DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 44 is objected to because of the following informalities: In line 5, “high voltage” should be deleted.
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 28-29, 34, 36, 38-39, and 46 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 28 recites the limitation "a production" in lines 3-4. The antecedent basis for this limitation is confusing, since it has already been recited.
Claim 34 recites the limitation "a first location" in line 2. The antecedent basis for this limitation is confusing, since it has already been recited.
Claim 36 recites the limitation "the damaged nerve tissue" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "a production of mucus from the mucus producing cells" in lines 3-4. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “production of mucous”.
Claim 46 recites the limitation "a wall of the airway lumen" in line 3. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “airway wall” (claim 37).
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 27, 34-37, and 44-46 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Danek, U.S. 6,634,363 (hereinafter Danek) in view of Demarais, U.S. 8,347,891 (hereinafter Quinn).
Regarding claims 27 and 34, Danek discloses a method of treating an airway comprising: delivering energy at a first location along the airway (note col. 8, line 56) so as to affect mucous producing cells (‘eliminates cells/glands’ - note col. 8, line 22) to reduce a production of mucous from the mucous producing cells. While Danek discloses using any of a variety of treatment modalities (e.g., radiofrequency, ultrasound, microwave - note col. 8, line 56) for treating the airway, Danek fails to explicitly disclose delivering pulsed high voltage energy to tissue. Demarais teaches (see abstract) a similar method for treating a body lumen using any of a variety of treatment modalities, including pulsed high voltage RF waveforms, microwaves, and ultrasound (note col. 5, line 1). It is well known in the art that a wide variety of treatment modalities could be used interchangeably for treating a body lumen (as seen in both references). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made, to have modified the procedure of Danek to comprise delivering pulsed high voltage energy to tissue (as taught by Demarais). This is because the modification would have merely comprised a simple substitution of interchangeable treatment modalities in order to produce a predictable result (see MPEP 2143). It should be noted that some form of patient assessment (i.e., ‘test’) would necessarily occur before (e.g., to determine if the procedure is needed) and after (e.g., to determine if the procedure is complete) tissue treatment as a part of routine performance of this procedure (note Danek: col. 13, line 16 – col. 14, line 54).
Regarding claim 35, Danek in view of Demarais teaches (see above) a method wherein delivering pulsed high voltage energy comprises: outputting the pulsed high voltage energy from an activatable element of an intraluminal device positioned in the airway to affect mucous producing cells in an airway wall at the first location (note abstract; col. 8, line 3).
Regarding claim 36, Danek in view of Demarais teaches (see above; as best understood by Examiner) a method wherein delivering pulsed high voltage energy comprises: delivering energy from an ablation element of an intraluminal device positioned in the airway lumen to destroy tissue along a wall of the airway lumen (note abstract; col. 8, line 3) while avoiding injury to airway tissue distal the damaged nerve tissue (note col. 12, line 63).
Regarding claims 37 and 44, Danek discloses a method of treating an airway comprising: delivering energy to target tissue along the airway (note col. 8, line 56) so as to reduce a production of mucous (note col. 8, line 22), without significantly damaging a portion of an airway wall of the airway adjacent to the target tissue (note col. 12, line 63). While Danek discloses using any of a variety of treatment modalities (e.g., radiofrequency, ultrasound, microwave - note col. 8, line 56) for treating the airway, Danek fails to explicitly disclose delivering pulsed energy to tissue. Demarais teaches (see abstract) a similar method for treating a body lumen using any of a variety of treatment modalities, including pulsed RF waveforms, microwaves, and ultrasound (note col. 5, line 1). It is well known in the art that a wide variety of treatment modalities could be used interchangeably for treating a body lumen (as seen in both references). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made, to have modified the procedure of Danek to comprise delivering pulsed energy to tissue (as taught by Demarais). This is because the modification would have merely comprised a simple substitution of interchangeable treatment modalities in order to produce a predictable result (see MPEP 2143). It should be noted that some form of patient assessment (i.e., ‘test’) would necessarily occur before (e.g., to determine if the procedure is needed) and after (e.g., to determine if the procedure is complete) tissue treatment as a part of routine performance of this procedure (note Danek: col. 13, line 16 – col. 14, line 54).
Regarding claim 45, Danek in view of Demarais teaches (see above) a method wherein delivering pulsed energy comprises: outputting the pulsed energy from an activatable element of an intraluminal device positioned in the airway proximate the target tissue (note abstract; col. 8, line 3).
Regarding claim 46, Danek in view of Demarais teaches (see above) a method wherein delivering pulsed energy comprises: delivering energy from an ablation element of an intraluminal device positioned in the airway lumen to destroy the target tissue along a wall of the airway lumen (note abstract; col. 8, line 3) while avoiding significant injury to the portion of the airway wall adjacent to the target tissue (note col. 12, line 63).
Claims 28-33 and 38-43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Danek in view of Demarais as applied to claims 27, 34-37, and 44-46 above, and further in view of Quinn, U.S. 6,632,440 (hereinafter Quinn).
Regarding claim 28, Danek in view of Demarais teaches (see above) a method of treating an airway comprising: delivering pulsed high voltage energy to cause damage to tissue at the first location along the airway, so as to reduce a production of mucous from the mucous producing cells. However, Danek fails to explicitly disclose a method that reduces mucus production by damaging nerve tissue at a first location along the airway to attenuate transmission of signals to/from mucus producing cells at a second location along the airway. Quinn teaches (note abstract) a similar method that reduces mucus production by damaging mucus producing cells or damaging nerve tissue (i.e., neuronal cells) in the claimed manner to attenuate transmission of signals to/from the mucus producing cells (note col. 2, line 24; col. 3, line 13). It is well known in the art (as can be seen in Quinn) that either of these sites (i.e., mucus producing cells or the nerves that control them) could be targeted interchangeably for reducing mucus production. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made, to have further modified the procedure of Danek to comprise reducing mucus production by damaging nerve tissue at a first location along the airway to attenuate transmission of signals to/from the mucus producing cells at a second location along the airway. This is because the modification would have merely comprised a simple substitution of interchangeable target sites in order to produce a predictable result (see MPEP 2143).
Regarding claim 38, Danek in view of Demarais teaches (see above) a method of treating an airway comprising: delivering pulsed energy to cause damage to the target tissue at a first location along the airway, so as to reduce a production of mucous from the mucous producing cells. However, Danek fails to explicitly disclose a method that reduces mucus production by damaging nerve tissue at a first location along the airway to attenuate transmission of signals to/from mucus producing cells at a second location along the airway. Quinn teaches (note abstract) a similar method that reduces mucus production by damaging mucus producing cells or damaging nerve tissue (i.e., neuronal cells) in the claimed manner to attenuate transmission of signals to/from the mucus producing cells (note col. 2, line 24; col. 3, line 13). It is well known in the art (as can be seen in Quinn) that either of these sites (i.e., mucus producing cells or the nerves that control them) could be targeted interchangeably for reducing mucus production. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made, to have further modified the procedure of Danek to comprise reducing mucus production by damaging nerve tissue at a first location along the airway to attenuate transmission of signals to/from the mucus producing cells at a second location along the airway. This is because the modification would have merely comprised a simple substitution of interchangeable target sites in order to produce a predictable result (see MPEP 2143).
Regarding claims 29, 31-33, 39, and 41-43, Danek in view of Demarais and Quinn teaches (see above) a procedure that would necessarily meet these limitations during its routine performance.
Regarding claims 30 and 40, Danek in view of Demarais and Quinn teaches (see above) a procedure that would necessarily meet these limitations during its routine performance (note Quinn – col. 1, line 24).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/ Primary Examiner, Art Unit 3794