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 .
Specification
The disclosure is objected to because of the following informalities: the RELATED APPLICATIONS data, found in paragraph 001, needs to be updated to reflect the status of the copending applications (abandoned, allowed, etc.).
Appropriate correction is required.
Claim Objections
Claim1 objected to because:
in line 9: “an energy source being connected to the first array of energy delivery elements”, should read “an energy source being connected to the first array of the energy delivery elements”, for proper and complete antecedent basis.
in line 10: “the second array of energy delivery elements” should read “the second array of the energy delivery elements”, for proper and complete antecedent basis.
in line 17: “providing energy” should read “providing the energy”, for proper and complete antecedent basis.
in lines 17-18: “the first array of energy delivery elements” should read “the first array of the energy delivery elements”, for proper and complete antecedent basis.
in line 22 “the second array of energy delivery elements” should read “the second array of the energy delivery elements”, for antecedent basis.
line 27 reads “wherein a level of energy provided to the first array of energy delivery elements” should read “wherein the level of the energy provided to the first array of the energy delivery elements”, for proper antecedent basis.
line 29 reads “the first array of energy delivery elements” should read “the first array of the energy delivery elements”, for proper and complete antecedent basis.
Claim 2 is objected to because the claim recites “wherein the first array of energy delivery elements and the second array of energy delivery elements comprise an array of bipolar radiofrequency electrodes” which should read “wherein the first array of the energy delivery elements and the second array of the energy delivery elements comprise an array of bipolar radiofrequency electrodes”, for proper and complete antecedent basis.
Claim 3 is objected to because the claim recites “wherein the array of bipolar radiofrequency electrodes comprises multiple rows of bipolar radiofrequency electrodes, and wherein each of the multiple rows of bipolar radiofrequency electrodes comprises multiple bipolar electrode pairs” which should read “wherein the array of the bipolar radiofrequency electrodes comprises multiple rows of bipolar radiofrequency electrodes, and wherein each of the multiple rows of the bipolar radiofrequency electrodes comprises multiple bipolar electrode pairs” for proper and complete antecedent basis.
Claim 4 is objected to because the claim recites “wherein the array of bipolar radiofrequency electrodes comprises multiple rows of bipolar radiofrequency electrodes, and wherein each of the multiple rows of bipolar radiofrequency electrodes comprises at least three bipolar radiofrequency electrodes” which should recite “wherein the array of the bipolar radiofrequency electrodes comprises multiple rows of bipolar radiofrequency electrodes, and wherein each of the multiple rows of the bipolar radiofrequency electrodes comprises at least three bipolar radiofrequency electrodes” for proper and complete antecedent basis.
Claim 5 is objected to because the claim recites “wherein each of the first array of energy delivery elements and the second array of energy delivery elements comprises bipolar electrode pairs” which should recite “wherein each of the first array of the energy delivery elements and the second array of the energy delivery elements comprises bipolar electrode pairs” for proper and complete antecedent basis.
Claim 10, lines 11-12 recite “of other individual subsystems” this should read “of the other individual subsystems” for proper and complete antecedent basis.
Claim 11 recites “wherein the array of energy delivery elements comprises multiple rows of array of energy delivery elements” which should read “wherein the array of the energy delivery elements comprises multiple rows of array of energy delivery elements” for proper and complete antecedent basis.
Claim 12 recites “wherein each of the multiple rows of array of energy delivery elements comprises multiple bipolar electrode pairs” which should read “wherein each of the multiple rows of the array of the energy delivery elements comprises multiple bipolar electrode pairs” for proper and complete antecedent basis.
Claim 13 recites “wherein each of the multiple rows of array of energy delivery elements comprises at least three electrodes” which should read “wherein each of the multiple rows of the array of the energy delivery elements comprises at least three electrodes” for proper and complete antecedent basis.
Claim 14 recites “wherein the array of energy delivery elements comprises bipolar electrode pairs” which should read “wherein the array of the energy delivery elements comprises bipolar electrode pairs” for proper and complete antecedent basis.
Claim 17 recites “wherein the array of energy delivery elements are energized in a cyclical fashion to repeatedly heat the first area of tissue and the second area of tissue” which should read “wherein the array of the energy delivery elements are energized in a cyclical fashion to repeatedly heat the first area of tissue and the second area of tissue” for proper and complete antecedent basis.
Claim 18, line 1 recites “wherein activating, in a cyclical fashion,” this should read “wherein the activating, in the cyclical fashion,” for proper and complete antecedent basis.
Claim 20 objected to because line 19 recites “the first array of energy delivery elements” this should read “the first array of the energy delivery elements” for proper and complete antecedent basis.
Claim 21 recites “wherein the first array of energy delivery elements and the second array of energy delivery elements comprise multiple rows of energy delivery elements” this should read “wherein the first array of the energy delivery elements and the second array of the energy delivery elements comprise multiple rows of energy delivery elements” for proper and complete antecedent basis.
Claim 22 recites “wherein each of the multiple rows of energy delivery elements comprises multiple bipolar electrode pairs” this should recite “wherein each of the multiple rows of the energy delivery elements comprises multiple bipolar electrode pairs” for proper and complete antecedent basis.
Claim 23 recites “wherein each of the multiple rows of energy delivery elements comprises at least three electrodes” this should read “wherein each of the multiple rows of the energy delivery elements comprises at least three electrodes” for proper and complete antecedent basis.
Claim 25 recites “wherein at least one first area of tissue and the second area of tissue are nerve tissue” this should read “wherein at least one of the first area of tissue and the second area of tissue are nerve tissue” for proper and complete antecedent basis.
Claim 26:
line 4 recites “the first array of energy delivery elements” this should read “the first array of the energy delivery elements” for proper and complete antecedent basis.
lines 4-5 recite “a first level of energy” this should read “the first level of energy” for proper and complete antecedent basis.
Claim 27 recites “wherein each of the first array of energy delivery elements and the second array of energy delivery elements comprises bipolar electrode pairs” this should read “wherein each of the first array of the energy delivery elements and the second array of the energy delivery elements comprises bipolar electrode pairs” for proper and complete antecedent basis.
Appropriate correction is required.
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.
Claims 6, 15 and 24 are rejected under 35 U.S.C. 101 because 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.
Claim 6 is 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 6 recites “the inferior turbinate” which lacks proper antecedent basis and positively recites a human body structure. It is suggested that the language is amended to read “inferior turbinate”.
Claims 15 and 24 are 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 recites “the posterior aspect of the inferior turbinate” which lacks proper antecedent basis and positively recites a human body structure. It is suggested that the language is amended to read “a posterior aspect of an inferior turbinate”.
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 1-30 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.
Claims 1, 9, 10, 18-20 and 26 each recite the word “desired” with respect to a treatment level. The metes and bounds of the word “desired” cannot be determined and the use of the word is therefore indefinite. It is suggested that the word “desired” is removed from the claim language.
Claim 1, lines 27-29 recite “wherein a level of energy provided to the first array of energy delivery elements and the second array of energy delivery elements is configured to be independently adjustable”. In this language an energy provided, which is considered to be a signal, is “configured to be independently adjustable”. The energy/signal can be adjusted however the energy/signal itself cannot be configured to be adjusted. The device is configured to adjust the energy/signal. It is suggested that the language is amended to recite that the device is configured and not the energy/signal.
Claim 19, lines 1-3 recite “wherein a level of energy provided to one or more first individual subsystems and the one or more second individual subsystems is configured to be independently adjustable”. In this language an energy provided, which is considered to be a signal, is “configured to be independently adjustable”. The energy/signal can be adjusted however the energy/signal itself cannot be configured to be adjusted. The device is configured to adjust the energy/signal. It is suggested that the language is amended to recite that the device is configured and not the energy/signal.
The remainder of the claims not specifically addressed are also rejected in that they depend from independent claims 1, 10 or 20 which is rejected above.
Allowable Subject Matter
Claims 1-30 are allowed.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is an examiner’s statement of reasons for allowance: the claims are directed towards a method of treating tissue, specifically nasal tissue in a patient.
Regarding claim 1: the prior art fails to disclose or render obvious all of the limitations of claim 1 in combination with an energy source with two output channels to operably connect to the first array and second array of energy delivery elements with cycling energy provided to the tissue by switching the energy between the output arrays.
Regarding claim 10: the prior art fails to disclose or render obvious all of the limitations of claim 10 in combination with individual output channels which electrically isolate the individual outputs in order to activate cyclically the first and second subsystems.
Regarding claim 20: the prior art fails to disclose or render obvious all of the limitations of claim 20 in combination with the first and second output channels allowing for indecent adjustments of the individual subsystems.
DINGER et al. US 20180177546 discloses a soft palate treatment device and method which include advancing the treatment device through a patients mouth to treat soft tissue of the palate (abstract). The device includes a single treatment element with multiple RF electrodes (paragraph 0022, figure 1). However, there is no independent control of input channels as required by the independent claims.
Gonzales et al. US 20120078377 discloses a system, device and method for dilating an anatomical structure (abstract) which includes a treatment device which can treat the sinus cavity (figure 2A). However, there is no independent control of input channels as required by the independent claims.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-272-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
Prosecution Insights