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 9 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.
Regarding Claim 9, there is an issue of antecedent basis with the second “a water-dissolvable film” that renders the claim indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berry et al. (US 2005/0019588 A1).
Regarding Claim 1, Berry teaches a water-dissolvable film (Paragraph 0003) comprising pullulan (Paragraph 0020), carboxymethyl cellulose (Paragraph 0028, 0035, 0053) and cellulose (Paragraph 0036).
Regarding Claim 9, Berry teaches a method of making a water-dissolvable film including cellulose (Abstract; Claim 1 of Berry) comprising making a mixed solution (Paragraph 0083) of pullulan (Paragraph 0020), carboxymethyl cellulose (Paragraph 0028, 0035, 0053) and cellulose (Paragraph 0036), cast on to a flat sheet/plate of polyethylene or paper, (Fig. 2; Paragraph 0086) and drying the mixed solution to form the film. (Paragraph 0087).
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.
Claims 2-3 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Berry.
Regarding Claim 2, Berry teaches the pullulan can range from 10 to 90 wt% of the film (Paragraph 0030), carboxymethyl cellulose can range from up to 20 wt% or 0.1 to 2 wt% of the film (Paragraph 0035, 0053) and cellulose can range from 10 to 90 wt% of the film. (Paragraph 0032-0033). This overlaps the claimed range of pbw. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP §2144.05).
Regarding Claim 3, Berry teaches the film can be formed using a mixed solution having a viscosity of 15 to 20000 centipose. (Paragraph 0080). This overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP §2144.05).
Regarding Claim 6, Berry teaches the film includes main raw materials of the pullulan, the carboxymethyl cellulose and the cellulose, as discussed above. Berry further teaches plasticizers and/or stabilizers, which can affect the mechanical strength, flexibility and dissolution characteristics of the film, as an auxiliary raw material. (Paragraph 0037-0039, 0042). Berry teaches the amount of the raw auxiliary material can range from 20 wt%, 0 to 50 wt%, 0.5 to 5 wt% or 0 to 10 wt%. (Paragraph 0037-0039, 0042). This overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP §2144.05).
Regarding Claim 7, Berry teaches the raw auxiliary material can be carrageenan, sorbitol or glycerin (Paragraph 0037-0039, 0042).
Regarding Claim 8, Berry teaches the film can include a surfactant (Paragraph 0041). Berry teaches the film can have a final viscosity of 15 to 20,000 centipose. (Paragraph 0080). This overlaps the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP §2144.05).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Berry in view of Mullen (US 2022/0016044 A1)
Regarding Claim 4, Berry teaches the tensile strength of the film should be low so the film can be dissolved when placed in a moisture environment such as the mouth. (Paragraph 0082)
Mullen states that British Pharmacopeia declares that dissolvable oral films should have a suitable mechanical strength to resist handling without being damaged. (Paragraph 0212-0213). Mullen then teaches a tensile strength range of 15.5-37.2 N Paragraph (0238-0239) is suitable, which overlaps the claimed range. Thus, it would have been obvious to one with ordinary skill in the art to set the claimed tensile strength range of Berry to the claimed range taught by Mullen, to ensure the film of Berry is dissolvable while being able to resist handling without being damaged.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Berry as evidenced by Thangavelu et al. (NPL).
Regarding Claim 5, Berry does not teach an intermolecular hydrogen bonding network between the pullulan and the carboxymethyl cellulose. Thangavelu teaches a mixture of pullulan and carboxymethyl cellulose will inherently form intermolecular hydrogen bond network. (Page 5). Thus, the film of Berry would inherently have this intermolecular hydrogen bond network between the pullulan and the carboxymethyl cellulose.
Claim Rejections – 35 USC §§ 102/103
Claim 5 is rejected under 35 U.S.C. 102(a)(1), or in the alternative over 35 U.S.C. 103, over Berry.
Regarding Claim 5, Berry teaches a water-dissolvable film (Paragraph 0003) comprising pullulan (Paragraph 0020), carboxymethyl cellulose (Paragraph 0028, 0035, 0053) and cellulose (Paragraph 0036). The instant Application states an intermolecular hydrogen bonding network is formed between the pullulan and the carboxymethyl cellulose if there is no PVA. (Page 12-13) Berry does not require PVA. Therefore, the film of Berry would inherently have an intermolecular hydrogen bonding network between the pullulan and the carboxymethyl cellulose.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ZHANG whose telephone number is (571)270-0358. The examiner can normally be reached Monday through Friday: 9:30am-3:30pm, 8:30PM-10:30PM.
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/Michael Zhang/Primary Examiner, Art Unit 1781
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