The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is responsive to the amendment filed on June 16, 2026.
Claims 1-7, 9-12 and 14-15 are pending. Claims 8 and 13 are cancelled. Claims 1, 3-4, 7, 9, 11, 14 and 15 are currently amended.
The objection to claims 3-4 for minor informalities is withdrawn in view of Applicant’s amendment.
The rejection of claims 3-4 and 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of Applicant’s amendment.
The rejection of claims 1-2 under 35 U.S.C. 102(a)(1) as being anticipated by DE 29612148 is withdrawn in view of Applicant’s amendment.
The rejection of claims 1-3, 5-7, 10-12 and 14-15 under 35 U.S.C. 102(a)(1) as being anticipated by Courchay et al. (US 2021/0189303), hereinafter “Courchay” is withdrawn in view of Applicant’s amendment.
The rejection of claim 4 under 35 U.S.C. 103 as being unpatentable over Courchay as applied to claims 1-3, 5-7, 10-12 and 14-15 above, and further in view of Souter et al. (US 2017/0067003) is withdrawn in view of Applicant’s amendment.
Claim Objections
Claim 11 is objected to because of the following informalities: in line 2, “40%wt. to 99%” should be replaced with “40%wt. to 99%wt.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 15 stands 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 15 is indefinite in the recital of “forming a film from a forming a unit dose product from said film” in line 3 (not line 2 as previously mentioned) because this limitation is not understood. While Applicant stated in the Remarks dated June 16, 2026 that claim 15 has been amended to correct typographical error by replacing “forming a film from a forming a unit dose product from said film” with “forming a film and forming a unit dose product from said film” please note that the present claim 15 does not incorporate the corrections.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 5-7, 10, 12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Courchay et al. (US 2021/0189303, already of record), hereinafter “Courchay” in view of Dreher et al. (US 2015/0072915), hereinafter “Dreher.”
Regarding claims 1-2 and 5-7, Courchay teaches a water-soluble film which comprises a water-soluble polymer comprising a blend of a caseinate polymer and a polyvinyl alcohol homopolymer, wherein the caseinate polymer is preferably sodium caseinate (see [0024]); and preferably the water-soluble film comprises a bittering agent which includes denatonium benzoate (see [0020]). It noted that the water-soluble film of Courchay does not contain gelatine. Courchay, however, fails to disclose the water-soluble film comprising a plant protein.
Dreher, an analogous art, teaches water-soluble film materials, for pouches containing fabric care active agents (see abstract), like casein, polyvinyl alcohol, soy protein and mixtures thereof (see [0091]), and the films exhibit a shorter dissolution time (see [0086]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have incorporated soy protein in the water-soluble film of Courchay which comprises caseinate and polyvinyl alcohol because their mixture would provide a shorter dissolution time as taught by Dreher.
Regarding claim 10, Courchay in view of Dreher teaches the features as discussed above. In addition, Courchay teaches that the water soluble film preferably comprises a surfactant (see [0016]).
Regarding claim 12, Courchay in view of Dreher teaches the features as discussed above. In addition, Courchay teaches that the water soluble film preferably comprises a non-aqueous plasticizer like polyols (see [0015]).
Regarding claim 14, Courchay in view of Dreher teaches the features as discussed above. In addition, Courchay teaches a water-soluble unit dose article, like a laundry unit dose article (see [0003]), comprising the above water-soluble films, wherein during manufacture, a first water-soluble film may be shaped to comprise an open compartment into which the treatment composition is added; a second water-soluble film is then laid over or superposed to the first film in such an orientation as to close the opening of the compartment; and the first and second films are then sealed together along a seal region (see [0035]-[0037] and [0043]). Courchay need not disclose a thermoformed recess because “thermoformed” is a product-by-process limitation. Burden is on applicants to show product differences in product by process claims, see In re Thorpe, 227 USPQ 964 (Fed. Cir. 1985); In re Best, 195 USPQ 430 (CCPA 1977); In re Fessman, 180 USPQ 324 (CCPA 1974); In re Brown, 173 USPQ 685 (CCPA 1972).
Regarding claim 15, Courchay in view of Dreher teaches the features as discussed above. In addition, Courchay teaches a method of making a film which comprises admixing the caseinate and polyvinyl alcohol and implicitly the bittering agent to form a film (see [0034]) and the water-soluble film is used in preparing a water-soluble unit dose article (see [0034]-[0037]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Courchay in view of Dreher as applied to claims 1-2, 5-7, 10, 12 and 14-15 above, and further in view of Souter et al. (US 2017/0067003), hereinafter “Souter.”
Regarding claim 4, Courchay in view of Dreher, as discussed above, teaches bittering agents like denatonium benzoate (see [0020]). Courchay in view of Dreher, however, fails to disclose a bittering agent like capsaicin.
Souter, an analogous art, teaches water soluble articles that include a water-soluble film, where the film includes an aversive agent or bittering agent (see [0001]). Souter also teaches the equivalency of denatonium benzoate with capsaicin as aversive agent or bittering agent (see [0059]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the denatonium benzoate of Courchay in view of Dreher with capsaicin because the substitution of art recognized equivalents as shown by Souter is within the level of ordinary skill in the art. In addition, the substitution of one aversive or bittering agent for another is likely to be obvious when it does no more than yield predictable results.
Claims 1-4, 7, 10-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Puri et al. (US 2007/0042023), hereinafter “Puri.”
Regarding claims 1-4, Puri teaches dissolvable films, i.e., dissolve in aqueous environment (see [0014]) for the administration of an active ingredient, wherein the film comprises degraded pectin and at least one other filming forming ingredient (see abstract), wherein the active ingredient includes capsaicin (which reads on the bittering agent), among others (see [0035]), and wherein the at least one other film forming ingredient includes soy protein isolate and/or whey protein isolate (which are plant proteins), among a few selections (see [0021] and claim 8). Puri, however, fails to specifically disclose a dissolvable film comprising protein isolate and/or whey protein isolate and capsaicin as recited in claim 1.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have prepared a dissolvable film comprising protein isolate and/or whey protein isolate and capsaicin because these are some of the selections of the other film forming ingredients, and active agents, respectively, taught by Puri.
Regarding claim 7, Puri also teaches that the dissolvable films do not include gelatin (see Tables I and II).
Regarding claims 10 and 12, Puri further teaches that in addition to the degraded pectin, other film forming ingredients, and the desired active, the films may also comprise surfactants, among others (see 0032]) and a plasticizer which includes polyol and/or polyethylene glycol, among others (see [0033]).
Regarding claim 11, Puri further teaches that the mixture of film forming ingredients comprises from about 25 to about 75 dry weight % of a film forming ingredient other than the pectin (see claim 7) which includes soy protein isolate and/or whey protein isolate (i.e., plant protein) (see claim 8). Puri, however, fails to disclose wherein the plant protein is present from 40 wt% to 99 wt% of the film.
Considering the teachings of Puri above, the subject matter as a whole would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the overlapping portion of the range disclosed by the reference because overlapping ranges have been held to be a prima facie case of obviousness, see In re Malagari, 182 U.S.P.Q 549; In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). In addition, a prima facie case of obviousness exists because the claimed ranges "overlap or lie inside ranges disclosed by the prior art", see In re Wertheim, 541 F.2d 257,191 USPQ 90 (CCPA 1976; In re Woodruff; 919 F.2d 1575,16USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I).
Regarding claim 15, Puri further teaches that the dissolvable film may be made by mixing the active material, like the capsaicin with the film forming ingredients, which include the soy protein isolate and/or whey protein isolate (see [0045], forming the film (see [0046]) and forming a single dosage unit, like a strip of film (see [0050] and [0055]).
Claims 5-6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Puri as applied to claims 1-4, 7, 10-12 and 15 above, and further in view of Labeque et al. (US 2016/0102279), hereinafter “Labeque.”
Regarding claims 5-6, Puri teaches the features as discussed above. In particular, Puri teaches capsaicin as one of the active agents (see [0035]). In addition Puri teaches that the film may be used for delivering any active agent for a variety of applications including personal care or skin care, among others (see [0054]). Puri, however, fails to disclose denatonium benzoate.
Labeque, an analogous art in personal care products (see [0109], [0197] and claim 28), teaches the equivalency of capsaicin with denatonium benzoate as aversive agents in a water-soluble film (see [0067]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the capsaicin of Puri with denatonium benzoate because the substitution of art recognized equivalents as shown by Labeque is within the level of ordinary skill in the art. In addition, the substitution of one aversive agent for another is likely to be obvious when it does no more than yield predictable results.
Regarding claim 14, Puri teaches the features as discussed above. In addition, Puri teaches that the films can be made in the form of an article such as a strip, tape, a patch, a sheet, a dressing or any other form known to those skilled in the art; the dosage system may be produced in any desirable unit form; and in addition to having various shapes, the dosage units produced may come in various sizes depending on the end use application (e.g., whether designed for oral or topical administration). Puri, however, fails to disclose a unit dose product as recited in claim 14.
Labeque, an analogous art in personal care products (see [0109], [0197] and claim 28), teaches a pouch that comprise a single compartment, i.e., unit dose product, in which a water-soluble pouch 100 is formed from water-soluble polymer films 10, 20 sealed at an interface 30, and the films 10, 20 define an interior pouch container volume 40 which contains any desired composition 50 for release into an aqueous environment (see [0080] and FIG. 1), and wherein the film 10 is prepared by thermoforming (see [0093]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have prepared the dissolvable film of Puri which comprises soy protein isolate and/or whey protein isolate, and capsaicin as a unit dose product because Puri specifically desires the dissolvable films to be in any desirable unit form having various shapes and sizes and Labeque teaches such unit dose product in the form of a single compartment pouch.
Allowable Subject Matter
Claim 9 stands objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: As discussed in the previous office action, DE 29612148 teaches a packet for water-soluble household cleaning agents having fluid soluble wrapping, i.e., film, of gelatin (a protein) containing bitter aromatic substance, i.e., bittering agent, as a safety feature (see Title of English abstract). Courchay, another close prior art, teaches a water-soluble film which comprises a water-soluble polymer comprising a blend of a caseinate polymer and a polyvinyl alcohol homopolymer, wherein the caseinate polymer is preferably sodium caseinate (see [0024]), which is a protein; and preferably the water-soluble film comprises a bittering agent (see [0020]). However, DE ‘148 and Courchay, fails to teach, disclose or suggest a water soluble film comprising pulse protein and a bittering agent.
CN 105288697, another close prior art, teaches a surgical medical film which comprises 42-54 parts by weight polyvinyl alcohol and 9-17 parts by weight mung bean, a pulse protein, among others (see English abstract). However, there is seen no direction, motivation or guidance in the incorporation of a bittering agent in the surgical medical film.
Each of Courchay in view of Dreher; and Puri, other close prior art, teaches the features as discussed above. Courchay in view of Dreher, or Puri, however, fails to teach, disclose or suggest a water soluble film comprising pulse protein and a bittering agent.
Response to Arguments
Applicant's arguments filed on June 16, 2026 have been fully considered but they are not persuasive.
With respect to the obviousness rejection over Courchay in view of Dreher, as they apply to the present claims, Applicant argues that one of ordinary skill in the art would not be motivated to modify Courchay with soy protein based on Dreher as Dreher does not establish any connection between soy protein and improved dissolution times.
The Examiner respectfully disagrees with the above arguments because Dreher teaches suitable examples of film wall materials which can be included with polyvinyl alcohol and casein, such as those in Courchay, like soy protein as disclosed in para. [[0091]), and the resulting film which includes mixtures of the film wall materials provide a shorter dissolution time as disclosed by Dreher in para [0086]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORNA M DOUYON whose telephone number is (571)272-1313. The examiner can normally be reached Mondays-Fridays; 8:00 AM-4:30 PM.
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/LORNA M DOUYON/Primary Examiner, Art Unit 1761
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