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
Claims 53-55 and 57-63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. After further consideration, the species elections for cancer type and retinoid type are withdrawn.
Claims 44-45, 47-50, and 56 are under consideration in this office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 22, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Withdrawn Rejections
Any objection or rejection of record pertaining to cancelled claims 46 and 51-52 is rendered moot by applicant’s cancellation of said claims.
The rejection of claims 44-45, 47-50, and 56 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by US 2019/0359727, is withdrawn in view of applicant’s amendment of claim 44 to limit the retinoid to ATRA.
The rejection of claim 44-45, 47-50, and 56 under 35 U.S.C. 103 as being unpatentable over US 2019/0359727 (“Riddell”) in view of Degos et al is withdrawn in view of applicant’s amendment of claim 44 to limit the cancer to myeloma.
New Objections/Rejections Necessitated by Amendment
Claim Objections
Claim 44 is objected to because of the following informalities:
In claim 44, the phrase “to the patient” in line 3 is misplaced, as it is positioned too far from the word it modifies. Moving this phrase to after “administering” in line 2 would obviate this objection. Appropriate correction is required.
In claim 44, “BMCA”, which is used incorrectly twice in line 4, should be “BCMA”.
Claim Rejections - 35 USC § 112(b)
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.
Claims 44-45, 47-50, and 56 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 44 recites the limitation "the patient" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 44 recites the limitation "the binding domain" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claims 45, 47-50, and 56 are included in this rejection for failing to cure the indefiniteness of the base claim.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 45 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitation “hematological cancer” is broader in scope than the myeloma of claim 44. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
Claims 44-45 and 48-50 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by US 20150344583, December 3, 2015 (“Armitage”; see instant PTO-892).
Armitage teaches a method of treating multiple myeloma by administering an anti-BCMA antibody drug conjugate and an additional therapy, including all-trans retinoic acid (ATRA) ([0059]; [0074]; [0255]), which reads on claims 44-45 and 48. The anti-BCMA antibody drug conjugate is conjugated to a cytotoxic agent ([0225]; 0224]), which reads on instant claim 49. The BCMA binding protein the protein taught by Armitage can be a bispecific antibody [0120], which reads on instant claim 50.
Riddell anticipates claims 44-45 and 48-50.
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 44-45, 47-50, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over by US 20150344583, December 3, 2015 (“Armitage”) in view of US 2019/0359727, published November 28, 2019 (“Riddell”; PTO-892 from 9/22/2025).
The teachings of Armitage are discussed above; Armitage does not teach the limitation of claim 47 directed to a CAR or the limitation of claim 56 directed to administration of a gamma secretase inhibitor.
Riddell teaches a method of treating multiple myeloma [0180] by administering an anti-BCMA antibody or CAR that is conjugated to the aromatic retinoic tretinoin (see abstract, [0088], [0163], [0180]), as in claims 44 and 47. The method of Riddell further comprises administration of a gamma secretase inhibitor (abstract, [0088], [0182]), as in instant claim 56.
Given that Armitage teaches a method of treating multiple myeloma by administering an anti-BCMA antibody and ATRA and further given that Riddell teaches a method of treating multiple myeloma by administering an anti-BCMA antibody and an aromatic retinoid, it would have been obvious to one of ordinary skill in the art to substitute the CAR of Riddell for the antibody of Armitage and have a reasonable expectation of success. This is because, as is stated in MPEP §2144.06, substituting one equivalent element for another known for the same purpose renders an invention obvious and an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious.
Given that Armitage teaches a method of treating multiple myeloma by administering an anti-BCMA antibody and ATRA and further given that Riddell teaches a method of treating multiple myeloma by administering an anti-BCMA antibody, an aromatic retinoid, and a gamma secretase inhibitor, it would have been obvious to add a gamma secretase inhibitor to the method of Armitage. The motivation to do so comes from Riddell, which teaches that gamma secretase inhibition is associated with increased BCMA levels on myeloma cells, allowing for improved recognition of BCMA positive myeloma cells by T cells ([0209]; [0215]). Therefore, a method of myeloma comprised of an anti-BCMA antibody or CAR comprising an anti-BCMA binding domain, ATRA, and gamma-secretase would have been obvious and predictable given the prior art teachings of the Riddell to treat myeloma with the combination therapy. The artisan has good reason to pursue known options within their technical grasp to obtain predictable results. Such would amount to the combining of prior art elements according to known methods to achieve predictable outcomes.
Modified Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 44-45, 47-50, and 56 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 inventor(s), 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.
Claim 44 is directed to an immunotherapeutic anticancer agent that comprises the binding domain of an anti-BCMA antibody or fragment thereof. The anti-BCMA antibody is defined entirely by function, binding to BCMA and anti-cancer activity.
Antibodies generally share certain characteristics such as Fc regions or hinge regions. However, these structures are not correlated with the binding function of the antibody. It is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three complementarity determining regions (CDRs) that provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity, which is characteristic of the immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences, which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites (see Almagro et al, Section 3 “Antibody Structure and the Antigen Binding Site” and Figure 1; PTO-892 from 9/22/2025).
There is no way to a priori look at an antigen sequence (e.g., BA) and envisage the combination of six CDRs that will bind that antigen. First, even highly related CDRs may not bind the same target. See for example Kussie (PTO-892 from 9/22/2025), who demonstrates that a single amino acid change in the heavy chain of an antibody that binds p-azophenylarsonate (Ars) completely abrogates the ability of the antibody to bind Ars but adds the functionality of binding the structurally related p-azophenylsulfonate (see abstract). Second, even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (pg 7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor’s antibodies which bound the same target but shared only 50% sequence similarity (see table on pg 11).
While the prior art teaches some understanding of the structural basis of antigen-antibody recognition, it is noted that the art is characterized by a high level of unpredictability, since the skilled artisan still cannot accurately and reliably predict the consequences of amino acid substitutions, insertions, and deletions in the antigen-binding domains.
According to the specification, the applicant has disclosed 20+ specific species of anti-BCMA antibody, which are known in the art and are comprised of specific combinations of heavy chain CDRs and light chain CDRs. However, the specification does not provide adequate written description for the entire claimed genus of anti-BCMA antibodies, because one skilled in the art would be unable to immediately envision, recognize, or distinguish most of the members comprised within the genus claimed, specifically which heavy chain and light chain amino acid sequences should be combined to yield an antigen-binding region that is capable of binding BCMA.
To satisfy the written description requirement, a patent 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.
In the instant case, the specification provides insufficient direction or guidance concerning the relationship between the structure of the possible antibody to demonstrate possession of the breadth of the genus of anti-BCMA antibodies encompassed by the instant claim, especially in view of the unpredictability of such an endeavor. The prior art, as evidenced by Edwards et al., 2003 (PTO-892 from 9/22/2025), teaches there is a substantially huge antibody diversity produced to one single antigen target. Edwards provides evidence that over 1000 antibodies, all different amino acid sequences, were generated towards one single protein antigen target (see abstract). Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Applicant has not described the claimed invention sufficiently to show they had possession of the claimed genus of antibodies that bind BCMA. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004).
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only 20 species within the genus.
For claims drawn to a genus, a generic statement that defines a genus of 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, 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. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., high affinity, neutralization activity, competing with a reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011). An antibody described only by functional characteristic, such as antibody that binds BCMA, without any known or disclosed correlation between that function and the structure of the sequence, is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993). In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995).
With the exception of specifically disclosed antibodies with specific CDRs, the skilled artisan cannot envision the detailed chemical structure of all of the encompassed antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Therefore, claims 44-45, 47-50, and 56 do not meet the written description requirement.
Response to Arguments
Applicant's arguments filed January 22, 2026 have been fully considered.
Regarding the rejection of claims 44-45, 47-50, and 56 under 35 U.S.C. 112(a) for failing to comply with the written description requirement, applicant argues that BCMA is a well-known cancer antigen and that there are numerous anti-BCMA antibody sequences known in the art (remarks, pg 5).
Applicant is reminded that products described by function alone are not special and are not excluded from the written description requirement. As was held in University, Rochester v G.D. Searle Co., 358 F.3d 916 (Fed. Cir. 2004), a functional genus cannot be described by a method of obtaining or screening for the agent that meets the functional limitations of the claim. The written description requirement applies to whatever is claimed and methods of use are not excluded therefrom. The skilled artisan would not have understood that Applicant was in possession of genus of anti-BCMA antibodies, as the specification merely exemplifies only a few different molecules in the asserted larger class of functionally claimed generic antibodies.
Applicant’s assertion that these inhibitors were well known in the art and would be immediately appreciated by one of skill in the art upon view of the instant claims and/or specification is not persuasive, as assertion of Applicant cannot take the place of evidence in the record. Statements of this nature are clearly unpersuasive in accordance with guidance provided at MPEP 2145., which states, "The
arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602
145 USPQ 716, 178 (CCPA 1965); In re Geisler 116 F.3d 1465, 438 USPQ2d 1362 (Fed. Cir. 1997)." Here, there is no evidence of the prior art of record to support Applicant’s assertion of the immediate appreciation beyond the limited specifically enumerated anti-BCMA antibodies of the specification. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus or such can be provided by the art. Applicant merely asserts that it would be readily apparent, but no evidence of record establishes that the skilled artisan would readily appreciate the genus of agents as claimed by either a representative number of species or that there is a known structure/function correlation in the prior art. Moreover, the claims require the antibody to be a treatment for myeloma, and there is no evidence in the specification or prior art that any known antibody for BMCA would be capable of producing the required effect. The antibody claimed requires a very specific function, and because there is no disclosure of the specific structure to perform the requisite function, the antibody is not sufficiently described
Applicant’s assertion of immediate appreciation by the skilled artisan is not persuasive because
that is not the standard of the statute. The purpose of the written description requirement is to "lead a
person of ordinary skill in the art to understand that the inventors possessed the entire scope of the
claimed invention," Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).
Any arguments related to the rejections under 35 U.S.C. 102 and 103 and the Riddell reference have been considered but are moot because the new grounds of rejection under 35 U.S.C. 102(a)(1) and 103 do not rely on Riddell alone as applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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