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 .
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement(s) (IDS), filed 04 August 2025, 18 November 2025, and 07 May 2026, which have been placed of record in the file. An initialed, signed, and dated copy of each PTO-1449 or PTO-SB-08 form is attached to the Office action.
Response to Amendment
Receipt is acknowledged of an amendment, filed 07 May 2026, which has been placed of record and entered in the file.
Status of the claims:
Claims 12-23, 26-29, and 32 are pending.
Claims 1-11, 24-25, and 30-31 are canceled.
Specification and Drawings:
Amendments to the specification and drawings have not been submitted in the amendment filed 07 May 2026.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 12-23 and 26 in the reply filed on 07 May 2026 is acknowledged.
Claims 27-29 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07 May 2026.
Claim Objections
Claim 17 is objected to because of the following informalities:
In claim 17, line 4, “a the first center cavity” appears to include an editorial error. It is suggested that “a” be deleted.
Appropriate correction is required.
Claim 19 depends from claim 17, and is likewise objected to.
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.
Claims 20-23 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 20 is ambiguous as it is not clear whether “a joint dispensing tube” is the same element as “the second dispensing tube is either the same as the first dispensing tube or separate from the first dispensing tube” as set forth in claim 12, on which claim 20 depends.
Claims 21-23 depend from claim 20 and are likewise rejected.
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 12-19 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fang et al. (US Patent Publ. No. 2015/0238429).
With respect to claim 12, Fang et al. disclose a method for forming a multi-phase fill composition (capsules are multiphasic, fig. 1A, [0031]), the method comprising: preparing a first fill composition (a tablet is prepared by compression or granulation, [0038], [0040]); preparing a second fill composition comprising an active pharmaceutical ingredient (API) (liquid or semisolid fill including an active pharmaceutical is prepared by dissolving or mixing, [0031], [0037]); forming a continuous first film (film 40) on a first rotating encapsulation die (rotating encapsulation die 48) comprised of a first set of die cavities (cavities in die 48, fig. 4); forming a continuous second film (film 42) on a second rotating encapsulation die (rotating encapsulation die 48) comprised of a second set of die cavities (cavities in die 50, fig. 4); mechanically dispensing, using a first mechanical dispensing mechanism, a first amount of the first fill composition via a first feeding tube to a first dispensing tube (tablet is fed from a tablet hopper 90 to a first feeding tube and to a first dispensing tube, [0053], Annotated Figure 4), the first dispensing tube being integrated into a wedge positioned between the first rotating encapsulation die and the second rotating encapsulation die and aligned with at least one cavity in the first set of die cavities or in a second set of die cavities (first dispensing tube integrated in wedge 52, fig. 4); mechanically dispensing, using a second mechanical dispensing mechanism, a second amount of the second fill composition via a second feeding tube to a second dispensing tube (liquid or semisolid fill is fed from a pump to a second feeding tube to a second dispensing tube, [0051], [0053], Annotated Figure 4), wherein the second dispensing tube is either the same as the first dispensing tube or separate from the first dispensing tube (dispensing tubes are separate, Annotated Figure 4); rotating the first rotating encapsulation die and the second rotating encapsulation die in counter directions to contact the continuous first film and continuous second film between the first rotating encapsulation die and the second rotating encapsulation die to form a closed capsule and trap the first amount of the first fill composition and the second amount of the second fill composition within the closed capsule between the continuous first film and the continuous second film (encapsulation dies 48, 50 are counter-rotated and the films are sealed to form a closed capsule, fig. 4, [0053]).
See MPEP 2111.02 II. which states:
During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art.
See MPEP 2111.04 I. which states:
However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’"
See MPEP 2111.04 II which states:
The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.
See MPEP 2114 which states:
A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.
The phrase in the preamble “for improving content uniformity of a multi-phase fill composition” is a statement reciting the intended use of the claimed invention that results in no manipulative difference between the claimed invention and the prior art. The claimed method neither recites nor requires any improving of content uniformity. The claimed method recites manipulatives steps for forming a capsule. There is no manipulative step of improving content uniformity; any improving of content uniformity that may or may not performed would be performed outside of the scope of the method claimed. Thus, the phrase “for improving content uniformity” is a statement of intended use of the formed capsule. Thus, one is fully capable of using the capsule making method “for improving content uniformity”.
The intended use recitation language (some of which has been italicized supra) carries no weight in the absence of any distinguishing manipulative step. Fang et al. disclose the method steps as claimed and is thus capable of performing the functions.
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With respect to claim 13, Fang et al. disclose fusing a first pair of edges of the continuous first film and a second pair of edges of the continuous second film to hermetically seal the closed capsule (capsule is sealed to form a capsule 98, [0053], fig. 4).
With respect to claim 14, Fang et al. disclose the mechanically dispensing the first amount of the first fill composition is synchronized with the mechanically dispensing the second amount of the second fill composition and the rotating of the first encapsulation die and the second encapsulation die to allow for timely trapping of the first amount of the first fill composition and the second amount of the second fill composition within the closed capsule (counter-rotating the encapsulation dies to form a partially closed capsule, providing a tablet and injecting a fill in the partially closed capsule, and counter-rotating the encapsulation dies and sealing the partially closed capsule to form a sealed capsule, [0009]).
With respect to claim 15, Fang et al. disclose the first feeding tube is connected, separately or integrally, to the first dispensing tube (first feeding tube connected to first dispensing tube, Annotated Figure 4), and wherein the second feeding tube is connected, separately or integrally, to the second dispensing tube (second feeding tube connected to second dispensing tube, Annotated Figure 4), wherein the second dispensing tube is separate from the first dispensing tube (Annotated Figure 4), and wherein the first dispensing tube is offset laterally from the second dispensing tube (dispensing tubes are laterally offset, fig. 4).
With respect to claim 16, Fang et al. disclose injecting the first amount of the first fill composition, via the first dispensing tube, to a first off-center cavity in the first set of die cavities or in the second set of die cavities (tablet 92 is provided to off-center cavity 94, fig. 4), wherein the first dispensing tube is positioned off- center in the wedge and is aligned with the off-center cavity in the first set of die cavities or in the second set of die cavities (first dispensing tube is positioned off-center in the wedge 52 and aligned with cavity 94, Annotated Figure 4).
With respect to claim 17, Fang et al. disclose injecting the second amount of the second fill composition, via the second dispensing tube, to a first center cavity in the first set of die cavities and to a second center cavity in the second set of die cavities (liquid or semisolid fill is injected to center cavities, Annotated Figure 4), wherein the second dispensing tube is centered in the wedge and is aligned with the first center cavity and the second center cavity, wherein the first center cavity and the second center cavity together are a pair of die cavities configured to form a complete capsule (second dispensing tube is centered in the wedge 52, Annotated Figure 4).
With respect to claim 18, Fang et al. disclose injecting the second amount of the second fill composition, via the second dispensing tube, to a second off-center cavity in the first set of die cavities or in the second set of die cavities that is different from the first off- center cavity (an additional tablet may be injected via an additional dispensing tube at an end of the encapsulation wedge 52 opposite the first table hopper 90, fig. 5, [0054]), wherein the second dispensing tube is positioned off-center in the wedge and is aligned with the second off-center cavity (additional dispensing tube is off-center in the wedge 52 and aligned with a second off-center cavity, fig. 5).
With respect to claim 19, Fang et al. disclose the injecting the first amount of the first fill composition and the injecting the second amount of the second fill composition are done sequentially or simultaneously (counter-rotating the encapsulation dies to form a partially closed capsule, providing a tablet and injecting a fill in the partially closed capsule, and counter-rotating the encapsulation dies and sealing the partially closed capsule to form a sealed capsule, [0009]).
With respect to claim 26, Fang et al. disclose forming a plurality of closed capsules having a multi-phase fill composition such that there is substantially no variability in the multi-phase fill composition amongst the plurality of closed capsules. Fang et al. disclose the filled capsule defines an encapsulated space having a predetermined volume ([0002]). Since Fang et al. disclose the filled capsules include a uniform space, and since Fang et al. does not disclose any variation in the encapsulation die cavities, Fang et al. is considered to disclose closed capsules having substantially no variability in the composition amongst the closed capsules.
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 20 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Fang et al. in view of Yang et al. (US Patent Publ. No. 2020/0022874).
With respect to claim 20, Fang et al. fail to disclose the first feeding tube and the second feeding tube converge into a joint dispensing tube.
Yang et al. disclose in a similar type of system that it is old and well known to have a joint dispensing tube, wherein the first feeding tube (804) and the second feeding tube (805) converge into the joint dispensing tube.
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It 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 to modify the Fang et al. method by substituting a joint dispensing tube, suggested by Yang et al., for the two separate dispensing tubes of Fang et al., in order to allow two different components to be mixed prior to being filled into the capsule halves. In this instance, a skilled artisan would have recognized that the substitution of the joint dispensing tube from the Yang et al. reference for the two separate dispensing tubes of the Fang et al. reference involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have substituted one known element for another and the results of the substitution would have been predictable.
With respect to claim 22, the Fang et al. method, as modified by Yang et al. above, teaches the method of claim 20, wherein the joint dispensing tube (substituted from Yang et al.) is centered in the wedge and is aligned with a first center cavity in the first set of die cavities and a second center cavity in the second set of die cavities, wherein the first center cavity and the second center cavity together are a pair of die cavities configured to form a complete capsule.
With respect to claim 23, the Fang et al. method, as modified by Yang et al. above, teaches the method of claim 20, and further comprising injecting jointly, via the joint dispensing tube (substituted from Yang et al.), the first amount of the first fill composition and the second amount of the second fill composition into a single cavity.
Allowable Subject Matter
Claim 21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Antonioli (EP 4,071,059) disclose a method of forming pharmaceutical capsules including providing precise volumetric delivery of the compositions ([0043]).
Yoon et al. (KR 20140080844) disclose a capsule forming method including controlling the composition of the preparation.
Draper et al. (WO 2011150506) disclose a capsule forming method including preparing and feeding a pharmaceutical composition to rotating encapsulation dies.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linda J. Hodge whose telephone number is (571)272-0571. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/LINDA J. HODGE/Primary Examiner, Art Unit 3731
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