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 .
Claim Objections
Claim 2 is objected to because of the following informalities: there should be recited a period (.) at the end of the sentence. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: “Citrem” in line 2 appears to be an acronym referring to citric acid esters of monoglycerides and diglycerides. However, the full term should be introduced with the acronym immediately following in parentheses, prior to an independent recitation of the acronym. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “compositions” in line 1 should be recited as --- composition ---. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “a liquid” in the penultimate line should be recited as --- the liquid ---. 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.
Claims 7, 10, and 14 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.
Regarding claim 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 recites the limitation "the stable emulsions" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which it depends, recites an emulsion. To obviate this issue, it is suggested for the claim to recite --- the emulsion ---.
Regarding claim 10, the phrase "preferrable" in lines 3 and 4 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 14 recites wherein the composition further comprises determining if the patient lacks the ApoE4 genotype, which renders the claim indefinite because it is unclear how a composition further comprises a process. Moreover, it is not clear how the determination further limits the composition. Clarification is requested.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Badenoch et al. (WO 2018/170235 A1, 09/20/2018, IDS reference) (hereinafter Badenoch).
Badenoch discloses compositions comprising medium chain triglycerides (MCT) (abs), such as caprylic triglyceride, in amounts of at least about 35% by wt. ([0006], [0045]); about 2-10% by wt. each ([0052]) of at least one surfactant, including lecithin and polyoxyl hydrogenated castor oil, in a 2:1 to 1:1 ratio, relative to each other ([0007]); and at least one co-surfactant including a propylene glycol ester of caprylic acid (i.e. instantly claimed monoglycerides and diglycerides of fatty acids) ([0053]), such that the compositions form stable emulsions on reconstitution in water. The emulsions are stable at ambient conditions, for example, for at least about 24 hours, and have a mean droplet diameter of less than about 1000 nm, but greater than about 100 nm ([0042]). The compositions may further comprise additional excipients such as flavor enhancers ([0036]).
The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claims 1 and 6 reciting amounts of caprylic triglyceride, the claimed ranges (i.e. at least 30% by weight, or between about 30% and about 60% by weight, respectively) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. at least about 35% by weight). 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).
Regarding claims 7, 8, and 9 reciting amounts or ratios of at least one surfactant, the claimed ranges (i.e. between about 1% and about 10% by weight, or at least 2.0% by weight, respectively) and ratio (i.e. 1:1 to 2:1 ratio) would have been obvious to one of ordinary skill in the art since they overlap with the ranges and ratios of the prior art (i.e. between about 2.0% and about 10.0% wt., and 3:1 to 1:1 ratio, respectively). See MPEP § 2144.05(I).
Regarding claims 1 and 10 reciting an emulsion stability or an average particle diameter, the claimed ranges under ambient conditions (i.e. for at least one month, or less than 0.5 µm for at least one month) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. for at least about 24 hours or between about 0.1 µm and about 1 µm). See MPEP § 2144.05(I). Moreover, in the case of emulsion stability, since the emulsion of Badenoch comprises substantially the same caprylic triglyceride and surfactants in substantially the same amount as instantly claimed, one of ordinary skill in the art would reasonably conclude that the emulsion of Badenoch is stable for at least one month under ambient conditions like the claimed invention. See MPEP § 2111.02(II).
Regarding claim 11 reciting wherein the flavoring agent is oil soluble, although Badenoch does not explicitly disclose a solubility of the flavor enhancing agent, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at a claimed flavoring agent through routine experimentation based on the flavor desired.
Regarding claims 12-15 reciting a use of the liquid pharmaceutical composition of claim 1, such limitations are merely stating a purpose or intended use of said composition, rather than any distinct definition of any of the claimed invention’s limitations that would result in a structural difference between the claimed invention and the prior art. As the claims are directed to a product, the “for” statements are interpreted as intended use. Accordingly, where the same active agent is present in the prior art as instantly claimed, the intended use is met.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,559,488 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 34 of the patented claims recite wherein the MCP pharmaceutical composition is an emulsion, and claim 35 recites wherein the emulsion does not phase separate for at least 24 hours. Accordingly, the claimed ranges of stability under ambient conditions (i.e. for at least one month, or less than 0.5 µm for at least one month) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. for at least about 24 hours or between about 0.1 µm and about 1 µm ([claim 36]). See MPEP § 2144.05(I). Moreover, in the case of emulsion stability, since the emulsion of the patented claims comprise substantially the same caprylic triglyceride and surfactants in substantially the same amount as the pending claims, one of ordinary skill in the art would reasonably conclude that the emulsion of the patented claims is stable for at least one month under ambient conditions like the pending claims. See MPEP § 2111.02(II).
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dang et al. (US 2020/0346174 A1, 11/05/2020), directed to a process for producing a nano-microemulsion system of plant oil triglycerides comprising a carrier of propylene glycol monocaprylate and lecithin.
Conclusion
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/LUCY M TIEN/Examiner, Art Unit 1612
/FREDERICK F KRASS/Supervisory Patent Examiner, Art Unit 1612