The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Arguments
The previously applied claim objections, and rejections under 35 USC 112(b) and 101 are herein withdrawn in light of the amendments to the claims. Additionally, applicant’s arguments with respect to the previous prior art rejections of the claims have been considered but are moot in view of the new grounds of rejection, which are necessitated by the amendments.
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.
Claims 1, 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (US Patent Pub. No. 2010/0211131) in view of Lovett et al. (US Patent No. 8,715,327).
Regarding claims 1 and 8, Williams discloses an intravascular system and method for blood pressure control (see Title). Williams teaches, in one embodiment, that micro-actuators 240 may be provided on a stent 223e as shown in Figures 20A-20B (see paragraph 75). “When activated, the micro-actuators 240 can vibrate or mechanically expand the stent, causing the carotid to experience mechanical pressure and to thereby activate a baroreceptor response” (see paragraph 76). This teaches “positioning a stent within a blood vessel…”, and “activating the … baroreceptor: (a) only via stretching of the vasculature by the stent; ... allowing an increased flow of blood through the vasculature that is stretched”.
In a different embodiment, Williams teaches “Referring to FIG. 16, the first component is an intravascular lead 214… The lead includes an energy generating component 218 that is positioned such that it may effectively transfer energy E … across the interstitial space to a second component 222… The energy generating component 218 can be composed of various classical energy transmission technologies, including … electrical” (see paragraph 67). “The second component 222 is an energy receiving component positioned to receive the energy E from the first component 218 and relay that energy in some form towards target structures. In preferred embodiments, the second component 222 is positioned for stimulation of the baroreceptors of the carotid bulb, or the associated carotid sinus nerves, to activate a baro-response for the treatment of hypertension” (see paragraph 68). This teaches “introducing a separate lead within the blood vessel at or near… a baroreceptor, the lead comprising a proximal end (which is not shown in Williams) and a distal end (which is shown in Williams) and an electrode connected to the distal end of the lead (see it would be obvious that there is an electrode for transferring the energy, as taught by Williams in paragraph 67), activating the … baroreceptor: (b) only via causing the electrode to emit one or more electrical signals defining an electrical stimulus to the … baroreceptor (see paragraphs 67-68 as quoted above), … allowing an increased flow of blood through the vasculature that is stretched.”
While Williams teaches each of these embodiments separately, Williams explicitly states that “additional features may be added to the disclosed components to supplement stimulation capabilities, and the various embodiments can be combined in a number of ways to form additional embodiments” (see paragraph 78). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the two above-described embodiments of Williams into a single embodiment in which both separate embodiments are combined, thereby forming an additional embodiment, which is explicitly disclosed by Williams in paragraph 78. By this stated combination, this would teach option (c) as presented in the claims, where a combination of stretching and electrical stimulation would be used.
With regard to the claimed “low-pressure volume baroreceptor”, Williams teaches that “the description of FIGS. 16 through 20B has largely discussed use of the system in the internal jugular and carotid artery, but has applications elsewhere in the vasculature” (see paragraph 78). While this teaches to use these methods in other areas of the vasculature, which can include low-pressure volume baroreceptor locations, assuming the applicant disagrees that this passage of Williams is sufficient, then attention is made to Lovett, who teaches baroreflex modulation using light-based stimulation (see Title). While Lovett teaches embodiments in which light is used to stimulate the baroreceptor(s), what is more important here is that Lovett teaches that “the present invention may activate baroreceptors, mechanoreceptors, pressoreceptors, stretch receptors, chemoreceptors, or any other venous, heart, or cardiopulmonary receptors which affect the blood pressure, nervous system activity, and neurohormonal activity in a manner analogous to baroreceptors in the arterial vasculation. For convenience, all such venous receptors will be referred to collectively herein as "baroreceptors" or "receptors" unless otherwise expressly noted” (see column 6, lines 17-26). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date
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of the instant application to activate venous receptors, as taught by Lovett, within the system and methods of Williams, if and when such treatment is desired and needed for a patient.
With regard to the claimed “in or near the superior vena cava”, Williams teaches that “the description of FIGS. 16 through 20B has largely discussed use of the system in the internal jugular and carotid artery, but has applications elsewhere in the vasculature” (see paragraph 78). While this teaches to use these methods in other areas of the vasculature, it is noted that the internal jugular veins are both near the superior vena cava (SVC), as shown in the image to the right.
Regarding claim 5, it is noted that Williams teaches the use of a pulse generator (see paragraph 14, “The lead and electrode(s) conduct energy from the pulse generator to the nervous system target”). Obviously, a pulse generator would generate pulses.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Lovett as applied to claim 1 above, and further in view of Kieval (US Patent No. 8,583,236).
Williams in combination with Lovett is described above with respect to claim 1. While there is a rejection which states that it would be obvious that a pulse generator would generate pulses, there is no description of a constant electrical energy.
Kieval teaches “devices, systems and methods are disclosed by which the blood pressure, nervous system activity, and neurohormonal activity may be selectively and controllably reduced by activating baroreceptors” (see Abstract). Kieval discloses that the electrode is configured to emit an intermittent electrical stimulus (see column 12, Line 44-53, electrical activation can be modulated pulses), and also that the electrode is configured to emit an intermittent electrical stimulus (see column 12, Line 42-44, electrical activation can be constant current or constant voltage).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use either one of a constant current/voltage or a pulsed electrical stimulation, as taught by Kieval, with the system and methods of Williams depending upon the needs of the patient and the desired results for the baroreceptor stimulation, and because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Conclusion
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 JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p 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, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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