CTNF 18/004,889 CTNF 81547 DETAILED ACTION 07-03-fti AIA The present application is being examined under the pre-AIA first to invent provisions. Applicant’s election without traverse of group I, claims 1-7, 11, and 15-27, in the reply filed on 11/7/25, is acknowledged. Applicant has elected a viral antigen as the species of antigen, CCL19 as the type of targeting unit, and a hinge region comprising h1+h4 or h4. Upon reconsideration, the species election requirement between targeting CCR7 and mature dendritic cells and the species of linkers is withdrawn. Claims 28-29, 31-43 and 51 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 2-3 and 11 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to non-elected species. Claims 1, 4-7, 15-27 are being acted upon. Acknowledgment is made of applicant's claim for foreign priority to EP20207526.3 and EP20185741.0. However, the priority documents do not disclose the limitations of instant claims 24-26, wherein the antigen unit comprises an amino acids sequence from a b -coronavirus, an RBD from SARS-CoV-2 spike protein, or an amino acid sequence of residues 319-541 of NCBI reference YP_009724390. Consequently, claims 24-26 have been accorded the priority of the filing date of the EP21171319.3, i.e. 4/29/01. 07-30-02 AIA 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. 07-34-01 Claims 1, 4-7, and 15-27 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) Claims 1, 5-7, and 27 are indefinite in the use of “which”, i.e. “which multimerization unit”, “which APC targeting unit”. A recitation of “which unit” (especially since claim 1 refers to multiple different types of units, multimerization, APC targeting or antigenic units), is unclear and indefinite. For example, “which unit” or “which APC targeting unit” would usually refer to a specific one from a set of things, i.e. which APC targeting unit from a set of APC targeting units. However, it appears that the claims are intending to further limit the previous recitation of “a multimerization unit” or “an APC targeting unit”, i.e. “which” should be interrupted as “the” or “said”. The use of “which” in this context renders the claims unclear and indefinite, and is suggested to amend the claims to replace “which” with “wherein the”. For example, in claim 1, optionally a multimerization unit, wherein the multimerization unit provides for multimerization, or in claim 5, to recite “wherein the APC targeting unit is targeting mature dendritic cells”. 07-34-05 B) Claim 7 recites the limitation "the receptor" in line 2. There is insufficient antecedent basis for this limitation in the claim. C) Claim 17 is indefinite in the recitation that the comprises a “carboxyterminal” CH3 domain. It is unclear what the CH3 domain is carboxyterminal to. For example, does the claim require a linker with two different elements, wherein the CH3 domain is a second element that is carboxyterminal to the first linker element? Would the claims encompass a fusion protein consisting of antigenic unit-CH3 linker- targeting unit, since in this construct the CH3 linker is carboxyterminal with respect to the antigenic unit? The scope of the claim is unclear and indefinite. Claim 17 is also indefinite in that it recites that the linker comprises a “C domain (CH3 domain)”. The C domain appears to be referring to the constant domain of an immunoglobulin, which comprises different domains, such as CH1, hinge, CH2 and CH3 domain. However the claim also recites (CH3) in parentheses. It is not clear if the claim encompass any “C-domain”, i.e. CH1, and the parenthetical CH3 is merely exemplary? Or does the claim require the entire C-domain including CH3? The scope of the claim is unclear and indefinite. D) Claim 22 is indefinite in the recitation of an epitope that exhibits an MHC binding stability which is “above average”. The claim does not specify what the average is with respect to, i.e. above average compared to what? E) Claim 23 recites the bacterial or viral antigen, “which exhibits an MHC binding stability which is above average". It appears to refer to a previous recitation of a bacterial antigen “which exhibits an MHC binding stability which is above average”, however, there is no antecedent basis for such an antigen in clams 1 and 4 from which the claim depends. Is the claim intending to specify an additional limitation of the bacterial or viral antigen from claim 4, i.e. wherein the bacterial or viral antigen exhibits an MHC binding stability which is above average? The claim also recites above average among “the antigens of the respective bacteria or virus”, which lacks antecedent basis and the scope of the claim is unclear and indefinite. F) Claims 22-23 are indefinite since it is not clear what is meant by MHC binding “stability”. Does it mean binding affinity? Does it refer to dissociation rate? Some other measurement? The scope of the claims is unclear and indefinite. G) Claim 25 recites the limitation "the RBD" and “the SARS-CoV-2 spike protein in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. 07-34-05 H) Claim 27 recites the limitation "the formation" in line 2. There is insufficient antecedent basis for this limitation in the claim. 07-34-03 I) The term “about” in claim 21 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. 07-07-fti 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— 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1, 4-5, 15-23, 27 , is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by WO 2013/041966 (of record), as evidenced by Heger, 2023 and Jiao, 2023 . WO 2013/041966 teaches a fusion polypeptide comprising an antigenic unit and an APC targeting unit, wherein the antigenic unit is connected to the targeting unit through a linker (See pages 1-4, in particular). WO 2013/041966 teaches that the linker comprising a hinge region comprising h1+h4 of IgG and a CH3 domain of IgG3 (i.e. a dimerization motif), wherein the hinge and CH3 domain are connected via a linker comprising G3S2 (i.e. GGGSS, and a carboxyterminal CH3, see page 3, in particular). WO 2013/041966 teaches that the antigen unit can be a viral antigen (see pages 2 and 4, in particular). WO 2013/041966 teaches that the viral antigen can be influenza HA (see page 3, in particular). WO 2013/041966 teaches that the APC targeting unit binds to XCR1 on dendritic cells (see page 2, in particular). WO 2013/041966 teaches that the construct forms homodimers (See page 1-2, in particular). As evidenced by Heger, XCR1 is expressed on mature dendritic cells, and therefore said fusion polypeptide comprising an XCR1 targeting unit inherently targets mature dendritic cells. Furthermore, as evidenced by Jiao, influenza HA is a 500 amino acid+ multidomain protein that inherently contains at least 5 epitopes. Regarding claims 22-23, which recites that the polypeptide comprises at least one epitope with an MHC binding stability which is “above average”, it is noted that every viral antigen, such as HA contains numerous different epitopes and each epitope would exhibit a level of binding stability (some being of high binding affinity, or “stability” and some being lower). Therefore, said HA would inherently comprise at least some epitopes that exhibit “above average” MHC binding stability relative to other epitopes. WO 2013/041966 teaches that the fusion polypeptides are useful as a vaccine for inducing an immune response for the viral antigen and can treat infectious disease (see page 4, in particular) . 07-15-aia AIA Claim(s) 1, 4-7, 15, 21-23, and 27 , is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Yan, 2015, as evidenced by Bender, 2007 . Yan teaches a fusion polypeptide comprising CCL19 (i.e. an APC targeting unit that targets CCR7 and mature dendritic cells) and a viral antigen (i.e. an antigenic unit, see page 329-330, in particular). Yan teaches that the antigen and the CCL19 are connected via a linker and a multimerization domain, wherein the polypeptides form oligomers (i.e. multimers of higher order, see page 329, Fig. 1, and page 332, in particular). Yan teaches a IZ leucine multimerization domain, which would inherently multimerize via hydrophobic interactions (see page 33, in particular). Said CCL19 inherently binds to and targets CCR7, which is the receptor for CCL19 and is also expressed on mature dendritic cells, i.e. it targets CCR7 and mature dendritic cells. Yan teaches that the viral antigen is glycoprotein B of HSV, and as evidenced by Bender, said glycoprotein B is inherently a large multidomain protein containing more than 5 different epitopes (see Fig. 1, in particular). Regarding claims 22-23, which recite that the polypeptide comprise at least one epitope with an MHC binding stability with is “above average”, it is noted that every viral antigen, such as glycoprotein B of HSV contains numerous different epitopes and each epitope would exhibit a level of binding stability (some being of high binding affinity, or “stability” and some being lower). Therefore, said glycoprotein B would inherently comprise at least some epitopes that exhibit “above average” MHC binding stability relative to other epitopes of the antigen. Yan teaches that the fusion protein act as a vaccine to induce antigen specific immune responses and is capable of promoting humoral and cellular immune response against several types of viral antigens (see page 329, in particular) . 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-21-aia AIA Claim s 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2013/041966 or Yan, 2015, in view of 20210260180 . The teachings of WO 2013/041966 and Yan are described above. The references differ from the claimed invention in that they not explicitly teach b -corona virus SARS-COV-2 spike protein. The ‘180 publication teaches that there is an urgent need for immunogenic compositions that can be used to induce an immune response against SARS-CoV2 and that the spike protein of SARS-CoV-2, or RBD domain comprising residues 319-541 is an immunogenic antigen (see paragraphs 8-10 and 122, 481, Figure 3A, in particular). The ‘180 publication teaches that spike protein is from GenBank QYD43416.1 (see Fig. 3A, which identical to the SARS-COV spike protein in NCBI YP_009724390 (see attached alignment between YP_009724390 and GenBank QYD43416.1). Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use the SARS-CoV-2 antigens of the ‘180 publication, as the viral antigen in the fusion polypeptides of WO 2013/041966 or in the fusion polypeptides of Yan. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because the ‘180 publication teaches that there is an urgent need for immunogenic compositions that can be used to induce an immune response against SARS-CoV2 and that the spike protein of SARS-CoV-2, or RBD domain comprising residues 319-541 are immunogenic antigens . 08-33 AIA 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer. 08-35 AIA Claim s 1, 4-7, 15-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 27-30, 34-36, 39-45, 47-48, 50-52 of copending Application No. 17/995,601 (reference application), in view of WO 2013/041966, Yan, 2015 and 20210260180 . Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘601 application claims a method of inducing an immune response using an expression vector which encodes a fusion polypeptide having an antigenic unit, an APC targeting unit, an optional multimerization domain, and wherein the APC targeting unit consists of CCL19 or CCL21, i.e. targeting unit for CCR7 and mature dendritic cells. The fusion protein encoded in the method claimed in the ‘601 thus anticipates claims 1, 6-7, of the instant application. The ‘601 application further claims that the antigenic unit is connected to the targeting unit through a linker comprising a hinge, and CH3 domain connected by GGGSS, and that the linker dimerizes through hydrophobic interactions, and comprises a h1+h4 derived from IgG. Although the ‘601 application does not explicitly claim that the antigenic construct is a viral antigen, such as a SARS-COV-2 spike protein RBD, it would be obvious to use a viral antigen in order to produce an immune response and treat viral infections as taught by Yan, WO 2013/041966 and the ‘180 publication for the same reasons set forth above , This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker, can be reached at telephone number 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. Amy E. Juedes Patent Examiner Technology Center 1600 /AMY E JUEDES/Primary Examiner, Art Unit 1644 Application/Control Number: 18/004,889 Page 2 Art Unit: 1644 Application/Control Number: 18/004,889 Page 3 Art Unit: 1644 Application/Control Number: 18/004,889 Page 4 Art Unit: 1644 Application/Control Number: 18/004,889 Page 5 Art Unit: 1644 Application/Control Number: 18/004,889 Page 6 Art Unit: 1644 Application/Control Number: 18/004,889 Page 7 Art Unit: 1644 Application/Control Number: 18/004,889 Page 8 Art Unit: 1644 Application/Control Number: 18/004,889 Page 9 Art Unit: 1644