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 .
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 two, three or more flexible components are arranged on the circumference as described in claim 9 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.
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.
Claims 1-13 are 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.
Claim 1 recites the limitation "the tube-like insulating insert" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claims 2-13 are also rejectedbecause they are dependent on claim 1. Appropriate correction is required.
Claim 1 recites the limitation "the tube-like insulating insert" in line 2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether the tube-like insulating insert is different from the insulating insert already cited in claim 1, or if they are the same structure. For examination purposes, Examiner will treat both inserts as the same structure on the surgical device of claim 1. Claims 2-13 are also rejected because they are dependent on claim 1. Appropriate correction is required.
Claim 7 recites the limitation "the distal direction" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 8 recites the limitation "the outer side", “the inner side and/or the front side”, and “the direction” in lines 3-4. There is insufficient antecedent basis for these limitations in the claim. Appropriate correction is required.
Claim 10 recites the limitation "the axial direction" in line 3. There is insufficient antecedent basis for these limitations in the claim. Appropriate correction is required.
Claim 13 recites the limitation "a hand-held surgical device" in line 1. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this hand-held surgical device is different from the hand-held surgical device already cited in claim 1, or if they are the same structure. For examination purposes, Examiner will treat both devices as the same. Appropriate correction is required.
Claim 13 recites the limitation "an insulating insert as claimed in claim 1" in line 3. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this insulating insert is different from the insulating insert already cited in claim 1, or if they are the same structure. For examination purposes, Examiner will treat both inserts as the same structure on the surgical device of claim 1. Appropriate correction is required.
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 1-9 and 11-13 are rejected under 35 U.S.C. 103 as being obvious over Brockmann (U.S. Application No. 20220015822 A1), and further in view of Orczy-Timko (U.S. Application No. 20140336643 A1).
Regarding independent claim 1 and claims 2-4, as best understood, Brockmann discloses an insulating insert (23) for a hand-held surgical device (10), in particular for a resectoscope (pa. 0030, 0032 & Figs. 1-2), wherein the tube-like insulating insert has, at a proximal end region, coupling means (26) for detachable coupling to a distal end (25) of a tubular shaft (13) of the hand-held device (pa. 0032 & Figs. 3-4).
However, Brockmann does not disclose a circumference of the tube-like insulating insert has at least one flexible component, wherein the at least one flexible component is arranged on the circumference of a distal end region of the insulating insert, wherein the flexible component is produced from silicone or an elastomer, and wherein the flexible component extends in a ring shape around the entire circumference of the distal end region.
Orczy-Timko, in the same field of endeavor, teaches an electrosurgical tissue resecting probe (100) (pa. 0044 & Fig. 1) comprising an inner sleeve (122), wherein the distal end portion of the sleeve is manufactured using a sputtering process that deposits a ceramic material on a surface of a component (202), and a polymer material (220) grips an outer surface of the ceramic material (pa. 0055), wherein the polymer material may be a silicone material (pa. 0063), which is durable and highly flexible.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the sputtering manufacturing method of Orczy-Timko in order to deposit the ceramic and the polymer materials onto the ringed-shaped outer distal end region of the circumference of the insulating insert of Brockmann for the purpose of making the distal end region strong, durable, and flexible.
Regarding claim 5, Brockmann discloses the invention substantially as claimed in claim 1 discussed above.
However, Brockmann does not disclose wherein the flexible component has a hardness of 10 Shore A to 90 Shore A.
Orczy-Timko, in the same field of endeavor, teaches the polymer material may be a silicone material having a durometer of Shore A 30 to 90 (pa. 0063).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the sputtering manufacturing method of Orczy-Timko in order to deposit the ceramic and the polymer materials onto the ringed-shaped outer distal end region of the circumference of the insulating insert of Brockmann for the purpose of making the distal end region strong, durable, and flexible.
Regarding claim 6, Brockmann discloses the invention substantially as claimed in claim 1 discussed above.
However, Brockmann does not disclose wherein the flexible component extends over an angular range of 45º to 180º on the entire circumference of the distal end region.
Orczy-Timko, in the same field of endeavor, teaches the ceramic material and the polymer material extends around all inner and outer surfaces of the distal portion of the sleeve (pa. 0063).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the sputtering manufacturing method of Orczy-Timko in order to deposit the ceramic and the polymer materials onto the distal end region, with an angular range of 45º to 180º of the circumference of the insulating insert of Brockmann for the purpose of making the distal end region strong, durable, and flexible.
Regarding claim 7, as best understood, Brockmann discloses the invention substantially as claimed in claim 1 discussed above.
However, Brockmann does not disclose wherein the flexible component is arranged on a portion of the circumference of the distal end region that reaches furthest in the distal direction.
Orczy-Timko, in the same field of endeavor, teaches the ceramic material and the polymer material extends around all inner and outer surfaces of the distal portion of the sleeve that reach in the furthest distal direction (pa. 0063).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the sputtering manufacturing method of Orczy-Timko in order to deposit the ceramic and the polymer materials onto the distal end region that reach in the furthest in the distal direction of the insulating insert of Brockmann for the purpose of making the distal end region strong, durable, and flexible.
Regarding claim 8, as best understood, Brockmann discloses the invention substantially as claimed in claim 1 discussed above.
However, Brockmann does not disclose wherein the flexible component is arranged on the outer side or top side and/or the inner side and/or the front side of the distal end region.
Orczy-Timko, in the same field of endeavor, teaches the ceramic material and the polymer material extends around all inner and outer surfaces of the distal portion of the sleeve (pa. 0063).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the sputtering manufacturing method of Orczy-Timko in order to deposit the ceramic and the polymer materials onto the outer side or top side and/or the inner side and/or the front side of the distal end region of the insulating insert of Brockmann for the purpose of making the distal end region strong, durable, and flexible.
Regarding claim 9, as best understood, Brockmann discloses the invention substantially as claimed in claim 1 discussed above.
However, Brockmann does not disclose wherein two, three or more flexible components are arranged on the circumference.
Orczy-Timko, in the same field of endeavor, teaches the ceramic material and the polymer material extends around all inner and outer surfaces of the distal portion of the sleeve (pa. 0063).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the sputtering manufacturing method of Orczy-Timko in order to deposit the ceramic and the polymer materials onto the entire circumference of the distal end region of the insulating insert of Brockmann for the purpose of making the distal end region strong, durable, and flexible.
In view of the combination explained above, Examiner is interpreting an upper or side hemisphere of the circumference of the distal end region of the insulating insert to be one flexible component and a lower or opposite side hemisphere of the circumference of the distal end region of the insulating insert to be another/second flexible component. The claim language is still broad and does not prevent the two or more flexible components from touching each other on the circumference of the insulating insert.
Regarding claim 11, Brockmann discloses the invention substantially as claimed in claim 1 discussed above.
However, Brockmann does not disclose wherein the distal end region of the insulating insert has an axial and/or radial or ring-like undercut for improved adherence of the flexible component.
Orczy-Timko, in the same field of endeavor, teaches an electrosurgical tissue resecting probe (100) (pa. 0044 & Fig. 1) comprising an inner sleeve (122), wherein the distal end portion of the inner sleeve is manufactured using a sputtering process that deposits a ceramic material on a surface of a component (202), wherein the ceramic material provides an adherent surface with undercuts (216) (see Fig. 5B) for permitting a polymer material (220) to grip the surface (pa. 0055).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the undercut microstructure in order to enhance attachment of the surface polymer layer (Orczy-Timko, pa. 0054).
Regarding claim 12, Brockmann discloses a jacket surface (27) (pa. 0032) forming a continuous surface with the distal end region of the insulating insert (see Fig. 4).
However, Brockmann does not disclose the flexible component.
Orczy-Timko, in the same field of endeavor, teaches the ceramic material and the polymer material extends around all inner and outer surfaces of the distal portion of the sleeve (pa. 0063).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the flexible component of Orczy-Timko to distal end region of the insulating insert of Brockmann for the purpose of making the distal end region strong, durable, and flexible.
Regarding claim 13, as best understood, Brockmann/Orczy-Timko combination discloses a hand-held surgical device (10) with an inner shaft (13) or shaft tube and with an outer shaft (12) or outer tube, and with an insulating insert (23) as claimed in claim 1 (Brockmann, pa. 0029), wherein the insulating insert is able to be coupled detachably to the inner shaft (Brockmann, pa. 0032), and the outer shaft is movable over the inner shaft and the insulating insert (Brockmann, pa. 0037).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Brockmann and Orczy-Timko as applied to claim 1 above, and further in view of Liu (C.N. Application No. 217938361 U).
Regarding claim 10, Brockmann/Orczy-Timko combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose wherein the flexible component has a length in the axial direction of 0.3 mm to 7.0 mm.
Liu, in the same field of endeavor, teaches an insulating insert (200) for a hand-held surgical device (page 3, lines 10-11 & Fig. 1), wherein a circumference of the insulating insert has at least one flexible component (page 3, lines 22-24, bottom-up), and wherein the flexible component has a length in the axial direction of 0-0.6 mm (page 3, lines 17-18 & Fig. 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the flexible component to be within a range of 0.3 mm to 7.0 mm, as taught by Liu, in order to promote safely when using the device.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 15 of U.S. Application No. 20220015822 A1 in view of Orczy-Timko (U.S. Application No. 20140336643 A1).
Regarding instant claim 1, it is the Examiner’s position that copending independent claim 1 is narrower in some aspects given that the copending claim recites a plurality of the limitations that overlap, or otherwise narrower in scope than, those in instant claim 1. These narrower aspects include the claimed insulating insert, a hand-held surgical device, coupling means, a tubular shaft, an inner shaft, and an outer shaft. With respect to the narrower aspects, the Examiner notes that it has been held that the generic aspects of the instant invention would be anticipated by the narrower species aspects of the copending claim. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
With respect to the broader aspects of the copending claim, the Examiner notes that the difference between the instant claim 1 and the copending claim 1 exists in that the copending claim 1 fails to provide the insulation insert with “at least one flexible component.” Orczy-Timko, however, provides for a similar device as that of the copending claim and specifically contemplates the modifying the insulation insert to include a flexible component (pa. 0055, 0063). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have modified the distal end region of the insulating insert of the copending application to include the flexible component of Orczy-Timko in order to provide for a combined insulating insert that is strong, durable, and flexible.
With respect to dependent claim 13, see copending application dependent claim 10.
Conclusion
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794