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 .
Election/Restrictions
Applicant’s election of Group II (claims 8-15) in the reply filed on March 24, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant has, however, cancelled all claims and presented new claims 21-37. The restriction requirement is therefore considered moot and has been withdrawn.
Status of Application
Receipt of Applicant’s remarks and amended claims filed on March 24, 2026 is acknowledged.
Claims 21-37 are pending in this application.
Claims 1-20 have been cancelled.
Claims 21-37 are new.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on June 4, 2025 is acknowledged. A signed copy is attached to this office action.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The title recites “Multilayered capsule with controllable arrangement of layers and industrial systems and processing of fabricating the same”, however, the instant claims are not drawn to a capsule but rather a “complex” which the specification defines as a plurality of pellets. The specification in paragraph 0036 discloses the terms capsule and pellet as referred to herein are to be construed as interchangeable. More specifically, a singular instance of the product is referred to as capsule. Whereas plural instances of the product, incorporated in a readily dissolvable cartridge complex, are referred to as pellets. It is suggested Applicant utilize one term throughout the title and claims.
Claim Interpretation
The instant claims recite contingent limitations. For example, the recitation of “upon immersion in a volume of water, to perform a sequence of processes to generate a product composition” will have the functional properties recited when immersed in water. Applicant’s attention is directed to MPEP 2111.04 II which discloses “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”. The instant claims have been interpreted to be a coated capsule/pellet.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In response to a restriction requirement, all previous pending claims were cancelled and new claims 21-37 were presented. In the remarks filed on March 24, 2026, Applicant states “the new claims are directed to a dissolvable solid complex exemplified by FIGS 12A and 12B and the accompanying description. No new matter has been added.” No further identification of support location for the amendments is disclosed. Figures 12A and 12B appear to disclose a rendering of the layered pellet.
Claim 1 recites “a solid body”, however, after a review of the specification, the Examiner was unable to locate support for the term “solid body” and what would constitute said solid body.
This is a new matter rejection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 27-29 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 27 recites “wherein the solid body is one pellet of a plurality of pellets”, however, claim 21 from which it depends recites “a dissolvable solid complex”. After a review of the specification, in paragraph 0036, the terms capsule and pellet as referred to herein are to be construed as interchangeable. More specifically, a singular instance of the product is referred to as capsule. Whereas plural instances of the product, incorporated in a readily dissolvable cartridge complex, are referred to as pellets. Therefore, claim 27 does not further limit the subject matter of claim 21.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 21-26 and 30-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Digenis et al. (US 5,672,359).
Digenis discloses a hard capsule made from a material such as gelatin, starch, or a hydrophilic polymer. The capsule of is formulated into a delivery system which incorporates pharmacologically active components in three or more distinct compartments. When three compartments are utilized in the capsule, the outer compartment incorporates a drug and excipients into a layer which coats the outer part of the capsule. This layer represents the rapid release portion of the delivery system. The intermediate compartment comprises a powder formulation comprised of a drug and excipients which represents the intermediary speed release portion of the delivery system. The innermost compartment incorporates the active ingredient or ingredients in a multiparticulate form, such as small pellets, and represents the slow release component of the delivery system (abstract).
The outer compartment incorporating a drug and excipients into a layer which coats the outer part of the capsule is interpreted as (a): a first soluble composition containing a quantity of at least a first payload substance.
The hard capsule shell is interpreted as (b): a second soluble composition containing a quantity of at least a second payload substance different from the first payload substance.
As noted above, the first soluble composition is implemented as a layer overlying and encapsulating the second soluble composition so that, when the dissolvable solid complex is immersed in the volume of water, the first soluble composition dissolves to release the first payload substance, thereby performing a first process on the water to generate a first interim solution and, on subsequent exposure of the second soluble composition, the second soluble composition dissolves to release the second payload substance, thereby performing a second process on the first interim solution, the first and second processes being at least part of the sequence of processes to generate the product composition (abstract).
Regarding claim 22, as noted above, the first soluble composition is coated on the second soluble composition. The claim appears to be a product by process limitation. Applicant’s attention is directed to MPEP 2113 which discloses "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 23, as noted above, the compartments comprise different particle size formulations (i.e. powder versus small pellets).
Regarding claim 24, as noted above, there can be three compartments.
Regarding claim 25, as noted above, the capsule can contain an outer compartment incorporated a drug and excipients into a layer which coats the outer part of the capsule.
Regarding claim 26, the drug is said outer fast rate releasing layer and said intermediate rate and slow rate releasing compartments can be an antimicrobial drug (claim 14).
Regarding claims 30-36, the instant claims recite product by process limitations and contingent limitations. The instant claims are drawn to a composition of matter and not a process of making or using. The instant claim does not provide any additional structural element to claim 21, from which the instant claim depends. Therefore, it would necessarily preform the cited process step. Applicants attention is directed to Applicant is directed to MPEP 2113 and MPEP 2111.04.
Regarding claim 37, the intermediate compartment comprises a disintegrant (column 6, lines 53-64; Example 8).
Digenis, therefore, anticipates the rejected claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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