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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/19/26 has been entered.
Response to Arguments
Applicant's arguments filed 3/10/26 have been fully considered but they are not persuasive. Regarding claims 1, 9 and 16, the Applicant argues that Arneson reference includes sensors that extend out creating the grooves and therefore fails to render obvious every limitation of claim 1. The Examiner respectfully disagrees. The sensors of Arneson extend out creating one or more grooves that allow for the wicking of fluids thereby reading on the claim limitations. It is noted that the claims are silent as to the size, shape or location of the grooves. Since Imran in view of Fischell and Arneson teaches each and every limitation the rejections stand.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4-5, 7-9, 11, 13 and 15-16, 21-22, 24 and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imran et al. (U.S. Pub. 2011/0046479 hereinafter "Imran”) in view of Fischell et al. (U.S. Pat. 6,591,137 hereinafter “Fischell”) and Arneson et al. (U.S. Pub. 2009/0088618 hereinafter “Arneson”).
Regarding Claim 1, Imran discloses an ingestible electronic device (e.g. treatment capsule system is an ingestible capsule that will electrically stimulate a predetermined portion of the intestinal tract ¶34) comprising: a non-expandable housing (e.g. capsule body 111 contains and protects the enclosed circuitry from body fluids while passing through the intestinal tract...capsule body 111 is constructed of an ultrasound transmitting material that is compatible for use in the human body such as, for example, a medical grade plastic [a known non-expandable material], ¶85); capsule passes along the intestinal tract, it continues to supply successive stimuli through the intestine...controlled by the stimulating parameters such as frequency or amplitude of the signals utilized for supplying electrical stimuli or pulses to the intestinal tract. The capsule may provide certain stimulation patterns in the small intestine until it reaches the colon...electrical stimuli can be terminated or alternatively they can continue to be generated at the same or different parameters as the capsule passes through the colon until it exits from the body through the rectum in a bowel movement, ¶150), wherein the non-expandable housing is configured to pass through a pyloric orifice of the subject without being actively retained in a stomach of the subject (e.g. initial location of the capsule is preferably first identified, such as, when it reaches the pylorus. Such position may be determined by a number of means such as by determining capsule movement indicative that the capsule is moving from the stomach into the small intestine, including, for example change in location, or acceleration. Alternatively a capsule's initial location may be determined, for example by pressure, which changes when the capsule passes through the pylorus, or pH, which changes when the capsule enters the duodenum, ¶23); and at least two electrodes disposed on an exterior surface of the non-expandable housing (e.g. stimulation capsule of the present invention may include a plurality of electrodes that may be utilized for forward or backward electrical stimulation, e.g., where the order in which a series of electrode pairs are activated can cause peristalsis to move in a directional manner, ¶38; stimulation signals to the capsule to be delivered through the electrodes on the capsule, ¶44; Fig. 16), wherein the at least two electrodes are configured to apply electrical stimulation to a tissue proximate to the at least two electrodes when the ingestible device is disposed in the stomach of the subject, and wherein the ingestible device is configured to apply the electrical stimulation to the tissue (organs of the intestinal tract such as the stomach, (e.g. ¶13); electrodes deliver a signal that is designed to cause desired therapeutic effect, for example, a smooth muscle response, i.e., stimulation or inhibition of contraction or peristaltic motion. The electrodes may deliver the electrical stimulation to the smooth muscle by contacting...the tissue that forms the intestinal lining [stomach] or the mucosal tissue of the intestinal tract, (e.g. ¶35); stimulation capsule of the present invention may include a plurality of electrodes that may be utilized, (e.g. ¶38); instructions may be a trigger signal to trigger a stimulation pulse or burst of pulses with predetermined stimulation parameters...to be emitted by the capsule...trigger and/or specify a stimulation pulse or burst of pulses to be delivered to the intestinal wall [stomach], (e.g. ¶114)) for a time period less than or equal to 1 hour (after stimulation device 180 no longer senses the selected condition or the correct amount of time has elapsed, the device may return to its original configuration, (e.g. ¶109)); duration can vary from about 0.6 ms to 1 second...there are many different types of electrical stimulation programs and strategies which can be utilized for providing electrical stimulation parameters through the circuitry (e.g. 113), the principal focus being providing electrically stimulating parameters for the intestinal tract, (e.g. ¶131). Imran discloses the claimed invention except for the time period for stimulation of the stomach to be greater than or equal to 5 minutes. However, Fischell teaches that it is known to use a stimulation lasting between 5 and 10 minutes as set forth in Column 6, lines 31-48 to provide the stimulation for the right time period to digest and expel food. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the time period as taught by Imran, with time period as taught by Fischell, since such a modification would provide the predictable results of stimulating the stomach with known periods that provide for stomach digestion and expelling of food. Imran in view of Fischell discloses the claimed invention including being able to sample the fluids, but fails to explicitly state that the system uses grooves and posts to sample gastrointestinal fluids. However, Arneson teaches that it is known to use posts arranged in grooves as set forth in Figure 2A (element 202b posts) and Figure 12 (posts arranged in grooves) to provide a means for evenly sampling gastrointestinal fluids. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Imran in view of Fischell, with posts and grooves as taught by Arneson, since such a modification would provide the predictable results of using posts and grooves for providing a means for evenly sampling gastrointestinal fluids.
Regarding claims 4-5, meeting the limitations of claim 1 above, Imran further discloses wherein the non-expandable housing is at least partially encapsulated in a dissolvable material, wherein the dissolvable material isolates the at least two electrodes from an environment surrounding the ingestible device and where the dissolvable material is configured to be dissolved in the stomach of the subject such that once the dissolvable material is dissolved, the two or more electrodes apply electrical stimulation to the tissue proximate to the at least two electrodes (e.g. ¶¶126, 140).
Regarding claims 7-8, meeting the limitations of claim 1 above, Imran further discloses determining that the ingestible device is within the stomach of the subject; applying electrical stimulation to the tissue with two electrodes while the ingestible device is disposed within the stomach; and ending the electrical stimulation once the ingestible device passes out of the stomach (e.g. ¶¶26, 29 and 45).
Regarding Claim 9, meeting the limitations of claim 1 above, Imran further discloses a method of applying electrical stimulation to tissue within a stomach of a subject (e.g. organs of the intestinal tract such as the stomach, ¶13; electrodes deliver a signal that is designed to cause desired therapeutic effect, for example, a smooth muscle response, i.e., stimulation or inhibition of contraction or peristaltic motion. The electrodes may deliver the electrical stimulation to the smooth muscle by contacting...the tissue that forms the intestinal lining [stomach] or the mucosal tissue of the intestinal tract, ¶35; stimulation capsule of the present invention may include a plurality of electrodes that may be utilized, ¶38; instructions may be a trigger signal to trigger a stimulation pulse or burst of pulses with predetermined stimulation parameters...to be emitted by the capsule...trigger and/or specify a stimulation pulse or burst of pulses to be delivered to the intestinal wall [stomach], ¶114), the method comprising: positioning an ingestible electronic device in the stomach of the subject without actively retaining the ingestible electronic device in the stomach (treatment capsule system is an ingestible capsule that will electrically stimulate a predetermined portion of the intestinal tract, ¶34; capsule body 111 contains and protects the enclosed circuitry from body fluids while passing through the intestinal tract...capsule body 111 is constructed of an ultrasound transmitting material that is compatible for use in the human body such as, for example, a medical grade plastic, ¶85; capsule passes along the intestinal tract, it continues to supply successive stimuli through the intestine...controlled by the stimulating parameters such as frequency or amplitude of the signals utilized for supplying electrical stimuli or pulses to the intestinal tract. The capsule may provide certain stimulation patterns in the small intestine until it reaches the colon...electrical stimuli can be terminated or alternatively they can continue to be generated at the same or different parameters as the capsule passes through the colon until it exits from the body through the rectum in a bowel movement, ¶150); and applying electrical stimulation to a tissue of the stomach of the subject proximate to the ingestible electronic device (e.g. organs of the intestinal tract such as the stomach, ¶13; electrodes deliver a signal that is designed to cause desired therapeutic effect, for example, a smooth muscle response, i.e., Stimulation or inhibition of contraction or peristaltic motion. The electrodes may deliver the electrical stimulation to the smooth muscle by contacting...the tissue that forms the intestinal lining [stomach] or the mucosal tissue of the intestinal tract, ¶35; stimulation capsule of the present invention may include a plurality of electrodes that may be utilized, ¶38; instructions may be a trigger signal to trigger a stimulation pulse or burst of pulses with predetermined stimulation parameters...to be emitted by the capsule...trigger and/or specify a stimulation pulse or burst of pulses to be delivered to the intestinal wall [stomach], ¶114) for a time period less than or equal to 1 hour (e.g. after stimulation device 180 no longer senses the selected condition or the correct amount of time has elapsed, the device may return to its original configuration, ¶109; duration can vary from about 0.6 ms to 1 second...there are many different types of electrical stimulation programs and strategies which can be utilized for providing electrical stimulation parameters through the circuitry 113, the principal focus being providing electrically stimulating parameters for the intestinal tract, ¶131). Imran discloses the claimed invention except for the time period for stimulation of the stomach to be greater than or equal to 5 minutes. However, Fischell teaches that it is known to use a stimulation lasting between 5 and 10 minutes as set forth in Column 6, lines 31-48 to provide the stimulation for the right time period to digest and expel food. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the time period as taught by Imran, with time period as taught by Fischell, since such a modification would provide the predictable results of stimulating the stomach with known periods that provide for stomach digestion and expelling of food. Imran in view of Fischell discloses the claimed invention including being able to sample the fluids, but fails to explicitly state that the system uses grooves and posts to sample gastrointestinal fluids. However, Arneson teaches that it is known to use posts arranged in grooves as set forth in Figure 2A (element 202b posts) and Figure 12 (posts arranged in grooves) to provide a means for evenly sampling gastrointestinal fluids. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Imran in view of Fischell, with posts and grooves as taught by Arneson, since such a modification would provide the predictable results of using posts and grooves for providing a means for evenly sampling gastrointestinal fluids.
Regarding Claim 11, meeting the limitations of claim 9 above, Imran further discloses including passing the ingestible electronic device out of the stomach of the subject (e.g. capsule passes along the intestinal tract, it continues to supply successive stimuli through the intestine...controlled by the stimulating parameters such as frequency or amplitude of the signals utilized for supplying electrical stimuli or pulses to the intestinal tract. The capsule may provide certain stimulation patterns in the small intestine until it reaches the colon...electrical stimuli can be terminated or alternatively they can continue to be generated at the same or different parameters as the capsule passes through the colon until it exits from the body through the rectum in a bowel movement, ¶150).
Regarding claim 13, meeting the limitations of claim 9 above, Imran further discloses sensing that the ingestible device is within the stomach of the subject, and wherein applying the electrical stimulation to the tissue of the stomach is based at least partly on sensing that the ingestible device is within the stomach (e.g. ¶¶26, 29, 45).
Regarding claim 15, meeting the limitations of claim 9 above, Imran further discloses wherein the non-expandable housing is at least partially encapsulated in a dissolvable material that dissolves when contacting stomach acid (e.g. ¶¶126, 140).
Regarding claims 16, lmran discloses an ingestible electronic device (e.g. treatment capsule system is an ingestible capsule that will electrically stimulate a predetermined portion of the intestinal tract, ¶34) comprising: a non-expandable housing (e.g. capsule body 111 contains and protects the enclosed circuitry from body fluids while passing through the intestinal tract...capsule body 111 is constructed of an ultrasound transmitting material that is compatible for use in the human body such as, for example; a medical grade plastic, ¶85; capsule passes along the intestinal tract, it continues to supply successive stimuli through the intestine...controlled by the stimulating parameters such as frequency or amplitude of the signals utilized for supplying electrical stimuli or pulses to the intestinal tract. The capsule may provide certain stimulation patterns in the small intestine until it reaches the colon...electrical stimuli can be terminated or alternatively they can continue to be generated at the same or different parameters as the capsule passes through the colon until it exits from the body through the rectum in a bowel movement, ¶150), wherein the non-expandable housing is configured to pass through a pyloric orifice of the subject without being actively retained in a stomach of the subject (e.g. initial location of the capsule is preferably first identified, such as, when it reaches the pylorus. Such position may be determined by a number of means such as by determining capsule movement indicative that the capsule is moving from the stomach into the small intestine, including, for example change in location, or acceleration. Alternatively a capsule's initial location may be determined, for example by pressure, which changes when the capsule passes through the pylorus, or pH, which changes when the capsule enters the duodenum, ¶23); and at least two electrodes disposed on an exterior surface of the non-expandable housing (e.g. stimulation capsule of the present invention may include a plurality of electrodes that may be utilized for forward or backward electrical stimulation, e.g., where the order in which a series of electrode pairs are activated can cause peristalsis to move in a directional manner, ¶38; stimulation signals to the capsule to be delivered through the electrodes on the capsule, ¶44; Fig. 16), wherein the at least two electrodes are configured to apply electrical stimulation to a tissue proximate to the at least two electrodes when the ingestible device is disposed in the stomach of the subject, wherein the at least two electrodes are configured to contact tissue disposed on multiple sides of the non-expandable housing (e.g. organs of the intestinal tract such as the stomach, ¶13; electrodes deliver a signal that is designed to cause desired therapeutic effect, for example, a smooth muscle response, i.e., stimulation or inhibition of contraction or peristaltic motion. The electrodes may deliver the electrical stimulation to the smooth muscle by contacting...the tissue that forms the intestinal lining [stomach] or the mucosal tissue of the intestinal tract, ¶35; stimulation capsule of the present invention may include a plurality of electrodes that may be utilized, (e.g. ¶38); stimulation electrodes wrapped about the capsule, (e.g. ¶79); instructions may be a trigger signal to trigger a stimulation pulse or burst of pulses with predetermined stimulation parameters...to be emitted by the capsule...trigger and/or specify a stimulation pulse or burst of pulses to be delivered to the intestinal wall [stomach], ¶114). Imran discloses the claimed invention except for the exact stimulation parameters for stimulation of the stomach. However, Fischell teaches that it is known to use a stimulation parameters of (10) Typical stimulation signals to close the esophageal sphincter would be one to 30 hertz, each pulse being between 0.5 and 2 ms long. The peak-to-peak voltage and current should be between 1 to 25 v and 1 to 20 ma as set forth in Column 6, lines 25-30 to provide typical stimulation to enhance ingestion and provide for stomach digestion and expelling of food. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the time period as taught by Imran, with time period as taught by Fischell, since such a modification would provide the predictable results of stimulating the stomach with known parameters that provide for stomach digestion and expelling of food. Imran in view of Fischell discloses the claimed invention including being able to sample the fluids, but fails to explicitly state that the system uses grooves and posts to sample gastrointestinal fluids. However, Arneson teaches that it is known to use posts arranged in grooves as set forth in Figure 2A (element 202b posts) and Figure 12 (posts arranged in grooves) to provide a means for evenly sampling gastrointestinal fluids. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Imran in view of Fischell, with posts and grooves as taught by Arneson, since such a modification would provide the predictable results of using posts and grooves for providing a means for evenly sampling gastrointestinal fluids.
Regarding claims 21-22, meeting the limitations of claim 16 above, Imran further discloses wherein the non-expandable housing is at least partially encapsulated in a dissolvable material, wherein the dissolvable material isolates the at least two electrodes from an environment surrounding the ingestible device and where the dissolvable material is configured to be dissolved in the stomach of the subject such that once the dissolvable material is dissolved, the two or more electrodes apply electrical stimulation to the tissue proximate to the at least two electrodes (e.g. ¶¶126, 140).
Regarding claims 24 and 26, Imran in view of Fischell in view of Arneson discloses the claimed grooves and posts as detailed above, but fails to disclose that the grooves and posts decrease an impedance between the electrodes and tissue. However, the design of the grooves and posts are the same design as the current invention and therefore would necessarily have the same function. Therefore, It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Imran in view of Fischell, with posts and grooves as taught by Arneson, since such a modification would provide the predictable results of using posts and grooves for providing a means for evenly sampling gastrointestinal fluids and would have the same function of decreasing the impedance between the electrodes and tissue.
Regarding claims 27, meeting the limitations of claim 9 above, Imran in view of Fischell teach the exact same stimulation to the exact same portion of the stomach and therefore, necessarily would have the same result of increasing the Ghrelin plasma concentration of the subject. It is noted that the Applicant’s Specification page 4 states that electrical stimulation of stomach for approximately 1 hour or less may produce clinically significant changes in the production of Ghrelin. The combined references teach stimulating the stomach for less than an hour (e.g. Fischell; Col. 3, ll. 1-11).
Claim(s) 3, 12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Fischell as applied to claims 1, 9, 11 and 16 above, and further in view of Semler (U.S. Pub. 2011/0257490).
Regarding claims 3, 12 and 17, Imran in view of Fischell discloses the ingestible electronic device of claims 1, 9 and 16, but fails to explicitly disclose wherein the ingestible device is configured to pass through the stomach of the subject in less than or equal to 4 hours. Semler is in the field of evaluating constipation using ingestible capsules (e.g. title; abstract) and teaches wherein the ingestible device is configured to pass through the stomach of the subject in less than or equal to 4 hours (e.g. healthy subject showed normal GET at 2.5 hours, ¶24; gastric emptying time (GET) is the time interval between ingestion of capsule and...the time of an abrupt rise in pH profile [exit stomach to small intestine], usually >2 pH units from the gastric pH baseline. This change occurs when the capsule passes from the acidic antrum to the alkaline duodenum [exit stomach to small intestine], ¶43). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the ingestible device of Imran in view of Fischell to include an ingestible device that passes through the stomach in less than or equal to 4 hours with Semler to provide a system with ingestible capsules that are efficient for evaluation of medical conditions, but without an extended wait for the data results (e.g. ¶51).
Claim(s) 6, 14, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Fischell as applied to claims 1, 9, 11 and 16 above, and further in view of Sabesan et al. (U.S. Pub. 2019/0275330 hereinafter “Sabesan”).
Regarding Claims 6, 14 and 18-19, Imran in view of Fischell discloses the ingestible device of claims 1, 9 and 16, wherein the two or more electrodes extend along a length of the non-expandable housing (e.g. stimulation capsule of the present invention may include a plurality of electrodes that may be utilized for forward or backward electrical stimulation, e.g., where the order in which a series of electrode pairs are activated can cause peristalsis to move in a directional manner, ¶38), but fails to explicitly disclose two or more electrodes in a helical pattern. Sabesan is in the field of tissue stimulation (title; abstract) and teaches electrodes in a helical pattern (e.g. ¶¶18, 32) can be used to allow for the device to be inserted in a small space while still allowing for a large stimulation area. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the electrode pattern of Imran in view of Fischell to include two or more electrodes in a helical pattern with Sabesan to provide a stimulation system which elicits maximal stimulation in order to achieve a therapeutic effect with the added ability to be easily compacted for insertion.
Conclusion
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/REX R HOLMES/ Primary Examiner, Art Unit 3796