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 .
Applicant’s election of Species (A) directed to claims 1-9 and 13 without traverse in the reply filed 20 October 2025 is acknowledged.
Claims 10-12, 14-17 have been withdrawn.
Claims 1-9 and 13 are presented for examination on the merits.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claims 1-9 and 13 are 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.
Claim 1 is rendered vague and indefinite by the phrase “wherein the curcumin nanoparticle complex can further comprise …”. It is unclear if this limitation is optional or not, since the phrase employs the term “can”. Thus it is not clear that any of the following language limits the claimed composition at all. Similarly, Claim 1 is rendered vague and indefinite by the phrase “wherein the second coating layer is comprised only when the first coating layer is comprised”. Firstly, what does “is comprised” mean in this context? Typically, the term “comprised” is follow by elements that are included within the composition. Secondly, does Applicant mean that the second coating is only present when there is also a first coating present? This would seem to be redundant, anytime that there is a second of anything, there has to be a first. Does the language mean that any time a first coating is present that a second coating is also present?
Appropriate clarification is required.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under U.S.C. 112, second paragraph, for the reasons set forth above.
Note: “[W]here there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 35 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 USC 103 should not be based on considerable speculation about the meaning of terms employed in a claims or assumptions that must be made as to the scope of the claims.” MPEP 2173.06 II.
However, in order to practice compact prosecution and expedite examination of the claims as drafted are given their broadest reasonable interpretation (BRI) in light of the specification in order to search the prior art. Given the indefiniteness of the claims the cited prior art is simply the closest prior art assuming that the BRI of the claimed composition includes the coatings, since from the description of the specification they appear to be the distinguishing characteristic. It should be noted that if the coating are meant to be optional and not meant to limit the claimed composition, the prior art is extremely full of curcumin nanoparticles with lecithin (see attached documents as well as references cited in the Specification).
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.
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) 1-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pathak et al. (2017). [cited by Applicant in IDS filed 9/1/23]
Pathak et al. beneficially disclose sodium alginate-chitosan core shell nanoparticles comprising a first chitosan coating layer for coating a curcumin-loaded lecithin nanoparticle core (5 mg of curcumin is loaded); and a curcumin-loaded sodium alginate-chitosan double coating comprising a secondary sodium alginate coating layer shell (see entire document, including e.g., Abstract, pages 271-274 and 279).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the instant Application to combine the curcumin with lecithin to increase its bioavailability as known on the prior art.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
The cited references do not specifically teach using the extract in the amounts claimed by applicant. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[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). The adjustment of particular conventional working conditions is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. V. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) As both dosages, routes of administration, dosage frequency and timing are known to the ordinary artisan, it would have been obvious to optimize the mode of administration as well as dosage amounts and frequency. It also would have been prima facie obvious to optimize the dosage regimen for an additive or synergistic therapeutic result because the general conditions of the dosages are disclosed in the prior art and it is not inventive to discover the optimum or workable ranges by routine experimentation and the art expects that dosages of the invention will vary depending upon such factors as the subject's age, weight, height, sex, general medical conditions and previous medical conditions.
Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient (i.e., ratio of curcumin to surfactants, such as lecithin) to add in order to best achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant's invention.
Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/ Examiner, Art Unit 1655
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