DETAILED ACTION
This action is in response to applicant's preliminary amendments filed 08/07/24.
The examiner acknowledges the amendments to the claims and specification.
Claims 19-32 are pending in this application.
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 Objections
Claim 30 is objected to because of the following informalities:
Line 5 recites “the channel” and should read as --the at least one channel--.
Line 6 recites “the channel” and should read as --the at least one channel--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In lines 1-2, Claim 22 recites “the angled region supports a ramp”. In [0044] of the present application specification it states “the inner tube 98 may include a ramp or angled region”. Therefore, the angled region is a ramp, wherein the ramp is not a separate element that is supported by the angled region. It is suggested that “supports a ramp” be deleted from the claim (similar to the examiner’s amendment of claim 1 in parent application no. 16/741,152; see office action filed 04/02/24, page 3).
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 19-32 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 19, line 10 recites the limitation "the plurality of connections". There is insufficient antecedent basis for this limitation in the claim. It is unclear if this limitation is referring to previously recited “plurality of projections” (Claim 19, line 9) instead. For examination purposes the limitation will be read as --the plurality of projections--. Claims 20-32 are rejected due to their dependence on Claim 19.
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.
Claims 19 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Perez et al., hereinafter “Perez” (U.S. Patent No. 6,132,448) in view of Barrett (U.S. Patent No. 5,989,209).
Regarding claim 19, Perez discloses an instrument assembly for a surgical instrument, comprising:
a handle (handpiece 39; Figure 8) operably coupled to a chuck assembly 10 (Figures 1-2) configured to secure a proximal end of a shaft of a surgical tool (such as proximal end of inner member 22 of cutting tool 24; Id.);
an irrigation passage connection (irrigation liquid connection 18; Figures 1-2, 4, col. 2, lines 48-53) operably associated with the chuck assembly (Id.), the irrigation passage connection configured to supply fluid from a fluid source to a distal end of the surgical tool along at least one channel 13 (Figure 6; col. 3, lines 39-46) defined within the instrument assembly and extending along the shaft of the surgical tool (Id.); and
a distal bushing (bearing sleeve 34; Figure 5) configured to rotatably support a distal end of the surgical tool (col. 3, lines 10-13; bearing sleeve 34 rotatably supports inner member 22 of cutting tool 24), the distal bushing configured to secure the distal bushing and the surgical tool within a distal end of the instrument assembly (Id.), and configured to allow fluid to flow along the outer peripheral surface of the distal bushing and exit the distal end of the instrument assembly (col. 3, lines 47-54; the irrigation liquid will flow through the instrument assembly via grooves 13).
However, Perez does not disclose the distal bushing including a plurality of projections extending from the outer peripheral surface thereof, the plurality of connections (projections) configured to secure the distal bushing and the surgical tool within a distal end of the instrument assembly, the plurality of projections defining a corresponding plurality of fluid passageways therebetween configured to allow fluid to flow along the outer peripheral surface of the distal bushing and exit the distal end of the instrument assembly.
In Figures 8A-8B, Barrett teaches an instrument assembly including a distal bushing 41 including a plurality of projections 24 extending from an outer peripheral surface thereof, the plurality of connections (projections) 24 configured to secure the distal bushing and a surgical tool (tubular portion 21 and tip 18 of needle) within a distal end of the instrument assembly (col. 4, lines 59-64; sleeve tube 17 is compressed against distal bushing projections 24 and form channels or grooves 30), the plurality of projections defining a corresponding plurality of fluid passageways 30 therebetween (Id. and abstract; the grooves 30 formed by projections 24 provide passageways for fluid to flow) configured to allow fluid to flow along the outer peripheral surface of the distal bushing and exit the distal end of the instrument assembly (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify Perez to have a plurality of projections on the distal bushing defining a corresponding plurality of fluid passageways as claimed, as taught by Barrett, instead of the fluid passageways 13 in Figure 6. Perez acknowledges that distal bushing 34 (Figures 5-6) would tend to block the flow of irrigation liquid toward the distal end of the instrument assembly were it not for the elongated fluid passageways (grooves 13) formed on the inside of outer member 11 (Figure 6, col. 3, lines 47-54). Barrett teaches another known technique for forming fluid passageways by having projections 24 extending from an outer peripheral surface of distal bushing 41 (Figures 8A-8B) such that irrigation liquid toward the distal end of the instrument assembly is not blocked. A skilled artisan would have found it obvious to modify the distal bushing of Perez with a plurality of projections defining a corresponding plurality of fluid passageways, since doing so would yield the predictable result of allowing irrigation fluid to flow freely to exit the distal end of the instrument assembly. See MPEP 2143.
Regarding claim 23, Perez as modified teaches the plurality of projections 24 (Barrett; Figures 8A-8B) includes fluid guides 30 for directing the flow of fluid along the distal bushing and toward the distal end of the instrument assembly.
Claims 20-21, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Perez (U.S. Patent No. 6,132,448) in view of Barrett (U.S. Patent No. 5,989,209), as applied to claim 19 above, and further in view of Rubin et al., hereinafter “Rubin” (U.S. Pub. No. 2009/0270894).
Regarding claim 20, Perez as modified teaches the claimed invention, as discussed above, including an elongated member 11 (Perez; Figures 1-2), except for the instrument assembly further comprises: a first elongated member defining an internal cannula; and a second elongated member extending around the first elongated member, wherein the at least one channel is formed between the first elongated member and the second elongated member, and wherein the at least one channel is fluidly connected to the irrigation passage connection.
Rubin teaches an instrument assembly including a first elongated member 104 (Figures 8-9, 11) defining an internal cannula; and a second elongated member 102 (Figures 5-6, 11) extending around the first elongated member, wherein at least one channel 160 ([0042]-[0043], Figure 11) is formed between the first elongated member and the second elongated member, and wherein the at least one channel is fluidly connected to an irrigation passage connection 30 (Id. and Figure 1).
It would have been obvious to one of ordinary skill before the effective filing date to modify the elongated member in Perez as modified to have a first elongated member and a second elongated member with the at least channel formed therebetween, as taught by Rubin, since instead of one outer elongated member 11 in Perez, having a second elongated member extending around the first elongated member that defines fluid passageways as a known alternative technique to achieve a sidewall fluid channel ([0035] of Rubin). A skilled artisan would have found applying this known technique to Perez as modified as obvious, since doing so would yield predictable results, including keeping the instrument assembly with a smaller cross-sectional profile, therein increasing maneuverability and preventing the assembly from catching on soft tissues and bony structures encountered along a path to a treatment site (Rubin; [0044]). See MPEP 2143.
Regarding claim 21, Perez as modified teaches fluid is directed along the at least one channel from the irrigation passage connection to an angled region proximate a distal end of the first elongated member (Perez teaches in Figures 1, 5, col. 2, lines 25-28 that elongated member has an angled [45 degree] region in which fluid is directed, which one of ordinary skill in the art would acknowledge facilitates advancement of the device through tissue).
Regarding claim 26, Perez as modified teaches the second elongated member is formed over the first elongated member (Rubin, Figures 4-6, 8-9, 11; second elongated member 102 is formed over first elongated member 104).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Perez (U.S. Patent No. 6,132,448) in view of Barrett (U.S. Patent No. 5,989,209), as applied to claim 19 above, and further in view of Brunnett et al., hereinafter “Brunnett” (U.S. Pub. No. 2006/0241630).
Regarding claims 24-25, Perez as modified teaches the claimed invention, as discussed above, including the distal bushing made from a material capable of acting as a bushing (Perez, col. 3, lines 9-13; the distal bushing 34 is made of a thermoplastic, Teflon and rotatably supports an inner member tool 24), except for the distal bushing is made from a material capable of acting as a seal, or wherein the distal bushing is made from a high performance thermoplastic material, PolyEtherEtherKetone (PEEK), or PolyArylEtherKetone (PAEK).
Brunnett teaches in [0031], [0055] a distal bushing 24 being formed from a material capable of acting as a seal, such as high performance thermoplastic material, PolyEtherEtherKetone (PEEK), or PolyArylEtherKetone (PAEK).
It would have been obvious to one of ordinary skill before the effective filing date to modify the distal bushing with the claimed materials above, as taught by Brunnett, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Perez (U.S. Patent No. 6,132,448) in view of Barrett (U.S. Patent No. 5,989,209) and Rubin (U.S. Pub. No. 2009/0270894), as applied to claim 20 above, and further in view of Malla et al., hereinafter “Malla” (U.S. Pub. No. 2011/0270293).
Regarding claim 27, Perez as modified teaches the claimed invention, as discussed above, except for the second elongated member is a heat shrink material positioned over the first elongated member.
Malla teaches an instrument assembly including a second elongated member 86 (Figures 4, 6) being a heat shrink material ([0038]-[0040]) positioned over a first elongated member 14/28.
It would have been obvious to one of ordinary skill before the effective filing date to modify the second elongated member to be heat shrink material, as taught by Malla, in order to keep a low profile for the second elongated member (Id.), which increases maneuverability through a patient’s body, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Regarding claim 28, Perez as modified teaches the claimed invention, as discussed above, including the first elongated member 104 (Rubin, Figures 9, 11) has an exterior surface; wherein at least a portion of the at least one channel is formed in the exterior surface (between raised protrusions 150 in Figures 9, 11 of Rubin); wherein the at least one channel formed in the exterior surface is formed to extend toward a central longitudinal axis of the first elongated member from a first portion of the exterior surface (from near the top of protrusions 150 to radially inwardly toward elongated recesses 130).
However, Perez as modified does not teach the second elongated member contacts the first portion of the exterior surface and forms a fluid tight seal with the first portion of the exterior surface.
As discussed above, Malla teaches a second elongated member 86 (Figures 4, 6) being a heat shrink material ([0038]-[0040]) positioned over a first elongated member 14/28, wherein the second elongated member contacts a first portion of an exterior surface of the first elongated member and forms a fluid tight seal with the first portion of the exterior surface ([0038]; the heat shrink material 86 is snugly disposed over first elongated member 28 in a sealed manner such that fluid passageways are enclosed and sealed).
It would have been obvious to one of ordinary skill before the effective filing date to modify the second elongated member to form a fluid tight seal with the first portion of the exterior surface, as taught by Malla, in order to keep the fluid passageways from leaking fluid from the instrument assembly (Id.).
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 19-23, 26-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,053,200 in view of Perez (U.S. Patent No. 6,132,448) and Barrett (U.S. Patent No. 5,989,209). It is clear that the application claim elements are to be found in the patent claims (Claims 19-22 in patent claim 1, Claim 26 in patent claim 2, Claim 27 in patent claim 3, Claim 28 in patent claim 4, Claim 29 in patent claim 5, Claim 30 in patent claim 6, Claim 31 in patent claim 7), except for features that are merely obvious.
Perez teaches a handle (handpiece 39; Figure 8) operably coupled to a chuck assembly 10 (Figures 1-2) configured to secure a proximal end of a shaft of a surgical tool (such as proximal end of inner member 22 of cutting tool 24; Id.), and a distal bushing (bearing sleeve 34; Figure 5) configured to rotatably support a distal end of the surgical tool (col. 3, lines 10-13; bearing sleeve 34 rotatably supports inner member 22 of cutting tool 24), the distal bushing configured to secure the distal bushing and the surgical tool within a distal end of the instrument assembly (Id.), and configured to allow fluid to flow along the outer peripheral surface of the distal bushing and exit the distal end of the instrument assembly (col. 3, lines 47-54; the irrigation liquid will flow through the instrument assembly via grooves 13).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims to have a handle, chuck assembly, and distal bushing, as taught by Perez, in order to securely attach and rotatably support a cutting tool such that the tool can be rotated at very high speeds.
Furthermore, in Figures 8A-8B, Barrett teaches an instrument assembly including a distal bushing 41 including a plurality of projections 24 extending from an outer peripheral surface thereof, the plurality of connections (projections) 24 configured to secure the distal bushing and a surgical tool (tubular portion 21 and tip 18 of needle) within a distal end of the instrument assembly (col. 4, lines 59-64; sleeve tube 17 is compressed against distal bushing projections 24 and form channels or grooves 30), the plurality of projections defining a corresponding plurality of fluid passageways 30 therebetween (Id. and abstract; the grooves 30 formed by projections 24 provide passageways for fluid to flow) configured to allow fluid to flow along the outer peripheral surface of the distal bushing and exit the distal end of the instrument assembly (Id.), and the plurality of projections 24 includes fluid guides (30 in between) for directing the flow of fluid along the distal bushing and toward the distal end of the instrument assembly (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims and Perez to have a plurality of projections on the distal bushing defining a corresponding plurality of fluid passageways as claimed, as taught by Barrett, instead of the fluid passageways 13 in Figure 6. Perez acknowledges that distal bushing 34 (Figures 5-6) would tend to block the flow of irrigation liquid toward the distal end of the instrument assembly were it not for the elongated fluid passageways (grooves 13) formed on the inside of outer member 11 (Figure 6, col. 3, lines 47-54). Barrett teaches another known technique for forming fluid passageways by having projections 24 extending from an outer peripheral surface of distal bushing 41 (Figures 8A-8B) such that irrigation liquid toward the distal end of the instrument assembly is not blocked. A skilled artisan would have found it obvious to modify the patent claims and distal bushing of Perez with a plurality of projections defining a corresponding plurality of fluid passageways, since doing so would yield the predictable result of allowing irrigation fluid to flow freely to exit the distal end of the instrument assembly. See MPEP 2143.
Claims 24-25, 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,053,200 in view of Perez (U.S. Patent No. 6,132,448) and Barrett (U.S. Patent No. 5,989,209), as applied to claims 19 and 31 above, and further in view of Brunnett (U.S. Pub. No. 2006/0241630).
Regarding claims 24-25, 32, the patent claims as modified teaches the claimed invention, as discussed above, including the distal bushing made from a material capable of acting as a bushing (Perez, col. 3, lines 9-13; a proximal bushing 33 and a distal bushing 34 are made of a thermoplastic, Teflon and rotatably supports an inner member tool 24), except for the distal bushing is made from a material capable of acting as a seal, or wherein the proximal and distal bushings are made from a high performance thermoplastic material, PolyEtherEtherKetone (PEEK), or PolyArylEtherKetone (PAEK).
Brunnett teaches in [0031], [0055] a distal bushing 24 being formed from a material capable of acting as a seal, such as high performance thermoplastic material, PolyEtherEtherKetone (PEEK), or PolyArylEtherKetone (PAEK).
It would have been obvious to one of ordinary skill before the effective filing date to modify the proximal and distal bushings with the claimed materials above, as taught by Brunnett, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Allowable Subject Matter
Claim 22 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, and U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and the double patenting rejection set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 29-32 would be allowable if rewritten to overcome the rejection(s) under U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and the double patenting rejections set forth in this Office action and to include all of the limitations of the base claim and any intervening claims
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior art of record, alone or in combination, teaches or renders obvious an instrument including, inter alia, a handle operably coupled to a chuck assembly configured to secure a proximal end of a shaft of a surgical tool, a distal bushing configured to rotatably support a distal end of a surgical tool and including a plurality of projections defining a corresponding plurality of fluid passageways to allow fluid to flow and exit a distal end of the instrument assembly, a second elongated member extending around a first elongated member that defines an internal cannula, wherein at least one channel is formed between the first and second elongated members, wherein fluid is directed along the at least one channel from an irrigation passage connection to an angled region proximate a distal end of the first elongated member, wherein the angled region is angled in a radially outward direction to continuously seal against an inner periphery of the second elongated member to allow fluid to flow toward the internal cannula, as recited in claim 22. Also see parent application no. 16/741,152 office action filed 04/02/2024, page 4 indicating reasons for allowance directed to the same allowable subject matter.
Additionally, none of the prior art of record, alone or in combination, teaches or renders obvious an instrument including, inter alia, a handle operably coupled to a chuck assembly configured to secure a proximal end of a shaft of a surgical tool, a distal bushing configured to rotatably support a distal end of a surgical tool and including a plurality of projections defining a corresponding plurality of fluid passageways to allow fluid to flow and exit a distal end of the instrument assembly, a second elongated member extending around a first elongated member that defines an internal cannula, wherein at least one channel is formed between the first and second elongated members, wherein the at least one channel is formed in an exterior surface of the first elongated member and extends toward a central longitudinal axis of the first elongated member from a first portion of the exterior surface, wherein the at least one channel terminates prior to the distal end of the first elongated member and wherein the second elongated member forms a fluid tight seal with the first portion of the exterior surface at the distal end of the first elongated member, as recited in claim 29.
Conclusion
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/DIANE D YABUT/Primary Examiner, Art Unit 3771