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 .
Claims 1-21 are pending and will be examined on the merits.
Claim Objections
Claims 5-6 and 8-21 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend on another multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims not been further treated on the merits.
Note the following is a list of claims in the current (and only) claim set. Multiple dependent claims are bold, multiple dependent claims that depend on other multiple dependent claims are bold and underlined and non-multiple dependent claims that depend on multiple dependent claims that depend on other multiple dependent claims are underlined.
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21
Claim Rejections - 35 USC § 102
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 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(s) 1-4 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Jong (De Jong, et al., WO 2020/037433A1; Published 2/27/2020; Priority to 8/24/2018 via US 62/722,687).
Regarding claim 1, De Jong discloses an immunomodulator for enhancing an innate immune response comprising: a TLR agonist covalently or non-covalently linked to glycogen-based polysaccharide nanoparticles having a molecular weight of 106 to 107 Da comprising alpha-D glucose chains having an average length of 11-12, with 1[Wingdings font/0xE0]4 linkage and branching point occurring at 1[Wingdings font/0xE0]6 and with a branching degree between 6% and 13% (De Jong, p 4, lines 6-10). Regarding the sole active method step (contacting the cancer cell with the immunomodulatory claimed compound), De Jong teaches that the immunomodulatory compound of De Jong (which is identical to the instant claimed immunomodulatory compound) is administered to subjects in therapeutically effective amounts in cancer immunotherapy (tumor cells will inherently be contacted by the immunomodulatory compound of De Jong) (De Jong, claims 14 & 17). Regarding claims 2-3 teaches that the immunomodulatory compounds of De Jong induce CXCL10, IFN-b and ISG-15 very strongly (De Jong, Fig. 4). Regarding instant claim 4, as evidenced by the instant Specification, performing the contacting of a cancer cell with the immunomodulator of De Jong would inherently result in an increase of sensitivity to chemotherapeutics, wherein EC50 is lowered by greater than 10% (Specification, ¶ 0004). Regarding instant claim 7, as evidenced by the instant Specification, performing the contacting of a cancer cell with the immunomodulator of De Jong would inherently result in sensitizing the contacted cancer cell to checkpoint inhibiters via inducing the expression of PD-L1 on the contacted cancer cell. (Specification, ¶ 0004).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over HogenEsch (HogenEsch, et al., US 2017/0128567 A1; Published 3/11/2017) as evidenced by Gilbert (Gilbert Aust. J. Chem. 2014 67:538).
HogenEsch teaches on the subject of vaccine adjuvants (HogenEsch, Abstract). HogenEsch teaches that the adjuvants of HogenEsch comprise a core molecule 10-300 nm in size comprising highly branched alpha-D glucans including glycogen (HogenEsch, ¶ 0004). HogenEsch teaches that glycogen is a highly branched alpha-D glucan, formed by alph-D-1,4 and alpha-D-1,6 glycosidic linkages (HogenEsch, ¶ 0023). HogenEsch teaches that the branching density of glycogen is about 8-11% (HogenEsch, ¶ 0024). HogenEsch teaches that the glycogen adjuvant nanoparticles of HogenEsch have immunostimulatory molecules that are poly(I:C) and CpG DNA oligonucleotides (TLR agonists) adsorbed to the particles and that this enhances the potency and decreases the systemic toxicity of these TLR agonists (HogenEsch, ¶ 0032). HogenEsch teaches that the glycogen nanoparticle adjuvants of HogenEsch may be administered intramuscularly, subcutaneously or intradermally and are useful in therapeutic vaccines against cancer (HogenEsch, ¶ 0032).
HogenEsch does not teach that the glycogen nanoparticles with TLR agonist adsorbed comprise nanoparticles that are 20-30 nm in size.
It would be prima facie obvious to one of ordinary skill in the art to start with the 10-300 nm glycogen nanoparticles with adsorbed TLR agonist and branching degree between 8-11% and arrive at 20-30 nm glycogen nanoparticles with adsorbed TLR agonist and branching degree between 8-11% via routine experimentation. One of ordinary skill in the art would be motivated to do this in order to optimize the size of the glycogen nanoparticle adjuvant. One of ordinary skill in the art would have a reasonable expectation of success starting with the 10-300 nm glycogen nanoparticles with adsorbed TLR agonist and branching degree between 8-11% and arrive at 20-30 nm glycogen nanoparticles with adsorbed TLR agonist and branching degree between 8-11% via routine experimentation because HogenEsch teaches glycogen nanoparticle adjuvants between 10-300 nm in size and arriving at 20-30 nm nanoparticles via routine experimentation is within the purview of one of skill in the art. Additionally, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Note: As evidenced by Gilbert, the resulting 20-30 nm glycogen nanoparticles with adsorbed TLR agonist of HogenEsch are structurally identical to the instant claimed immunomodulator as glycogen always has an average chain length of 11 units (Gilbert, 538, ¶ 1) and 20-30 nm glycogen particles have mW ~ 106 -107 (Gilbert, p 538, ¶ 1).
It would be prima facie obvious to one of ordinary skill in the art to administer 20-30 nm glycogen nanoparticles with TLR adjuvant adsorbed of HogenEsch in methods of treating cancer using cancer vaccines. One of ordinary skill in the art would be motivated to do this in order to better treat cancer. One of ordinary skill in the art would have a reasonable expectation of success administering 20-30 nm glycogen nanoparticles with TLR adjuvant adsorbed of HogenEsch in methods of treating cancer using cancer vaccines because: 1) HogenEsch teaches multiple methods of administering the glycogen nanoparticle adjuvants of HogenEsch and 2) HogenEsch teaches the glycogen nanoparticle adjuvants of HogenEsch are useful in cancer vaccines.
Regarding claim 1, Note that this administration of the 20-30 nm glycogen nanoparticles with TLR agonist adsorbed of HogenEsch, which is identical to the instant claimed immunostimulatory compound, will inherently be result in the tumor cells being contacted and sensitized to the chemotherapeutic. Regarding claims 2-3, as evidenced by the instant Specification, the 20-30 nm glycogen nanoparticles with TLR agonist adsorbed of HogenEsch will inherently induce CXCL10, IFN-b and ISG-15 very strongly (Specification, ¶ 0004). Regarding instant claim 4, as evidenced by the instant Specification, performing the contacting of a cancer cell with the 20-30 nm glycogen nanoparticles with TLR agonist adsorbed of HogenEsch would inherently result in an increase of sensitivity to chemotherapeutics, wherein EC50 is lowered by greater than 10% (Specification, ¶ 0004). Regarding instant claim 7, as evidenced by the instant Specification, performing the contacting of a cancer cell with the 20-30 nm glycogen nanoparticles with TLR agonist adsorbed of HogenEsch would inherently result in sensitizing the contacted cancer cell to checkpoint inhibiters via inducing the expression of PD-L1 on the contacted cancer cell. (Specification, ¶ 0004).
Conclusion
Claims 5-6 and 8-21 are objected to.
Claims 1-4 and 7 are rejected.
No claims are allowed.
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/SYDNEY VAN DRUFF/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643