DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 15, 2026 has been entered.
Claims 1-15, 18, 29, and 32 have been canceled.
Claim 16 has been amended.
Claim 34 has been added.
Claims 16, 17, 19-28, 30, 31, 33, and 34 are pending in the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of claim 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, has been rendered moot by its cancelation as part of the February 23, 2026 response.
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.
The rejection of claims 16, 17, 19-28, 30, 31, and 33 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement has been withdrawn in view of applicant’s claim amendments received June 15, 2026.
Claim Rejections - 35 USC § 102
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 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.
The rejection of claims 16, 17, 19-28, 30, 31, and 33 under 35 U.S.C. 102(a)(1) as being anticipated by Witztum et al. (WO 2014/131034) has been withdrawn in view of applicant’s claim amendments received June 15, 2026 which limit the practice of the claimed administration methods to patient population not reasonably disclosed by the teachings of Witztum et al.
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.
The rejection of claims 16, 17, 19-28, 30, 31, and 33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,530,259 as evidenced by Witztum et al. (WO 2014/131034) has been withdrawn in view of applicant’s claim amendments received June 15, 2026 such that the intended patient populations of the instant administration methods are not recited in the issued claims.
The rejection of claims 16, 17, 19-28, and 30 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,008,382 as evidenced by Witztum et al. (WO 2014/131034) has been withdrawn.
Specifically, applicant has amended the independent claim to recite diseases not reasonably disclosed or rendered obvious by the issued claims.
The rejection of claims 16, 17, 19-28, and 30 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,008,381 as evidenced by Witztum et al. (WO 2014/131034) has been withdrawn.
Specifically, applicant has amended the independent claim to recite diseases not reasonably disclosed or rendered obvious by the issued claims.
The rejection of claims 16, 17, 19-28, and 30 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,655,288 as evidenced by Witztum et al. (WO 2014/131034) has been withdrawn in view of the amendments received June 15, 2026 which limit the instant recited patient populations to those which are distinct from that of the issued claims.
The rejection of claims 16, 17, 19-28, and 30 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,209,119 as evidenced by Witztum et al. (WO 2014/131034) has been withdrawn as the issued claims are limited to treating rheumatoid arthritis, a patient population which is not part of the instant claimed methods.
The rejection of claims 16, 17, 19-28, 30, 31, and 33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,897,969 as evidenced by Witztum et al. (WO 2014/131034) has been withdrawn in view of the claim amendments received June 15, 2026 which limit the patient populations of the instant treatment methods to those distinct from that of the previously issued claims.
The rejection of claims 31 and 33 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,008,382 and/or claims 1-15 of U.S. Patent No. 11,008,381, and/or claims 1-18 of U.S. Patent No. 11,655,288, and/or claims 1-19 of U.S. Patent No. 12,209,119 in view of Witztum et al. (WO 2014/131034) has been withdrawn.
Specifically, the instant claims as amended June 15, 2026 no longer recite patient populations recited, disclosed, or rendered obvious by the issued claims and/or cited prior art.
The following are new grounds of rejection necessitated by applicant’s claim amendments received June 15, 2026.
Claim 34 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant has broadly claimed methods of inhibiting one or more cytokines present in a small Markush group (recited in the claim as “immunopotentiating agents”) by performing the step of “contacting” a macrophage with an effective amount of an antibody defined by SEQ ID number that binds to oxidized phospholipids (OxPL). The antibody defined by SEQ ID number is further identified as having the functional properties of inhibiting “the level of the immunopotentiating agent associated with TLR2 mediated pathway activation by OxPL. To support such a claim, the specification discloses a working example demonstrating that a transgenic mouse constitutively expressing the E06 antibody in a scFv format had reduced expression of cytokines after challenge with a bacterial cell wall extract in a mouse mode mimicking Kawasaki disease (see [00156-00163]).
The methods as presently claimed are very broad. Notably, the method requires a macrophage and an antibody defined by SEQ ID number to be “contacted” in order to perform the claimed method, with no indication of where such “contacting” occurs. Thus the breadth of the claim reads upon a setup wherein macrophage cells in media are placed into a test tube and the recited antibody is added to the media with reasonably gentile agitation such that the “contacting” occurs by simple diffusion.
It is well known that macrophages, subsequent to activation, can secrete the cytokines recited in claim 34 as is readily evidenced by Arango Duque et al. (see entire document, particularly the right column of page 1). However, there is no requirement in the claim as presently written that a) the macrophages are already activated or b) a substance capable of activating macrophages is necessarily present in the closed in vitro system of cells, tissue culture media, and anti-OxPL antibody. Claim 34 explicitly indicates that the antibody necessarily present to perform the claimed methods binds OxPL headgroups, yet there is no requirement that OxPL are actually present when performing the claimed method. Also, there is no data indicating that E06 (the prior art lead antibody which is the source of the CDRs recited as being present in the “contacted” antibody) cross-reacts with cytokines such that it binds say TNFalpha and/or IL-12in addition to OxPL. While OxPL can occur spontaneously in response to the generation of free radicals, it is increasingly apparent that many are deliberately made via enzymatic processes with the exact structure generated being responsible for the resulting physiological response, such as being pro or anti inflammatory (Ni et al., see entire document). Indeed, Witztum et al. (WO 2014/131034, of record) disclose that “innate natural antibodies (NAbs) provide the first line of host defense against common oxidation-specific epitopes (OSE) on endogenous neo-epitopes (OXLDL and apoptotic cells) and exogenous epitopes of pathogens, and maintain host homeostasis. OSEs are ubiquitous, formed in many inflammatory tissues, including atherosclerotic lesions, and are a major target of IgM NAbs. The prototypic IgM NAb E06, binds to the phosphocholine (PC) headgroup in oxidized phospholipids (OxPL), and blocks uptake of OxLDL by macrophages. We have cloned and characterized a murine IgM natural antibody to OxPL that binds to the phosphorylcholine ("PC") headgroup of OxPL but not to native, non-oxidized phospholipids ("PL")” (see entire document, particularly the abstract, claims, and paragraphs [0052] and [00109]).
Thus, based upon the instant disclosure as well as the prior art, it appears that applicant’s working hypothesis is that an anti-OxPL antibody (such as that recited in the claim 34) will bind to OxPL prior to the OxPL being taken up by a macrophage, and by thus inhibiting the uptake of OxPL by macrophages the macrophages will not become activated to secrete the cytokines (“immunopotentiating agents”) recited in the claim preamble. However, if no OxPL is present, the antibody does not reasonably bind anything. Further, no change to macrophage function reasonably will ever occur as no OxPL is necessarily present, and even if it were present the antibody reasonably is at sufficient quantity to neutralize it such that it will have no impact on the macrophages. Thus, minimum system required by the claims does not seem to have any purpose as the cytokines in question will never be secreted from the macrophages which are necessarily present. While the claims do recite open “comprising” language which allows for, but does not require, an infinite number of additional process steps and limitations to be present, the claims are limited by what they actually require, and as discussed above the instant method simply requires mixing macrophages with the SEQ ID limited antibody in a test tube or other container for the cells and their tissue culture fluid which reasonably is needed for the continued existence of said macrophages even though tissue culture media isn’t a recited limitation. Liberal incorporation of unrecited limitations from the specification could reasonably turn claim 34 into say instant claim 16, but as per MPEP 2111.01(II), it is improper to import such limitations from the specification into the claims. 35 USC 112 requires applicant to teach artisans how to make and use the claimed invention, and while adding an antibody to cells in a test tube is trivially easy, as discussed above there seems to be no point to such an exercise and thus there is no use for it. As such, applicant has not taught artisans how to use that which is claimed, in contrast to instant claim 16 which clearly identifies what is done and why it is being done, namely administering of an antibody to treat a disorder in a clinically identifiable patient population. Thus it is clear that artisans would not reasonably accept that the full breadth of what has been presently claimed is fully enabled because in the absence of additional extensive, unrecited, and therefore not required, limitations the current invention does not appear to have any purpose, and indeed the working example is very significantly narrower in scope that that which applicant is trying to claim.
Therefore, in view of the breadth of the claim, the teachings of the art, and the guidance and direction of the instant specification, artisans would not be able to practice the full extent of the claimed methods without first conducting additional unpredictable basic science research and experimentation.
Claims 16, 17, 19-28, 30, 31, and 33 are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 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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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
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