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 .
Applicant’s amendments and remarks filed December 4, 2025 have been received and reviewed. Claims 1, 5-14, 24, 29 and 49 are now pending in this application.
The amendment to the claims filed on December 4, 2025 does not comply with the requirements of 37 CFR 1.121(c) because appropriate underlining are missing in the newly added text of claim 1. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states in relevant part:
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
Since the reply filed on December 4, 2025 appears to be bona fide, THE OFFICE HAS USED ITS DISCRETION TO CONTINUE PROSECUTION. Applicants are still required to submit an amendment in compliance with 37 CFR 1.121.
Claim Rejections - 35 USC § 112
Claims 1, 5-12, 14, 24, 29 and 49 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.
ii) The groups “heteroalkylamino,” “alkylheteroalklyamino,” “diheteroalkylamino,” “heteroalkoxy” and “heteroalkyl” in the definitions of R2 and R3 are still indefinite because it is not known what these heteroatoms are, how many heteroatoms may be present or where they are located. For example, is a -CF3 intended as a heteroalkyl? How about an alkoxy or alkylamino, and the like? A clarification is still required. See also, “heteroalkeny, heteroalkynyl, cycloheteroalkyl and cyclohetroalkenyl. The specification paragraph that Applicants’ point to is directed to mere examples, see “such as, but not limited to, B, N, O and S,” does not say what the maximum number permitted is nor does it say whether groups, such as say, -C(Si)3, is permitted within this definition. The definition in the specification that Applicants rely on is open-ended.
iv) and v) The term “heteroaryl” and “heterocyclic” are indefinite because it is not known how many atoms make up the ring, which atoms are present and what kind of a ring (monocyclic, bicyclic, spiro, fused, bridged, saturated, etc.) is intended. “Heteroaryl” is indefinite because it is not known how many atoms are present, how many and what kind of heteroatoms are involved, what size ring is intended and how many rings are present. Similarly, the lines Applicants refer to is open-ended and lacks the limitations for one skilled in the art to determine the metes and bounds of the claims
vii) The term “substituted” without saying which substituents are intended is indefinite. Applicants need to insert the intended substituents into the claim because the specification does not state which other substituents beyond the examples are intended. One skilled in the art still cannot say which substituents are permitted and which ones are not.
ix) In claims 14 and 29, the N-oxide, hydrate, solvate, tautomer or optical isomer” lack antecedent basis in claim 1 from which it depends. Deletion is required. Contrary to Applicant’s response, claim 14 has not been canceled and no amendment to claim 29 has been done.
xi) Regarding claims 24 and 49, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). This has not been corrected.
xii) The “compound of claim 1 linked to a degrader, or a targeting agent, such as an antibody or small molecule or peptide that binds to a surface receptor to internalize the active ligand” in claims 24 and 49 lacks antecedent basis in the claims from which they depend. There is no such mention in claims 1 and/or 13 that the compound of formula (I) may be further substituted by such. One skilled in the art cannot say what the degrader, targeting agent, small molecule or peptide look like. One skilled in the art cannot say what the product looks like. Arriving at a compound of claim 1 linked to a degrader, or a targeting agent, such as an antibody or small molecule or peptide that binds to a surface receptor to internalize the active ligand requires research. It is improper to require research to understand the metes and bounds of a claim.
xiii) Regarding claims 34 and 49, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 24 and 49 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 claims contain 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.
The claims require “compound of claim 1 linked to a degrader, or a targeting agent, such as an antibody or small molecule or peptide that binds to a surface receptor to internalize the active ligand.” The claims do not require that the compound possess any particular conserved structure, or other distinguishing feature, such as a specific biological activity. Thus, the claims are drawn to a genus of compounds that is defined by novelty.
A chemical compound can be a pharmaceutical composition, a protein, a peptide, a non-peptide compound, an animal tissue extract, nucleic acids, sugars, antisense molecules, peptidomimetic, transformed cells, radiation, antibodies, antibody fragments, cyclic peptides, agonists, antagonists, inhibitors, enhancers, vegetable extracts, cell extracts, synthetic agents, biologically derived substances as well as proteinaceous substances, known, and unknown compounds.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The specification does not identify any particular portion of the structure that must be conserved, nor does it provide a disclosure of structure/function correlation. The distinguishing characteristics of the claimed genus are not described. Accordingly, the specification does not provide adequate written description of the claimed genus.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997) (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”); In re Gosteli, 872 F.2d 1008, 1012 [10 USPQ2d 1614] (Fed. Cir. 1989) (“the 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.
See University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424 (DC WNY 2003) and University of Rochester v. G.D. Searle & Co. et al. CAFC [(03-1304) 13 February 2004]. In University of Rochester v. G.D. Searle & Co. a patent directed to method for inhibiting prostaglandin synthesis in a human host using an unspecified compound, in order to relieve pain without side effect of stomach irritation, did not satisfy written description requirement of 35 U.S.C. §112, since the patent described the compound's desired function of reducing activity of the enzyme PGHS-2 without adversely affecting PGHS-1 enzyme activity, but did not identify said compound, since the invention consists of performing “assays” to screen compounds in order to discover those with the desired effect. The patent did not name even one compound that assays would identify as suitable for practice of the invention, or provide information such that one skilled in art could identify a suitable compound. And since the specification did not indicate that compounds are available in public depository, the claimed treatment method cannot be practiced without the compound. Thus, the inventors cannot be said to have “possessed” the claimed invention without knowing of a compound or method certain to produce said compound. Thus, said patent constituted an invitation to experiment to first identify, then characterize, and then use a therapeutic a class of compound defined only by their desired properties.
According to the MPEP §2163 I. A. “the issue of a lack of adequate written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.” The MPEP states in §2163 II 3 ii) “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.” Applicants have made no assertion that there is any correlation between the biological function of the compound being claimed and its structure.
According to the MPEP §2163.02 Standard for Determining Compliance With the Written Description Requirement,
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed". In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter". Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
This case was filed before Applicants had a clear idea of the structures of their desired compounds, how to make their compounds and how to use them.
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.")".
Therefore, the full breadth of the claim fails to meet the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision.
Allowable Subject Matter
Claim 13 is 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.
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 BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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December 27, 2025
/BRUCK KIFLE/Primary Examiner, Art Unit 1624