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 3-16) in the reply filed on 11/17/2025 is acknowledged.
2. Claims 3-23 are pending. Claims 3-16 are currently under consideration.
Information Disclosure Statement
3. The information disclosure statement filed on 09/03/2024, 03/28/2024, and 08/03/2023 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 06/12/2023 are accepted by the examiner.
Claim Rejections [Symbol font/0xBE]35 U.S.C. § 101
5. 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.
6. Claims 3-12 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
Claims 3-12 are drawn to a method of suppressing immune cells comprising contacting an immune cell with a composition comprising a cytokine linked to a ligand, wherein the ligand specifically binds to a receptor on the immune cell thereby suppressing the immune cell. The claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility. A specific and substantial utility is one that is particular to the subject matter claimed and that identifies a “real world” context of use for the claimed invention which does not require further research.
First, since the claims are directed to a specific method of use, the utility of the claims are limited to that use. Consequently, there is no "well-established" utility for the method (See REVISED INTERIM UTILITY GUIDELINES TRAINING
MATERIALS, Example 12, http://www.uspto.gov/web/patents/guides.htm).
Secondly, there is no specific and substantial utility for the claimed method of suppressing immune cells comprising contacting an immune cell with a composition comprising a cytokine linked to a ligand, wherein the ligand specifically binds to a receptor on the immune cell thereby suppressing the immune cell. Such uses are all considered research uses only designed to identify a particular function of the composition comprising a cytokine linked to a ligand and are not a substantial utility. See, e.g., Brenner v. Manson, 383 U.S. 519, 148 USPQ 689 (Sup. Ct. 1966) wherein a research utility was not considered a "substantial utility." Clearly, further research would be required to identify a disease that can be treated with the recited molecules. See Brenner v. Manson, 383 U.S. 519, 148 USPQ 689 (Sup. Ct. 1966), noting that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion."
In summary, the uses of composition comprising a cytokine linked to a ligand in the claimed method are not specific and substantial because they do not identify or reasonably confirm a "real world" context of use, for example, treatment of a particular disease. "Congress intended that no patent be granted on a chemical compound whose sole 'utility' consists of its potential role as an object of use-testing." Brenner v. Manson, 148 USPQ at 696.
7. Claims 3-12 are also rejected under 35 U.S.C. 112, first paragraph. Specifically, since the claimed invention is not supported by either a specific and substantial asserted utility or a well established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
8. 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.
9. Claims 3-7 and 11-16 are rejected under 35 U.S.C. 112(a), 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. 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.
Claim 3 is drawn to a method of suppressing immune cells comprising contacting an immune cell with a composition comprising a cytokine linked to a ligand, wherein the ligand specifically binds to a receptor on the immune cell thereby suppressing the immune cell. The claim does not require that the cytokine and the receptor possess any particular conserved structure or any distinguishing feature. Claims 4-7 and 11-16 depend from claim 3. Thus, the claims recite a genus of compositions without structural features.
The specification discloses IL-2-linked to OMCP (Table A; Example 1-6) and NKG2D-targeted delivery of an IL-2 (Example 1). The specification discloses mutants of IL-2, R38A, F42K, and C125S (page 34, paragraph [0084]; page 36, paragraph [0089]; page 70, paragraph [0166]). The specification discloses IL-15 linked to OMCP and NKG2D-targeted delivery of an IL-15 (Example 17-20). However, such a disclosure is insufficient to support the broad genus of cytokines, ligands, and compositions comprising a cytokine linked to a ligand.
Vas-Cath Inc. v Mahurkar, 19 USPQ2d 1111 (Fed. Cir.1991), clearly states that “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 purpose 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). Adequate written description requires more than a mere statement that it is part of the invention are 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 (Fed. Cir.1991).
An adequate written description of a chemical invention “requires a precise definition, such as by structure, formula, chemical name, or physical properties." University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927 (Fed. Cir.2004); Regents of the Univ. of Cal. V. Eli Lilly & Co., Inc., 119 F.3d 1559, 1556 (Fed. Cir.1997); Fiers v. Revel, 984F.2d 1164, 1171 (Fed. Cir.1993). “A description of what a material does, rather than of what it is, usually does not suffice.” Rochester, 358F.3d at 923; Eli Lilly, 119 F.3d at 1568. In addition, possession of a genus “may be achieved by means of a recitation of a representative number of [compounds]…falling within the scope of the genus.” Eli Lilly, 119 F.3d at 1569. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus. See Rochester, 358 f. 3d at 927. For the reasons above, one skilled in the art would not recognize from the disclosure that Applicant was in possession of the instantly claimed invention.
10. Claims 13-16 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).
Claim 13 recites a limitation, “wherein suppression of the immune cells results in treatment, stabilization and prevention of an autoimmune disease in a subject caused by overactive immune cells”, whereas claim 16 recites a limitation, “suppression of the immune cells results in prevention of transplant/graft rejection”. Claims 14-15 depend from claim 13. Thus, the claims encompass not only treatment of an autoimmune disease in a subject, but also prevention of an autoimmune disease in a subject and prevention of transplant/graft rejection.
The specification discloses IL-2-linked to OMCP (Table A; Example 1-6) and NKG2D-targeted delivery of an IL-2 (Example 1). The specification discloses mutants of IL-2, R38A, F42K, and C125S (page 34, paragraph [0084]; page 36, paragraph [0089]; page 70, paragraph [0166]). The specification discloses IL-15 linked to OMCP and NKG2D-targeted delivery of an IL-15 (Example 17-20). However, the specification does not provide sufficient guidance/direction or working examples on how to treat or prevent an autoimmune disease in a subject caused by overactive immune cells or how to prevent transplant/graft rejection. It is unpredictable whether contacting an immune cell with a composition comprising a cytokine linked to a ligand, wherein the ligand specifically binds to a receptor on the immune cell, results in treatment, stabilization and prevention of an autoimmune disease in a subject caused by overactive immune cells or results in prevention of transplant/graft rejection.
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 composition of the present application to treat or prevent an autoimmune disease in a subject caused by overactive immune cells or how to prevent transplant/graft rejection,
the lack of directions/guidance presented in the specification regarding the same, the lack of the 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)
11. 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.
12. Claims 13-16 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.
Claim 13 recites a limitation, “wherein suppression of the immune cells results in treatment, stabilization and prevention of an autoimmune disease in a subject caused by overactive immune cells”, whereas claim 16 recites a limitation, “suppression of the immune cells results in prevention of transplant/graft rejection”. It is unclear how the contacting step recited in claim 3 results in treatment, stabilization and prevention of an autoimmune disease in a subject or prevention of transplant/graft rejection, since there is no requirement for administering the composition of claim 3 to a subject. Moreover, it is unclear whether claims 13-16 are drawn to a method treating an autoimmune disease in a subject or a method of preventing transplant/graft rejection. Claims 14-15 are rejected as dependent claims.
Conclusion
13. 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/ Examiner, Art Unit 1646
December 4, 2025