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 .
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 1-4, 6-8, 11-17, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Nerandzic (US 2022/0104916).
As for claim 1, Nerandzic shows a device comprising: an elongated and flexible base having a proximal portion (14a, fig. 5) and a distal portion (14b, fig. 5); and a hydrochromic absorbent unit extending from the distal portion (16, fig. 1), the hydrochromic absorbent unit configured to visually indicate when moisture is present ([0074], color changing material is hydrochromic), the hydrochromic absorbent unit sized and shaped for insertion into an endoscope channel (16, 12, fig. 1), wherein when inserted into the endoscope channel, the hydrochromic absorbent unit fills the endoscope channel and absorb any moisture therein 16, 12, fig. 1, abstract).
As for claim 2, Nerandzic shows the hydrochromic absorbent unit is about 1.0 to about 1.2 mm in diameter ([0060], in addition [0062] Nerandzic discloses that the hydrochromic absorbent material preferably conforms to the shape of the channel, thereby ensuring the entire region is swept by the hydrochromic absorbent material).
As for claim 3, Nerandzic shows the hydrochromic absorbent unit is about 1.5 to about 2.5 mm in diameter ([0062] Nerandzic discloses that the hydrochromic absorbent material preferably conforms to the shape of the channel, thereby ensuring the entire region is swept by the hydrochromic absorbent material).
As for claim 4, Nerandzic shows the hydrochromic absorbent unit is about 2.6 to about 4.8 mm in diameter ([0062] Nerandzic discloses that the hydrochromic absorbent material preferably conforms to the shape of the channel, thereby ensuring the entire region is swept by the hydrochromic absorbent material).
As for claim 6, Nerandzic shows the hydrochromic absorbent unit comprises a hydrochromic fabric [0017].
As for claim 7, Nerandzic shows the hydrochromic absorbent unit comprises a hydrochromic ink or hydrochromic dye infused material [0059].
As for claim 8, Nerandzic shows the hydrochromic absorbent unit comprises a sponge [0064].
As for claim 11, Nerandzic shows the hydrochromic absorbent unit circumferentially surrounds the distal portion of the elongated and flexible base (16, 14b, fig. 1).
As for claim 12, Nerandzic shows the hydrochromic absorbent unit surrounds and extends outward from the distal portion of the elongated and flexible base (16, 14b, fig. 1).
As for claim 13, Nerandzic shows a method of drying an endoscope channel, the method comprising: traversing a device including an elongated base and a pliable hydrochromic material into the endoscope channel ([0074], claim 18); running the device through the endoscope channel to soak up any excess moisture [0061]; and observing color of the hydrochromic material upon exit from the endoscope channel to determine whether excess moisture was present in the endoscope channel (claim 18).
As for claim 14, Nerandzic shows wherein pushing the device comprises inserting the device at a proximal end of the endoscope channel (12, 14, fig. 3).
As for claim 15, Nerandzic shows wherein running the device comprises pulling the device through a distal end of the endoscope channel (12, 14, fig. 3).
As for claim 16, Nerandzic shows wherein observing color of the hydrochromic material comprises comparing color of the hydrochromic material upon removal of the device from the channel to color of the hydrochromic material upon insertion in the endoscope channel [0074].
As for claim 17, Nerandzic shows selecting the device based on a size of the endoscope channel [0061].
As for claim 19, Nerandzic shows a kit comprising: an elongated and flexible body for insertion into a lumen of an endoscope (12, 14, fig. 3); and a drying portion attachable to the elongated and flexible body (16, fig. 1), the drying portion comprising a material configured to change color when in contact with moisture [0074], wherein the drying portion is configured to expand within the lumen when inserted, such that the drying portion contacts walls of the lumen and absorbs moisture therein [0062].
As for claim 20, Nerandzic shows the color-changing material comprises a hydrochromic pigment hosted in a substrate, the hydrochromic pigment configured to change color when in contact with moisture [0074].
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nerandzic as applied to claim 1 above.
Nerandzic discloses the claimed invention except for the elongated and flexible base is about 200 cm to about 250 cm in length. However, the length of the elongated and flexible base is a result effective variable which achieves a recognized result in the ability to extend through and beyond the length of the endoscopic channel. Beyond this result, the determination of the optimal workable range would require no more than routine experimentation by one of ordinary skill in the art at the time of filing. Therefore It would have been obvious for one of ordinary skill in the art at the time of filing to modify the dryer as disclosed by Nerandzic with the elongated and flexible base is about 200 cm to about 250 cm in length as a routine matter of experimentation to facilitate working in and out of the endoscopic channel.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Nerandzic as applied to claim 1 above and further in view of Sweeney (US 2014/0237748).
As for claims 9 and, Nerandzic discloses a flexible metal catheter [0063] and the claimed invention except for the elongated and flexible base comprises a polymer catheter; and wherein the elongated and flexible base comprises a twisted polymer cable. Sweeney teaches the elongated and flexible base comprises a polymer catheter (120, fig. 1, [0028]); wherein the elongated and flexible base comprises a twisted polymer cable (100, fig. 1, [0027], microfiber is made from polymers) in order to provide an inexpensive disposable material. Nerandzic would benefit equally from a less expensive material that could be readily disposable. It would have been obvious for one of ordinary skill in the art at the time of filing to modify the dryer as disclosed by Nerandzic with the elongated and flexible base comprises a polymer catheter; and wherein the elongated and flexible base comprises a twisted polymer cable as taught by Sweeney in order to provide an inexpensive disposable material.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nerandzic as applied to claim 13.
Nerandzic does not expressly disclose repeating the method if moisture was detected in the endoscope channel. However, Nerandzic does disclose in [0058] to run the flexible base through the channel and determine whether there is still residual water in the channel. Since [0003] discloses the need for the process to continue until the channel is dry, It would have been obvious for one of ordinary skill in the art at the time of filing to use the drying method disclosed by Nerandzic repeatedly until the method indicated no presence of water, at which time the method is completed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN PATRICK MCCORMACK whose telephone number is (571)270-7472. The examiner can normally be reached 9:00 - 1:30 PST.
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/JOHN P MCCORMACK/Primary Examiner, Art Unit 3762
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