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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30 April 2026 has been entered.
Formal Matters
Applicant’s claim amendments and arguments in the reply filed on 22 June 2026 are acknowledged and have been fully considered due to the entered request for continued examination. Claims 1-4, 7-11, and 15 are pending. Claims 1-4, 7-8, 10-11, and 15 are under consideration in the instant office action. Claim 9 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 5-6 and 12-14 are canceled. Applicant’s claim amendments and arguments necessitated a new ground of rejections under 35 USC 103 as set forth below.
Moot Arguments
Applicant’s arguments with respect to claim(s) 1-4, 7-8, 10-11, and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
Objection to the Specification
Applicant Amended the specification on paragraphs 0019, 0024, and 0052 and in the abstract changing the phrase “filled with” to “formed of”. The amendment filed on 22 June 2026 to the specification is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. As originally presented (prior to the amendment), the specification on paragraphs 0019, 0024, 0052 described the removable cap and the tab as being “filled with soft gelatin.” The phrase “filled with” has a well-understood ordinary meaning in the pharmaceutical packaging and soft gelatin capsule art: it denotes a hollow or partially hollow structure whose interior volume contains soft gelatin (i.e., the part itself functions as a container that has been filled). By contrast, the newly introduced phrase “formed of soft gelatin” denotes that the structural material of the cap and the tab is soft gelatin itself (i.e., the parts are fabricated from, consist of, or are constituted by soft gelatin). These two phrases are not synonyms. “Filled with” describes a relationship of containment; “formed of” describes material composition of the structure. The amendment therefore, changes the nature of what is being claimed for both the removable cap and the opposite-side tab. A review of the specification as originally filed (including the abstract, detailed description, any drawings, and original claims) reveals no disclosure that the removable cap or the tab is “formed of” soft gelatin in the sense now claimed. The original disclosure uses language consistent with the parts being filled with soft gelatin or otherwise containing soft gelatin. Applicant’s assertion that the change merely corrects a “translational error” from the original French does not cure the deficiency. Under 35 USC 112 and MPEP 263.06-2163.07, the written description requirement is evaluated against the disclosure as filled in the US application (or against a properly translated priority document that itself provides the necessary support). A post filling assertion of translation error without contemporaneous evidence in the originally filed papers showing that the original French text conveyed “formed of” is insufficient to introduce new language in the specification that alters the meaning of the invention. Applicant is required to cancel the new matter or amend the specification to language that finds clear support in the application as originally filed. Any reliance on the alleged French original must be accompanied by a certified translation of the relevant portion of the priority document together with a showing that the original French text in fact supports the broader or different meaning now added in the specification. Where a U.S. application as originally filed was in a non-English language and an English translation thereof was subsequently submitted pursuant to 37 CFR 1.52(d), if there is an error in the English translation, applicant may rely on the disclosure of the originally filed non-English language U.S. application to support correction of an error in the English translation document MPEP 2163.07 (II). Applicant is required to cancel the new matter in the reply to this Office Action.
New Rejections-Necessitated by Amendment
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 1-4, 7-8, 10-11, and 15 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. Claim 1 recites “A device for the delivery of a liquid formulation comprising a pharmaceutical or food, the device comprising: a soft gelatin reservoir; a removable cap formed of soft gelatin hermetically closing the reservoir; a weakening line serving as a connection between the removable cap and the reservoir; and a tab arranged on an opposite side of the reservoir relative to the removable cap, the tab being formed of soft gelatin, wherein the tab has a cross-section less than or equal to a cross-section of the reservoir.” As originally presented (prior to the amendment), the claim language described the removable cap and the tab as being “filled with soft gelatin.” The phrase “filled with” has a well-understood ordinary meaning in the pharmaceutical packaging and soft gelatin capsule art: it denotes a hollow or partially hollow structure whose interior volume contains soft gelatin (i.e., the part itself functions as a container that has been filled). By contrast, the newly introduced phrase “formed of soft gelatin” denotes that the structural material of the cap and the tab is soft gelatin itself (i.e., the parts are fabricated from, consist of, or are constituted by soft gelatin). These two phrases are not synonyms. “Filled with” describes a relationship of containment; “formed of” describes material composition of the structure. The amendment therefore, changes the nature of what is being claimed for both the removable cap and the opposite-side tab. A review of the specification as originally filed (including the abstract, detailed description, any drawings, and original claims) reveals no disclosure that the removable cap or the tab is “formed of” soft gelatin in the sense now claimed. The original disclosure uses language consistent with the parts being filled with soft gelatin or otherwise containing soft gelatin. Applicant’s assertion that the change merely corrects a “translational error” from the original French does not cure the deficiency. Under 35 USC 112 and MPEP 263.06-2163.07, the written description requirement is evaluated against the disclosure as filled in the US application (or against a properly translated priority document that itself provides the necessary support). A post filling assertion of translation error without contemporaneous evidence in the originally filed papers showing that the original French text conveyed “formed of” is insufficient to introduce new claim language that alters the meaning of the invention. Applicant is required to cancel the new matter or amend the claim to language that finds clear support in the application as originally filed. Any reliance on the alleged French original must be accompanied by a certified translation of the relevant portion of the priority document together with a showing that the original French text in fact supports the broader or different meaning now claimed. Where a U.S. application as originally filed was in a non-English language and an English translation thereof was subsequently submitted pursuant to 37 CFR 1.52(d), if there is an error in the English translation, applicant may rely on the disclosure of the originally filed non-English language U.S. application to support correction of an error in the English translation document MPEP 2163.07 (II).
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.
Claim 2 is 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.
The terms “substantially cylindrical” and ‘substantially conical” in claim 2 are a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. A person of ordinary skill in the art would not be reasonably certain of the scope of the claim because it is unclear how much variation from a pure cylindrical shape or pure conical shape is permitted by the term “substantially”.
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.
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.
Claims 1-4 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Schurig (US Patent No. 5,380,534, newly cited) in view of Scherer (US 2,134,489, newly cited).
Applicants’ claims
Applicants claim a device for the delivery of liquid formulation.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
Schurig teaches soft gelatin capsules for delivery of liquid medicaments (pharmaceutical preparations) by opening and squeezing (abstract, column 1, lines 10-25). The same structure is usable for food/nutraceutical liquids. Motivation to use for either is identical (unit-dose, hermitic, portable liquid delivery). Schurig teaches a hollow soft gelatin shell 12/bulb portion that encapsulates (reservoirs) the liquid medicament (column 2, lines 55-65; column 3, lines 1-10; and Figures 1-4). Soft gelatin construction is conventional and hermitically /sealed during rotary-die manufacture. Schurig teaches a removable tab14 integrally formed of the same soft gelatin material with the shell to seal the capsule; the tab is removed by twisting or tearing (column 2, lines 55-65; column 3, lines 5-15). The continuous gelatin wall provides the hermitic closure. Schurig teaches twisting/tearing off the integrally formed tab at the neck. Schurig provides a soft gelatin tab and further teaches gripping features on the shell/bulb and/or tab to improve handling, especially when hands or the capsule are wet/oily (column 1, lines 25-45 and Figures 1-5).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Schurig does not specifically teach the head/cap geometry and a weakening line serving as a connection between the removable cap and the reservoir. These deficiencies are cured by the teachings of Scherer.
Scherer teaches a hollow head/enlargement of gelatin that closes the capsule until severed. Scherer teaches a gelatin capsule having a projecting tubular spout portion closed normally at its outer end, said capsule being filled with content material dispensible through said spout when the same is open, said spout portion terminating in its outer end in a hollow protuberance communicating with the main portion through a weakened tubular portion of restricted diameter as compared with the remainder of the spout (see claim 1). A capsule formed of material adapted to permit collapsing of the capsule, said capsule wall having a portion projecting therefrom in the form of a nipple communicating with the interior of the capsule and terminating at its outer end in a hollow head communicating with the remainder of the nipple through a weakened neck of a restricted diameter as compared with the said head, said capsule carrying content material dispensible through said nipple and neck portion (see claim 2).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill before the effective filing date of the instant invention to modify the teachings of Schurig by including the head/cap geometry and a weakening line serving as a connection between the removable cap and the reservoir because Scherer teaches a hollow head/enlargement of gelatin that closes the capsule until severed. Scherer teaches a gelatin capsule having a projecting tubular spout portion closed normally at its outer end, said capsule being filled with content material dispensible through said spout when the same is open, said spout portion terminating in its outer end in a hollow protuberance communicating with the main portion through a weakened tubular portion of restricted diameter as compared with the remainder of the spout (see claim 1). A capsule formed of material adapted to permit collapsing of the capsule, said capsule wall having a portion projecting therefrom in the form of a nipple communicating with the interior of the capsule and terminating at its outer end in a hollow head communicating with the remainder of the nipple through a weakened neck of a restricted diameter as compared with the said head, said capsule carrying content material dispensible through said nipple and neck portion (see claim 2). It should be noticed that both Schurig and Scherer are directed to the identical problem soft gelatin unit dose containers for liquid pharmaceuticals that must be opened by the user (twisting/tearing a portion) and then squeezed to dispense. Schurig improves grip and handling of such capsules; Scherer improves the severability of the opening portion via a weakened neck. Combining the references requires only routine skill of use of soft gelatin hollow reservoir and integral removable portion of Schurig; form the connection as a weakening line/restricted neck as taught by Scherer for clean severance, and ; place a soft gelatin gripping tab of limited cross-section on the opposite end to enhance the gripping already emphasized by Schurig. The results are predictable. The claim merely recites the expected combination of known elements performing their known functions. One of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Schurig and Scherer because both references are drawn to soft gelatin capsules for the delivery of liquid formulations.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 7-8 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schurig (US Patent No. 5,380,534, newly cited) in view of Scherer (US 2,134,489, newly cited) as applied to claims 1-4 and 10-11 above, and further in view of Salazar et al. (US Patent No. 8,739,698, previously cited) and Shelley (US Patent No. 5,505,961, newly cited).
Applicant Claims
Applicants claim a device for the delivery of liquid formulation. Instant claim 7 recite that the tab bears variable information.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Schurig and Scherer are described in detail above and are incorporated herein by reference.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.012)
Schurig and Scherer do not specifically teach that the tab bears variable information and the list of liquid formulations recited in claims 8 and 15. These deficiencies are cured by the teachings of Salazar et al. and Shelley respectively.
Salazar et al. teach a method and apparatus for printing on the surface of soft gelatin capsules during filling. In particular, the invention relates to an apparatus and method for printing a pre-determined figure or symbol on the surface of a soft gelatin capsule while a product is being encapsulated, including means for transporting the gelatin ribbon, inking means and means for shaping the soft capsule, including an injection, molding and die-cutting station and additional printing means (see abstract). The present invention relates to printing on the surface of soft gelatin capsules during filling. In particular, the invention relates to an apparatus and method for printing a pre-determined figure or symbol on the surface of a soft gelatin capsule while the product is being encapsulated, including means for transporting the gelatin ribbon; inking means; and means for shaping the soft capsule, including an injection, casting, and die-cutting station, and additional printing means. The present invention meets these needs and provides for some other related advantages (column 1, lines 11-20).
Shelley teaches a soft gelatin capsule for subsequent oral administration having a soft gelatin shell encapsulating a fill, the fill consisting essentially of a pharmaceutically acceptable highly concentrated solution of acetaminophen comprising from about 20% to about 40% by weight acetaminophen, from about 18% to about 65% polyethylene glycol by weight, said polyethylene glycol having an average molecular weight of between about 200 and about 800, from about 0% to about 15% propylene glycol by weight, from about 0% to about 15% water by weight, from about 0% to about 15% polyvinylpyrrolidone by weight and from about 0.6% to about 25% of an alkali metal acetate by weight, the alkali metal acetate being present in an amount sufficient to increase the maximum solubility of the acetaminophen in the solution, the alkali metal acetate being selected from the group consisting of sodium acetate and potassium acetate (see claim 1)
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of Schurig and Scherer by including variable information on the tab because Salazar et al. teach a method and apparatus for printing on the surface of soft gelatin capsules during filling. In particular, the invention relates to an apparatus and method for printing a pre-determined figure or symbol on the surface of a soft gelatin capsule while a product is being encapsulated, including means for transporting the gelatin ribbon, inking means and means for shaping the soft capsule, including an injection, molding and die-cutting station and additional printing means (see abstract). One of ordinary skill in the art would have been motivated to do so because Salazar et al. teach that the present invention relates to printing on the surface of soft gelatin capsules during filling. In particular, the invention relates to an apparatus and method for printing a pre-determined figure or symbol on the surface of a soft gelatin capsule while the product is being encapsulated, including means for transporting the gelatin ribbon; inking means; and means for shaping the soft capsule, including an injection, casting, and die-cutting station, and additional printing means. The present invention meets these needs and provides for some other related advantages (column 1, lines 11-20). The printed matter on the capsule help patients understand on doses and other compliance information. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of Schurig and Scherer by delivering liquid formulation containing such as acetaminophen in soft gel capsule because Shelley teaches a soft gelatin capsule for subsequent oral administration having a soft gelatin shell encapsulating a fill, the fill consisting essentially of a pharmaceutically acceptable highly concentrated solution of acetaminophen comprising from about 20% to about 40% by weight acetaminophen, from about 18% to about 65% polyethylene glycol by weight, said polyethylene glycol having an average molecular weight of between about 200 and about 800, from about 0% to about 15% propylene glycol by weight, from about 0% to about 15% water by weight, from about 0% to about 15% polyvinylpyrrolidone by weight and from about 0.6% to about 25% of an alkali metal acetate by weight, the alkali metal acetate being present in an amount sufficient to increase the maximum solubility of the acetaminophen in the solution, the alkali metal acetate being selected from the group consisting of sodium acetate and potassium acetate (see claim 1). It should be noticed that the soft gelatin capsule of Schurig and Scherer are used for the delivery of liquid formulations containing medicaments. The skilled artisan would have had a reasonable expectation of success in combining the teachings of Schurig, Scherer, Salazar et al., and Shelley because all of the references are drawn devices for the delivery of liquids.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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