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 .
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.
Claims 7, 8 and 14 are 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 7 recites the limitation "the second power source module" in line 1. There is insufficient antecedent basis for this limitation in the claim. The examiner assumes this should be the second power source.
Claim 8 recites the limitation "the first power source module" in line 1. There is insufficient antecedent basis for this limitation in the claim. The examiner assumes this should be the first power source.
Claim 14 recites the limitation "the first power source module" in line 1. There is insufficient antecedent basis for this limitation in the claim. The examiner assumes this should be the first power source.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4 and 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barolat et al (US Publication 2012/0232615).
Referring to Claim 1, Barolat et al teaches a system for treating a gastrointestinal condition of a patient with a plurality of detachably interconnectable modules, the system comprising: a microstimulator module (e.g. Figure 5a, Element 330) comprising a pulse generator (e.g. Figure 5a, Element 350) in electrical communication with a detachable lead (e.g. Figure 5a, Element 324) and a first power source to stimulate a treatment site (e.g. Figure 5a, Element 332); a macrostimulator module (e.g. Figure 5a, Element 370) comprising a second power source (e.g. Figure 5a, Element 372) and a receptacle adapted to place the macrostimulator module in electrical communication with the detachable lead (e.g. Figure 5a, Element 378).
Referring to Claim 2, Barolat et al teaches the system of claim 1 wherein the first power source is adapted to be detachably attachable to said pulse generator of the microstimulator module (e.g. pulse generator 350 is detachable from first power source 332 as disclosed in Paragraph [0046]).
Referring to Claim 3, Barolat et al teaches the system of claim 1, wherein the first power source is adapted to be detachably attachable to the pulse generator of the microstimulator module through an intermediate lead (e.g. Figure 5a, lead 356 and Paragraph [0046]).
Referring to Claim 4, Barolat et al teaches the system of claim 1, wherein the first power source is detachably attachable directly to the pulse generator of the microstimulator module (e.g. pulse generator 350 is detachable from first power source 332 as disclosed in Paragraph [0046]).
Referring to Claim 10, Barolat et al teaches the system of claim 1, wherein the macrostimulator module does not have a pulse generator (e.g. Figure 5a, Element 370 and Paragraph [0047] disclose the components in 370 do not contain a pulse generator).
Referring to Claim 11, Barolat et al teaches the system of claim 1, wherein the macrostimulator module and the microstimulator module are adapted to be implanted within a subcutaneous space of the patient (e.g. Paragraph [0048] disclose the system 310 made up of the various modules is implanted).
Referring to Claim 12, Barolat et al teaches the system of claim 1, wherein the macrostimulator module and the microstimulator module are adapted to be implanted within an intra-abdominal space of the patient (e.g. Paragraph [0048]. The examiner notes the recitation of intended use and is capable of being implanted within an intra-abdominal space of the patient. In addition, the prior art does not preclude it from being used within intra-abdominal space of the patient.).
Referring to Claim 13, Barolat et al teaches the system of claim 1, wherein the pulse generator of the microstimulator is adapted to be detachably attachable to the macrostimulator module through an intermediate lead (e.g. Figure 5a, lead 376).
Referring to Claim 14, Barolat et al teaches the system of claim 1, wherein the first power source module is detachably attachable to the pulse generator of the micro stimulator module (e.g. Figure 5a, pulse generator 350 is detachable from first power source 332 as disclosed in Paragraph [0046]).
Referring to Claim 15, Barolat et al teaches the system of claim 14, wherein the macrostimulator is attachable to at least one of the pulse generator of the microstimulator module and the detachable lead (e.g. Figure 5a).
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slavin (US Publication 2014/0194953).
Referring to Claim 1, Slavin teaches a system for treating a gastrointestinal condition of a patient with a plurality of detachably interconnectable modules, the system comprising: a microstimulator module (e.g. Figures 1 and 8C, Element 26”) comprising a pulse generator (e.g. Figure 8C, Element 18) in electrical communication with a detachable lead (e.g. Figure 8C, Element 34 based on Paragraph [0029]) and a first power source to stimulate a treatment site (e.g. Figure 8C, Element 22”); a macrostimulator module (e.g. Figures 1 and 8A, Element 26) comprising a second power source (e.g. Figure 8A, Element 22) and a receptacle adapted to place the macrostimulator module in electrical communication with the detachable lead (e.g. Figures 1 an 8A, Element 34 based on Paragraph [0029]).
Referring to Claim 4, Slavin teaches the system of claim 1, wherein the first power source is detachably attachable directly to the pulse generator of the microstimulator module (e.g. Figure 8c and Paragraph [0031]).
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.
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.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barolat et al (US Publication 2012/0232615) in view of Bar-Yoseph et al (US Publication 2011/0301662).
Referring to Claim 5, Barolat et al teaches the system of claim 1, except wherein the detachable lead has a length in a range of 1 cm to 40 cm and a diameter in a range of 0.1 mm to 3 mm.
Bar-Yoseph et al teaches that it is known to use leads has a length in a range of 1 cm to 50 cm and a diameter in a range of 0.1 mm to 5 mm as set forth in Paragraph [0704] to provide facilitating positioning at and provide the desired amperage toa treatment site in or near the abdominal wall. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Barolat et al, with lead has a length in a range of 1 cm to 40 cm and a diameter in a range of 0.1 mm to 3 mm as taught by Bar-Yoseph et al, since such a modification would provide the predictable results of facilitating positioning at and provide the desired amperage toa treatment site in or near the abdominal wall.
Additionally, 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 Barolat et al with lead having a length in a range of 1 cm to 40 cm and a diameter in a range of 0.1 mm to 3 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Referring to Claim 6, Barolat et al teaches the system of claim 1, except wherein the detachable lead has a length ranging from 1 cm to 100 cm and a diameter ranging from 0.5 mm to 4 mm.
Bar-Yoseph et al teaches that it is known to use leads has a length in a range of 1 cm to 50 cm and a diameter in a range of 0.1 mm to 5 mm as set forth in Paragraph [0704] to provide facilitating positioning at and provide the desired amperage toa treatment site in or near the abdominal wall. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Barolat et al, with lead has a length ranging from 1 cm to 100 cm and a diameter ranging from 0.5 mm to 4 mm as taught by Bar-Yoseph et al, since such a modification would provide the predictable results of facilitating positioning at and provide the desired amperage toa treatment site in or near the abdominal wall.
Additionally, 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 Barolat et al with lead having a length in a range of 1 cm to 100 cm and a diameter in a range of 0.5 mm to 4 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slavin (US Publication 2014/0194953) in view of Rooney et al (US Publication 2007/0073353).
Referring to Claim 7, Slavin teaches the system of claim 1, wherein the second power source module is rechargeable (e.g. Paragraph [0019]). However, Slavin does not explicitly disclose a capacity ranging from 1 milliamp hour (mAh) to 1000 mAh.
Rooney et al teaches that it is known to use a power source with a capacity ranging from 1 milliamp hour (mAh) to 1000 mAh as set forth in Paragraph [0066] to provide sufficient power for the device to operate for a period of time. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Slavin, with a power source with a capacity ranging from 1 milliamp hour (mAh) to 1000 mAh as taught by Rooney et al, since such a modification would provide the predictable results of sufficient power for the device to operate for a period of time.
Additionally, 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 Slavin with a capacity ranging from 1 milliamp hour (mAh) to 1000 mAh, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Referring to Claim 8, Slavin teaches the system of claim 1, wherein the first power source module is non-rechargeable (e.g. Paragraph [0024]). However, Slavin does not explicitly disclose a capacity ranging from 1 milliamp hour (mAh) to 1000 mAh.
Rooney et al teaches that it is known to use a power source with a capacity ranging from 1 milliamp hour (mAh) to 1000 mAh as set forth in Paragraph [0066] to provide sufficient power for the device to operate for a period of time. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Slavin, with a power source with a capacity ranging from 1 milliamp hour (mAh) to 1000 mAh as taught by Rooney et al, since such a modification would provide the predictable results of sufficient power for the device to operate for a period of time.
Additionally, 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 Slavin with a capacity ranging from 1 milliamp hour (mAh) to 1000 mAh, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barolat et al (US Publication 2012/0232615) in view of Maschino et al (US Patent 7,499,752).
Referring to Claim 9, Barolat et al teaches the system of claim 1, except wherein the pulse generator of the microstimulator module is adapted to generate pulses with an amperage ranging from 0.1 mA to 10mA, a frequency ranging from 1 Hz to 100 Hz, a duration ranging from 50 μsec to 1000 μsec, a duty cycle ranging from 1% to 100% and pulse shapes that are either monopolar or bipolar.
Maschino et al teaches that it is known to use a pulse generator with an amperage ranging from 0.1 mA to 10mA, a frequency ranging from 1 Hz to 100 Hz, a duration ranging from 50 μsec to 1000 μsec (e.g. Column 11 lines 24-27) a duty cycle ranging from 1% to 100% (e.g. Column 13 lines 45-48, off time is approximately 1.8 times the length of the on time) and pulse shapes that are either monopolar or bipolar (e.g. Column 17 lines 30-35) to provide optimizing and making treatment adjustable to treat a variety of symptom. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Barolat et al, with a pulse generator with an amperage ranging from 0.1 mA to 10mA, a frequency ranging from 1 Hz to 100 Hz, a duration ranging from 50 μsec to 1000 μsec a duty cycle ranging from 1% to 100% and pulse shapes that are either monopolar or bipolar as taught by Maschino et al, since such a modification would provide the predictable results of optimizing and making treatment adjustable to treat a variety of symptoms.
Additionally, 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 Slavin with a pulse generator with an amperage ranging from 0.1 mA to 10mA, a frequency ranging from 1 Hz to 100 Hz, a duration ranging from 50 μsec to 1000 μsec a duty cycle ranging from 1% to 100% and pulse shapes that are either monopolar or bipolar, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Starkebaum et al (US Publication 2004/01932239) is directed to gastric electrical stimulation for treatment of gastro-esophageal reflux disease.
Swoyer et al (US Publication 2004/0215287) discloses an implantable trial neurostimulation device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM J LEVICKY/Primary Examiner, Art Unit 3796