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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I and SEQ ID NO: 48 in the reply filed on 9/22/2025 is acknowledged.
Claims 5, 13, 18, 20-21, 24, 26, 28, 36, 41-47 and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/22/2025.
Status of the Claims
Claims 1-14, 16, 18, 20-24, 26, 28, 31-36, 41-47 and 49 are pending in this application.
Claims 5, 13, 18, 20-21, 24, 26, 28, 36, 41-47 and 49 are withdrawn from consideration as being drawn to a non-elected species/invention.
Claims 1-4, 6-12, 14, 16, 22-23 and 31-35 are presently under consideration as being drawn to the elected species/invention.
Claim Rejections - 35 USC § 103
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.
Claims 1-4, 6-12, 14, 16, 22-23 and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Samuelsson et al. (WO 2019/011286) in view of Tam (US 5229490).
Samuelsson et al. teach a mussel adhesive protein or a derivative thereof for use in the treatment of a viral infection (claim 1), comprising a derivative of a mussel adhesive protein, which is a peptide of the sequence Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-Tyr-Lys or a salt thereof (claim 10), “[i]n admixture with a pharmaceutically acceptable adjuvant, diluent or carrier, which may be selected with due regard to the intended route of administration and standard pharmaceutical or other (e.g. cosmetic) practice. Acceptable carriers may be chemically inert to the active compounds and may have no detrimental side effects or toxicity under the conditions of use. Such carriers may also impart an immediate, or a modified, release of active ingredient” (page 6, lines24-31).
Samuelsson et al. also teach that the mussel adhesive protein derivative is Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lys (claim 9; page 4, lines 16-18; page 11, lines 19-22).
Samuelsson et al. do not teach a dendritic homopolymer comprising multiple copies of the peptide.
Tam teaches an antigenic product comprising a dendritic homopolymer containing up to 10 monomeric residues to which an antigenic peptide is joined by a covalent bond (claims 1-2, 12-13, 15-16, 18-19, 21-22, 24-25, 27-28 and 30-31).
Tam also teaches a representation of a typical antigen product of the invention in which 8 peptide antigens are linked through glycine linkers to a dendritic lysine substrate (Fig. 1), and further teaches possible configurations of the products of the invention with the same or different antigens in a dendritic polymer (Figs. 8A-8L).
Tam further teaches that the principal advantage of the Multiple antigen peptide systems (MAPS) of this invention as the basis for vaccines is that unlike previous systems using natural carriers such as keyhole limpet hemocyanin, tetanus toxoid and bovine serum albumin, the carriers of this invention are fully defined chemical entities on which the antigens are dispersed in known concentrations. Additionally, the antigen comprises a large part of the molecule not a relatively small and undefined proportion of the molecule as in the case of natural carriers.
It would be obvious to one of ordinary skill in the art to make a dendritic homopolymer comprising the mussel adhesive proteins of Samuelsson et al. for the treatment of a viral infection because Tam teaches that the principal advantage of said MAPS comprise carriers on which the antigens (e.g. mussel adhesive proteins) are dispersed in known concentrations, and further teaches that the antigen comprises a large part of the molecule not a relatively small and undefined proportion of the molecule as in the case of natural carriers.
One of ordinary skill in the art would have reasonably expected the resulting dendritic homopolymer (i.e. [Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thr-DOPA-Lys)2-Lys]2-Lys), which corresponds to the elected species, to enhance the effect of the mussel adhesive protein of Samuelsson et al.
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 1-4, 6-12, 14, 16, 22-23 and 31-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-14, 16-47, 50-53, 55-58, 61-68 and 70 of copending Application No. 17/781543 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same compound.
‘543 teaches the same compound instantly claimed (see claims).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6-12, 14, 16, 22-23 and 31-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-40, 43-44, 47, 50 and 53 of copending Application No. 18/282362 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same compound.
‘362 teaches the same compound instantly claimed (see claims).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658