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 .
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 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hangzhou Xing'ao Biological Technology Co ltd. CN 113384710A (Hangzhou).
Hangzhou teaches the preparation of immune agonist and metal complex thereof. Cyclic dinucleotide cGAMP (i.e. 2'3' -cGAMP) is synthesized catalytically by cyclic cGMP-AMP dinucleotide synthetase (cGAS) under activating conditions after binding to DNA as described in the literature (Example 1). Immune agonist metal complexes ([ M (cGAMP) L0-2]M ═ Zn, Mn, Cu, Ru, etc. transition metal ions, L ═ small molecule ligand containing O, N, S coordination atom) is generated by heating and stirring reaction of transition metal ion metal salt and immune agonist (such as cGAMP) in the presence of small molecule ligand, then purifying by ion exchange column to obtain pure immune agonist metal complex. The metal complex of the immune stimulant is verified by metal content analysis and element analysis. Hangzhou explicitly teaches MncGAMP [0131] and ZncGAMP [0160]. Hangzhou teaches that the immune agonist compound medicine comprises unit preparations with different specifications and pharmaceutically acceptable medicinal preparations, including but not limited to one or more of intravenous injection, intramuscular injection, subcutaneous injection, intravenous drip, nasal drip, oral administration and the like, for preventing or treating the related diseases. See claim 10.
Hangzhou teaches that the immune agonist complex can effectively activate type I interferon signaling pathway, significantly induce humoral immunity and cellular immunity (including memory immune T cells), and significantly enhance immune function in vivo (Abstract). This new type of complex can effectively inhibit the replication of coronavirus and viral pneumonia, effectively inhibit the growth and metastasis of solid tumor tumors, can significantly improve the cognitive function of Alzheimer's disease (AD) mice, and effectively reduce the brain starch in AD mice. It has obvious curative effect on brain diseases such as ischemic cerebrovascular or craniocerebral injury. Hangzhou teaches that; therefore, this new type of immune agonist complex has a good application prospect in the preparation of anti-disease drugs, including anti-viral inflammation, anti-tumor, anti-Alzheimer's disease and other neurodegenerative diseases and brain injury diseases.
Thus, Hangzhou teaches or reasonably suggests a MncGAMP and ZncGAMP both of which are embraced by the instantly claimed formula, and a pharmaceutical composition comprising MncGAMP or ZncGAMP in the form of intraperitoneal injections. Thus, claims 1 and 15 are anticipated.
Claim(s) 6, 8, 11, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hangzhou Xing'ao Biological Technology Co ltd. CN 113384710A (Hangzhou) as applied to claims 1 and 15 above.
Hangzhou teaches or reasonably suggests the administration of a composition comprising MncGAMP or ZncGAMP to an instant subject in need thereof. Thus, claims 6, 8, 11, and 13 are anticipated.
Claim Rejections - 35 USC § 103
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 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) 2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hangzhou Xing'ao Biological Technology Co ltd. CN 113384710A (Hangzhou) as applied to claims 1 and 15 above, and further in view of Hangzhou Xing'ao Biological Technology Co ltd. CN 111138508A (Hangzhou2).
Hangzhou differs from the instantly claimed invention in that Hangzhou does not explicitly teach a cyclic dinucleotide metal compound wherein the metal is Mg2+; however, this deficiency would have been obvious in view of the teachings of Hangzhou2.
In the instant case, the references may be combined to show obviousness because Hangzhou and Hangzhou2 are each drawn to a cyclic dinucleotide metal compound useful in the treatment of cancer. They are from the same field of endeavor, and/or are reasonably pertinent to a cyclic dinucleotide metal compound, wherein the metal is Mg2+.
Hangzhou2 belongs to the technical field of biological medicines, and discloses an innovative transition metal cyclodiphosphate complex which is prepared by synthesizing metal salt and cyclodiphosphate under the conditions of heating and stirring (Abstract). These metal complexes show more significant antitumor activity in mouse tumor model experiments than cyclic dinucleotides themselves. Hangzhou2 particularly relates to preparation and structural composition of a novel cyclic dinucleotide metal complex [M (cGAAMPX)L], and application of the novel cyclic dinucleotide metal complex [M (cGAAMPX)L] in preparation of anti-tumor drugs, senile dementia drugs and the like (Technical Field). Hangzhou2 teaches that M is a metal ion, including but not limited to manganese, zinc, magnesium, calcium, cobalt, nickel, copper, iron , ruthenium, rhodium, iridium, etc.; cGAMPX refers to cyclic dinucleotides (2'3'-cGAMP and its various derivatives). See claim 1.
In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983); Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983).
In the absence of unexpected results, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute Mn2+ or Zn2+ in the cyclic dinucleotide metal compound of Hangzhou with Mg2+ with a reasonable expectation of success in view of the teachings of Hangzhou2. The simple substitution of one known element for another to obtain predictable results is prima facie obvious. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art.
In the instant case, all of the instant limitations are disclosed by Hangzhou with the exception of the metal being Mg2+; however, it would have been obvious to substitute/employ Zn2+ or Mn2+ in the cyclic dinucleotide metal compound Hangzhou with Mg2+. As set forth supra, Hangzhou teaches that MncGAMP or ZncGAMP are useful as an anticancer agent. Hangzhou2 teaches McGAMP which is useful as an anticancer agent, wherein M can be Mg2+, Zn2+, or Mn2+.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
All of the instant limitations are taught by the combination of Hangzhou and Hangzhou2. A person of ordinary skill in the art would have had a reason to combine the teachings of Hangzhou and Hangzhou2. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Hangzhou and Hangzhou2. Thus, claims 2 and 9 would have been obvious based on the preponderance of the evidence.
Conclusion
Claims 1-16 are pending. Claims 1-2, 6, 8-9, 11, 13, and 15 are rejected. Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 3, 5, 7, 10, 12, 14, and 16 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Hangzhou Xing'ao Biological Technology Co ltd. CN 113384710A (Hangzhou) is representative of prior art. Hangzhou does not teach or suggest a cyclic dinucleotide metal compound, wherein the metal is Li+.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/
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