Patent Application 16806492 - SYSTEM AND METHOD FOR PULMONARY TREATMENT - Rejection

Patent Application 16806492 - SYSTEM AND METHOD FOR PULMONARY TREATMENT

Title: SYSTEM AND METHOD FOR PULMONARY TREATMENT

Application Information

• Invention Title: SYSTEM AND METHOD FOR PULMONARY TREATMENT
• Application Number: 16806492
• Submission Date: 2025-05-22T00:00:00.000Z
• Effective Filing Date: 2020-03-02T00:00:00.000Z
• Filing Date: 2020-03-02T00:00:00.000Z
• National Class: 606
• National Sub-Class: 041000
• Examiner Employee Number: 81356
• Art Unit: 3792
• Tech Center: 3700

Rejection Summary

• 102 Rejections: 0
• 103 Rejections: 1

Cited Patents

The following patents were cited in the rejection:

• US 0039746🔗
• US 0055328🔗

Office Action Text

    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 .

Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 May 2025 has been entered.
New claim 14 is entered; claims 1-13 are pending.

Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.

Response to Arguments
Applicant's arguments filed 14 May 2025 have been fully considered but they are not persuasive. Applicant argues (pages 7-8, “Remarks”) the amendments to the claims. These arguments will be addressed below in the prior art and other rejections.

Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

The following is a quotation of the first paragraph of pre-AIA  35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA  35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims require “delivering unfocused energy from an active portion of the energy delivery element to the treatment site.” No citation of support is provided by the Applicant, and the Examiner is unable to find the term “unfocused” in the Specification. There is no industry specific definition for the term “unfocused energy”, in terms of the metes and bounds of parameters or steps required to provide such energy to a patient. It appears that this amendment is intended to read over the prior art, and contrast to the “focused” energy provided by the references; indeed, this is the heart of the Applicant’s arguments. However, in the originally filed application there is no embodiment where the energy is not focused. In contrast, there are several instances where “focused” energy is provided to the patient. Therefore, there is no evidence that the Applicant’s invention included “unfocused energy” at the time of filing, or indeed what “unfocused energy” is, either in the enclosed arguments or in the originally filed application.

Claim Rejections - 35 USC § 103
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.  
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hissong et al (U.S. 2008/0039746) in view of Mayse et al (U.S. 2007/0055328). Hissong discloses (par. 0118) inserting a first elongate member through at least a portion of a trachea of the subject; positioning an energy delivery element coupled to a distal end of the elongate member proximate a treatment site in or along an airway of the subject; positioning a second elongate member in an esophagus while the first elongate member is positioned in the first airway; delivering energy from an active portion of the energy delivery element to the treatment site (par. 0030); simultaneously while delivering energy, protecting the esophagus and esophageal branches of the vagus nerve outside of the airway to prevent or inhibit permanent damage to the esophagus and/or surrounding tissue proximate or adjacent to the esophagus by flowing a heat absorbing fluid to the second elongate member to absorb heat from a wall of the esophagus; and simultaneously while delivering energy, protecting tissue between the treatment site and the active portion of the energy delivery element by cooling the energy delivery element (par. 0144).
Hissong discloses the claimed invention except for positioning the second elongate member via the pharynx. Mayse, however, discloses (Figure 4; par. 0010; par. 0034) implanting an esophageal probe via a trachea for ablating tissue while proving a cooling fluid to reduce damage to surrounding tissues. Mayse and Hissong both disclose systems for providing both electrical energy and cooling fluid for targeted control of electrical therapeutic delivery. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Hissong’s esophageal placement of both elongate member’s with Mayse’s pharyngeal placement of an elongate device in order to provide a minimally invasive implantation process for greater patient safety and comfort.
Mayse and Hissong disclose the claimed invention but do not disclose expressly delivering “unfocused energy”. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the HIFU as taught by Hissong and the not explicitly focused or unfocused energy of Mayse, with the unfocused energy delivery, because the applicant has not disclosed the use of “unfocused energy” provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the applicant's invention to perform equally well with the HIFU regiment as taught by Hissong and Mayse, because Hissong and Mayse are able to minimize damage to the tissue to be treated as in the claimed invention. Therefore, it would have been an obvious matter of design choice to modify Hissong and Mayse’s method to obtain the invention as specified in the claim.
Regarding claim 2, Hissong discloses (par. 0030) imaging a position of the esophagus relative to the treatment site of the airway of the subject.
Regarding claim 3, Hissong discloses (par. 0030) at least ultrasound.
Regarding claim 4, Hissong discloses (par. 0085) imaging is conducted prior to performing energy delivery.
Regarding claim 5, Hissong discloses (par. 0085) imaging is conducted during energy delivery.
Regarding claims 6-7, Hissong and Mayse disclose the claimed invention but does not disclose expressly the relative sizes of the first and second elongate members. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the sizes of the first and second elongate members as taught by Hissong and Mayse, with the relative sizes in claims 6-7, because the applicant has not disclosed the sizes provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the applicant's invention to perform equally well with undisclosed sizes of the first and second elongate members as taught by Mayse and Hissong, because Mayse and Hissong’s systems are able to safely and effectively deliver energy to targeted regions while protecting surrounding tissue, as in the claims. Therefore, it would have been an obvious matter of design choice to modify Hissong and Mayse’s methods to obtain the invention as specified in the claims.
Regarding claim 8, Hissong discloses (par. 0084) at least controlling energy delivery by rate of power delivery to the energy delivery element.
Regarding claim 9, Hissong discloses (par. 0144) the heat absorbing fluid is circulated within the second elongate member.
Regarding claim 10, Hissong discloses (par. 0144) the heat absorbing fluid is circulated within the second elongate member only while delivering energy from the active portion of the energy delivery element.
Regarding claim 11, Hissong discloses (par. 0146) a second heat absorbing fluid is circulated within the first elongate member to cool the energy delivery element.
Regarding claim 12, Hissong discloses (par. 0118) positioning the energy delivery element in one of the left or right main bronchus distal from a bifurcation of the left and right bronchus such that minimal or no permanent damage to the esophagus and esophageal branches of the vagus nerve occurs during delivery of energy to the treatment site.
Regarding claim 13, Hissong discloses (par. 0229) the active portion of the energy delivery element comprises at least one electrode, and wherein delivering energy while simultaneously protecting the esophagus and esophageal branches of the vagus nerve comprises delivering RF energy to the treatment site.
Regarding claim 14, Hissong discloses (par. 0118) inserting a first elongate member through at least a portion of a trachea of the subject; positioning an energy delivery element coupled to a distal end of the first elongate member proximate a treatment site in or along a lumen of the subject; delivering energy from an active portion of the energy delivery element to the treatment site (par. 0030); simultaneously while delivering energy, protecting the esophagus and esophageal branches of the vagus nerve outside of the lumen to prevent or inhibit permanent damage to the esophagus and/or surrounding tissue proximate or adjacent to the esophagus by flowing a heat absorbing fluid to the second elongate member to absorb heat from a wall of the esophagus; and simultaneously while delivering energy, protecting tissue between the treatment site and the active portion of the energy delivery element by cooling the energy delivery element (par. 0144).
Hissong discloses the claimed invention except for positioning the second elongate member via the pharynx. Mayse, however, discloses (Figure 4; par. 0010; par. 0034) implanting an esophageal probe via a trachea for ablating tissue while proving a cooling fluid to reduce damage to surrounding tissues. Mayse and Hissong both disclose systems for providing both electrical energy and cooling fluid for targeted control of electrical therapeutic delivery. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Hissong’s esophageal placement of both elongate member’s with Mayse’s pharyngeal placement of an elongate device in order to provide a minimally invasive implantation process for greater patient safety and comfort.
Mayse and Hissong disclose the claimed invention but do not disclose expressly delivering “unfocused energy”. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the HIFU as taught by Hissong and the not explicitly focused or unfocused energy of Mayse, with the unfocused energy delivery, because the applicant has not disclosed the use of “unfocused energy” provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the applicant's invention to perform equally well with the HIFU regiment as taught by Hissong and Mayse, because Hissong and Mayse are able to minimize damage to the tissue to be treated as in the claimed invention. Therefore, it would have been an obvious matter of design choice to modify Hissong and Mayse’s method to obtain the invention as specified in the claim.

Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106.  The examiner can normally be reached on Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/           Primary Examiner, Art Unit 3792