DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1, 3-5, 7, 9, 10, 13, 14, 19, 26-28, 32, 37-40, 46, 47 and 51 are pending upon entry of amendment filed on 3/27/24.
Upon further consideration, the restriction requirement filed on 4/8/26 has been withdrawn.
Claim 1, 3-5, 7, 9, 10, 13, 14, 19, 26-28, 32, 37-40, 46, 47 and 51 are under consideration in the instant application.
3. Applicant’s IDS filed on 3/27/24, 5/2/25, 8/14/25, 12/30/25 and 7/7/26 have been acknowledged.
4. The oath filed on 8/31/23 has been acknowledged.
5. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
6. 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.
7. Claims 1, 3-5, 7, 9, 10, 13, 14, 19, 26-28, 32, 37-40, 46, 47 and 51 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method of immunotolerizing a subject comprising administering o-phospho-L-serine (OPLS), o-phospho-L-tyrosine (OPLT) or o-benzyl-L-tyrosine (OBLT) or method of treating an autoimmune disease comprising administering OPLS, OPLT or OBLT, does not reasonably provide enablement for more.
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/or use of the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would make and use amino acid derivatives set forth in claim 1 in induction of immunotolerance.
Examples 1-4 disclose reduction of immune response to FVIII using OPLT and OPLS and OPLS is a critical part of inducing immune tolerance. As disclosed in U.S. Pub. 2016/0243220 (IDS reference), OPLS is essential part of inducing tolerance toward antigen specific response in the presence of antigen (claims, disclosure). However, instant claims recite in the absence of OPLS in lack of antigen in claim 1 but derivatives of hydroxyamino acid.
The claims of the instant application is a method of immunotolezing a subject comprising administering of thiamino acid, hydroxyamino acid or derivatives thereof. The instant application fails to disclose induction of tolerance comprising thiamino acid, hydroxyamino acid or derivatives thereof other than OPLS, OPLT or OBLT, especially OPLS is not allowed embodiment.
As such, immunotolerizing effect cannot be extrapolated to any thiamino acid, hydroxyamino acid or derivatives thereof other than OPLS, OPLT or OBLT, at any concentration ranges encompassed by the claimed invention.
The specification fails to provide sufficient guidance to direct a person of skilled in the art to make and achieve the intended use of the claimed invention without undue experimentation. The specification discloses OPLS, OPLT or OBLT but the OPLS is not a required component. It is unpredictable to develop thiamino acid, hydroxyamino acid or derivatives thereof other than OPLS, OPLT or OBLT in the example cannot be extrapolated to various derivatives encompassed by the claimed invention to achieve the intended use.
To summarize, reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view or the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breath of the claims, it would take undue trials and errors to practice the claimed invention. Applicant is advised to limit induction method to inclusive of
OPLS, OPLT or OBLT.
8. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
9. Claims 1, 3-5, 7, 9, 10, 13, 14, 19, 26-28, 32, 37-40, 46, 47 and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-45 of U.S. Application No. 18/659,715 (issued to U.S. Pat 12,390,434).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘715 application recite a method of inducing tolerance comprising tyrosine derivatives including OBLT or OPLT and method of treating autoimmune disorders comprising administering tyrosine derivatives including OBLT or OPLT.
10. Claims 1, 3-5, 7, 9, 10, 13, 14, 19, 26-28, 32, 37-40, 46, 47 and 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-46 of U.S. Application No. 19/273,261.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘261 application recite a method of inducing tolerance comprising tyrosine derivatives including OBLT or OPLT and method of treating autoimmune disorders comprising administering tyrosine derivatives including OBLT or OPLT.
11. No claims are allowable.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
August 18, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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