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 .
FINAL DETAILED ACTION
1. Applicant’s response filed on November 25, 2025 is acknowledged. Claims 28, 37-43, 45 and 46 have been amended. Claims 28, 37-43 and 45-46 are currently pending and under examination.
Rejections Withdrawn
2. In view of Applicant’s amendment, the rejection of claim(s) 28, 37-43 and 45-46 under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Fattori et al., WO 03/045438 A1; Published: 6/5/03 is withdrawn.
New Ground of Rejection Necessitated by Amendment
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(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.
3. Claim(s) 28, 39-40, 43 and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamazaki et al., Jpn. J. Infect. Dis., 2011; 64:40-49.
Independent claim 28 is drawn to a method of delivering a plasmid encoding an antigen or a monoclonal antibody to a subject, the method comprising: administering to the subject a hyaluronidase polypeptide or a polynucleotide encoding a hyaluronidase polypeptide; and administering the plasmid encoding a monoclonal antibody to the subject.
Yamazaki discloses genetic delivery of therapeutic monoclonal antibodies by in vivo production. The expression plasmids were electro-transferred into a mouse muscle. All muscles were pretreated by injection of bovine hyaluronidase about 10 minutes prior to the gene transfer. Further, Yamazaki discloses that the plasmid encoding the mAbs were electro transferred into the adductor muscles after pretreatment with hyaluronidase (see page 41 and 44; meets claims 28, 39-40, 43 and 45).
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.
4. Claim(s) 41 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Yamazaki et al., Jpn. J. Infect. Dis., 2011; 64:40-49 as applied to claims 28, 39-40, 43 and 45 above, and further in view of Guidance for Industry Codevelopment of two or more new investigational drugs for use in combination; US Department of Health and Human services/FDA/CDER, 2013, pages 1-16 ‘HHS’.
Yamazaki teaches the genetic delivery of therapeutic monoclonal antibodies by in vivo production. The expression plasmids were electro-transferred into a mouse muscle. All muscles were pretreated by injection of bovine hyaluronidase about 10 minutes prior to the gene transfer. Further, Yamazaki discloses that the plasmid encoding the mAbs were electro transferred into the adductor muscles after pretreatment with hyaluronidase (see page 41 and 44; meets claims 28, 39-40, 43 and 45).
Yamazaki does not specifically teach that their hyaluronidase polypeptide and plasmid encoding a mAb are co-formulated prior to administration, as required in claim 46 or that the one is administered to the subject one hour prior to administration of the other, as required by claim 41.
HHS teaches that combination therapy is an important treatment modality in many disease settings, including cancer, cardiovascular disease, and infectious diseases. Recent scientific advances have increased understanding of the pathophysiological processes that underlie these and other complex diseases. This increased understanding has provided further impetus to develop new therapeutic approaches using combinations of drugs directed at multiple therapeutic targets to improve treatment response, minimize development of resistance, or minimize adverse events. In settings in which combination therapy provides significant therapeutic advantages, there is growing interest in the development of combinations of new investigational drugs. Because existing developmental and regulatory pathways focus primarily on assessment of the safety and effectiveness of a single new investigational drug acting alone, or in combination with a previously approved drug, FDA believes guidance is needed to assist sponsors in the codevelopment of two or more new investigational drugs. Although interest in codevelopment has been most prominent in oncology and infectious disease settings, codevelopment also has potential application in other therapeutic settings. Therefore, this guidance is intended to describe a high-level, generally applicable approach to codevelopment of two or more new investigational drugs. It describes the criteria for determining when codevelopment is an appropriate option, makes recommendations about nonclinical and clinical development strategies, and addresses certain regulatory process issues.
It would have been obvious before the effective filing date of the presently claimed invention to employ the use of co-formulation therapy in methods suggested by Yamazaki et al. with a reasonable expectation of success. This modification may be viewed as a combination of a known method step as generally suggested by the combined teachings of HHS. The skilled artisan would have been motivated to make this modification because HHS suggests coformulation and combination therapy having developed new therapeutic approaches using combinations of drugs directed at multiple therapeutic targets to improve treatment response, minimize development of resistance, or minimize adverse events. Further, the skilled artisan would have been motivated to make this modification because the combination therapy provides significant therapeutic advantages with existing developmental and regulatory pathways focusing primarily on assessment of the safety and effectiveness of a single new investigational drug acting alone, or in combination with a previously approved drug. Codevelopment is an appropriate option and the FDA makes recommendations about nonclinical and clinical development strategies, and addresses certain regulatory process issues. The skilled artisan would have had a reasonable expectation of success because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See the recent Board decision Ex parte Smith,--USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396).
Lastly, the decision to administer one component one hour prior to the other component is viewed as limitations of optimizing experimental parameters. Accordingly, the subject matter of the rejected claims would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
5. No claim is allowed.
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.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 March 2, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645