DETAILED ACTION
Status of Application
The claim set filed 9/20/2024 is acknowledged.
Claims 1-20 are under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) filed on 9/20/2024 and 12/4/2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is drawn to a liquid formulation of plasmid DNA, comprising 30-50 mM potassium phosphate, 0.5-1.5% NaCI, and plasmid DNA, with a pH of 7.5-8.5.
The broadest reasonable interpretation of the claimed compositions would be the material that is named, that is potassium phosphate, NaCI, and plasmid DNA. Potassium phosphate is a naturally occurring product. NaCl is a naturally occurring product. Plasmid DNA is a naturally occurring product.
Thus, the compositions claimed in claims 1-20 are not markedly different from how the individual components in nature. It is not integrated into a practical application because nothing in claim 1 relies on or uses the exception. There is nothing significantly more than the judicial exception because there are no additional elements in the claim. With regard to claims 2-20 the enumeration of the amounts or additional products of nature do not make the combination of the products of nature markedly different from how they occur in nature.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because the formulation at the broadest interpretation of the claim language is a mixture of products of nature comprising potassium phosphate, NaCI, and plasmid DNA, which does not appear to change the biological/pharmacological functions, chemical/physical properties, or the structure/form of said ingredients. Because the claimed formulation does not have markedly different characteristics, it is a product of nature.
Claim Rejections - 35 USC §102/103
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 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.
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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Chang (US20200023075A1).
Anticipation
Regarding claims 1-20, Chang is drawn to novel lyophilized pharmaceutical composition that maintains the stability of a DNA plasmid. The novel lyophilization formulation further allows uniform reconstitution of the DNA plasmid in a pharmaceutically acceptable solution, enabling complete recover of the active ingredients, minimizing partial loss of potency and allowing administration of the active ingredients in an accurate and consistent manner (abstract).
Chang discloses the novel lyophilized formulation comprises plasmid DNA, wherein the pharmaceutical composition is obtained by lyophilizing a liquid composition that comprises, prior to lyophilization: a. DNA of a first plasmid; b. potassium phosphate buffer with pH in the range from 7.0 to 9.0; c. mannitol at a concentration in the range from 0% to 3% (w/v); d. sucrose at a concentration greater than 0.5% and less than 1.1% (w/v); and e. NaCl at a concentration in the range from 0.1% to 0.9% (w/v). The first plasmid can be selected from the group consisting of VM202, pTx-HGF-X7, pTx-IGF-1Ec, pTx-IGF-1Ea, pTx-IGF-1X6, pTx-IGF-X10, and pCK-SDF-1α [0007].
Chang discloses at least 90% of the plasmid DNA in the liquid composition is supercoiled. In some embodiments, at least 92.5% of the plasmid DNA in the liquid composition is supercoiled. In some embodiments, at least 95% of the plasmid DNA in the liquid composition is supercoiled. In some embodiments, at least 97% of the plasmid DNA in the liquid composition is supercoiled. In some embodiments, at least 98% of the plasmid DNA in the liquid composition is supercoiled [0015].
Chang discloses at least 80% of the plasmid DNA remains supercoiled 30 minutes after reconstitution, wherein the lyophilized pharmaceutical composition had been stored at 40° C. for 10 weeks before reconstitution [0018].
Chang discloses NaCl at a concentration in the range from 0.1% to 0.9% (w/v) [0046]. Chang discloses the liquid composition comprises sucrose at a concentration in the range from 0.75% to 1.1% (w/v) [0025]. Chang discloses the unit dosage form is a vial, ampule, bottle, or pre-filled syringe [0224].
Obviousness
Chang does not explicitly disclose each of the formulation in one single embodiment for an anticipation rejection.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Chang, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Chang discloses all the required components and Chang discloses lyophilized pharmaceutical composition that maintains the stability of a DNA plasmid (abstract). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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