Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 17, 2026 has been entered.
Amendment filed May 18, 2026 is entered.
Claims 1-7, 9-12 are pending. Claim 8, 13-18 are canceled. Claims 1-7, 9-12 are examined.
Double Patenting
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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
Claims 1-7, 9-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,479,791 in view of Grahames et al. (US 2009/0305321). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-15 of U.S. Patent No. 11,479,791 does not teach the mammalian host cell of claims 1-7, 9-12 of this application.
Grahames teach the expression of GPCR nucleci acid in host cells including mammalian cells (para 323).
It would have been obvious to one of ordinary skill in the art at the time of the filing to express the vectors of the Grahames in the mammalian host cells. One of ordinary skill in the art would have been motivated to express the mammalian GPCR in the mammalian host cells to study structure in a protein expressed in mammalian cell environment. It is obvious to combine prior art elements according to known methods to yield predictable results.
Applicant argued that rejection be held in abeyance. The rejection is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 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.
Claims 1-7, 9-12 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for claimed method of expressing with a host cell comprising first exogenous membrane protein which is a hCXCR4 protein and the second exogenous binding domain is a nanobody which binds hCXCR4 , does not reasonable provide enablement for the claimed host cell comprising first exogenous membrane protein and the second exogenous binding domain ISVD generically claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The first paragraph of § 112 requires that the patent specification enable "those skilled in the art how to make and use the full scope of the claimed invention without `undue experimentation."' Genentech, Inc. v. Novo Nordisk AIS, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)); see also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). ("[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art."). Whether making and using the invention would have required undue experimentation, and thus whether the disclosure is enabling is a legal conclusion based upon several underlying factual inquiries. See In re Wands, 858 F.2d 731, 735, 736-37, 8 USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988). As set forth in Wands, the factors to be considered in determining whether a claimed invention is enabled throughout its scope without undue experimentation include the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims.
Likewise, in Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991), the court affirmed the holding of invalidity of claims to analogs of the EPO gene under § 112 for lack of enablement where applicants had claimed every possible analog of the EPO gene but had disclosed only how to make EPO and a very few analogs. "[D]espite extensive statements in the specification concerning all analogs of the EPO gene that can be made, there is little enabling disclosure of the particular analogs and how to make them .... There may be many other genetic sequences that code for EPO-type products. Amgen has told how to make and use only a few of them and is therefore not entitled to claim all of them." Id., 927 F.2d at 1213-14, 18 USPQ2d at 1027.
Claims encompass method of exrepssing a host cell comprising membrane protein and ISVD binding domain generically wherein the expression level of the membrane protein is increased as compared to a host cell not comprising the second exogenous polynucleotide. However, the specification does not teach a host cell comprising membrane protein and binding domain generically wherein the expression level of the membrane protein is increased two-fold as compared to a host cell not comprising the second exogenous polynucleotide. The amount of direction provided in the specification is limited to host cell comprising first exogenous membrane protein which is a hCXCR4 protein and the second exogenous binding domain is a nanobody which binds hCXCR4. One skilled in the art would require empirical experimentation in order to determine whether all membrane proteins have increased expression level with all binding domain generically. CXCR4 belongs the G-protein receptor family for which there are variety of structure and function whose membrane protein structure creates unpredictability in expression of the protein. Furthermore, G-proteins are just one receptor types whereas there are many different membrane receptors and membrane proteins in general whose structure vary from one another. No nexus exist in the increased expression level between all different types of membrane proteins and binding to ISVD. Claims also encompass binding domain generically whereas there many different types of binding domains including different types of antibody as well protein interaction domains. The specification teaches the host cell expressing nanobody which binds hCXCR4. The state of the art is such that there are many different types of transmembrane protein including single transmembrane receptors to multiple transmembrane spanning channels (Rasmussen et al.(Nature, 2011)). One skilled in the art would require empirical experimentation in order to determine expression level relationship to all the different types of membrane proteins and binding domains. In view of the extent and the unpredictability of the experimentation required to practice the invention as claimed, one skilled in the art could not make the invention without undue experimentation. Therefore, based on the above Wands analysis, a preponderance of the evidence supports a conclusion that one skilled in the art would not have been enabled to make and use the claimed invention without undue experimentation.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible.
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/MICHAEL D PAK/Primary Examiner, Art Unit 1674
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