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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1 December 2025 has been entered.
Status of the Claims
Claims 1-5 were originally filed June 4th, 2021. The preliminary amendment filed the same day has been entered. Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim in Non-Final mailed 8 November 2024. Claims 7-11, 13, 14 and 20-24 are currently under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
Claims 7-11, 13, 14 and 20-24 are drawn to “a syndecan-3 ligand possessing specificity” (e.g., see claim 7 line 2), “wherein said ligand comprises an antibody” (e.g., see claim 7 last line), and “amino acid positions 45-384 of human SDC3” (e.g., see claim 7 line 3). The recitation of “comprising” is considered open language which allows for the presence of additional structures (see MPEP § 2111.03(1)). Therefore, the scope of claim 7 encompasses any structure that acts as a ligand for syndecan-3 (SDC3) (e.g., small molecule, natural ligand, peptide) with specificity for the claimed region linked to an antibody or wherein the ligand itself is an antibody. In addition, the claims recite “a syndecan-3 ligand possessing specificity for a region at amino acid positions 45 to 384 of human syndecan-3 core protein” (e.g., see claim 7 lines 2-3). The specification does not provide a limiting definition for “specificity for a region” while the state of the art teaches the extracellular domain of SDC3 comprises heparin sulfate chains as evidenced by Gondelaud and Blum (see PTO-892 mailed 8 November 2024, in particular figure 1). Therefore, given the broadest reasonable interpretation “a syndecan-3 ligand possessing specificity for a region” will be understood as any ligand that binds directly or indirectly to SDC3 in the claimed region (see Definition: Region. Merriam Webster. Accessed online 20 January 2026, in particular definition 3a, b). For example, claim 7 encompasses a structure that binds directly to the amino acids at positions 45-384 of human syndecan-3 core protein or indirectly by binding to a secondary structure (e.g., heparin sulfate chains) that binds to the claimed region of human syndecan-3 protein.
Claim 23 is drawn to a method of treating Alzheimer’s Disease wherein the antibody is administered alone or “in combination with an active ingredient conjugated to a carrier”. This claim is understood being drawn to limitations in the active ingredient. For example, the active ingredient is required to be conjugated to a carrier while the syndecan-3 ligand of claim 7 does not require a carrier.
Withdrawn Claim Objections
In view of Applicant’s amendments to claims 7, 8, and 23 the claim objections over said claims are hereby withdrawn.
Withdrawn Rejections
In view of Applicant’s amendments to claim 7 to specify the claimed amino acids refer to positioning the 35 USC 112(b) rejection of claim 7 regarding this ambiguity is hereby withdrawn.
In view of Applicant removing the term “macromolecular” the 35 USC 112(b) rejection regarding this ambiguity is hereby withdrawn.
In view of Applicant amending claim 22 to include “administration comprises” and to specify the claimed amino acids refer to positioning the 35 112(b) rejection regarding these matters are hereby withdrawn.
In view of Applicant amending the claims to remove “single domain antibodies” the 35 USC 112(a) rejection (i.e., new matter) of claims 7-11, 13, 14 and 20-24, the 35 USC 112(b) rejection of claims 9-11 and 13, and the 35 USC 112(d) rejection of claims 14 and 19 are hereby withdrawn.
Upon further consideration the 35 USC 112(d) rejection of claim 23 is hereby withdrawn.
Maintained Rejections
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 7-11, 13, 14 and 20-24 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.
Applicant's arguments filed 1 December 2025 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues the specification and the Declaration under 37 CFR 0167 1.132 filed 1 December 2025 (referred to herein as Affidavit) satisfies the written description requirement (see Remarks pg. 6, 4th para).
To satisfy the written description requirement, the specification must either disclose a representative number of species falling with the genus, or disclose a correlation between structure and function. The specification does not disclose any structure/function correlation, and species disclosed are not representative. Nor is there any evidence of record that the structure-function relationship was known to those of ordinary skill in the art. See MPEP 2163, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are “representative of the full variety or scope of the genus,” or by the establishment of “a reasonable structure-function correlation.” Such correlations may be established “by the inventor as described in the specification,” or they may be “known in the art at the time of the filing date.” See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014). Applicant specifically points to three antibodies in the Affidavit (i.e., R&D systems anti-human SDC3 antibody, Proteintech rabbit polyclonal anti-SDC3 antibody, and a rabbit monoclonal anti-SDC3 antibody) and two antibodies from the specification (i.e., both R&D systems) (see Affidavit pg. 2, middle of the page; see specification para spanning pgs. 8-9). Both the specification and Affidavit disclose the overlapping R&D systems anti-human SDC3 antibody (i.e., cat. No. FAB3539A) (see R&D Systems catalog # FAB3539A pg. 1 product source). Furthermore, the 4 total antibodies disclosed consist of two polyclonal (i.e., Proteintech 10886-1-AP, R&D Systems FAB3539A) and two monoclonal antibodies (i.e., ABIN7270679, R&D Systems MAB35391) (see Proteintech 10886-1-AP product information; see R&D Systems FAB3539A and MAB35391 product information; see Antibodies Online ABIN7270679 product information). Given polyclonal antibodies are a mixture of antibodies that recognize multiple epitopes these two species do not support the written description requirement as there is no structure function correlation (see Lipman et al. (2005) Monoclonal versus polyclonal antibodies: distinguishing characteristics applications, and information resources, ILAR Journal, Vol. 46, No. 3, pgs. 258-268, in particular para spanning pgs. 259-260, pg. 260, 1st col. end of 1st full para). Applicants have demonstrated one of two monoclonal antibodies binds to amino acids 100-114 while the second antibody epitope is not provided (see Affidavit pg. 3 last row of Table). Therefore, Applicant has not provided a representative number of species for the breadth of the instant claims which encompasses i. VHH, ii. single domain antibodies, iii. multispecific antibodies (e.g., bispecific antibodies), iv. humanized, v. human, and vi. antibodies from addition species beyond rat and rabbit which function to both bind to the instantly claimed region and treat Alzheimer’s Disease (AD) (see claim 7). In addition, Applicant has not provided a representative number of species for the breadth of the instant claims which encompasses VHH, single domain antibodies, and multispecific antibodies (e.g., bispecific antibodies) and which function to both bind to the instantly claimed region and traverse the blood brain barrier (see claim 8).
Therefore, the 35 U.S.C. 112(a), written description rejection of claims 7-11, 13, 14 and 20-24 is hereby maintained.
Claim 7-11, 13, 14 and 20-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating Alzheimer’s Disease or a method of brain targeting comprising administering SDC3 antibodies FAB3539A, MAB2734, or AF2734 (see R&D Systems catalog nos.), does not reasonably provide enablement for administration of any SDC3 antibodies that both specifically bind the 45-384 amino acid region of SDC3 and either treat AD (see claim 7) or cross the blood brain barrier (see claim 8). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Applicant's arguments filed 1 December 2025 have been fully considered but they are not persuasive.
Applicant argues the specification and the Affidavit satisfies the written description requirement (see Remarks pg. 6, 4th para).
Applicants have provided 4 antibodies (i.e., two polyclonal and two monoclonal antibodies) which bind to three regions of SDC3 comprising a total of 44 amino acids of the approximately 340 amino acid region claimed (see Affidavit pg. 3, Table). Furthermore, Applicant has demonstrated all four antibodies cross the blood brain barrier while two reduce Aβ uptake into neuronal cells (see Affidavit pg. 5, last para, figure 7; see specification pg. 9 last 2 paras). It is noted all the working examples provided are full length monoclonal or polyclonal antibodies. Applicant has not provided guidance or working examples of the breadth of antibody structures claimed (e.g., VHH, single domain antibodies, multi-specific antibodies) nor disclosed or a representative number of species which will bind to the disclosed region and either treat AD or cross the blood brain barrier.
Therefore, the 35 U.S.C. 112(a), enablement rejection of claims 7-11, 13, 14 and 20-24 is hereby maintained.
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 7-11, 13, 14 and 20-24 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.
Claims 7-11, 13, 14 and 20-24 are drawn to the following structures with SDC3 binding specificity: a mono- or bi- specific antibody, wherein said structures have specificity for a region at amino acid positions 45 to 384 human SDC3 core protein. First, the language of claim 1 refers to both a particular amino acid positions and a particular structure. The scope of the antibody specificity is unclear. For example, does the SDC3 core protein consist of the extracellular domain alone, or alternatively, the extracellular domain, transmembrane domain, and intracellular domain. To put another way, is the amino acid numbering in reference to a SDC3 sequence which comprises the signal sequence or alternatively does not comprise the signal sequence. Furthermore, there are at least two splice isoforms of SDC3 comprising either a 28 amino acid substitution for amino acids 1-86 or a deletion of amino acids as evidenced by R&D Systems (see R&D Systems catalog no. AF3539, pg. 2, 1st para). Therefore, without a reference sequence it is unclear which residues are within the scope of the instant claims.
Claim 10 and 13 recite the limitation “the mono- or bi- specific antibody” in lines 3-4 (see claim 10) or lines 1-2 (see claim 13). There is insufficient antecedent basis for this limitation in the claim.
Claim 21 is drawn to a method of treating neurodegenerative disorders comprising administering to the subject a mono- or bi-specific antibody with specificity for the 45-384 amino acid region of the syndecan-3 core protein. It is unclear if the mono- or bi- specific antibody of claim 21 is in addition to the antibody of claim 7 or alternatively if the mono- or bi-specific antibody of claim 21 is a structural limitation of the antibody recited in claim 7.
Applicant's arguments filed 1 December 2025 have been fully considered but they are not persuasive.
Applicant argues the claims have been amended to correct each of the deficiencies listed above (see Remarks pg. 6, 5th para). However, the claims have not been amended to resolve the indefiniteness set forth above.
Therefore the 35 U.S.C. 112(b) rejection of claims 7-11, 13, 14 and 20-24 are hereby maintained for the reasons made of record.
Claim Objections
Applicant is advised that should claim 10 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
New Claim Rejections - 35 USC § 112(b)
Claims 7-11, 13, 14, and 20-24 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 7 is drawn to wherein the SDC3 ligand with specificity for a region at amino acids 45-384 of human SDC3 core protein comprises an antibody. The scope of the ligand is unclear. For example, is the claimed limited to wherein the antibody must have specificity for the claimed region or alternatively is the claim broader encompasses alternative structures (e.g., natural ligands, small molecules) with specificity for the claimed language linked and antibody.
The scope of Claim 8 is unclear. First, while claim 8 is drawn to “a method” (line 1) and “delivering said ligand into the brain of a patient” (line 4), claim 10 specifies the delivery comprises, “attaching the mono- or bi specific antibody… on endothelial cells” and “via systemic circulation”. It is thus unclear if “delivering said ligand” is synonymous with “administration” or alternatively with the inherent property of antibody binding (i.e., attaching). To put another way, it is unclear if claim 7 drawn to a method wherein “delivering” is synonymous with administering or alternatively whether the “delivering” encompasses the process or mechanism by which the antibody crosses the blood brain barrier.
Claim 10 is drawn to “attaching the mono- or bi- specific antibody… to the region at amino acid positions 45-384 of the human SDC3”. However, claim 8 is drawn to “a SDC3 ligand possessing specificity for a region at amino acid positions 45 to 384 of human SDC3… and wherein said ligand comprises an antibody”. The scope of the antibody of claim 10 is unclear. For example, does claim 10 require the antibody directly bind to the claimed region or alternatively encompass both direct and indirect attachment.
Claim 11 is drawn to wherein a bispecific antibody is used. It is unclear if the bispecific antibody is a limitation in the antibody recited in claim 8 or alternatively is a second structure independent from the first structure. In addition, it is unclear what the bispecific antibody is “used” for.
Claim 22 recite the limitation “the antibody with specificity for the region at positions 45-384 of human syndecan-3” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 is drawn to wherein the antibody is administered alone. The scope of alone is unclear. For example, is alone drawn to the timing of the dose or alternatively the composition itself. To put another way is a syndecan antibody administered from one syringe while a second agent is administered from a second syringe within the scope of “alone”, or alternatively, does “alone” limit the claim to wherein no additional agents are administered.
New-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.
In so far as Applicant is claiming “delivery” as recited in claim 8 as encompassing “attaching” as recited in claim 10 the following rejection is provided.
Claims 8-11, 13, 14, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more (see below).
The following 35 USC 101 analysis using the Alice/Mayo test was performed (see MPEP § 2106(III):
Step 1: Yes, claim 8 is drawn to a method.
Step 2A Prong 1: Yes, claim 8 is drawn to a method comprising delivering said ligand into the brain of a patient. It is noted dependent claim 10 recites, “wherein the delivery comprises attaching the mono- or bi specific antibody, via systemic circulation” and “on endothelial cells of the blood-brain-barrier”. Therefore, the recitation of “delivering said ligand into the brain of a patient” is a natural phenomenon/consequence of the antibody binding (i.e., attaching). Therefore, claim 8 requires an inherent property of antibody (i.e., binding) structure as evidenced by Baran (see Baran et al. (2017) Principles for computational design of binding antibodies, Proc. Natl. Acad. Sci. U.S.A. 114 (41) 10900-10905, in particular, blue box, Significance).
Step 2A Prong 2: No, the claim does not recite additional elements that integrate the judicial exception into a practical application. The claim does not require the antibody be administered to a patient.
Step 2B: No, the additional elements do not amount to an inventive concept.
Claim 8 also recites limitations in the particular region of human SDC3 the ligand has specificity for.
Claims 9, 11, 13, 14, and 20 recite limitations in the structure the ligand.
Claim 10 recites limitations in a route of administration however no administration step is set forth in claim 8.
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 8-10 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 14 of copending Application No. 17/924,427 (referred to herein as ‘427 application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘427 application claims a method of treating SARS-CoV-2 comprising administering to a patient an anti-syndecan antibody (see claim 13), in particular, an antibody specific for the extracellular domains or residues 1-384 of SDC3 (see claim 14). Therefore, the ‘427 application recites a method comprising delivering to the brain a syndecan-3 antibody with the claimed specificity. Regarding the instantly claimed “for brain targeting”, this is an intended use and therefore does not further limit the method (see MPEP § 2111.02(II)). Regarding recitation of “delivering into the brain of a patient”, this is an inherent property of the antibody binding; therefore, claiming an antibody that binds to the claimed region would necessarily cross the blood brain barrier. This is pertinent to instant claims 8 and 9.
Regarding claims 10 and 14 the ordinary artisan would find it obvious to administer the antibody systemically in order to treat SARS-CoV-2 thereby attaching to the claimed region of human syndecan-2 core protein expressed on endothelial cells of the blood-brain barrier.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim allowed.
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/H.A.P./Examiner, Art Unit 1644
/AMY E JUEDES/Primary Examiner, Art Unit 1644