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 .
Priority
This application is a national stage entry of PCT/US2022/023484 filed on 04/05/2022, which claims priority to U.S. Provisional No. 63/170,977 filed on 04/05/2021.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-3, 7-9 and 11-13) drawn to a composition for targeting OTUD7A, the composition comprising a component sufficient to block and/or reduce OTUD7A-mediated deubiquitination of EWS-FLI1 in a cell, wherein the component comprises 7Ai and variants thereof, in the reply filed on February 6, 2026 is acknowledged.
The reply filed on February 6, 2026 is not fully responsive to the prior Office action because of the following omission(s) or matter(s): No election of a species of a component sufficient to block and/or reduce OTUD7A-mediated deubiquitination of EWS-FLI1 in a cell as detailed on page 4 of the restriction requirement dated 01/30/2026 was made.
During a telephone conversation with Leon Legleiter on March 25, 2026 a provisional election was made without traverse to prosecute the invention of Group I with compound 7ai as a species of a component sufficient to block and/or reduce OTUD7A-mediated deubiquitination of EWS-FLI1 in a cell. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-24 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-3, 7-9 and 11-13 are being examined as they read on the elected species.
Claim Rejections - 35 USC § 112(a)
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 1-3, 7-9 and 11-13 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.
Claims 1-3 and 7-9 of the instant application are drawn to a composition for targeting OTUD7A, the composition comprising a component sufficient to block and/or reduce OTUD7A-mediated deubiquitination of EWS-FLI1 in a cell, wherein the component comprises 7Ai and variants thereof. Claims 11-13 of the instant application are drawn to an OTUD7A catalytic inhibitor, the catalytic inhibitor comprising a 7Ai compound or variant thereof. The claims are rejected for failing to comply with the written description requirement because the specification does not provide sufficient information to demonstrate that Applicant was in possession of any 7Ai variant compound.
In the present case, the important factors leading to a conclusion of inadequate written description are the breadth of the claims, the absence of any working example of a variant compound as claimed, and the lack of predictability in the art.
35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description"). The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert, denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
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. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Bees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm.,927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). An application specification may show actual reduction to practice by describing testing of the claimed invention.
The claims are drawn to a composition comprising 7Ai and variants thereof as well as compound 7Ai or any variant thereof. Thus, the claims are broad since they encompass not only the 7Ai compound but any variant thereof.
Applicant has described in the instant specification compound 7Ai having the following structure:
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. There is no disclosure of any other compound in the instant specification. In addition, there is no definition or any description of what is meant by a variant of compound 7Ai. There is no working examples found in the instant specification teaching how to prepare a variant of compound 7Ai. Thus, the instant specification does not provide any evidence that Applicant was in possession of the claimed invention of a 7Ai variant, prior to the effective filing date of the claimed invention.
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "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).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966(1997); In re Gosteli, 872 F.2d 1008, 1012,10 USPQ2d 1614, 1618 (Fed Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.") Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021.
Thus, since Applicant has not described in adequate detail, variant compounds of 7Ai and furthermore have not provided any evidence that such compounds exist, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided any evidence that Applicant was in possession of 7Ai variant compounds prior to the effective filing date of the instant application. Thus, the claims of the instant application are not supported by the instant specification and thus a rejection under 35 USC 112 (a) for failing to comply with the written description requirement is proper.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 7-9 and 11-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-3 and 7-9 of the instant application are drawn to a composition for targeting OTUD7A, the composition comprising a component sufficient to block and/or reduce OTUD7A-mediated deubiquitination of EWS-FLI1 in a cell, wherein the component comprises 7Ai and variants thereof. Thus, the composition of claims 1-3 and 7-9 comprises compound 7Ai as well as variants thereof. Claims 11-13 of the instant application are drawn to an OTUD7A catalytic inhibitor, the catalytic inhibitor comprising a 7Ai compound or variant thereof.
Claims 1-3, 7-9 and 11-13 are indefinite since these claims encompass the limitation “variant thereof”. It is unclear what is meant by a variant. It is unclear what changes to the structure of compound 7Ai are permissible to be considered a variant of compound 7Ai. The word variant is mentioned numerous times in the instant specification, however, no definition of what a variant refers to is provided in the instant specification. Thus, the claims are rejected since an ordinary skilled artisan cannot ascertain the metes and bounds of the claims.
Claims 1-3 and 7-9 are further indefinite since the claims recite “the component comprises 7Ai and variants thereof”. It is unclear how a component comprises 7Ai and variants thereof, because either the component is the 7Ai compound or the variants thereof or it is not.
Claims 11-13 are further indefinite since the claims recite “an OTUD7A catalytic inhibitor, the catalytic inhibitor comprising a 7Ai compound or variant thereof”. It is unclear how an inhibitor comprises 7Ai or variants thereof, because either the inhibitor is the 7Ai compound or the variants thereof or it is not.
Claim 7 is further indefinite since the claim recites “wherein 7Ai comprises the following structure.” It is unclear how 7Ai comprises a structure, because either the structure is the 7Ai compound or it is not.
Claim 13 is further indefinite since the claims recite “wherein 7Ai compound comprises the following structure.” It is unclear how a 7Ai compound comprises a structure, because either the structure is the 7Ai compound or it is not.
Claims 3 and 12 are further indefinite because of the use of the word “substantially.” The use of the word “substantially” renders the claims indefinite since an ordinary skilled artisan could not ascertain the scope of the claims.
The term "substantially" is often used in conjunction with another term to describe a particular characteristic of the claimed invention. It is a broad term. In re Nehrenberg, 280 F.2d 161, 126 USPQ 383 (CCPA 1960). The court held that the limitation "to substantially increase the efficiency of the compound as a copper extractant" was definite in view of the general guidelines contained in the specification. In re Mattison, 509 F.2d 563, 184 USPQ 484 (CCPA 1975). The court held that the limitation "which produces substantially equal E and H plane illumination patterns" was definite because one of ordinary skill in the art would know what was meant by "substantially equal." Andrew Corp. v. Gabriel Electronics, 847 F.2d 819, 6 USPQ2d 2010 (Fed. Cir. 1988).
In the instant case, the instant specification does not provide any definition of what is meant by substantially as recited in claims 3 and 12. The ordinary meaning of substantially is a considerable or significant amount. Thus, it could mean 50% or it could mean 99%. In Ex parte Oetiker, 23 USPQ2d 1641 (Bd. Pat. App. & Inter. 1992), the phrases "relatively shallow," "of the order of," "the order of about 5mm," and "substantial portion" were held to be indefinite because the specification lacked some standard for measuring the degrees intended.
Therefore, the claims are indefinite since after applying the broadest reasonable interpretation, the metes and bounds of the claimed invention are not clear.
Claim 12 is further indefinite since a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph is appropriate when examining means-plus-function claim limitations under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because although claim 12 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph there is no disclosure of structure, material, or acts for performing the claimed function (see 112(f) rejection below). The specification does not teach what to do to the catalytic inhibitor or how to configure the catalytic inhibitor so that it substantially limits Ewing sarcoma growth in vivo by degrading EWS-FLI1. Thus claim 12 is further indefinite since it is unclear how to configure the catalytic inhibitor to perform the claimed use.
Claim Rejections - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: configured to in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PubChem CID19589879 (equivalent to SID32300086 Provided on IDS) (create date 12-5-2007). (National Center for Biotechnology Information. PubChem Compound Summary for CID 19589879. https://pubchem.ncbi.nlm.nih.gov/compound/19589879.)
Claims 11-13 of the instant application are interpreted as an OTUD7A catalytic inhibitor that is the 7Ai compound having the following structure:
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wherein said compound limits the growth of Ewing sarcoma in vivo by degrading EWS-FLI1.
CID19589879 is N-[1-(2,6-dichlorobenzyl)-1H-pyrazol-4-yl]-5,7-bis(1-methyl-1H-pyrazol-5-yl)pyrazolo[1,5-a]pyrimidine-2-carboxamide having the following structure:
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.
Thus, CID19589879 is the same 7Ai compound as claimed in claims 11-13 of the instant application.
It is noted that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPTQ2d 1161, 1165 (Fed. Cir. 1999).
Thus, CID19589879 of the prior art is inherently an OTUD7A catalytic inhibitor as claimed in the preamble of claims 11-13.
It is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Therefore, since CID19589879 is the same 7Ai compound as claimed having the same structure, the CID19589879 compound is inherently capable of being a catalytic inhibitor that limits the growth of Ewing sarcoma in vivo by degrading EWS-FLI1 as claimed in claim 12 of the instant application.
Where applicant claims a compound in terms of a function, property or characteristic and the compound of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, a rejection under 35 USC 102 is proper. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Thus claims 11-13 of the instant application are rejected.
Conclusion
Claims 1-3, 7-9 and 11-13 are rejected. Claims 14-24 are withdrawn. Claims 4-6, 10 and 25-32 are canceled. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 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, Adam C. Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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