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 .
Election/Restrictions
Applicant's election with traverse of Group V in the reply filed on August 21, 2026 is acknowledged. The traversal is on the ground(s) that there is no serious search burden. This is not found persuasive because art applicable to one group is not necessarily applicable to another group and the groups require different searches. For example, claim 62 recites an air egress port and a heater. These elements are not found in claim 72 which recites different limitations to two catheter systems and is a specific method for treatment of the lungs. The device of claim 62 does not require multiple catheters and is not specific to method steps of use in the respiratory system.
The requirement is still deemed proper and is therefore made FINAL.
Claims 21, 24, 32, 34-39, 54, and 72-74 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 21, 2026
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 43. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because in Fig. 2 reference number 45 appears twice. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the air egress port and flex heating circuit must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: [0095] has two commas after “10”.
Appropriate correction is required.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: terminology to an air egress port and air egress lumen is not explicitly found in the claims, it is not immediately clear which features correspond to the recited claim limitations.
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.
Claim 76 is 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.
It is not clear what is meant by the term “a flex heating circuit.” As this feature is not shown in the figures it is not clear if this refers to electrical circuitry, a path that the heat travels, or some other component involved in heat transmission.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 62, 75, and 77-80 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eshel et al. (US 2021/0059856 A1).
With regard to claims 62 and 75, Eshel et al. teach an apparatus for local delivery of a liquid drug solution to a target tissue area of an internal body organ of a patient, the apparatus comprising: a catheter having: an elongate flexible shaft (Fig. 10B member 202), an expandable member disposed about a distal region of the elongate flexible shaft and being transformable between a collapsed delivery configuration and an expanded configuration for sealing against a wall of a non-vascular natural lumen extending through the target tissue area to form a sealed treatment chamber defined by the wall of the non-vascular natural lumen distal of the expandable member (Fig. 10B member 208 chamber within BL, Fig. 10L inflated via 214 [0073]), an air egress lumen extending from a proximal end of the elongate flexible shaft to an air egress port disposed in the distal region of the elongate flexible shaft, wherein the air egress port is located at a distal end of the expandable member, and is immediately adjacent to the expandable member (Figs. 10B and 10N port member 226, capable of air egress connects to lumen member 220), and a liquid flow lumen for delivery of the liquid drug solution into the sealed treatment chamber, and extending from the proximal end of the elongate flexible shaft to a liquid flow port disposed in the distal region of the elongate flexible shaft, at a location distal to the air egress port (Fig. 10B 222 and 224 connect to liquid lumens 216 and 218, [0073]); a holding container configured to hold the liquid drug solution, the holding container being fluidly coupled with the liquid flow lumen of the catheter external to the patient (Fig. 11C member 56); and a heater configured to heat the liquid drug solution held within the holding container (Fig. 11C member 54), wherein the air egress port is configured to facilitate air evacuation when the heated liquid drug solution is being delivered into the sealed treatment chamber (air is capable of entering the port and lumen as fluid enters), wherein the heated liquid drug solution is heated to a treatment temperature prior to delivery of the heated liquid drug solution into the sealed treatment chamber ([0073] discloses heated fluid is introduced indicating the fluid is heated prior to arrival, [0086] temperature is preset), wherein, after the sealed treatment chamber is filled with the heated liquid drug solution, the air egress lumen, holding container and the liquid flow lumen are configured to be fluidly coupled with each other and the sealed treatment chamber to form a closed fluid circuit, and wherein the closed fluid circuit is configured to permit the heated liquid drug solution to circulate through the sealed treatment chamber ([0073]).
With regard to claims 77-80, fluid is recirculated via peristaltic pump 52 ([0052], [0073]).
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.
Claim(s) 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eshel et al. (US 2021/0059856 A1) as applied to claim 62 above, and further in view of Albalat (WO 2012/168451 A1).
With regard to claim 76, Eshel et al. teach a heat exchanger thermally coupled to the container is used but do not disclose specific details of the heat exchanger. However, Albalat teaches a heat exchanger which includes a metallic layer for conducting heat and providing high performance with improved heat transfer (Pg. 9, Figs. 6 and 8, the non-metallic layers are taken to form the heating circuit as they form the channels through which the fluid flows). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a heat exchanger in Eshel et al. as in Albalat as this provides improved heat transfer and increased performance.
Claim(s) 62 and 75-80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Craig (US 2020/0254225 A1) in view of Albalat (US 2017/0151414 A1) which incorporates Albalat (WO 2012/168451 A1, hereinafter Albalat WO).
With regard to claims 62 and 75-80, Craig teaches an apparatus for local delivery of a liquid drug solution to a target tissue area of an internal body organ of a patient, the apparatus comprising: a catheter having: an elongate flexible shaft (Fig. 8 member 810), an expandable member disposed about a distal region of the elongate flexible shaft and being transformable between a collapsed delivery configuration and an expanded configuration for sealing against a wall of a non-vascular natural lumen extending through the target tissue area to form a sealed treatment chamber defined by the wall of the non-vascular natural lumen distal of the expandable member ([0041], Fig. 8 member 811, [0034] exemplary how such balloons are inflated), an air egress lumen extending from a proximal end of the elongate flexible shaft to an air egress port disposed in the distal region of the elongate flexible shaft, wherein the air egress port is located at a distal end of the expandable member, and is immediately adjacent to the expandable member (Fig. 8 port 814), and a liquid flow lumen for delivery of the liquid drug solution into the sealed treatment chamber, and extending from the proximal end of the elongate flexible shaft to a liquid flow port disposed in the distal region of the elongate flexible shaft, at a location distal to the air egress port (Fig. 8 port 813, see at least [0041] and [0018]-[0021] regarding circulation through ports); a holding container configured to hold the liquid drug solution, the holding container being fluidly coupled with the liquid flow lumen of the catheter external to the patient (exemplary Fig., 6 reservoir 66)); Craig teaches circulating fluid with a pump after air evacuation for chemotherapy treatment (abstract, Fig. 6 pump 67, [0035]) but does not disclose a heater or the specific type of pump. However, Albalat teaches heating chemotherapy fluid is heated with a heat exchanger with a metallic plate which aids in an increase in drug uptake, fluid is recirculated with a peristaltic pump ([0005], [0019], [0037]) The heat exchanger as provided by Albalat WO (incorporated at [0019]) teaches a heat exchanger which includes a metallic layer for conducting heat and providing high performance with improved heat transfer (Pg. 9, Figs. 6 and 8, the non-metallic layers are taken to form the heating circuit as they form the channels through which the fluid flows). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to heat the fluid and use a peristaltic pump in Craig as in Albalat as Albalat teach such a pump is effective for circulating the fluid and heat allows for better uptake of the drug.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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