DETAILED ACTION
This is a non-final rejection in response to application filed 10/11/23. Claims 1-20 are currently pending.
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.
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) 1-11 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaine et al. (US 2011/0054386) in view of Gorham (US 2007/0282400).
Regarding independent claim 1 and claim 19, Blaine teaches a device for preparing a skin tissue site for needle puncture comprising: a framework 11, the framework comprising a framework first side, a framework second side, and a framework adjustable side, the framework first side and framework second side each connected to the framework adjustable side, and the framework first side and framework second side defining a space between each other; wherein the framework is sized and configured to be attached to a body adjacent to skin [0017, 0024]; a vibrator 26 connected to the framework and operable to convey vibrations to at least one of the framework first side and the framework second side.
Blaine is silent to an electrical stimulation device having a portion connected to the framework and operable to electrically stimulate nerves in tissue.
Gorham teaches an electrical stimulation device having a portion connected to the framework and operable to electrically stimulate nerves in tissue [0021,0038, 0045-0046].
It would have been obvious to one of ordinary skill at the time of filing to provide the device of Blaine with the electrical stimulation of Gorham, as Gorham teaches a TENS-based electrical stimulation device rapid synergistic healing effect when combining vibratory and electrical neuromodulation and improved stimulation [0021,0046].
Regarding dependent claim 2, Blaine in view of Gorham teaches the invention as claimed and discussed above. Blaine further teaches a vibrator but is silent to wherein the vibrator is on the framework first side and comprising a second vibrator on the framework second side. It would have been obvious to provide a second vibrator on the framework second side for optimization of both ergonomics and clinical applicability to tailor the device for specific puncture sites.
It has been held in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, see MPEP 2144.04 VIB.
Regarding dependent claim 3, Blaine in view of Gorham teaches the invention as claimed and discussed above. Blaine in view of Gorham teaches the motor on the head of the housing or within the head of the applicator [0031 Blaine, 0042 Gordon] but is silent to wherein the vibrator is on the framework adjustable side.
It would have been obvious to one of ordinary skill in the art at the time of filing to locate the vibrator is on the framework adjustable side, to ensure consistent vibration delivery directly at the point of adjustment.
Regarding dependent claim 4, Blaine in view of Gorham teaches the invention as claimed and discussed above. Gorham teaches wherein the electrical stimulation device is a transcutaneous electrical nerve stimulation device [0025].
Regarding dependent claim 5, Blaine in view of Gorham teaches the invention as claimed and discussed above. Gorham teaches wherein the electrical stimulation device comprises a first electrode 18 on a skin-facing side of the framework first side, and a second electrode 18 on a skin facing side of the framework second side [0024-0025].
Regarding dependent claim 6, Blaine in view of Gorham teaches the invention as claimed and discussed above. Gorham teaches electrodes 18 on the applicator head common plane 19 which contacts the tissue 20. However, Blaine in view of Gorham is silent to wherein the first electrode is on an outer surface of the framework first side, and wherein the second electrode is on an outer surface of the framework second side.
It would have been obvious to one of ordinary skill in the art at the time of filing to locate the first electrode is on an outer surface of the framework first side, and wherein the second electrode is on an outer surface of the framework second side, to maximize contact area with the skin during the needle preparation procedure.
Regarding dependent claim 7, Blaine in view of Gorham teaches the invention as claimed and discussed above. Blaine further teaches further comprising a power supply 16 operable to provide electrical power to the vibrator and to the electrical stimulation device. As combined, the power source would be adapted to provide power to the electrical stimulation device as well.
Regarding dependent claim 8, Blaine in view of Gorham teaches the invention as claimed and discussed above. Blaine further teaches further comprising a controller 30 [0031] (Gorham also teaches a controller 12), the controller in electronic communication with both the vibrator and the electrical stimulation device and operable to control an operation of each.
Regarding dependent claim 9, Blaine in view of Gorham teaches the invention as claimed and discussed above. Blaine further teaches further comprising a controller 30 [0031] (Gorham also teaches a controller 12), the controller in electronic communication with both the vibrator and the electrical stimulation device and operable to control an operation of each.
Regarding dependent claim 10, Blaine in view of Gorham teaches the invention as claimed and discussed above. Gorham further teaches wherein the controller is programmed to activate and deactivate the vibrator and electrical stimulation device simultaneously [0042].
Regarding dependent claim 11, Blaine in view of Gorham teaches the invention as claimed and discussed above. Gorham further teaches wherein the controller is programmed to activate and deactivate the vibrator and electrical stimulation device sequentially [0042].
Regarding dependent claim 15, Blaine in view of Gorham teaches the invention as claimed and discussed above. Gorham further teaches further comprising a cord retention post attached to the controller, the cord retention post configured to secure a wire connecting the power supply to the framework [0041].
Regarding independent claim 16, Blaine teaches a skin stimulation system comprising a framework 11, the framework comprising a framework first side, a framework second side, and a framework adjustable side, the framework first side and framework second side each connected to the framework adjustable side, and the framework first side and framework second side defining a space between each other; wherein the framework is sized and configured to be attached to a body adjacent to skin [0017, 0024]; a vibrator 26 connected to the framework and operable to convey vibrations to at least one of the framework first side and the framework second side; a power supply 16 operable to provide electrical power to the vibrator and to the electrical stimulation device; a controller 30.
Blaine is silent to an electrical stimulation device having a portion connected to the framework and operable to electrically stimulate nerves in tissue; wherein the electrical stimulation device is a transcutaneous electrical nerve stimulation device, wherein the electrical stimulation device comprises a first electrode on an outer surface of a skin-facing side of the framework first side, and a second electrode on an outer surface of a skin facing side of the framework second side; the controller in electronic communication with both the vibrator and the electrical stimulation device and operable to control an operation of each, wherein the controller has a first programming operable to activate and deactivate the vibrator and electrical stimulation device simultaneously, and has a second programming operable to activate and deactivate the vibrator and electrical stimulation device sequentially.
Gorham teaches an electrical stimulation device having a portion connected to the framework and operable to electrically stimulate nerves in tissue [0021,0038, 0045-0046]. Gorham teaches wherein the electrical stimulation device comprises a first electrode 18 on a skin-facing side of the framework first side, and a second electrode 18 on a skin facing side of the framework second side [0024-0025]. Gorham further teaches wherein the controller is programmed to activate and deactivate the vibrator and electrical stimulation device simultaneously [0042].
It would have been obvious to one of ordinary skill at the time of filing to provide the device of Blaine with the electrical stimulation of Gorham, as Gorham teaches a TENS-based electrical stimulation device rapid synergistic healing effect when combining vibratory and electrical neuromodulation and improved stimulation [0021,0046].
Regarding dependent claim 17, Blaine in view of Gorham teaches the invention as claimed and discussed above. Blaine further teaches a vibrator but is silent to wherein the vibrator is on the framework first side and comprising a second vibrator on the framework second side. It would have been obvious to provide a second vibrator on the framework second side for optimization of both ergonomics and clinical applicability to tailor the device for specific puncture sites.
It has been held in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, see MPEP 2144.04 VIB.
Gorham teaches electrodes 18 on the applicator head common plane 19 which contacts the tissue 20. However, Blaine in view of Gorham is silent to wherein the first electrode is on an outer surface of the framework first side, and wherein the second electrode is on an outer surface of the framework second side.
It would have been obvious to one of ordinary skill in the art at the time of filing to locate the first electrode is on an outer surface of the framework first side, and wherein the second electrode is on an outer surface of the framework second side, to maximize contact area with the skin during the needle preparation procedure.
Regarding dependent claim 18, Blaine in view of Gorham teaches the invention as claimed and discussed above. Blaine in view of Gorham teaches the motor on the head of the housing or within the head of the applicator [0031 Blaine, 0042 Gordon] but is silent to wherein the vibrator is on the framework adjustable side.
It would have been obvious to one of ordinary skill in the art at the time of filing to locate the vibrator is on the framework adjustable side, to ensure consistent vibration delivery directly at the point of adjustment.
Regarding dependent claim 20, Blaine in view of Gorham teaches the invention as claimed and discussed above. Gorham further comprising the step of applying a saline solution to skin at or close to the electrical stimulation device of the patient before the step of activating the electrical stimulation device [0042].
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaine in view of Gorham and further in view of McEwen et al. (US 8048105).
Regarding dependent claim 12, Blaine in view of Gorham teaches the invention as claimed and discussed above. Blaine in view of Gorham is silent to further comprising a tourniquet.
McEwen teaches it was known to have a tourniquet system in a similar device (col. 3, l. 62-col.4 l. 51).
It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Blaine in view of Gorham with the tourniquet system of McEwen, as McEwen teaches pressure regulation (col. 5, l. 26-39), which would in turn improve efficiency and predictability.
Regarding dependent claim 13, Blaine in view of Gorham and further in view of McEwen teaches the invention as claimed and discussed above. McEwen further teaches further comprising a power supply 76 attached to the tourniquet, the power supply operable to provide electrical power to the vibrator and to the electrical stimulation device, and further comprising a controller attached to the tourniquet, the controller in electronic communication with both the vibrator and the electrical stimulation device and operable to control an operation of each. As combined, the power source would be adapted to provide power to the electrical stimulation device as well.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaine in view of Gorham and further in view of Cherubini (US 5015251).
Regarding dependent claim 14, Blaine in view of Gorham teaches the invention as claimed and discussed above. Blaine in view of Gorham is silent to further comprising an adjustable strap connected to the framework.
Cherubini teaches further comprising an adjustable strap connected to the framework (col. 1, l. 21-35).
It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Blaine in view of Gorham with the adjustable strap of Cherubini, as Cherubini teaches versatility and low cost strap which is reusable and easily applied (col. 1, l. 21-35).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG SANG KIM whose telephone number is (571)270-1418. The examiner can normally be reached 7:00 AM - 3:00 PM.
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, Devon Kramer can be reached at 571-272-7118. 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.
/CRAIG KIM/
Primary Examiner
Art Unit 3741