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 Amendments
This office action is responsive to amendments filed June 17, 2026.
Claims 46 and 54 have been amended.
Claims 16-24, 30-32, 46-47, 54, and 56-59 remain pending for examination.
Response to Arguments
Applicant's arguments filed June 17, 2026 have been fully considered but they are not persuasive.
Regarding claim 16, Applicant argues that the Office Action mischaracterizes the references with respect to radiation sensors “on the plurality of arms” and that there is no motivation to combine Langer (US Publication No. 2019/0209090), hereinafter, Langer, and Kimchy (US Patent No. 8,036,731), hereinafter, Kimchy. These arguments are not persuasive.
Applicant’s argument that the Office Action relies on a nonexistent ‘Figure 18’ in Langer based on a misunderstanding; Langer’s resident structure and arms are shown in figs. 1B-1C and 2H, which were correctly cited in the prior Office Action.
Langer discloses the claimed article structure, including a central core, tissue-engaging surface, and plurality of arms connected to the core (e.g., figs. 1B, 1C, 2H; paras. [0023], [0063], [0066], [0068], [0171], claim 10).
Kimchy teaches radiation sensors configured to detect ionizing radiation (col. 13, lines 41-45; see also col. 29, lines 4-12 regarding gamma and beta radiation).
It would have been obvious to one of ordinary skill in the art to incorporate the radiation sensors of Kimchy onto the arms of Langer’s gastric-resident structure. Langer’s arms provide stable contact with the gastric wall, making them a logical location for sensors to monitor local radiation exposure in the stomach. While Langer already contemplates sensors on the core for various parameters (e.g., pH, biochemical, gas, etc. in para [0061]), the combination of Kimchy’s radiation sensors added to the arms of Langer is a natural diagnostic/therapeutic expansion in a gastric platform and is a predictable improvement that yields the claimed closed-loop sensing and drug release functionality. The fact that Kimchy’s exemplary disclosure involves tumor imaging does not negate the sensor teachings or the motivation to adapt them to a long-residence platform for radiation threat monitoring.
The claims require a device configured to perform the recited functions (e.g., radiation detection). Prior art teaches the necessary structure and capability satisfies the limitation, regardless of the reference’s primary intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s arguments in Section (i) primarily contend that Langer fails to disclose the claimed radiation sensor on the arms of the gastric-resident article and that Kimchy does not cure this alleged deficiency. As explained above, Langer discloses a gastric-resident article including a core, arms, tissue-engaging surfaces, and optional sensors, while Kimchy teaches ingestible radiation detectors; the rejection is based on the combination of these references, not on either reference alone. The Office has articulated a rational reason to combine these teachings, and Applicant’s arguments that the additional references “do not cure” the alleged deficiency merely repeat the improper individual attack on the references in a combination rejection. See MPEP 2145.
Applicant’s Section (ii) arguments rely on the amendments to claims 46 and 54 to enumerate specific toxic and nerve agents and assert that the prior art does not disclose these particular agents. As explained in the rejection above, Langer provides the gastric-resident article with a core, arms, tissue-engaging surface, and drug-releasing electronics; Gazdzinski (US Publication No. 2001/0051766), hereinafter, Gazdzinski, provides GI chemical sensor arrays on tissue-contacting structures; and Harmon (US Patent No. 6,821,738), hereinafter, Harmon, teaches sensors configured to detect nerve agents including V-series agents such as VX. Under MPEP §2114, these claims are directed to an apparatus and the recitation that the sensor is “configured to detect” particular agents does not introduce new structure; the prior art combination is structurally capable of detecting at least one of the listed agents and therefore meets the amended limitations.
Applicant further argues that Harmon is unsuitable for combination with Langer and Gazdzinski because Harmon’s apparatus depends on a light source for detection that would allegedly not be available in vivo. Harmon, however, merely specifies that the sensor uses a light source emitting in the 400-800nm range (see col. 5, lines 8-10), which is a standard visible band used for optical chemical sensing. Gazdzinski teaches gastrointestinal probes that deliver excitation light and measure the spectrum of fluorescence of tissue exposed to wavelengths in the 450-700nm range using fiber-optic components (see fig. 2 and para [0074]), thereby demonstrating that in vivo GI sensing using visible-range light sources and optical fibers is well known in the art. It would have been obvious to a person of ordinary skill in the art to implement Harmon’s nerve-agent detection chemistry within the GI-compatible optical sensor architecture of Gazdzinski, using in vivo light delivery and collection in the overlapping 400-800nm spectral range, and to mount such sensors on the arms of Langer’s gastric-resident article. Accordingly, Harmon’s use of a light source does not render the reference unsuitable for combination or overcome the 35 U.S.C. §103 rejection.
Applicant’s arguments do not rebut the prima facie case of obviousness, and claims 46, 47, 54, and 56-59 remain unpatentable under 35 U.S.C. §103.
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.
The factual inquiries 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.
Claims 16-19, 21, 26, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Langer in view of Kimchy.
Regarding claim 16, Langer discloses an article (Langer; resident structure 102 in fig. 1B, 1C, 2H), comprising:
a central core (Langer; elastic core 130 in figs. 1B,1C, 2H),
a tissue-engaging surface (Langer; external surface of arms 120 in figs. 1B, 1C, 2H; para [0063]),
a plurality of arms (Langer; arms 120 in figs. 1B, 1C, 2H) connected to the central core (Langer; figs. 1B, 1C, 2H; para [0023, 0063, 0066, 0068, 0171], claim 10),
a drug releasing component (Langer; electronic component 110 in figs. 1B, 1C, 2H) associated with the tissue-engaging surface (Langer; para [0020, 0054, 0059-0062]; configured to release pharmaceutical agent).
Langer, however, does not disclose one or more radiation sensors on the plurality of arms, wherein the one or more radiation sensors are configured to detect ionizing radiation.
Kimchy teaches one or more radiation sensors (Kimchy; col. 13, lines 41-45) on the plurality of arms (Langer; arms 120 in figs. 1B, 1C, 2H), wherein the one or more radiation sensors are configured to detect ionizing radiation (Kimchy; col. 13, lines 41-45; capsule may include emitters and sensors that relate electromagnetic and x-ray radiation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor system of the gastric-resident article of Langer to include one or more radiation sensors configured to detect ionizing radiation as taught by Kimchy in order to monitor radiation exposure from outside sources and thereby expand its diagnostic and therapeutic capabilities.
Regarding claim 17, modified Langer discloses the article of claim 16 article (Langer; resident structure 102 in fig. 1B, 1C, 2H), further comprising an active pharmaceutical composition (Langer; para [0054, 0059, 0061-0062]).
Regarding claim 30, modified Langer discloses that the article of claim 17 is configured to deliver the active pharmaceutical composition (Langer; para [0054, 0059, 0061-0062]) agent using the drug releasing component (Langer; electronic component 110 in figs. 1B, 1C, 2H), but fails to disclose that the drug release takes place upon detection of radiation above a threshold level.
Kimchy teaches active pharmaceutical agent delivery upon detection of radiation above a threshold level (Kimchy; col. 13, lines 41-45; radiation sensors/detectors in the ingestible capsule; col. 24, lines 18-30; radiation detector in the capsule/device distinguish forms of radiation and respond by administration of a radiopharmaceutical; col. 29, lines 4-12; gamma/beta radiation detection and related operations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the control electronics of the gastric-resident article of Langer to implement the threshold-based sensor-triggered drug-release logic taught by Kimchy in order to configure the device so that upon detection of ionizing radiation above a predetermined threshold level, it automatically actuates the drug-releasing component to deliver a radioprotective pharmaceutical agent.
Regarding claim 18, modified Langer discloses the article of claim 16 (Langer; resident structure 102 in fig. 1B, 1C, 2H), having an expanded configuration (Langer; second configuration 100B in fig. 1A) and a retracted configuration (Langer; first configuration 100A in fig. 1A; both configurations also shown in figs 2B-2D, 2H; para [0046]).
Regarding claim 21, modified Langer discloses the article of claim 18, wherein in the retracted configuration (Langer; first configuration 100A in fig. 1A), the article may be ingested (Langer; figs. 2C-2E; para [0075])
Regarding claim 19, modified Langer discloses the article of claim 16, wherein the article further comprises one or more elastic components (Langer; para [0064, 0066]) connected to the plurality of arms (Langer; arms 120 in figs. 1B, 1C, 2H) and configured to bias the arms away from the central core (Langer; elastic core 130 in figs. 1B,1C, 2H), and one or more biasing components (Langer; portions of elastic arms and core system under compression in the folded configuration in figs. 1B, 1C, 2H; para [0064, 0066]) connected to the plurality of arms (Langer; arms 120 in figs. 1B, 1C, 2H) and configured to bias the arms towards the central core (Langer; elastic core 130 in figs. 1B,1C, 2H).
Regarding claim 26, modified Langer discloses the article of claim 16, but fails to disclose that the ionizing radiation comprises alpha, beta, gamma, neutron, proton, and/or heavy ion radiation.
Kimchy teaches that the ionizing radiation comprises alpha, beta, gamma, neutron, proton, and/or heavy ion radiation (Kimchy; nuclear-radiation detector, arranged for detecting gamma and beta radiation; col. 20, lines 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ionizing radiation detected by the radiation sensor in the gastric-resident article of Langer to include beta and gamma radiation as taught by Kimchy in order to specify known type of ionizing radiation that such sensors are routinely designed to detect.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Langer in view of Kimchy, as applied to claim 16 and 17 above, and in further view of Gazdzinski.
Regarding claim 22, modified Langer discloses the article of claim, but fails to disclose that the active pharmaceutical composition (Langer; para [0054, 0059, 0061-0062]) comprises a counter-radiation agent.
Gazdzinski teaches an active pharmaceutical composition that comprises a counter-radiation agent (Gazdzinski; para [0051-0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pharmaceutical agent contained in the drug-releasing component of the gastric-resident article of Langer to be a counter-radiation agent as taught by Gazdzinski in order to provide localized delivery of a therapeutic agent capable of mitigating or treating radiation-induced injury within the gastrointestinal tract.
Regarding claim 23, modified Langer discloses the article of claim 17, wherein the active pharmaceutical composition (Langer; para [0054, 0059, 0061-0062]) is a counter-radiation agent (Gazdzinski; para [0051-0052]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Langer in view of Kimchy, as applied to claims 16 and 17 above, further in view of Abbate (US Patent No. 10,357,640), hereinafter, Abbate.
Regarding claim 24, modified Langer discloses the article of claim 17, wherein the active pharmaceutical composition (Langer; para [0054, 0059, 0061-0062]), but fails to disclose that it comprises an iodine, a chelating agent, and/or a reactive oxygen species scavenger.
Abbate teaches an active pharmaceutical composition that comprises an iodine salt (Abbate; iodine or iodine derivatives; col. 21, lines 4-5), a chelating agent (Abbate; chelated compounds; col. 21, lines 8-10), and/or a reactive oxygen species scavenger (Abbate; col. 24 line 64 - col. 25, line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the active pharmaceutical composition in the drug-releasing component of the gastric-resident article of Langer to comprise an iodine salt, a chelating agent, and/or a reactive oxygen species scavenger as taught by Abbate in order to provide radioprotective therapy that both blocks uptake or enhances removal of radioactive species and scavenges radiation-induced reactive oxygen species.
Claims 20 are rejected under 35 U.S.C. 103 as being unpatentable over Langer in view of Kimchy, as applied to claim 16 and 18 above, further in view of Shin (US Patent No. 11,511,093), hereinafter, Shin.
Regarding claim 20, modified Langer discloses the article of claim 18, wherein the article further comprises a plurality of arms (Langer; arms 120 in figs. 1B, 1C, 2H) at a distal end of the arm connector with two configurations of the article, the expanded configuration (Langer; second configuration 100B in fig. 1A) and the retracted configuration (Langer; first configuration 100A in fig. 1A; both configurations also shown in figs 2B-2D, 2H; para [0046]).
Langer does not, however, disclose that the article comprises a rigid body, an arm connector coupled to the rigid body at a proximal end of the arm connector and coupled to an arm of the plurality of arms at a distal end of the arm connector; and an electro-mechanical actuator configured to translate the rigid body in a direction parallel to a central axis; wherein translation of the rigid body in the direction parallel to the central axis changes the configuration.
Shin teaches: a rigid body (Shin; capsule body 1 in fig. 1);
an arm connector (Shin; moving arm part 4 with arm support 5 in figs. 1-2) coupled to the rigid body (Shin; capsule body 1 in fig. 1) at a proximal end of the arm connector and coupled to an arm (Shin; arms 3 in figs. 1-2) of the plurality of arms (Langer; arms 120 in figs. 1B, 1C, 2H) at a distal end of the arm connector; and
an electro-mechanical actuator (Shin; elastic body 6 in fig. 2, 4) configured to translate the rigid body (Shin; capsule body 1 in fig. 1) in a direction parallel to a central axis (Shin; col. 6, line 61 – col. 7, line 4);
wherein translation of the rigid body (Shin; capsule body 1 in fig. 1) in the direction parallel to the central axis (Shin; col. 6, line 61 – col. 7, line 4) changes the configuration (Shin; figs. 2-6; col. 7, lines 30-59) of the article between the expanded configuration (Langer; second configuration 100B in fig. 1A) and the retracted configuration (Langer; first configuration 100A in fig. 1A; both configurations also shown in figs 2B-2D, 2H; para [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the arm-support and configuration-changing structure of the gastric-resident article of Langer to incorporate a rigid body coupled to the arms via arm connectors and an electro-mechanical actuator that translates the rigid body parallel to the central axis as taught by Shin in order to provide controllable, repeatable actuation between the expanded and retracted configurations of the article.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Langer in view of Kimchy, as applied to claims 16 above, further view of Burnett (US Patent No. 9,498,366), hereinafter, Burnett.
Regarding claim 31, modified Langer discloses the article of claim 16 comprises a drug releasing component (Langer; electronic component 110 in figs. 1B, 1C, 2H), but fails to disclose that the drug releasing component is a needle.
Burnett teaches a drug releasing component that comprises a needle (Burnett; col. 18, lines 1-3); probes for insertion into the surrounding tissue; Burnett’s probes function as needles that penetrate tissue to deliver a drug).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug-releasing component associated with the tissue-engaging surface of the gastric-resident article of Langer to comprise one or more needles or microneedles as taught by Burnett in order to deliver the active pharmaceutical composition across the engaged tissue by trans-tissue injection.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Langer in view of Kimchy, as applied to claims 16 above, in view of Abramson (Abramson et al., “An ingestible Self-Orienting System for Oral Delivery of Macromolecules,” Science 363, 611-615, (2019), DOI: 10.1126/science.aau2277), hereinafter, Abramson.
Regarding claim 32, modified Langer discloses the article of claim 16, but fails to disclose that the article is self-righting.
Abramson teaches an ingestible capsule whose geometry and internal mass distribution cause it to self-orient/self-right so that its injection mechanism consistently faces the gastric mucosa after swallowing (FIG. S16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the geometry and mass distribution of the gastric-resident article of Langer to incorporate the self-orienting, self-righting design principles taught by Abramson in order to ensure that the article passively returns to a preferred orientation within the stomach and reliably presents its tissue-engaging and drug-releasing components to the gastric mucosa.
Claims 46-47 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Langer in view of Gazdzinski and further in view of Harmon (US Patent No. 6,821,738), hereinafter, Harmon.
Regarding claim 46, Langer discloses an article, comprising: a central core (Langer; elastic core 130 in figs. 1B,1C, 2H),
a tissue-engaging surface (Langer; external surface of arms 120 in figs. 1B, 1C, 2H; para [0063]),
a plurality of arms (Langer; arms 120 in figs. 1B, 1C, 2H) connected to the central core (Langer; figs. 1B, 1C, 2H; para [0023, 0063, 0066, 0068, 0171], claim 10),
one or more chemical sensors (Gazdzinski; sensor arrays 3202 in fig. 32; para [0070]) on the plurality of arms (Langer; arms 120 in figs. 1B, 1C, 2H), wherein the one or more sensors are configured to detect a toxic chemical (Gazdzinski; para [0070, 0411]; sensing arrays detect antigens via molecular receptor sites 3210 in fig. 32), and
a drug releasing component (Langer; electronic component 110 in figs. 1B, 1C, 2H) associated with the tissue-engaging surface (Langer; para [0020, 0054, 0059-0062]; resident structure configured to release pharmaceutical agent).
Langer, however, fails to disclose one or more chemical sensors on the plurality of arms, wherein the one or more sensors are configured to detect a toxic chemical, and wherein the toxic chemical is:
(i) a biotoxin selected from the group consisting of: abrin, anthrax toxin, brevetoxin, colchicine, digitalis, nicotine, ricin, saxitoxin, strychnine, tetrodotoxin, and trichothecene;
(ii) a blood agent selected from the group consisting of: arsine, carbon monoxide, and a cyanide;
(iii) an incapacitating agent selected from the group consisting of: 3-quinuclidinyl benzilate and an opioid;
(iv) a metallic poison selected from the group consisting of: arsenic, barium, mercury, and thallium; or
(v) a nerve agent selected from the group consisting of: a G agent, a V agent, a Novichok agent, a carbamate, and an insecticide.
Gazdzinski teaches one or more chemical sensors (Gazdzinski; sensor arrays 3202 in fig. 32; para [0070]) on the plurality of arms (Langer; arms 120 in figs. 1B, 1C, 2H), wherein the one or more sensors are configured to detect a toxic chemical (Gazdzinski; para [0070, 0411]; sensing arrays detect antigens via molecular receptor sites 3210 in fig. 32; these antigens include toxic chemical agents).
Furthermore, Harmon contemplates that the toxic chemical is a V agent (Harmon contemplates detection of presence of nerve agents such as VX, which is a V-series nerve agent; col. 19, lines 41-49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gastric-resident article of Langer to employ, on the arms, chemical sensor arrays configured to detect toxic chemicals as taught by Gazdzinski in order to provide the article with the capability to sense hazardous chemical agents in the gastrointestinal environment and respond therapeutically.
It would have been further obvious to one of ordinary skill in the art at the time of the invention to configure the chemical sensor to detect a V-series nerve agent, such as VX, as contemplated by Harmon, in order to provide the article with the capability to detect a known class of highly toxic nerve agents and thereby expand the range of hazardous chemical exposures that can be identified and responded to by the device.
Regarding claim 47, modified Langer discloses the article of claim 46, further comprising an active pharmaceutical composition (Langer; fig. 2H; drug delivery modules; para [0046]).
Regarding claim 54, modified Langer discloses the article of claim 46, wherein the chemical sensor is configured to detect a nerve agent (Harmon; col 4, lines 62-65) selected from the group consisting of: a G agent, a V agent, a Novichok agent, a carbamate, and an insecticide (Harmon contemplates detection of presence of nerve agents such as VX, which is a V-series nerve agent; col. 19, lines 41-49).
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Langer in view of Gazdzinski and Harmon, as applied to claims 46 and 47 above, and further in view of Kimchy.
Regarding claim 57, modified Langer discloses the article of claim 47, wherein upon detection of a toxin (Gazdzinski; para [0070, 0411]; sensing arrays detect antigens via molecular receptor sites 3210 in fig. 32; these antigens include toxic chemical agents), the article is configured to deliver the active pharmaceutical composition (Langer; Langer; fig. 2H; drug delivery modules; para [0046]) using the drug releasing component (Langer; electronic component 110 in figs. 1B, 1C, 2H).
Langer, however, fails to disclose delivery of an active pharmaceutical composition upon detection of a toxin.
Kimchy teaches delivery of an active pharmaceutical composition upon detection of a sensed parameter (Kimchy; col. 13, lines 41-45; sensors/detectors in the ingestible capsule; col. 24, lines 18-30; detection in the capsule/device and response by administration of a radiopharmaceutical).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gastric-resident article of Langer to implement the sensor-triggered drug-release logic taught by Kimchy in order to configure the device such that upon detection of a toxic chemical above a predetermined level by the chemical sensor the article automatically actuates the drug-releasing component to deliver the active pharmaceutical composition.
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Langer in view of Gazdzinski and Harmon, as applied to claim 46 above, and further in view of Munro (Munro, N. B., Watson, A. P., Ambrose, K. R., & Griffin, G. D. (1990). Treating exposure to chemical warfare agents: implications for health care providers and community emergency planning. Environmental health perspectives, 89, 205–215. https://doi.org/10.1289/ehp.9089205; hereinafter, Munro).
Regarding claim 56, modified Langer discloses the article of claim 46, wherein the article comprises an active pharmaceutical agent (Langer; fig. 2H; drug delivery modules; para [0046]) appropriate for treating symptoms associated with exposure to a nerve agent (Harmon; col 4, lines 62-65), but Langer fails to disclose that the active pharmaceutical agent comprises atropine.
Munro teaches that atropine is a primary antidote for symptoms of exposure to chemical warfare nerve agents, and is administered to treat the characteristic effects of such exposure (Page 207, 2nd column, 3rd and 4th paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the active pharmaceutical agent contained in the drug-releasing component of the nerve-agent-sensing gastric-resident article of Langer so that the agent comprises atropine as taught by Munro in order to ensure that the device delivers appropriate therapy when nerve-agent exposure is detected.
Claim 58 is rejected under 35 U.S.C. 103 as being unpatentable over Langer in view of Gazdzinski and Harmon, as applied to claim 46 above, and further in view of Burnett.
Regarding claim 58, modified Langer discloses the article of claim 46, wherein the drug releasing component (Langer; electronic component 110 in figs. 1B, 1C, 2H), but fails to disclose that the drug releasing component is a needle.
Burnett teaches a drug releasing component that comprises a needle (Burnett; col. 18, lines 1-3); probes for insertion into the surrounding tissue; Burnett’s probes function as needles that penetrate tissue to deliver a drug).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug-releasing component associated with the tissue-engaging surface of the gastric-resident article of Langer to comprise one or more needles or microneedles as taught by Burnett in order to deliver the active pharmaceutical composition across the engaged tissue by trans-tissue injection.
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Langer in view of Gazdzinski and Harmon, as applied to claim 46 above, and further in view of Abramson.
Regarding claim 59, modified Langer discloses the article of claim 46, but fails to disclose that the article is self-righting.
Abramson teaches an ingestible capsule whose geometry and internal mass distribution cause it to self-orient/self-right so that its injection mechanism consistently faces the gastric mucosa after swallowing (FIG. S16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the geometry and mass distribution of the gastric-resident article of Langer to incorporate the self-orienting, self-righting design principles taught by Abramson in order to ensure that the article passively returns to a preferred orientation within the stomach and reliably presents its tissue-engaging and drug-releasing components to the gastric mucosa.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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