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
This office action is responsive to the amendment filed on 12/29/2025. As directed by the amendment: claims 1 and 27 have been amended and claims 13-26 have been cancelled. Thus, claims 1-12 and 27-34 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pg. 6, filed 12/29/2025, with respect to the rejection of claim 1 under 35 U.S.C. 102 have been fully considered and are persuasive. The rejection of claim 1 under 35 U.S.C. 102 has been withdrawn.
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Applicant argues that “it is not reasonable to select only one portion of the inner tube of Winkler (i.e., the tip 66) together with the coating 60 as the claimed inner tube, and select another portion of the inner tube 22 of Winkler (i.e., the body 64) as a structure other than the inner tube as claimed; such an interpretation is associated with hindsight bias”. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant further argues “it is unclear how one would modify the device above with the "jacket," as cited in Winkler, with the tubular liner 78 of Harvey in the manner claimed. Attempts to do so would change the principal mode of operation of Winkler, as the gall-resistant tip is the basis of its disclosure and claims”. The Office respectfully disagrees. Winkler is not being modified thus the gall-resistant of the tip is not relevant to the modification. Instead, Harvey is being modified by Winkler and one of ordinary skill in the art would understand how a tubular liner could connect to a counter bore. Thus, The Office maintains that it would be obvious to modify Harvey with Winkler.
Regarding claim 31, applicant argues “the tip 66 and the body 64 of the inner tube 22 of Winkler are appropriately analogized to the claimed inner tube, Winkler fails to teach or suggest the claimed jacket”. The Office respectfully disagrees. The claimed inner tube is not required to be equated to 66+64+22 as argued by applicant. The interpretation taken by The Office of a cutting tip 66, an inner tube 60 and an inner jacket 64 is reasonable. The Office is not required to interpret the prior art in the same way or with the same terminology as applicant.
Regarding claim 27, applicant argues that the “stationary inner tube 50 of Nakano” is not rotatable … “a proximal end of inner tube to be coupled to the drive hub, which is no longer met by the current interpretation of Nakano” as now required by amended claim 27. The Office respectfully disagrees. Both of these limitations are taught by the primary reference Harvey, thus they are not required to be taught by the teaching reference Nakano.
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 1-3, 5, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Harvey (US 20120221035 A1) in view Winkler (US 5,269,798)
Regarding claim 1 Harvey discloses (fig. 1-4, 6A, and 7) a cutting assembly configured to be coupled to an irrigation source (see [0041]) and an aspiration source (see [0040]), the cutting assembly comprising:
a housing 13 (see fig. 2 and [0025]);
an outer tube 40 comprising a proximal end coupled to the housing (see fig. 2 and [0026]);
a drive hub 14 (see fig. 2 and [0024]);
an inner tube 46 coupled to the drive hub 14 (see fig. 2 and [0027]) and rotatably and coaxially disposed within the outer tube (see [0027] and [0035]), wherein an irrigation path is defined between the inner tube and the outer tube (see [0041]);
a cutting tip 61 secured to the inner tube 46 (see fig. 2, [0027]-[0028], and [0039]); and
an inner jacket 78 coupled to the drive hub 14 (78 can extend along the length of 46 and 46 is coupled to the drive hub, see [0027] and [0036]) and coaxially disposed within the inner tube (see fig. 7 and [0036]), wherein an aspiration path is defined within the inner jacket (see [0040]), and wherein the inner jacket is configured to provide a fluid seal between the aspiration path and the irrigation path (see [0036]).
Harvey is silent regarding the cutting tip defines a counterbore, and wherein the distal end of the inner jacket is secured to the cutting tip within the counterbore.
However Winkler, in the same filed of endeavor, teaches (fig. 7-8) a cutting tip 66 defines a counterbore (see fig. 7), and wherein a distal end 68 of an inner jacket 64 is secured to the cutting tip 66 within the counterbore (see fig. 7 and col. 10 ln. 52 – col. 11 ln. 31).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harvey as modified to the cutting tip defines a counterbore, and wherein the distal end of the inner jacket is secured to the cutting tip within the counterbore as taught by Winkler, for the purpose of being able to mass manufacture the tube and attach the necessary tip thereto.
Regarding claim 2 Harvey as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Harvey further discloses (fig. 1-4, 6A and 7) the inner tube defines slots (92-95; see fig. 6A and [0030]), wherein the fluid seal provided by the inner jacket 78 is configured to prevent ingress of irrigation fluid through the slots (see [0036]).
Regarding claim 3 Harvey as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Harvey further discloses (fig. 1-4, 6A and 7) the outer tube 40 comprises a bend, wherein the slots of the inner tube are axially positioned along the bend (see fig. 1 and [0038]).
Regarding claim 5 Harvey as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Harvey further discloses (fig. 1-4, 6A and 7) the inner jacket 78 is not secured to the cutting tip (see fig. 7).
Regarding claim 9 Harvey as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Harvey further discloses (fig. 1-4, 6A and 7) the outer tube 40 comprises an outer tip portion defining an outer window 43 (see [0026]), and an inner tip portion comprises an inner window 49 (see [0028]) such that the cutting assembly is a shaver (see [0037] and [0039]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Harvey in view of Winkler, as applied to claim 1 above, and further in view of Nakano et al. (US 20200397458 A1).
Regarding claim 4, Harvey discloses the claimed invention substantially as claimed, as set forth above for claim 1. Harvey is silent regarding the inner jacket is coupled to the drive hub at a position proximal to where a proximal end of the inner tube is coupled to the drive hub.
However Nakano, in the same field of endeavor, teaches (fig. 2) an outer tube 30, an inner tube 50, an inner jacket 20, a fluid path between the inner 50 and outer 30 tubes (see fig. 2) and a fluid path in the inner jacket 20 (see fig. 2), wherein the inner jacket 20 is coupled to a drive hub 60 at a position proximal to where a proximal end of the inner tube 50 is coupled to the drive hub 60 (see fig. 2, [0038], and [0041]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harvey to have the inner jacket is coupled to the drive hub at a position proximal to where a proximal end of the inner tube is coupled to the drive hub as taught by Nakano, for the purpose of being able to have a side port to connect the aspiration device to (see Nakano [0039]).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Harvey Harvey in view of Winkler, as applied to claim 1 above, and further in view of in view of Escudero et al. (US 20090018566 A1).
Regarding claims 6-8, Harvey as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Harvey as modified is silent regarding the inner jacket is a multilayer reinforced tube; the multilayer reinforced tube comprises a braid disposed between inner and outer layers of polymeric material; the braid is stainless steel, and the polymeric material is polyether block amide.
However Escudero, in the same field of endeavor, teaches a tube can be formed of a multilayer reinforced tube; the multilayer reinforced tube comprises a braid disposed between inner and outer layers of polymeric material; the braid is stainless steel, and the polymeric material is polyether block amide (see [0199] and [0202]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harvey as modifed to have the inner jacket is a multilayer reinforced tube; the multilayer reinforced tube comprises a braid disposed between inner and outer layers of polymeric material; the braid is stainless steel, and the polymeric material is polyether block amide as taught by Escudero, for the purpose of reinforcing the device to provide a stiffer structure (see Escudero [0199]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Harvey in view of Nakano.
Regarding claim 27 Harvey discloses (fig. 1-4, 6A, and 7) a cutting assembly configured to be coupled to an irrigation source (see [0041]) and an aspiration source (see [0040]), the cutting assembly comprising:
a housing 13 (see fig. 2 and [0025]);
an outer tube 40 comprising a proximal end coupled to the housing (see fig. 2 and [0026]);
a drive hub 14 (see fig. 2 and [0024]) rotatable within the housing (see fig. 2 and [0039]);
an inner tube 46 comprising a proximal end 50 coupled to the drive hub 14 (see fig. 2 and [0027]) and rotatably and coaxially disposed within the outer tube (see [0027] and [0035]), wherein an irrigation path is defined between the inner tube and the outer tube (see [0041]);
a cutting tip 61 secured to the inner tube 46 (see fig. 2, [0027]-[0028], and [0039]); and
an inner jacket 78 coaxially disposed within the inner tube (see fig. 7 and [0036]), wherein an aspiration path is defined within the inner jacket (see [0040]), and wherein the inner jacket is configured to provide a fluid seal between the aspiration path and the irrigation path (see [0036]);
the proximal end 50 of the inner jacket positioned distal to a proximal end of the drive hub 14 (see fig. 2 and [0027]).
Harvey is silent regarding a proximal end of the inner jacket is coupled to the drive hub at a position proximal to where a proximal end of the inner tube is coupled to the drive hub.
However Nakano, in the same field of endeavor, teaches (fig. 2) an outer tube 30, an inner tube 50, an inner jacket 20, a fluid path between the inner 50 and outer 30 tubes (see fig. 2) and a fluid path in the inner jacket 20 (see fig. 2), wherein a proximal end of the inner jacket 20 is coupled to a drive hub 60 at a position proximal to where a proximal end of the inner tube 50 is coupled to the drive hub 60 (see fig. 2, [0038], and [0041]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harvey to have a proximal end of the inner jacket is coupled to the drive hub at a position proximal to where a proximal end of the inner tube is coupled to the drive hub as taught by Nakano, for the purpose of being able to have a side port to connect the aspiration device to (see Nakano [0039]).
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Harvey in view of Nakano as applied to claim 27 above, and further in view of Winkler (US 5,269,798).
Regarding claims 28 and 29, Harvey as modified discloses the claimed invention substantially as claimed, as set forth above for claim 27. Harvey as modified is silent regarding a distal end of the inner tube is secured to a proximal end of the cutting tip, and wherein a distal end of the inner jacket is positioned distal to the distal end of the inner tube; the cutting tip defines a counterbore, and wherein the distal end of the inner jacket is secured to the cutting tip within the counterbore.
However Winkler, in the same filed of endeavor, teaches (fig. 7-8) a distal end of an inner tube 60 is secured to a proximal end of a cutting tip 66 (see fig. 7), and wherein a distal end of an inner jacket 64 is positioned distal to the distal end of the inner tube 64 (junction 68 of 64 extends distal of 60, see fig. 2 and col. 10 ln. 52 – col. 11 ln. 31); the cutting tip 66 defines a counterbore (see fig. 7), and wherein the distal end 68 of the inner jacket 64 is secured to the cutting tip 66 within the counterbore (see fig. 7 and col. 10 ln. 52 – col. 11 ln. 31).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harvey as modified to have a distal end of the inner tube is secured to a proximal end of the cutting tip, and wherein a distal end of the inner jacket is positioned distal to the distal end of the inner tube; the cutting tip defines a counterbore, and wherein the distal end of the inner jacket is secured to the cutting tip within the counterbore as taught by Winkler, for the purpose of being able to mass manufacture the tube and attach the necessary tip thereto.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Harvey in view of Nakano as applied to claim 27 above, and further in view of Escudero.
Regarding claim 30, Harvey as modified discloses the claimed invention substantially as claimed, as set forth above for claim 27. Harvey as modified is silent regarding the inner jacket is a multilayer reinforced tube comprising a braid disposed between inner and outer layers of polymeric material.
However Escudero, in the same field of endeavor, teaches a tube can be formed of a multilayer reinforced tube; the multilayer reinforced tube comprises a braid disposed between inner and outer layers of polymeric material (see [0199] and [0202]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harvey as modified to have the inner jacket is a multilayer reinforced tube; the multilayer reinforced tube comprises a braid disposed between inner and outer layers of polymeric material as taught by Escudero, for the purpose of reinforcing the device to provide a stiffer structure (see Escudero [0199]).
Claims 31, 33, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Harvey in view of Winkler.
Regarding claim 31 Harvey discloses (fig. 1-4, 6A, and 7) a cutting assembly configured to be coupled to an irrigation source (see [0041]) and an aspiration source (see [0040]), the cutting assembly comprising:
a housing 13 (see fig. 2 and [0025]);
an outer tube 40 comprising a proximal end coupled to the housing (see fig. 2 and [0026]);
a drive hub 14 (see fig. 2 and [0024]);
an inner tube 46 coupled to the drive hub 14 (see fig. 2 and [0027]) and rotatably and coaxially disposed within the outer tube (see [0027] and [0035]), wherein an irrigation path is defined between the inner tube and the outer tube (see [0041]);
a cutting tip 61 comprising a proximal end secured to a distal end of the inner tube 46 (see fig. 2, [0027]-[0028], and [0039]); and
an inner jacket 78 coaxially disposed within the inner tube (see fig. 7 and [0036]), wherein an aspiration path is defined within the inner jacket (see [0040]), and wherein the inner jacket is configured to provide a fluid seal between the aspiration path and the irrigation path (see [0036]).
Harvey is silent regarding a distal end of the inner jacket is positioned distal to the proximal end of the cutting tip.
However Winkler, in the same filed of endeavor, teaches (fig. 7-8) a distal end of an inner tube 60 is secured to a proximal end of a cutting tip 66 (see fig. 7), and wherein a distal end of an inner jacket 64 is positioned distal to the proximal end of the cutting tip 66 (junction 68 of 64 extends distal of the end of 66, see fig. 2 and col. 10 ln. 52 – col. 11 ln. 31).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harvey as modified to have a distal end of the inner jacket is positioned distal to the proximal end of the cutting tip as taught by Winkler, for the purpose of being able to mass manufacture the tube and attach the necessary tip thereto.
Regarding claims 33 and 34, Harvey discloses the claimed invention substantially as claimed, as set forth above for claim 1. Harvey is silent regarding a distal end of the inner tube is secured to a proximal end of the cutting tip, and wherein the distal end of the inner jacket is positioned distal to the proximal end of the cutting tip; the cutting tip defines a counterbore, and wherein a distal end of the inner jacket is secured to the cutting tip within the counterbore.
However Winkler, in the same filed of endeavor, teaches (fig. 7-8) a distal end of an inner tube 60 is secured to a proximal end of a cutting tip 66 (see fig. 7), and wherein a distal end of an inner jacket 64 is positioned distal to the proximal end of the cutting tip 66 (junction 68 of 64 extends distal of the end of 66, see fig. 2 and col. 10 ln. 52 – col. 11 ln. 31); the cutting tip 66 defines a counterbore (see fig. 7), and wherein the distal end 68 of the inner jacket 64 is secured to the cutting tip 66 within the counterbore (see fig. 7 and col. 10 ln. 52 – col. 11 ln. 31).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harvey as modified to have a distal end of the inner tube is secured to a proximal end of the cutting tip, and wherein the distal end of the inner jacket is positioned distal to the proximal end of the cutting tip; the cutting tip defines a counterbore, and wherein a distal end of the inner jacket is secured to the cutting tip within the counterbore as taught by Winkler, for the purpose of being able to mass manufacture the tube and attach the necessary tip thereto.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Harvey in view of Winkler as applied to claim 31 above, and further in view of Nakano.
Regarding claim 32, Harvey as modified discloses the claimed invention substantially as claimed, as set forth above for claim 31. Harvey as modified is silent regarding a proximal end of the inner jacket is coupled to the drive hub at a position proximal to where a proximal end of the inner tube is coupled to the drive hub.
However Nakano, in the same field of endeavor, teaches (fig. 2) an outer tube 30, an inner tube 50, an inner jacket 20, a fluid path between the inner 50 and outer 30 tubes (see fig. 2) and a fluid path in the inner jacket 20 (see fig. 2), wherein a proximal end of the inner jacket 20 is coupled to a drive hub 60 at a position proximal to where a proximal end of the inner tube 50 is coupled to the drive hub 60 (see fig. 2, [0038], and [0041]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Harvey as modified to have a proximal end of the inner jacket is coupled to the drive hub at a position proximal to where a proximal end of the inner tube is coupled to the drive hub as taught by Nakano, for the purpose of being able to have a side port to connect the aspiration device to (see Nakano [0039]).
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 KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771