Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 15 and 25 objected to because of the following informalities:
Claim 15 recites “to at least on radio transmitter” in lines 9-10. It should read “to the at least one radio transmitter”.
Claim 25 recites “employing at least on tension sensor”. It should read “employing the at least one tension sensor”.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 'E' in fig. 3. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 25 recites the limitation "pylorus anchor" in lines 8-9 and 10. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 15-22 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 15 is interpreted to read on a human organism by stating “residing in a body cavity”. The body cavity is considered a human organism and not able to be patented. This can be overcome by changing the language to “configured to be implanted in a body cavity”. Dependent claims 16-22 are likewise rejected.
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.
Claim(s) 15-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalfon (US 2019/0358066 A1) in view of Gertner (US 2006/0089571 A1), Pool (US 2008/0172072 A1) and Turner (US 2005/0165317 A1).
Regarding claim 15, Kalfon teaches a gastrointestinal device (fig. 9), comprising:
an anchor residing in a body cavity (900, device, fig. 9);
an intestinal sleeve configured to be conducted down through intestines (408, sleeve, fig. 9), the intestinal sleeve including, at a proximal end thereof, a pylorus anchor (508, anchor, fig. 9);
a cord connecting the anchor residing in the body cavity with the intestinal sleeve (904, string, fig. 9).
Kalfon fails to teach a tension sensor. However, Gertner teaches an obesity treatment system that includes at least one tension sensor (¶ [0037]); and wherein the at least the one tension sensor senses tension caused by migration of the intestinal sleeve and the pylorus anchor (¶ [0037]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Kalfon to include a tension sensor as taught by Gertner in order to reduce slippage that can result in reduced effectiveness of the device as taught by Pool (¶ [0158])
Kalfon and Gertner fail to teach a radio wave transmitter. However, Turner teaches a medical device for implantation in the digestive system that includes at least one radio wave transmitter (¶ [0081]); wherein the at least the one tension sensor communicates a migration value to at least one radio transmitter (¶ [0081]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Kalfon and Gertner to include a radio wave transmitter as taught by Turner since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 16, Kalfon further teaches the body cavity is a stomach (¶ [0002]).
Regarding claim 17, Kalfon further teaches the cord connecting the anchor residing in the body cavity with the intestinal sleeve, is one of a group of cords consisting of a flexible sleeve cord and a rigid lever (904, string, fig. 9, string is a type of flexible sleeve cord).
Regarding claim 18, recites features of the rigid lever which is only optionally recited in claim 17. As Kalfon discloses a flexible sleeve cord, the optional features of the rigid lever are met by the Kalfon reference.
Regarding claim 19, Kalfon further teaches a node connecting the anchor residing in the body cavity with the intestinal sleeve (see annotated fig. 9, below).
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Kalfon and Gertner do not explicitly disclose the tension sensor is located at a node, however it would be obvious to try placing it at a node because the sensor must be placed where movement can be measured between the anchor and the sleeve as it measures the force acting between the anchor and the sleeve, it can be where the string connects the anchor, where the string connects to the sleeve, in the middle of the string or on the pylorus anchor sensing the anchor expand/contract. Since placing the tension sensor merely involves choosing from a finite number of identified, predictable solutions which are known to be successful, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the invention to place the tension sensor at a node (see MPEP 2143 (I)(E))).
Regarding claim 20, Kalfon further teaches the pyloric anchor comprises a plurality of windings (see annotated fig. 9).
Kalfon and Gertner do not explicitly disclose the tension sensor is located between the windings, however it would be obvious to try placing it between the windings because the sensor must be placed where movement can be measured between the anchor and the sleeve as it measures the force acting between the anchor and the sleeve, it can be where the string connects the anchor, where the string connects to the sleeve, in the middle of the string or on the pylorus anchor sensing the anchor expand/contract. Since placing the tension sensor merely involves choosing from a finite number of identified, predictable solutions which are known to be successful, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the invention to place the tension sensor between the windings (see MPEP 2143 (I)(E))).
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Regarding claim 21, Kalfon and Gertner fail to teach the tension sensor is configured to communicate the migration amplitude to at least one calibrating device. However, Turner further teaches the migration value comprises a migration amplitude (data, ¶ [0081]), and wherein the at least one tension sensor is configured to communicate the migration amplitude to at least one calibrating device (remote device, ¶ [0081]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Kalfon and Gertner to include the tension sensor is configured to communicate the migration amplitude to at least one calibrating device as taught by Turner since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 22, Kalfon fails to teach the tension sensor is configured to continuously sense and monitor. However, Gertner further teaches the at least one tension sensor is configured to continuously sense and monitor a location of the intestinal sleeve. The phrase “the at least one tension sensor is configured to continuously sense and monitor a location of the intestinal sleeve” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the strain gauge is considered to be capable of continuously sensing and monitoring a location of the intestinal sleeve. Further it would by obvious to try as there are a finite number frequencies with the sensor can collect data (discontinuously or continuously). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Kalfon to include the tension sensor is configured to continuously sense and monitor as taught by Gertner in order to reduce slippage that can result in reduced effectiveness of the device as taught by Pool (¶ [0158]).
Regarding claim 23, Kalfon teaches an intestinal sleeve, comprising:
a flexible tubular sleeve open on both ends (408, sleeve, fig. 9);
a pylorus anchor incorporated in one of the ends of the flexible sleeve (508, anchor, fig. 9), the pylorus anchor comprising a plurality of windings (see annotated fig. 9, below).
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Kalfon fails to teach a tension sensor. However, Gertner teaches an obesity treatment system that includes a tension sensor located between the windings (¶ [0037]), the tension sensor configured to sense and communicate a force acting on the pylorus anchor (¶ [0037]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Kalfon to include a tension sensor as taught by Gertner in order to reduce slippage that can result in reduced effectiveness of the device as taught by Pool (¶ [0158]).
Kalfon and Gertner do not explicitly disclose the tension sensor is located between the windings, however it would be obvious to try placing it between the windings because the sensor must be placed where movement can be measured between the anchor and the sleeve as it measures the force acting between the anchor and the sleeve, it can be where the string connects the anchor, where the string connects to the sleeve, in the middle of the string or on the pylorus anchor sensing the anchor expand/contract. Since placing the tension sensor merely involves choosing from a finite number of identified, predictable solutions which are known to be successful, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the invention to place the tension sensor between the windings (see MPEP 2143 (I)(E))).
Regarding claim 24, Kalfon fails to teach the tension sensor is configured to sense strain induced on the pylorus' anchor's windings due to changes in dimensions of the pylorus anchor. However, Gertner further teaches the tension sensor is configured to sense strain induced on the pylorus' anchor's windings due to changes in dimensions of the pylorus anchor (¶ [0037], it would measure the change in dimension as the “spring anchor” of Kalfon expands and contracts). The phrase “the tension sensor is configured to sense strain induced on the pylorus' anchor's windings due to changes in dimensions of the pylorus anchor” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the strain gauge is considered to be capable of sensing strain induced on the pylorus' anchor's windings due to changes in dimensions of the pylorus anchor. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Kalfon to include the tension sensor is configured to sense strain induced on the pylorus' anchor's windings due to changes in dimensions of the pylorus anchor as taught by Gertner in order to reduce slippage that can result in reduced effectiveness of the device as taught by Pool (¶ [0158]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalfon (US 2019/0358066 A1) in view of Gertner (US 2006/0089571 A1), Pool (US 2008/0172072 A1), Forsell (US 2016/0231523 A1) and Turner (US 2005/0165317 A1).
Regarding claim 25, Kalfon teaches inserting intraorally into intestines (¶ [0002]) a gastrointestinal device (fig. 9) and fixing an intestinal sleeve at the entrance to the intestines (408, sleeve, fig. 9, ¶ [0035]).
Kalfon fails to teach at least one tension sensor. However, Gertner teaches an obesity treatment system that includes at least one tension sensor (¶ [0037]); employing at least one tension sensor (the sensor is attached to the gastrointestinal device, it would be employed when the device is implanted) and continuously monitoring a strain applied by the intestinal sleeve and pylorus anchor caused by migration of the intestinal sleeve and pylorus anchor (the sensor monitors strain caused by increasing and decreased the distance between two points, it would by obvious to try continuous monitoring as there are a finite number frequencies with the sensor can collect data [discontinuously or continuously]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Kalfon to include a tension sensor as taught by Gertner in order to reduce slippage that can result in reduced effectiveness of the device as taught by Pool (¶ [0158])
Kalfon and Gertner fail to teach a RFID transmitter. However, Turner teaches a medical device for implantation in the digestive system that includes a RFID transmitter (¶ [0081]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Kalfon and Gertner to include a RFID transmitter as taught by Turner since it is combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Kalfon, Gertner and Turner fail to teach providing a warning when a value of the strain exceeds a preset strain value. However, Forsell teaches a device for an intestinal disorder that includes when a value of the strain caused by migration of the intestinal sleeve and pylorus anchor exceeds a preset strain value, providing a warning to a caregiver (¶ [0103]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Kalfon, Gertner and Turner to include a warning when a value of the strain exceeds a preset strain value as taught by Forsell since it is a combining prior art elements according to known methods to yield predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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