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 Arguments
Applicant's arguments filed 5/26/2026 have been fully considered but they are not persuasive. In response to applicant's argument that Barolat does not disclose the particular staged therapeutic architecture now expressly required by the amended claim 1, 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. In this instance Barolat disclose modular implantation hardware is capable of being inserted in the staged manner as claimed.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, 10-13, and 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 wherein the microstimulator module is one of the plurality of detachable interconnectable modules and wherein the microstimulator module and the first power source are adapted for deployment during a first phase of treatment (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 wherein the receptacle is configured to connect with an already implanted lead or microstimulator module remaining implanted from the first phase of treatment, and wherein the macrostimulator module is adapted for deployment during a second phase of treatment by replacing at least the first power source while the detachable lead remains implanted (e.g. Figure 5a, Element 378).
The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 44 USPQ2d 1429. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 15 USPQ2d 1525 (Fed. Cir. 1990). In this case, the patented apparatus of Barolat discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed system.
Referring to Claim 2, Barolat et al teaches the system of claim 1 wherein the first power source is adapted to be detachably coupled 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 module is adapted to be detachably attachable to the macrostimulator module through an intermediate lead (e.g. Figure 5a, lead 376).
Referring to Claim 15, Barolat et al teaches the system of claim 1, wherein the macrostimulator module 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 wherein the microstimulator module is one of the plurality of detachable interconnectable modules and wherein the microstimulator module and the first power source are adapted for deployment during a first phase of treatment (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, wherein the receptacle is configured to connect with an already implanted lead or microstimulator module remaining implanted from the first phase of treatment, and wherein the macrostimulator module is adapted for deployment during a second phase of treatment by replacing at least the first power source while the detachable lead remains implanted (e.g. Figures 1 an 8A, Element 34 based on Paragraph [0029]).
The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 44 USPQ2d 1429. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 15 USPQ2d 1525 (Fed. Cir. 1990). In this case, the patented apparatus of Slavin discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed system.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 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 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
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