DETAILED ACTION
Claims 1, 6, 7, 11, 14, 19, 22, and 24 are currently amended.
Claims 21 and 26 are cancelled.
Claims 1-20, 22-25, and 27 are examined in this office 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 .
Claim Rejections - 35 USC § 103
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 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) 1-4, 7-16, 19-20, 22-25, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mojarrad et al. (WO 2022/055779 A1).
Regarding claim 1, Mojarrad discloses an ingestible device (drug delivery device 100, Fig. 1A) comprising:
a body (capsule 102, Fig. 1A);
at least one limb (tissue attachment member 106, Fig. 1B) configured to deploy from a first configuration (Fig. 1A) to a second configuration (Fig. 1B) after exposure to a predetermined condition within a gastrointestinal tract of a subject ("The tissue attachment member 106 may be configured to change from the initial state to the activated state in response to an in vivo condition associated with the gastrointestinal tract at the predetermined location." - Para [0055], Figs. 1A-1B), wherein in the first configuration the at least one limb is wrapped around at least a portion of an outer surface of the body ("… an initial state (Fig. 1A) wherein the tissue attachment member 106 allows the capsule 102 to pass freely through at least a portion of the gastrointestinal tract …" - Para [0054]), and wherein in the second configuration the at least one limb extends outward from the body ("… an activated state (Fig. 1B) wherein the tissue attachment member 106 temporarily or permanently attaches the capsule 102 to the inner wall 118 of the gastrointestinal tract …" - Para [0054]); and
an active portion (wall of tissue attachment member 116, Fig. 1A) of the ingestible device disposed on an exterior portion of the body and/or the at least one limb ("… the tissue attachment member 106 may have one or more openings which are configured to deliver the drug into a lumen …" - Para [0053]), wherein the at least one limb is configured to orient the body such that the active portion contacts an adjacent tissue surface when the at least one limb is in the second configuration, and wherein the active portion is configured to interact with the adjacent tissue surface ("… an activated state (Fig. 1B) wherein the tissue attachment member 106 temporarily or permanently attaches the capsule 102 to the inner wall 118 of the gastrointestinal tract …" - Para [0054]).
The embodiment depicted in Figs. 1A and 1B of Mojarrad does not expressly disclose that the active portion contacts an adjacent tissue surface below the body relative to a direction of gravity.
The embodiment depicted in Figs. 7A-7C of Mojarrad teach that the active portion (penetrating delivery member 708, Fig. 7B) contacts an adjacent tissue surface (wall 118, Fig. 7B) below the body relative to a direction of gravity ("In the activated state, a pointed end of the tissue penetrating delivery member 708 may extend outwardly from the inflatable bladder 740b and may be oriented in a direction perpendicular or substantially perpendicular to the longitudinal axis A of the capsule 702." - Para [0090]).
Examiner interprets that the position of the active portion (708) as depicted in Fig. 7B is oriented substantially perpendicular to the longitudinal axis A in a direction that is above the body in relation to gravity. However, as cited above, the orientation may be in any direction that is substantially perpendicular to the longitudinal axis, which is inclusive of a position that is below the body in relation to gravity.
The embodiment of Figs. 1A-1B can be modified by the positioning of the active portion at any point substantially perpendicular to the longitudinal axis A (which includes a point that is below the body relative to a direction of gravity) as taught by the embodiment depicted in Figs. 7A-7C. For example, the wall 116 can extend in a substantially perpendicular position that is above the body as shown in Fig. 1B or it could be in a substantially perpendicular position that is below the body.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the embodiment depicted in Figs. 1A-1B of Mojarrad to include that the active portion contacts an adjacent tissue surface below the body relative to a direction of gravity as taught by the embodiment depicted in Figs. 7A-7C of Mojarrad so the inflatable bladders in the active state may extend entirely across a lumen of the gastrointestinal tract at the predetermined location for attachment and drug delivery (Mojarrad, Para [0090]).
Regarding claim 2, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
the body (capsule 102, Fig. 1A) is an elongated body ("… the capsule 102 may have , at least initially, an elongated shape …" - Para [0045]).
Regarding claim 3, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
the at least one limb (tissue attachment member 106, Fig. 1B) is configured to deploy radially outwards from the first configuration (Fig. 1A) to the second configuration (Fig. 1B) in a direction that is angled to a longitudinal axis of the body (See annotated Fig. 1B).
PNG
media_image1.png
316
532
media_image1.png
Greyscale
Regarding claim 4, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
the at least one limb (tissue attachment member 106, Fig. 1B) is at least partially formed from at least one of a shape-memory material, a carbohydrate, a hydrating starch, a lipid, cellulose, a protein, gelatin, and a polymer bilayer ("… the tissue attachment member 106 may be made of a shape memory material such as … a shape memory polymer …" - Para [0055]).
Examiner interprets a shape memory polymer to be inclusive of a polymer bilayer.
Regarding claim 7, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein the at least one limb includes a first limb (inflatable bladder 640a, Fig. 6A) and a second limb (inflatable bladder 640b, Fig. 6A), and wherein the first limb is offset from the second limb in a direction parallel to a longitudinal axis of the body ("The inflatable bladders 640a, 640b, and 640c may be arranged at distinct axial positions along the longitudinal axis A of the capsule 602 …" - Para [0084], Fig. 6B).
Regarding claim 8, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein the at least one limb (expandable member 330, Fig. 3B) is configured to roll the body across the adjacent tissue surface ("… the second end of the expandable member 330 in the activated state may come into contact with a side of the inner wall 118 of the gastrointestinal tract and push the capsule 302 towards an opposite side of the inner wall 118 of the gastrointestinal tract …" - Para [0075]) as the at least one limb deploys from the first configuration to the second configuration ("… as a consequence of expansion of the expandable member 330, pointed ends of the tissue penetrating delivery member 308 may be inserted into the wall 118 of the gastrointestinal tract." - Para [0075], Fig. 3B).
Examiner interprets the first configuration of the penetrating delivery members 308 to be shown in Fig. 3B and the second configuration to be when the penetrating delivery members 308 are inserted into the wall of the target tissue.
Regarding claim 9, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
the active portion (tissue attachment member 106, Fig. 1A) comprises at least one selected from the group of a coating of an active pharmaceutical ingredient disposed on an exterior surface of the body, a jet outlet, an injection needle outlet, a sensor, one or more electrodes, one or more microneedle patches, an adhesive ("… the tissue attachment member 106 may be an adhesive …" - Para [0058]), a mechanical fastener, and one or more biopsy tools.
Regarding claim 10, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
the active portion includes at least one sensor integrated with the at least one limb, and wherein the at least one sensor is configured to sense one or more parameters of the adjacent tissue surface ("… electronic sensors … may be incorporated into the swallowable drug delivery device 100 for detecting the in vivo condition." - Para [0056]).
Examiner interprets a sensor incorporated in the drug delivery device as inclusive of the sensor being integrated with a limb, which is a part of the drug delivery device.
Regarding claim 11, Mojarrad discloses an ingestible device (drug delivery device 100, Fig. 1A) comprising:
a body (capsule 102, Fig. 1A);
a reservoir (reservoir 104, Fig. 1A) configured to contain an active pharmaceutical ingredient ("… a reservoir 104 filled with a drug …" - Para [0044]);
an outlet disposed on an exterior portion of the body (tissue penetrating delivery member 108, Fig. 1A); and
at least one limb (tissue attachment member 106, Fig. 1B) configured to deploy from a first configuration (Fig. 1A) to a second configuration (Fig. 1B) after exposure to a predetermined condition within a gastrointestinal tract of a subject ("The tissue attachment member 106 may be configured to change from the initial state to the activated state in response to an in vivo condition associated with the gastrointestinal tract at the predetermined location." - Para [0055], Figs. 1A-1B), wherein in the first configuration the at least one limb is wrapped around at least a portion of an outer surface of the body ("… an initial state (Fig. 1A) wherein the tissue attachment member 106 allows the capsule 102 to pass freely through at least a portion of the gastrointestinal tract …" - Para [0054], Fig. 1A), and wherein in the second configuration the at least one limb extends outward from the body ("… an activated state (Fig. 1B) wherein the tissue attachment member 106 temporarily or permanently attaches the capsule 102 to the inner wall 118 of the gastrointestinal tract …" - Para [0054]), wherein the at least one limb is configured to orient the body such that the outlet is oriented towards an adjacent tissue surface when the at least one limb is in the second configuration ("The tissue penetrating delivery member 108 may be coupled to the wall 114 of the capsule 102 with the first end of the tissue penetrating delivery member 108 extending outwardly from the wall 114 of the capsule 102, as illustrated in Figs. 1 A and 1 B." - Para [0051]), and wherein the outlet and the reservoir are configured to apply the active pharmaceutical ingredient to the adjacent tissue surface ("The tissue penetrating delivery member 108 may be configured to deliver the drug from the reservoir 104 into an inner wall 118 of the gastrointestinal tract …" - Para 0048).
The embodiment depicted in Figs. 1A and 1B do not expressly disclose that the outlet is oriented towards an adjacent tissue surface below the body relative to a direction of gravity.
The embodiment depicted in Figs. 7A-7C of Mojarrad teach that the outlet (penetrating delivery member 708, Fig. 7B) it oriented towards an adjacent tissue surface (wall 118, Fig. 7B) below the body relative to a direction of gravity ("In the activated state, a pointed end of the tissue penetrating delivery member 708 may extend outwardly from the inflatable bladder 740b and may be oriented in a direction perpendicular or substantially perpendicular to the longitudinal axis A of the capsule 702." - Para [0090]).
Examiner interprets that the position of the outlet (708) as depicted in Fig. 7B is oriented substantially perpendicular to the longitudinal axis A in a direction that is above the body in relation to gravity. However as cited above, the orientation may be in any direction that is substantially perpendicular to the longitudinal axis, which is inclusive of a position that is below the body in relation to gravity.
The embodiment of Figs. 1A-1B can be modified by positioning the outlet at any point substantially perpendicular to the longitudinal axis A (which includes a point that is below the body relative to a direction of gravity) as taught by the embodiment depicted in Figs. 7A-7C. For example, the wall 116 can extend in a substantially perpendicular position that is above the body as shown in Fig. 1B or it could be in a substantially perpendicular position that is below the body.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the embodiment depicted in Figs. 1A-1B of Mojarrad to include that the outlet is oriented towards an adjacent tissue surface below the body relative to a direction of gravity as taught by the embodiment depicted in Figs. 7A-7C of Mojarrad so the inflatable bladders in the active state may extend entirely across a lumen of the gastrointestinal tract at the predetermined location for attachment and drug delivery (Mojarrad, Para [0090]).
Regarding claim 12, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
in the second configuration (Fig. 1B), the outlet is in contact with the adjacent tissue surface ("… a delivery position where the first end of the tissue penetrating delivery member 108 … for insertion into the inner wall 118 of the gastrointestinal tract." - Para [0052]).
Regarding claim 13, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
the body (capsule 102, Fig. 1A) is an elongated body ("… the capsule 102 may have , at least initially, an elongated shape …" - Para [0045]).
Regarding claim 14, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
the ingestible device includes a second portion (See annotated Fig. 1B) disposed on the exterior portion of the body (See annotated Fig. 1B) remotely from the outlet (tissue penetrating delivery member 108, Fig. 1A), wherein, in the second configuration (Fig. 1B), the at least one limb (tissue attachment member 106, Fig. 1B) is configured to cooperate with the adjacent tissue surface underlying the body ("… an activated state (Fig. 1B) wherein the tissue attachment member 106 temporarily or permanently attaches the capsule 102 to the inner wall 118 of the gastrointestinal tract …" - Para [0054]) to provide spacing between the second portion and the adjacent tissue surface (See annotated Fig. 1B), thereby tilting the body to orient the outlet towards the adjacent tissue surface (See annotated Fig. 1B).
PNG
media_image2.png
340
530
media_image2.png
Greyscale
Regarding claim 15, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
the at least one limb (tissue attachment member 102, Fig. 1B) is configured to deploy radially outwards from the first configuration (Fig, 1A) to the second configuration (Fig. 1B) in a direction that is angled to a longitudinal axis of the body (See annotated Fig. 1B above).
Regarding claim 16, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
the at least one limb (tissue attachment member 106, Fig. 1B) is at least partially formed from at least one of a shape-memory material, a carbohydrate, a hydrating starch, a lipid, cellulose, a protein, gelatin, and a polymer bilayer ("… the tissue attachment member 106 may be made of a shape memory material such as … a shape memory polymer …" - Para [0055]).
Examiner interprets a shape memory polymer to be inclusive of a polymer bilayer.
Regarding claim 19, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
the at least one limb includes a first limb (inflatable bladder 640a, Fig. 6A) and a second limb (inflatable bladder 640b, Fig. 6A), and wherein the first limb is offset from the second limb in a direction parallel to a longitudinal axis of the body ("The inflatable bladders 640a, 640b, and 640c may be arranged at distinct axial positions along the longitudinal axis A of the capsule 602 …" - Para [0084], Fig. 6B).
Regarding claim 20, Mojarrad discloses the ingestible device (drug delivery device 100, Fig. 1A) as recited above, wherein
the at least one limb (expandable member 330, Fig. 3B) is configured to roll the body across the adjacent tissue surface ("… the second end of the expandable member 330 in the activated state may come into contact with a side of the inner wall 118 of the gastrointestinal tract and push the capsule 302 towards an opposite side of the inner wall 118 of the gastrointestinal tract …" - Para [0075]) as the at least one limb deploys from the first configuration to the second configuration ("… as a consequence of expansion of the expandable member 330, pointed ends of the tissue penetrating delivery member 308 may be inserted into the wall 118 of the gastrointestinal tract." - Para [0075], Fig. 3B).
Examiner interprets the first configuration of the penetrating delivery members 308 to be shown in Fig. 3B and the second configuration to be when the penetrating delivery members 308 are inserted into the wall of the target tissue.
Regarding claim 22, Mojarrad discloses a method (“… methods for use related to a drug delivery device …” – Para [0127]) of orienting an ingestible device (drug delivery device 100, Fig. 1A), the method comprising:
exposing the ingestible device to a predetermined condition within a gastrointestinal tract of a subject ("… exposure to a … in vivo condition." - Para [0073]);
deploying at least one limb (tissue attachment member 106, Fig. 1B) attached to a body of the ingestible device (capsule 102, Fig. 1A) such that the at least one limb transitions from a first configuration (Fig. 1A) to a second configuration (Fig. 1B) after exposure to the predetermined condition ("The tissue attachment member 106 may be configured to change from the initial state to the activated state in response to an in vivo condition associated with the gastrointestinal tract at the predetermined location." - Para [0055], Figs. 1A-1B), wherein in the first configuration the at least one limb is wrapped around at least a portion of the body ("… an initial state (Fig. 1A) wherein the tissue attachment member 106 allows the capsule 102 to pass freely through at least a portion of the gastrointestinal tract …" - Para [0054], Fig. 1A) and wherein in the second configuration the at least one limb extends outward from the body ("… an activated state (Fig. 1B) wherein the tissue attachment member 106 temporarily or permanently attaches the capsule 102 to the inner wall 118 of the gastrointestinal tract …" - Para [0054]) such that an active portion of the ingestible device (tissue attachment member 106, Fig. 1B) is approximated next to or comes into contact with an adjacent tissue surface; and
interacting with the adjacent tissue surface with the active portion of the ingestible device during and/or after deployment of the at least one limb ("… an activated state (Fig. 1B) wherein the tissue attachment member 106 temporarily or permanently attaches the capsule 102 to the inner wall 118 of the gastrointestinal tract …" - Para [0054]).
The embodiment depicted in Figs. 1A and 1B of Mojarrad does not expressly disclose that the active portion is approximated next to or comes into contact with an adjacent tissue surface below the body relative to a direction of gravity.
The embodiment depicted in Figs. 7A-7C of Mojarrad teach that the active portion (penetrating delivery member 708, Fig. 7B) is approximated next to or comes into contact with an adjacent tissue surface (wall 118, Fig. 7B) below the body relative to a direction of gravity ("In the activated state, a pointed end of the tissue penetrating delivery member 708 may extend outwardly from the inflatable bladder 740b and may be oriented in a direction perpendicular or substantially perpendicular to the longitudinal axis A of the capsule 702." - Para [0090]).
Examiner interprets that the position of the active portion (708) as depicted in Fig. 7B is oriented substantially perpendicular to the longitudinal axis A in a direction that is above the body in relation to gravity. However as cited above, the orientation may be in any direction that is substantially perpendicular to the longitudinal axis, which is inclusive of a position that is below the body in relation to gravity.
The embodiment of Figs. 1A-1B can be modified by positioning the active portion at any point substantially perpendicular to the longitudinal axis A (which includes a point that is below the body relative to a direction of gravity) as taught by the embodiment depicted in Figs. 7A-7C. For example, the wall 116 can extend in a substantially perpendicular position that is above the body as shown in Fig. 1B or it could be in a substantially perpendicular position that is below the body.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the embodiment depicted in Figs. 1A-1B of Mojarrad to include that the active portion is approximated next to or comes into contact with an adjacent tissue surface below the body relative to a direction of gravity as taught by the embodiment depicted in Figs. 7A-7C of Mojarrad so the inflatable bladders in the active state may extend entirely across a lumen of the gastrointestinal tract at the predetermined location for attachment and drug delivery (Mojarrad, Para [0090]).
Regarding claim 23, Mojarrad discloses the method (“… methods for use related to a drug delivery device …” – Para [0127]) as recited above, further comprising
rolling the body across the adjacent tissue surface ("… the second end of the expandable member 330 in the activated state may come into contact with a side of the inner wall 118 of the gastrointestinal tract and push the capsule 302 towards an opposite side of the inner wall 118 of the gastrointestinal tract …" - Para [0075]) as the at last one limb is deployed ("… as a consequence of expansion of the expandable member 330, pointed ends of the tissue penetrating delivery member 308 may be inserted into the wall 118 of the gastrointestinal tract." - Para [0075], Fig. 3B).
Examiner interprets the first configuration of the penetrating delivery members 308 to be shown in Fig. 3B and the second configuration to be when the penetrating delivery members 308 are inserted into the wall of the target tissue.
Regarding claim 24, Mojarrad discloses the method (“… methods for use related to a drug delivery device …” – Para [0127]) as recited above, wherein
deploying the at least one limb (tissue attachment member 106, Fig. 1B) includes extending the at least one limb in a direction (Fig. 1B) at least partially perpendicular to a longitudinal axis of the body (See annotated Fig. 1B above).
Examiner interprets the tilt angle shown in annotated Fig. 1B above to be partially perpendicular.
Regarding claim 25, Mojarrad discloses the method (“… methods for use related to a drug delivery device …” – Para [0127]) as recited above, wherein
deploying the at least one limb (expandable member 330, Fig. 3B) includes deploying a first limb (expandable member 330, Fig. 3B) and subsequently deploying a second limb (tissue penetrating delivery member 308, Fig. 3B) ("… as a consequence of expansion of the expandable member 330, pointed ends of the tissue penetrating delivery member 308 may be inserted into the wall 118 of the gastrointestinal tract." - Para [0075], Fig. 3B).
Examiner interprets the first configuration of the penetrating delivery members 308 to be shown in Fig. 3B and the second configuration to be when the penetrating delivery members 308 are inserted into the wall of the target tissue.
Regarding claim 27, Mojarrad discloses the method (“… methods for use related to a drug delivery device …” – Para [0127]) as recited above, further comprising
applying an active pharmaceutical ingredient ("The term drug … can be used to refer to pharmaceuticals …" - Para [0127]) to the adjacent tissue surface ("…deliver the drug into a lumen of the gastrointestinal tract …" - Para [0053]).
Claim(s) 5-6 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mojarrad et al. (WO 2022/055779 A1) in view of Menachem et al. (US Patent No. 11,547,839 B2).
Regarding claim 5, Mojarrad in view of Menachem discloses the ingestible device (Mojarrad, drug delivery device 100, Fig. 1A) as recited above, wherein
Mojarrad does not expressly disclose that the at least one limb includes a first limb and a second limb, and wherein at least a portion of the first limb overlaps at least a portion of the second limb in the first configuration.
Menachem teaches that the at least one limb includes a first limb (arm 1003, Fig. 1A) and a second limb (arm 1002, Fig. 1A), and wherein at least a portion of the first limb overlaps at least a portion of the second limb in the first configuration ("… the arms are able to overlay one another for example to form a nested arrangement in the compressed configuration as illustrated in FIG. 4C." – Col. 29, Lines 37-40).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the ingestible device of Mojarrad to include that the at least one limb includes a first limb and a second limb, and wherein at least a portion of the first limb overlaps at least a portion of the second limb in the first configuration as taught by Menachem to form a nested arrangement (Menachem, Col. 26, Line 39).
Regarding claim 6, Mojarrad in view of Menachem discloses the ingestible device (Mojarrad, drug delivery device 100, Fig. 1A) as recited above,
wherein the first limb and the second limb are configured to deploy sequentially (Mojarrad, "… as a consequence of expansion of the expandable member 330, pointed ends of the tissue penetrating delivery member 308 may be inserted into the wall 118 of the gastrointestinal tract." - Para [0075], Fig. 3B).
Regarding claim 17, Mojarrad in view of Menachem discloses the ingestible device (Mojarrad, drug delivery device 100, Fig. 1A) as recited above, wherein
Mojarrad does not expressly disclose that the at least one limb includes a first limb and a second limb, and wherein at least a portion of the first limb overlaps at least a portion of the second limb in the first configuration.
Menachem teaches that the at least one limb includes a first limb (arm 1003, Fig. 1A) and a second limb (arm 1002, Fig. 1A), and wherein at least a portion of the first limb overlaps at least a portion of the second limb in the first configuration ("… the arms are able to overlay one another for example to form a nested arrangement in the compressed configuration as illustrated in FIG. 4C." - Col. 29, Lines 37-40).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the ingestible device of Mojarrad to include that the at least one limb includes a first limb and a second limb, and wherein at least a portion of the first limb overlaps at least a portion of the second limb in the first configuration as taught by Menachem to form a nested arrangement (Menachem, Col. 26, Line 39).
Regarding claim 18, Mojarrad in view of Menachem discloses the ingestible device (Mojarrad, drug delivery device 100, Fig. 1A) as recited above, wherein
the at least one limb includes a first limb (Mojarrad, expandable member 330, Fig. 3B) and a second limb (Mojarrad, tissue penetrating delivery member 308, Fig. 3B), and wherein the first limb and the second limb are configured to deploy sequentially (Mojarrad, "… as a consequence of expansion of the expandable member 330, pointed ends of the tissue penetrating delivery member 308 may be inserted into the wall 118 of the gastrointestinal tract." - Para [0075], Fig. 3B).
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 8/27/2026, with respect to the rejection(s) of claim(s) 1-20, 22-25, and 27 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a different interpretation of Mojarrad.
Examiner interprets that the combination of multiple embodiments of Mojarrad teach the claimed limitation that “the active portion contacts an adjacent tissue surface below the body relative to a direction of gravity” of claim 1 as recited above. Independent claims 11 and 22 and all claims that depend from the independent claims are rejected under a similar rationale as claim 1.
With respect to applicant’s argument the rejection above teaches the claimed limitation. The rejection above is maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
