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
1. Claims 1-19 are currently pending.
Election/Restrictions
2. Applicant’s election of Group II, claims 17-19 in the reply filed on July 6, 2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 6, 2026. Claims 17-19 are currently under examination.
Claim Objections
3. Claim 17 is objected to because of the following informalities: on first sight, T1D should be accompanied by “type 1 diabetes” and LADA should be accompanied by “latent immune diabetes of an adult”. Appropriate correction is required.
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.
4. Claim 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20-22 of copending Application No. 18/674,217 (reference application 2024/0382589 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims are drawn to a method of diagnosing a subject with T1D or LADA, the method comprising: obtaining a blood sample from the subject; analyzing the blood sample to determine an amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present; comparing the determined amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in the blood sample from the subject to a control amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in a control sample from a donor without T1D or LADA; and diagnosing the subject as having T1D or LADA if the amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in the blood sample is greater than the control amount.
Meanwhile, the co-pending claims are drawn to a method of diagnosing a subject with TID or LADA, the method comprising: obtaining a blood sample from the subject; analyzing the blood sample to determine an amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present; comparing the determined amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in the blood sample from the subject to a control amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in a control sample from a donor without TID or LADA; and diagnosing the subject as having TID or LADA if the amount of CD4+CD25− IFNg+IL17+FOXP3+ T cells present in the blood sample is greater than the control amount.
The pending claims anticipate the co-pending claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
5. Claims 17-19 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.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must 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 fully describe the method as claimed. In the instant case, to fulfill the written description requirement, the invention as claimed must be adequately described.
The claimed invention is drawn to a method of diagnosing a subject with T1D or LADA, the method comprising: obtaining a blood sample from the subject; analyzing the blood sample to determine an amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present; comparing the determined amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in the blood sample from the subject to a control amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in a control sample from a donor without T1D or LADA; and diagnosing the subject as having T1D or LADA if the amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in the blood sample is greater than the control amount.
The specification describes methods for inducing plasticity in effector T cells to exhibit a regulatory T cell phenotype comprising administering an effective amount of GC7 to a subject, administering an effective amount of an anti-DLL4 antibody, and administering GAD65-specific CAR Tregs as a treatment for type 1 diabetes; a method for treating type 1 diabetes comprising administering GC7 to inhibit eIF5A signaling, administering anti-DLL4 antibody to inhibit Notch signaling , and administering GAD65-specific CAR Tregs; and a method for enriching Tregs cells in a subject comprising simultaneously inhibiting eIF5A signaling with GC7 and Notch signaling with an anti-DLL4-antibody wherein the subject is being prepared for an organ transplant.
However, the specification does not adequately describe methods for diagnosing a subject with T1D or LADA, the method comprising: obtaining a blood sample from the subject; analyzing the blood sample to determine an amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present; comparing the determined amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in the blood sample from the subject to a control amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in a control sample from a donor without T1D or LADA; and diagnosing the subject as having T1D or LADA if the amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in the blood sample is greater than the control amount.
Traditionally, diagnosis of Type 1 diabetes include Glycated hemoglobin (A1C) test. Mayo Clinic -Type 1 diabetes, 2024; https://www.mayoclinic.org/diseases-conditions/type-1-diabetes/diagnosis-treatment/drc-20353017?p=1 teaches that this blood test shows your average blood sugar level for the past 2 to 3 months. It measures the amount of blood sugar attached to the oxygen-carrying protein in red blood cells (hemoglobin). The higher the blood sugar levels, the more hemoglobin you'll have with sugar attached. An A1C level of 6.5% or higher on two separate tests means you have diabetes.
Moreover, Lundholm et al., Cleveland Clinic Journal of Medicine, 2025; 92(12):757-763 teaches that Diagnosing LADA requires careful consideration of clinical and laboratory findings. The following criteria are used, although none are categorical13:
Adult-onset diabetes (age generally ≥ 30 years)
Presence of diabetes-associated autoantibodies (e.g., GAD65, IA-2, ZnT8, ICA)
Absence of insulin requirement for at least 6 months after diagnosis.
These criteria reflect the slower progression to insulin dependence in LADA than in type 1 diabetes while emphasizing the autoimmune nature of the disease. Cutoff values for GAD65 antibody positivity are assay dependent and should be interpreted according to the manufacturer’s reference range; most commercial enzyme-linked immunosorbent assays define a positive result as greater than 5.0 U/mL. Serial monitoring of GAD65 antibodies is not standard because titer fluctuations do not meaningfully correlate with disease activity or progression. In patients with negative GAD65 antibody results, repeat testing is not generally recommended because seroconversion is unlikely. However, patients with high clinical suspicion should be tested for other diabetes-associated autoantibodies (e.g., IA-2, ZnT8, ICA).
The written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or teach correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the claimed invention.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
Written description requirement 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. The Guidelines further state, "[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus.
Therefore, absent a detailed and particular description the skilled artisan could not immediately recognize or distinguish members of the claimed method. Therefore, because the art is unpredictable, in accordance with the Guidelines, the description do not meet the written description requirements.
Conclusion
6. No claim is allowed.
7. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bluestone et al., WO 2007/140472 is the closest prior art. It is not applicable because it does not teach or disclose determining an amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present; comparing the determined amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in the blood sample from the subject to a control amount of CD4+CD25−IFNg+IL17+FOXP3+ T cells present in a control sample from a donor without TID or LADA.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 July 24, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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