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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/15/22 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
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 1 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. “M channels” is unclear. Claims 2-9 are further rejected based on dependency on claim 1.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1-3, 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suzhou Genke Medical Technology Co. LTD (CN 104434258) (“Suzhou”).
Suzhou discloses: a catheter comprising [0016-0022], Figs. 1-9: a catheter hub located at the proximal end of the catheter, a dilation balloon 4 located at the distal end of the catheter and a balloon dilation channel 15, a positioning and detection channel 13, a supply channel 14 and a secretion removal channel 16; the catheter hub is a multi-channel connection device through which the at least four channels are respectively connected to the external therapeutic devices of the catheter (Fig. 1, elements 9-12).
The balloon dilation channel 15 connected to a balloon inflation device (a balloon inflation apparatus) through the catheter hub and the dilation balloon 4 has a dilation port 7; the secretion removal channel 16 is connected to a sputum aspirator or a pressure syringe through the catheter hub and has a lavage port 8, 17; the supply channel is connected to the supply device through the catheter hub and has a supply port; the positioning and detection channel 13 runs through both ends of the catheter and can be used for a guide wire, biopsy forceps or fiber optic endoscope to pass through.
The cross-sectional area of the secretion removal channel is larger than that of the balloon dilation channel and the supply channel. (Fig. 2)
The catheter and channels are made from a polymer material. (inherent material selection for a medical use catheter)
A Luer connector (elements 9-12) is connected to the catheter hub, used for connecting the channels and corresponding external therapeutic devices.
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Suzhou.
Suzhou discloses the invention as substantially claimed but does not directly disclose the diameters of the channels or the dilation pressures and sizes of the dilation balloon. These elements in claims 4-6 are design considerations dependent on use of the device. Accordingly, depending on the desired use of the device, such modifications would be made to the size of the channels and the pressures and sizes of the dilation balloon in accordance with this use. Such a modification would have been considered a mere design consideration which fails to patentably distinguish over Suzhou.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Suzhou in view of Fischer, Jr. (US 5,544,648) (“Fischer”).
Suzhou discloses the device as substantially claimed but does not directly disclose the method of inserting the catheter into the bronchus of the lungs to supply oxygen or medicine to the designated position and performing lavage and sputum suction in the designated position. Fischer, in the analogous art, teaches delivery of a similar device into the bronchus of the lungs to supply oxygen and to suction the lungs as appropriate, see Figs. 1-2. Therefore, 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 the device of Suzhou in a similar manner as the method as taught by Fischer to provide therapy to the lungs.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 9:00am-5:30pm est.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783