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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 and 3-14) as drawn to a method of identifying and treating lupus, in the reply filed on 01/21/2026 is acknowledged. Claims 1-15 are pending; claims 2, 10 and 11 (since both depend on claim 2), and 15 are withdrawn from prosecution for being drawn to non-elected subject matter. Claims 1, 3-9, and 12-14 are examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/25/2025 was considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claims 1, 3-9, 12 and 14 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 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the
right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s
contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04. (emphasis added).
In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad
Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), it is noted that to show
invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358). Also, it is not enough for the specification to show how to make and use the
invention, i.e., to enable it (see Amgen at page 1361).
An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
In the instant case, the claims are drawn to a method of treating or
preventing lupus or SLE in a subject, comprising: (a) identifying the subject as having at
least one differentially regulated biomarker selected from CD40, CD40L, CD86, CD80,
and PD1; and (b) administering an agent that inhibits the CD40 or CD28 signaling
pathway.
There is no actual disclosure of any reagents used, no administration regimens,
no actual dosages or positive steps in the "methods" claimed. There is no guidance or
actual data of any reagent use for treatment (let alone prevention) of lupus. In the sole
working example in the specification Applicants analyzed the B cell compartment of
African American and European American SLE patients and healthy volunteer controls.
Applicants discovered a distinct activated B cell signature in African American SLE
patients with expansion of CD19+IgD-CD27- double negative (DN) B cells, higher
expression of CD86 and CD40 ligand (CD40L) and lower CD40 surface expression in B
cells, suggestive of a constitutively active CD40 pathway in these patients. There is no
mentioning of treating or preventing any form of lupus. The specification presents, as
“incorporated by reference”, the following antibodies that may be used for treating lupus:
the anti-CD40L antibody (a domain antibody which binds to and antagonize the
CD40L activity) BMS-986004.
the anti-CD40 antibody (a domain antibody which binds to and antagonize the
CD40 activity) BMS-986090.
the anti-CD28 antibody (a domain antibody which binds to and antagonize the
CD28 activity) BMS-931699.
The first paragraph of 35 U.S.C. 112 requires that the "specification shall contain
a written description of the invention * * *." This requirement is separate and distinct from the enablement requirement. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991). See also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)
(discussing history and purpose of the written description requirement); In re Curtis, 354
F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a
claim's enablement is not equally conclusive of that claim's satisfactory written
description"). The written description requirement has several policy objectives. "[T]he
'essential goal' of the description of the invention requirement is to clearly convey the
information that an applicant has invented the subject matter which is claimed." In re
Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977).
Another objective is to put the public in possession of what the applicant claims as the invention. See Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). *>"The 'written description' requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent's term.
The art is aware of using humanized anti-CD40 antibodies (De Boer et al. - U.S. Pat. No. 5,874,082; Barrett et al. - U.S. Pat. No. 8,591,900) or anti-CD28 antibodies (McKinnon et al. - U.S. Pat. No. 8,168,759).
However, the claims broadly encompass any reagent for treating/preventing lupus while not showing any working examples in this respect and basing the claim on the potential use of three different antibodies BMS-986004, BMS-986090, BMS-931699. Thus Applicants instant disclosure, including the claims fail to disclose a representative number of species falling with the scope of the genus or structural common to the members of the genus so the one of skill in the art can visualize or recognize the member of the genus.
One of skill in the art would conclude that the specification fails to disclose a
representative number of species to describe the claimed genera.
Regarding the prevention aspect, Applicant is made aware that no proof is described to fulfill this goal.
If Applicant is in possession of experimental data that show the use of other
reagents than antibodies that inhibit the CD40 or CD28 and are used for treating lupus, they are strongly encouraged to present them for critical examination.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-9, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Borrebaeck et al. (U.S. Pub. No. 20130288912) in view of Katsiari et al. (Clinical Immunol. 103, 54-62, 2002- cited by Applicant), Chen et al. (U.S. Pub. No. 20140302070) and in further view of Nadler et al. (U.S. Pat. No. 8,895,010).
The claims are drawn to a method of treating or preventing lupus (which may be
systemic lupus erythematosus (SLE)) in a subject, comprising: (a) identifying the subject
as having at least one (up to three) differentially regulated biomarker selected from CD40, CD40L, CD86, CD80, and PD1; and (b) administering an agent that inhibits the CD40 or CD28 signaling pathway. One of the differentially regulated biomarker could be the downregulated expression of CD40. The inhibitory agent may specifically bind specifically binds to CD40, CD40L, or CD28 and may be an anti-CD40, anti-CD40L or anti-CD28 antibody.
Borrebaeck et al. teaches that Systematic lupus erythematosus is a chronic,
multisystem autoimmune disease with a broad range of possible clinical and serological
presentations. Establishing a diagnosis of lupus is difficult and relies on a list of eleven
classification criteria that were developed over twenty years ago by the American College of Rheumatology (ACR). These classification criteria can guide the initial assessment of the patient with SLE but are not sufficient to adequately diagnose SLE, pin-point the phenotypic subclasses of SLE with high confidence, or to predict disease flares and remissions; as of 2010 there was no multiplexed serum biomarker signatures able to resolve these key unmet clinical issues ([0002]). The reference proposes a method for determining a Systemic Lupus Erythematosus-associated disease state in a subject comprising the steps of: a) providing a sample to be tested; and b) measuring the presence and/or amount in the test sample of one or more biomarker(s) selected from the group defined in Table 1; wherein the presence and/or amount in the test sample of the one or more biomarker(s) selected from the group defined in Table 1 is indicative of a Systemic Lupus Erythematosus-associated disease state ([0005]). Two of the markers in Table 1 are CD40 and CD40L.
The reference does not mention administering inhibitors of signaling pathways for CD40 or CD28.
Katsiari et al. further underscore the importance in the detection of CD40L in SLE. They found a highly significant sevenfold increase in CD40L-expressing peripheral
monocytes from patients with SLE as compared with healthy individuals.
Chen et al. further establishes the importance of CD40-CD40L axis, together with
other markers, for diagnosing SLE, disclosing that soluble forms of PD1, CD28, CD80,
CD86 and CTLA-4 can be found in sera of patients suffering from autoimmune diseases
such as systemic lupus erythematosus, and antibodies detecting naturally occurring
sΔ42PD1 can be used in diagnosis (including diagnostic reagents) and/or treatment of
auto immune diseases and infections ([0092]). (Nota bene: CD28 is a receptor for both CD8 and CD86; thus, using an anti-CD28 antibody would block the signal pathway for all three CDs).
Nadler et al. is accord with Katsiari et al. in indicating the use of anti-CD40 antibodies for treatment (claim 28).
Taken together, the references mentioned above establishes that it would have
been obvious to consider the differential expression of CD40, CD40L, CD86, CD80, and
PD1 for a method for diagnosing SLE since the markers were known to be associated
with lupus. A practitioner may detect one or more differentially regulated biomarkers as long as are regulated as known in the art, the identification of the subject as having lupus would be effected. Further, a skilled practitioner would have proceeded to treat the subject. Thus, a person of ordinary skill in the art would have applied known and tested methods in the art to solve a medical problem with reasonable expectation of success given the knowledge in the art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647