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 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.
Claim 3 is 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 3 recites percentages by weight of the components of the cannabis material that add up to greater that 100% in all cases. The amount of amount of extracted cannabis leaves or hurds can never be greater than about 89% by weight due to the minimum required amount of extracted cannabis buds and/or flowers and the minimum required amount of web-building fibers. The amount of amount of extracted buds and/or flowers can never be greater than about 89% by weight due to the minimum required amount of extracted cannabis leaves or hurds and the minimum required amount of web-building fibers.
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) 1,3,5,7,11,29,31,34,38 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Ashcraft et al ( US 7237559) as evidenced by Shipman (“Is hemp the same thing as marijuana?”)..
Claims 1, 5, 11, 29, 31: Ashcraft et al discloses wrapping paper for cigarettes (reads on a web, see col 4, lines 47-48 and Fig. 2) designed to exhibit reduced ignition propensity (Abs., col 13, lines 36-38). The paper incorporated a cellulosic fibrous material selected from flax fibers, hardwood pulp, softwood pulp, hemp fibers, etc. and mixtures of two or more types of fibers (col 14, lines 31-37). Hemp fibers ace cannabis fibers and can also function as web building fibers. The wood fibers read on web building fibers. It is known in the art that hemp is a species of cannabis having a THC content of less than 0.3% (for evidence, see Shipman, second page, heading “What's the difference between hemp and marijuana?”) The wrappers have a typical dry basis weight from about 20 g/m2 to about 80 g/m2 (col 13, lines 59-62) and inherent porosities (reads on permeability) from at least about 10 CORESTA and less than about 85 CORESTA (col 14, lines 1-10). A particularly preferable sheet has an inherent porosity of about 20 CORESTA to about 50 CORESTA (col 14, lines 16-19). Absent convincing evidence of unexpected results, it would have been obvious to one of ordinary skill in the art to form a wrapping paper of Ashcraft et al comprising hardwood or softwood pulp and hemp fibers and having a claimed basis weight and a claimed porosity, with a reasonable expectation of obtaining a suitable wrapping paper. Forming the web comprising hemp fibers from leaves, stems, buds and flowers would have been obvious as typical sources of fibers.
Claim 3: Ashcraft et al does not disclose the type and amounts of hemp and wood fibers forming the web. However, the courts have held that “One of ordinary skill in the art would certainly tailor a mixture to proportions to reach desired function/properties of the product. It is by now well settled that where patentability is predicated upon a change in a condition of a prior art composition, such as a change in concentration or the like, the burden is on the applicant to establish with objective evidence that the change is critical, i.e., it leads to a new, unexpected result. In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); In re Aller, 220 F.2d 454, 456 (CCPA 1955). In the present case, Applicants have advanced no objective evidence which establishes that using such ranges would produce anything other than expected results. Selection of the fiber mixture to reach desired function/properties of the wrapping paper is within the capability of one of ordinary skill in the art absent convincing evidence of unexpected results.
Claim 7: Ashcraft et al discloses that the wrapping paper normally comprises a filler material (col 14, lines 49-56), therefore a web comprising a filler combined with the cannabis fibers and web building fibers would have been obvious.
Claim 34: Ashcraft discloses that the wrapping papers comprise additives such as burn control additives (col 15, lines 34-37 and 47-48). Suitable burn control additives include alkali metal succinates, citrates, acetates, malates, carbonates, tartrates, propionates, nitrates and glycolates (col 15, lines 48-51), which are salts of carboxylic acids.
Claim 38: Ashcraft discloses that the wrapping papers comprise multi-layer coatings in the form of a series of spaced apart bands (Abs; col 3, lines 50-53). The coating formulation preferably comprises a film-forming agent (col 17, lines 59-60) such as a gum (col 18, lines 1-3).
Claim 44: Ashcraft et al discloses a smoking article comprising a rod of smokable material contained in a circumscribing wrapper of the invention (col 9, lines 57-61, Fig. 3).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ashcraft et al in view of Byrd, Jr. et al (US 2016/0208440), hereinafter Byrd.
The disclosure of Ashcraft et al is used as above. Ashcraft et al does not disclose delignified fibers. However, Byrd discloses a paper material for use in a smoking article in the form of a tipping material, a plug wrapper, and a wrapping material (Abs). Byrd discloses a web comprising web building fibers [0070], the web building fibers comprising delignified cellulosic fibers ([0059],[0110]). Byrd teaches that mechanical pulping does not separate the lignin from cellulose fibers and the resulting paper can be brittle and exhibit lower strength [0048]. Chemical pulping can be used in the tobacco papermaking process. A chemical pulping process separates lignin from cellulose fibers by dissolving lignin in a cooking liquor such that the lignin, which binds the cellulose fibers together, can be washed away from the cellulose fibers without seriously degrading the cellulose fibers [0050]. The wrapping paper comprises a web having a basis weight of from about 10 gsm to about 75 gsm and having a permeability of from about 5 to about 130 CORESTA [0088]. Absent convincing evidence of unexpected results, it would have been obvious to one of ordinary skill in the art to use delignified cellulosic fibers to avoid brittleness and lower strength in the paper.
Claims 16,20-23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Ashcraft et al in view of Kaplan et al (US 2018/0360103) and Greenbaum et al (US 2019/0022158).
The disclosure of Ashcraft et al is used as above. Ashcraft et al does not explicitly disclose an aerosol delivery composition applied to the web. Ashcraft et al does disclose that the web can contain fibers derived from Nicotiana species in an amount of about 5-100 weight percent [0011]. The tobacco generates aerosol when the smoking article is burned [0004]. Tobacco fibers contain nicotine, therefore the tobacco fibers are broadly construed as treating the web with an aerosol delivery composition comprising nicotine.
Alternatively, Ashcraft et al teaches that a reconstituted tobacco sheet is typically formed by extracting tobacco with water, separating the pulp portion and processing the pulp portion to form a mat or web, then reapplying the liquid extract to the mat or web [0003]. It would have been obvious to process tobacco fibers by the typical process disclosed by Ashcraft et al as a portion of the web-forming fibers of Ashcraft et al, therefore the tobacco fibers are broadly construed as treating the web with an aerosol delivery composition comprising nicotine.
In addition, Kaplan et al discloses a rolling paper made from hemp, rice, wood and/or flax fibers, and infused with a composition comprising a cannabis oil extract (Abs, [0001], [0029], [0031]-[0033], [0035]-[0038]). The composition comprising a cannabis oil extract is applied to the paper during pulping or during sizing processes. The cannabis oil extract contains active materials such as cannabinoids, CBD, THC, etc. [0040], which ae activated by heat during smoking of tobacco, cannabis or other leafy substance and boost the pleasant effect of smoking the same [0055].
Greenbaum et al discloses adding at least one cannabinoid to smokable or smokeless tobacco products to reduce the harm associated with tobacco use. The harm to be reduced includes irritation and carcinogenicity of tobacco (Abs, [0001], [0024]).. Other biological benefits are disclosed [0014]. For cigarette applications the cannabinoids may be inserted into a cigarette filter, and/or paper (Abs, [0018]). The cannabinoids can be isolated from the plant by extraction and include CBD, THC and other naturally occurring cannabinoids in the plant material.([0007], [0010]). In some embodiments terpenes, either alone or in combination with cannabinoids are added as additives to the tobacco products [0020]. The cannabinoids and terpenes are claimed aerosol delivery agents, therefore the compositions are aerosol delivery compositions.
It would have been obvious to one of ordinary skill in the art to apply claimed aerosol delivery agents to the wrapping paper of over Ashcraft et al in view of Kaplan et al and Greenbaum et al to obtain the disclosed benefits to the user.
. Claims 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Ashcraft et al in view of Herve et al (US 20090120450), hereinafter Herve..
The disclosure of Ashcraft et al is used as above. Ashcraft et al does not disclose that the wrapping material includes a plurality of discrete reduced ignition areas spaced along a first direction of the wrapping material, the reduced ignition areas having a diffusivity of less than about 0.5 cm/s at 23° C.
Herve teaches a wrapping material having reduced ignition proclivity (Abs, [0008]). the wrapping material comprises a plurality of discrete bands comprising a composition configured to reduce ignition proclivity (Fig. 2, bands 24; [0009], [0072]). These bands, or reduced ignition areas, are spaced in a first direction on the wrapping material 14 as shown in Fig. 2. Herve further teaches that the treated areas have a diffusion capacity of less than about 0.5 cm/s, such than about 0.4 cm/s. For instance, the diffusion capacity can be from about 0 cm/s to about 0.3 cm/s [0076]. The bands are applied to the web by a printing process [0045].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ashcraft et al to provide a wrapping material with banded regions and a diffusivity of less than about 0.5 cm/s as taught in Herve to reduce ignition proclivity, as desired by Ashcraft et al. A person of ordinary skill in the art would obviously include bands because control the burn of the cigarette (Herve [0072]-[0073]). Spacing the bands will affect the thermal inertia and the self- extinguishing of the cigarette ([0034], [0074]). Further a person of ordinary skill in the art would measure reduced ignition proclivity as a diffusion capacity of less than 0.5 cm/s. Doing so would provide a measure the reduction of the ignition proclivity (Herve [0076]-[0078]). This measurement would be understood to be done at 23°C, ambient temperature.
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 1-3,5,7,11,15-16,21-23,25,29,31,34,38,41-42 and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,388,925. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are a species of the instant claims, reciting all of the limitations of the instant claims and an additional limitation that the cannabis material be extracted cannabis fibers.
Claims 1-3,5,7,11,16,21-23 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,6-7,9-11 and 13-15 of U.S. Patent No. 11,963,547. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are a species of the instant claims, reciting limitations overlapping the limitations of the instant claims. It would have been obvious to one of ordinary skill in the art to modify the claims of the patent to obtain the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS R CORDRAY whose telephone number is (571)272-8244. The examiner can normally be reached Monday-Friday 8 AM-5 PM (EST).
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/DENNIS R CORDRAY/Primary Examiner, Art Unit 1748