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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Republic of Korea (KR), 10-2024-0053657 on 04/10/2023. It is noted, however, that applicant has not filed a certified copy of the KR 10-2024-0053657 application as required by 37 CFR 1.55.
Claim Status
The claim set filed August 28, 2024 has been entered.
Thus, claims 1-16 are examined on the merits herein.
Claim Interpretation
Claim 1, line 1, recites “for treating cancer”; and
Claim 2 further specifies the cancer of claim 1.
The Examiner reasonably interprets these limitations to be intended uses of the pharmaceutical composition comprising platycodin D2 as the pharmaceutically active ingredient.
Therefore, the Examiner reasonably interprets the limitations as recited above within claims 1-2 are not considered limitations; as MPEP 2111.02(II) states "If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.".
Thus, in view of the following reasons, the limitations of claims 1-2 as discussed above will not be considered by the Examiner in view of the prior art.
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.
Claims 1-4, 7-8 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al. (Published 08 April 2009, CN-101402666-A, PTO-892; English Machine Translation, PTO-892) as evidenced by Kim et al. (Published 21 June 2005, Planta Medica, Vol. 71, Issue 5, pp. 566-568, PTO-892).
Regarding claims 1-4, 7-8 and 11-14, Sun teaches a vaccine preparation (a pharmaceutical composition, required in claim 1, line 1) containing a saponin with immune adjuvant function (e.g. a pharmaceutically active ingredient, required in claim 1, line 2), wherein the saponin is platycodon saponin D, platycodin saponin D2 (e.g. platycodin D2, required in claim 1, line 1) or a combination thereof, see pg. 1, abstract.
Sun teaches their application in treating cancer (e.g. the method, required in claim 11, line 1), see pg. 1, abstract; specifically for treating tumors, see pg. 3, line 6.
Sun teaches the vaccine preparation is characterized in that platycodin D, platycodin D2 or the combination thereof is/are in amount of 0.1µg – 1g per single dose (e.g. a pharmaceutically effective amount, required in claim 11, lines 1-2), see pg. 1, claims, claim #5.
Sun teaches the vaccine formulation can be administered (e.g. administering, e.g. claim 11, line 1) to the subject (e.g. to a patient in need thereof, required in claim 11, line 2) to be vaccinated via parenteral administration; and when used for parenteral administration they can be made into forms such as and including liposomes (e.g. the liposome, required in claim 7), see pg. 3, lines 10-15.
Additionally, as evidenced by Kim, Kim discloses platycodin D2 as compound 8, and further discloses compounds 6-8 exhibited significant inhibition on the proliferation of five kinds of cultured human tumor cell lines, including A549 (non-small cell lung) and HCT-15 (colon) in vitro (e.g. the cancers, required in claim 12), see pg. 555, abstract.
With respect to the limitation (a) “wherein the platycodin D2 is encapsulated in a liposome”, required in claim 3 and claim 13; and (b) “wherein the platycodin D2 is fixed to a lipid bilayer of the liposome”, required in claim 4, claim 8 and claim 14; the Examiner reasonably interprets these limitations as physical limitations met as a result of interactions between the liposome and platycodin D2. Accordingly, since Sun teaches a vaccine formulation in the form of a liposome, wherein said vaccine formulation comprises platycodin D2 as discussed above; the Examiner reasonably interprets the physical limitations discussed above are met by the teachings of Sun.
Thus, in view of the teachings of Sun as evidenced by Kim, the teachings of Sun anticipate instant claims 1-4, 7-8 and 11-14.
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.
Claims 5-6, 9-10 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (Published 08 April 2009, CN-101402666-A, PTO-892; English Machine Translation, PTO-892) as evidenced by Kim et al. (Published 21 June 2005, Planta Medica, Vol. 71, Issue 5, pp. 566-568, PTO-892) as applied to claims 1-4, 7-8 and 11-14 above, and further in view of Nguyen et al. (Published 11 February 2019, Journal of Controlled Release, Vol. 298, pp. 142-153, PTO-892).
Sun as evidenced by Kim addresses claims 1-4, 7-8 and 11-14 as written above. Although, Sun does not teach the ATRAM protein represented by SEQ ID NO:1, required in claims 5-6, 9-10 and 15-16.
However, in the same field of endeavor of treating cancer with liposomes, Nguyen designed an acidity-triggered rational membrane (ATRAM) peptide to have a pH-responsive membrane interaction, see pg. 142, abstract.
Nguyen shows that ATRAM is able to deliver liposomes to cells in a pH dependent way; and that their data highlights the potential of ATRAM as a specific therapeutic agent for diseases that lead to acidic tissues, including cancer, see pg. 142, abstract.
Nguyen teaches ATRAM is a 34-amino acid peptide (sequence: GLAGLAGLLGLEGLLGLPLGLLEGLWLGLELEGN) (e.g. SEQ ID NO: 1, required in claims 6, 10, and 16), see pg. 142, right column, paragraph 2 – pg. 143, left column, paragraph 1. The Examiner notes the sequence of ATRAM taught by Nguyen has a 100% sequence similarity with SEQ ID NO: 1 as evidenced by the specification (see pg. 11, paragraph [0029]).
Nguyen specifically conjugated either the N-terminus (Nt) of ATRAM (PL-AN) or the C-terminus (Ct) of ATRAM (PL-AC) separately to the PEGylated liposome (PL), see pg. 145, section 3.1., paragraph 1. Nguyen depicts liposomes PL-AN and PL-AC in Figure 1J, see pg. 146-147, Figure 1J.
Nguyen teaches the method of conjugating ATRAM to PL, see pg. 143, section 2.2, paragraph 1.
Nguyen teaches ATRAM successfully targeted tumors in vivo, suggesting that ATRAM shows promise as a cancer therapeutics peptide, see pg. 142, left column, paragraph 1.
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have modified the liposomal form of the vaccine preparation as taught by Sun with the ATRAM peptide as taught by Nguyen as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to have made this modification in order to target tumors in vivo with ATRAM as taught by Nguyen above; as Sun is drawn to liposomal forms of vaccine formulations for treating cancer as discussed above. One of ordinary skill in the art would have had a reasonable expectation of success to have made the modification as discussed above; as both Sun and Nguyen are drawn to liposomes used in treating cancer; and Nguyen teaches a way to conjugate the ATRAM peptide to liposomes as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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