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 March 4, 2026 in reply to the First Office Action on the Merits mailed January 27, 2026. Claims 22, 40-42, 44, and 45 have been amended; claims 1-21, 27-29, 32, 33, 39, 43, and 46-50 have been canceled; and claim 51 has been newly added. Claims 26, 30, 31, 34-38, 41, 42, and 44 have been withdrawn. Claims 22-25, 40, 45, and 51 are currently under examination.
Withdrawal of Prior Claim Rejections - Obviousness-Type Double Patenting
A terminal disclaimer has been timely filed in compliance with 37 CFR 1.321(c) or 1.321(d), and signed in compliance with 37 CFR 1.321(b). Therefore, the Obviousness-Type Double Patenting rejection presented in the First Office Action on the Merits mailed January 27, 2026 is hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 102(a)(1) and 102(a)(2)
Claim 22 has been amended to include a product-by-process step which appears to be broader in scope than the specific manufacturing steps disclosed in Chidambaram. Therefore, the 35 USC 102(a)(1) and 35 USC 102 (a)(2) rejection presented in the First Office Action on the Merits mailed January 27, 2026 is hereby withdrawn.
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 22-25, 40, 45, and 51 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 indefinite for the following reasons:
1. 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? Moreover, even assuming, arguendo, the claim in fact does explicitly define the actual chemical compound that specifically constitutes the “active ingredient”, one of ordinary skill in the art, not knowing what disease, disorder, or condition is actually necessarily being treated, could not definitively ascertain the metes and bounds of the “therapeutically effective amount” of any specific chemical compound, even if disclosed.
2. Claim 22, in a product-by-process limitation, stipulates that the shell composition, after being exposed to the solution comprising calcium chloride, is “dried”. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of “dried” with respect to what can be included and what must be excluded in the final shell composition. For example, is the shell composition completely devoid of water? Is the shell composition completely devoid of any liquid constituent, e.g. water, ethanol, hydrochloric acid, etc.? Or rather, is “dried” limited to the context of the solution that contains calcium chloride, such that no additional water or other liquid from this particular solution is included in the final shell composition, but the shell composition can otherwise include water and other liquids? Or what?
Claim 25, which depends, ultimately, from claim 22, stipulates in a wherein clause that “the pectin is included in an amount of about 1 wt% to about 25 wt%, based on the total weight of the shell composition”. One of ordinary skill in the art cannot definitively ascertain whether this amount is based on the shell composition before or after the “treatment” with the solution containing calcium chloride, which provides a weight gain of about 3% to about 6% to the shell composition.
Claim 40, which depends from claim 39, is a product-by-process claim which stipulates that a “treatment solution” employed in the method of making the claimed softgel capsule comprises 1-25 wt% calcium chloride. One of ordinary skill in the art cannot definitively ascertain how this calcium chloride concentration of the “treatment solution” limits the actual calcium chloride concentration in the final claimed softgel capsule product. For example, is the calcium chloride concentration of the final softgel capsule product 1-25 wt%? Or, rather, does the calcium chloride concentration of the final softgel capsule product have a lower limit of at least 1 wt%? Or, rather, does the calcium chloride concentration of the final softgel capsule product have an upper limit of 25 wt%? Or, rather, is there no correlation or relationship at all between the concentration of calcium chloride in the “treatment solution” and the calcium chloride concentration in the claimed softgel capsule product?
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. Claim 51 depends from claim 22. Claim 22 says nothing at all about a “burst”. Hence, there is insufficient antecedent basis for the softgel capsule having a “burst” in the claim.
2. An “improved burst strength” is not defined by the claim, and represents an arbitrary and subjective criterion that may in fact even be context specific. For example, does an “improved burst strength” of at least 40% mean a lower amplitude burst, a higher amplitude burst, a lower rate of rise of the burst, or a higher rate of rise of the burst, or some combination, or what? Moreover, one of ordinary skill in the art cannot definitively ascertain whether the claimed softgel capsule necessarily has a “burst”. Perhaps having no “burst” is improved by 40% over the reference softgel capsule.
3. Further, the “improved burst strength” is relative to “a capsule that is untreated without calcium chloride”. Presumably, the reference capsule does not contain calcium chloride at all in the shell composition. However, there are a wide variety and countless number of “capsules without calcium chloride” that all have their own characteristic “burst” profile. One of ordinary skill in the art thus cannot definitively ascertain the specific “standard” burst profile by which the claimed softgel capsule burst profile must be deemed “improved”. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
4. 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.
Claims 23-25, 40, 45, and 51 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 22-25, 40, 45, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Chidambaram (U.S. Patent Application Pub. No. 2015/0024044).
Applicant Claims
Applicant’s elected subject matter is directed to a softgel capsule comprising a shell composition comprising pectin and calcium ions; and a fill material comprising an active agent; wherein the softgel capsule can be made via a solution containing 1-25 wt% calcium chloride and hydrochloric acid; wherein the treatment solution provides a weight gain of about 3-6% of the capsule.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Chidambaram discloses a softgel capsule comprising a shell composition comprising pectin, e.g. calcium ions and e.g. an acid; and a fill material comprising an active agent; wherein the calcium ions can be provided via calcium chloride (see e.g. abstract; paragraphs 0009-0011, 0018, 0019, 0023, 0026, 0031, 0038; examples; claims 44-47, 49, and 50).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Chidambaram does not explicitly anticipate the presently claimed subject matter with one specific example or preferred embodiment. However, the disclosure of Chidambaram is sufficient to render the claimed subject matter prima facie obvious within the meaning of 35 USC 103.
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 Chidambaram, outlined supra, to devise the presently claimed composition.
Chidambaram discloses a softgel capsule comprising a shell composition comprising pectin, e.g. calcium ions and e.g. an acid; and a fill material comprising an active agent; wherein the softgel capsule is gastric resistant, and prevents gastric reflux and esophageal irritation. Since Chidambaram discloses that the calcium ions can be provided as calcium chloride, one of ordinary skill in the art would thus include calcium chloride as the source of the calcium ions, with the reasonable expectation that the resulting softgel capsule will be gastric resistant, and prevent gastric reflux and esophageal irritation.
As noted, supra, 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, Chidambaram discloses that their softgel capsule comprising e.g. low methoxy pectin can indeed also contain both calcium chloride and an acid. 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 March 4, 2026 have been fully considered but they are not persuasive.
i) Applicant contends that “there is no motivation in Chidambaram to arrive at treating the shell composition with a solution including calcium chloride” but rather “teaches including calcium chloride directly into the gel mass composition during manufacturing”, while “in contrast, the claimed softgel capsule includes that the shell composition has calcium ions after being treated with a solution comprising calcium chloride”; that “the claimed treatment step should be given patentable weight because it provides a weight gain of the softgel capsule of about 3% to about 6%”; that “the post-encapsulation treatment with calcium chloride solution imparts unique structural characteristics to the shell composition” such as “ionotropic gelation, i.e. calcium bridging effect…the calcium ions bridge the shell composition to form a larger and stronger enhanced network”; that “Chidambaram teaches that the optional gelling agent, i.e. calcium ion, is included in the amount of less than about 2%...insufficient to produce any measurable weight gain in the softgel capsule”, and thus “claim 22 as amended recites a structurally distinct product”.
The Examiner, however, would like to point out the following:
1. Applicant has not adequately and properly established that they have a structurally distinct product from Chidambaram. Nor has Applicant even sufficiently established that their method of making the composition is really any different in any meaningful way from the method of Chidambaram.
2. Present claim 22 is directed to a softgel capsule that comprises a shell composition that includes calcium ions after treatment of the shell composition with a solution of calcium chloride. Chidambaram discloses a softgel capsule that comprises a shell composition that includes calcium ions only after addition of a solution comprising calcium chloride to the shell composition. Indeed, as Applicant points out, Chidambaram discloses that their shell composition necessarily includes a gastric resistant polymer and a film-forming natural polymer. The gelling agent, i.e. calcium chloride, is optional. When the solution comprising calcium chloride is applied, the shell composition thus contains calcium, and there is a weight gain to the shell composition from adding the solution of calcium chloride.
3. Hence, just like the composition of present claim 22, the Chidambaram composition includes calcium in the shell composition only after addition of a solution containing calcium chloride to the shell composition. In contrast to Applicant’s assertion, present claim 22 says nothing at all about “post encapsulation treatment”. Just like the addition of the solution of calcium chloride will cause a weight gain to the shell composition of the presently claimed composition, in Chidambaram the addition of the solution of calcium chloride will necessarily cause a weight gain to the shell composition of Chidambaram, since the solution of calcium chloride has mass. Moreover, Chidambaram clearly discloses, and one of ordinary skill in the art would clearly understand, that calcium chloride is a gelling agent in their shell composition and works by forming ionic crosslinks to thus bridge shell composition polymers to form a stronger, enhanced network. This structure is no different from what Applicant describes as the structure of their shell composition.
4. In contrast to Applicant’s assertion, the weight gain limitation is effectively meaningless. The reference baseline weight is an unknown, “x”. Hence, the weight gain is 0.03x to 0.06x, which is also an unknown variable. Moreover, what constitutes the weight gain is also an undefined and unknown variable “y”. The solution comprising calcium chloride can comprise any one of a wide variety of constituent elements, e.g. sugar, and e.g. water, etc., which could be responsible for the recited weight gain. The weight gain is not merely from calcium chloride alone, and indeed only a tiny fraction of the recited weight gain could be due to calcium chloride, even far less than 2%.
5. Applicant’s shell composition in claim 22 is exceedingly broad and generic. Indeed, the only expressly recited requisite constituent identified is the calcium ions. No specific requisite polymer is identified. As anyone of ordinary skill in the art would readily recognize, calcium ions are not going to facilitate “ionotropic gelation, i.e. calcium bridging effect” with any arbitrary polymer, or any arbitrary set of other constituents. Hence, Applicant’s described effect is not applicable to the entire scope of their claimed subject matter. In other words, the claimed composition is far broader in scope than merely compositions for which this “ionotropic gelation, i.e. calcium bridging effect” would even apply. In effect, the “ionotropic gelation, i.e. calcium bridging effect” is not necessarily even a required structural feature of claim 22.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Johann Richter can be reached at 571-272-0646. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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