DETAILED ACTION
Claims 1-3, 39-43, 50, 51, 134, 201, 277, 282, 286, 290, 295, 300, 304, and 308-312 are currently pending in the instant application. Claims 1-3, 39-43, 50, 134, 201, 282, and 308-312 are rejected. Claims 51, 277, 286, 290, 295, 300 and 304 are objected.
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 .
Terminal Disclaimer
The terminal disclaimer filed on 26 January 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 11,858,924 has been reviewed and is NOT accepted.
This application was filed on or after September 16, 2012. The person who signed the terminal disclaimer is not the applicant, the patentee or an attorney or agent of record. See 37 CFR 1.321(a) and (b).
This application was filed on or after September 16, 2012. The person who signed the terminal disclaimer has failed to state in what capacity it was signed on behalf of the juristic entity, and the person who signed it has not been established as being authorized to act on behalf of the juristic entity.
Note: PoA can be given to customer number, wherein all practitioners listed under the customer number have PoA. If PoA is given to a list of practitioners by registration number, the list may not comprise more than 10 practitioners or a separate paper signed by a 37 CFR 1.33(b) party must be in the record identifying which of the practitioners, up to 10, are recognized as having established that the representative is a party authorized to act on behalf of the applicant.
This application was filed on or after September 16, 2012. The party identified in the terminal disclaimer is not the applicant of record. A request to change the applicant under 37 CFR 1.46(c) must be filed and must include an application data sheet specifying the applicant in the applicant information section and comply with 37 CFR 3.71 and 3.73. To be reconsidered, the terminal disclaimer must be filed with the request under 37 CFR 1.46(c).
It should be noted that applicant is not required to pay another disclaimer fee as set forth in 37 CFR 1.20(d) when submitting a replacement or supplemental terminal disclaimer.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 26 January 2026 have been fully considered and entered into the instant application. Applicant’s amendment has overcome the objection to the specification. The nonstatutory double patenting rejection is maintained as the terminal disclaimer filed 26 January 2026 is not accepted for the reasons stated above. In regards to the 35 USC 112(a), the rejection is maintained as claim 309 still states that a subject can be “susceptible to the FAP-mediated condition” which is therefore administering to a subject before they have the FAP-mediated condition which would still include “prevention”. The 35 USC 112(b) rejection is maintained as claims 1 and 201 still include the rejected “comprises” and applicant has neither amended the claims or argued why the claims are proper. The objection to the claims 51, 277, 286, 290, 295, 300, and 304 as being dependent upon a rejected base claim is therefore maintained.
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 1-3, 39-43, 50, 134, 282, and 308-312 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,858,924. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims 1-13 of the ‘924 patent are drawn to products of the formula:
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(conflicting claim 1), specifically:
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(conflicting claims 2-7) with claims 8-1 drawn to methods of utilizing
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for treating liver disease, such as nonalcoholic steatohepatitis. The compound
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corresponds to the instant formula (I):
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(instant claims 1, 2, 134, ) wherein X1 is S; R1, R3, R4, R5 and R6 are each hydrogen; and R2 is (b) heterocyclyl containing a total of 5 to 10 ring atoms which is saturated and has one nitrogen atom and one oxygen atom with the remining ring atoms being carbon. The compound of the conflicting claims specifically corresponds to the formula (II), (III-A), (III-B), (III-C), (III-D), (III-E) (instant claims 3, 39-43), more specifically formula (IV-A) instant claim 50:
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. The conflicting claims read on instant claim 282:
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wherein R1, R3, R4, R5, and R6 are hydrogen and R30a-R30h are each hydrogen.
Claim Objections
Claims 51, 277, 286, 290, 295, 300, and 304 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claims 309-312 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 treating an FAP-mediated condition in a subject suffering from the FAP-mediated condition, the specification does not reasonably provide enablement for the prevention of an FAP-mediated condition, specifically, when the compound of claim 1 is administered in a subject susceptible to the FAP-mediated condition. 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.
As stated in the MPEP 2164.01 (a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
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 need 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.
In the instant case,
The nature of the invention
The nature of the invention of claims 309-312 is the treatment of an FAP-mediated condition, such as cardiovascular conditions and cancer (claim 310) and liver diseases such as nonalcoholic steatohepatitis (claims 311-312) in a subject suffering from or susceptible to the FAP-mediated condition. Treating an FAP-mediated condition in a subject susceptible to the FAP-mediated condition would still include prevention.
. The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat or prevent which specific diseases by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The instant claimed invention is highly unpredictable as discussed below:
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
Applicant’s are claiming the treatment of varying FAP-mediated conditions, including in subjects susceptible to the FAP-mediated condition, which would still include prevention.
As seen on page 1 of the specification:
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which provides that the inhibition of FAP may be useful for the treatment of NASH and other conditions and that there is currently no such therapeutic approach for treating NASH and other diseases associated with such activity.
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 the listing of diseases applicant considers treatable or preventable on pages 117-124 Page 462-473 provides hFAP inhibition Assay data and binding data. Pages 474-477 provide FAP Plasma inhibition Assay data. Pages 478-480 provide hDPP inhibition assays. Pages 480-87 provide metabolic stability assays. Pages 488-492 provide Caco-2 cell permeability. Pages 492-493 provide kinetic solubility assays. Page 494-497 provides FAP target engagement enzyme activity in mouse plasma. There is no data provided for the prevention of any FAP mediated condition.
The breadth of the claims
The breadth of the invention of claims 309-312 is the treatment of an FAP-mediated condition, such as cardiovascular conditions and cancer (claim 310) and liver diseases such as nonalcoholic steatohepatitis (claims 311-312). in a subject suffering from or susceptible to the FAP-mediated condition. Treating an FAP-mediated condition in a subject susceptible to the FAP-mediated condition would still include prevention.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine how to prevent any FAP mediated condition which includes the prevention of diseases such as cancer and cardiovascular diseases which have a multitude of causative agents, including environmental factors and diverse contributing genetic factors when, as stated on page 1 of the instant specification, while the inhibition of FAP may be useful for the treatment of NASH and other conditions, there is currently no such therapeutic approach for treating NASH and other diseases associated with such activity.
The level of the skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
Thus, the specification fails to provide sufficient support of the use of the compound of the instant claims for the prevention of any FAP mediated condition as a result necessitating one of skill to perform an exhaustive search for how to prevent any FAP mediated condition which have a multitude of causative agents, including environmental factors and diverse contributing genetic factors and as stated on page 1 of the instant specification, while the inhibition of FAP may be useful for the treatment of NASH and other conditions, there is currently no such therapeutic approach for treating NASH and other diseases associated with such activity.
Thus, factors such as “sufficient working examples”, “the level of skill in the art” and “predictability”, etc. have been demonstrated to be sufficiently lacking in the instantly claimed methods. In view of the breadth of the claim, the chemical nature of the invention, and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001 (3/13/1997), states that “ a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation with no assurance of success. It is suggested that “or susceptible to” be deleted from claim 309.
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 1-3, 39-43, 50, 201, and 308-312 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. Specifically, claims 1 and 201 have the language:
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. The use of “comprises” in (c) of the definition of R2 renders the claims indefinite as “comprises” is open-ended and thus, does not exclude additional, unrecited elements, according to MPEP 2111.03(I). Subsequently, it is unclear to the Examiner whether the abovementioned spiro heterocyclyl can have more rings that the two saturated rings mentioned. Accordingly, the metes and bounds of this claim is unclear, which rendered this claim indefinite.
The term “comprising” or forms of the term are considered open-ended language and therefore include additional subject matter that is not described in the instant specification and is not particularly pointed out or distinctly claimed. The identity of the additional atoms or groups is unknown and how to determine the identity of the additional atoms or groups is not pointed out or distinctly claimed.
The term “compound” contradicts the open language "comprising." A "compound" is defined as a substance whose molecules consist of unlike elements and whose constituents cannot be separated by physical means. Grant & Hackh's Chemical Dictionary (5th Ed. 1987) at page 148. By contrast, a composition is defined as elements or compounds forming a material or produced from it by analysis. Id. In other words, a compound is a molecule with more than one element, and a composition is a mixture of two or more compounds or molecules.
The transitional term "comprising" is synonymous with "including". "Comprising" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”).
Thus, a contradiction arises within the definition of instant discussed variables in claim 1 and its dependent 2-3, 39-43, 50, 201, and 308-312 because a "compound" requires a definite chemical formula, and the open-ended term "comprises" does not exclude unrecited elements. Furthermore, "comprises", used in conjunction with "compound" fails to articulate exactly what subject matter is excluded from the claimed scope of compounds, thereby rendering the scope of claims 1-3, 39-43, 50, 201, and 308-312 indefinite.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 23 February 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600