DETAILED ACTION Applicants claim amendments filed 8/28/2024 are acknowledged and entered into the record. Accordingly, Claims 1-37 are pending and will be examined on the merits. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 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. Claim s 18-22 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 a method of treating or delaying the progression of pathologies associated with aberrant GPC3 expression or activity , does not reasonably provide enablement for “preventing” such pathologies . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The nature of the invention is such that the composition of the instant claims must have a therapeutic benefit and be able to prevent a disease or disorder in a patient, much like a vaccine. The art teaches that a vaccine must be prophylactic (Stedman's Medical dictionary, 2000, lines 1-3). The specification does not provide any teachings of the prophylaxis of diseases or disorders, how to determine the individuals who will develop a particular disease or disorder, nor how to effectively prevent said particular disease or disorder before occurrence. Thus, one of skill in the art would not be able to use the composition of the invention as a preventing vaccine without undertaking to determine how to select for individuals who will develop a particular disease or disorder before it occurs in the individual. An effective therapeutic protocol for the prevention of a disease or disorder is subject to a number of factors, which enter the picture beyond simply the administration of an IL2Rb binding molecule. Predicting whether an individual is at risk for developing a disease or disorder is a very unpredictable art. Several factors play a role including, genetic makeup, environmental factors, age, diet, etc. For example Apantaku et al. (Breast cancer diagnosis and screening, American Family Physician 2000) reveals that most women with breast cancer have no identifiable risk factors. Although drawn to breast cancer it is relevant to the unpredictability in the art of identifying patients at risk for developing an unpredictable disease or disorder. The reference further teaches that women who have pre-menopausal first-degree relatives with breast cancer have a three- to four fold increased risk of developing breast cancer than women who do not. The risk factor of their having second-degree relatives with breast cancer has not been quantified. The reference further teaches that genetic testing is controversial and raises issues about the reliability of tests and the use made of test results. A woman who tests negative for a particular mutation may still be at risk for developing breast cancer from a sporadic mutation or a preexisting unidentified mutation. False negative results are also possible. The reference then goes on to detail factors that may be involved with increased risk of breast cancer and suggests change of diet may alter personal risk factors. Although one group is identified as being at increased risk, there is no teaching of how or when to begin an intervention protocol. A review of Martin et al (Journal of the National Cancer Institute, Vol.92, No. 14: pp.1126-1135, July 19, 2000) reveals that it is hoped that identification of genetic and environmental factors that contribute to the development of breast cancer will enhance prevention effects. The reference reviews the state of the art of breast cancer genetic components of susceptibility to breast cancer from the standpoint of both human genetics and rat models (see abstract). The reference specifically states that despite numerous studies published to date, the role of modifier genes in breast cancer susceptibility remains to be elucidated. The resolution of ambiguous results will require further carefully designed studies with sufficient sample sizes to detect small effects. The reference concludes that great strides have been made in determining the disease etiology but that further investigation is necessary and that these studies will be crucial to evaluate the importance of new genes involved in breast cancer etiology so that scientists can define better therapies and cancer prevention (p. 1132, col 1) Finally, there is no teaching of how or when to begin an intervention protocol. It is clear from the teachings of this reference that the art of identifying an individual at risk for malignant growth is a developing but as yet undeveloped art. The reference provides no guidance on how to determine which patients are at risk or when to administer treatment in order to inhibit the malignant cell growth for which the individual is at risk. These references clearly point to the undeveloped nature of the art of assessing the probability of developing a disease or disorder and do not teach what interventions would have a reasonable expectation of success nor teach when or how those protocols should be administered. Applicant is invited to amend the claims to recite only method s of treatment or delaying progression to obviate this rejection. Claims 1 -37 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 . MPEP § 2163 states 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, 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. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. “Functional” terminology may be used “when the art has established a correlation between structure and function” but “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing one has invented a genus and not just a species.” Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 598 F3d 1336, 94 USPQ2d 1161, 1171 (Fed Cir. 2010). The instant claims are drawn to a bispecific antibody that specifically binds NKp46 and Glypican 3 (GPC3) comprising a first heavy chain and light chain and a second heavy chain and light chain. The claims recite the phrase “an amino acid sequence of SEQ ID NO:” which read on amino acid fragments and do not require the entire SEQ ID NO recited. The claims therefore read on a number of possible alterations within the CDRs regions that could affect antigen binding. As was well-known in the antibody art, antibodies as a class share an overall structure generally comprising two heavy chain polypeptides that each comprises a heavy chain variable region (VH) and a heavy chain constant region made up of several domain (CH1, hinge, CH2, CH3, and for some antibodies, a CH4). Each of the heavy chains pairs with a light chain polypeptide that comprises a light chain variable region (VL) and a constant region. But while this overall structure is shared amongst antibodies from a wide variety of sources (human, rat, mouse, rabbit), the structure each antibody uses to bind its particular epitope on an antigen is structurally distinct and is formed by a recombination event that results in high variability at the amino acid sequence level. By the time the invention was made, it was well established in the art that the formation of an intact antigen-binding site in an antibody usually required the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three “complementarity determining regions” (“CDRs”) which provide the majority of the contact residues for the binding of the antibody to its target epitope. E.g., Almagro & Fransson, Frontiers in Bioscience 2008; 13:1619-33 (see Section 3 “Antibody Structure and the Antigen Binding Site” and Figure 1). Chimeric antibodies comprise the heavy and light chain variable regions of a rodent antibody linked to human constant regions and preserve the entirety of the VH and VL of the parent antibody. Id. at 1619-20. Humanized antibodies comprise only the CDRs, or in some cases an abbreviated subset of residues within the CDRs, of a parental rodent antibody in the context of human framework sequences. Id. at Section 4. All of the CDRs of the heavy and light chain, in their proper order of CDR1, then 2, then 3, and in the context of framework sequences which maintain their required conformation are generally required to produce a humanized antibody in which the heavy and light chains associate to form an antigen-binding region that binds the same antigen as the parental rodent antibody. Id. at Section 4. Almagro provides a detailed discussion regarding various methods of humanization, including rationale design approaches and empirical approaches based on random screening. Almagro , Sections 4 and 5. Examples of antigen binding domains comprising only a VH (or less commonly, a VL) that in turn comprise only three CDRs certainly do exist in the literature, but those antibodies generally comprise unique structures such as CDR1 and CDR3’s that are elongated in length and that are often disulfide linked. E.g., De Genst et al., Dev Comp Immunol 2006; 30:187-98. “Shuffling” of the VL (or less commonly the VH) had also been used to improve affinity of a parent antibody in certain instances. But the procedure generally required a "dominant" VH (i.e., a VH that is primarily responsible for antigen specificity). E.g., Yoshinaga et al., J. Biochem 2008; 143:593-601. Overall, at the time the invention was made, the level of skill for preparing antibodies and then selecting those antibodies with desired functional properties was high. However, even if a selection procedure was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010); see also Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1876 (Fed. Cir. 2011) (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”) Absent the conserved structure provided by CDRs of a parental antibody in the context of appropriate VH and VL framework sequences, the skilled artisan generally would not be able to visualize or otherwise predict, a priori, what an antibody with a particular set of functional properties would look like structurally. MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The specification does not provide guidance on which amino acid residues within the CDRs can be altered and still retain antigen binding to NKp46 and GPC3 , however the claims as written encompass amino acid fragments that do not require the entire CDR sequence . As noted above, the art generally accepted that the combination of the CDRs were essential for binding specificity. But the specification does not describe what residues within the CDRs confer the binding activity claimed. Accordingly, the skilled artisan would not be able to discern a structure/function correlation for antibodies other than those comprising 100% to the CDRs instantly claimed. Although Applicants may argue that it is possible to screen for antibodies which can bind to serum albumin, however the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. “As we held in Lilly, “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.” Applicant is invited to amend the claims to recite “the amino acid sequence of SEQ ID NO” throughout the claims to obviate this rejection. Conclusion Claims 1-37 are rejected. No claim is allowed. 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