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 .
Priority
The instant application is a CON of application 16/067,867 (filed 3 July 2018) which is the national stage entry of PCT/US17/12173 filed 4 January 2017. Acknowledgement is made of the Applicant’s claim of domestic priority to provisional US application 62/274,711 (filed 4 January 2016).
Examiner's Note
Applicant's amendments and arguments filed 3 June 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant's response, filed 3 June 2026, it is noted that claim 16 has been amended and claims 117-118 newly added. No new matter has been added. Support can be found in the claims as originally filed.
Status of the Claims
Claims 1, 7, 10, 16, 27, 55, 58-59, 64-65, 82-83, 111, and 116-118 are pending.
Claims 58-59, 64-65, 82-83, 111, and 116 are withdrawn.
Claims 1, 7, 10, 16, 27, 55, and 117-118 are rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 7, 10, 16, 27, 55, and 117-118 are rejected under 35 U.S.C. 103 as being unpatentable over Shea et al. (US 10,201,596) in view of Murray (US 2002/0064533).
Shea teaches compositions comprising a biodegradable carrier particle attached to an antigenic peptide wherein the zeta potential of the particles is from about -100 mV to about 0 mV (col 2, lns 50-62; col 3, ln 59). The particles can have a diameter of from about 0.1-10 mm (col 3, lns 9-16). The antigen coupled to the carrier can comprise an autoimmune antigen, an antigen expressed on a tissue to be transplanted into a subject, or an allergen, all of which read on the antigenic epitopes of instant claim 27 (col 3, lns 17-19). The antigen can be encapsulated in the particle (col 3, lns 57-58). Shea teaches that multiple antigens can be used and that encapsulation removes the competition between various molecules that might occur if the agents were attached to the surface of the particle (col 17, ln 63-67). It is noted that the invention of Shea can be used to treat hepatitis B virus (HBV) infections as well as various other viral infections (col 34, lns 37-45).
Shea does not teach wherein the antigens are separated by a linker in a fusion protein.
Murray teaches HBV core antigen particles comprising epitopes used as delivery systems (Abstract). Mixtures of more than one immunogen may be crosslinked to the same HBV core particle [0014] wherein the immunogens include any molecule containing one or more antigenic epitopes [0018]. The linkage of the immunogens to the HBV core may comprise peptide bonds [0067]. The HBV core may comprise a fusion protein [0031-0034].
It would have been prima facie obvious to incorporate the fusion protein of Murray, which comprises multiple antigenic epitopes linked by cleavable peptide bonds, as the encapsulated antigens of Shea. It is well known that protease enzymes cleave peptide (amide) bonds. It would have been obvious to modify Shea to include the antigen cores of Murray since they are taught as being useful in treating HBV and the particle of Shea is also useful for treating HBV. Generally, it is prima facie obvious to substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06). The resulting particle, useful for treating HBV, is a biodegradable particle comprising fusion proteins comprising multiple antigenic epitopes linked by cleavable peptide bonds in a core, wherein the zeta potential ranges from about -100 mV to about 0 mV and the diameter ranges from about 0.1-10 mm. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (I). Since proteases are known for breaking peptide bonds, the composition of Shea in view of Murray would have necessarily been susceptible to cleavage by an intracellular protease such as cathepsin protease and furin protease and thus renders obvious instant claims 1, 7, 10, 16, 27, 55, and 117-118.
Response to Arguments
Applicant's arguments filed 3 June 2026 have been fully considered but they are not persuasive. The Applicant argues, on pages 5-6 of their remarks, that Shea does not teach or suggest linked epitopes in a fusion polypeptide and that Murray does not teach a biodegradable particle comprising the fusion proteins. Applicant argues it would not have been obvious to substitute the antigen of Murray in the invention of Shea.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It would have been obvious to incorporate the fusion protein of Murray, which comprises multiple antigenic epitopes linked by cleavable peptide bonds, as the encapsulated antigens of Shea since the protein of Murray is taught as being useful in treating HBV and the particle of Shea is also useful for treating HBV. Generally, it is prima facie obvious to substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06). The Applicant has provided no evidence or data to show that combination of Murray and Shea would not have resulted in the claimed invention or would not have been possible.
The Applicant argues, on page 7 of their remarks, that it was not known until the present disclosure that a fusion protein would still induce tolerance in the model like the regular peptide does.
In response, the Applicant has not provided any data to support this assertion. The Applicant points to Examples 4-7 in the specification however these examples are unclear as to what is unexpected. Moreover, these examples are not commensurate in scope with the claims.
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 § 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.
Claims 1, 7, 10, 16, 27, 55, and 117-118 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, and 8-9 of U.S. Patent No. 12,502,436.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘436 claims do not recite the limitations of the instant application together in one claim. The ‘436 claims recite a particle comprising one or more antigens (i.e. a fusion protein) encapsulated within said particle wherein the antigens are covalently attached (i.e. linked) to the particle surface. ‘436 further recites wherein the zeta potential is from about -100 mV to about -15 mV and the diameter is from about 0.3 mm to about 5 mm. The antigens can comprise epitopes associated with an autoimmune disease. Thus, the claims of ‘436 encompass the subject matter of instant claims 1, 7, 10, 16, 27, 55, and 117-118.
Claims 1, 7, 10, 16, 27, 55, and 117-118 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5-9 of U.S. Patent No. 11,510,996.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘996 claims do not recite the limitations of the instant application together in one claim. The ‘996 claims recite a particle comprising one or more antigens (i.e. a fusion protein) encapsulated within said particle wherein the antigens are covalently attached (i.e. linked) to the particle surface. ‘136 further recites wherein the zeta potential is from about -80 mV to about -30 mV and the diameter is from about 0.3 mm to about 5 mm. The antigens can comprise epitopes associated with an autoimmune disease. Thus, the claims of ‘996 encompass the subject matter of instant claims 1, 7, 10, 16, 27, 55, and 117-118.
Response to Arguments
Applicant's arguments filed 3 June 2026 have been fully considered but they are not persuasive. The Applicant argues, on pages 7-8 of their remarks, that the related issued patents do not teach wherein the fusion proteins comprise intracellularly cleavable linkers.
In response, the related patents teach “covalently attached” antigens. While this broad term is not further limited within the claims, the specification further defines it as including peptide bonds, which are known to be cleaved by proteases (see 12,502,436 specification col 3, lns 32-40).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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