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 with traverse of Group I, claims 1, 2, 8-18, 21, 26, 28, 29, 41 in the reply filed on 1/22/26 is acknowledged. The traversal is on the ground(s) that Claim 37 is amended to be a method of making the device of claim 1 and Applicant states that on p. 2 of the Restriction Requirement there is a statement that claims are considered to have unity of invention if directed to a product and a process of manufacture. This is not found persuasive because the paragraph cited by Applicant has been misinterpreted. If the ONLY two categories of invention were the product and the process for manufacturing then Applicant’s remarks would be persuasive. However, in this case there were four statutory groups such that two products, a method of manufacture and a method of using were being claimed. Thus, the set of claims do not fall under the rule 37 CFR 1.475 (b) which states that “the claims are drawn only to one of the following combinations: a product, a process specially adapted for manufacture of said product. Because claim 31 and 41 were also part of the claims as a whole when the Restriction Requirement was made, the claims were not only drawn to one product and one method of manufacture but rather two different products and one method of manufacture and one method of using and therefore does not fall under 37 CFR 1.475 (b).
The requirement is still deemed proper and is therefore made FINAL.
Claim 31 and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/26/25.
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.
Claim 29 and all dependents thereof 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 29 recites the limitation "the second component", “the third component”, the fourth component” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 8 introduces a second component and that claim 16 introduces the third and fourth component. However the chain of dependency of claim 29 does not depend on these claims.
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.
Claim(s) 1-2, 8-18, 21, 26, 28, 29, 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2018/0116911 A1) in view of Bellinger et al. (WO 2015/191920 A1).
With regard to claim 1, Li discloses A drug dosage form comprising a first component (Fig. 1b, element 101 and 102) and a swellable component (104), wherein the first component and the swellable component are connected (see Fig. 1a and 1b), wherein at least one of the first component and the swellable component comprises a drug (drug is contained within chamber 103 which is formed by the components 101 and 102), wherein the swellable component, or a portion thereof, swells upon exposure to gastrointestinal fluid ([0082], [0005], body fluid can be used to swell the releaser 104 to open the compartment between the first and second piece of the first component), and wherein the swelling of the swellable component, or the portion thereof, increases the dimension of the drug dosage form (the release liner 104 expands in order to break open the first component and therefore is considered to increase the dimension of the drug dosage form), thereby allowing the drug to be retained in the stomach (this is a functional limitation and the drug dosage form would be capable of being used in the stomach).
However, Li does not explicitly teach retaining the drug in the stomach for at least about 24 hours.
Bellinger teaches a drug dosage form (Fig. 1b and 1c) having a first component (110) and a swellable component (120)(p. 24, lines 1-11, the elastic polymer component 120 swells when placed in gastric fluids) and is further designed to be administered orally and retained n the patient for at least abou 24 hours (abstract, p. 3, lines 19-24).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Li to last at least 24 hours within the stomach as taught by Bellinger for the purpose of improving adherence rates in patients that need to self-administer a medication but may forget to do so when symptoms are not actively present (p.1, lines 18-25). Further, the current state of the art requires move invasive techniques to navigate the gastric tract, thus the need for an oral solution, which has the potential for the widest patient acceptance is needed (p.1, line 26 to p. 2 line 26).
With regard to claim 2, Li discloses wherein the swellable component comprises an exterior lid (Fig. 1a, element 104) and a swelling agent (inherent because 104 is a hydrogel designed to swell), and wherein the exterior lid is connected to the swelling agent (they are one component where the agent is within element 104), and wherein the exterior lid is configured such that it forms at least a part of an exterior surface (see Fig. 1a showing 104 being part of the bottom exterior surface) of the drug dosage form.
With regard to claim 8, Li discloses further comprising a second component (drug dosage form can be made stacked as shown in Fig. 2a, thus having a first component 210 and a swellable component 214 and a second component 200 formed by 220 with a swellable component 224), wherein the first component and the second component are connected, at least in part, via the swellable component (224 connects the first and second component as shown in Fig. 2a).
With regard to claim 9, Li discloses wherein the swelling of the swellable component shifts the relative positions of the first component and the second component, thereby increasing the dimension of the drug dosage form (see Fig. 3a showing the first swellable component after swelling and Fig. 3b showing the second swellable component after swelling).
With regard to claim 10, Li discloses wherein the first component has a first axis from a first proximal end to a first distal end (see Fig. below), wherein the second component has a second axis from a second proximal end to a second distal end (see Fig. below), and wherein the swellable component has a central axis (see Fig below), wherein upon swelling of the swellable component, the first axis and the second axis are shifted relative to each other (see Fig. 3a and 3b showing after swelling the first and second component have not “burst” open and are not aligned on the first and second axis).
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With regard to claim 11, Li discloses wherein the first axis and the second axis are aligned with each other without swelling of the swellable component (see annotated Fig above), and rotate relative to each other upon swelling of the swellable component (see Fig. 3a and 3b).
With regard to claim 12, Li discloses wherein the first axis and the second axis become perpendicular to each other upon swelling of the swellable component (see Fig. 3a and 3b, the first component of Fig .3a flares outwardly and the first axis becomes perpendicular to the second axis of the second component that has not broken yet).
With regard to claim 13, Li discloses wherein at least a portion of the first component is configured to interface with the second component such that it creates a point of rotation (see annotated Fig below).
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With regard to claim 14, Li discloses wherein the first axis and the second axis are aligned with each other (see annotated Fig associated with claim 10), and are shifted away from the central axis upon swelling of the swellable component (see Fig. 3a where the first component shifts away and swivels outward from the first and second axis).
With regard to claim 15, Li discloses wherein the drug dosage form further comprises a first guiding track (see annotated drawing of Fig. 13 showing the point of rotation which can be considered a guiding track as it “guides” and retains the piece of the first component to the second component. Further definition of the guiding track or its function is needed to overcome the current interpretation of the art) and a second guiding track (the second component breaks open similarly to the first component and is shown doing so in Fig. 3b, thus the point of rotation for the second component were it attaches to the top square cap is considered the guiding track. This is a similar interpretation taken for the first guiding track), wherein the upon swelling of the swellable component the first component shifts along with the first guiding track away from the central axis (the first component swings outwardly along the first guiding track), and wherein the second component shifts along with the second guiding track away from the central axis (as shown in fig. 3b).
With regard to claim 16, Li discloses wherein the drug dosage form except for a third and fourth component.
Bellinger teaches a first and second component (Fig. 1c, there are at least 2 element 120’s shown in the drawings) however more than 2 such as third or fourth component can be added as well (p. 20, lines 14-26). Thus more than two components can be added to the device of Li in a similar way that the second component was added to the first component. Further the addition of a third and fourth component and track could be considered a mere duplication of parts.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Li with a third and fourth component as taught by Bellinger for the purpose of delivering additiona/other agents the body (p. 20, lines 14-26).
With regard to claim 17, Li discloses wherein the first component comprises the drug (in the compartment 212).
With regard to claim 18, Li discloses further comprising a second drug, where the second drug is the same or different than the drug (in compartment 222).
With regard to claim 21, Li discloses wherein the swellable component comprises a core drug (in the compartment 212 that is sealed by the swellable material).
With regard to claim 26, Li discloses wherein any one of the drug or the second drug is in a compartment embedded in a substrate material (compartment 212 and 222).
With regard to claim 28, Li discloses wherein the compartment comprises a plug (212 and 222 can be considered a plug as it is a rounded plug shaped compartment containing the drug).
With regard to claim 29, Li discloses wherein the first component (210), the second component (220), the third component, and/or the fourth component (see rejection of claim 16) comprises more than one drug-filled compartment (each of the components contain a separate drug filled compartment, ex. 212 and 222, thus forming more than one drug filled compartment).
With regard to claim 41, Li discloses A method of delivering a drug in an individual and allowing the drug to be retained in the stomach of the individual for an extended time, the method comprising orally administering to the individual a drug dosage form of claim 1 ([0003], [0045]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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