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
This office action is in response to applicant’s reply filed on May 26, 2026.
Restrictions/Elections.
Applicant’s election without traverse of Group I (Claims 1-15) in the reply filed on May 26, 2026, is acknowledged.
Applicant further election of the following species:
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is also acknowledged.
Since the above species was found to be free of prior art, the Examination was expanded to the following species:
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Status of Claims
Claims 1-20 are currently pending and are the subject of this office action.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 26, 2026.
The elected species is encompassed by claims 1-4 and 7-14.
The expanded species reads on claims 1-2 and 9-14.
The combined claims that encompass one or both species, and consequently are under examination are: claims 1-4 and 7-14.
Claims 5-6 and 15 are further withdrawn, since they do not encompass any of the above species.
Priority
The present application does not claim priority to any other application. The priority date is the filing date of the present application: 03/14/2024.
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 9-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims 9-14 recite: the compound of claim 1, wherein the compound binds to at least one anti-apoptotic protein, or wherein the compound has an IC50 for Bcl-xl of less than about 10 micromolar, etc.
M.P.E.P. #2163 states: “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”.
Claims 9-14 encompass a group of structurally similar compounds (see Formula I in claim 1) further limited by their biological properties (binds to at least one anti-apoptotic protein, or wherein the compound has an IC50 for Bcl-xl of less than about 10 micromolar). Therefore, the claims encompass a genus of structurally similar compounds further defined by its biological properties, which is simply a wish to know the identity of such subset of compounds with that biological property. Accordingly, there is insufficient written description encompassing compounds of Formula I as in claim 1 wherein the compounds bind to at least one anti-apoptotic protein, or wherein the compounds have an IC50 for Bcl-xl of less than about 10 micromolar because the relevant identifying characteristics of the genus such as structure or other physical and/or chemical characteristics of compounds of Formula I as in claim 1 that bind to at least one anti-apoptotic protein, or wherein the compounds have an IC50 for Bcl-xl of less than about 10 micromolar are not set forth in the specification as-filed, commensurate in scope with the claimed invention. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (see page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (see Vas-Cath at page 1116).
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddles v.Baird, 30 USPQ2d 1481, 1483. In Fiddles v. Baird, claims directed to mammalian FGF’s were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Thus, the specification fails to describe these DNA sequences. The Court further elaborated that generic statements are not adequate written description of the genus because it does not distinguish the claimed genus from others, except by function.
Per the Enzo court’s example, (Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609 (CA FC 2002) at 1616) of a description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) couched “in terms of its function of lessening inflammation of tissues” which, the court stated, “fails to distinguish any steroid from others having the same activity or function” and the expression “an antibiotic penicillin” fails to distinguish a particular penicillin molecule from others possessing the same activity and which therefore, fails to satisfy the written description requirement. Similarly, compounds of Formula I as in claim 1 wherein the compounds bind to at least one anti-apoptotic protein, or wherein the compounds have an IC50 for Bcl-xl of less than about 10 micromolar does not distinguish any particular compound of Formula I from others having similar structure or function and as such does not satisfy the written-description requirement.
Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the entire claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. The specification provides biological data for small list of compounds within the structural limitations of Formula I (see pages 62-67 of the specification. These compounds have a relatively low degree of variability, all the examples provided fit within a very narrow set of structural diversity. This limited number of compounds cannot be considered representative of the much larger genus of compounds of Formula I as in claim 1 wherein the compounds bind to at least one anti-apoptotic protein, or wherein the compounds have an IC50 for Bcl-xl of less than about 10 micromolar.
In the absence of enough structural characteristics (other than the ones disclosed on pages 62-67 of the specification) that are shared by members of the genus of compounds of Formula I as in claim 1 wherein the compounds bind to at least one anti-apoptotic protein, or wherein the compounds have an IC50 for Bcl-xl of less than about 10 micromolar; one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus. See University of California v. Eli Lilly and Co. 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997).
Given the broad scope of the claimed subject matter, applicant has not provided sufficient written description that would allow the skilled artisan to recognize that applicant was in possession of the claimed structures encompassed by compounds of Formula I as in claim 1 wherein the compounds bind to at least one anti-apoptotic protein, or wherein the compounds have an IC50 for Bcl-xl of less than about 10 micromolar.
In summary, the skilled in the art will not know what other compounds within Formula I (besides the ones tested in the specification), will also bind to at least one anti-apoptotic protein, or wherein the compounds have an IC50 for Bcl-xl of less than about 10 micromolar.
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) 1-2 and 9-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuroda (JP 2009086655, 04/23/2009).
For claims 1-2, Kuroda teaches the following compound:
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(see compound 27 on page 14), wherein Y1 = Y2 = OR1, wherein R1 = -CH3, and X1 - X8 are Hydrogen.
For claims 9-14, the prior art does not teach that the above compound:
binds to at least one anti-apoptotic protein, or wherein the compound has an IC50 for Bcl-xl of less than about 10 micromolar, etc. However, the biological/pharmaceutical properties of a compound are close related to the structural characteristics. In the instant case, the above compound falls within the structural limitations of claim 1.
The office does not have the facilities and resources to provide the factual evidence needed to establish that the compound of the prior art does not possess the same material, structural and functional characteristics of the compounds claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the compounds encompassed by claims 9-14 are different from the one disclosed by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Claim Objections
Claims 3-4 and 7-8 are objected to in part 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, and to recite only the elected species.
Note that claims 3-5 and 7-8 are objected to in part herein insofar as it contains non-elected subject matter to which the prior art search has not yet been extended. That part which has been searched, however (consistent with the election of species requirement as previously discussed), would be allowable if the claim was amended in independent form including all the limitations of the base claim and any intervening claims, and to remove the currently non-elected subject matter (i.e. all the species except for the elected species).
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
June 2, 2026.
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