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 .
This Office Action is in response to the amendments dated February 4, 2026.
Claims 17-20, 22, 25-27, and 39-49 are pending.
Drawings
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 “deformable sheath”, “distensible portion”, “operating channel” must be shown or the feature(s) canceled from the claim(s). The claimed embodiment is shown in Figs. 8A-8B. These figures do not show a working channel 150, nor do they show expandable portion 122. 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.
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.
Claims 17-18, 20, 25-27, 39, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Reid, Jr. (US 4,800,870) in view of Kucharski et al. (US 2017/0035277).
Regarding Claim 17, Reid discloses:
An endoscopy system comprising:
a sheath (6) comprising a lumen (see Fig. 2 showing sheath 6 surrounding a lumen), a distal-most end of the sheath comprising an opening (see Fig. 6 showing 7 extending out of an opening at the distal end of the sheath); and
a working channel (5) disposed within the lumen, and
a stylet configured to perform an arthroscopic procedure, the stylet sized to fit within the working channel (see Fig. 2, for example, showing stylet 7 withing channel 5 of endoscope 6), and the stylet having a rigidity sufficient to bend the distal portion of the sheath when the stylet is advanced distally past at least a portion of the image sensor (see Col 3 Lines 32-36 discussing how the stylet provides the rigidity and shape to the larger device).
Reid does not explicitly disclose a distal portion of the sheath being deformable; an image sensor disposed within the lumen of the distal portion of the sheath; an illuminating element disposed within the lumen adjacent to the image sensor (although 3 is a cable containing viewing and light fiber bundles); the working channel comprising a distensible portion that extends past at least a portion of the image sensor.
Kucharski teaches using a sheath with a deformable section (21) and a distensible working channel (23; see Figs. 2-4) to provide a reduced profile during insertion and an increased profile for larger tools to be inserted at the target site. 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 modify Reid’s system to include Kucharski’s deformable and distensible elements. Such a modification allows for a reduced insertion profile and an enlarged working profile.
Kucharski also discloses an imaging sensor (22 is a CMOS camera) and an illuminating element (25). As seen in Fig. 4, the distensible portion of the channel extends past the imaging system 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 modify Reid’s system to include Kucharski’s image sensor. Such a modification incorporates old and well-known elements (CCD or CMOS chips) to yield predictable results, namely to obtain an image. These chips are small and are commonly placed at the distal end of the scope in place of imaging fibers.
Regarding Claim 18, Reid as modified further discloses wherein the stylet is malleable and can be re-formed by a user (Col 4 Line 21).
Regarding Claim 20, Reid as modified further discloses wherein the stylet, when received within the working channel, extends through the sheath along with an operating channel (see Fig. 2 showing additional channels like channel 4) that is sized to receive a tissue-cutting tool. The Examiner notes that adding additional channels is known in the art for allowing multiple tools to be used at the site at the same time. This of course increases the diameter of the device, but that is a tradeoff a person having ordinary skill in the art may decide to make if the procedure dictates it. Kucharski teaches as much indicating that multiple channels can be used if desired (see Paragraph 00062). 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 modify Reid’s system to include an operating channel sized to receive a tissue-cutting tool.
Regarding Claim 25, Reid as modified further discloses wherein the sheath can deform from a low-profile configuration to a high-profile configuration, the sheath having a first greatest outer diameter in the low-profile configuration and having a second greatest outer diameter in the high-profile configuration (see Kucharski Figs. 3 and 4), a ratio between first and second greatest diameters being within a range of between 0.1 and 0.8 (see Kucharski Paragraph 0068 discussing the various sizes). The Examiner notes that modifying the amount of increase is considered obvious as it is simply routine optimization. A person having ordinary skill in the art would have a reasonable expectation of success in that any modification is the simple change in relative dimensions. Therefore, to the extent the references do not read on the claim, a person having ordinary skill in the art before the effective filing date of the claimed invention would have found such a modification obvious.
Regarding Claim 26, Reid further discloses wherein the distensible portion of the working channel can deform from a low-profile configuration to a high-profile configuration, the distensible portion of the working channel having a first greatest outer diameter in the low-profile configuration and having a second greatest outer diameter in the high-profile configuration (see Kucharski Figs. 3 and 4), a ratio between first and second greatest outer diameters being within a range of between 0.1 and 0.8 (see Kucharski Paragraph 0068 indicating that the size can be less than or equal to twice the diameter of the insertion tube). The Examiner notes that modifying the amount of increase is considered obvious as it is simply routine optimization. A person having ordinary skill in the art would have a reasonable expectation of success in that any modification is the simple change in relative dimensions. Therefore, to the extent the references do not read on the claim, a person having ordinary skill in the art before the effective filing date of the claimed invention would have found such a modification obvious.
Regarding Claim 27, Reid as modified further discloses wherein a ratio of the first greatest outer diameter to a greatest diameter of the image sensor is no more than about 1.4 (see Kucharski Paragraph 0112 discussing the 1.2 mm camera and Paragraph 0068 discussing the low-profile diameter of between 1.5 and 20 mm). The Examiner also notes that modifying the relative size of the sheath to the image sensor is considered obvious as it is simply routine optimization. A person having ordinary skill in the art would have a reasonable expectation of success in that any modification is the simple change in relative dimensions. Therefore, to the extent the references do not read on the claim, a person having ordinary skill in the art before the effective filing date of the claimed invention would have found such a modification obvious.
Regarding Claim 39, Reid as modified further discloses:
A method of preparing the stylet of the endoscopy system of claim 17 for use with an arthroscopic procedure (see rejection of Claim 17 above), the method comprising:
bending a distal portion of the stylet to a desired shape (Col 3 Lines 49-53); and
inserting the distal portion of the stylet into the working channel of the endoscopy system (Col 3 Lines 49-53).
Regarding Claim 42, Reid as modified further discloses wherein the stylet is inserted into the working channel of the endoscopy system prior to inserting the endoscopy system into a patient (Col 3 Lines 51-62; stylet is shaped, inserted into the scope, and then the entire system is moved toward the patient).
Regarding Claim 43, Reid as modified further discloses wherein the stylet is inserted into the working channel of the endoscopy system after the endoscopy system has been inserted into a patient (Col 4 Lines 18-24, the scope is inserted into the patient, removed, the stylet reshaped, and then the system is reinserted; this means the stylet is inserted at some point after the system was initially inserted).
Claims 19 and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Reid, Jr. (US 4,800,870) and Kucharski et al. (US 2017/0035277), as applied to claims 17 and 39 above, and further in view of Oneda et al. (US 6,174,280).
Reid and Kucharski disclose the invention substantially as claimed as stated above.
Regarding Claims 19 and 40-41, Reid also discloses that stylet 7 is a fine wire and a malleable wire (Col 3 Lines 14 and 29), but Reid does not explicitly mention re-forming the stylet by hand without requiring use of a tool. The Examiner asserts two things. First, a person having ordinary skill in the art would consider Reid’s malleable wire to be capable of this. The stylet is a relatively small diameter wire, and as is known in the art and life in general, such wires, like those in pipe cleaners, are shapeable by hand. Second, Oneda teaches in a similar device a shapeable member that is bent by hand (see Col 7 Lines 35-40). 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 make Reid’s stylet shapeable by hand without the need of a tool. Such a modification allows the user to easily adjust the shape as is known in the art.
Claims 22 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Reid, Jr. (US 4,800,870) and Kucharski et al. (US 2017/0035277) in view of Wappler (US 2,118,631).
Reid and Kucharski disclose the invention substantially as claimed as stated above.
Regarding Claim 22, Reid does not explicitly disclose wherein the stylet comprises a material selected from the group consisting of steel, tungsten, titanium, a shape memory material (for example, nitinol), and polymeric material. Wappler teaches using steel (Col 3 Lines 8-9) for a flexible, malleable wire. Furthermore, the claimed materials are old and well-known in the art. 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 modify Reid’s stylet to be made from steel or another well-known material. Such a modification incorporates a well-known biocompatible material into the device as is known in the art.
Regarding Claim 44, Reid further discloses selecting the stylet from a plurality of stylets (the stylet in Reid is selected and there are numerous stylets known in the art, one of which is Wappler, such that the stylet is selected from among a plurality of stylets), but does not explicitly disclose at least one of the plurality of stylets having a length or outer diameter dimension that is different from that of the stylet that is selected. The Examiner considers this obvious for several reasons. First, giving the user options when picking a stylet allows the user to choose a stylet that most fits the procedure and the patient anatomy. This is common in surgical procedures as kits come with different components and similar components in different sizes. Second, even if the limitation were not obvious using general principles, Reid’s stylet is clearly not the only known stylet in the world. When a user selects Reid (or any other stylet), the selection is relative to other options. These options are going to have different dimensions. For example, a user may select a stylet sized for a pediatric procedure. The size of the stylet will be smaller than that of a normal or adult-sized stylet. Therefore, it would have been obvious to a person having ordinary skill in the art to modify Reid’s method to have the user select from a plurality of differently dimensioned stylets. Such a modification incorporates standard practices involving having different sizes available so that the user can select the appropriate size given the patient and procedure. Furthermore, the reality of there being a variety of known stylets that will not all have the exact same dimensions means that the user is selecting one stylet from many.
Claims 45-49 are rejected under 35 U.S.C. 103 as being unpatentable over Reid, Jr. (US 4,800,870) and Kucharski et al. (US 2017/0035277), as applied to claims 17 and 39 above, and further in view of Adair (US 4,782,819).
Reid and Kucharski disclose the invention substantially as claimed as stated above.
Regarding Claims 45-46, Reid further discloses performing a procedure with the stylet and endoscopy system, said arthroscopic procedure comprising: inserting the stylet into a proximal end of the working channel (see Fig. 2, for example, showing stylet 7 withing channel 5 of endoscope 6); advancing the stylet within the working channel distally past at least a portion of the portion of the working channel (see Fig. 6 showing 7 past the distal end of 6); and bending the sheath (see Col 3 Lines 32-36 discussing how the stylet provides the rigidity and shape to the larger device).
Reid does not explicitly disclose performing an arthroscopic procedure and extending the stylet past a distensible portion of the working channel. Adair teaches using an endoscope assembly that can be bent as desired within a joint (Col 3 Lines 29-33). 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 modify Reid and Kucharski’s method to be performed in a joint. Such a modification applies Reid’s system to a known procedure that is known to have similar requirements of a bendable, malleable device.
Regarding Claim 47, Reid as modified further discloses wherein bending the sheath changes a field illuminated by the illuminating element (3 will change direction when the sheath bends).
Regarding Claim 48, Reid as modified further discloses wherein bending the sheath changes a range accessible by a tool extending distally through the opening of the sheath (channel 4 will change its direction such that a tool will have a different range upon exiting).
Regarding Claim 49, Reid as modified further discloses bending a distal portion of the stylet to a desired shape prior to inserting the stylet into a proximal end of the working channel (Col 3 Lines 51-62; stylet is shaped, inserted into the scope, and then the entire system is moved toward the patient).
Response to Arguments
Applicant’s arguments with respect to claim(s) 17 and its dependents have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795
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