DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendments and Arguments
2. Claims 1, 2, 4 and 7-12 are pending.
Claims 3, 5 and 6 have been cancelled.
Claims 10-12 have been added.
Claims 1, 2, 4 and 7-12 are examined on the merits.
New and Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 1, 2, 4 and 7-12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
a. Applicant has amended claim 1 to recite “consisting” on lines 3 and 4 of the claim, as well as “comprising” and “optionally” on lines 3 and 4 of the claim. This claim language within the claim is vague and indefinite because it attempts to limit the components of the fusion protein, however there is open and closed language cited with the components. Hence, the metes and bounds cannot be determined.
Claim Rejections - 35 USC § 102
5. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
6. The rejection of claim(s) 1, 2 and 7-9 under pre-AIA 35 U.S.C. 102(b) as being anticipated by Svendsen et al., US 2008/0299137 A1 (published December 4, 2008/ IDS U.S. Patent Application Publication reference #3 on sheet 2 submitted April 11, 2024) is maintained and made. Claims 3, 5 and 6 have been cancelled.
Applicant asserts with the amendment to claim 1 to recite additional features of the NKG2D-Fc, Svendsen does not teach the fusion protein as recited in amended claim 1.”, see Remarks submitted July 29, 2025, page 4, last paragraph (para.).
Applicant’s argument has been carefully considered, but fails to persuade.
The NKG2D-Fc chimera molecule of Svendsen and in particular, the human NKG2D receptor has a target-binding protein, see page 2, section 0012. “[A] target-binding portion or membrane protein extracellular domain portion of a fusion protein provided by this invention refers to any one or more amino acid sequences that comprise, consist, or consist essentially of the functional portion of the extracellular domain of a cell membrane protein, or a functional variant thereof, that is capable of binding at least one "second" or "secondary" cell-associated molecule or target (typically a cell-associated protein that serves as a receptor or ligand for the membrane protein that the target-binding protein corresponds or is most related to in terms of sequence identity and other relevant properties).”, see page 9, sections 0069-0071.
Moreover, as claim 1 is amended, the claim is indefinite as set forth in the pending 112(b) rejection, see paragraphs (paras.) 3 and 4 spanning pages 2 and 3. Furthermore, Svendsen continues to anticipate the claimed invention.
Hence, for the reasons of record and cited herein the rejection is maintained and made.
Svendsen discloses administering fusion proteins, a NKG2D-Fc chimera molecules comprising an antibody portion that is specific for NKG2D for cancer treatment, see Fig. 1 and corresponding description on page 2, sections 0010 and 0012; page 7, section 0061; page 8, section 0063; page 21, section 0168; and page 23, sections 0174, 0177 and 0180. The NKG2D portion or target-binding portion is also referred to as a membrane protein extracellular portion, see page 2, sections 0012 and 0020.
These compositions are comprised in a pharmaceutical composition, see page 25, sections 0194 and 0198. “[T]he antibody and target-binding portions are separated by a linker...”, see page 2, section 0023. “NKG2D binds to multiple ligands, including members of the MIC-A, MIC-B and ULBP families. These all are stress-inducible ligands whose expression is induced in several types of tumors"...including lung and colorectal cancers and leukemias, see page 21, section 0168. Treatment of other carcinomas of the melanoma, lymphomas, ovary, colon, pancreas, prostate are disclosed by Svendsen, see page 23, section 0177. A fusion protein can be administered with one or more anti-cancer agents such as radiation, radiopharmaceuticals and chemotherapeutic agents, see bridging paragraph of pages 26 and 27; and page 27, sections 0213 and 0214.
Claim Rejections - 35 USC § 103
7. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
8. The rejection of claims 1, 2, 4, 7-9 and new claims 10-12 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Svendsen et al., US 2008/0299137 A1 (published December 4, 2008/ IDS U.S. Patent Application Publication reference #3 on sheet 2 submitted April 11, 2024), and further in view of Thøgersen et al., US Patent # 5,739,281 (issued April 14, 1998/ IDS U.S. Patent reference #3 submitted April 11, 2024) is maintained and made. Claims 3, 5 and 6 have been cancelled.
Applicant asserts with the amendment to claim 1 reciting additional features of the administered NKG2D-Fc fusion protein, Svendsen does not teach the fusion protein as recited in amended claim 1.”, see Remarks submitted July 29, 2025, page 5, III.
Applicant’s argument has been carefully considered, but fails to persuade.
The NKG2D-Fc chimera molecule of Svendsen and in particular, the human NKG2D receptor has a target-binding protein, see page 2, section 0012. “[A] target-binding portion or membrane protein extracellular domain portion of a fusion protein provided by this invention refers to any one or more amino acid sequences that comprise, consist, or consist essentially of the functional portion of the extracellular domain of a cell membrane protein, or a functional variant thereof, that is capable of binding at least one "second" or "secondary" cell-associated molecule or target (typically a cell-associated protein that serves as a receptor or ligand for the membrane protein that the target-binding protein corresponds or is most related to in terms of sequence identity and other relevant properties).”, see page 9, sections 0069-0071.
Moreover, as claim 1 is amended, the claim is indefinite as set forth in the pending 112(b) rejection, see paragraphs (paras.) 3 and 4 spanning pages 2 and 3. And for the reasons cited within the pending anticipatory rejection, Svendsen does not fall. Accordingly, for the reasons of record and cited herein the rejection is maintained and made.
Svendsen teaches administering fusion proteins, a NKG2D-Fc chimera molecules comprising an antibody portion that is specific for NKG2D for cancer treatment, see Fig. 1 and corresponding description on page 2, sections 0010 and 0012; page 7, section 0061; page 8, section 0063; page 21, section 0168; and page 23, sections 0174, 0177 and 0180. The NKG2D portion or target-binding portion is also referred to as a membrane protein extracellular portion, see page 2, sections 0012 and 0020.
These compositions are comprised in a pharmaceutical composition, see page 25, sections 0194 and 0198. “[T]he antibody and target-binding portions are separated by a linker...”, see page 2, section 0023. “NKG2D binds to multiple ligands, including members of the MIC-A, MIC-B and ULBP families. These all are stress-inducible ligands whose expression is induced in several types of tumors"...including lung and colorectal cancers and leukemias, see page 21, section 0168. Treatment of other carcinomas of the melanoma, lymphomas, ovary, colon, pancreas, prostate are disclosed by Svendsen, see page 23, section 0177. A fusion protein can be administered with one or more anti-cancer agents such as radiation, radiopharmaceuticals and chemotherapeutic agents, see bridging paragraph of pages 26 and 27; and page 27, sections 0213 and 0214.
Svendsen does not teach the NKG2D-Fc chimera for administration, wherein the chimeric NKG2D-Fc polypeptide has peptide linker, SEQ ID NO: 1.
However, Thøgersen teaches sequence #38, a cleavage targeted polypeptide segment. It is the same as IEGR, Applicants’ SEQ ID NO: 1, see column 81. It would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to utilize the peptide linker, IEGR, which covalently can join NKG2D to an amino acid of Fc. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by the teachings of Thøgersen because the teachings set forth an applicable method for producing correctly folded proteins and establishing places within proteins required for efficient fusion protein construction, see entire document.
Double Patenting
9. 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 § 2146 et seq. 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.
10. The nonstatutory double patenting rejection of claims 1, 2, 4, 7-9 and new claims 10-12 as being unpatentable over claims 1-13 of U.S. Patent No. 10,865,233 B2 (issued December 15, 2020/ IDS U.S. Patent reference #3 on sheet 1 submitted April 11, 2024) is maintained and made. Claims 3, 5 and 6 have been cancelled.
“In response, Applicant respectfully requests that the rejection be held in abeyance until the claims are otherwise allowable.”, see page 5, IV. of the Remarks submitted June 29, 2025.
Applicant’s response has been considered, however it is not persuasive. At this point in prosecution the claims are not deemed allowable. Accordingly, the rejection is maintained and made.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on a method for treating a NKG2D ligand expressing cancer comprising administering a NKG2D-Fc chimera and a pharmaceutically acceptable carrier with an additional anti-cancer therapy.
Conclusion
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
12. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached between 8AM-8PM, Monday through Friday.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
23 October 2025
/Alana Harris Dent/Primary Examiner, Art Unit 1643