DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment and Arguments
2. Claims 27-30, 34-36, 39-45, 47, 48 and 50-70 are pending.
Claims 53-70 have been added.
Claims 50-52, drawn to non-elected species are not examined.
Claims 40-42 have been cancelled.
Claims 27, 29, 35, 39, 43-45, 47 and 48 have been amended.
Claims 27-30, 34-36, 39, 43-45, 47 and 48 with species, (composition components): A) one expression vector; and (APC targeting unit): chemokine (C-C motif) ligand 19 (CCL19).
Withdrawn Objections
Drawings
3. The drawings are no longer objected to under 37 CFR 1.83(a) because they show Figure 3B; and Figure 21D as described in the specification, see Amendments to the Drawings and Drawing Replacements sheets, both submitted March 5, 2026.
4. The drawings are no longer objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “Fig. 21C” has been used to designate vector, “pTVG4a mCCL19 hih4CH3 SI6T13 opt, 6.251bp” and “Fig. 21D” designates “pTVG4a mCCL19 hih4CH3 SI6T13 opt, 6.211bp”., see Drawing Replacement sheets, 21/29 and 22/29, respectively submitted March 5, 2026.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 112
5. The rejection of claims 27-30, 34-36, 39, 43-45, 47 and 48 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of Applicant’s amendment to claims, see Amendments to the Claims submitted March 5, 2026. Claims 40-42 have been cancelled.
New and Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
6. 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.
7. Claim 55 recites the limitation "…the parenteral administration…" bridging lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
8. 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.
9. The rejection of claim(s) 27-30, 34-36, 39, 43-45, 47, 48 and new claims 53-70 under 35 U.S.C. 103 as being unpatentable over Granum et al., WO 2017/118695 A1 (published 13 July 2017/ IDS reference, Foreign Patent Documents #1 submitted November 11, 2022), and further in view of June et al., WO 2019/152660 A1 (published 08 August 2019) is maintained and made. Claims 40-42 have been cancelled.
Applicant asserts the prior art does not make obvious the claimed invention and cite is required to make a proper case of obviousness, see Remarks submitted March 5, 2026, page 14.
Applicant further asserts the currently amended claims are “…directed towards a method comprising the administration of an
immunogenically effective amount of a composition, wherein the composition includes, inter alia, an expression vector (or a system of at least two expression constructs) which comprises a sequence of nucleotides encoding a fusion polypeptide, where the fusion polypeptide includes at least one defined antigenic unit, see claim 27. The at least one antigenic unit is defined by the APC targeting unit consisting of or comprising a ligand selected from chemokine ligand 19 (CCL19) and chemokine ligand 21 (CCL21), ligands of CCR7. These APC targeting unit have been shown to have superior characteristics over CCL3 and CCL5 (ligands of CCR1, CCR3 and CCR5).”, see paragraph (para.) bridging pages 14 and 15.
Applicant disagrees with the teaching of June, wherein “…CCL19 within a viral vector suitable for treating a human and biopolymer delivery methods" and that it would have been obvious for the skilled person to insert CCL19, as taught in June, within the targeting unit of Granum, and that the skilled person would have been motivated to do so to elicit a strong T cell response and to ensure the delivery for the treatment of cancer.”, see page 15 of the Remarks, last full para. Applicant argues “June fails to cure any deficiencies that would allow one of skill in the art to exchange the targeting unit of Granum with CCL19” as “[t]he purpose of the virus-encoded cytokine…appears to be to increase the attraction of CAR T-cells to a tumor, not to improve recruitment of APCs to the administration site of a vaccine. Thus the purpose of CCL19 or CCL21 in June is quite different than the purpose of the APC targeting unit in Granum.”, see page 20 of the Remarks, 1st full para.
Applicant further argues “[t]here is no teaching or contemplation the targeting unit may be CCL19 or CCL21.”, see last full sentence on page 15. Applicant follows with their teachings, see para. bridging pages 14 and 15; and para. bridging pages 15 and 16 and para. bridging pages 16 and 17.
Applicant further provides a reference article by Bobanga referencing the state of the art in regard to “…the function of different chemokines in different DC subsets.”, see para. bridging pages 18 and 19; and para. bridging pages 19 and 20. Applicant’s arguments, points of view and Bobanga have been carefully considered, but fail to persuade.
Foremost, the claim limitation reading on the first citation of CCL19 and CCL21 is optional, see claim 27, A), iii). Hence, this limitation is not required, nor essential. Notwithstanding, it would not be outside the scope of the skilled artisan to substitute a targeting unit of Granum with the CCL19 targeting unit of June. It is obvious to those skilled in the art to substitute one known equivalent for another. See In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”).
The cytokine molecule, CCL19 and the nucleic acid molecule encoding CCL19 is not only an additional therapeutic agent for the treatment of cancer, but also a targeting agent to improve treatment compositions and strategies, see June abstract and entire document.
The modification of the primary reference in light of the secondary reference is proper because the applied references are so related that the appearance of features shown in one would suggest the application of those features to the other. See In re Rosen, 673 F.2d 388, 213 USPQ 347 (CCPA 1982); In re Carter, 673 F.2d 1378, 213 USPQ 625 (CCPA 1982), and In re Glavas, 230 F.2d 447, 109 USPQ 50 (CCPA 1956). Further, it is noted that case law has held that a designer skilled in the art is charged with knowledge of the related art; therefore, the combination of old elements, herein, would have been well within the level of ordinary skill. See In re Antle, 444 F.2d 1168,170 USPQ 285 (CCPA 1971) and In re Nalbandian, 661 F.2d 1214, 211 USPQ 782 (CCPA 1981). The combination of references would not change the principle of operation of the prior art invention being modified, hence the teachings of the references are sufficient to render the claims prima facie obvious.
Notwithstanding “obviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007). Here, a reasonably probability of success has been established and Applicants’ contentions regarding unpredictability are found to be unpersuasive.
A reasonable expectation of success does not refer to the reasonable expectation of predictability, but rather “to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). In the absence of adequate evidence of unexpectedly superior results, the specific properties achieved are merely inherent properties of the combination. Accordingly, the rejection is maintained and made.
Granum teaches methods of treating cancer with “… a therapeutic anticancer neoepitope vaccine comprising an immunologically effective amount of
1) a polynucleotide comprising a nucleotide sequence encoding
-a targeting unit
-a dimerization unit
-a first linker
-an antigenic unit, wherein said antigenic unit comprises n-1 antigenic subunits, each subunit comprising at least a part of a cancer neoepitope sequence and a second linker and said antigenic unit further comprising a final cancer neoepitope sequence, wherein n is an integer of from 3 to 50.”,
see abstract; page 1, 1st paragraph (para.); para. bridging pages 2 and 3; page 10, line 15 – page 11, line 9; and page 34, Example 1. “[E]xpressed in vivo, the polypeptides/dimeric proteins target antigen presenting cells (APCs),”, see page 10, lines 19-22. An expression vector comprises the said polynucleotide sequence, see page 22, last para.
Granum teaches the targeting unit has affinity for a chemokine receptor and the nucleotide sequence encoding the targeting unit encodes a chemokine, see page 17, lines 29-32; and page 18, lines 7-10. Target surface molecules on APCs include chemokine receptors, while “[t]he polypeptide/dimeric protein of the invention can be targeted to said surface molecules by means of targeting units comprising for example… natural ligands like chemokines,…”, see page 17, lines 24-32.
“[T]he dimerization unit consists of hinge exons h[1] and h4 connected through a third linker to a CH3 domain of human lgG3.”, see page 19, lines 30 and 31; and SEQ ID NO: 29 on page 47, lines 28-31.
A linker may be a serine-glycine linker including multiples of GGGSS, the same as Applicant’s SEQ ID NO: 13, see page 15, lines 24 -page 16, line 22; and para. bridging pages 15 and 16.
“The vaccine may further comprise a pharmaceutically acceptable carrier, diluent, adjuvant or buffer. Pharmaceutically acceptable carriers, diluents, and buffers include, but are not limited to, saline, buffered saline, dextrose, water, glycerol, ethanol, sterile isotonic aqueous buffer, and combinations thereof.”, see page 26, lines 3-8. “The DNA vaccine may be formulated by dissolving in a saline solution, such as PBS...”, see page 42, last para.
“The vaccine may be administered in any suitable way for either a polypeptide/protein vaccine or a polynucleotide vaccine, such as administered by injection intradermally, intramuscular, subcutaneously, or by mucosal or epithelial application, such as intranasally, orally, enteral or to the bladder.”, see page 26, Administration segment.
“The vaccine is administered in an immunologically effective amount. By "immunologically effective amount" is meant the amount of the vaccine required to establish a tumor reducing effect. Ultimately, the physician determines the dosage that typically is in the range of 0.3-6 mg for DNA vaccines, and in the range of 5 μg-5 mg for polypeptide/protein vaccines”, see para. bridging pages 27 and 28.
Granum does not teach the targeting unit consists or comprises a ligand that is CCL19 and the composition comprises an amphiphilic block co-polymers comprising blocks of poly(ethylene oxide) and poly(propylene oxide). Granum does not explicitly teach the patient is human.
June teaches CCL19 within a viral vector suitable for treating a human and biopolymer delivery methods, see page 56, lines 10-21; and Biopolymer…segment beginning on page 147. Biopolymers include polyethylene oxide (PEO) and polypropylene oxide (PPO), see para. bridging pages 147 and 148.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to insert chemokine ligand 19 (CCL19) within the targeting unit of Granum and further into the vaccine composition Granum comprising an amphiphilic block co-polymer comprising PEO or PPO. One of ordinary skill in the art would have been motivated to include the nucleotide sequence encoding the targeting unit encoding CCL19 that is able to bind its cognate receptor expressed on the cell surface of APCs and amongst several different targeting units to elicit a strong T cell response, as well as ensuring delivery for the treatment of cancer, see Granum, page 2; Targeting unit segment beginning on page 17; and the entirety of both documents.
Double Patenting
10. 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.
11. The provisional nonstatutory double patenting rejection of claims 27-30, 34-36, 39, 43-45, 47, 48 and new claims 53-70 as being unpatentable over claims 1, 2, 6, 15, 17, 20, 21, 28, 29, 40, 41, 43 and 51 of copending Application No. 18/004,889 (effective filing date, 07/14/2020) is maintained and made. Claims 40-42 have been cancelled in the instant application. As of March 20, 2026, claims 11, 19 and 27 have been cancelled within the copending application.
Applicant initially argues the instant “…claims require antigenic unit(s) comprising amino acid sequence(s) of at least one neo-epitope of the patient’s neoplastic cells”, while the copending application, ‘889 does not. And second, Applicant argues the APC target unit of the instant claims consists or comprise a ligand selected from CCL19 and CCL21 and the copending claims do not. Applicant’s arguments and the copending claims of ‘889 have been carefully considered, but fail to persuade.
The Examiner does not concur with Applicant’s arguments as the antigenic unit of ‘889 does read on at least one antigenic unit with a sequence of amino acids of at least one neo-epitope of neoplastic cells from a patient, see at least claims 1, 2, 40 and 41. Furthermore, at least claim 6 cites the APC targeting unit is either CCL19 or CCL21. Hence, the claims are coextensive and the rejection is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims teach a method for treating a disease, namely a neoplasm with the administration of composition comprising an expression vector containing a sequence of nucleotides encoding a fusion polypeptide comprising an (i) an antigenic unit; (ii) an antigen presenting cell (APC) targeting unit; and optionally, (iii) a multimerization unit providing multimerization of said fusion polypeptide to comprise antigenic units and APC targeting units including a chemokine ligand, CCL19.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
12. 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.
13. 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 normally be reached 8AM-8PM, Monday through Friday and occasionally Saturday evening.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached at 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 May 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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