DETAILED OFFICE ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's species election of a homotrimer filed on 02 December 2025 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 § 818.03(a)).
Applicant’s amendment filed on 02 December 2025 is acknowledged and entered. Following the amendment, claims 1 and 30 are canceled, claims 3, 6 and 29 are amended, and the new claims 31-35 are added.
Currently, claims 3, 6, 29 and 31-35 are pending, and claims 3, 6, 29 and 31 are under consideration (to the extent that they read on the elected species), as they seem close to the previously claimed “system”, and claims 3, 6 and 29 had been examined. The new claims 32-35 are withdrawn from further consideration as being drawn to a non-elected invention.
Withdrawal of Objections and Rejections:
All objections and rejections of claims 1 and 30 are moot as the applicant has canceled the claims.
Formal Matters:
Claims
Claim 29 and 31 are objected to for the following informalities, appropriate correction is required:
Claim 29 recites “wherein each of the recombinant polypeptides contain at least …”; the following is suggested: “wherein each of the recombinant polypeptides comprises at least …”.
Claim 31 recites “wherein when the trimeric receptor complex is a homotrimer, the three recombinant polypeptides forming the trimeric receptor complex have three identical binding moieties and the artificial ligand has three identical binding segments; or wherein when the trimeric receptor complex is a heterotrimer, at least two of the recombinant polypeptides forming the trimeric receptor complex comprise at least two different cytoplasmic signaling domains and the artificial ligand comprises at least two different binding segments, …” in part iii), which is quite redundant. The following is suggested: “wherein the trimeric receptor complex is a homotrimer; or wherein the trimeric receptor complex is a heterotrimer, in which at least two of the recombinant polypeptides comprise two different cytoplasmic signaling domains …”.
Rejections under 35 U.S.C. §112:
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claims 3, 6, 29 and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The independent claim 31 is indefinite for the recitation “said trimeric receptor complex is designed to bind an artificial ligand comprising a plurality of binding segment” because it is unclear what it is meant; for example, is “is designed to bind” equal to actually “bind”? And what does “a plurality of binding segment” encompass; are there more than 3 binding segments (“a plurality”); and what are the chemical entity and function of the binding segments? The metes and bounds of the claim, therefore, cannot be determined. The claim is further indefinite for the recitation “and wherein the cytoplasmic signaling domain of the recombinant polypeptide is a cytoplasmic signaling domain derived from …” because it is unclear which of the three recombinant polypeptides (or all 3?) of the trimeric receptor complex is indicated here as “the recombinant polypeptide”. The metes and bounds of the claim, therefore, cannot be determined.
Claim 3 recites the limitation “the first domain containing a first binding partner” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation “the first binding partner” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
The remaining claim is included in this rejection because it is dependent from the specifically mentioned claim without resolving the indefiniteness issue belonging thereto.
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.
Written Description
Claims 3, 6, 29 and 31 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.
Claims 3, 6, 29 and 31 are drawn to an engineered cell expressing a trimeric receptor complex, wherein each of the three polypeptides comprises i) a binding moiety selected from the group consisting of a nanobody, a single-chain antibody and a fragment thereof; ii) a transmembrane domain; and iii) a cytoplasmic signaling domain derived from a cytokine receptor; wherein at least two of the first domain, the transmembrane domain and the cytoplasmic signaling domain within each polypeptide are not derived from a same naturally-occurring polypeptide or cytokine receptor; and wherein the trimeric receptor complex is a homotrimer (elected) or a heterotrimer (the independent claim 31, for example). However, while the specification discloses an engineered cell expressing a heterotrimeric SyCyRs of IL-23R (Fig. 4, for example), no homotrimer (elected) meeting the limitation of the claims is ever disclosed or particularly described.
The first paragraph of 35 U.S.C. § 112 "requires a 'written description of the invention' which is separate and distinct from the enablement requirement." “[A]pplicant 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.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 1111, 1116, 1117 (Fed. Cir. 1991).
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. Sufficient description of a genus requires the disclosure of either (1) a representative number of species falling within the scope of the genus or (2) description of 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. In the instant case, 0 species is disclosed for the claimed engineered cell expressing a homotrimer receptor complex (elected). Further, there is no teaching as to what the functional activity is associated with the claimed homotrimer (since no structure is disclosed), other than “said trimeric receptor complex is designed to bind an artificial ligand comprising a plurality of binding segment”, which artificial ligand is not defined either structurally or functionally. Thus, both the structure and function of either the trimeric receptor complex or the “artificial ligand” are disclosed; there is no way to predict the structure and/or function of the claimed homotrimer; one of skill in the art cannot envision the detailed chemical structure of the encompassed genus of homotrimer; and conception is not achieved regardless of the complexity or simplicity of the method of making an engineered cell expressing a homotrimer receptor complex. Accordingly, the specification does not provide adequate written description for the claimed genus of the engineered cell expressing a homotrimer receptor complex; and those of skilled in the art would not conclude that the applicant was in possession of the claimed genus of the engineered cell expressing a homotrimer receptor complex.
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 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. 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.
As such, the present claims do not meet the written description provision of 35 U.S.C. 112(a), as no construct meeting the limitations of the claims is ever disclosed or particularly described in the specification. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112(a) is severable from its enablement provision (see page 1115).
Conclusion:
No claim is allowed.
Advisory Information:
Any inquiry concerning this communication should be directed to Examiner DONG JIANG whose telephone number is 571-272-0872. The examiner can normally be reached on Monday - Friday from 9:30 AM to 7:00 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 phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DONG JIANG/
Primary Examiner, Art Unit 1646
1/4/26