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
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 17/509,487, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, the prior-filed application fails to provide adequate support or enablement for the following:
Claim 1 recites hydrophilic molecules/polymers, but the prior-filed application does not disclose hydrophilic molecules other than polymers, but rather only discloses the more narrow category of hydrophilic polymers (paragraph [11]).
Claim 1 recites a mixture of cannabinoid drug molecules, reductant, and hydrophilic molecules/polymers, but the prior-filed application does not disclose such a mixture, but rather discloses polymer added later as an additional layer of capping agent (paragraph [23]).
Claim 1 recites attachment by non-covalent interactions of the cannabinoid, reductant, and hydrophilic molecules/polymers, but the prior-filed application does not disclose such broad or generic type of attachment, but rather only discloses charge interaction for polymer coating (paragraph [23]).
Claim 1 recites non-covalent interactions of charge interaction, hydrophobic interactions, and hydrogen bonding, but the prior-filed application does not disclose all such interaction species for all of cannabinoid, reductant, and hydrophilic molecules/polymers, but rather only discloses charge interaction for polymer coating (paragraph [23]).
Claim 1 recites that the hydrophilic molecules/polymers act as emulsifier, hydrotropic, and chelating agent, but the prior-filed application does not disclose such function of the hydrophilic molecules/polymers.
Accordingly, as claim 2 depends upon claim 1, claims 1-2 are not entitled to the benefit of the prior application.
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 1-2 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 recites hydrophilic molecules/polymers, but it is unclear whether the hydrophilic molecules/polymers must be polymers or whether they may be molecules other than polymers. Claim 2 is rejected as depending from rejected claim 1 without remedying such deficiency.
Claim 1 recites hydrophobic molecules/polymers, but it is unclear whether the hydrophobic molecules/polymers must be polymers or whether they may be molecules other than polymers. Claim 2 is rejected as depending from rejected claim 1 without remedying such deficiency.
Claim 1 recites the limitation "the hydrophobic molecules/polymers" in line 7. There is insufficient antecedent basis for this limitation in the claim.
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) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okamura et al. (WO 2011/052637 A1; published 05 May 2011; citations herein to English machine translation made 07 March 2026) in view of Selvaraj et al. (US 2022/0211630 A1; published 07 July 2022).
Regarding claim 1, Okamura et al. discloses a nanocarrier drug delivery colloidal solution (page 4 FIG. 1 description), comprising: a) a gold core in size range of nanometers (FIGS. 1, 2); b) a surface layer comprising a mixture of a cannabinoid drug molecules, reductant, and hydrophilic molecules/polymers (FIG. 2 showing gold core surface with mixture of dendritic molecules with hydrophilic hydroxyl groups, reducing agent, and pyrene in hydrophobic spaces wherein water-insoluble pharmaceuticals are incorporated into the hydrophobic spaces, for drug delivery, as discussed in page 4 FIGS. 1, 2 descriptions), wherein the mixture is attached onto a surface of the gold core by non-covalent interactions, comprising of change interaction, hydrophobic interactions, and hydrogen bonding, wherein the hydrophobic molecules/polymers bind on the surface of the gold core and interact with each other and with the cannabinoid drug molecules which are hydrophobic through charge interaction, hydrophobic interactions, and hydrogen bonding, and act as stabilizer, emulsifier, hydrotropic and chelating agent to make the nanocarrier drug delivery colloidal solution hydrophilic and stable (FIGS. 1, 2; discussed in page 4 FIGS. 1, 2 descriptions).
Further regarding claim 1, Okamura et al. does not disclose that the water-insoluble pharmaceuticals are cannabinoid drug molecules as claimed.
Further regarding claim 1, Selvaraj et al. discloses nanoparticle formulations of water insoluble pharmaceutical substances (title) wherein cannabidiol is a water-insoluble pharmaceutical agent (paragraph [0030]).
Further regarding claim 1, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Okamura et al. and Selvaraj et al. by using the cannabidiol (i.e., CBD, a cannabinoid drug molecule) of Selvaraj et al. as the water-insoluble pharmaceutical agent in the colloidal solution of Okamura et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use therein a pharmaceutical agent known to be water-insoluble, given that Okamura et al. suggest using a water-insoluble pharmaceutical agent therein, and also given that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination per MPEP 2144.07.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617