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 .
DETAILED ACTION
Claims 1-28 are currently pending and the claims as originally filed on 03/06/2024 are acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The two (2) information disclosure statements (IDS) submitted on 05/14/2024 were filed before the mailing date of the instant first action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies are enclosed herewith.
Claim Objections
Claims 3, 4, 17, 18, and 27-28 are objected to minor informalities under 37 CFR 1.75.
Claim 3 recites abbreviation “CBD” in line 1 should be spelled out.
Claim 4 recites abbreviations such as “CBD-C1”, “CBDV” or “CBD-C4” in lines 2-3 should be spelled out.
Each of claims 17-18 recites “saturated or unsaturated C8-C22 fatty acid monoglyceride;(semicolon)…” but which would be better to recite “saturated or unsaturated C8-C22 fatty acid monoglyceride,(comma) …”
Claim 27 recites “comprising a chelating agent” in line 1, but which would be better to write “further comprising a chelating agent”.
Claim 28 recites abbreviation “EDTA” should be spelled out.
Appropriate correction is requested.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-4 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 2 recites “the drug substance comprises 70-100% w/w cannabinoids”. Base claim 1 recites “a. a drug substance comprises one or more cannabinoids at an amount ranging from about 5 % to about 75%, b. a porous solid carrier at an amount ranging from about 10 to about 60%, c. a lipophilic material at an amount ranging from about 1 to about 75%, and d. one or more antioxidant”. Since the claimed drug-containing particle essentially requires components a-d, “100%” of cannabinoid recited in instant claim 2 cannot be drug-containing entire particle, and therefore, claim 2 is indefinite.
Claims 3-4 directly or indirectly depending from claim 2 are also rejected.
Claims 2-4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites “the drug substance comprises 70-100% w/w cannabinoids”, and however, base claim 1 recites “the drug substance comprises one or more cannabinoids at an amount ranging from about 5 % to about 75%”. That is, the scope of dependent claim 2 is greater than that of base claim 1. Therefore, it may not be said that claim 2 further limits claim 1 in a proper manner.
Claims 3-4 directly or indirectly depending from claim 2 are also rejected due to the rejection of claim 2.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-28 are rejected under 35 U.S.C. 103 as being unpatentable over Friedman (US2021/0212946A1) and further in view of Nowak et al. (US2020/0046642A1, IDS of 05/14/2024) as evidenced by Waters et al., “ Enhancing the dissolution of phenylbutazone using Syloids based mesoporous silicas for oral equine applications”, Journal of Pharmaceutical Analysis 8 (2018), pp. 181-186.
Applicant claims the below claim 1 filed on 03/06/2024:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a cannabinoid medical/pharmaceutical composition research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Friedman discloses a lipid-based delivery composition which increases the solubility, dissolution, and bioavailability of many insoluble drugs cannabinoid (abstract and [0003]) in the form of e.g., microparticles, powder, granule, pellets, etc. ([0076] and [0132]); the composition comprises at least one cannabinoid or mixture thereof such as cannabidiol (CBD) or THC ([0050])([0017]) which reads on the claimed drug substance (a) in an amount of about 0.01 to about 20% ([0046]) that overlaps the range of about 5 to about 75% of instant claim 1 or touches about 20% of instant claim 5. MPEP 2144.05 stating that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)(drug substance (a) of instant claims 1, 3 and 5), and CBDV can be present at a minimum amount of about 0.01 ([0123]) which overlaps the instant range of no more than about 0.5% and this prior art remains silent about CBD-C1 and CBD-C4 (instant claim 4); the composition further comprises sorbent such as silica, colloidal silicon or fumed silica (Aerosil®) (=amorphous silica), synthetic magnesium aluminum silicate (Neusilin®) (=mesoporous silicate), etc. in which the cannabinoid is absorbed onto the silica that reads on the claimed mesoporous or amorphous solid carrier in an amount of about 20 to about 90% ([0012], [0045] and [0129]) which overlaps the range of about 10 to about 60% of instant claim 1 or about 30 to about 50% of instant claim 9. See MPEP 2144.05 above, and the composition containing porous carrier silica or silicate is formed into microparticles ([0076]), and thus, the porous carrier is a microparticle (porous solid carrier (b) and its amounts of instant claims 1, 6-9 and 13); the composition further comprises emulsifier(s) for improving cannabinoid solubilization such as polyoxyl glyceride, lauroyl polyoxyl-32 glycerides, polyglyceryl fatty acid esters, propylene glycol dicaprylate/dicaprate (Miglyol® 840), glyceryl laurate, glyceryl dilaurate, MCT, glyceryl monooleate, glycerol esters of saturated C8-C18 fatty acids (Gelucire® 33/01), glyceryl esters of saturated C12-C18 fatty acids (Gelucire® 39/01 and 43/01), glyceryl laurate/PEG-32 laurate (Gelucire® 44/14), glyceryl stearate/PEG-32 stearate (=Gelucire 53/10)(= stearoyl polyoxy-32-glyceride), polyoxyl 40 hydrogenated castor oil (Cremophor RH 40 or Kolliphor 40) (=PEG-40 hydrogenated castor oil), Labrafil® M 2130 CS (= lauroyl polyoxyl-6-glyceride), apricot kernel oil PEG-6 esters (Labrafil® M1944CS)(= oleoyl polyoxyl-6-glyceride), etc. in an amount of about 1% to about 25% or about 2 to 10% ([0010] and [0065]) which overlaps the range of about 1-about 75% of instant claim 1 or about 5 to about 50% of instant claim 16. See MPEP 2144.05 (lipophilic material (c) and its amount of instant claims 1 and 16-21). Although Friedman does not expressly teach propylene glycol monocaprylate of instant claim 22, Friedman teaches equivalent emulsifiers such as propylene glycol dicaprylate/dicaprate (Miglyol® 840) ([0010], [0018] and [0065]) to help dissolution of cannabidiol, and thus, selecting propylene glycol monocaprylate of those species would be obvious variation from the standpoint of the ordinary artisan (lipophilic material (b) of instant claim 22); and the composition further comprises at least one or two antioxidants such as ascorbyl palmitate, butylated hydroxy anisole, butylated hydroxy toluene, propyl gallate, α-tocopherol, and γ-tocopherol, etc. ([0087]) (antioxidant (d) of instant claims 1 and 23-24). Friedman further teaches the composition contain chelating agent ([0093]) (instant claim 27).
However, Friedman does not expressly teach properties of porous solid carrier of instant claims 1, 10-12 and 14; higher amount of cannabinoid of instant claim 2; the amount of antioxidant of instant claims 25-26; and chelating agent ETDA of instant claim 28. The deficiencies are cured by Nowak as evidenced by Waters.
Nowak discloses multiparticulate formulations containing about 1 to about 90% cannabinoids ([0061]) that overlaps the instant range of 70-100% (instant claim 2) and porous bead core comprising a mesoporous silica bead e.g., Syloid® XDP 3050 and 3150 (Grace, USA), Davisil® LC150A (Grace, USA), Neusilin® US2 (Fuji Chemicals, Japan([0070] and [0231]-[0232]), and the bead has specific surface area of 300-340m2/g (Table 2 – [0086]) which is within the range of about 250 to about 375m2/g of instant claims 1 and 11 and a pore volume of 1.2-1.7 mL/g which is within the range of about 1mL/g to about 2mL/g of instant claim 1. See MPEP 2144.05 above (carrier properties of instant claims 1 and 10-11), and the bead has about 10 microns and 1000 microns or between about 20 and about 2000 microns of diameter ([0017] and [0075]) which overlaps the instant average particle size of about 50 to about 150 microns. See MPEP2144.05 above (instant claim 14). Although Nowak does not expressly teach about 15nm-about 30nm of particle diameter of solid porous carrier of instant claim 12, document Water evidences that e.g., Syloid® XDP 3050 and 3150 have pore diameter 200-229 angstrom (=20-29nm) (Table 1 on page 182) which is within the claimed range of about 15-about 30nm (instant claim 12); and the composition further comprises stabilizing agent including tocopherols, butylated hydroanisole, butylated hydroxytoluene, ascorbic acid, ascorbyl palmitate which reads on the claimed antioxidant and EDTA which reads on the claimed chelating agent, and the stabilizing agent is used in an amount of 0.001 to about 5% ([0079] and [0103]) which overlaps the instant range of about 0.05 to about 1.5% or about 0.2 to about 1%. See MPEP 2144.05 above (instant claims 25, 26 and 28).
It would have been obvious to modify the amount of cannabinoid of Friedman with higher amount (e.g., 70-90%) of Nowak because Nowak teaches about 1 to about 90% of cannabinoid and thus, in order to enhance therapeutic effects, the amount of cannabinoid would be increased.
It would have been obvious to further define porous silica and antioxidant of Friedman with Nowak’s silica/stabilizing agent and such definition would have yielded no more than the predictable results, e.g., enhanced properties of the composition obtained by using silica and stabilizing agent of antioxidant and/or chelating agent.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-17, 19 and 21-31 of copending application No. 19/210719 (allowed).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require a drug substance comprising cannabidiol, a porous solid carrier and its properties, lipophilic material, antioxidant and overlapping amounts thereof. The difference between them is that claim 1 of copending ‘719 requires specific lipophilic materials and instant claim 1 does not. However, instant claims 19-22 requires such specific lipophilic materials.
It would have been obvious to modify the lipophilic material of copending ‘717 with specific lipid material species of instant claim 19 because selecting such specific lipophilic material would be a matter of choice or design and thus, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613