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 .
DETAILED ACTION
Restriction/Election
1. Applicant’s election without traverse of Group I (claims 1-6 and 8-13) in the reply filed on 03/19/2026 is acknowledged. In response to species election requirement, Applicant elected, without traverse, the species of an anti-sCD22 antibody of claim 4.
2. Claims 1-6 and 8-24 are pending. Claims 1-4 and 9-13 are currently under consideration. Claims 5-6, 8, and 14-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species.
Information Disclosure Statement
3. The information disclosure statement filed on 04/04/2025 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawings filed on 11/10/2022 are objected to because the labels in Figs 1-4 are illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
5. The following is a quotation of the first paragraph of 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.
6. Claims 1-4 and 9-13 are rejected under 35 U.S.C. 112(a), 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 at the time the application was filed, had possession of the claimed invention.
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. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claim 1 is drawn to a method of treating a lysosomal storage disorder, comprising: exposing a subject's microglia to a soluble CD22 (sCD22) inhibitor wherein said exposing treats said lysosomal storage disorder. Claim 4 recites a limitation, “wherein said sCD22 inhibitor is an anti-sCD22 antibody”. Claims 2-3 and 9-13 depend from claim 1. The claims do not require that the sCD22 inhibitor or anti-sCD22 antibody possess any particular conserved structure nor other disclosed distinguishing feature. Thus, the claims encompass a genus of sCD22 inhibitors or anti-sCD22 antibodies
without any structural features.
For each claim drawn to a genus, MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “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”. In the instant case, the specification discloses CD22-blockin mAb generation strategy and 51 clones with intermediate to strong binding (page 32, the second paragraph; Figure 4). However, none of the antibodies were structurally identified. Moreover, the specification does not disclose any particular sCD22 inhibitors that can be used to a lysosomal storage disorder, such as Niemann-Pick Disease Type C (NPC). Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what sCD22 inhibitors or anti-sCD22 antibodies might be.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of sCD22 inhibitors or anti-sCD22 antibodies.
7. Claims 1-4 and 9-13 are rejected under 35 U.S.C. 112(a), 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 use the invention.
The factors that are considered when determining whether a disclosure satisfies enablement requirement include: (i) the quantity of experimentation necessary; (ii) the amount of direction or guidance presented; (iii) the existence of working examples; (iv) the nature of the invention; (v) the state of the prior art; (vi) the relative skill of those in the art; (vii) the predictability or unpredictability of the art; and (viii) the breadth of the claims. Ex Parte Forman, 230 USPQ 546 (Bd Pat. App. & Int. 1986); In re Wands, 858 F. 2d 731, 8 USPQ 2d 1400 (Fed. Cir. 1988).
Claims 1-4 and 9-13 drawn to a method of treating a lysosomal storage disorder, comprising: exposing a subject's microglia to a soluble CD22 (sCD22) inhibitor. Claim 4 recites a limitation, “wherein said sCD22 inhibitor is an anti-sCD22 antibody”. The claims are broad because they encompass a method of treating a genus of lysosomal storage disorders comprising exposing a subject's microglia to a broad genus of soluble CD22 (sCD22) inhibitors or anti-sCD22 antibodies.
The specification discloses the following: (i) oligodendrocyte-derived sCD22 binds to sialic acid-dependent ligands on microglia (page 29), (ii) genetic and proteomic screens identify IGF2R as a sCD22 ligand on microglia (page 30); (iii) CD22 blocks IGF2R at M6P binding sites and inhibits lysosomal trafficking (page 31); and (iv) that anti-CD22 antibodies disrupt sCD22-IGF2R interactions and rescue lysosomal dysfunction (page 32). The specification also discloses CD22-blockin mAb generation strategy and 51 clones with intermediate to strong binding (page 32, the second paragraph; Figure 4). However, none of the antibodies were structurally identified. Moreover, the specification does not disclose any particular sCD22 inhibitors that can be used to treat a lysosomal storage disorder, such as Niemann-Pick Disease Type C (NPC).
The specification does not provide sufficient guidance/direction or working examples on how to make the genus of sCD22 inhibitors or anti-sCD22 antibodies; the specification does not provide sufficient guidance/direction or working examples on how to treat a lysosomal storage disorder, such as Niemann-Pick Disease Type C (NPC), in a human subject comprising exposing a subject’s microglia to a CD22 inhibitor, such as an anti-sCD22 antibody. It is unpredictable if administer a CD22 inhibitor, such as an anti-sCD22 antibody, to a human subject can treat a lysosomal storage disorder, such as Niemann-Pick Disease Type C (NPC). As a further note, the specification does not provide sufficient guidance on how “in vitro exposing” can treat a lysosomal storage disorder in a human subject as recited in claim 10.
The courts have stated that patent protection is granted in return for an enabling disclosure. Reasonable detail must be provided in order to enable members of the public to understand and carry out the invention. See Genetech v. Novo Nordick A/S (CAFC) 42 USPQ2d 1001 (1997). Similarly, as stated in Rasmusson v SmithKline Beecham Corp., 75 USPQ2d 1297-1303 (CAFC 2005), “if mere plausibility were the test for enablement under section 112, Applicants could obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the 'inventor’ would be rewarded the spoils instead of the party who demonstrated that the method actually worked. The scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis. In the instant case, the evidence on the record supports that the specification does not enable the claimed invention.
Due to the large quantity for experimentation necessary to make and use the broad genus of CD22 inhibitors or anti-sCD22 antibodies to treat a broad genus of lysosomal storage disorders, the lack of directions guidance presented in the specification regarding the same, the lack of working example directed to the same, the complex nature of the invention, the unpredictability in the art, and the breadth of the claims, undue experimentation would be required for the skilled artisan to make and use the claimed invention.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
8. The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
9. Claims 10 and 13 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(ii). Claim 13 is indefinite because it does not indicate what to be assayed in a cerebrospinal fluid (SCF) sample from a subject, how the assay is carried out in part (a); and how the subject to which an agent is administered in part b.
(i). Claim 10 recites a limitation, “wherein said exposing is in vivo exposing, ex vivo exposing or in vitro exposing”. It is unclear how “in vitro exposing” can treat a lysosomal storage disorder in a human subject.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)
10. 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.
11. Claims 1-4, 9-11, and 13 are rejected under 35 U.S.C. 102 (a) (1) or 102 (a)(2) as being anticipated by WO 2019/126725 A1 (International Publication Date: 27 June 2019; International Filing Date: 21 December 2018), US 2020/0317778 A1 or US 11,891,442 B2. The rejection below is set forth based upon the teachings of WO 2019/126725 A1.
WO 2019/126725 A1 teaches a method of treating a lysosomal storage disorder, such as Niemann-Pick Disease Type C (NPC), in a human subject comprising exposing a subject’s microglia to a CD22 inhibitor (page 7, paragraphs 1-2; claims 39-42), which is an anti-CD22 antibody (page 3, lines 3-4) and interferes with CD22 expression (page 3, line 17). The exposing is in vivo exposing, ex vivo exposing or in vitro exposing (page 3, line 18). WO 2019/126725 A1 teaches a CD22 ligand-blocking antibody (page 6, line 8; page 72, paragraph 2), which comprises a soluble CD22 inhibitor or an anti-sCD22 antibody. WO 2019/126725 A1 teaches the exposing routes as recited in claim 10 (page 3, line 19-23) and assaying a cerebrospinal fluid (SCF) sample from a subject (page 6, paragraph 4; page 72, paragraph 2; page 86, paragraph 1). Thus, the teachings of WO 2019/126725 A1 meet the limitations of claims 1-4, 9-11, and 13.
Claim Rejections[Symbol font/0xBE] Nonstatutory Obviousness-Type Double Patenting
12. Basis for nonstatutory 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. See 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);and, 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/ guidance/eTD-info-I.jsp.
13. Claims 1-4 and 9-13 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 of US Patent No. 11,891,442 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-7 of US Patent No. 11,891,442 B2 are drawn to a method of treating Niemann-Pick Disease Type C (NPC), comprising exposing one or more of a subject’s microglia to an anti-CD22 antibody. On the other hand, claims 1-4 and 9-13 of the instant application are drawn to a method of treating a lysosomal storage disorder, including Niemann-Pick Disease Type C (NPC), comprising: exposing a subject's microglia to a soluble CD22 (sCD22) inhibitor, including an anti-sCD22 antibody. Claims 1-7 of US Patent No. 11,891,442 B2 and claims 1-4 and 9-13 of the instant application vary in scope and are obvious over each other.
Claim Objection
14. Claim 8 is objected to because the claim should be numbered sequentially. Appropriate correction is required.
Conclusion
15. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
April 15, 2026
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