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 . Claims included in prosecution are claims 1-14.
Response to Restriction Requirement
Applicant’s election without traverse of Group I, claims 1-14, in the reply filed on 5/4/26 is acknowledged.
Accordingly, claims 21-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Applicant is advised that should claim 12 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 1-14 are objected to because of the following informalities: claim 1 recites “P2Et” without first defining the abbreviation. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
1. Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “common” in claim 4 is a relative term which renders the claim indefinite. The term “common” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what degree of commonality would be considered “common” such that one of ordinary skill in the art would recognize the scope of “common bulk agent” and be able to identify such bulk agents.
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.
1. Claim(s) 1-8 and 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teodor et al. (Anti-Cancer Agents in Medicinal Chemistry, 2020, 20) (hereinafter Teodor) in view of Gil et al. (Food and Chemical Toxicology, 106, 2017, 477-486) (hereinafter Gil).
Teodor discloses that the tendency of using herbs extracts or natural compounds extracted from herbs for preventing or treating different illnesses, including cancer, continues to be an alternative to drug use. Phenolic compounds, as important secondary metabolites from plants, are one of them (Abstract). Tannins are bitter non-nitrogenous polyphenolic compounds from plants having a molecular weight between 500 and 3000 in the case of gallic acid esters and up to 20,000 for pro-anthocyanidins (Sec. 1). Usually, the bioavailability of flavonoids and tannins is very low, being generally excreted into feces after passing through the gut. Moreover, tannins and flavonoids with high molecular weight are hardly absorbed in their native form because of their relatively large molecular size (Sec. 1). A gallotannin-rich fraction was obtained from Caesalpinia spinosa (P2Et), a plant used in South America (traditionally and extensively in Peruvian folk medicine) to treat inflamed tonsils, fever, cold and stomach aches. The ethanolic extract contains hydrolysable tannins, such as galloylquinic acid derivatives, in high proportions and pentagalloyl glucose and gallic acid-containing compounds (gallates) in lower proportions. The Immune Response (IR) activation and antitumor properties of breast tumor 4T1 cells treated with gallotannin-rich fraction from C. spinosa were evaluated. Data reveal the potential of using this fraction as an adjuvant in breast cancer treatment and as an adjuvant to chemotherapy (Sec. 1.2.2). The low bioavailability of tannins in systemic circulation can be overcome with new delivery systems which use nanoparticles (Sec. 1.3).
Teodor differs from the instant claim insofar as not disclosing wherein the composition comprises casein or an amino acid.
However, Gil discloses that casein nanoparticles have been proposed as carriers for the oral delivery of biologically active compounds (Abstract). One of the advantages of using nanoencapsulation of food ingredients is that they may protect the compound of interest from its premature degradation and improve its oral bioavailability (Sec. 1). Polyphenols are one of only a few examples of bioactive compounds that can be encapsulated to increase their bioaccessibility or improve their biological activity (Sec. 1). Casein has been used to produce nanoparticles to promote the oral absorption and bioavailability of chemotherapeutic drugs and bioactive compounds (Sec. 1). Materials for forming the casein nanoparticles included lysine (satisfies amino acid of claim 1), mannitol (satisfies excipient of claim 3-4), calcium chloride (satisfies divalent cation of claim 7-8), ethanol and DI water (satisfies solvent of claim 5-6) (Sec. 2.1). Casein nanoparticles, intended for oral delivery purposes, were prepared in an aqueous environment following a coacervation process of the protein with calcium. Then, the resulting nanoparticles were purified and dried by spray-drying using mannitol as protectant (satisfies solid of claim 2 and nanoparticle of claim 10) (Sec. 3.1). The resulting nanoparticles displayed a mean size of 138 ± 13 nm and a negative surface charge with a zeta potential value of -12 ± 1 mV (satisfies claim 11-12 & 14). All the prepared batches were quite homogeneous with a polydispersity index of 0.19 ± 0.02 (satisfies claim 13) (Sec. 3.1). The highest dose of casein nanoparticles was defined as 500 mg/kg whereas 150 mg/kg was defined as the intermediate dose of nanoparticles (Sec. 3.2).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have used a casein nanoparticle as the carrier for the P2Et of Teodor motivated by the desire to protect the P2Et from premature degradation and improve its bioavailability, bioaccessibility and/or biological activity as taught by Gil. One of ordinary skill in the art would have a reasonable expectation of success since Teodor discloses that polyphenolic compounds such as tannins, which may be used to treat cancer, and their bioavailability can be improved through the use of nanoparticles and therefore, one reasonably expect that the casein nanoparticles of Gil are suitable for use in improving the bioavailability of polyphenols and chemotherapeutic drugs such as those of Teodor.
Therefore, the combined teachings of Teodor and Gil render obvious claims 1-8 and 10-14.
2. Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teodor et al. (Anti-Cancer Agents in Medicinal Chemistry, 2020, 20) (hereinafter Teodor) in view of Gil et al. (Food and Chemical Toxicology, 106, 2017, 477-486) (hereinafter Gil) and further in view of Uruena et al. (BMC Complementary and Alternative Medicine, 2013, 13:74) (hereinafter Uruena).
The teachings of Teodor and Gil are discussed above.
The combined teachings of Teodor and Gil do not disclose wherein the composition comprises 3.00-9.14% of P2Et.
However, Uruena conducted a study which evaluated cytotoxic, antitumor, and tumor progression activities of a gallotannin-rich fraction derived from Caesalpinia spinosa (P2Et) (Abstract). The study found that the lethal dose, 50% (LD50) of P2Et was 69.6 mg/kg, and the therapeutic dose was 4-fold less to ensure low toxicity. The therapeutic dose was 18.7 mg/kg or 9.3 mg/kg (Results).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the composition of Teodor in view of Gil to comprise 18.7 mg/kg or 9.3 mg/kg P2Et motivated by the desire to ensure a therapeutic effect while maintaining low toxicity as taught by Uruena.
Regarding the concentration recited in instant claim 9 (i.e., 3.00-9.14%), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Teodor in view of Gil disclose wherein the highest concentration of nanoparticles is 500 mg/kg and the intermediate dose is 150 mg/kg. As such, when the highest dose of nanoparticles is administered (i.e., 500 mg/kg), and the composition comprises 18.7 mg/kg P2Et, this would result in a P2Et concentration of 3.74%. Furthermore, when the intermediate dose of nanoparticles is administered (i.e., 150 mg/kg), and the composition comprises 9.3 mg/kg P2Et, this would result in a P2Et concentration of 6.20%. Accordingly, because the resulting concentrations disclosed by Teodor in view of Gil and further in view of Uruena lie inside the range recited in the instant claims, the amounts disclosed by Teodor in view of Gil and further in view of Uruena meet the instantly recited limitations.
Therefore, the combined teachings of Teodor, Gil, and Uruena render obvious claim 9.
Conclusion
Claims 1-14 are rejected.
Claims 21-26 are withdrawn.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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