DETAILED ACTION
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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-5 in the reply filed on July 13, 2026 is acknowledged. The traversal is on the grounds that there is no search or examination burden between protein, nucleic acid/vector, and cellular product claims as they are linked by the chimeric polypeptide as recited in Group I. Applicant traverses that as claims 6-9 (corresponding to Group II) recite the nucleic acids encoding the polypeptide of claim 1 and claims 10-15 (corresponding to Group III) recite NK or T cells expressing the polypeptide of claim 1, search of Group I should be coextensive with Groups II and III. This is not found persuasive because Groups II and III comprise nucleic acid SEQ ID NOs which are structurally distinct from the polypeptides of Group I and which have not been found in the prior art of record. The prior art of Bridgeman discloses a nucleic acid sequence of SEQ ID NO: 11 as a codon optimized nucleic acid sequence encoding a thrombopoietin receptor (Para. [0057]) which does not comprise the intracellular signaling domain as instantly claimed and which are encompassed by SEQ ID NOs: 8 and 21-25. Further although the prior art of Bridgeman discloses several amino acid sequences (SEQ ID NOs 1, 5-10), Bridgeman is silent to the corresponding nucleic acid sequences. Therefore, the search of the structurally distinct nucleic acids and cellular products comprising the nucleic acids in Groups II and III is not considered to be coextensive with the search of the polypeptides of Group I and is considered to constitute a further search and examination burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 18 and 19 have been canceled. Claims 6-17 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected groups, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 13, 2026.
Claims 1-5 are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant claims priority to U.S. provisional application 62/980854 filed February 24, 2020 and as a continuation-in-part of Application 17/821703 filed August 23, 2022. However, Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 62/980854 and 17/821703, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Provisional application 62/980854 and parent application 17/821703 do not contain support for a chimeric thrombopoietin protein comprising an extracellular domain of c-MPL, transmembrane domain (which can be derived from CD8α, CD28, CD16, ICOS, KIR2DS2 of NKG2D as recited in claim 3), and intracellular signaling domain of IL2rB, IL21R, IL7R, INFAR2, or IL12RB2 as recited in claim 1 and as is required for claims 2-5 which depend from claim 1. Although, U.S. provisional application 62/980854 discloses a chimeric erythropoietin receptor (Pg. 10, last para.), it does not disclose a chimeric thrombopoietin receptor as instantly claimed. Further, provisional application 62/980854 and parent application 17/821703 do not contain support for SEQ ID NOs: 8 and 21-25 as instantly claimed. Although parent application 17/821703 discloses SEQ ID NO: 1 as the amino acid sequence of an exemplary c-MPL receptor, this appears to be an amino acid sequence encoding the human c-MPL receptor, not a chimeric protein.
Accordingly, claims 1-5 are not entitled to the benefit of the prior applications and are given a priority date of the instant filing, October 3, 2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on October 3, 2023 and May 15, 2025 are in compliance with the provisions of 37 CFR 1.97 and are being considered by the examiner.
Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites the abbreviations CD8α, CD28, CD16, ICOS, KIR2DS2, and NKG2D which are not accompanied by the full name corresponding to the abbreviation. Initial recitation of terms should be the full name followed by abbreviations in parentheses. Appropriate correction is required.
Claim Interpretation
The abbreviations c-MPL as instantly recited as well as the abbreviations TpoR and CD110 are all understood to refer to the same thrombopoietin receptor (Para. [0009]).
Claim Rejections - 35 USC § 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.
Claim 4 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the c-MPL" in line 1. There is insufficient antecedent basis for this limitation in the claim as the prior recitation is to an extracellular domain of c-MPL. As claimed, it is unclear whether “the c-MPL” is intended to refer to the extracellular domain of c-MPL, a different domain, or another c-MPL. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Bridgeman (US 2020/0263130 A1, U.S. filing of WO 2017/103596A1 found in IDS dated 05/15/2025) and as evidenced by Gurney et al. (1995, Distinct regions of c-Mpl cytoplasmic domain are coupled to the JAK-STAT signal transduction pathway and Shc phosphorylation. PNAS, 92(12), 5292-5296, hereafter “Gurney”).
With regard to claim 1, Bridgeman discloses a recombinant growth factor receptor (rGFR) comprising an extracellular domain, a transmembrane domain, and an intracellular domain which may be of modular form with the EC, TM and IC domains derived from different receptors (Para. [0057]). Bridgeman discloses that the rGFR can comprise a thrombopoietin receptor (i.e., c-MPL or TpoR) extracellular domain (Para. [0041], [0062], SEQ ID NO: 2), a c-MPL transmembrane domain (Para. [0039], [0062], [0077], SEQ ID NO: 3), and a “growth factor like” intracellular domain from IL2RB (Para. [0086], see also SEQ ID NO: 10).
With regard to claim 2, Bridgeman discloses that the intracellular domain of the rGFR may include a JAK binding domain from c-MPL (Para. [0042]). Although Bridgeman is silent as to box 1 and box 2 being JAK binding domains, Gurney evidences that box 1 and box 2 of c-MPL are known as JAK binding domains (See Fig. 1A and Fig. 2).
With regard to claim 3, Bridgeman discloses that the transmembrane domain can be from c-MPL (Paras. [0039], [0057], [0084]; see also SEQ ID NO: 3).
With regard to claim 4, Bridgeman discloses the c-MPL extracellular domain can be from human c-MPL (Para. [0041], [0077], claim 6; see also SEQ ID NO: 2).
With regard to claim 5, Bridgeman discloses an rGFR having the amino acid sequence of SEQ ID NO: 10 (Para. [0056], [0074]), claim 32) which has at least 90% sequence identity to the amino acid sequence of SEQ ID NO: 8 (search results 09/02/2026, SEQ ID NO: 8, .rapbm file, result 2).
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Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN V PAULUS whose telephone number is (571)272-6301. The examiner can normally be reached Mon-Fri 8 AM-5 PM.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631
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