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
1. Applicant's election with traverse of species of antibody of Group I in the reply filed on December 08, 2025 is acknowledged. The traversal is on the ground(s) that there is no serious burden for the Examiner to search both antibodies because they “are in the same classification and field of art, which is not “so complex,” p. 2. This is not found persuasive because, as explained earlier, the antibodies recited within the pending claims are structurally unrelated and, therefore, represent different molecular embodiments and require separate sequence search. Applicant is reminded that if the methods using the elected antibody are found to be allowable, the second antibody will be examined.
The requirement is still deemed proper and is therefore made FINAL.
2. Claims 1-28 are under examination.
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.
3. Claims 14-22 and 24-28 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 claim(s) contains 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.
Independent claim 14 is directed to administration of an antibody that specifically binds to semaphoring-4D (SEMA4D) and provides for specific therapeutic effect in a subject having, determined to have, or suspected of having a neurodegenerative disorder. Dependent claims 24-27 narrow the antibody function to inhibiting SEMA4D binding to its receptor, Plexin-B1 and Plexin-B2, and to inhibiting SEMA4D-mediated signal transduction. However, the specification only discloses the structure of two antibodies currently recited within claim 23, and fails to convey to the artisan that Applicant was in possession of a method of treating a neurodegenerative disorder and specifically the symptoms thereof as in claim 28 by administering any anti-SEMA4D antibody that is within the genus of the instant claims.
Section 112 states that “[t]he specification shall contain a written description of the invention … in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same . . . .” This requirement ensures “that the inventor actually invented the invention claimed.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). To show invention, a patentee must convey in its disclosure that it “had possession of the claimed subject matter as of the filing date.” Id. at 1350. Demonstrating possession “requires a precise definition” of the invention. Id. To provide this “precise definition” for a claim to a genus, a patentee must disclose “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id.
MPEP 2163, II A3(a)(ii) states,
For each claim drawn to a genus:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the gen[us]”. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the specification discloses certain antibodies, each with a specific combination of six CDRs (see, for example, claim 23), and provides the description of the binding antigen, SEMA4D. However, knowing that an antibody binds to a particular amino acid does not tell you anything at all about the structure of the antibody.
MPEP §2163(I)(A) states: "The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” Furthermore, the art teaches that 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, and there is no way to a priori look at an antigen sequence (such as the structure of SEMA4D) and envisage the structure of the antibody that will bind that antigen. Moreover, reference to one prior art antibody does not inform the artisan about any other antibodies with the same specificity.
In the instant case, the specification does not provide a complete structure of those antibodies that specifically bind to SEMA4D and are suitable for clinical administration, fails to convey a sufficient number of species to warrant a claim to the breadth of the genus described above, and does not describe a conserved structure reasonably correlated to the function across the genus. As such, the claims fail to meet the written description requirement.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of 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 compound 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. The specification provided only the bovine sequence.
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).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
4. Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, claim(s) 1-13 is/are determined to be directed to an abstract idea. The rationale for this determination is explained below.
The Supreme Court in Bilski v. Kappos, 561 U.S. ___, 130 S. Ct. 3218, 95 USPQ2d 1001 (2010), clarified the requirements for a process claim to be statutory under 35 U.S.C. 101, it must be limited to a particular practical application – A claim that attempts to patent an abstract idea is ineligible subject matter under 35 U.S.C. 101. See Bilski, 561 U.S. at ___, 130 S. Ct. at 3230, 95 USPQ2d at 1009 (‘‘[A]ll members of the Court agree that the patent application at issue here falls outside of § 101 because it claims an abstract idea.’’). Thus, not every claimed method qualifies as a statutory process. This ensures that the process is not simply claiming an abstract idea, or substantially all practical uses of (preempting) a law of nature, or a physical phenomenon.
In the instant case, based upon an analysis with respect to the claim as a whole, claims 1-13 are determined to be directed to a judicial exception without significantly more. The rationale for this determination is explained below in view of controlling legal precedent set forth in 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618) dated December 16, 2014 and 2019 Revised Patent Subject Matter Eligibility Guidance (84 FR 50) dated January 07, 2019.
The instant claims 1-13 encompass a process. (Step 1: Yes).
Next, Step 2, is the two-part analysis from Alice Corp. (also called the Mayo test) to determine whether the claim is directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions). (In Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) the Supreme Court sets forth a two-step test for determining patent eligibility. First, determine if the claims encompass a judicial exception (a natural phenomenon/law of nature/abstract idea). If so, then ask whether the remaining elements/steps, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to ‘“transform the nature of the claim’ into a patent-eligible application.” Id. at 2355 (quoting Mayo, 132 S. Ct. at 1297). Put another way, there must be a further “inventive concept” to take the claim into the realm of patent eligibility. Id. at 2355. In the recent Myriad v Ambry case, the CAFC found claims (drawn to methods comprising obtaining tissue samples, analyzing sequences of cDNA and comparing germline sequences of a gene to wild-type sequences) to encompass the abstract mental processes of ‘comparing’ and ‘analyzing’. Recitation of specific techniques (in Myriad claims 7 and 8 further recited hybridization and PCR) were deemed not “enough” to make the claims patent-eligible since the claims contained no otherwise new process. The elements/steps recited in addition to the judicial exception did nothing more than spell out what practitioners already knew). The instant claims 1-13 encompass abstract ideas of selecting subjects for treatment by practicing cognitive tests, which is essentially an attempt to recite limitations directed to mental steps and a thought process. Furthermore, the "selecting" step itself is an abstract idea that is does not include or require any physical method step, since the selecting could be determined by review of an assessment score record. As such, recitation of an abstract idea is a judicial exception (Step 2A/1: Yes). Next, prong two of Step 2A requires identifying whether there are additional elements recited in the claim beyond the judicial exception(s) and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration in to a practical application” requires an additional element or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such as the claim is more than a drafting effort designed to monopolize the exception. In the instant case, the claims do not recite any additional elements to integrate the judicial exception into a practical application because all the steps of the claimed methods are limited only to mental steps of determining the score and selecting the subjects that meet the score record. (Step 2A/2: No).
Finally, claims 1-13 do not recite any elements, or combinations of elements to ensure that the claim as a whole amounts to significantly more than the judicial exception because the active steps of the claimed method are routine data gathering steps instructing a practitioner to collect information necessary to practice of the abstract idea. Moreover, the determining or selecting steps consist of well-understood, routine, conventional activity already engaged in by the scientific community, see claim 15 reciting all known cognitive tests. (Step 2B: No).
Thus, for reasons fully explained above, claims 1-13 do not satisfy the requirement of 35 U.S.C. 101 and are therefore rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
5. Claim(s) 14-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 9,598,495, the ‘495 patent hence forth, in view of Gluhm et al., IDS of 02/17/2026.
Claims 14-28 are drawn to a method of treating neurodegenerative disorders and Huntington’s disease in particular by administration of an antibody to SEMA4D, wherein the antibody is identified by reference to the SEQ ID NOS: 6, 7, 8, 14, 15 and 16. The ‘495 patent fully teaches and claims the treatment, and especially the treatment of Huntington’s disease, within the text of the disclosure. The ‘495 patent describes the antibody which is structurally identical to the one of the instant claims. Since the cited prior art is Applicant’s own patent, no sequence alignment is provided.
The ’495 patent generally teaches specialized assessment of subject under treatment with anti-SEMA4D antibody, see c. 18, 32 and 33, for example; however, fails to recite specifically the tests and scores as within pending claims. Gluhm et al. explain usefulness of the MoCA test in Huntington’s disease.
It would have been obvious for one of ordinary skill in the art at the time of filing of the instant patent specification to treat a subject having Huntington’s disease by administration of the anti-SEMA4D antibody as fully taught by the ‘495 patent, and add as an assessment step to evaluate the subject as disclosed by Gluhm et al. The inventive concept of treating Huntington’s by administration of an antibody structurally identical to the one disclosed within the instant specification has been fully explained by the ‘495 patent, therefore one of ordinary skill in the art would be able to practice the method in full, and further, because examination of cognitive decline and mental state of patients is rather a routine diagnostic procedure, an ordinary practitioner would find the cognitive test disclosed by Gluhm et al. to be used for Huntington’s pathology a reliable first choice to add. This makes the instant method obvious over the cited prior art.
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.
6. Claims 14-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,598,495. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to the method of treating the same pathology, Huntington’s, by administration of the same antibody for which patent protection has been already granted.
7. Claims 14-28 are further rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,800,853. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to the method of treating the same pathology, Huntington’s, by administration of the same antibody for which patent protection has been already granted.
8. Claims 14-28 are further rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,534,488. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to the method of treating the same pathology, Alzheimer’s, by administration of the same antibody for which patent protection has been already granted.
9. Claims 14-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18/168,002 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘002 patent application encompass treatment of Huntington’s disease by administration of an anti-SEMA4D antibody and another therapeutic agent, wherein the instant claims encompass treatment of Huntington’s comprising administration of the same an anti-SEMA4D antibody, thus essentially encompassing the same invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14-28 are further provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/654,538 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘538 patent application encompass treatment of Huntington’s disease by administration of an anti-SEMA4D antibody, which is the subject matter of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
February 25, 2026