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 .
Response to Amendment
The Amendments filed on June 23, 2026 have been entered. Applicant’s amendments have overcome the Drawing objection and the 112(b) rejections previously set-forth in the Non-Final Office Action mailed on 02/25/2026. Currently, claims 1, 3-8, 10-13 have been amended, claim 9 has been cancelled, and claims 1-8, 10-13 are pending in the application.
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 4, 6-8, and 11 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 4 recites the limitation "the distal end region" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the distal end region" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the distal end region" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the distal end region" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the distal end region" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-4, 6-8 and 12-13 are rejected under 35 U.S.C. 103 as being obvious over Brockmann (U.S. Application No. 20220015822 A1), and further in view of Gruba (U.S. Application No. 20220062632 A1).
Regarding independent claim 1, Brockmann discloses an insulating insert (23) for a hand-held surgical instrument (10), in particular for a resectoscope (pa. 0030, 0032 & Figs. 1-2), wherein:
the insulating insert is tubular (see Fig. 3) and, at a proximal end region, has a coupling means (26) for detachable coupling to a distal end (25) of a tubular shaft (13) of the hand-held instrument (pa. 0032 & Figs. 3-4), and
the insulating insert includes a rigid material (e.g., ceramics or plastics) (pa. 0003).
However, Brockmann does not disclose a circumference of the insulating insert has at least one flexible component, the at least one flexible component is configured to deform upon contact with urethra tissue, such that an elastic deformation of the at least one flexible component occurs upon contact with the urethra tissue.
Gruba, in the same field of endeavor, teaches a medical device (100) (pa. 0051 & Fig. 6) comprising a shaft (130) with a distal tip/flexible component (139). The flexible component is inserted into a body via an opening, e.g., a natural orifice (an anus or a urethra) (pa. 0054) and is formed of a bendable and/or compressible material, e.g., silicone, which may deform when in contact with a wall of a body lumen in order to reduce trauma to the wall of the body lumen during insertion and/or removal of medical device from the body (pa. 0052).
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 taught by Gruba to the distal outer circumference of the insulating insert of Brockmann for the purpose of reducing trauma to the wall of the body lumen (urethra) during insertion and/or removal of hand-held surgical instrument from the body (Gruba, pa. 0052).
Regarding claim 2, Brockmann discloses the invention substantially as claimed in claim 1 discussed above.
However, Brockmann does not disclose wherein the at least one flexible component is arranged on the circumference of a distal end region of the insulating insert.
Gruba, in the same field of endeavor, teaches a medical device (100) (pa. 0051 & Fig. 6) comprising a shaft (130) with a distal tip/flexible component (139). The flexible component is inserted into a body via an opening, e.g., a natural orifice (an anus or a urethra) (pa. 0054) and is formed of a bendable and/or compressible material, e.g., silicone, which may deform when in contact with a wall of a body lumen in order to reduce trauma to the wall of the body lumen during insertion and/or removal of medical device from the body (pa. 0052).
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 taught by Gruba to the circumference of a distal end region of the insulating insert of Brockmann for the purpose of reducing trauma to the wall of the body lumen (urethra) during insertion and/or removal of hand-held surgical instrument from the body (Gruba, pa. 0052).
Regarding claim 3, Brockmann discloses the insulating insert is produced from a rigid material (e.g., ceramics or plastics) (pa. 0003).
However, Brockmann does not disclose wherein the at least one flexible component is produced from silicone or an elastomer.
Gruba, in the same field of endeavor, teaches a medical device (100) (pa. 0051 & Fig. 6) comprising a shaft (130) with a distal tip/flexible component (139). The flexible component is inserted into a body via an opening, e.g., a natural orifice (an anus or a urethra) (pa. 0054) and is formed of a bendable and/or compressible material, e.g., silicone, which may deform when in contact with a wall of a body lumen in order to reduce trauma to the wall of the body lumen during insertion and/or removal of medical device from the body (pa. 0052).
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 made of silicone as taught by Gruba to the circumference of a distal end region of the insulating insert of Brockmann for the purpose of reducing trauma to the wall of the body lumen (urethra) during insertion and/or removal of hand-held surgical instrument from the body (Gruba, pa. 0052).
Regarding claim 4, Brockmann discloses the invention substantially as claimed in claim 1 discussed above.
However, Brockmann does not disclose wherein the at least one flexible component extends in a ring shape around an entirety of the circumference of the distal end region.
Gruba, in the same field of endeavor, teaches a medical device (100) (pa. 0051 & Fig. 6) comprising a shaft (130) with a distal tip/flexible component (139). The flexible component is inserted into a body via an opening, e.g., a natural orifice (an anus or a urethra) (pa. 0054) and is formed of a bendable and/or compressible material, e.g., silicone, which may deform when in contact with a wall of a body lumen in order to reduce trauma to the wall of the body lumen during insertion and/or removal of medical device from the body (pa. 0052). As seen in the cross-section of Figure 6, the flexible component extends in a ring shape around an entirety of the circumference of a distal end region of the shaft.
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 taught by Gruba to the entirety of the circumference of a distal end region of the insulating insert of Brockmann for the purpose of reducing trauma to the wall of the body lumen (urethra) during insertion and/or removal of hand-held surgical instrument from the body (Gruba, pa. 0052).
Regarding claim 6, Brockmann discloses the invention substantially as claimed in claim 1 discussed above.
However, Brockmann does not disclose wherein the at least one flexible component extends over an angular range of 45º to 180º on an entirety of the circumference of the distal end region.
Gruba, in the same field of endeavor, teaches a medical device (100) (pa. 0051 & Fig. 6) comprising a shaft (130) with a distal tip/flexible component (139). The flexible component is inserted into a body via an opening, e.g., a natural orifice (an anus or a urethra) (pa. 0054) and is formed of a bendable and/or compressible material, e.g., silicone, which may deform when in contact with a wall of a body lumen in order to reduce trauma to the wall of the body lumen during insertion and/or removal of medical device from the body (pa. 0052). As seen in the cross-section of Figure 6, the flexible component extends in a ring shape, over an angular range of 45° to 180°, around an entirety of the circumference of a distal end region of the shaft.
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 taught by Gruba to the entirety of the circumference of a distal end region of the insulating insert of Brockmann for the purpose of reducing trauma to the wall of the body lumen (urethra) during insertion and/or removal of hand-held surgical instrument from the body (Gruba, pa. 0052).
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 at least one flexible component is arranged on a portion of the circumference of the distal end region that reaches furthest in a distal direction.
Gruba, in the same field of endeavor, teaches a medical device (100) (pa. 0051 & Fig. 6) comprising a shaft (130) with a distal tip/flexible component (139). The flexible component is formed of a bendable and/or compressible material, e.g., silicone, which may deform when in contact with a wall of a body lumen in order to reduce trauma to the wall of the body lumen during insertion and/or removal of medical device from the body (pa. 0052). As seen in the cross-section of Figure 6, the flexible component is arranged on a portion of the circumference of the distal end region of the shaft that reaches furthest in a distal direction.
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 taught by Gruba to the circumference of a distal end region of the insulating insert of Brockmann for the purpose of reducing trauma to the wall of the body lumen (urethra) during insertion and/or removal of hand-held surgical instrument from the body (Gruba, pa. 0052).
Regarding claim 8, Brockmann discloses the invention substantially as claimed in claim 1 discussed above.
However, Brockmann does not disclose wherein the at least one flexible component is arranged on an outer side or top side, and at least one of an inner side and a front side of the distal end region, and the at least one flexible component extends on the outer side in a direction of a proximal end.
Gruba, in the same field of endeavor, teaches a medical device (100) (pa. 0051 & Fig. 6) comprising a shaft (130) with a distal tip/flexible component (139). The flexible component is formed of a bendable and/or compressible material, e.g., silicone, which may deform when in contact with a wall of a body lumen in order to reduce trauma to the wall of the body lumen during insertion and/or removal of medical device from the body (pa. 0052).
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 taught by Gruba to an outer side or top side, at least one of an inner side and a front side of the distal end region of the insulating insert, wherein the at least one flexible component extends on the outer side in a direction of a proximal end of the insulating insert of Brockmann for the purpose of reducing trauma to the wall of the body lumen (urethra) during insertion and/or removal of hand-held surgical instrument from the body (Gruba, pa. 0052).
Regarding claim 12, Brockmann discloses a jacket surface (27) (pa. 0032) forming a continuous surface with a distal region of the insulating insert (see Fig. 4).
However, Brockmann does not disclose the at least one flexible component.
Gruba, in the same field of endeavor, teaches a medical device (100) (pa. 0051 & Fig. 6) comprising a shaft (130) with a distal tip/flexible component (139). The flexible component is formed of a bendable and/or compressible material, e.g., silicone, which may deform when in contact with a wall of a body lumen in order to reduce trauma to the wall of the body lumen during insertion and/or removal of medical device from the body (pa. 0052).
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 taught by Gruba to the circumference of a distal end region of the insulating insert of Brockmann for the purpose of reducing trauma to the wall of the body lumen (urethra) during insertion and/or removal of hand-held surgical instrument from the body (Gruba, pa. 0052).
Regarding claim 13, Brockmann/Gruba combination discloses the hand-held surgical instrument (10) with an inner shaft (13) or shaft tube and with an outer shaft (12) or outer tube, and with the 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 Gruba as applied to claim 1 above, and further in view of Liu (C.N. Application No. 217938361 U).
Regarding claim 10, Brockmann/Gruba 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 at least one flexible component to be within a range of 0.3 mm to 7.0 mm, as taught by Liu, in order to promote safety when using the device.
Claims 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Brockmann and Gruba as applied to claim 1 above, and further in view of Orczy-Timko (U.S. Application No. 20140336643 A1).
Regarding claim 5, Brockmann/Gruba combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they 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 a polymer material such as silicone has 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 modified the at least one flexible component to have a durometer of Shore A 30 to 90, as taught by Orczy-Timko, for the purpose of making the distal end region of the insulating insert durable and flexible.
Regarding claim 11, Brockmann/Gruba combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do 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 at least one 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 of Orczy-Timko to the distal end region of the insulating insert in order to enhance attachment of the at least one flexible component (Orczy-Timko, pa. 0054).
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 Gruba (U.S. Application No. 20220062632 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, wherein the at least one flexible component is configured to deform upon contact with urethra tissue, such that an elastic deformation of the at least one flexible component occurs upon contact with the urethra tissue.” Gruba, 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. 0051 & Fig. 6), configured to deform upon contact with urethra tissue, such that an elastic deformation of the at least one flexible component occurs upon contact with the urethra tissue (pa. 0052, 0054). 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 Gruba for the purpose of reducing trauma to the wall of the body lumen (urethra) during insertion and/or removal of hand-held surgical instrument from the body (Gruba, pa. 0052).
With respect to dependent claim 13, see copending application dependent claim 10.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 06/23/2026, with respect to the 103 rejection of claim 1 under Brockmann and Orczy-Timko have been fully considered and are persuasive. Specifically, Applicant’s amendments to claim 1 to further require the at least one flexible component to be configured to deform upon contact with urethra tissue, such that an elastic deformation of the at least one flexible component occurs upon contact with the urethra tissue is defined over both Brockmann and Orczy-Timko given that they do not contemplate this claimed structure. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-4, 6-8 and 12-13 are rejected under 35 U.S.C. 103 as being obvious over Brockmann (U.S. Application No. 20220015822 A1), and further in view of Gruba (U.S. Application No. 20220062632 A
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Brockmann and Gruba as applied to claim 1 above, and further in view of Liu (C.N. Application No. 217938361 U).
Claims 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Brockmann and Gruba as applied to claim 1 above, and further in view of Orczy-Timko (U.S. Application No. 20140336643 A1).
It is the Examiner’s position that the newly filed rejections based on the combination of references are tenable for at least the reasoning set forth in the action above.
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.
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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