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
This action is in response to Applicant’s amendment filed February 5, 2026 in reply to the Non-final Office Action mailed November 5, 2025. Claims 1, 10, and 38 have been amended; claims 15-30 and 35-37 have been canceled; and claim 40 has been newly added. Claims 2-9, 11, 13, 14, and 31-33 have been withdrawn. It is noted that claim 34 depends from withdrawn claim 2 and is thus also hereby withdrawn. Claims 1, 10, 12, and 38-40 are currently under examination.
Claim Objections
Claim 1 is objected to because of the following:
i). In claim 1, there should be a comma between “does not comprise glycerin” and “and wherein the film”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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, 10, 12, 38, 39, and 40 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.
Claims 1 and 38, as now amended, stipulate that the film composition comprises a non-gelatin biobased material comprising maltodextrin and a plasticizer”, which renders these claims indefinite for the following reasons:
1. While a “non-gelatin biobased material” is clearly a requisite constituent element of the film composition, and that this “material” necessarily comprises maltodextrin and a plasticizer, one of ordinary skill in the art cannot definitively ascertain what is necessarily included and excluded (other than gelatin) from this element referred to as “a non-gelatin biobased material”. The element “non-gelatin biobased material” is not defined by the specification. Indeed, the phrase “non-gelatin biobased material” appears nowhere at all in the original specification and claims. Rather, the specification repeatedly and exclusively discloses “a non-gelatin biobased polymer”**. Clearly, a “non-gelatin biobased material” that includes maltodextrin and a plasticizer is not one and the same as “a non-gelatin biobased polymer”.
**It was noted in the prior Office Action mailed November 5, 2025 that the term “a non-gelatin biobased polymer” is indefinite in this case because Applicant has admitted on the record that the term “polymer” does not have its ordinary and customary meaning, since “stearic acid” is included as a “polymer”. Absolutely no one of ordinary skill in the art would recognize “stearic acid” as a “polymer” by the ordinary and customary meaning of “polymer”. Applicant contends they are permitted to call “stearic acid” a “polymer” by acting as their own lexicographer. However, to act as their own lexicographer, the Applicant must clearly set forth a special definition of a claim term in the specification that differs from the plain and ordinary meaning it would otherwise possess. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366, 62 USPQ2d 1658, 1662 (Fed. Cir. 2002). Applicant has not pointed to where the term “polymer” is so defined in the specification. One of ordinary skill in the art thus has no idea what constitutes a “polymer”. Indeed, if “stearic acid” is a “polymer”, would a “triglyceride” also be a “polymer”? What about talc? What about aluminum? What about water?
2. Claims 1 and 38 provide that the “non-gelatin biobased material” comprises a plasticizer which comprises sorbitol and sorbitan. As anyone of ordinary skill in the art would recognize, sorbitan is not a “biobased material”, rather sorbitan is a synthetic material. Hence, one of ordinary skill in the art cannot make heads or tails out of the limitation “a non-gelatin biobased material”. Indeed, if “a non-gelatin biobased material” can contain components that are not biobased, can this material also contain gelatin?
3. One of ordinary skill in the art cannot definitively ascertain whether a gelatin material can also be included as an additional element (i.e. in addition to the required non-gelatin biobased material element) in the film composition, or rather is gelatin necessarily excluded from the film composition as a whole.
***Indeed, while the film composition requires “a non-gelatin biobased material” as a constituent element, the film composition as a whole appears open to the further inclusion of other, unrecited elements. Therefore, for examination at this time, the claims are being interpreted as the film composition necessarily contains “a non-gelatin biobased material” as a constituent, but that this is not being construed as meaning that the film necessarily excludes gelatin or some sort of gelatin-based material. Hence, while a non-gelatin biobased material is a requisite constituent of the film, a gelatin-based material is not necessarily excluded from the film.
Claims 1 and 38, as now amended, stipulate that the film composition contains a plasticizer, but stipulate in a wherein clause that “the plasticizer does not comprise glycerin”. While the plasticizer element does not comprise glycerin, one of ordinary skill in the art cannot definitively ascertain whether the film composition as a whole can still include, or rather necessarily excludes, glycerin. Indeed, while glycerin is not included as a plasticizer, glycerin could be included for another purpose. In effect, by this interpretation, the noted wherein clause appears to be devoid of any real substance, as glycerin could be included in any amount for some other stated purpose (i.e. not as a plasticizer). One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
***For examination at this time, the claim is being interpreted as the film composition can include glycerin in any amount, as long as the stated purpose of including the glycerin is something other than being a plasticizer.
Claims 10, 12, 39, and 40 are (also) indefinite for depending from an indefinite claim.
Claim Rejections - 35 USC § 103 (I-IV)
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.
I. Claims 1, 12, 38, 39, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Chinese Patent Application Pub. No. 113332257 A), in view of Sukuru et al. (U.S. Patent Application Pub. No. 2006/0088590).
I. Applicant Claims
Applicant’s elected subject matter is directed to a softgel capsule comprising i) a film comprising e.g. 1.5-25 wt% maltodextrin, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”.
I. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Chen et al. disclose a softgel capsule comprising i) a film comprising e.g. 18-35 wt% gelatinized starch, and a plasticizer including e.g. sorbitol; and ii) a filler material; wherein the gelatinized starch can be e.g. maltodextrin; and wherein the softgel capsule can be employed as a medicine.
Sukuru et al. disclose a softgel capsule comprising i) a film comprising e.g. non-gelatin materials, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”; wherein the softgel capsule is intended to provide immediate-release (abstract; paragraphs 0002-0009, 0015, 0020, 0030, 0042, 0043).
I. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Chen et al. do not explicitly disclose that the plasticizer further includes sorbitan. This deficiency is cured by the teachings of Sukuru et al.
I. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Chen et al. and Sukuru et al., outlined supra, to devise Applicant’s presently claimed softgel capsule.
Chen et al. disclose a softgel capsule comprising i) a film comprising e.g. 18-35 wt% gelatinized starch, and a plasticizer comprising sorbitol; and ii) a filler material; wherein the gelatinized starch can be e.g. maltodextrin. Since Chen et al. disclose that their softgel capsule can be employed as a medicine; one of ordinary skill in the art would understand that the filler material can thus contain an “active agent”, or would at the very least be motivated to include an “active agent” in the filler material, with the reasonable expectation that the resulting softgel capsule can be successfully employed as a medicine. Moreover, since Sukuru et al. disclose that softgel capsule films containing sorbitol as a plasticizer do not become brittle over time, but that sorbitol is susceptible to blooming as sorbitol forms white precipitates, and that the combination of sorbitol and sorbitan removes this susceptibility to blooming, one of ordinary skill in the art would thus be motivated to employ the combination of sorbitol and sorbitan as the plasticizer, with the reasonable expectation that the resulting softgel capsule film will not become brittle over time and will not be susceptible to blooming.
Since one of ordinary skill in the art, in view of the cited prior art, would thus arrive at an immediate release softgel capsule with the same constituents in the same amounts as the claimed softgel capsule, this softgel capsule would reasonably be expected to have the same properties as the claimed softgel capsule as well, including the film dissolving in less than 20 minutes if the film were to be subjected to the USP Apparatus II test with paddles at 75 RPM in 900 ml of 0.1N HCl and deionized water at “37 degrees” . See also Fang et al., WO 2021/072092, published 4/15/2021.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the 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 references, especially in the absence of evidence to the contrary.
II. Claims 1, 12, 38, 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Kamaguchi et al. (U.S. Patent Application Pub. No. 2005/0069579), in view of Sukuru et al. (U.S. Patent Application Pub. No. 2006/0088590).
II. Applicant Claims
Applicant’s elected subject matter is directed to a softgel capsule comprising i) a film comprising e.g. 1.5-25 wt% maltodextrin, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”.
II. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Kamaguchi et al. disclose a non-gelatinous capsule comprising i) a film comprising e.g. less than 25 wt%, or about 15%, maltodextrin, and a plasticizer; and ii) a content (i.e. fill material) containing e.g. MCT (i.e. an “active agent”); wherein the capsule can be in the form of a softgel capsule; and wherein the softgel capsule can be employed as a pharmaceutical and can achieve excellent disintegration properties in vivo (abstract; paragraphs 0001, 0010-0016, 0023, 0029, 0038, 0042-0044, 0048, 0052; Table 1).
Sukuru et al. disclose a softgel capsule comprising i) a film comprising e.g. non-gelatin materials, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”; wherein the plasticizer can further include e.g. glycerol, and wherein the softgel capsule is intended to provide immediate-release
II. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Kamaguchi et al. do not explicitly disclose that the plasticizer includes sorbitol and sorbitan. This deficiency is cured by the teachings of Sukuru et al.
II. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Kamaguchi et al. and Sukuru et al., outlined supra, to devise Applicant’s presently claimed softgel capsule.
Kamaguchi et al. disclose a non-gelatinous capsule comprising i) a film comprising e.g. less than 25 wt%, or about 15%, maltodextrin, and a plasticizer; and ii) a content (i.e. fill material) containing e.g. MCT (i.e. an “active agent”); wherein the softgel capsule can be employed as a pharmaceutical and can achieve excellent disintegration properties in vivo. Since Kamaguchi et al. disclose that their non-gelatinous capsule can be in the form of a softgel capsule, one of ordinary skill in the art would thus be motivated to employ a softgel capsule, with the reasonable expectation that the resulting softgel capsule can be successfully employed as a pharmaceutical and can achieve excellent disintegration properties in vivo. Moreover, since Sukuru et al. disclose that softgel capsule films containing sorbitol as a plasticizer do not become brittle over time, unlike softgel capsule films containing e.g. glycerol as a plasticizer, but that sorbitol is susceptible to blooming as sorbitol forms white precipitates, and that the combination of sorbitol and sorbitan removes this susceptibility to blooming, one of ordinary skill in the art would thus be motivated to include the combination of sorbitol and sorbitan as the plasticizer, with the reasonable expectation that the resulting softgel capsule film will not become brittle over time and will not be susceptible to blooming.
Since one of ordinary skill in the art, in view of the cited prior art, would thus arrive at a rapidly disintegrating softgel capsule with the same constituents in the same amounts as the claimed softgel capsule, this softgel capsule would reasonably be expected to have the same properties as the claimed softgel capsule as well, including the film dissolving in less than 20 minutes if the film were to be subjected to the USP Apparatus II test with paddles at 75 RPM in 900 ml of 0.1N HCl and deionized water at “37 degrees” . See also Fang et al., WO 2021/072092, published 4/15/2021.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the 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 references, especially in the absence of evidence to the contrary.
III. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Chinese Patent Application Pub. No. 113332257 A), in view of Fujii et al. (U.S. Patent Application Pub. No. 2013/0189522), and Sukuru et al. (U.S. Patent Application Pub. No. 2006/0088590).
I. Applicant Claims
Applicant’s elected subject matter is directed to a softgel capsule comprising i) a film comprising e.g. 1.5-25 wt% maltodextrin, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material; wherein the plasticizer can further include triacetin and/or polysorbate.
III. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Chen et al. disclose a softgel capsule comprising i) a film comprising e.g. 18-35 wt% gelatinized starch, and a plasticizer including e.g. sorbitol; and ii) a filler material; wherein the gelatinized starch can be e.g. maltodextrin; and wherein the softgel capsule can be employed as a medicine.
Fujii et al. disclose e.g. a softgel capsule comprising i) a film comprising a non-gelatin polymer, and a plasticizer including e.g. sorbitol and glycerol triacetate (i.e. triacetin); and ii) a filler material comprising an oil (abstract; paragraphs 0007, 0010, 0011, 0017, 0024).
Sukuru et al. disclose a softgel capsule comprising i) a film comprising e.g. non-gelatin materials, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”; wherein the plasticizer can further include e.g. glycerol, and wherein the softgel capsule is intended to provide immediate-release (abstract; paragraphs 0002-0009, 0015, 0020, 0030, 0042, 0043).
III. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Chen et al. do not explicitly disclose that the plasticizer further includes sorbitan and triacetin. These deficiencies are cured by the teachings of Fujii et al. and Sukuru et al.
III. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Chen et al., Fujii et al., and Sukuru et al., outlined supra, to devise Applicant’s presently claimed softgel capsule.
Chen et al. disclose a softgel capsule comprising i) a film comprising e.g. 18-35 wt% gelatinized starch, and a plasticizer comprising sorbitol and glycerol; and ii) a filler material; wherein the gelatinized starch can be e.g. maltodextrin. Since Chen et al. disclose that their softgel capsule can be employed as a medicine; one of ordinary skill in the art would understand that the filler material can thus contain an “active agent”, or would at the very least be motivated to include an “active agent” in the filler material, with the reasonable expectation that the resulting softgel capsule can be successfully employed as a medicine. Moreover, since Fujii et al. disclose that a film for a softgel capsule comprising a non-gelatin polymer, and a plasticizer including e.g. sorbitol and glycerol triacetate (i.e. triacetin) has excellent stability and disintegration ability; and since Sukuru et al. disclose that softgel capsule films containing sorbitol as a plasticizer do not become brittle over time, but that sorbitol is susceptible to blooming as sorbitol forms white precipitates, and that the combination of sorbitol and sorbitan removes this susceptibility to blooming, one of ordinary skill in the art would thus be motivated to employ the combination of sorbitol with triacetin and sorbitan as the plasticizer, with the reasonable expectation that the resulting softgel capsule film will exhibit excellent stability, will not become brittle over time, will not be susceptible to blooming, and will exhibit excellent disintegration ability.
Since one of ordinary skill in the art, in view of the cited prior art, would thus arrive at an immediate release softgel capsule with the same constituents in the same amounts as the claimed softgel capsule, this softgel capsule would reasonably be expected to have the same properties as the claimed softgel capsule as well, including the film dissolving in less than 20 minutes if the film were to be subjected to the USP Apparatus II test with paddles at 75 RPM in 900 ml of 0.1N HCl and deionized water at “37 degrees” . See also Fang et al., WO 2021/072092, published 4/15/2021.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the 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 references, especially in the absence of evidence to the contrary.
IV. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kamaguchi et al. (U.S. Patent Application Pub. No. 2005/0069579), in view of Fujii et al. (U.S. Patent Application Pub. No. 2013/0189522), and Sukuru et al. (U.S. Patent Application Pub. No. 2006/0088590).
IV. Applicant Claims
Applicant’s elected subject matter is directed to a softgel capsule comprising i) a film comprising e.g. 1.5-25 wt% maltodextrin, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material; wherein the plasticizer can further include triacetin and/or polysorbate.
IV. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Kamaguchi et al. disclose a non-gelatinous capsule comprising i) a film comprising e.g. less than 25 wt%, or about 15%, maltodextrin, and a plasticizer, such as e.g. glycerol; and ii) a content (i.e. fill material) containing e.g. MCT (i.e. an “active agent”); wherein the capsule can be in the form of a softgel capsule; and wherein the softgel capsule can be employed as a pharmaceutical and can achieve excellent disintegration properties in vivo (abstract; paragraphs 0001, 0010-0016, 0023, 0029, 0038, 0042-0044, 0048, 0052; Table 1).
Fujii et al. disclose e.g. a softgel capsule comprising i) a film comprising a non-gelatin polymer, and a plasticizer including e.g. sorbitol and glycerol triacetate (i.e. triacetin); and ii) a filler material comprising an oil (abstract; paragraphs 0007, 0010, 0011, 0017, 0024).
Sukuru et al. disclose a softgel capsule comprising i) a film comprising e.g. non-gelatin materials, and a plasticizer comprising sorbitol and sorbitan; and ii) a fill material comprising an “active agent”; wherein the plasticizer can further include e.g. glycerol, and wherein the softgel capsule is intended to provide immediate-release
IV. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Kamaguchi et al. do not explicitly disclose that the plasticizer further includes sorbitan and triacetin. These deficiencies are cured by the teachings of Fujii et al. and Sukuru et al.
IV. Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Kamaguchi et al., Fujii et al., and Sukuru et al., outlined supra, to devise Applicant’s presently claimed softgel capsule.
Kamaguchi et al. disclose a non-gelatinous capsule comprising i) a film comprising e.g. less than 25 wt%, or about 15%, maltodextrin, and a plasticizer, such as e.g. glycerol; and ii) a content (i.e. fill material) containing e.g. MCT (i.e. an “active agent”); wherein the softgel capsule can be employed as a pharmaceutical and can achieve excellent disintegration properties in vivo. Since Kamaguchi et al. disclose that their non-gelatinous capsule can be in the form of a softgel capsule, one of ordinary skill in the art would thus be motivated to employ a softgel capsule, with the reasonable expectation that the resulting softgel capsule can be successfully employed as a pharmaceutical and can achieve excellent disintegration properties in vivo. Moreover, since Fujii et al. disclose that a film for a softgel capsule comprising a non-gelatin polymer, and a plasticizer including e.g. sorbitol and glycerol triacetate (i.e. triacetin) has excellent stability and disintegration ability; and since Sukuru et al. disclose that softgel capsule films containing sorbitol as a plasticizer do not become brittle over time, but that sorbitol is susceptible to blooming as sorbitol forms white precipitates, and that the combination of sorbitol and sorbitan removes this susceptibility to blooming, one of ordinary skill in the art would thus be motivated to employ the combination of sorbitol with triacetin and sorbitan as the plasticizer, with the reasonable expectation that the resulting softgel capsule film will exhibit excellent stability, will not become brittle over time, will not be susceptible to blooming, and will exhibit excellent disintegration ability.
Since one of ordinary skill in the art, in view of the cited prior art, would thus arrive at a rapidly disintegrating softgel capsule with the same constituents in the same amounts as the claimed softgel capsule, this softgel capsule would reasonably be expected to have the same properties as the claimed softgel capsule as well, including the film dissolving in less than 20 minutes if the film were to be subjected to the USP Apparatus II test with paddles at 75 RPM in 900 ml of 0.1N HCl and deionized water at “37 degrees” . See also Fang et al., WO 2021/072092, published 4/15/2021.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the 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 references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments filed February 5, 2026 have been fully considered but they are not found persuasive:
i) Applicant contends that “one of ordinary skill in the art would understand that Sukuru’s teaching is directed to using sorbitol and sorbitan in combination with glycerin, not as a replacement for glycerin”; that “Chen and Sukuru do not contemplate a glycerin-free plasticizer”; that “Kamaguchi teaches the capsule shell composition may optionally contain a plasticizer” and that the plasticizer could include “glycerin”; and “that a plasticizer system consisting of sorbitol and sorbitan without glycerin would achieve the same dissolution properties as claimed”.
The Examiner, however, would like to point out the following:
1. In stark contrast to Applicant’s assertion, none of the cited references; i.e. not Chen, not Kamaguchi, and not Sukuru; requires glycerin at all.
2. Further, in stark contrast to Applicant’s assertion, the plasticizer system claimed does not necessarily “consist of” sorbitol and sorbitan. On the contrary, the plasticizer can include any plasticizer known to man, except glycerin. Indeed, while the claimed film composition does not include glycerin as a “plasticizer”, the claimed film composition does not appear to necessarily exclude inclusion of glycerin for any other purpose, as discussed supra.
3. Sukuru discloses, e.g. in the abstract, that their plasticizer, i.e. the mixture of sorbitol and sorbitan, can be employed alone (i.e. no requirement for glycerin) in a capsule shell with e.g. non-gelatin materials, and further with e.g. an oil-based fill, e.g. bath oils. Moreover, Sukuru discloses that the softgel capsule is intended to provide immediate-release.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
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.
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/DAVID BROWE/Primary Examiner, Art Unit 1617