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 .
DETAILED ACTION
Status of the Claims
1. Claims 1-22 are the original claims filed 1/14/2022. In the Preliminary Amendment of 9/26/2023, Claims 1-22 are canceled and new Claims 23-38 are added. In the second Preliminary Amendment of 10/3/2023, new Claims 39-40 are added. In the Reply of 9/4/2024, Claims 23-39 are canceled and new Claims 41-55 are added. Claims 40-55 are all the claims. In the Response of 1/27/2025, Claims 40-54 are canceled, Claim 55 is amended and new Claims 56-57 are added. Claims 55-57 are the pending claims.
The finality of the Office Action of 2/24/2025 is withdrawn. This Office Action contains new grounds for rejection.
Priority
2. USAN 17/576,109, filed 01/14/2022, is a Divisional of 17/107,334, filed 11/30/2020, now abandoned, 17/107,334 is a Divisional of 15/953,201, filed 04/13/2018, now U.S. Patent # 10851164, claims foreign priority to NL 2018708, filed 04/13/2017, claims foreign priority to NL 2019166, filed 07/03/2017.
Rejections Maintained
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.
Written Description
3. The rejection of Claims 55-57 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 is maintained.
Claim construction/ interpretation
Claim 55 is drawn to a composition comprising (a) any means that binds human SIRPαV1 protein having the sequence of SEQ ID NO: 34 with an EC50<1 nM and does not cross-react with SIRPα1 protein having the sequence of SEQ ID NO: 38.
Claim 56 is drawn to the composition of Claim 55 that requires the use of the CELISA assay based on CHO-K1 cells expressing human SIRPalpha V1 protein in order to determine the EC50 value for the means.
Claim 57 is drawn to the composition of Claim 56 that requires the use of the CELISA assay based on CHO-K1 cells expressing human SIRPbeta 1 protein in order to determine that the means does not cross-react with SIRPbeta 1 protein.
A) Applicants interpretation is seemingly that the single ARP discussion of 5/21/2024 for Chamberlain is controlling for a universal two-step process of construing means-plus-function claim language.
Response to Arguments
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation(s) is/are: “a means for binding human SIRPaV1 protein” in claim 55 falling within a composition and absent any structure/function correlation.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Excerpted parts from the Memorandum from March 18, 2024 for Examining Means-Plus-Function and Step-Plus-Function Claim Limitations (35 U.S.C. 112(f)) (PTO 892):
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The Appeals Review Panel in Chamberlain upheld the PTAB's rejection of Claim 9 for lack of written description support based on the preamble language "treating a patient" for the only two anti-C5, Fc-modified antibodies disclosed in the Chamberlain application, and that were NOT shown to possess that functional capacity.
The ARP addressed pending claim 9 of U.S. Patent Application No. 16/803,690 (the “’690 application”). The claim relates to use of anti-C5 antibodies with a modified Fc domain. The Applicant drafted the claim 9 in the means-plus-function claim format:
9. A method of treating a patient by administering an anti-C5 antibody comprising: a) means for binding human C5 protein; and b) an Fc domain comprising amino acid substitution M428L/N434S as compared to a human Fc polypeptide, wherein numbering is according to the EU index of Kabat, wherein said anti-C5 antibody with said amino acid substitution has increased in vivo half-life as compared to said antibody without said substitutions.
Here is the case that generic claim 55 requires the “means” to bind human SIRPαV1 protein having the sequence of SEQ ID NO: 34 with an EC50<1 nM and does not cross-react with SIRPα1 protein having the sequence of SEQ ID NO: 38, where each of claims 56 and 57 defines the assays used to determine the EC50 value for the means and the cross-reactivity with SIRPbeta 1 protein for the means, respectively.
“means”: the specification does NOT define per se the meaning of the term “means” nor does it use the term in the context of a composition as instant claimed. The use of the term “means” is limited to reagents used in diagnostic or detection kits for signal generation taught at
[0712] Also provided are diagnostic or detection reagents and kits comprising one or more such reagents for use in a variety of detection assays, including for example, immunoassays such as ELISA (sandwich-type or competitive format). The kit's components may be pre-attached to a solid support, or may be applied to the surface of a solid support when the kit is used. In some embodiments of the invention, the signal generating means may come pre-associated with an antibody or fragment of the invention or may require combination with one or more components, e.g., buffers, antibody-enzyme conjugates, enzyme substrates, or the like, prior to use. Kits may also include additional reagents, e.g., blocking reagents for reducing nonspecific binding to the solid phase surface, washing reagents, enzyme substrates, and the like. The solid phase surface may be in the form of a tube, a bead, a microtiter plate, a microsphere, or other materials suitable for immobilizing proteins, peptides, or polypeptides. In particular aspects, an enzyme that catalyzes the formation of a chemilluminescent or chromogenic product or the reduction of a chemilluminescent or chromogenic substrate is a component of the signal generating means. Such enzymes are well known in the art. Kits may comprise any of the capture agents and detection reagents described herein. Optionally the kit may also comprise instructions for carrying out the methods of the invention.
The use of the term “means” is limited to containers used in diagnostic or detection kits for signal generation taught at
[0716] The therapeutic and detection kits disclosed herein may also be prepared that comprise at least one of the antibody, peptide, antigen-binding fragment, or polynucleotide disclosed herein and instructions for using the composition as a detection reagent or therapeutic agent. Containers for use in such kits may typically comprise at least one vial, test tube, flask, bottle, syringe or other suitable container, into which one or more of the detection and/or therapeutic composition(s) may be placed, and preferably suitably aliquoted. Where a second therapeutic agent is also provided, the kit may also contain a second distinct container into which this second detection and/or therapeutic composition may be placed. Alternatively, a plurality of compounds may be prepared in a single pharmaceutical composition, and may be packaged in a single container means, such as a vial, flask, syringe, bottle, or other suitable single container. The kits disclosed herein will also typically include a means for containing the vial(s) in close confinement for commercial sale, such as, e.g., injection or blow-molded plastic containers into which the desired vial(s) are retained. Where a radiolabel, chromogenic, fluorigenic, or other type of detectable label or detecting means is included within the kit, the labeling agent may be provided either in the same container as the detection or therapeutic composition itself, or may alternatively be placed in a second distinct container means into which this second composition may be placed and suitably aliquoted. Alternatively, the detection reagent and the label may be prepared in a single container means, and in most cases, the kit will also typically include a means for containing the vial(s) in close confinement for commercial sale and/or convenient packaging and delivery.
“equivalents”: the specification does NOT define the meaning of the term “equivalent”. The specification teaches two antibodies hSIRPa.40A and hSIRPa.50A corresponding to a structure/function for “a means for binding human SIRPaV1 protein having the sequence of SEQ ID NO: 34 with an EC50<1 nM, and not cross-reacting with SIRPB1 protein having the sequence of SEQ ID NO: 3.” The specification does not identify equivalents of the antibodies or other generic “means” in the context of SIRPαV1 protein and SIRPbeta 1 protein with respect to binding.
Equivalent of a SIRPαV1 binder- Burgess et al. (PTO 892) teaches examples of SIRPα binders that comprise decoy SIRPα receptors and small molecules, and Hazama et al (PTO 892) teaches macrocyclic peptides that target SIRPalpha /CD47 signaling axis as immunotherapeutic agents. None of these generic or specific examples as means or equivalents are contemplated in the application as filed.
The specification provides no guidance as to what structure having a function that meets the instant claimed requirements corresponds to the meaning of an equivalent under the definition of 112(f).
B) Applicants allege the present specification discloses structures corresponding to the claimed means having the recited function, namely, the clones hSIRPalpha.40A and hSIRPalpha.50A.
Response to Arguments
The truth of the matter is acknowledged, namely, that the specification discloses all of two examples that meet the structure function requirements, namely, the clones hSIRPalpha.40A and hSIRPalpha.50A.
C) Applicants allege and the specification need not disclose or describe the equivalents of the corresponding structure in order to satisfy the written description requirement where “adequate corresponding structure to the claimed means has been identified.” The means plus function claims “are statutorily guaranteed a range of equivalents extending beyond that which is explicitly disclosed in the patent document itself citing McGinley v. Franklin Sports, Inc.”
Response to Arguments
Both the Courts and the MPEP elucidate the balance that must be achieved between predictability for and possession of a claimed invention. MPEP 2163 II(A)(3)(a)(ii) stating in part:
Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are “representative of the full variety or scope of the genus,” or by the establishment of “a reasonable structure-function correlation.” Such correlations may be established “by the inventor as described in the specification,” or they may be “known in the art at the time of the filing date.” See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Here is the case where the unpredictability of antibody variants is discussed and analyzed in the prosecution history. See section E) below where Applicants response is incomplete.
The decision from McGinley v. Franklin Sports, Inc. does not apply to a biological moiety, a small molecule drug, or decoy receptors and much less that for antibodies, where it is established on the record, that form and function are unpredictable. The McGinley case pertains to a patent infringement suit involving a baseball patent (U.S. Patent No. 5,407,193). The Court ruled in favor of McGinley on infringement but later set aside the jury’s verdict on validity, concluding the patent was invalid for obviousness. The case does not address the validity of a biological or antibody means which are a different legal and scientific scope and context.
D) Applicants allege an improper written description analysis for the means-plus-function claim is incomplete and that is mandated by 35 USC 112(f)/ 35 USC 112, 6th paragraph.
Response to Arguments
The written description requirement is not exempt from means-plus-function claims. According to the USPTO’s guidelines, means-plus-function claim limitations must be interpreted to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. This means that if the specification does not provide sufficient corresponding structure, materials or acts that perform the entire claimed function, the claim is lacking in adequate written description. MPEP 2181(IV)
The Federal Circuit has recognized the problem of providing a sufficient disclosure for functional claiming, particularly with generic claim language, explaining that “The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant [inventor] has made a generic invention that achieves the claimed result and do so by showing that the applicant [inventor] has invented species sufficient to support a claim to the functionally-defined genus.” Ariad Pharmaceuticals Inc. v. Eli & Lilly Co., 598 F.3d 1336, 1349, 94 USPQ2d 1161, 1171 (Fed. Cir. 2010) (en banc).
E) Applicants have not responded to the outstanding grounds for rejection set forth in the OA (10/16/2024) and excerpted below for convenience and record history. Applicants response is incomplete.
“Structural limitations for an amino acid sequence of the binding means, including VH (or VHH) CDR1-3 domains and/or VL CDR1-3 domains, are not recited in any of the rejected claims. In summary, the claims recite only functional features absent even minimal structural features or partial structural features.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through establishment of a structure-function correlation (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) or through a sufficient description of a representative number of species. Either is considered sufficient to show the applicant was in possession of the claimed genus.
Regarding structure-function correlation, it is noted that one of skill in the art was aware that there is a lack of structure-function correlation in antibody molecules. Evidence of such in the form of publications in the art include the following.
The prior art also recognizes that a single protein can be bound by a very large and structurally diverse genus of antibodies (i.e., there is no common structural relationship even for antibodies that bind to the same protein, epitope, or overlapping epitopes). For example, Edwards et al. (2003, JMB 334:103-118) teach that over 1,000 different antibodies to a single protein can be generated, all with different sequences, and representative of almost the entire extensive heavy and light chain germline repertoire (42/49 functional heavy chain germlines and 33 of 70 V-lambda and V-kappa light chain germlines), and with extensive diversity in the HCDR3 region sequences (that are generated by VDJ germline segment recombination) as well.
Goel et al. (2004, J. Immunol. 173: 7358-7367) teach that three mAbs that bind to the same short (12-mer) peptide, exhibit diverse V gene usage, indicating their independent germline origin. Said reference further teaches that two of these mAbs recognize the same set of amino acid residues defining the epitope (alternate amino acid residues spread over the entire sequence), however, the relative contribution of each set of residues in the peptide showed significant variation. The reference notes that all of the mAbs do not show any kind of V gene restriction among themselves, implying variable paratope structure, despite that two of these mAbs bind to the peptide through a common set of residues. (See entire reference).
Khan et al. (2014, J. Immunol. 192: 5398-5405) teach that two structurally diverse germline mAbs recognizing overlapping epitopes of the same short peptide do so in different topologies, the antibodies possessing entirely different CDR sequences. Said reference teaches that unrelated mAbs structurally adjust to recognize an antigen, indicating that the primary B cell response is composed of BCRs having a high degree of structural adaptability. Said reference also teaches that the common epitope(s) also adopt distinct conformations when bound to different mAbs, with the higher degree of structural plasticity inherent to the mAbs. Said reference further teaches “It has been shown that both the framework region and the CDRs have a considerable amount of inherent conformational plasticity...Therefore, it is not surprising that distinct germline Abs recognize the same epitope by rearranging the CDR conformations. This may well have implications of Ag specificity beyond the naive BCR repertoire, because Kaji et al... .have shown in a recent report that the B cell memory can contain both germline-encoded and somatically mutated BCRs.” (See entire reference).
Poosarla et al. (2017, Biotechn. Bioeng. 114(6): 1331 -1342) teach substantial diversity in designed mAbs (sharing less than 75% sequence similarity to all existing natural antibody sequences) that bind to the same 12-mer peptide, binding to different epitopes on the same peptide. Said reference further teaches “most B-cell epitopes... in nature consist of residues from different regions of the sequence and are discontinuous...de novo antibody designs against discontinuous epitopes present additional challenges...". (See entire reference.)
The combination of evidentiary publications thus underscores a lack of structure-function correlation in antibody molecules.
Regarding a representative number of species, the instant specification fails to describe a representative number of species to provide adequate written description of the claimed genus as per MPEP § 2163.
Disclosure in the Specification
“disrupting SIRPα-CD47 signaling”: [00612]
Applicant’s specification fully discloses antibody clones comprising VH CDR1-3 of SEQ ID NOS: 69, 70 and 71 or SEQ ID NOS: 1, 2 and 3; VL CDR1-3 of SEQ ID NOS: 72, 73 and 74 or SEQ ID NOS: 4, 5 and 6; and humanized VH and VL domains set forth in Example 27.
Are the disclosed species representative of the claimed genus?
It is asserted that the disclosed species are not representative of the claimed genus because the claims encompass all conservative amino acid substitutions in all of the claimed CDRs of the parent CDRs. The genus of all possible anti-human SIRPα antibodies encompassed by the claimed CDR variation would be structurally distinct but unpredictable whether the structure/function correlation was met for binding to human SIRPα. Yet the specification does not identify which CDRs, which combination of fewer than all six CDRs, or which subset of residues in the combination of CDRs is essential for the recited function of binding human SIRPα. Neither the specification nor the prior art provides guidance as to what structural changes can be made to the parent sequences and still predictably arrive at an antibody that binds human SIRPα. The disclosed species therefore do not represent the claimed genus.
Has Applicant provided a common structure sufficient to visualize the genus?
Applicant has not provided a common structure sufficient to visualize the genus of all possible functional variants.
While the prior art contains disclosure as to the structural features of several anti- SIRPα antibodies, it is unclear what structural features these antibodies need to share in order to maintain binding affinity and stability.
Applicants specification does not place them in possession for the full breadth and scope of the genus claim. The specification teaches epitope mapping methodologies common to the art, see [0615], general disclosures for antibodies binding “the same epitope” as the inventive antibodies, see [0553, 1032; 1176], and mapping studies in Example 25. The specification does not demonstrate a single example of a competitive or cross-competitive antibody that binds to the same epitope as for the complete list of VH/VL domains of Claim 38.
While one may be able to assay whether an antibody “competes” with the recited monoclonal antibody, it is apparent that the degree to which an antibody competes with another antibody is a relative or subjective expression, and the requisite degree to which the claimed antibody competes with a monoclonal antibodies cannot be ascertained from the disclosure.
Contrary to the assertion in the specification that such a binding assay determines whether two antibodies bind to the same antigenic determinant (i.e., epitope), competing antibodies do not necessarily bind the same epitopes. For example, “competing” antibodies may bind spatially overlapping but discrete epitopes. Simply because two antibodies cannot simultaneously occupy the same space, such an antibody, once bound to the antigen, sterically hinders or blocks binding of another such antibody. As another example, a “competing” antibody might not necessarily bind to the same epitope of an antigen as another antibody, if one of the antibodies induces conformational shifts in the three-dimensional structure of the antigen upon binding, which prevents binding of the other antibody to the antigen because the epitope to which it would otherwise bind is unrecognizable as a consequence of the structural change.
In addition, it is recognized that the degree of binding of an antibody, which is observed in the exemplified competitive binding assay, will depend upon the concentration of the detectably labeled antibody and the unlabeled competing antibody. Typically, the higher the concentration of the unlabeled competitor, the lower the percentage of binding of the labeled antibody. So, at high concentrations, any antibody might be deemed capable of “competing” for binding to an antigen with any other antibody, regardless of whether or not the different antibodies bind to the same, or even overlapping epitopes.
George et al. (Circulation. 1998; 97: 900-906), for example, describes different antibodies, which do not bind to the same epitope of an antigen, but are nevertheless capable of competing with one another for binding to the antigen; see entire document (e.g., page 903, paragraph bridging columns 1 and 2). More particularly, George et al. describes three antibodies, which bind decidedly different, non-cross-reactive epitopes on b2GPI; yet, George et al. teaches each is able to “compete” by a measurable extent with any of the others for binding to the antigen (page 903, paragraph bridging columns 1 and 2). For example, George et al. teaches monoclonal antibody ILA-4 competed with itself for binding to the antigen (% inhibition = 90 ± 11%), but George et al. discloses, despite its binding a non-overlapping epitope, monoclonal antibody ILA-1 also “competed”, albeit with monoclonal antibody ILA-4 for binding to the antigen (% inhibition = 9 ± 4%).
Accordingly, George et al. illustrates the capricious and arbitrary nature of determinations that different antibodies bind to the same or different epitopes, which are based upon the results of competitive binding assays, such as the assays exemplified in the specification.”
The rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
4. The rejection of Claims 55-57 on the ground of nonstatutory double patenting as being unpatentable over claims 15-16 in view of Claim 1 of U.S. Patent No. 10851164 is maintained.
Applicants allege the instant claims 55-57 correspond to non-elected Group VI consisting of original claims 26-28 in parent application 15/953,201 (See Office Action of 10/3/2019). Applicants allege the claims of elected Group I in parent application 15/953,201 (U.S. Patent No. 10851164; ‘164) are entitled to safe harbor under 35 USC 121 because of a divisional status.
Response to Arguments
Elected Group I in ‘164 included claim 4 (claim set 4/13/2018) drawn to species that read on the instant claims.
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In the claim set of 2/21/2020, claim 4 is not amended or canceled and claims 26-28 (Group VI) are canceled.
In the claim set of 6/23/2020, claim 1 is amended and claim 4 is canceled.
In the claim set of 9/30/2020, claim 1 is amended to incorporate subject matter from canceled claim 4 or canceled claim 26:
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Here is the case that thru the course of prosecution in the reference application/patent, the amendment of claim 1 advances the subject matter towards non-elected Group VI
The reference antibody clones are hSIRPa.40A and hSIRPa.50A in ref Claim 1, i.e., clone 40A VH/VL CDR1-3 of SEQ ID NOS: 69-75 and clone 50A VH/VL CDR1-3 of SEQ ID NOS: 1-6. The reference antibody clones bind the SIRPalphaV1 protein with an EC50 <1 nM. The functional attributes of the clones as determined by CELISA assay using SIRPalpha V1 and SIRPbeta 1 proteins to determine EC50 and binding, respectively, is inherent to the clones. Under MPEP 804, The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) (“[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.”).
The patent reference is effective prior art because it anticipates and/or renders obvious the generic “means” of the instant claims.
New Grounds for Rejection
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.
Written Description
5. Claims 55-57 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 55-57 are drawn to a means for binding human SIRPα having the sequence of SEQ ID NO: 34 and an EC50 <1 nM. Not only is the range for EC50 infinite in scope, it reads on the “means” having unlimited super potency. Still further the EC50 serves as a proxy for the potency of the “means” that stimulates a response, where here is the case that the response is not defined.
Accordingly, where any one of the claims recites or encompasses the limitation to the upper range for an EC50 (or a KD or a IC50), Applicants are expected to have demonstrated a reasonable number of working embodiments falling within the claimed ranges. The examiner's search of the specification for each of the limitations does not identify actual support for a “means” falling within the range limitation. (MPEP 706.03(m) states in part "New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 to § 608.04(c). See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.").”
Conclusion
6. No claims are allowed.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643