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
Acknowledgment is made to the amendment received 6/16/2026.
Applicant's amendments to the claims are sufficient to overcome the 35 USC § 112(b) rejections set forth in the previous office action.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive. Regarding claim 23, applicant argues that Hiller does not disclose the claim language “delivering energy… to the organ wall to partition the organ wall”. In applicant’s specification partitions are considered areas that are completely or partially isolated from each other by ablation patterns. Paragraph [0099] of Hiller states “step 1608 may include methods to ablate the stomach wall”. After ablation is complete, there will be two types of tissue: ablated and non-ablated. The ablated tissue is surrounded by non-ablated tissue. Thus, there is no longer continuous non-ablated tissue. There is a partition where the ablation site is. Non-ablated tissue immediately to one side of the ablation site is at least partially isolated from non-ablated tissue on the other side of the ablation site. Thus, Hiller does create partitions in the organ wall as the claim language requires. Therefore, the previous rejection of claim 23 under 35 U.S.C. 102(a)(1) as being anticipated by Hiller stands.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 23-29, and 32-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiller et al., US 20180110979, herein referred to as “Hiller”.
Regarding claim 23, Hiller discloses a method for treating a medical condition of a patient (Figure 16 and Abstract), including: identifying a patient having the medical condition ([0023]); placing a device comprising a flexible bipolar electrode (Figure 6 and [0045]: “Sensing elements 608 may be circular band electrodes configured to both measure electrical activity within the duodenum and/or small intestine, and deliver therapeutic energy.” And [0047]: “Wire elements 834 may be configured to deliver therapeutic energy (e.g., RF, electrical fields) to tissue in a monopolar or bipolar manner.”) in an organ of the patient's gastro-intestinal tract ([0007] and [0009]); ensuring contact with the organ wall ([0036]); delivering energy at once in a single procedure ([0007]: “The controller may be configured to determine one or more treatment locations based on the comparison, and cause the device to deliver therapy to the one or more treatment locations.” Wherein energy is delivered at once in a single procedure where there is one treatment location), without moving the device during the procedure ([0093]: “For example, the analyzer 210 or medical practitioner may determine that a particular sensing element is closest to the gastric pacemaker (or another suitable location to be treated), and without moving the mapping device from its recording position, may deliver therapy using that given electrode.”), via the flexible bipolar electrode to the organ wall ([0036]: “For example, in ablative or other therapies, once optimal electrode and tissue contact is confirmed, ablative or therapeutic energy may be delivered according to the contact force that is indicative of electrode and tissue contact, ensuring optimal and safe energy delivery parameters are selected.”) to partition the organ wall such that propagation of activity through the organ wall is altered ([0099]-[0100]); and removing the device (Figure 16: once the treatment is finished, the device is removed as the procedure is done).
Regarding claim 24, Hiller discloses the method of claim 23, wherein the medical condition is any of obesity, constipation, gastro-esophageal reflux disease, dumping syndrome, diabetes mellitus, or metabolic syndrome ([0099]).
Regarding claim 25, Hiller discloses the method of claim 23, wherein placing the device in the patient's organ is done endoscopically ([0028]: “FIG. 2 is a schematic diagram of a system and environment for collecting, processing, and displaying electrical data obtained endoscopically from within the stomach or other portion of the GI tract, and for treating obesity conditions, according to an example of the present disclosure.” And Figure 7: endoscopic member 702).
Regarding claim 26, Hiller discloses the method of claim 23, wherein ensuring contact with the organ wall includes measurement of any one or more of: impedance ([0036]: “The contact force could be obtained by analyzing the value of the electrode/tissue impedance. The electrode contact force also can be obtained via an array of optical sensors or mechanical sensors. The optimal range of the impedance value may indicate the optimal tissue contact that leads efficient resistive tissue heating and lower the risk of tissue charring and perforation.”), temperature, pressure, imaging, stimulation, and effect on heart rate or its variability.
Regarding claim 27, Hiller discloses the method of claim 23 including: analyzing the organ activity prior to ablation (Figure 16: step 1606: process data is prior to step 1608: apply treatment); and determination of the ablation pattern according to the analysis results ([0088]: “In particular, the comparison may reveal that the measured electrical data has the same or similar pattern and/or shape as an electrogram stored in the database, and may provide a recommendation for treating the patient based on a treatment associated with the stored electrogram” and [0100]).
Regarding claim 28, Hiller discloses the method of claim 23, wherein: the organ is a stomach; and no partition may be larger than three quarters of the total inner surface area of the stomach (Figure 4 and [0100] wherein the fundus is smaller than three quarters of the total inner surface area of the stomach).
Regarding claim 29, Hiller discloses the method of claim 23, wherein: the organ is a stomach; and no partition may be larger than two thirds of the total inner surface area of the stomach (Figure 4 and [0100] wherein the fundus is smaller than two thirds of the total inner surface area of the stomach).
Regarding claim 32, Hiller discloses the method of claim 23, wherein: the organ is a stomach; and the partitioning of the stomach wall is at the region of the fundus ([0099]: “In some examples, treatments at step 1608 may be designed to inhibit stomach function by interfering with peristalsis, and by reducing the extensibility of the fundus.” And [0100]: “Ablation may be performed endoscopically in the fundus of the stomach to target the gastric mucosa, the stomach muscles, the vagus nerve, or any of its subsidiaries and the submucosal and myoenteric plexuses.”).
Regarding claim 33, Hiller discloses the method of claim 23, wherein: the organ is a stomach; and the partitioning of the stomach wall is localized to the intrinsic gastric pacemaker ([0093]: “In one example, endoscopic mapping and ablation may occur around the gastric pacemaker for an obesity treatment” and [0097]).
Regarding claim 34, Hiller discloses the method of claim 23, wherein: the organ is a stomach; and the partitioning of the stomach wall is localized to a gastric pacemaker in the antrum ([0093]: “In one example, endoscopic mapping and ablation may occur around the gastric pacemaker for an obesity treatment” and [0097]).
Regarding claim 35, Hiller discloses the method of claim 23, wherein: the condition is obesity ([0002]); the organ is a stomach; the partitioning is shaped as a ring or band (Figures 9-10: the arrangement of wire elements 834 and wires 934 would create a ring-shaped partition) around the mid corpus of the stomach ([0101] wherein the fundus is around the mid corpus of the stomach); and the partitioning is further configured to create contraction of the stomach wall ([0099]: “The damage caused from ablation may result in the formation of fibrotic tissue, which may alter the extensibility of the stomach wall, and thus its ability to expand and contract.”) and impede gastric emptying ([0101]).
Regarding claim 36, Hiller of claim 23, wherein: the condition is obesity; the organ is a stomach ([0002]) and wherein the partitioning is located at the fundus of the stomach; and the partitioning is further configured to create contraction of the fundus ([0099]: “The damage caused from ablation may result in the formation of fibrotic tissue, which may alter the extensibility of the stomach wall, and thus its ability to expand and contract.”) and limit the total volume of gastric filling ([0101]).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Hiller in view of Starkebaum et al., US 20040215180, herein referred to as “Starkebaum”.
Regarding claim 30, Hiller discloses the method of claim 23, but does not explicitly disclose a method wherein the organ is a stomach and wherein the partitioning of the stomach wall is at the region of the antrum.
However, Starkebaum teaches a method wherein: the organ is a stomach; and the partitioning of the stomach wall is at the region of the antrum ([0042]: “ablation system 18 may be configured and used to ablate sub-mucosal tissue, e.g., in the corpus, fundus, or antrum”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Hiller so that the partitioning of the stomach wall is at the region of the antrum as taught by Starkebaum to alter the myoelectric activity of the stomach (Starkebaum [0042]).
Regarding claim 31, Hiller discloses the method of claim 23, but does not explicitly disclose a method wherein the organ is a stomach and wherein the partitioning of the stomach wall is at the region of the corpus.
However, Starkebaum teaches a method wherein: the organ is a stomach; and the partitioning of the stomach wall is at the region of the corpus ([0042]: “ablation system 18 may be configured and used to ablate sub-mucosal tissue, e.g., in the corpus, fundus, or antrum”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Hiller so that the partitioning of the stomach wall is at the region of the corpus as taught by Starkebaum to alter the myoelectric activity of the stomach (Starkebaum [0042]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Hiller in view of Gross et al. US 20020062060, herein referred to as “Gross”.
Regarding claim 37, Hiller discloses the method of claim 23, but does not explicitly disclose a method wherein: the condition is constipation; the organ is a cecum and/or an ascending colon; and the partitioning is further configured to create contraction and/or decreased compliance of the cecum and/or ascending colon to prevent stasis of stool.
However, Gross teaches a method wherein: the condition is constipation ([0024]: “principles of the present invention may be applied to treating constipation”); the organ is a cecum and/or an ascending colon ([0024]: typically by stimulating some muscles to contract (i.e., muscles of the colon) “”); and the partitioning is further configured to create contraction and/or decreased compliance of the cecum and/or ascending colon to prevent stasis of stool ([0024]: “Alternatively or additionally, principles of the present invention may be applied to treating constipation or pathological retention of urine, typically by stimulating some muscles to contract (i.e., muscles of the colon), while stimulating some parasympathetic nerves to induce relaxation of other muscles (e.g., the muscles of the anus).”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Hiller so that the condition treated is constipation and the partitioning is configured to create contraction of the colon as taught by Gross to treat fecal incontinence, particularly following a spinal cord injury (Gross [0024]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
Prosecution Insights