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 .
RCE
The request for continued examination (RCE) under 37 CFR 1.114 (d) filed on 01/21/2006 is acceptable and a RCE has been established. The previous office action mailed on 11/14/2025 has been withdrawn and a new office action on the RCE follows.
Claims amendment filed on 09/29/2025 are summarized herein:
Claims 1 and 35 were amended .
Claims 5-6, 10, 24, 30- 32 were canceled.
Claims 1-4, 7-9, 11-22, 25-29 and 33-36 are pending.
Claims 23, 25-29, 33 were withdrawn from consideration.
Claims 1-4, 7-9, 11-13, 34-36 are considered.
Claim Rejections - 35 USC § 112
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.
The term “derived” cited in claims 2, 25 and 26 is a relative term which renders the claim indefinite. The term “derived” 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. Please amend claims in order to overcome the rejection.
Claims 2, 25 and 26 are indefinite because they recite improper Markush group. The applicant is referred to MPEP 2173.05(h) and advised to reformat the claim to read “wherein R is a material selected from the group consisting of A, B, C and D” or “wherein R is A, B, C or D”. In the instant case, the claim is cited with more than one option such as or mutein, or a biologically active fragment …. or multiple subunit of …… It is unclear and confusing which ono is entitled for the in that the markush claim should be cited clearly there is only one alteration is intended. Therefore, the metes and bounds of the claimed subject matter is not vague and defined.
MPEP 21703.05 (h) cites: “A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112 (b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. If a claim is intended to encompass combinations or mixtures of the alternatives set forth in the Markush grouping, the claim may include qualifying language preceding the recited alternatives (such as "at least one member" selected from the group), or within the list of alternatives (such as "or mixtures thereof"). Id. at 1281. See also MPEP § 2111.03.
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.
Claim 1 is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by US 20080131461A1 (146A) to Pau et al.
Pau et al. teach an applicability of simian adenovirus for use in human gene therapy or vaccines is well appreciated by those of ordinary skill in the art. Besides this, other non-human adenoviruses such as canine and bovine adenoviruses were found to infect human cells in vitro and are therefore also applicable for human use since their seroprevalence is low in human samples. Thus, the invention also relates to a kit of parts comprising a replication-defective recombinant simian, canine or bovine adenovirus in a pharmaceutically acceptable excipient, said adenovirus comprising a heterologous nucleic acid encoding a codon-optimized circumsporozoite (CS) antigen from Plasmodium falciparum; and an adjuvated proteinaceous antigen comprising RTS,S, wherein it is preferred that said proteinaceous antigen is adjuvated with QS21 and 3D-MPL, preferably in a formulation with cholesterol-containing liposomes.
Therefore, the cited reference anticipates claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAO Q LI whose telephone number is (571)272-0904. The examiner can normally be reached M-F 8 am to 8 pm EST.
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, Michael Allen can be reached at 571-270-3497. 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.
BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/ Primary Examiner, Art Unit 1671
Prosecution Insights