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 .
Response to Amendment
The amendment filed 07/30/2025 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 05/15/2025.
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) 1-5, 10, 15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederiksen (US 20230233821 A1), hereinafter Frederiksen, in view of Imran et al. (US 2023/0372237), hereinafter Imran.
Regarding claim 1, Frederiksen discloses an in vivo delivery device for attaching to tissue within the body of a patient (abstract), the in vivo delivery device comprising: a housing dimensioned as a capsule ([0011]: “a capsule housing sized”); at least one anchoring structure ([0019]: “spike members anchor the capsule device relative to tissue wall of the stomach.”) that includes: a micro-actuator ([0072]: “An actuator 150 coupled to an energy source (drive spring 140) is furthermore arranged within the capsule device 100 for generating movement of the API needle 130 and deployment of the spike assembly 180 relative to the capsule parts 110/120.”); a micro-needle extending from the micro-actuator ([0085]: “the API needle 130 is inserted into tissue of the lumen wall where it will anchor generally in a direction along the firing axis.”, Fig 1 element 130); a cap element configured to be in contact with the micro-needle ([0081]: a dissolvable pellet 160 is arranged between the two deflectable arms 152”), be dissolvable or meltable in contact with the tissue ([0081]: “the pellet 160 is arranged in a compartment inside the upper capsule part 110, and a proximally arranged upper opening in upper capsule part 110 facilitates fluid exposure to the dissolvable pellet when the capsule device is submerged in a fluid”, Fig 1 elements 160, 152) and positioned to keep the micro-actuator in a compressed state ([0081]: “. The pellet 160 is designed to become gradually dissolved so that after a predefined activation time, the pellet has been dissolved to a degree allowing the two deflectable arms 152 to become sufficiently deflected inwards enabling the blocking portions 153 of actuator 150 to be moved distally past the retainer portions 113.”); and a payload that is disposed outside of the at least one anchoring structure and configured to be repositionable outside of the at least one anchoring structure ([0071]: “The capsule device 100 accommodates a therapeutic payload 130 for carrying an agent for release internally of a subject user that ingests the article.”).
Frederiksen fails to disclose a plurality of micro-darts extending from the micro-needle.
Imran discloses an in vivo delivery device for attaching to tissue within the body of a patient ([0003]: "swallowable drug delivery devices for delivering drugs to the small intestine"), comprising a micro-needle extending from the micro-actuator ([0007]: "coupled to tissue penetrating members"); and a plurality of micro-darts extending from the micro-needle ([0074]: " a needle or dart-like structure (with or without barbs) configured to penetrate and be retained in the intestinal wall", Fig 18b elements 143, wherein the barbs 143 extend from the needle 140).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Frederiksen to include the micro-darts disclosed by Imran in order to improve retention of the device within the patient’s tissue (Imran [0111]).
Regarding claim 2, Frederiksen discloses the micro-actuator is a micro-spring ([0055]: " the energy source is or comprises at least one spring configured as a drive spring. Exemplary spring configurations include one or more compression springs, torsion springs, leaf springs or constant-force springs. The spring(s) may either be strained or configured for being strained for powering the actuator ").
Regarding claim 3, Frederiksen fails to disclose the micro-spring is a conical micro-spring.
Imran discloses the micro-spring is a conical micro-spring ([0078]: " (including conical shaped springs)").
As Frederiksen discloses the micro-spring may be a compression spring, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known spring disclosed by Frederiksen with the conical spring disclosed by Imran for the predictable result of driving actuation.
Regarding claim 4, Frederiksen further discloses wherein the at least one anchoring structure is contained, in the compressed state under the cap element, in a mold under the cap element (Fig 3a and 3b to Fig 3c and 3d, wherein the anchoring structure is kept compressed under the cap element and uncompressed after it dissolves).
Regarding claim 5, Frederiksen discloses the payload comprises a sensor ([0056]: "and delivering a monitoring or analysis device, e.g. by disposing or positioning a sensor device from the capsule device into the lumen or lumen wall.").
Regarding claim 10, Frederiksen discloses the payload is a therapeutic ([0057]).
Regarding claim 15, Frederiksen discloses wherein the patient is a human, and wherein the device is dimensioned to fit into the patient via the patient's gastrointestinal (GI) tract ([0010]: “a capsule device suitable for swallowing into a lumen of a gastrointestinal tract of a patient is provided, the lumen having a lumen wall”).
Regarding claim 20, Frederiksen a method for delivering a payload within a patient's body, comprising (abstract) comprising: providing an in vivo delivery device comprising: a housing dimensioned as a capsule ([0011]: “a capsule housing sized”); at least one anchoring structure ([0019]: “anchor the capsule device relative to tissue wall of the stomach.”) that includes: a micro-actuator ([0072]: “An actuator 150 coupled to an energy source (drive spring 140) is furthermore arranged within the capsule device 100 for generating movement of the API needle 130 and deployment of the spike assembly 180 relative to the capsule parts 110/120.”); a micro-needle extending from the micro-actuator ([0085]: “the API needle 130 is inserted into tissue of the lumen wall where it will anchor generally in a direction along the firing axis.”, Fig 1 element 130); a cap element configured to be dissolvable or meltable ([0081]: a dissolvable pellet 160 is arranged between the two deflectable arms 152”) in contact with the tissue ([0081]: “the pellet 160 is arranged in a compartment inside the upper capsule part 110, and a proximally arranged upper opening in upper capsule part 110 facilitates fluid exposure to the dissolvable pellet when the capsule device is submerged in a fluid”, Fig 1 elements 160, 152) and positioned to keep the micro-actuator in a compressed state ([0081]: “. The pellet 160 is designed to become gradually dissolved so that after a predefined activation time, the pellet has been dissolved to a degree allowing the two deflectable arms 152 to become sufficiently deflected inwards enabling the blocking portions 153 of actuator 150 to be moved distally past the retainer portions 113.”); and a payload that is disposed outside of the at least one anchoring structure and configured to be repositionable outside of the at least one anchoring structure ([0071]: “The capsule device 100 accommodates a therapeutic payload 130 for carrying an agent for release internally of a subject user that ingests the article.”); positioning the in vivo delivery device inside the body of the patient ([0010]: “a capsule device suitable for swallowing into a lumen of a gastrointestinal tract of a patient”); allowing the in vivo delivery device to passively self-anchor to an anatomy of interest of the patient ([0012]: “the tissue interfacing component configured to interact with the lumen wall at a target location” ); and monitoring the in vivo delivery device until removal from the patient's body ([0038]: “a monitoring device for obtaining medical data from the environment surrounding the capsule device.”).
Frederiksen fails to disclose a plurality of micro-darts extending from the micro-needle.
Imran discloses an in vivo delivery device for attaching to tissue within the body of a patient ([0003]: "swallowable drug delivery devices for delivering drugs to the small intestine"), comprising a micro-needle extending from the micro-actuator ([0007]: "coupled to tissue penetrating members"); and a plurality of micro-darts extending from the micro-needle ([0074]: " a needle or dart-like structure (with or without barbs) configured to penetrate and be retained in the intestinal wall", Fig 18b elements 143, wherein the barbs 143 extend from the needle 140).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Frederiksen to include the micro-darts disclosed by Imran in order to improve retention of the device within the patient’s tissue (Imran [0111]).
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederiksen in view of Imran in further view of of Ek et al. (US 20120123318 A1), hereinafter Ek.
Regarding claim 6, Frederiksen as modified by Imran discloses the device of claim 5, but fails to specify the payload comprises an electrode.
Ek discloses an implantable sensor (abstract) wherein the sensor comprises a plurality of electrodes ([0001]: “an array of microelectrodes and/or microelectrode bundles”).
As Frederiksen discloses the payload may be a sensor but fails to specify a type, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to specify the sensor disclosed by Frederiksen as modified by Imran to the plurality of electrodes as disclosed by Ek in order to allow for the detection of multiple biomarkers (Ek [0095]: “electrodes of an electrode bundle allows to record electrical signals from different neurons”).
Regarding claim 7, Frederiksen as modified by Imran and Ek discloses the device of claim 6. Frederiksen further discloses the micro-actuator is at least partially surrounded by said cap element (Fig 1, wherein element 150 in contact with elements 152 and 160), but fails to disclose the cap element includes polyethylene glycol (PEG).
Ek further discloses the a micro-actuator partially surrounded by polyethylene glycol (PEG) ([0050]: “micro-manipulator rod or similar is attached to the matrix or embedded in the matrix near or at the proximal end thereof”, [0069]: “Polymers which can be used for forming the matrix include… (PEG)”).
As Frederiksen discloses a variety of different materials that may comprise the cap ([0084]), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the material disclosed by Frederiksen to include PEG in order to ensure the cap fully dissolves (Ek [0069]: “that can be dissolved”).
Regarding claim 8, Frederiksen as modified by Imran and Ek discloses the device of claim 6. Ek further discloses the plurality of electrodes comprises: at least one electrode having a gold (Au) coating ([0040]: “The electrically conducting layer on a non-conducting core consists or comprises a metal of high electrical conductivity, such as silver, gold”); at least one electrode having a silver (Ag) coating ([0040]: “The electrically conducting layer on a non-conducting core consists or comprises a metal of high electrical conductivity, such as silver, gold”); at least one other electrode ([0040]: “suitable metal alloy, e.g. platinum-iridium”); wherein the electrodes are disposed, under said cap element, in a mold (as modified by Frederiksen, wherein the payload is stored under the cap element, Fig 1 element 160 in a mold, the chamber in which element 130 is stored), and wherein the electrodes are configured to detect changes in the concentration of a biomarker ([0085]: “combine electrodes and microdialysis or electrodes and voltammetry to measure released bioactive molecules in the tissue as a consequence of electrical stimulation or natural tissue activity. i.e. neurotransmitters such as small molecule neurotransmitters (for example acetylcholine, dopamine, serotonin,”).
Regarding claim 9, Frederiksen as modified by Imran and Ek discloses the device of claim 8. Ek further discloses the electrodes are configured to detect changes in a concentration of serotonin ([0085]: “small molecule neurotransmitters (for example acetylcholine, dopamine, serotonin,”).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederiksen in view of Imran in further view of Lee et al. (US 20220211987 A1).
Regarding claim 11, Frederiksen as modified by Imran further discloses the device of claim 10, but fails to disclose the payload is a drug disk.
Lee discloses an implantable device (title) wherein the payload is a drug disk (Fig 8b element 808, [0068]: “Drug tablets are provided within the lumen of cylindrical tube 804, with the drug tablets 809 adjacent to the disks 806 having a smaller diameter than tablets 808.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the payload disclosed by Frederiksen as modified by Imran to the drug disk as disclosed by Lee in order to allow for controlled release of a therapeutic over a period of time (Lee [0003]).
Regarding claim 12, Frederiksen furth discloses the drug disk (as modified above) is positioned to separate the micro-needle from the micro-actuator. ([0040]: “the actuator may be coupled with the therapeutic payload to provide the force to introduce the therapeutic payload from the capsule device into the lumen wall”)
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederiksen in view of Imran in view of Ek in further view of Moller et al. (US 3973555 A), hereinafter Moller.
Regarding claim 13, Frederiksen as modified by Imran and Ek discloses the device of claim 6, and Ek further discloses a foot structure supporting the electrode tip (Fig 20 element 1808), and an electrical member electrically connecting the outer surface with a base of the electrode. while not electrically connecting the outer surface to the foot structure. (Fig 20 element 1804), and an outer metal coated surface ([0164]: “extendable electrode body 82 of copper 87 covered by a thin coat 88 of gold”)
EK fails to disclose an electrode of the plurality of electrodes includes a conical tip.
Moller discloses an plurality of electrodes (title) wherein an electrode of the plurality of electrodes includes a conical tip ([0037]: “Each of the electrode member 3 may have a conical or substantially conical shape tapering toward the tip end 31 entirely, and each of the electrode members 3 is required to have a shape having the tip end 31 and projecting from the support member 2.”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the electrode tip disclosed by Frederiksen as modified by Imran and Ek to include the conical shape disclosed by Moller in order to allow for insertion of the electrodes into tissue (Moller col 2 lines 36-40)
Regarding claim 14, Ek further discloses wherein the electrical member is configured to not electrically connect the outer surface to the foot structure ([0167]: “The wires 1804 running in the lead 1806 are electrically connected with a microprocessor control unit (not shown). A short rear end portion of the electrode bodies 1809 extends from the respective electrode matrices 1801, 1802, 1803.”, wherein the wires only connect to the microprocessor).
Claim(s) 16 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederiksen in view of Cannehan et al. (US 20120172820 A1), hereinafter Cannehan.
Regarding claim 16, Frederiksen discloses an anchor for an in vivo medical device deliverable within a patient's body, the anchor comprising (abstract): a micro-spring ([0072]: “An actuator 150 coupled to an energy source (drive spring 140) is furthermore arranged within the capsule device 100 for generating movement of the API needle 130 and deployment of the spike assembly 180 relative to the capsule parts 110/120.”); a micro-needle (Fig 1 element 130), wherein the at least one micro-needle is connected to a distal end of the micro- spring (Fig 1 element 130 to elements 150 and 140); and a dissolvable cap formed to cover both the micro-spring and micro- needle from the same side and positioned such that the micro-spring is releasably held in a compressed position by the dissolvable cap ([0081]: “.The pellet 160 is designed to become gradually dissolved so that after a predefined activation time, the pellet has been dissolved to a degree allowing the two deflectable arms 152 to become sufficiently deflected inwards enabling the blocking portions 153 of actuator 150 to be moved distally past the retainer portions 113.”).
Frederiksen fails to disclose the micro-needle includes a conical tip that (i) contains multiple inlets of corresponding capillary channels to said conical tip, (ii) is supported by a foot structure, and (iii) includes a doubly-reentrant overhang at a circumference of a bottom of the conical tip to enable self-localization of fluid thereat.
Cannehan discloses a micro-needle (title) including a conical tip that ([0036]: “a conical part located at the distal end 35 of the micro-needle 4”) (i) contains multiple inlets of corresponding capillary channels to said conical tip (Fig 3 elements 7 and 8), (ii) is supported by a foot structure (Fig 3 element 32) , and (iii) includes a doubly-reentrant overhang at a circumference of a bottom of the conical tip to enable self-localization of fluid thereat (Fig 3 elements 33 and 34).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the micro-needle disclosed by Frederiksen to the micro-needle disclosed by Cannehan in order to allow for the delivery of multiple fluids (Cannehan [0017]).
Regarding claim 18, Frederiksen further discloses the micro-spring is connected to and forms a single, unitary, integral part with a single micro-needle ([101]: “the actuator and the API needle may be formed as a unitary component”).
Regarding claim 19, Frederiksen discloses a payload ([0040]: “payload”) wherein the payload is connected to the micro-spring (Frederiksen, ([0040]: “the actuator may be coupled with the therapeutic payload).
Cannehan discloses wherein the at least one micro-needle comprises a plurality of micro-needles (Fig 5), wherein the payload is connected to at least three micro-needles [0018]: “and a small channel for the drug delivery”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to further modify the micro-needle disclosed by Frederiksen as modified by Cannehan to the multiple micro-needle disclosed by Cannehan in order to allow for the delivery of multiple fluids (Cannehan [0017]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederiksen in view of Cannehan in further view of Imran.
Regarding claim 17, Frederiksen as modified by Cannehan discloses the device of claim 16, but fails to disclose wherein the at least one micro-needle includes a stack structure containing first and second cones stacked upon o e another and a capillary channel in an outer surface of the stack structure configured to wick a liquid through said capillary channel.
Imran discloses a swallowable drug delivery device (title) wherein wherein the at least one micro-needle includes a stack structure containing first and second cones stacked upon one another (Figure 18 d, wherein element 143 forms the edges of the cones stacked on one another) and a capillary channel in an outer surface of the stack structure configured to wick a liquid through said capillary channel (Fig 18d element 101, [0013]: “e tissue penetrating member lumen”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the micro-needle disclosed by Frederiksen to the micro-needle disclosed by Imran in order to improve retention of the needle in tissue (Imran [0111]).
Response to Arguments
Applicant’s arguments, see remarks filed 07/30/2025 with respect to the rejection of claims 1-3, 5, 10-11, 15-16, and 20 under 35 USC 102 and claim 4, 6-9, 12-14, and 17-20 under 35 USC 103 have been considered but are moot because the new ground of rejection does not rely on any matter specifically challenged in the argument (see rejection above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Langer et al. (US 20200246545 A1) – discloses a similar swallowable drug delivery device
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KAVYA SHOBANA BALAJI/ Examiner, Art Unit 3791
/DANIEL L CERIONI/ Primary Examiner, Art Unit 3791
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