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 .
Previous Office Vacated
The previous office action mailed on June 23, 2026 has been vacated. A new office action is made on the record to replace the previous one hereto after interview with Applicants’ attorney who is responsible for the current Application on the record.
Remarks
The response was filed on May 20, 2026. Claims 2 and 26 were amended. The status of the claims is summarized below:
Claims 5-6, 10, 12-22, 24, 30- 32 were canceled.
Claims 1-4, 7-9, 11, 23, 25-29 and 33-36 are pending.
Claims 23, 25-29, 33 were withdrawn from consideration.
Claims 1-4, 7-9, 11, 34-36 with the elected species of Pluronic are considered.
Claim Rejections - 35 USC § 112
(Moot) The rejection of claims 2, 25 and 26 using relative word of derived has been removed moot in view of a new ground of rejection.
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.
(Moot) The rejection of Claim 1 under 35 U.S.C. 102 (a) (1) as being anticipated by US 20080131461A1 (146A) to Pau et al. is moot in view of a new ground of rejection necessitated by Applicants’ amendment.
(New ground of rejection) Claims 1-2 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by US 20080131461A1 (146A) to Pau et al.
In the response, Applicants traverse the rejected by arguing that the reference by Paul et al. does not teach any of the adjuvant cited in the claim 1.
Applicants’ argument has bene respectably considered; however, it is not found persuasive because Pau et al. do teach an adjuvant of MPL at paragraph [0070], which cites that : “Th1-type immunostimulants which may be formulated to produce adjuvants suitable for use in the present invention may include Monophosphoryl lipid A, in particular 3-de-O-acylated monophosphoryl lipid A (3D-MPL). 3D-MPL is a well-known adjuvant manufactured by Ribi Immunochem.
Regarding the newly amended claim 2 that cites the claimed bioadhesive excipient is selected from cellulose polymer. For instance, Pau et al. teach at paragraph [0068] that “suitable adjuvants for use in the invention include an aluminum salt such as aluminum hydroxide gel (alum) or aluminum phosphate, but may also be a salt of calcium, iron or zinc, or may be an insoluble suspension of acylated tyrosine, or acylated sugars, cationically or anionically derivatized polysaccharides, etc”.
It is worth to note based on the molecular structure and biological activities of polysaccharides known in the art, that polysaccharides are often heterogeneous, containing slight modifications of the repeating unit of amorphous (e.g. starch) or insoluble in water (e.g. cellulose). Therefore, polysaccharide is celluloses in structure and function or vice versa, i.e. cellulose is a polysaccharide, which is also considered as a type of carbohydrate polymers, which may be composed of hundreds to thousands of repeating glucose monosaccharide monomers linked together by β-1, 4-glycosidic bonds as evidenced by V Gopinath et al. (Biomedicine $ Pharmacotherapy , Volume 107, November 2018, Pages 96-108, See Abstract). For example, V Gopinath et al. teach that many polysaccharides with different molecular weights are superior to other polymers for their ease in tailoring, bio-compatibility, bio-activity, homogeneity and bio-adhesive. In particular, Gopinath et al. also teach that The major concern in the selecting polysaccharides as suitable inexpensive polymers without losing specific bio-activity and minimizing serious side effects are potentially negated by the natural polysaccharides such as cellulose, starch, and glycogen (See the section 2, Pharmaceutical benefits of molecular polysaccharides). Hence, the polysaccharides as one of the ingredient of the simian adenovirus vector composition taught by Pau et al. at paragraph [0068] meets the limitaiton of cellulose polymer cited in claims 1 and 2 in structure of cellulose polymer and function of being bio-adhesive.
Additionally, the adjuvant of aluminum salt and a salt of calcium, iron or zinc ingredient, the limitation of claim 8 is also met.
Therefore, the cited reference anticipates claims 1 and 2 implicitly or inherently.
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 BAO Q LI whose telephone number is (571)272-0904. The examiner can normally be reached M-F 8 am to 8 pm EST.
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671
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