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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 26, 2026, that includes a response to the Final Office Action mailed March 27, 2026, has been entered. Claims 22, 24, 30, 34, 36, 38, 40, and 51 have been amended; claims 1-21, 23, 25, 27-29, 31-33, 39, 43, and 46-50 have been canceled; and claims 52 and 53 have been newly added. Claims 26, 30, 34-38, 41, 42, and 44 have been withdrawn. Claims 22, 24, 40, 45, and 51-53 are currently under examination.
Withdrawal of Prior Claim Rejections - 35 USC § 103
Chidambaram (U.S. Patent Application Pub. No. 2015/0024044) does not explicitly disclose that the pectin is included in the shell composition in the amount of 7.5-15 wt%, as now stipulated in newly amended claim 22. On the contrary, Chidambaram discloses that pectin is included in the amount of less than 5 wt%, preferably 2-4 wt%, and thus teaches away from the presently claimed subject matter. Therefore, the 35 USC 103 rejection presented in the Final Office Action mailed March 27, 2026 is hereby withdrawn. Upon further search and consideration, however, new prior art has been procured, and a new ground of rejection has been formulated that addresses the pending claim limitations, and is presented herein below.
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 22, 24, 40, 45, and 51-53 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 22 is directed to a composition, not to a method of treatment. Claim 22 says nothing at all about what is being treated. In other words, what is being treated is undefined and unknown. Since one of ordinary skill in the art thus has no idea what disease, disorder, or condition is actually being treated, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of “active ingredient”. Is NaCl an “active ingredient”? What about water? What about boron?
Claim 45, which depends from claim 22, stipulates in a wherein clause that “the treatment solution further comprises hydrochloric acid”. One of ordinary skill in the art cannot definitively ascertain whether or not hydrochloric acid is a requisite constituent of the final claimed softgel capsule product itself, i.e. is necessarily included as part of the shell composition weight gain stipulated in claim 22 of about 3% to about 6%. Indeed, it is noted that neither claim 22 nor claim 45 explicitly discloses that the shell composition necessarily contains hydrochloric acid as a requisite constituent.
***For examination at this time, since no claim definitively states that hydrochloric acid is a requisite constituent of the shell composition, or any part of the final softgel capsule product, the claim is being interpreted as the hydrochloric acid is necessarily present in the “treatment solution” but not necessarily present in the final product.
Claim 51 is indefinite for the following reasons:
1. The requisite “burst strength” of the claimed capsule is relative to “a capsule that is untreated with a solution comprising calcium chloride”. The claim does not provide that the reference capsule is the very same as the claimed capsule, but without being “treated with calcium chloride”. Indeed the claim appears to provide an arbitrary comparison between apples and oranges. One of ordinary skill in the art cannot definitively ascertain whether or not the reference capsule necessarily contains or necessarily excludes calcium in the shell composition. Indeed, the reference capsule could certainly contain a calcium salt, even calcium chloride, without being “treated by the solution comprising calcium chloride” as presented in claims 22 and 40. Moreover, even assuming, arguendo, that the reference capsule necessarily excludes calcium chloride from the shell, there are a wide variety and countless number of “capsules without calcium chloride in the shell” that all have their own characteristic “burst” profile. One of ordinary skill in the art thus cannot definitively ascertain the specific “standard” burst profile, which is an undefined and unknown variable. Since the reference burst is an unknown and undefined variable, the requisite burst is also an unknown and undefined variable. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
2. Claim 51 provides for an improved burst strength of “at least about 40%”. While the terms “at least” or “about” when employed individually are generally considered definite, the expression “at least about” is generally considered indefinite.
Claim 52, which depends from claim 22, and presents a product-by-process limitation, stipulates that drying is for the purpose of removing “excess” water from the shell. The limitation “excess water” is undefined by the claim, and is an arbitrary and subjective criterion. One of ordinary skill in the art cannot definitively ascertain what water is “excess” water, and what water is not “excess” water.
Claim 53, which depends from claim 52, stipulates in a wherein clause that “the dried shell has a weight gain of about 3% to about 6% of the shell weight”, but never defines what the weight gain is based on or in reference to. In claim 52, “excess” water is removed. Is the weight gain due to the non-“excess” water not removed, or what? What reference weight is this weight gain being calculated from? Is the 3-6 wt% based on the total weight of the capsule shell before treatment? Or is the 3-6 wt% based on the total weight of the applied treatment solution before drying? Or what? One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims 24 40, 45, and 51-53 are (also) indefinite for depending from an indefinite claim.
NEW GROUNDS OF REJECTION
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.
Claims 22, 24, 40, 45, and 51-53 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (Chinese Patent Application Pub. No. CN 101461792 A), in view of Okayama et al. (U.S. Patent Application Pub. No. 2021/0038526).
Applicant Claims
Applicant’s elected subject matter is directed to a softgel capsule comprising a shell composition comprising gelatin, 7.5-15 wt% pectin, and calcium ions; and a fill material comprising an active agent; wherein the pectin can be low methoxy pectin; wherein the softgel capsule can be made via a solution containing 1-25 wt% calcium chloride and hydrochloric acid; and wherein the dried shell composition exhibits a weight gain of about 3-6% (presumably of calcium chloride).
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Wu discloses e.g. an enteric soft gelatin capsule (i.e. an enteric softgel capsule) comprising a shell composition comprising gelatin, up to 18 wt% “hydrophilic jelly”, and up to 5 wt% of a “coagulant”; wherein the “hydrophilic jelly” can be pectin, and wherein the “coagulant” can be calcium chloride. One of ordinary skill in the art would readily understand in the context of a softgel capsule that the shell composition encapsulates a fill material that typically contains an active ingredient.
Okayama et al. disclose an enteric softgel capsule comprising a shell composition comprising gelatin, and 3-15 wt% low methoxy pectin; and a fill material comprising an active agent; wherein the 3-15 wt% pectin contributes to the enteric property of the shell without the need for an enteric coating or the addition of conventional enteric polymers (abstract; paragraphs 0001-0012, 0027, 0031, 0036, 0040).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Wu does not explicitly disclose that the pectin is low methoxy pectin and is a required constituent of the shell composition. These deficiencies are cured by the teachings of Okayama et al.
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 combine the respective teachings of Wu and Okayama et al., outlined supra, to devise the presently claimed composition.
Wu discloses e.g. an enteric soft gelatin capsule (i.e. an enteric softgel capsule) comprising a shell composition comprising gelatin, up to 18 wt% “hydrophilic jelly”, and up to 5 wt% of a “coagulant”; wherein the “hydrophilic jelly” can be pectin, wherein the “coagulant” can be calcium chloride, and wherein one of ordinary skill in the art would readily recognize, the enteric property is intended to protect an active ingredient from the gastric environment by delivering the active ingredient to the intestine. Since Okayama et al. disclose that an enteric softgel capsule comprising a shell composition comprising gelatin and 3-15 wt% low methoxy pectin exhibits enteric properties due to the inclusion of the pectin without the need for an enteric coating or the inclusion of conventional enteric polymers; that coating a capsule with an enteric coating may adversely affect performance and appearance; and that the addition of conventional enteric polymers can lead to capsules that are prone to leaking due to insufficient sealing (see Okayama et al., paragraphs 0002-0006, 0009, 0040); one of ordinary skill in the art would thus be motivated to include about 3-15 wt% low methoxy pectin in Wu’s shell composition, with the reasonable expectation that the resulting softgel capsule will retain the enteric properties without the risks or disadvantages of adversely affecting performance or appearance, or rendering the capsule prone to leaking due to insufficient sealing.
Since no claim definitively states that hydrochloric acid is a requisite constituent of the final softgel capsule product itself, claim 45 is being interpreted as the hydrochloric acid is necessarily present in the “treatment solution” but not necessarily present in the final softgel capsule product. Nevertheless, as one of ordinary skill in the art would have recognized at the time of filing the present application, the combination of calcium and an acid can facilitate the gelation of (amidated) low methoxy pectin (see e.g. Capel et al. Food Hydrocolloids. 2006; 20: 901-907).
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 June 26, 2026 have been fully considered but they are moot in view of the new grounds of rejection.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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