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
This office action is responsive to the claim amendments filed on 1/29/2026. As directed by the amendment: claims 1, 9-10, 22, and 34 have been amended; claims 23-33 and 35-40 have been cancelled; and no claims have been added. Thus, claims 1-22, and 34 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 1/28/2026 with regard to US 8562589 to Imran not teaching a capsule housing having an interior volume are considered persuasive. See amended rejection below.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 1-2, 9-22 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 8,562,589 B2 to Imran in view of WO 2014/159604 A1 to Imran et al. (herein after referenced as Imran-604).
In regard to claim 1:
A swallowable delivery device (Fig. 23a element 410) comprising: a capsule housing (Fig. 23a elements 420 and 420c); at least one tissue penetrating member (Fig. 23a elements 440) in a sealed compartment in the capsule housing (Col 31:3-30 “In these and related embodiments, at least a portion of the capsule surface including the portion containing the at least one aperture is desirably coated with a protective layer, such as an enteric coating which also degrades in response to pH or other conditions within the small intestine. Such coatings provide a protective seal over the at least one aperture so that digestive fluids do not enter the capsule interior and start to degrade the separation valve until the capsule has reached the small intestine.”), wherein the at least one tissue penetrating member is configured to release a payload (Col 36:40-41 “In various embodiments, penetrating members 440 can carry the same or a different drug 4101 or other therapeutic agent.”); and an actuator (Fig. 430 col 36:59-60 “balloon 430 or other expandable member 430 “), wherein the actuator is configured to advance the at least one tissue penetrating member out of the sealed compartment (col 36:14-20 “Also, platforms 486 can be placed on either side of balloon 430 to allow for bilateral deployment of tissue penetrating members 440 into intestinal wall IW as is shown in the embodiment of FIGS. 23a and 23b”).
Imran does not appear to explicitly disclose the capsule housing having an interior volume as claimed. Imran-604 teaches, a capsule housing (Fig. 12A element 20) having an interior volume (see annotated fig. 12A below); a sealed compartment arranged in the interior volume of the capsule housing (see annotated fig. 12A below); at least one tissue penetrating member arranged in the sealed compartment (Fig. 12A element 40); and an actuator arranged in the interior volume of the capsule housing and at least partially outside the sealed compartment (Fig. 12A elements 253 and 252, see annotated Fig. 12A below).
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Annotated Fig. 12A
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the swallowable delivery device taught by Imran to include the interior volume, and sealed compartment in the interior volume with at least one tissue penetrating member and actuator as taught by Imran-604. This would have been motivated by having redundancy for the outer housing to ensure delivery happened at the expected and desired treatment location. Having a secondary sealed compartment inside the housing would reduce risk of premature activation and contamination of the tissue penetrating member.
In regard to claim 2:
The delivery device of claim 1, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, wherein the sealed compartment comprises a first seal, and wherein the actuator is configured to advance the at least one tissue penetrating member through the first seal (Col 31:3-30 “In these and related embodiments, at least a portion of the capsule surface including the portion containing the at least one aperture is desirably coated with a protective layer, such as an enteric coating which also degrades in response to pH or other conditions within the small intestine. Such coatings provide a protective seal over the at least one aperture so that digestive fluids do not enter the capsule interior and start to degrade the separation valve until the capsule has reached the small intestine.” Actuator considered fully capable of advancing the at least one tissue penetrating member through the first seal due to col 36:14-20 “Also, platforms 486 can be placed on either side of balloon 430 to allow for bilateral deployment of tissue penetrating members 440 into intestinal wall IW as is shown in the embodiment of FIGS. 23a and 23b”).
In regard to claim 9:
The delivery device of claim 1, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, wherein the at least one tissue penetrating member comprises a plurality of tissue penetrating members (Fig. 23a element 440).
In regard to claim 10:
The delivery device of claim 9, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches the plurality of needles, see claim 9 rejection above.
Imran does not appear to explicitly disclose the plurality of tissue penetrating members are each in a respective sealed compartment arranged in the interior volume as claimed. Imran-604 teaches, wherein each of the plurality of tissue penetrating members is in a respective sealed compartment arranged in the interior volume of the capsule housing (Fig. 12A elements 40, see annotated Fig. 12A above under claim 1 rejection for sealed compartment. para. 110 specifically “(PCA) 250 for delivering one or more needles”, Fig. 12C elements 40 in respective sealed compartments 330).
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the plurality of needles taught by Imran to each be in a sealed compartment as taught by Imran-604. This would have been motivated by having redundancy for the outer housing to ensure delivery happened at the expected and desired treatment location. Having a secondary sealed compartment inside the housing would reduce risk of premature activation and contamination of the tissue penetrating member.
In regard to claim 11:
The delivery device of claim 9, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, comprising a plurality of driving members (Figs. 22a-23a elements 480 and 480a, col 35:65-col 36:5 “Support member 486 may correspond to a platform 486 having one surface 487 attached to the balloon surface 438 and the other surface 488 attached to the advancement member 480a (one or both of these attachments can be an adhesive attachment”), wherein each driving member is configured to advance a respective tissue penetrating member (Fig. 22.
In regard to claim 12:
The delivery device of claim 1, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, wherein the actuator comprises a driving member (Fig. 22a elements 480,480a) and an expandable device configured to actuate the driving member (Fig. 23a element 430, col 35:63-col 36:5 “In some embodiments, the advancement member 480a can be coupled to the balloon 430 via a support member 486 as is shown in the embodiments of FIGS. 22a and 22b. Support member 486 may correspond to a platform 486 having one surface 487 attached to the balloon surface 438 and the other surface 488 attached to the advancement member 480a”).
In regard to claim 13:
The delivery device of claim 12, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, further comprising a restraint (Fig. 23a element 450), wherein absence of the restraint activates the expandable device (Col 12:40-col 13:25 “A balloon or other expandable member is disposed within the capsule interior volume and coupled to the tissue penetrating member. The balloon will typically be attached to an interior wall of the capsule in a least a partially non-expanded state and can comprise various non-compliant polymers known in the art such as PET, polyethylene and polyimide. Desirably, the balloon will be thin walled e.g., less than about 0.001 inches. The balloon also will typically include at least a first and a second portion or compartment which are separated by be a separation valve or other separation means. A liquid, typically water, can be disposed within the first compartment and at least one reactant disposed in the second compartment which can be liquid though typically is solid. The reactants will typically include at least two reactants for example, an acid such as citric acid and a base such as sodium hydroxide, which can have about a 1:2 ratio. Other reactants including other acids, e.g., ascetic acid and bases are also contemplated. When the valve or other separation means opens, the reactants mix in the liquid and produce a gas such as carbon dioxide which expands the balloon and advances the tissue penetrating member into the intestinal wall as will be explained more fully herein. In addition to advancing the tissue penetrating members into tissue, the device can also be configured to have the inflated balloon break or otherwise separate apart the capsule into one or more pieces for easier passage through the intestinal tract. The separation valve can be configured to open in a number of ways and responsive to a number of conditions. Typically, the separation valve will be configured to open by having one or more portions degrade in response to the higher pH or other conditions found within the small intestine so that upon degradation, the valve opens. Also, typically, the separation valve will be placed in a central portion of the balloon, though other locations are also contemplated. In particular embodiments, the separation valve can have a beam like structure that is placed within the capsule to compress the portion of the balloon between the first and second compartments. The beam can be attached at one or both ends to the internal surface of the capsule. In preferred embodiments, the beam is attached to the radial sides of the capsule preferably, using an interference fit so that the beam can be snapped into place using pick and place and other like methods known in the manufacturing arts. When the beam degrades, the compressive forces are released. These and other embodiments of the valve can include one or more pinching features such as a ridge which engages a depression or other mating feature on the internal surface of the capsule to apply additional force on the balloon wall beneath the pinching feature and redundancy to the seal. In another embodiment, the separation valve can comprise a necked section of the expandable member with an overlying pinching collar made from biodegradable material. The collar holds the valve closed and releases the valve when degraded.”).
In regard to claim 14:
The delivery device of claim 13, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, wherein the restraint comprises a biodegradable material (Fig. 23a element 450, Col 12:66-Col 13:25 The separation valve can be configured to open in a number of ways and responsive to a number of conditions. Typically, the separation valve will be configured to open by having one or more portions degrade in response to the higher pH or other conditions found within the small intestine so that upon degradation, the valve opens. Also, typically, the separation valve will be placed in a central portion of the balloon, though other locations are also contemplated. In particular embodiments, the separation valve can have a beam like structure that is placed within the capsule to compress the portion of the balloon between the first and second compartments. The beam can be attached at one or both ends to the internal surface of the capsule. In preferred embodiments, the beam is attached to the radial sides of the capsule preferably, using an interference fit so that the beam can be snapped into place using pick and place and other like methods known in the manufacturing arts. When the beam degrades, the compressive forces are released. These and other embodiments of the valve can include one or more pinching features such as a ridge which engages a depression or other mating feature on the internal surface of the capsule to apply additional force on the balloon wall beneath the pinching feature and redundancy to the seal. In another embodiment, the separation valve can comprise a necked section of the expandable member with an overlying pinching collar made from biodegradable material. The collar holds the valve closed and releases the valve when degraded., and wherein degradation of the restraint is configured to activate the expandable device.)
In regard to claim 15:
The delivery device of claim 12, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, wherein the expandable device comprises a spring (Alternative embodiment, Col 3:45-56 “various embodiments, the actuating mechanism can comprise a preloaded spring mechanism which is configured to be released by the release element. Suitable springs can include both coil (including conical shaped springs) and leaf springs with other spring structures also contemplated. In particular embodiments, the spring can be cone shaped to reduce the length of the spring in the compressed state even to the point where the compressed length of the spring is about the thickness of several coils (e.g., two or three) or only one coil.”
Alternative embodiments considered usable together due to Col 46:15-25 “Elements, characteristics, or acts from one embodiment can be readily recombined or substituted with one or more elements, characteristics or acts from other embodiments to form numerous additional embodiments within the scope of the invention. Moreover, elements that are shown or described as being combined with other elements, can, in various embodiments, exist as standalone elements. Hence, the scope of the present invention is not limited to the specifics of the described embodiments, but is instead limited solely by the appended claims” (emphasis added).
In regard to claim 16:
The delivery device of claim 12, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, wherein the expandable device comprises an inflatable device (Figs. 23a-23b element 430)
In regard to claim 17:
The delivery device of claim 12, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, wherein the expandable device comprises one or more expandable arms (Alternative embodiment, Col 3:45-56 “various embodiments, the actuating mechanism can comprise a preloaded spring mechanism which is configured to be released by the release element. Suitable springs can include both coil (including conical shaped springs) and leaf springs with other spring structures also contemplated. In particular embodiments, the spring can be cone shaped to reduce the length of the spring in the compressed state even to the point where the compressed length of the spring is about the thickness of several coils (e.g., two or three) or only one coil.” Leaf spring considered to be one or more expandable arm as a leaf spring expands linearly under compression.)
Alternative embodiments considered usable together due to Col 46:15-25 “Elements, characteristics, or acts from one embodiment can be readily recombined or substituted with one or more elements, characteristics or acts from other embodiments to form numerous additional embodiments within the scope of the invention. Moreover, elements that are shown or described as being combined with other elements, can, in various embodiments, exist as standalone elements. Hence, the scope of the present invention is not limited to the specifics of the described embodiments, but is instead limited solely by the appended claims” (emphasis added).
In regard to claim 18:
The delivery device of claim 1, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, wherein the capsule housing comprises a biodegradable polymer (col 7:1-3 “The capsule includes an interior volume and can be fabricated from various biocompatible polymers known in the art including various biodegradable polymers.”)
In regard to claim 19:
The delivery device of claim 1, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, wherein the at least one tissue penetrating member comprises a biodegradable material surrounding a drug (col 2:51-56 “The tissue penetrating member can be fabricated from various biodegradable materials (e.g., PGLA) so as to degrade within the small intestine and thus provide a fail-safe mechanism for detaching the tissue penetrating member from the intestinal wall should this component become retained in the intestinal wall.”, col 14:20-25 “The tissue penetrating member in this aspect of the invention can be fabricated from various drugs and other therapeutic agents. Typically, the drug or other therapeutic agent will be mixed in with a biodegradable polymer such as PGLA.”).
In regard to claim 20:
The delivery device of claim 1, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, wherein the at least one tissue penetrating member comprises a drug formed into a penetrating member (col 14:20-25 “The tissue penetrating member in this aspect of the invention can be fabricated from various drugs and other therapeutic agents. Typically, the drug or other therapeutic agent will be mixed in with a biodegradable polymer such as PGLA.”).
In regard to claim 21:
The delivery device of claim 1, taught by Imran in view of Imran-604 as described above in parent claim rejection.
Imran teaches, wherein the at least one tissue penetrating member comprises a biodegradable material comprising a coating comprising a drug (col 14:20-62 “The tissue penetrating member in this aspect of the invention can be fabricated from various drugs and other therapeutic agents. Typically, the drug or other therapeutic agent will be mixed in with a biodegradable polymer such as PGLA. In such embodiments, the penetrating member may comprise a substantially heterogeneous mixture of drug and biodegradable polymer. Alternatively, the penetrating member may include a portion formed substantially from biodegradable and a separate section or compartment that is formed from or contains the drug. The penetrating member can be formed to have a shaft and a needle tip or other pointed distal tip so as to readily penetrate tissue of the intestinal wall” (emphasis added) considered a coating as it is a portion on the penetrating member that is formed from the drug).
In regard to claim 22:
A method of delivering a payload to tissue of a patient, the method comprising: administering a swallowable delivery device to the patient by swallowing, wherein the delivery device comprises a capsule housing (Col 16:15-20 “the invention provides a swallowable device for delivering drugs or other therapeutic agent into the wall of the small or large intestine comprising a capsule sized to be swallowed and pass through the intestinal tract”, Fig. 23a element 410), at least one tissue penetrating member (Fig. 23a elements 440) configured to release a payload (Col 36:40-41 “In various embodiments, penetrating members 440 can carry the same or a different drug 4101 or other therapeutic agent.”), and an actuator in the capsule housing (Fig. 23a element 430) and at least partially outside the sealed compartment (Col 36:40-41 “In various embodiments, penetrating members 440 can carry the same or a different drug 4101 or other therapeutic agent.” Considered partially outside the sealed compartment as element 430 contains its own internal compartment separate from the sealed compartment), wherein the actuator is configured to advance the at least one tissue penetrating member to release the payload (col 36:14-20 “Also, platforms 486 can be placed on either side of balloon 430 to allow for bilateral deployment of tissue penetrating members 440 into intestinal wall IW as is shown in the embodiment of FIGS. 23a and 23b”).
Imran does not appear to explicitly disclose the capsule housing having an interior volume as claimed. Imran-604 teaches, a capsule housing (Fig. 12A element 20) having an interior volume (see annotated fig. 12A below); a sealed compartment arranged in the interior volume of the capsule housing (see annotated fig. 12A below); at least one tissue penetrating member arranged in the sealed compartment (Fig. 12A element 40); and an actuator arranged in the interior volume of the capsule housing and at least partially outside the sealed compartment (Fig. 12A elements 253 and 252, see annotated Fig. 12A below), wherein the actuator is configured to advance the at least one tissue penetrating member out of the sealed compartment to release the payload (See annotated fig. 12A below, elements 253 and 252)
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Annotated Fig. 12A
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the swallowable delivery device taught by Imran to include the interior volume, and sealed compartment in the interior volume with at least one tissue penetrating member and actuator as taught by Imran-604. This would have been motivated by having redundancy for the outer housing to ensure delivery happened at the expected and desired treatment location. Having a secondary sealed compartment inside the housing would reduce risk of premature activation and contamination of the tissue penetrating member.
In regard to claim 34:
A method of delivering a payload to tissue of a patient, the method comprising: administering a swallowable delivery device to the patient by swallowing wherein the delivery device comprising a capsule housing (Col 16:15-20 “the invention provides a swallowable device for delivering drugs or other therapeutic agent into the wall of the small or large intestine comprising a capsule sized to be swallowed and pass through the intestinal tract”, Fig. 23a element 410), at least one tissue penetrating member (Fig. 23a elements 440) configured to release a payload (Col 36:40-41 “In various embodiments, penetrating members 440 can carry the same or a different drug 4101 or other therapeutic agent.”) and an actuator in the capsule housing (Fig. 23a element 430); allowing the capsule housing to degrade in the presence of an intestinal environmental condition (Col 31:3-30 “In these and related embodiments, at least a portion of the capsule surface including the portion containing the at least one aperture is desirably coated with a protective layer, such as an enteric coating which also degrades in response to pH or other conditions within the small intestine. Such coatings provide a protective seal over the at least one aperture so that digestive fluids do not enter the capsule interior and start to degrade the separation valve until the capsule has reached the small intestine.” Actuator considered fully capable of advancing the at least one tissue penetrating member through the first seal due to col 36:14-20 “Also, platforms 486 can be placed on either side of balloon 430 to allow for bilateral deployment of tissue penetrating members 440 into intestinal wall IW as is shown in the embodiment of FIGS. 23a and 23b”); and allowing the actuator to advance the at least one tissue penetrating member out of the housing after the capsule housing is degraded, thereby releasing the payload (Considered a functional limitation due to “allowing” actuator is considered fully capable of this limitation due to Col 12:40-col 13:25 “A balloon or other expandable member is disposed within the capsule interior volume and coupled to the tissue penetrating member. The balloon will typically be attached to an interior wall of the capsule in a least a partially non-expanded state and can comprise various non-compliant polymers known in the art such as PET, polyethylene and polyimide. Desirably, the balloon will be thin walled e.g., less than about 0.001 inches. The balloon also will typically include at least a first and a second portion or compartment which are separated by be a separation valve or other separation means. A liquid, typically water, can be disposed within the first compartment and at least one reactant disposed in the second compartment which can be liquid though typically is solid. The reactants will typically include at least two reactants for example, an acid such as citric acid and a base such as sodium hydroxide, which can have about a 1:2 ratio. Other reactants including other acids, e.g., ascetic acid and bases are also contemplated. When the valve or other separation means opens, the reactants mix in the liquid and produce a gas such as carbon dioxide which expands the balloon and advances the tissue penetrating member into the intestinal wall as will be explained more fully herein. In addition to advancing the tissue penetrating members into tissue, the device can also be configured to have the inflated balloon break or otherwise separate apart the capsule into one or more pieces for easier passage through the intestinal tract. The separation valve can be configured to open in a number of ways and responsive to a number of conditions. Typically, the separation valve will be configured to open by having one or more portions degrade in response to the higher pH or other conditions found within the small intestine so that upon degradation, the valve opens. Also, typically, the separation valve will be placed in a central portion of the balloon, though other locations are also contemplated. In particular embodiments, the separation valve can have a beam like structure that is placed within the capsule to compress the portion of the balloon between the first and second compartments. The beam can be attached at one or both ends to the internal surface of the capsule. In preferred embodiments, the beam is attached to the radial sides of the capsule preferably, using an interference fit so that the beam can be snapped into place using pick and place and other like methods known in the manufacturing arts. When the beam degrades, the compressive forces are released. These and other embodiments of the valve can include one or more pinching features such as a ridge which engages a depression or other mating feature on the internal surface of the capsule to apply additional force on the balloon wall beneath the pinching feature and redundancy to the seal. In another embodiment, the separation valve can comprise a necked section of the expandable member with an overlying pinching collar made from biodegradable material. The collar holds the valve closed and releases the valve when degraded.”.
Imran does not appear to explicitly disclose the capsule housing having an interior volume as claimed. Imran-604 teaches, a capsule housing (Fig. 12A element 20) having an interior volume (see annotated fig. 12A below); a sealed compartment arranged in the interior volume of the capsule housing (see annotated fig. 12A below); at least one tissue penetrating member arranged in the sealed compartment (Fig. 12A element 40); and an actuator arranged in the interior volume of the capsule housing and at least partially outside the sealed compartment (Fig. 12A elements 253 and 252, see annotated Fig. 12A below), allowing the actuator to advance the at least one tissue penetrating member out of the sealed compartment after the capsule housing is degraded, thereby releasing the payload (para. 110-114. Describes dissolution of the components that facilitate allowance of the actuator to advance the tissue penetrating member out of the sealed compartment after degradation of the capsule housing.)
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Annotated Fig. 12A
It would have been obvious to one having ordinary skill in the art, prior to the effective date of filing, to modify the swallowable delivery device taught by Imran to include the interior volume, and sealed compartment in the interior volume with at least one tissue penetrating member and actuator as taught by Imran-604. This would have been motivated by having redundancy for the outer housing to ensure delivery happened at the expected and desired treatment location. Having a secondary sealed compartment inside the housing would reduce risk of premature activation and contamination of the tissue penetrating member.
Claim(s) 3-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 8,562,589 B2 to Imran in view of WO 2014/159604 A1 to Imran et al. (herein after referenced as Imran-604), further in view of US 2020/02476545 A1 to Langer et al.
In regard to claim 3:
The delivery device of claim 2, taught by Imran in view of Imran-604 as described in parent claim rejection above.
Imran does not appear to explicitly disclose the second seal as claimed. Langer teaches, wherein the sealed compartment comprises a second seal (para. 57 “when the first spring component assumes the first configuration, the tissue penetrating end of the injection needle is embedded in the penetrable seal, and wherein, when the first spring component assumes the second configuration, the injection needle pierces the penetrable seal.”)
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the sealed compartment taught by Imran to have a second seal as taught by Langer. This would have been motivated by Imran Col 12:40-col 13:25 “A balloon or other expandable member is disposed within the capsule interior volume and coupled to the tissue penetrating member… … The collar holds the valve closed and releases the valve when degraded.”. This requires the fluid to enter the sealed compartment and start degrading element 450.This is therefore considered motivation to provide a second seal isolating the tissue penetrating member (Imran element 440) from the isolation valve (Imran element 450) so that the tissue penetration member does not degrade prior to penetration of the patient’s tissue.
In regard to claim 4:
The delivery device of claim 3, taught by Imran in view of Imran-604 as described in parent claim rejection above.
Imran does not appear to explicitly disclose driving member as claimed. Langer teaches, wherein the actuator (Fig. 6 elements 125) comprises a driving member (Fig. 6 element 130) configured to pierce the second seal (para. 57 “when the first spring component assumes the first configuration, the tissue penetrating end of the injection needle is embedded in the penetrable seal, and wherein, when the first spring component assumes the second configuration, the injection needle pierces the penetrable seal.”, injection needle considered to be the driving member)
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the sealed compartment taught by Imran to have a second seal and the actuator comprising a driving member configured to pierce the second seal as taught by Langer. This would have been motivated by Imran Col 12:40-col 13:25 “A balloon or other expandable member is disposed within the capsule interior volume and coupled to the tissue penetrating member… … The collar holds the valve closed and releases the valve when degraded.”. This requires the fluid to enter the sealed compartment and start degrading element 450.This is therefore considered motivation to provide a second seal isolating the tissue penetrating member (Imran element 440) from the isolation valve (Imran element 450) so that the tissue penetration member does not degrade prior to penetration of the patient’s tissue.
In regard to claim 5:
The delivery device of claim 3, taught by Imran in view of Imran-604 as described in parent claim rejection above.
Imran does not appear to explicitly disclose the second seal formed by an engineering fit between a sealing feature and at least one surface of the sealed compartment as claimed. Langer teaches, wherein second seal is formed by an engineering fit between a sealing feature and at least one surface of the sealed compartment (Para. 149 “In some embodiments, the end wall comprises a penetrable seal. In some embodiments, when the first spring component assumes the first configuration, the tissue penetrating end of the tissue interfacing component is embedded in the penetrable seal. In some embodiments, when the first spring component assumes the second configuration, the tissue interfacing component pierces the penetrable seal” (emphasis added). See annotated fig. 35 below. The sealing features considered to be sealing features as they form the sealed compartment with the penetrable seal of the end wall.).
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Langer Annotated Fig. 35
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the sealed compartment taught by Imran to have a second seal and the second seal is formed by an engineering fit between a sealing feature and at least one surface of the sealed compartment as taught by Langer. This would have been motivated by Imran Col 12:40-col 13:25 “A balloon or other expandable member is disposed within the capsule interior volume and coupled to the tissue penetrating member… … The collar holds the valve closed and releases the valve when degraded.”. This requires the fluid to enter the sealed compartment and start degrading element 450.This is therefore considered motivation to provide a second seal isolating the tissue penetrating member (Imran element 440) from the isolation valve (Imran element 450) so that the tissue penetration member does not degrade prior to penetration of the patient’s tissue.
In regard to claim 6:
The delivery device of claim 5, taught by Imran in view of Imran-604 as described in parent claim rejection above.
Imran does not appear to explicitly disclose the actuator comprising the sealing feature as claimed. Langer teaches, wherein the actuator comprises the sealing feature (See annotated fig. 35 below. The sealing features considered to be sealing features as they form the sealed compartment with the penetrable seal of the end wall.).
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It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the sealed compartment taught by Imran to have a second seal and the actuator comprises the sealing feature as taught by Langer. This would have been motivated by Imran Col 12:40-col 13:25 “A balloon or other expandable member is disposed within the capsule interior volume and coupled to the tissue penetrating member… … The collar holds the valve closed and releases the valve when degraded.”. This requires the fluid to enter the sealed compartment and start degrading element 450.This is therefore considered motivation to provide a second seal isolating the tissue penetrating member (Imran element 440) from the isolation valve (Imran element 450) so that the tissue penetration member does not degrade prior to penetration of the patient’s tissue.
In regard to claim 7:
The delivery device of claim 3, taught by Imran in view of Imran-604 as described in parent claim rejection above.
Imran does not appear to explicitly disclose the first or the second seals made of foil as claimed. Langer teaches, wherein at least one of the first seal and the second seal comprises foil (para. 132 “In some embodiments, the hole (e.g., hole 140 of FIG. 2) may comprise a fluidic gate (e.g., a plug, a coating, a barrier). In some cases, the fluidic gate may prevent a fluid (e.g., a fluid external to the system) from entering the system at the hole until a desired time. In certain embodiments, the fluidic gate comprises a barrier material. Non-limiting examples of suitable barrier materials include foils of polycaprolactone, thermoplastic elastomers, cellulose, and silicone. The barrier material may comprise one or more hydrophobic materials. In certain embodiments the barrier material may comprise one or more hydrophilic materials (e.g., sugar, PEG)” (emphasis added))
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the sealed compartment taught by Imran to have a second seal and the second seal comprises foil as taught by Langer. This would have been motivated by Imran Col 12:40-col 13:25 “A balloon or other expandable member is disposed within the capsule interior volume and coupled to the tissue penetrating member… … The collar holds the valve closed and releases the valve when degraded.”. This requires the fluid to enter the sealed compartment and start degrading element 450.This is therefore considered motivation to provide a second seal isolating the tissue penetrating member (Imran element 440) from the isolation valve (Imran element 450) so that the tissue penetration member does not degrade prior to penetration of the patient’s tissue. The choice of seal material is considered to be motivated by design choice as merely picking from a list of known seal materials (as taught by Langer para. 149) is considered to be within the level of ordinary skill in the art.
In regard to claim 8:
The delivery device of claim 3, taught by Imran in view of Imran-604 as described in parent claim rejection above.
Imran does not appear to explicitly disclose the first or the second seals made of biodegradable material as claimed. Langer teaches, wherein at least one of the first seal and the second seal comprises a biodegradable material (para. 132 “In some embodiments, the hole (e.g., hole 140 of FIG. 2) may comprise a fluidic gate (e.g., a plug, a coating, a barrier). In some cases, the fluidic gate may prevent a fluid (e.g., a fluid external to the system) from entering the system at the hole until a desired time. In certain embodiments, the fluidic gate comprises a barrier material. Non-limiting examples of suitable barrier materials include foils of polycaprolactone, thermoplastic elastomers, cellulose, and silicone. The barrier material may comprise one or more hydrophobic materials. In certain embodiments the barrier material may comprise one or more hydrophilic materials (e.g., sugar, PEG)” (emphasis added))
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the sealed compartment taught by Imran to have a second seal and the second seal comprises a biodegradable material as taught by Langer. This would have been motivated by Imran Col 12:40-col 13:25 “A balloon or other expandable member is disposed within the capsule interior volume and coupled to the tissue penetrating member… … The collar holds the valve closed and releases the valve when degraded.”. This requires the fluid to enter the sealed compartment and start degrading element 450.This is therefore considered motivation to provide a second seal isolating the tissue penetrating member (Imran element 440) from the isolation valve (Imran element 450) so that the tissue penetration member does not degrade prior to penetration of the patient’s tissue. The choice of seal material is considered to be motivated by design choice as merely picking from a list of known seal materials (as taught by Langer para. 149) is considered to be within the level of ordinary skill in the art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/M.A.I./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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