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 .
Election/Restrictions
Applicant’s election without traverse of Group I, and the cancer-cell species of HER2 and Siglec-9 as the lectin, in the reply filed on 21 May 2026 is acknowledged.
Claims 56-57, 62, 70-71, and 73-76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 54-55, 58-61, 63-69, and 72 are examined upon their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The instant application claims is the national stage entry of PCT/US2022/023166 filed 1 April 2022; which claims the benefit of US Provisional Application No. 63/170,297 filed on 2 April 2021.
Claims 54-55, 58-61, 63-69, and 72 have an effective US filing date of 2 April 2021.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on: 28 September 2023; 23 April 2025; 21 May 2026; and 5 June 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
Claims 55 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of 55 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use that flows from that common structure for the following reasons: The grouping of claim 55 is directed to molecules that have no structural similarity like, for examples, Cluster of Differentiation (CD) molecules, and Wilms tumor 1, a gene crucial for gonad and kidney development, which have no common structure with, for example, T cell immunoglobulin.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 54-55, 58-61, 63-69, and 72 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.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. Claim 54 recites two genera: a cancer cell-targeting moiety and a glycan-binding moiety. While depending claims might remedy one, no single claim remedies both. Therefore, claims 55, 58-61, 63-69, and 72 are included in the rejection. The claims do not require that the “moieties” possess any particular structure or other distinguishing feature. Therefore, claims 54-55, 58-61, 63-69, and 72 are drawn to a genus of molecules.
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 MPEP 2163(II)(3)(a)( i)(A), reduction to drawings MPEP 2163(II)(3)(a) (i)(B), 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 MPEP 2163(II)(3)(a) (i)(C). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
In the instant case, the only factor present in the claim is a recitation of requisite activity (“cancer cell-targeting moiety” and “glycan-binding moiety”). There is not even identification of any particular portion of a structure that must be conserved for said activities. Regarding the cancer cell-binding moiety the specification lists many moieties (claim 55) but fails to describe the distinguishing characteristics of the genus as a whole in such a way as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention. Regarding the glycan-binding moiety, the claims recite multiple species within the genus, however, these do not constitute a representative number of species for the genus encompasses as a whole. In other words, a person having ordinary skill in the art could not at once envision what glycan-binding moieties are encompassed by the species because they fail to define those distinguishing characteristic of the genus as a whole. Thus, the claims are drawn to a genus of molecules that is defined merely defined by function, and the instant specification fails to describe the entire genus of molecules that are encompassed by these claims.
Thus, the specification fails to provide adequate description for the genera, as a whole, of moieties encompassed by the claims. Accordingly, in the absence of sufficient recitation of those distinguishing, identifying characteristics that define the genus, or a representative number of species within the genus, the specification does not provide adequate written description of the claimed genus.
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 (see page 1115).
Claims 54-55, 58-61, 63-69, and 72 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 the AbLecs and antibodies described in the table beginning on page 47 (consisting of SEQ ID NOs: 1-96), does not reasonably provide enablement for any other bispecific molecule encompassed by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
With respect to claim breadth, the standard under 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. In addition, when analyzing the scope of enablement, the claims are analyzed with respect to the teachings of the specification and are to be “given their broadest reasonable interpretation consistent with the specification.” See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
As such, the broadest reasonable interpretation of the claimed invention is that it encompasses any bispecific molecule comprising any cancer cell-targeting moiety; and a glycan-binding moiety.
As stated above, the specification teaches specific and discrete antibody-lectin (AbLec) bispecifics described in the table beginning on page 47 (consisting of SEQ ID NOs: 1-96). In contrast, the claims encompass an unlimited array of bispecifics comprising any any cancer cell-targeting moiety and a glycan-binding moiety, even those that have yet to be discovered.
What is enabled by the working examples is narrow in comparison to the breadth of the claims. Specifically, the specification table beginning on page 47 (consisting of SEQ ID NOs: 1-96) teaches specific AbLecs. With respect to the instantly-elected species, HER2 and Siglec-9, it is unclear which specific AbLecs within that table fulfill those requirements, Applicant is encouraged to identify those that bind both Siglec-9 and HER2 if that is what prosecution upon the merits is to proceed on.
However, the standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentech, Inc, v. Novo Nordisk, 42 USPQ 2d 1001, (CAFC 1997), the court held that:
"[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" and that "[t]ossing out the mere germ of an idea does not constitute enabling disclosure". The court further stated that "when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art", "[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement".
The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the claimed method without first making a substantial inventive contribution.
In AMGEN INC. ET AL. v. SANOFI ET AL. (No. 21-757, decided May 18, 2023), the Supreme Court held that Amgen was not enabled for “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors]” (872 F. 3d 1367, 1372) even though Amgen identified the amino acid sequences of 26 antibodies that perform these two functions. The case law applies to the instant claims because the claims encompass a genus of bispecific antibodies that are described solely by functional language (“cancer cell-targeting” and “glycan-binding”), which is even less than describing an antibody according to the antigen to which it binds as in Amgen.
In Amgen, the Supreme Court has stated:
“An antibody’s structure does much to dictate its function—its ability to bind to an antigen and, in some instances, to block other molecules in the body from doing the same. ‘For an antibody to bind to an antigen, the two surfaces have to fit together and contact each other at multiple points.’ Id., at 11. But just because an antibody can bind to an antigen does not mean that it can also block. To bind and block, the antibody must establish a sufficiently broad, strong, and stable bond to the antigen. See ibid. Different antibodies have different binding and blocking capacities based on the amino acids that compose them and their three-dimensional shapes. See id., at 11–12.
Despite recent advances, aspects of antibody science remain unpredictable. For example, scientists understand that changing even one amino acid in the sequence can alter an antibody’s structure and function. See id., at 14. But scientists cannot always accurately predict exactly how trading one amino acid for another will affect an antibody’s structure and function. Ibid.”
Given that structure is essential to function; and given the unpredictability within the art with respect to creating antibodies. A person having ordinary skill in the art would have to perform further experimentation in order to make the vast array of bispecific molecules encompassed by the claims, in order to demonstrate how to make the invention with a reasonable expectation of success. This amount of experimentation goes well-beyond what is considered “a reasonable degree of experimentation” and constitutes undue further experimentation in order to enable the invention commensurate in scope with the breadth of what is claimed.
For all of these reasons, the specification does not enable the claims, and Claims 54-55, 58-61, 63-69, and 72 are rejected under 35 U.S.C. 112(a).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/Examiner, Art Unit 1675
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