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 .
Applicant’s response and amendments received February 23, 2026 are acknowledged.
Claims 1-15, 18, 29, and 32 have been canceled.
Claims 16, 19-23, and 25 have been amended.
Claims 16, 17, 19-28, 30, 31, and 33 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.
Claims 16, 17, 19-28, 30, 31, and 33 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 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 by administering an antibody that binds to oxidized phospholipids in a subject. The claims as presently amended are minimally required to comprise six CDR polypeptide sequences recited by SEQ ID number. No claims recite any specific disease or condition that the practitioner of the claimed method is seeking to ameliorate by the claimed administration methods. The working example demonstrates 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]).
Artisans in this field typically hold advanced degrees, such as M.D., Ph.D., or both and see patients who have clinically observable signs and symptoms of a disease or disorder. In other words the patient/subject felt unwell and thus went to the doctor for evaluation. As presently written, the “subject” upon whom the claimed administration methods are performed are not required to have anything “wrong” with them. Thus the claims literally encompass administering an antibody that binds oxidated phospholipids to all vertebrates (see paragraph [0062] for definition of “subject”) on the planet, with such an administration hoping to achieve the recited goal/endpoint of inhibiting the level of the immunopotentiating agent in subject plasma, wherein the immunopotentiating agent is TNFa, CCL5, CCL2, CXCL1, IL6 and IL12. Thus the claimed methods reduce cytokine expression in all vertebrate animals.
The art has a long history of administering agents to reduce cytokines, and while in some specific disease setting such diminutions are clinically efficacious, reducing cytokines have consequences and thus are not reasonably suitable for administration to the entire population. For example, antibodies that bind and inhibit TNFa are used in many disorders, but such administrations increase the risk of opportunistic infections (see for example Ali et al. and well as Andersen et al.). It should be noted that depending on what ails the patient such increased infection risk may be reasonable but it is not reasonable to administer a reagent to an otherwise healthy patient that may cause them to get sick. This is because TNFa is an integral part of the innate immune system and thus reducing its level unless pathologically elevated due to an underlying disease process is expected to yield negative patent experiences (see for example Zelova et al.). Similarly, reducing IL6 is beneficial in clinical settings wherein excess IL6 is promoting pathology (Hu et al., see entire document) yet knockout animals lacking IL6 have defects in responses to infection, maintenance of body weight, neuronal repair and other defects (Poli et al., see entire document). Thus while it is clear that reducing cytokine expression can be beneficial in treating some specific diseases and conditions wherein high cytokine levels are causative of pathology, blanket reduction in cytokines in everyone, including healthy individuals, is ill-advised yet this is what applicant recites doing in the claims as currently presented.
Therefore, in view of the breadth of the claimed inventions, the guidance and direction of the instant specification, and the teachings of the art artisans would be unable to practice the full extent of the instant claimed methods without first performing additional undue basic science research and experimentation.
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive. Applicant argues that the specification teaches how to make and use the claimed invention based upon the transgenic mouse model and the ubiquity of antibody administration in the art. Applicant further asserts that there is no need for a therapeutic benefit, that simply inhibiting cytokines is enough. Therefore applicant believes the rejection should be withdrawn.
These arguments have been considered and are not persuasive. Applicant has claimed a method comprising a single active process step, namely the administration of an antibody defined by SEQ ID numbers for the CDR sequences. The claimed methods recite that the intended result of such an administration is to inhibit one or more cytokines chosen from a small Markush group. None of the pending claims recite any particular patient population, for example rheumatoid arthritis or Kawasaki disease, upon whom the administration method is practiced. While applicant is correct that the physical act of administering an antibody to a patient, such as via a hypodermic needle, is well known are reasonably trivial, identifying who is and who is not to receive such an administration is decidedly non-trivial. As set forth in the rejection of record, the claims as presently presented encompass administration to literally anyone and everyone an artisan can conceive. Applicant argues that this is acceptable since all that needs to happen is that cytokine levels get reduced. However, as set forth in the rejection of record artisans would not accept that a blanket cytokine reduction in all patients absolutely everywhere is acceptable or desirable, and no data is supplied in the instant specification indicating that such concerns that are readily apparent from the teachings about the role of cytokines in vivo in the art are unwarranted. The fact that the claimed methods may be suitable and desirable for some particularly defined patient population does not mean that it is suitable for everyone. Informing artisans as to how to make and use the claimed method necessarily involves informing artisans as to upon whom the claimed invention is to be practiced rather than simply stating what applicant expects to happen via an intended result, especially as no drug mass or timing intervals are provided. As such the methods as presently recited are of vastly greater breadth than what artisans would reasonably accept as being enabled. While it is true that a working example is not required for all embodiments, there should be a reasonable correlation between what artisans reasonably would accept as working based upon the data and teachings of the specification in conjunction with knowledge in the art and that which is claimed. Presently there is no such correlation in the instant application. The rejection is maintained.
The rejection of claims 16-20 and 22-24 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 has been withdrawn in view of applicant’s claim amendments received February 23, 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, and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Silverman (WO 2006/086288) has been withdrawn in view of applicant’s claim amendments received February 23, 2026 which add biological sequence limitations on the administered antibody which are not disclosed by Silverman.
Claims 16, 17, 19-28, 30, 31, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Witztum et al. (WO 2014/131034).
Witztum et al. 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]). Witztum et al. disclose turning their antibody into a scFv format, and their scFv are 100% identical to SEQ ID NOs:2 and 4 of the instant specification (see particularly paragraphs [00111-00115] and [00187-00196]). Such antibodies are disclosed as being administered to treat a wide variety of inflammatory conditions including calcific aortic stenosis, rheumatoid arthritis, multiple sclerosis, non-alcoholic steatohepatitis (NASH), pneumococcal infections, and complications of PCI procedures (see particularly claims 30 and 31 as well as paragraphs [0017], [0020-0024], [0066], [00108], and [00169-00175]). Such antibodies are disclosed as reducing the expression of pro-inflammatory cytokines including CCL2 and IL6 (see particularly paragraph [0037] and Figure 13). Therefore the prior art anticipated the instant claimed invention.
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive. Applicant argues that the cited reference does not teach using an antibody to inhibit cytokine production and therefore the rejection should be withdrawn.
This argument is not persuasive. As stated in the rejection of record, the antibody administered in the methods of Witztum et al. is the same antibody as that presently recited for administration, and applicant has not argued or provided evidence that the administered antibodies are distinct. As set forth in the rejection of record, Witztum et al. disclose administering such antibodies to treat meany readily identifiable clinical conditions, and demonstrate that administration of such antibodies reduces cytokines including IL6 (see again most particularly paragraph [0037] and Figure 13). Thus the prior art teaches that administering the instant recited antibodies reduces cytokines including IL6. As was discussed in greater depth above, the instant claims are not limited to any particular patient population whatsoever, and thus any administration of the E06 reasonably reads upon the methods as presently claimed. It should be pointed out that even if Witztum et al. did not demonstrate reductions in cytokines including IL6 following antibody administration, the courts have long ruled that "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Thus if the same product is administered to a subset of the patient population encompassed by the instant claims, the same results will necessarily happen, which in the instant situation is a reduction in cytokine levels. See also MPEP 2112. 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.
Claims 16, 17, 19-28, 30, 31, and 33 are rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate the breadth of what is presently claimed.
Specifically, the claims of the ‘259 patent are drawn to methods of treating Kawasaki disease by administering antibodies that bind oxidized phospholipids and comprise the same biological sequences are recited by SEQ ID number in the instant claims (see all issued claims). It is noted that the issued claims do not recite that such an administration reduces cytokine levels. However, as evidenced by Witztum et al., such an administration does reduce cytokine expression (see entire document, most particularly Figure 13). Further, even if such an outcome of the administration was not disclosed in the prior art the issued claims would still anticipate the instant claimed invention. As discussed earlier in this office action, the breath of patient population upon whom the instant claimed methods are practiced encompasses all living vertebrates whether sick or not. Given that the issued claims are for treating a well-defined patient population while the instant claimed patient population is literally anyone the issued claims necessarily anticipate . Further, as per MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). While the instant claims are method rather than products, the logic is sound that identifying a superior mechanistic answer for why or how a prior art method “works” does not make the old method into a new patent. In the instant case, the diminution in cytokines is a better scientific explanation for why and how the claimed methods of the ‘259 patent work to treat Kawasaki disease as compared to what is disclosed in the issued claims themselves. Additionally, as is also set forth in MPEP 2112, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Given that the antibodies of the issued claims and those of the instant claims have the same biological sequences as recited by SEQ ID number, the same outcomes must occur upon administration to the same population (or subpopulation thereof) even if such outcomes are not observed, measured or otherwise appreciated. In view of all of the above, it is clear that the narrower issued claims anticipate the breadth of what is presently claimed.
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive. Applicant asks that the rejection be held in abeyance and that applicant will consider filing a terminal disclaimer at a later time.
Since no terminal disclaimer has been filed and applicant’s claim amendments fail to provide patentable distinctiveness, the rejection is maintained.
Claims 16, 17, 19-28, and 30 are rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate the breadth of what is presently claimed.
Specifically, the claims of the ‘382 patent are drawn to methods of treating calcific aortic stenosis by administering antibodies that bind oxidized phospholipids and comprise the same biological sequences are recited by SEQ ID number in the instant claims (see all issued claims). It is noted that the issued claims do not recite that such an administration reduces cytokine levels. However, as evidenced by Witztum et al., such an administration does reduce cytokine expression (see entire document, most particularly Figure 13). Further, even if such an outcome of the administration was not disclosed in the prior art the issued claims would still anticipate the instant claimed invention. As discussed earlier in this office action, the breath of patient population upon whom the instant claimed methods are practiced encompasses all living vertebrates whether sick or not. Given that the issued claims are for treating a well-defined patient population while the instant claimed patient population is literally anyone the issued claims necessarily anticipate . Further, as per MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). While the instant claims are method rather than products, the logic is sound that identifying a superior mechanistic answer for why or how a prior art method “works” does not make the old method into a new patent. In the instant case, the diminution in cytokines is a better scientific explanation for why and how the claimed methods of the ‘382 patent work to treat calcific aortic stenosis as compared to what is disclosed in the issued claims themselves. Additionally, as is also set forth in MPEP 2112, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Given that the antibodies of the issued claims and those of the instant claims have the same biological sequences as recited by SEQ ID number, the same outcomes must occur upon administration to the same population (or subpopulation thereof) even if such outcomes are not observed, measured or otherwise appreciated. In view of all of the above, it is clear that the narrower issued claims anticipate the breadth of what is presently claimed.
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive. Applicant’s arguments for why this nonstatutory double patenting rejection should be withdrawn are the same as those presented by applicant in conjunction with the rejection under 35 USC 102(a)(1) to Witztum et al.
Applicants arguments have been considered and are not persuasive as explained earlier in this action with regard to the 102 rejection concerning the teaching of Witztum et al. (WO 2014/131034). The rejection is maintained.
Claims 16, 17, 19-28, and 30 are rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate the breadth of what is presently claimed.
Specifically, the claims of the ‘381 patent are drawn to methods of treating ischemic myocardium by administering antibodies that bind oxidized phospholipids and comprise the same biological sequences are recited by SEQ ID number in the instant claims (see all issued claims). It is noted that the issued claims do not recite that such an administration reduces cytokine levels. However, as evidenced by Witztum et al., such an administration does reduce cytokine expression (see entire document, most particularly Figure 13). Further, even if such an outcome of the administration was not disclosed in the prior art the issued claims would still anticipate the instant claimed invention. As discussed earlier in this office action, the breath of patient population upon whom the instant claimed methods are practiced encompasses all living vertebrates whether sick or not. Given that the issued claims are for treating a well-defined patient population while the instant claimed patient population is literally anyone the issued claims necessarily anticipate . Further, as per MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). While the instant claims are method rather than products, the logic is sound that identifying a superior mechanistic answer for why or how a prior art method “works” does not make the old method into a new patent. In the instant case, the diminution in cytokines is a better scientific explanation for why and how the claimed methods of the ‘381 patent work to treat ischemic myocardium as compared to what is disclosed in the issued claims themselves. Additionally, as is also set forth in MPEP 2112, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Given that the antibodies of the issued claims and those of the instant claims have the same biological sequences as recited by SEQ ID number, the same outcomes must occur upon administration to the same population (or subpopulation thereof) even if such outcomes are not observed, measured or otherwise appreciated. In view of all of the above, it is clear that the narrower issued claims anticipate the breadth of what is presently claimed.
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive. Applicant’s arguments for why this nonstatutory double patenting rejection should be withdrawn are the same as those presented by applicant in conjunction with the rejection under 35 USC 102(a)(1) to Witztum et al.
Applicants arguments have been considered and are not persuasive as explained earlier in this action with regard to the 102 rejection concerning the teaching of Witztum et al. (WO 2014/131034). The rejection is maintained.
Claims 16, 17, 19-28, and 30 are rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate the breadth of what is presently claimed.
Specifically, the claims of the ‘288 patent are drawn to methods of treating non-alcoholic steatohepatitis by administering antibodies that bind oxidized phospholipids and comprise the same biological sequences are recited by SEQ ID number in the instant claims (see all issued claims). It is noted that the issued claims do not recite that such an administration reduces cytokine levels. However, as evidenced by Witztum et al., such an administration does reduce cytokine expression (see entire document, most particularly Figure 13). Further, even if such an outcome of the administration was not disclosed in the prior art the issued claims would still anticipate the instant claimed invention. As discussed earlier in this office action, the breath of patient population upon whom the instant claimed methods are practiced encompasses all living vertebrates whether sick or not. Given that the issued claims are for treating a well-defined patient population while the instant claimed patient population is literally anyone the issued claims necessarily anticipate . Further, as per MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). While the instant claims are method rather than products, the logic is sound that identifying a superior mechanistic answer for why or how a prior art method “works” does not make the old method into a new patent. In the instant case, the diminution in cytokines is a better scientific explanation for why and how the claimed methods of the ‘288 patent work to treat non-alcoholic steatohepatitis as compared to what is disclosed in the issued claims themselves. Additionally, as is also set forth in MPEP 2112, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Given that the antibodies of the issued claims and those of the instant claims have the same biological sequences as recited by SEQ ID number, the same outcomes must occur upon administration to the same population (or subpopulation thereof) even if such outcomes are not observed, measured or otherwise appreciated. In view of all of the above, it is clear that the narrower issued claims anticipate the breadth of what is presently claimed.
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive. Applicant’s arguments for why this nonstatutory double patenting rejection should be withdrawn are the same as those presented by applicant in conjunction with the rejection under 35 USC 102(a)(1) to Witztum et al.
Applicants arguments have been considered and are not persuasive as explained earlier in this action with regard to the 102 rejection concerning the teaching of Witztum et al. (WO 2014/131034). The rejection is maintained.
Claims 16, 17, 19-28, and 30 are rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate the breadth of what is presently claimed.
Specifically, the claims of the ‘119 patent are drawn to methods of treating rheumatoid arthritis by administering antibodies that bind oxidized phospholipids and comprise the same biological sequences are recited by SEQ ID number in the instant claims (see all issued claims). It is noted that the issued claims do not recite that such an administration reduces cytokine levels. However, as evidenced by Witztum et al., such an administration does reduce cytokine expression (see entire document, most particularly Figure 13). Further, even if such an outcome of the administration was not disclosed in the prior art the issued claims would still anticipate the instant claimed invention. As discussed earlier in this office action, the breath of patient population upon whom the instant claimed methods are practiced encompasses all living vertebrates whether sick or not. Given that the issued claims are for treating a well-defined patient population while the instant claimed patient population is literally anyone the issued claims necessarily anticipate . Further, as per MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). While the instant claims are method rather than products, the logic is sound that identifying a superior mechanistic answer for why or how a prior art method “works” does not make the old method into a new patent. In the instant case, the diminution in cytokines is a better scientific explanation for why and how the claimed methods of the ‘119 patent work to treat rheumatoid arthritis as compared to what is disclosed in the issued claims themselves. Additionally, as is also set forth in MPEP 2112, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Given that the antibodies of the issued claims and those of the instant claims have the same biological sequences as recited by SEQ ID number, the same outcomes must occur upon administration to the same population (or subpopulation thereof) even if such outcomes are not observed, measured or otherwise appreciated. In view of all of the above, it is clear that the narrower issued claims anticipate the breadth of what is presently claimed.
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive. Applicant’s arguments for why this nonstatutory double patenting rejection should be withdrawn are the same as those presented by applicant in conjunction with the rejection under 35 USC 102(a)(1) to Witztum et al.
Applicants arguments have been considered and are not persuasive as explained earlier in this action with regard to the 102 rejection concerning the teaching of Witztum et al. (WO 2014/131034). The rejection is maintained.
Claims 16, 17, 19-28, 30, 31, and 33 are rejected 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). Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims anticipate the breadth of what is presently claimed.
Specifically, the claims of the ‘969 patent are drawn to methods of reducing cardiomyocyte death following ischemic events by administering antibodies that bind oxidized phospholipids and comprise the same biological sequences are recited by SEQ ID number in the instant claims (see all issued claims). It is noted that the issued claims do not recite that such an administration reduces cytokine levels. However, as evidenced by Witztum et al., such an administration does reduce cytokine expression (see entire document, most particularly Figure 13). Further, even if such an outcome of the administration was not disclosed in the prior art the issued claims would still anticipate the instant claimed invention. As discussed earlier in this office action, the breath of patient population upon whom the instant claimed methods are practiced encompasses all living vertebrates whether sick or not. Given that the issued claims are for treating a well-defined patient population while the instant claimed patient population is literally anyone the issued claims necessarily anticipate . Further, as per MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). While the instant claims are method rather than products, the logic is sound that identifying a superior mechanistic answer for why or how a prior art method “works” does not make the old method into a new patent. In the instant case, the diminution in cytokines is a better scientific explanation for why and how the claimed methods of the ‘969 patent work to reduce cardiomyocyte death following ischemic events as compared to what is disclosed in the issued claims themselves. Additionally, as is also set forth in MPEP 2112, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Given that the antibodies of the issued claims and those of the instant claims have the same biological sequences as recited by SEQ ID number, the same outcomes must occur upon administration to the same population (or subpopulation thereof) even if such outcomes are not observed, measured or otherwise appreciated. In view of all of the above, it is clear that the narrower issued claims anticipate the breadth of what is presently claimed.
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive. Applicant’s arguments for why this nonstatutory double patenting rejection should be withdrawn are the same as those presented by applicant in conjunction with the rejection under 35 USC 102(a)(1) to Witztum et al.
Applicants arguments have been considered and are not persuasive as explained earlier in this action with regard to the 102 rejection concerning the teaching of Witztum et al. (WO 2014/131034). The rejection is maintained.
Claims 31 and 33 are rejected 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).
The inventions of the issued patents have been discussed above and differ from the instant claimed inventions in that the issued patents do not disclose antibodies that bind oxidized phospholipids which comprise the CDRs and VH and VL of SEQ ID NO:4 of the instant application.
Witztum et al. 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]). Witztum et al. disclose turning their antibody into a scFv format, and their scFv are 100% identical to SEQ ID NOs:2 and 4 of the instant specification (see particularly paragraphs [00111-00115] and [00187-00196]). Such antibodies are disclosed as being administered to treat a wide variety of inflammatory conditions including calcific aortic stenosis, rheumatoid arthritis, multiple sclerosis, non-alcoholic steatohepatitis (NASH), pneumococcal infections, and complications of PCI procedures (see particularly claims 30 and 31 as well as paragraphs [0017], [0020-0024], [0066], [00108], and [00169-00175]). Such antibodies are disclosed as reducing the expression of pro-inflammatory cytokines including CCL2 and IL6 (see particularly paragraph [0037] and Figure 13).
Therefore it would have been obvious to ordinary artisans that antibodies based upon the scFv of SEQ ID NO:4 could be used in place of those based upon SEQ ID NO:2 as both bind oxidized phospholipids and are both taught as suitable to treat the same clinical diseases and conditions by Witztum et al. Note that as per MPEP 2144.06, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive. Applicant argues the base rejections are not tenable and the additional teachings of Witztum et al. (WO 2014/131034) do not rectify the alleged deficiencies.
This argument has been considered and is not persuasive as applicant’s arguments concerning the base rejections is not persuasive. See above.
No claims are allowable.
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).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641