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 .
This office action is in response to applicant’s communication of 2/20/2023. Currently claims 1-3, 5-6, 20-22, 35, 37-45, 49-54 are pending and rejected below.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-6, 20-22, 35, 37-45, 49-54 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Conrad (US 2015/0064241 A1).
Conrad discloses a swallowable drug delivery device (para [0006]) comprising: a capsule containing a drug and sized to move through at least a portion of a gastrointestinal tract of a patient (para [0005]); a tissue attachment member coupled to the capsule and having an initial state wherein the tissue attachment member allows the capsule to move through the at least a portion of the gastrointestinal tract and an activated state wherein the tissue attachment member is configured to at least selectively attach the capsule to a wall of the gastrointestinal tract (para [0071], [0089]); and the tissue attachment member being configured to change from the initial state to the activated state in response to an in vivo condition associated with the gastrointestinal tract at a predetermined location (para [0084]).
Concerning claim 2 and wherein at least a portion of the tissue attachment member moves away from a longitudinal axis of the capsule when the tissue attachment member changes from the initial state to the activated state (see figures 11a-11c).
Concerning claim 3 and wherein an outer dimension of the swallowable drug delivery device increases when the tissue attachment member changes from the initial state to the activated state. (again see figures 11a-11c).
Concerning claim 5 and at least a portion of the swallowable drug delivery device has a cross section perpendicular or non-parallel to a longitudinal axis of the capsule, wherein an area of the cross section of the swallowable drug delivery device increases when the tissue attachment member changes from the initial state to the activated state (again see figures 11a-11c).
Concerning claim 6 and wherein the tissue attachment member comprises one or more expandable members (see figures 14a-14c).
Concerning claim 20 and a coating applied to the tissue attachment member, wherein the coating degrades in response to exposure to the gastrointestinal tract to allow or cause the tissue attachment member to change from the initial state to the activated state (see para [0042], [0099]).
Concerning claim 21 and the in vivo condition causing the tissue attachment member to change from the initial state to the activated state comprises at least one of a predetermined temperature, pH, enzyme, and electrical conductivity associated with the gastrointestinal tract at the predetermined location (see para [0042], [0099]).
Concerning claim 22 and comprising an actuator disposed at least partially within the capsule (see element 62 for example).
Concerning claim 35 and comprising a tissue penetrating delivery member extending outwardly from the capsule and configured to deliver the drug from the capsule into the wall of the gastrointestinal tract (see para [0077]).
Concerning claim 37 and a swallowable drug delivery device comprising: a capsule (20) containing a drug (100) and sized to move through at least a portion of a gastrointestinal tract of a patient; an adhesive (see para [0100]) disposed on an exterior surface of the capsule and configured to at least selectively attach the capsule to a wall of the gastrointestinal tract; and a coating or shell (see para [0042], [0099]). covering at least a portion of the adhesive and configured to degrade to uncover the at least a portion of the adhesive in response to an in vivo condition associated with the gastrointestinal tract at a predetermined location (see figures 13a-13b).
Concerning claim 38 and the in vivo condition comprises at least one of a predetermined temperature, pH, enzyme, and electrical conductivity associated with the gastrointestinal tract at the predetermined location (see para [0042], [0099]).
Concerning claim 39 and comprising a tissue penetrating delivery member extending outwardly from the exterior surface of the capsule and having an interior passage in fluid communication or configured to be connected in fluid communication with the drug in the capsule (see figures 13a-13b).
Concerning claim 40 and the coating or shell initially covers an opening formed in the at least one tissue penetrating delivery member (see 36 for example).
Concerning claim 41 and the at least one tissue penetrating delivery member comprises one or more microneedles (see 40).
Concerning claim 42 and wherein the adhesive comprises a mucoadhesive (see para [0100] which examiner is of a position discloses that adhesives in the stomach tract would be mucoahesives).
Concerning claim 43 and comprising: a piston (120) moveably disposed within the capsule and dividing an interior of the capsule into a first chamber (figure 13a upper portion) and a second chamber (figure 13b lower portion), wherein the drug is disposed in the first chamber; an osmotic material (96) disposed in the second chamber; and a semipermeable membrane coupled to the capsule such that the osmotic material is between an interior surface of the semipermeable membrane and the piston, wherein the coating or shell initially covers an exterior surface of the semipermeable membrane (see operation of figure 13a-13b).
Concerning claim 44 and degradation of the coating or shell in response to the in vivo condition uncovers the exterior surface of the semipermeable membrane and allows at least one bodily fluid to diffuse through the semipermeable membrane into the second chamber, causing the piston to move the drug out of the first chamber for delivery to the gastrointestinal tract (see operation of figure 13a-13b).
Concerning claim 45 and a system comprising: a swallowable drug delivery device comprising: a capsule containing a drug and sized to move through at least a portion of a gastrointestinal tract of a patient; and a tissue penetrating delivery member having an interior passage in fluid communication or configured to be connected in fluid communication with the drug; and an ex vivo device positionable adjacent to an abdomen of the patient and configured to magnetically interact with the swallowable drug delivery device to position the swallowable drug delivery device against a wall of the gastrointestinal tract (see previously identified structures above as in claim 1 and further para [0050], [0115] discussing the use of magnetically interaction).
Concerning claim 46 and the ex vivo device (a) comprises an electromagnet, (b) is configured to wirelessly transmit power to swallowable drug delivery device, and/or (c) comprises an output device for notifying a user that the swallowable drug delivery device is proximate to the ex vivo device and further para [0050], [0115], and [0129] discussing the use of magnetically and wireless transmission and interaction).
Concerning claim 49 and the tissue penetrating delivery member being configured to move from an initial position to a delivery position wherein the tissue penetrating delivery member is outside of the capsule for penetrating into the wall of the gastrointestinal tract (see figure 13b for one example).
Concerning claim 50 and the ex vivo device being configured to transmit a signal to the swallowable drug delivery device causing the tissue penetrating delivery member to move from the initial position to the delivery position (See para [0050] discussing this).
Concerning claim 51 and the tissue penetrating delivery member comprises one or more microneedles (see element 40).
Concerning claim 52 and a swallowable drug delivery device (as in figure 13B) comprising: a capsule (20) sized to move through at least a portion of a gastrointestinal tract of a patient; and a projectile (40) containing a drug (100) and having an initial state (figure 13A) wherein the projectile is disposed at least partially within the capsule and an activated state (figure 13B) wherein the projectile moves in a direction away from the capsule for penetration into a wall of the gastrointestinal tract.
Concerning claim 53 and the projectile comprises a propellant for moving the projectile in the direction away from the capsule in the activated state (see 92/96).
Concerning claim 54 and the propellant undergoes a chemical reaction to generate a gas which propels the projectile in the direction away from the capsule in the activated state (see para [0095] discussing the gas in the balloon).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783