phenyl, or isopropyl, or replacement of the pyridyl ring with closely related aza-heteroaryl rings such as pyrimidinyl, pyrazinyl, or pyridinyl (see col. 19, line 66 to col. 20, line 10 of Liu, and the cited patent 12,162,848, and paragraph [0143]-[0185] of Mu)). Therefore, it would have been obvious to one skilled in the art to modify the heteroaryl portion of the active nicotinonitrile PTPN2 inhibitor lead compound disclosure in example 79 compound of Liu because Mu teaches that closely recited substituted pyridyl, cyano pyridyl, pyrimidinyl, pyrazinyl, and other aza-heteroaryl groups are suitable alternatives within the same class of PTPN2 inhibitor compounds. Such modification would have routine optimization of the heteroaryl binding element while preserving the common substituted phenyl moiety and arylmethylamino linkage without affecting their utility of treating cancer with reasonable expectation of success.
The applied reference has a common assignee and inventor 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.
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, 2, 7 and 8 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16 and 17 of U.S. Patent No. 12,162,848 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to one skilled in the art to prepare instant compounds with reasonable expectation of success since a genus of PTPN2 inhibitor compounds, specific compounds and a pharmaceutical composition that are disclosed in claims 1, 16 and 17 of ‘848.
In particular, claim 16 of ‘848 recites selected compounds including example 79 compound. That compound corresponds to the nicotinonitrile compound encompassed by instant claim 7 and falls within instant claims 1 and 2 when R1/R3/R4 are -C(R7)=/-C(R9)=/-C(R10)= wherein R7/R9/R10 are hydrogen, R2 is -C(R8)= wherein R8 is cyano, R5 is -N=, and R6 is hydrogen in the instant compounds of Formula (I). Moreover, claim 17 of ‘848 recites a pharmaceutical composition comprising a compound of Formula (I) according to claim 1, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier.
Claims 1, 2, 7 and 8 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-10 of copending Application No. 18/504,198 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of '198 teach closely related substituted pyridyl and cyano pyridyl PTPN2 inhibitor compounds within the same chemical series. The difference between the instant claims and the claims of ‘198 amount to routine heteroaryl positional variation and substituent optimization while preserving the same PTPN2 inhibitor scaffold, substituted phenyl moiety, arylmethylamino linkage, and therapeutic utility. Moreover, the instant example 7 compound in claim 7 is a positional isomer of the examples 2 and 3 compound of ‘198 in claim 9. Therefore, it would have been obvious to one of ordinary skill in the art to prepare the instant claimed compounds with a reasonable expectation of success in view of the claimed of ‘198. Claim 8 is not patentably distinct from claim 10 of ‘198 because both are directed to a pharmaceutical composition comprising a compound of Formula (I) according to claim 1, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable carrier.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 2, 7 and 8 are rejected.
Claims 1, 2 and 7 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner
should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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