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 .
Status of the Claims
Claims 1, 3-6, 12, 23-25, 28-33, 47, and 49 are currently pending and are subject to this Office Action.
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and
have been made of record.
Withdrawn Objections and Rejections
In view of Applicant’s claim amendments, the following objections and rejections are hereby withdrawn: Specification Objection; Drawings Objection; Claims Objections; Claim Rejections under 35 U.S.C. 112(a); and Claim Rejections under 35 U.S.C. 112(b).
New Claim Rejections, Necessitated by Amendment - 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.
Claims 1, 3-6, 12, 23-25, 28-33, 47, and 49 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
The specification does not provide sufficient support for the vast genus of structurally diverse antibodies encompassed by the instant claims. While the instant specification discloses two representative anti-PLA2G2D antibodies, “Ab1” and “Ab2”, which are capable of blocking PLA2G2D binding to T cells (see Example 6 and FIGs 12A-12C), it is unclear from the teachings of the instant specification how knowing this would put the skilled artisan in possession of the vast genus of antibodies encompassed in the instant claims. Furthermore, the sequences of Ab1 and Ab2 are not disclosed, and even if they were, the skilled artisan would not consider description of a single antibody or even a number of antibodies (e.g., the specific sequences of Ab1 and Ab2)), to be representative of the vast and unknowably large structural diversity encompassed in the instant claims, i.e., anti-PLA2G2D antibodies specifically capable of blocking PLA2G2D binding to (activated) T cells (as set forth in instant claims 1, 49), decreasing enzymatic activity level of PLA2G2D (as set forth in instant claim 4), blocking a (non)catalytic site on PLA2G2D (as set forth in instant claims 5, 47), and targeting the H67 catalytic site on human PLA2G2D according to SEQ ID NOs: 1 or 5 (as set forth in instant claim 6).
Generic claims drawn to substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone (e.g., anti-PLA2G2D antibodies specifically capable of blocking PLA2G2D binding to T cells), which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. See Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
Furthermore, it means little to invent a method if one does not have possession of the compound(s) that is (are) essential to practice the method. Without possession of the compound(s), the claimed endpoints are illusory and there is no meaningful possession of the method. See Ariad Pharms. Co. v. Eli Lilly & Co., 94 U.S.P.Q.2d 1161, 1172 (Fed. Cir. 2010) (en banc), if claims merely recite a "description of the problem to be solved while claiming all solutions to it" and "cover any compound later actually invented and determined to fall within the claim’s functional boundaries," they have not met the description requirement. See Ariad at 1172.
In the Federal Circuit decision, University of Rochester v. GD Searle & Co., Inc., 249 F. Supp. 2d 216 (W.D.N.Y. 2003), the patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described."
Therefore, claiming a method comprising the administration of agents solely with reference to said functional property would not be sufficient to meet the written description requirement when the structures of agents having those properties have not been adequately described. See MPEP § 2163.
Maintained Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-6, 12, 23-25, 28-33, 47, and 49 stand/are rejected under 35 U.S.C. 103 as being unpatentable over Hillman1, as evidenced by Ishizaki2 and Clark3, in view of Miki4, Kim5, and Gazzard6.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section and/or previous office action, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding claims 1, 3-6, 25, 47, and 49, Hillman discloses human phospholipases (HPPL), including Group IID secreted phospholipase A2 (i.e., PLA2G2D), as well as administering antagonists such as antibodies, and more specifically, polyclonal antibodies, directed against these enzymes to treat cancer associated with increased expression of the phospholipase (see Hillman, entire document, e.g., the abstract; p. 1-2; lines 1-5 on p. 5; lines 8-30 on p. 29; Fig. 1, and Table 2; reads on instant claims 1, 3, 25, 28). The disclosures of Hillman further suggest that the antagonist inhibits or attenuates the biological activity of the phospholipase (see Hillman, e.g., at lines 19-23 on p. 7 and lines 5-6 on p. 48; compare id. with instant claims 1, 4-5 and 47), and that the polyclonal antibodies produced are heterogenous in their affinities for multiple HPPL epitopes (see Hillman, e.g., at lines 11-12 of p. 31). Therefore, the polyclonal antibodies disclosed by Hillman, which are taught to be heterogenous in affinity for multiple HPPL epitopes and thus are expected to exhibit multiple functions, would necessarily possess the following functional capabilities set forth in the claims: “wherein the antagonist blocks the binding of PLA2G2D to a T cell… wherein the T cell is an activated T cell”; “wherein the antagonist decreases enzymatic activity of PLA2G2D”; “wherein the antagonist blocks a catalytic site on PLA2G2D”; and “wherein the antagonist blocks a noncatalytic site on PLA2G2D”. While Hillman does not explicitly disclose the sequences set forth in instant SEQ ID NOs: 1 and 5, these naturally occurring PLA2G2D sequences are known in the art, as evidenced by Ishizaki and Clark (as required by instant claim 6), and Hillman further states that the invention encompasses any naturally occurring HPPL and their variants (see Hillman, e.g., at lines 2-9 on p. 19).
Regarding claims 23, Hillman discloses the treatment of cancer including solid tumours such as breast cancer, liver cancer, thyroid cancer etc. with increased expression of the phospholipase (see page 29, lines 9-13; page 28, lines 8-12).
Regarding claim 29, Hillman discloses further administration of a second agent (see Hillman, e.g., at lines 17-23 on p. 29).
The prior art of Hillman differs from the instantly claimed invention as follows: Hillman does not expressly disclose all of the limitations set forth in instant claims 12, 24, 30-33, particularly those regarding treating malignant cancer, antibody conjugation to a second moiety, and the types of second therapeutic agents.
Miki teaches the role of Group IID-secreted phospholipase A2 (sPLA2-IID, i.e., PLA2G2D) in inflammation, cancer, and viral infection, and that this phospholipase is immunosuppressive in both cancer and viral infection (see Miki, entire document, e.g., the abstract and the discussion). More specifically, Miki teaches that sPLA2-IID exacerbates skin cancer by attenuating anti-tumour immunity (see Miki, e.g., at Figure 7; and col. 2 of p. 15592 to col. 1 of p. 15594) and prevents the anti-virus Th1 immune response by directing the anti-inflammatory PGD2-DP1 axis which prevents DC migration and enhances viral infection and lung inflammation (see Miki, e.g., at col. 1 of p. 15589; and col. 2 of p. 15595 to col. 1 of 15596). Miki further teaches that Pla2g2a knockout mice have reduced skin carcinogenesis in a DMBA/TPA-induced model of skin cancer (see Miki, e.g., at Figure 6). Importantly, Miki further suggests that "current studies point to potential prophylactic or therapeutic use of an agent that would specifically stabilize or inhibit sPLA2-llD according to disease contexts" (see Miki at col. 1 of 15597; provides motivation for specifically inhibiting the HPPL, PLA2G2D, for the treatment of both cancer and viral infection).
Kim discloses treating cancer, including malignant cancer, or infectious disease, including viral infections, through methods of stimulating the immune system and additionally administering an immune checkpoint inhibitor such as antibodies directed to PD-1, PD-L1, or CTLA4 (see Kim, entire document, e.g., the claims; para. [0003], [0013], and [0076]; reads on instant claims 24 and 30-33).
Gazzard demonstrates that immunoconjugates, as well as their advantages in cancer treatment and methods of making them, are well known in the art (see Gazzard, entire document, e.g., at para. [0003] to [0007]; reads on instant claim 12).
Obviousness Analysis: In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because methods of treating cancer with antagonists comprising antibodies directed to naturally occurring HPPL, such as PLA2G2D, were known in the prior art, and the teachings of Miki provide motivation for specifically targeting PLA2G2D in both cancer and viral infections (MPEP 2143(I)(G)).
Furthermore, the functional limitations set forth in claims 4-5 and 47 are merely inherent properties of polyclonal antibodies directed to PLA2G2D (MPEP 2112.02(I))7. In the present case, PLA2G2D inhibition, which would reasonably be achieved through administering a PLA2G2D antagonist, would necessarily result in reduced PLA2G2D signaling.
Moreover, a skilled artisan would have been motivated to modify the method of Hillman with teachings of Kim and Gazzard to arrive at the present invention, as it amounts to no more than: combining prior art elements according to known methods to yield predictable results (e.g., further administering a second therapeutic agent, as taught by Hillman, wherein the agent is specifically one of the known immune checkpoint inhibitors used in treating cancer, including malignant cancers, or viral infection, as taught by Kim); and applying a known technique to a known product ready for improvement to yield predictable results (e.g., conjugating the antibody of Hillman to a second moiety, as immunoconjugates are known to have advantageous effects in treating cancer, as taught by Gazzard) (MPEP 2143(I)(A), (D)).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)).
Accordingly, claims 1, 3-6, 12, 23-25, 28-33, 47, and 49 are rejected.
Maintained Rejections - 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.
Copending Application No. 18/293,765 (US20240327540A1)
Claims 1, 3-6, 12, 23-25, 28-33, 47, and 49 stand/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-9, 11, 14-20, 24, 26-27, 32, and 36 of copending Application No. 18/293,765 (reference application; corresponding to US20240327540A1). Although the claims at issue are not identical, they are not patentably distinct from each other as described below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section and/or rejection above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Legal Analysis: MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon both anticipation and obviousness analyses.
Anticipation analysis: Regarding instant claims 1, 4-6, 8, 10, 12, 14, 17-18, 23-25, 28-31, and 47-48, the reference application explicitly claims a method of treating cancer, including solid and/or malignant cancers, or viral infection comprising administering an anti-PLA2G2D antibody or immunoconjugate thereof (see ref. claims 1-2, 4-5, 7-9, 11, 14-19 and 36; compare id. with instant claims 1, 4-6, 12, 23-25) and further administering an immunomodulator (see ref. claims 26-27 and 32; compare id. with instant claims 29-31), wherein the expression level of PLA2G2D is increased at the cancer/infection site (see ref. claims 20 and 24; compare id. with instant claims 25 and 28). Furthermore, similar to the rejections under 35 U.S.C. 103 above, the functional limitations (i.e., “wherein the antagonist blocks the binding of PLA2G2D to a T cell”) are inherent properties. Here, it is the Examiner’s position that under an anticipation analysis, an artisan would at once envisage the claimed method, as the method recited in the reference claims meets all of the instant limitations discussed above.
Obviousness analysis: While the reference application does not explicitly claim the limitations set forth in instant claims 3 and 32-33, these limitations are merely obvious variants of the present invention. The reference specification8 indicates the following: the term “individual” is defined as referring to any mammal, including a human (see reference specification, e.g., at para. [0179]; reads on instant claim 3); and that the particular immune checkpoint inhibitors set forth in instant claims 32-33 (i.e., the species) are obvious variants of immunomodulator (i.e., the genus) (see reference specification, e.g., at para. [0129]; reads on instant claims 32-33). Accordingly, the present claims are directed to obvious variants of the representative claims because it is well-within the ordinary skill in the art to simply substitute one known element for another to obtain predictable results (e.g., “human” for “individual” in reference claim 19; a specific type of immune checkpoint inhibitor for “immunomodulator” in reference claim 27; and one type of PLA2G2D antagonist for another in the reference method) (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP 2143(I)(B)).
Accordingly, the instant claims are not patentably distinct from the reference claims.
Response to Arguments
Applicant's arguments, set forth in p. 6-13 of the Reply, filed 17 October 2025, have been fully considered. Examiner acknowledges the arguments set forth at pages 6 to 15 of the Reply.
Applicant’s arguments, see p. 6-9 of the Reply, with respect to the following have been fully considered, and in view of Applicant’s claim amendments, are hereby withdrawn: Specification Objection; Drawings Objection; Claims Objections; Claim Rejections under 35 U.S.C. 112(a); and Claim Rejections under 35 U.S.C. 112(b).
In response to the Applicant’s request to hold double patenting rejections in abeyance, and after further consideration, the prior examiner’s double patenting rejections on copending Applications No. 18/293,765 have been updated and maintained.
In response to Applicant's argument that “the feature of blocking the binding of PLA2G2D to an immune cell is not an inherent property to a PLA2G2D antagonist”, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Moreover, the MPEP states, "While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board’s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). See MPEP § 2114. In the present case, the antibodies set forth in the claims are defined by function rather than structure; the prior art of Hillman discloses polyclonal antibodies, which would necessarily carry out the functions that are used to define the claimed antibodies. As discussed above, the polyclonal antibodies disclosed by Hillman, which are taught to be heterogenous in affinity for multiple HPPL epitopes and thus are expected to exhibit multiple functions, would necessarily possess the following functional capabilities set forth in the claims: “wherein the antagonist blocks the binding of PLA2G2D to a T cell… wherein the T cell is an activated T cell”; “wherein the antagonist decreases enzymatic activity of PLA2G2D”; “wherein the antagonist blocks a catalytic site on PLA2G2D”; and “wherein the antagonist blocks a noncatalytic site on PLA2G2D”.
Furthermore, in response to applicant's arguments against references individually or less than all references relied upon by the Examiner (see, e.g., p. 9-12 of the Reply), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is neither disputed nor dispositive of obviousness that the primary references, taken alone, fail to satisfy the claimed invention, because no rejections over such individual references have been made.
Lastly, it is the Examiner’s understanding that Applicant attempts to define and/or summarize the claimed invention (see, e.g., p. 11 of the Reply). This is acknowledged but not dispositive of the claim scope because the claimed invention is understood to be defined by the limitations actually set forth in the pending claims.
Conclusion
Claims 1, 3-6, 12, 23-25, 28-33, 47, and 49 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Thursday 9:00AM - 7:00PM PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet Epps-Smith can be reached on (571) 272-0757. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 WO2000024911A2; art of record.
2 Ishizaki, J et al. “Cloning and characterization of novel mouse and human secretory phospholipase A(2)s.” The Journal of biological chemistry vol. 274,35 (1999): 24973-9. doi:10.1074/jbc.274.35.24973; art of record; also see SCV Search Results.
3 Clark, Hilary F et al. “The secreted protein discovery initiative (SPDI), a large-scale effort to identify novel human secreted and transmembrane proteins: a bioinformatics assessment.” Genome research vol. 13,10 (2003): 2265-70. doi:10.1101/gr.1293003; art of record; also see SCV Search Results.
4 Miki, Yoshimi et al. “Dual Roles of Group IID Phospholipase A2 in Inflammation and Cancer.” The Journal of biological chemistry vol. 291,30 (2016): 15588-601. doi:10.1074/jbc.M116.734624; art of record
5 US20170007698A1; art of record
6 US20070134243A1; art of record
7 This scenario is well illustrated by Ex parte Novitski, 26 USPQ 2d 1389 (BPAI 1993). The Board rejected a claim directed to a method for protecting a plant from plant pathogenic nematodes by inoculating the plant with a nematode inhibiting strain of P. cepacia. A U.S. patent to Dart disclosed inoculation using P. cepacia type Wisconsin 526 bacteria for protecting the plant from fungal disease. Dart was silent as to nematode inhibition but the Board concluded that nematode inhibition was an inherent property of the bacteria.
8 It is permissible to turn to the reference specification when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference application (see, e.g., MPEP § 804(II)(B)(1)).