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
Claims 1-4 and 9 are objected to because of the following informalities: and “and” should precede the last component in the claim, i.e., “f) one or more antioxidants; and” for claims 1-4.
Claims 2-4 are objected to because of the following informalities: repeat recitation of identical limitations appearing in the claim from which each claim depends.
Claim 8 is objected to because of the following informalities: “further comprising” should distinguish from claim 1; and “selected from…or mixtures thereof” should recite “and mixtures thereof”.
Appropriate corrections are 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 1-11 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 “cellulose derivatives” in limitation (e). The scope of “cellulose derivatives” is vague and indefinite. In chemistry a derivative is a compound that is produced from a similar, "parent" compound through a chemical reaction or process. Here the specification does not disclose any reaction or process. The specification also does not specify “cellulose derivatives” to any particular compounds (see rejection of claim 5 in the following paragraph), or which cellulose may be derivatized. Also the specification lists examples of component (e) that include monosaccharides, which are not celluloses. The range of reaction or process that could modify any cellulose is thus appears limitless. Consequently the skilled person would not be apprised regarding what qualifies as a “cellulose derivative”. None of the dependent claims resolves this issue and therefore are also rejected on this ground. Claim 6 also recites “derivatives” which raises the same issues due to lack of relevant disclosure.
For the purposes of examination now “cellulose derivatives” is construed as a pharmaceutically acceptable substance for contacting the oral and/or nasal mucosa and respiratory tract.
Claim 5 recites “other substances with a documented protective function of oral mucosa and respiratory tract” which render the claim vague. It is not clear what level of “documented protective function” is adequate. An anecdotal post in a social medium would be considered “documented” by some, whereas others would only consider publication in a peer-reviewed journal, of a double-blind and controlled clinical trial, rises to the same level.
Further regarding claims 5 and claim 6, the phrase "…including…" renders the claim indefinite because it is unclear whether the limitation(s) following the "…including…" are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 5 and 6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim 9 is 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 9 recites concentrations for water, 1,3-propanediol, and glycerol which are broader than those in claim 1 from which claim 9 depends. For example “<40% by weight” is broader than “10-50% or 20-50% by weight” in claim 1 because the former includes concentrations lower than 10%, e.g., 3%. 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 (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.
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.
Claim(s) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra (US 20160120224) in view of Watanabe (US 20210112855).
Mishra teaches a hydrogel composition for e-vaping cartridge, comprising a flavorant at about 0.2-15% by weight, a vapor former at about 20-90% by weight, water at about 5-40 % by weight, e.g., about 10%, a biopolymer, and nicotine (title; abstract; paras.0007-08, 0014-15, 0059, 0070-73). Flavorants include those in instant claim 8 (paras.0020, 0058, 0072), some of which are antioxidants, e.g., menthol and cinnamon. The hydrogel may be ethanol free (para.0021). Biopolymers include polysaccharides such as agar, pectin, and sodium alginate which are thickeners and protect a mucosal surface (para.0073). Biopolymers comprise about 0.01-2 % by weight (para.0073), and flavorant comprise about 0.2-15% by weight, e.g., about 1% (para.0072). Their sum therefore ranges between 0.21-17% by weight of the hydrogel, which range overlaps those in claims 1-4.
The “vapor former includes a diol and glycerin, the hydrogel including the diol and glycerin in range of ratios between about 1:4 and 4:1, the diol being one of propylene glycol, 1,3-propanediol, and combinations thereof” (para.0017(emphasis added)). The “one of” indicates the two diols are alternatives, not requirements. The vapor former comprises about 20-90% by weight of the hydrogel (para.0012). The ratio of diol or 1,3-propanediol to glycerol in the present claims range from 6.5 – 0.5 (65/10 – 20/40). The range of ratio that Mishra teaches is about 1:4 and 4:1 (para.0017), i.e., about 0.25 to 4. Thus the ranges substantially overlap.
Mishra does not specifically teach an example formulation of the hydrogel precisely as in claims 1-4 and 9 and comprising a preservative, or glycerol. However glycerin and glycerol are the same chemical compound and differ by the level of purity and contextual usage. Cosmetic arts tend to use the term glycerin, whereas chemical arts use the term glycerol. Therefore the skilled person would understand glycerin and glycerol are interchangeable unless expressly stated otherwise.
Watanabe is drawn to aroma cartridge for “heating-type smoking appliance” (title; abstract; para.0001). The cartridge preferably comprises polysaccharide-based gels (para.0268), flavorings, β-cyclodextrins “for causing temporary residence of the flavoring agent, microcrystalline cellulose having moldability and ease of release from a die or the like, sorbic acid, potassium sorbate, benzoic acid, sodium benzoate, or another food antimicrobial preservative for storage stability” (para.0269).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to modify the teachings of Mishra and Watanabe and include preservatives in Mishra’s hydrogel compositions as recited in the instant claim(s). The skilled person would have been motivated to do so because both Mishra and Watanabe are drawn to hydrogel compositions for liquid-type electronic cigarette, and Watanabe teaches including preservative for storage stability.
Regarding the concentrations of the components (a) through (g), Mishra teaches ranges overlapping those in the instant claims. For result-effective variables, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Regarding claim 3, Mishra teaches “diol being one of propylene glycol, 1,3-propanediol, and combinations thereof”. Therefore the skilled person would understand that propylene glycol is not required.
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 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8, 10-15, and 17-20 of copending Application No. 18/548,533 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a composition comprising water, a diol, glycerol, and a preservative. The two claim sets recite overlapping concentration ranges for each component. The difference is that the present claims recite ethanol, however they encompass 0% ethanol. The instant claims also recite a protective substance including cyclodextrin, which the ’533 application recites in dependent claims 4 and others. The present claims further recite antioxidants. However the ‘533 application claims menthol, which is an antioxidant, as a flavoring in claim 10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614