Notice of Pre-AIA or AIA Status
1. 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
Status of Application, Amendments, and/or Claims
2. Claims 1-49 are pending and the subject of this Office Action.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 08 September 2023, 25 September 2023, 02 February 2024 and 09 July 2024 have been considered by the Examiner.
Claim Rejections - 35 USC § 112, 1st Paragraph (Written Description)
4. The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-18, 22, 26, 30, 34, 38, 42 and 46 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
6. The U.S. Court of Appeals for the Federal Circuit recently reaffirmed, in an en banc decision, that the written description requirement for a genus may be satisfied either by (i) the disclosure of a representative number of species falling within the scope of the genus or (ii) structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus. Ariad Pharmaceuticals', Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350, 94 U.S.P.Q.2d 1161, 1171 (en banc) (Fed. Cir. 2010), citing Regents" of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568-69, 43 U.S.P.Q.2d 1398, 1406 (Fed. Cir. 1997).
7. The representative ways of satisfying the written description requirement as set out by the Federal Circuit in Ariad Pharmaceuticals comport with statements set out in the USPTO's Manual of Patent Examining Procedure (M.P.E.P.). In particular, the M.P.E.P. provides that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species of relevant identifying characteristics. M.P.E.P. § 2163, II, A, 3, (a), (ii).
8. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed, and correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. “Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163.
9. The claims are drawn very broadly to a method of activating or inducing differentiation or expansion of a memory T cell, the method comprising contacting a memory T cell in a liquid culture medium comprising: (1) an effective amount of a multi-chain chimeric polypeptide comprising:(a) a first chimeric polypeptide comprising: (i) a first target-binding domain; (ii) a soluble tissue factor domain; and (iii) a first domain of a pair of affinity domains; (b) a second chimeric polypeptide comprising: (i) a second domain of the pair of affinity domains; and (ii) a second target-binding domain, wherein the first chimeric polypeptide and the second chimeric polypeptide associate through the binding of the first domain and the second domain of the pair of affinity domains; and (2) an effective amount of an IgGI antibody construct comprising at least one antigen- binding domain that binds specifically to the soluble tissue factor domain. The claims also recite wherein the soluble tissue factor domain is a soluble human tissue factor domain; wherein the soluble tissue factor domain does not stimulate blood coagulation; and wherein the multi-chain chimeric polypeptide does not stimulate blood coagulation. The claims also recite wherein: the soluble tissue factor domain comprises a sequence that is at least 80% identical to SEQ ID NO: 1; the first domain of the pair of affinity domains comprises a sequence that is at least 80% identical to SEQ ID NO: 39; the second domain of the pair of affinity domains comprises a sequence that is at least 80% identical to SEQ ID NO: 10; and wherein: (A) the first target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 135 and the second target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 124; (B) the first target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 124 and the second target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 135; (C) the first target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 124 and the second target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 60; or (D) the first target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 60 and the second target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 60; or wherein the first target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 124; and the second target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 135; or wherein the first chimeric polypeptide comprises a sequence at least 80% identical to SEQ ID NO: 141; and the second chimeric polypeptide comprises a sequence at least 80% identical to SEQ ID NO: 145; or wherein he first chimeric polypeptide comprises a sequence that is at least 80% identical to SEQ ID NO: 126; and the second chimeric polypeptide comprises a sequence that is at least 80% identical to SEQ ID NO: 137. The claims also recite wherein the first target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 124; and the second target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 60; or wherein first chimeric polypeptide comprises a sequence that is at least 80% identical to SEQ ID NO: 126; and the second chimeric polypeptide comprises a sequence that is at least 80% identical to SEQ ID NO: 132; or wherein the first target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 60; and the second target-binding domain comprises a sequence that is at least 80% identical to SEQ ID NO: 60; or wherein the first chimeric polypeptide comprises a sequence that is at least 80% identical to SEQ ID NO: 161; and the second chimeric polypeptide comprises a sequence that is at least 80% identical to SEQ ID NO: 130. Thus, the claims have been broadly interpreted by the Examiner as reading upon method of activating or inducing differentiation or expansion of a memory T cell utilizing an extremely large genus of multi-chain chimeric polypeptides that are defined by only a desired function/activity, or by a partial structure and a desired function/activity.
10. While the Specification provides adequate written description for a number of single-chain and multi-chain chimeric polypeptides that are defined by particular amino acid sequences (See Examples), it does not provide adequate written description for the genus of variants encompassed by the claims that (1) comprise first and second target-binding domains, linker domains, and affinity domains without any disclosed structure; or (2) encompass variants having as little as 70% sequence identity to IL-7, IL-21, TGF-βRII and human tissue factor (See pp. 67-68 of the Specification), that have the recited functions and can be used in the claimed methods. Accordingly, the specification does not provide adequate written description of the claimed genus.
11. For genus claims, an adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries. A patent must set forth either a representative number of species falling within the scope of the genus or structural features common to the members of the genus. Kubin, Exparte, 83 USPQ2d 1410 (Bd. Pat. App. & Int. 2007); Ariad Pharms., Inc. v. Eli Lilly& Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010).
A “patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”), see MPEP 2163.IIAii.
12. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, 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 purposes 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).
13. It is well known that minor structural differences even among structurally related compounds can result in substantially different biology, expression and activities. While it is known that amino acid substitutions are generally possible in any given protein, the positions within the protein's sequence where such amino acid substitutions can be made with a reasonable expectation of success are limited. Certain positions in the sequence are critical to the protein's structure/function relationship, e.g. such as various sites or regions directly involved in binding, activity and in providing the correct three-dimensional spatial orientation of binding and active sites. These regions can tolerate only relatively conservative substitutions or no substitutions (see Wells, 1990, Biochemistry 29:8509-8517; Ngo et al., 1994, The Protein Folding Problem and Tertiary Structure Prediction, pp. 492-495). While art-recognized procedures for designing and producing variants is known, such does not provide adequate written description of the active variants that may be constructed, since the art recognizes that function cannot be predicted from structure alone (Skolnick et al., 2000, Trends in Biotech. 18(1):34-39, especially p. 36 at Box 2).
14. Therefore, without any recitation of the structure of the first and second target-binding domains, soluble tissue factor domains, and affinity domains, the skilled artisan cannot envision the detailed chemical structure of the encompassed polypeptides that have the recited activity, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product 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.
15. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Double Patenting
16. 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 claims at issue 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
17. 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
18. The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
19. Claims 1-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,884,712. The ‘712 Patent is not afforded safe harbor protection under 35 USC 121 because the claims do not share continuity nor a restriction/speciation with the claims of the instant application. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
20. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-28 of the ‘712 patent are drawn to a genus of multi-chain chimeric polypeptides, wherein the first target binding domain is IL-21 or IL-7 and the second target binding domain is IL-7 or IL-21, that is encompassed the genus of multi-chain chimeric polypeptides recited in the instant claims. While the claims of the ‘712 Patent do not recite methods of activating or inducing differentiation or expansion of a memory T cell, however the Specification discloses this as the sole purpose of the claimed multi-chain chimeric polypeptides. It is noted in In Sun Pharmaceutical Industries, Ltd. V. Eli Lilly & Co., No. 10-1105 (Fed. Cir.
July 28, 2010) the Federal Circuit stated that:
the “Pfizer decision shows that obviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound.” Id. At 10. (Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008)). Therefore, the Federal Circuit concluded that its obviousness-type double patenting analysis extends to any and all such uses disclosed in the specification of the earlier patent.
Therefor the instant claims are obvious over the claims of the ‘712 Patent.
21. Claims 1-17 and 42-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,509,494. The ‘494 Patent is not afforded safe harbor protection under 35 USC 121 because the claims do not share continuity nor a restriction/speciation with the claims of the instant application. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
22. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the ‘494 patent are drawn to a method of stimulating a T cell with a species of multi-chain chimeric polypeptides, wherein the first and second target binding domain is TGF-βRII, that is encompassed the genus of multi-chain chimeric polypeptides recited in the instant claims. Therefor the instant claims are obvious over the claims of the ‘494 Patent.
23. Claims 1-17 and 42-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of U.S. Patent No. 11,672,826. The ‘826 Patent is not afforded safe harbor protection under 35 USC 121 because the claims do not share continuity nor a restriction/speciation with the claims of the instant application. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
24. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the ‘826 patent are drawn to a method of treating a cancer in a subject with a species of multi-chain chimeric polypeptides, wherein the first and second target binding domain is TGF-βRII, that is encompassed the genus of multi-chain chimeric polypeptides recited in the instant claims. Therefor the instant claims are obvious over the claims of the ‘826 Patent.
25. Claims 1-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Application No. 18/497,169 (reference application). The reference application is not afforded safe harbor protection under 35 USC 121 because the claims do not share continuity nor a restriction/speciation with the claims of the instant application. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
26. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the reference application are drawn to a method of stimulating a T cell with a species of multi-chain chimeric polypeptides, wherein the first target binding domain is IL-21 or IL-7 and the second target binding domain is IL-7 or IL-21, that is encompassed the genus of multi-chain chimeric polypeptides recited in the instant claims.. Therefor the instant claims are obvious over the claims of the ‘169 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
27. Claims 1-17 and 42-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Application No. 18/497,163 (reference application). The reference application is not afforded safe harbor protection under 35 USC 121 because the claims do not share continuity nor a restriction/speciation with the claims of the instant application. See Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008).
28. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the reference application are drawn to a method of stimulating a method of treatment with a species of multi-chain chimeric polypeptides, wherein the first and second target binding domain is TGF-βRII, that is encompassed the genus of multi-chain chimeric polypeptides recited in the instant claims. Therefor the instant claims are obvious over the claims of the ‘163 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Summary
29. No claim is allowed.
Advisory Information
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/JON M LOCKARD/
Examiner, Art Unit 1647
March 18, 2026