DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2 Applicant's amendment, filed on 04/23/2024, is acknowledged.
3. Claims 1, 11, 25, 32, 46, 51, 55, 57, 61, 64, 69, 85, 90, 95, 100, 115, 120, 125, and 131 are pending and under examination.
4. Applicant’s IDS, filed 06/09/2025, 07/31/2025 and 06/01/2026, is acknowledged.
5. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(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.
6. Claims 1, 11, 25, 32, 46, 51, 55, 57, 61, 64, 69, 85, 90, 95, 100, 115, 120, 125, and 131 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 11, 25, 32, 46, 57, 61, 69 and 85 encompass a broad genus of antibodies and genus of antigen binding fragments, CAR, cell engagers, nucleic acids encoding, ADC and composition, comprising up to three amino acids variations in each and every VH-CDR1-3 of SEQ ID NO: 1-3 and 17-19 and VL CDR1-3 of SEQ ID NO: 9-11 and 25-27, without antigen specificity and without specific antibody framework. The claims encompass up to 375,461,660 antibody variants for each antibody. That is the claims encompasses 750,923,320 antibody variants.
Claims 90, 95, 100, 115, 120 and 125 are directed to a genus of anti-CD94/NKG2A antibody without provide the structure of the antibody.
Claim 100 encompasses a genus of second antigen binding domain with unknown target specificity and unknown structure. However, the specification does not fails to provide NK cell engagers comprising a genus of anti-NKG-A antibodies and a genus of unknown second antigen binding domain.
However, there does not appear to be an adequate written description in the specification as-filed of the essential structural feature that provides the recited function of CD94/NKG2A. The Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement make clear that 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, reduction to drawings, 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 genus.
The specification at [0155] discloses that a representative number of binders (e.g., antibodies, antigen binding fragments, and/or antibody domains) having the ability to bind to a CD94/NKG2A polypeptide (e.g., a human CD94/NKG2A polypeptide) are further described in Table 13.
Alternative nomenclature for Clones #1-#2. Alternative names Clone #1 is1B2 and Clone #2 is 1B2-6.
Claims 90, 95, 100, 115, 120 and 125 are directed to a genus of anti-CD94/NKG2A antibody without provide the structure of the antibody.
The USPTO has released a Memo on the Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, 02/22/2018.
See https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf.
The Memo clarifies the applicability of USPTO guidance regarding the written description requirement of 35 U.S.C. § 112(a) concerning the written description requirement for claims drawn to antibodies, including the following.
“In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional”.
In contrast to applicant’s reliance of describes the epitope of the CD94/NKG2A in providing a fully characterized antigen / specific epitope as well as claiming structural elements of the antigen, one or more functions of reducing expression of CD94/NKG2A killing HER2+ cancer cells, and treating a mammal having cancer, there is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed anti- CD94/NKG2A antibodies to demonstrate possession. Also, see Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017).
There is no evidence that knowledge of the chemical structure of an antigen gives the required kind of structure identifying information about the corresponding antibodies Applicants attempt to describe the invention by describing something that is not the invention: viz., the antigens to which the antibodies may bind. There nothing in the disclosure that describes the antibodies as required by the test set forth in Ariad.
However, the anti-CD94/NKG2A antibodies are required to practice the invention. The specification also fails to provide any specific structural or physical information so as to define a genus of antibodies having the desired therapeutic properties. Applicant is merely rely on the identification of CD94/NKG2A as the antigen and the well-known structure of antibodies in general. However, the claims do not recite a general antibody, but an antibody having a specific desired activity. However, Federal Circuit clarification of the law of written description as it applies to antibodies. Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017).
The claims are directed to a genus of anti-CD94/NKG2A antibodies. However, Federal Circuit clarification of the law of written description as it applies to antibodies. The U.S. Court of Appeals for the Federal Circuit (Federal Circuit) decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which concerned adequate written description for claims drawn to antibodies. The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called "newly characterized antigen" test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the "newly characterized antigen" test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.
Moreover, there is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed anti-CD94/NKG2A antibodies to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017). The Court reiterated that adequate written description must “contain enough information about the actual makeup of the claimed products . . . .” The Court simultaneously suggested that the “newly characterized antigen” test “flouts” section 112 because it “allows patentees to claim antibodies by describing something that is not the invention, i.e. the antigen.” The Court concluded that for written description of an antibody to be adequate when presented with “functional” terminology, there must be an established correlation in the art between structure and function.
For instance, citing to Centocor, the Court analogized an antigen and antibody to a lock and a key. For an antigen where there is only a finite number of binding antibodies, discovering those antibodies may be routine and conventional, and description of the antigen alone may be sufficient. By contrast, for antigens with millions of keys, or millions of potentially binding antibodies, description of the antigen and even a couple of examples may be far from sufficient.
Given the claimed broadly class of antibodies and in the absence of sufficient disclosure of relevant identifying characteristics for the broadly claimed class of antibodies to CD94/NKG2A, the patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims
AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014), MPEP 2163.
The specification at best describes plan for making antibodies that bind CD94/NKG2A and then identifying those that satisfy claim limitations, but mere “wish or plan” for obtaining claimed invention is not sufficient. Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011).
Claims 1, 11, 25, 32, 46, 57, 61, 69 and 85 encompass a broad genus of antibodies and genus of antigen binding fragments, CAR, cell engagers, nucleic acids encoding, ADC and composition, comprising up to three amino acids variations in each and every VH-CDR1-3 of SEQ ID NO: 1-3 and 17-19 and VL CDR1-3 of SEQ ID NO: 9-11 and 25-27, without antigen specificity and without specific antibody framework. The claims encompass up to 375,461,660 antibody variants for each antibody. That is the claims encompasses 750,923,320 antibody variants.
Tables 1-12 provides CDRs modification of 1B2 and 1B2-6 antibodies, however those modification is listed in tables 1-12 has not show to retain the binding of the CD94/NKG2A.
The specification provides two anti-CD94/NKG2A antibody, 1B2 and 1B2-6, which were not random combinations of VH and VL i.e., they had specific VH domain (SEQ ID NO: 8 and 24) paired with specific VL domain (SEQ ID NO: 16 and 32, respectively). No other VH/VL domain was provided that mix the CDRH1-3 of SEQ ID NO: 1-3 or SEQ ID NO:17-19, and CDRL1-3of SEQ ID NO: 9-11, and 25-27. The specification discloses only two species within the instant claim scope. The instant application encompasses (but does not exemplify) fragments and CDRs modification up to 3 amino acids (deletion/addition/substitution) to the claimed HCDRs and LCDRs of SEQ ID NOs: 1-3, 9-11, 17-19 and 25-27. There is no teaching identifying what amino acids can be varied within the VH-CDRs and/or VL-CDRs antibody regions and still retain antibody or fragments capable of binding CD94/NKG2A. Brown et al (J. Immuno. 1996 May, 3285-91 at 3290 and Tables 1 and 2) describes how a one amino acid change in the VH CDR2 of a particular antibody was tolerated whereas, the antibody lost binding upon introduction of two amino changes in the same region. Vajdos et al. (J. Mol. Biol. 2002, Jul 5, 320(2):415-28 at 416) teach that amino acid sequence and conformation of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. Aside from the CDRs, the Fv also contains more highly conserved framework segments which connect the CDRs and are mainly involved in supporting the CDR loop conformations, although in some cases, framework residues also contact antigen. The scope of the claims encompasses antibodies with VH or VL that encompass variation (addition, deletion, substitution) in their CDRs. The prior art discloses that 6 CDRs as being essential structure of antibody's binding site, and thus when intact, would provide enough structure to define the antibody's binding site (structure/function correlation) e.g., where amino acid substitutions can be made so as to change (e.g. 6CDR's) or retain (e.g., constant or variable framework) antigen binding. Neither the prior art nor applicant's disclosure defines sufficient representative antibodies and/or sufficient structure/function correlation between modifying the VLCDRs or VHCDRs regions of the disclosed antibody and the retention of a specific binding antibody that binds the CD94/NKG2A to satisfy the WD requirement for the claims.
It is unlikely that antibodies or fragments thereof as defined by the claims which may contain less than the full complement of CDRs from the heavy and light chain variable regions of the 1B2 and 1B2-6 antibody fused to framework sequence, have the required binding function. The specification provides no direction or guidance regarding how to produce monoclonal antibodies as broadly defined by the claims. Undue experimentation would be required to produce the invention commensurate with the scope of the claims from the written disclosure alone.
With respect to the recitation an antibody which does not comprise all 6 CDRs of the antibody 1B2 and 1B2-6, the Examiner directs Applicant's attention to the training material given by Bennett Celsa, Example 2: (Ab genus: modified CDR's) slides 34-40. Example 2 of the Training material ((https://www.aipla.org/docs/default-source/committee-documents/bcp-files/2020/uspto-bcp-antibody-slides-final.pdf?sfvrsn=b377f2cc_0) which requires that the claims explicitly recite the binding antigen in addition to all 6 CDR regions for fulfillment of the written description requirements under § 112, 1. Slide 39 indicates that a claim encompasses antibodies with 6 intact CDRs as well as a subgenus of antibodies that encompass up to 10% variation (fragments and/or analogs) in the 6 CDRs lacks written description. Slide 40 provide the conclusion that, a single antibody species would not be deemed by one of skill in the art to be representative of a claim that defines an antibody that binds antigen X comprising at least 90% homology to the 6 CDR of the VH and VL chains.
Regarding the amino acid substations in variable region, one skilled in the art have recognized challenge and trade-offs once it is applied in antibody. Rabia et al (Biochem Eng J. 2018 September 15; 137: 365-374) states that optimize antibody properties (affinity, specificity, stability, solubility and effector functions) with amino acid substitutions is challenge and is always trade-offs and states that an outstanding challenge in the field is that optimizing properties such as antibody affinity can lead to defects in other properties such as antibody stability, specificity and solubility. The resulting trade-offs between improvements in some antibody properties and reductions in others highlight that they are often interdependent and cannot be easily separated (introduction). Rabia et al further state given that the maximal chemical diversity of antibody CDRs is unimaginably large (>1078 antibody variants based on 20 different amino acids at ~60 sites in the CDRs), it is extremely challenging to define the sequence determinants of antibody specificity (para 2).
Brown et al (J. Immuno. 1996 May, 3285-91 at 3290 and Tables 1 and 2) describes how a one amino acid change in the VH CDR2 of a particular antibody was tolerated whereas, the antibody lost binding upon introduction of two amino changes in the same region.
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.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
Applicant is invited to point to clear support or specific examples of the claimed invention in the specification as-filed.
7. Claims 1, 11, 25, 32, 46, 51, 55, 57, 61, 64, 69, 85, 90, 95, 100, 115, 120, 125, and 131 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 anti-CD94/NKG2A antibodies or antigen binding fragments, CAR, cell engagers, nucleic acids encoding, ADC and composition comprising VH-CDR1-3 of SEQ ID NO: 1-3 and 17-19 and VL CDR1-3 of SEQ ID NO: 9-11 and 25-27, does not reasonably provide enablement for the claimed antibodies recited in 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 use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
Claims 1, 11, 25, 32, 46, 57, 61, 69 and 85 encompass a broad genus of antibodies and genus of antigen binding fragments, CAR, cell engagers, nucleic acids encoding, ADC and composition, comprising up to three amino acids variations in each and every VH-CDR1-3 of SEQ ID NO: 1-3 and 17-19 and VL CDR1-3 of SEQ ID NO: 9-11 and 25-27, without antigen specificity and without specific antibody framework. The claims encompass up to 375,461,660 antibody variants for each antibody. That is the claims encompasses 750,923,320 antibody variants.
Claims 90, 95, 100, 115, 120 and 125 are directed to a genus of anti-CD94/NKG2A antibody without providing the structure of the antibody.
Claims 100, 115, 120 and 125 encompasses a genus of second antigen binding domain with unknown target specificity and unknown structure.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The claims are directed to a broad class of antibodies was that the class was defined by its function—the ability to bind to CD94/NKG2A and treat treating a mammal having cancer, killing HER+ and reducing expression of CD94/NKG2A. However, the specification did not give the skilled in the art enough information to choose candidate antibodies from the 750,923,320 of options and therefore required scientists to engage in a great deal of experimentation and failure. “That is not enablement”—it is a “hunting license.”
The specification discloses only two species of anti-CD94/NKG2A antibodies, 1B2 and 1B2-6 antibody; while the claims are directed to a genus of 750,923,320 anti-CD94/NKG2A antibodies.
In Sanofi-Aventisub, the Federal Circuit relied on its prior precedential opinions when determining whether the full scope of a genus was enabled. These decisions included McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091 (Fed. Cir. 2020) (hereafter McRO); Wyeth & Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380 (Fed. Cir. 2013) (hereafter Wyeth); Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340 (Fed. Cir. 2019) (hereafter Enzo); and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149 (Fed. Cir. 2019) (hereafter Idenix).
The Federal Circuit, citing McRO, provided guidance on the application of enablement to genus claims, holding that “[a]lthough a specification does not need to describe how to make and use every possible variant of the claimed invention, when a range is claimed, there must be reasonable enablement of the scope of the range.” Sanofi-Aventisub, 987 F.3d at 1085 (internal quotations omitted). Additionally, the Federal Circuit characterized Wyeth as holding “that due to the large number of possible candidates within the scope of the claims and the specification's corresponding lack of structural guidance, it would have required undue experimentation to synthesize and screen each candidate to determine which compounds in the claimed class exhibited the claimed functionality.” Id. at 1086. Similarly, the Federal Circuit characterized Enzo as holding “that the specification failed to teach one of skill in the art whether the many embodiments of the broad claims would exhibit that required functionality.” Id. Finally, the Federal Circuit characterized Idenix as affirming “the district court's determination that the claims had both structural and functional limitations, and that undue experimentation would have been required to synthesize and screen the billions of possible compounds because, given a lack of guidance across that full scope, finding functional compounds would be akin to finding a `needle in a haystack.' ” Id.
This case is akin to the issue in Sanofi-Aventisub, the court relied on evidence showing that the scope of the claims encompassed millions of antibodies and that it was necessary to screen each candidate antibody in order to determine whether it met the functional limitations of the claim. Id. at 1088. Consequently, the Federal Circuit concluded that there was a lack of enablement. While the specification in Amgen identified 26 exemplary antibodies that performed the claimed function by their amino acid sequences, the claims at issue were directed to a class that included “a `vast' number of additional antibodies” that Amgen had not described by their amino acid sequences. Id. at 1256. The Supreme Court found that Amgen sought to monopolize an entire class of antibodies by their function, which was much broader than the 26 exemplary antibodies disclosed by their amino acid structure. In the instant case, the specification discloses only two species that performed the claimed function by their amino acid sequences, with the claimed genus of 750,923,320 different anti-CD94/NKG2A antibodies. The instant claims are directed to a class of anti-CD94/NKG2A antibodies that included “a `vast' number of additional antibodies” that the instant specification fails to describe their amino acid sequences.
The scope of the instant claims encompassed 750,923,320 of antibodies and that it was necessary to first generate and then screen each candidate to determine whether it met the functional limitations. The Federal Circuit concluded that there was a lack of enablement, which was affirmed by the Supreme Court in Amgen.
The claims simply direct skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the two antibodies they elected to disclose and that “[u]nder Amgen, such random trial-and-error discovery, without more, constitutes unreasonable experimentation that falls outside the bounds required by § 112(a).” Id. at *8, *10.
Amgen attempted to claim an entire class of compounds by their function, namely antibodies that bind to the “sweet spot” of PCSK9 thereby inhibiting it from binding to LDL, while only describing 26 amino acid sequences in its specification. The two processes, the “roadmap” and “conservative substitution” did not save Amgen. According to the Court, these amounted to “little more than two research assignments” which forced scientists to conduct “painstaking experimentation” to see what worked. (citing Incandescent Lamp). The Court therefore held that Amgen’s specification did not enable the claims.
Given that Claim 100 encompasses a genus of second antigen binding domain with unknown target specificity and unknown structure. However, the specification does not fail to provide NK cell engagers comprising a genus of anti-NKG-A antibodies and a genus of unknown second antigen binding domain. Accordingly, claims 115, 120 and 125 the specification is not enabled for a method for binding a molecule to a CD94/NKG2A polypeptide on the surface of an NK cell or a T cell without inhibiting the cytotoxic activity of said NK cell or said T cell, or a method for reducing express of CD94/NKG2A polypeptides on the surface of a NK cell or a T cell, comprises contacting said NK cell or said T cell with a cell engager of a cell engager comprising a first antigen binding domain comprises the ability to bind to a CD94/NKG2A. An in vitro method for killing HER2+ cancer cells, wherein said method comprises contacting immune cells positive for CD94/NKG2A polypeptides with (a) a cell engager comprising a first antigen binding domain comprises the ability to bind to a CD94/NKG2A and (b) an anti-HER2 antibody
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
8. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
9. Claims 90 and 95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20090208416 A1.
Composition comprising: a. an effective amount of a monoclonal antibody or a fragment thereof that: i. specifically binds to NKG2A; ii. does not specifically binding to an Fc receptor; and ii. when bound to NKG2A on a human NK cell, causes said NK cell to lyse a target human cell bearing HLA-E or Qa1b on the target cell surface when said target cell comes into contact with said NK cell; and b. a pharmaceutically acceptable carrier or excipient (see published claims 59, 63, and 74)
The reference teachings anticipate the claimed invention
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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September 30, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
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