DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the amendments received after a Non-Final Rejection on 15 January 2026. Claims 1-2, 4-11 and 13-17 are currently pending.
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.
Claims 4 and 13 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Independent claims 1 and 10 now require “a plurality of fluid exit ports.” Dependent claims 4 and 13 require “one fluid exit port.” As best understood by the examiner, and as previously presented, it appeared that dependent claims 4 and 13 previously limited the surgical instrument to “one fluid exit port” when “at least one fluid exit port” was recited. In view of the current amendments, it is unclear as to if that is still the case. If so, it is unclear as to how there can be a single “exit port” when a “plurality of exit ports” is required.
Note: It appears that canceling claims 4 and 13 would overcome this rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-7, 10-11 and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rubin et al. (U.S. Patent Application Publication 2009/0270894).
Regarding claims 1-2 and 4-7, Rubin et al. disclose (as to claim 1) a surgical instrument (10) comprising an outer tubular sleeve (102) capable of receiving a middle tubular member (104) coaxially therethrough to define an irrigation pathway (i.e. pathway defined between 102 and 104, see paragraphs 0042-0043) to a distal end (i.e. end defined by 144) of the outer tubular sleeve and a distal end (i.e. end defined by 144) of the middle tubular member, the outer tubular sleeve adapted to connect a source (32) of irrigation fluid to the irrigation pathway; an inner shaft (22) rotatably received within the middle tubular member, a distal end (i.e. end defined by 145) of the inner shaft forming a surgical bur (24) capable of cutting tissue or bone upon rotation thereof, the surgical bur extending distally beyond the distal end of the outer tubular sleeve (extension as best illustrated in Figure 1); and a plurality of fluid exit ports (160) defined at an end (i.e. top-left most end as best seen in Figure 10) of the irrigation pathway between the distal end of the outer tubular sleeve and the distal end of the middle tubular member (see Figure 11), each fluid exit port of the plurality of fluid exit ports capable of directing irrigation fluid (see paragraphs 0042-0043) in a narrow stream (i.e. stream defined by shape of each instance of 160 as best seen in Figure 11) toward the surgical bur, wherein an annular space (i.e. space defined by contact between 102 and 150) between each respective fluid exit port at the end of the irrigation pathway is sealed between adjacent fluid exit ports (i.e. due to sealing contact) to prevent irrigation fluid from leaking and obscuring a surgeon’s view of the surgical bur (see claim 9 referring to sealing contact made between protrusions (150) defined by the middle tubular member (104) and an inner surface (75) defined by the outer tubular member (102), see also paragraph 0042), wherein (as to claim 2) the middle tubular member includes at least one channel (130) defined within an outer peripheral surface (122) thereof capable of carrying irrigation fluid from the fluid source to a corresponding number of fluid exit ports between the distal end of the outer tubular sleeve and the distal end of the middle tubular member (see paragraphs 0037-0042), wherein (as to claim 4) one fluid exit port (i.e. any one instance of 160 as best seen in Figure 11) is defined between the distal end of the outer tubular sleeve and the distal end of the middle tubular member (i.e. due to the use of the open-ended transitional phrase “comprising” in independent claim 1, claim 4 does not exclude additional, unrecited elements (see MPEP 2111.03(I)); furthermore, see paragraph 0039 referring to the inclusion of at least one instance of 130), wherein the annular space between the distal end of the outer tubular sleeve and the distal end of the middle tubular member is sealed to prevent irrigation fluid from leaking from the annular space and obscuring the surgeon’s view of the surgical bur (see claim 9 referring to sealing contact made between protrusions (150) defined by the middle tubular member (104) and an inner surface (75) defined by the outer tubular member (102), see also paragraph 0042), wherein (as to claim 5) the inner shaft includes a proximal section (142) and a distal section (145), the distal section being made from a material (i.e. a spring material) enabling the distal section to bend allowing the inner shaft to bend in accordance with a shape of the outer tubular sleeve (see paragraph 0024), wherein (as to claim 6) the inner shaft includes a proximal section (142) and a distal section (147), the distal section including a geometry (i.e. geometry defined by a spring) enabling the distal section to bend allowing the inner shaft to bend in accordance with a shape of the outer tubular sleeve (see paragraph 0024), and wherein (as to claim 7) the inner shaft is segmented (i.e. segments defined by each single turn of the spring, see Figure 2) (see Figures 1-11, and paragraphs 0024-0044).
Regarding claims 10-11 and 13-16, Rubin et al. disclose (as to claim 10) a surgical instrument (10) comprising an outer tubular sleeve (102) capable of receiving a middle tubular member (104) coaxially therethrough to define an irrigation pathway (i.e. pathway defined between 102 and 104, see paragraphs 0042-0043) therebetween and therealong to a distal end (i.e. end defined by 144) of the outer tubular sleeve and a distal end (i.e. end defined by 144) of the middle tubular member, the outer tubular sleeve adapted to connect a source (32) of irrigation fluid to the irrigation pathway; an inner shaft (22) rotatably received within the middle tubular member, a distal end (i.e. end defined by 145) of the inner shaft forming a surgical bur (24) capable of cutting tissue or bone upon rotation thereof, the surgical bur extending distally beyond the distal end of the outer tubular sleeve (extension as best illustrated in Figure 1); and a plurality of fluid exit ports (160) defined proximate the distal end of the outer tubular sleeve (see Figure 11) at an end (i.e. top-left most end as best seen in Figure 10) of the irrigation pathway, each fluid exit port of the plurality of fluid exit ports capable of directing irrigation fluid (see paragraphs 0042-0043) in a narrow stream (i.e. stream defined by shape of each instance of 160 as best seen in Figure 11) toward the surgical bur, wherein an annular space (i.e. space defined by contact between 102 and 150) between each respective fluid exit port at the end of the irrigation pathway is sealed between adjacent fluid exit ports (i.e. due to sealing contact) to prevent irrigation fluid from obscuring a surgeon’s view of the surgical bur (see claim 9 referring to sealing contact made between protrusions (150) defined by the middle tubular member (104) and an inner surface (75) defined by the outer tubular member (102), see also paragraph 0042), wherein (as to claim 11) the middle tubular member includes at least one channel (130) defined within an outer peripheral surface (122) thereof capable of carrying irrigation fluid from the fluid source to a corresponding number of fluid exit ports defined within the outer tubular sleeve (i.e. the ports are defined by 102 and 104 and are therefore defined within the outer tubular sleeve and middle tubular member), wherein (as to claim 13) one fluid exit port (i.e. any one instance of 160 as best seen in Figure 11) is defined within the outer tubular sleeve (i.e. the ports are defined by 102 and 104 and are therefore defined within the outer tubular sleeve and middle tubular member) (i.e. due to the use of the open-ended transitional phrase “comprising” in independent claim 10, claim 13 does not exclude additional, unrecited elements (see MPEP 2111.03(I)); furthermore, see paragraph 0039 referring to the inclusion of at least one instance of 130) and wherein the annular space between the distal end of the outer tubular sleeve and the distal end of the middle tubular member is sealed to prevent irrigation fluid from leaking from the annular space and obscuring a surgeon’s view of the surgical bur (see claim 9 referring to sealing contact made between protrusions (150) defined by the middle tubular member (104) and an inner surface (75) defined by the outer tubular member (102), see also paragraph 0042), wherein (as to claim 14) the inner shaft includes a proximal section (142) and a distal section (145), the distal section being made from a material (i.e. a spring material) enabling the distal section to bend allowing the inner shaft to bend in accordance with a shape of the outer tubular sleeve (see paragraph 0024), wherein (as to claim 15) the inner shaft includes a proximal section (142) and a distal section (147), the distal section including a geometry (i.e. geometry defined by a spring) enabling the distal section to bend allowing the inner shaft to bend in accordance with a shape of the outer tubular sleeve (see paragraph 0024), and wherein (as to claim 16) the inner shaft is segmented (i.e. segments defined by each single turn of the spring, see Figure 2) (see Figures 1-11, and paragraphs 0024-0044).
Claim 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perez et al. (U.S. Patent 6,132,448).
Perez et al. disclose a surgical instrument (10) comprising an outer tubular sleeve (11) capable of receiving a middle tubular member (34) coaxially therethrough to define an irrigation pathway (i.e. pathway defined between 11 and 34, see column 3, lines 47-54) therebetween and therealong to a distal end (i.e. right-most end as best seen in Figure 2) of the outer tubular sleeve and a distal end (i.e. right-most end as best seen in Figure 2) of the middle tubular member, the outer tubular sleeve adapted to connect a source (i.e. source provided through 18) of irrigation fluid to the irrigation pathway; an inner shaft (22) rotatably received within the middle tubular member, a distal end (i.e. end defining 27) of the inner shaft forming a surgical bur (see column 2, lines 63-67) capable of cutting tissue or bone upon rotation thereof, the surgical bur extending distally beyond the distal end of the outer tubular sleeve (extension as best illustrated in Figure 2); and a plurality of fluid exit cutouts (13) defined in the distal end of the outer tubular sleeve (see Figure 6) at an end (i.e. right-most end as best seen in Figure 2) of the irrigation pathway, each fluid exit cutout of the plurality of fluid exit cutouts capable of directing irrigation fluid (see column 3, lines 47-54) in a narrow stream (i.e. stream defined by shape of each instance of 13 as best seen in Figure 6) toward the surgical bur, wherein an annular space (i.e. space defined by contact between 11 and 34) between each respective fluid exit port at the end of the irrigation pathway is sealed to between adjacent fluid exit cutouts to prevent irrigation fluid from leaking and obscuring a surgeon’s view of the surgical bur (i.e. although the term “sealed” is not explicitly stated, it is the examiner’s position that a seal is created due to contact of 34 with 11 to block irrigation fluid and direct it toward each instance of 13, see column 3, lines 47-58) (see Figures 1-8, and column 2, line 22 – column 4, line 12).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Rubin et al. (U.S. Patent Application Publication 2009/0270894), as applied to claims 7 and 16 above respectively, in view of Brunnett et al. (U.S. Patent 7,488,322).
Rubin et al. disclose the claimed invention except for wherein the inner shaft is segmented via at least one of laser cutting, die cutting, plasma cutting, flame cutting, drilling, metal turning, metal shape cutting, or water jet cutting.
Brunnett et al. teach the use of a surgical instrument (200) comprising an outer tubular sleeve (202) and an inner shaft (204), wherein the inner shaft includes a proximal section (228) and a distal section (222), the distal section including a geometry (i.e. geometry defined by 224) enabling the distal section to bend allowing the inner shaft to bend in accordance with a shape of the outer tubular sleeve (see column 15, lines 36-41), wherein the geometry of the inner shaft allows it to bend includes segmenting (i.e. segments defined by each single turn of a spiral, see Figure 8), and wherein the inner shaft is segmented via laser cutting (see column 15, lines 36-41) (see Figure 8, and column 15, lines 26-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Rubin et al. with wherein the inner shaft is segmented via laser cutting in view of Brunnett et al. in order to provide an alternative, well-known and obvious means for providing a flexible portion of the inner shaft capable of forming and maintaining a curved configuration to yield predictable results.
Response to Arguments
The applicant's arguments filed 15 January 2026 have been fully considered but they are not persuasive.
On numbered pages 6 and 7, the applicant argues that “Rubin fails to disclose that an annular space between each respective fluid exit port at the end of the irrigation pathway is sealed between adjacent fluid exit ports." The examiner respectfully disagrees. After further review of the disclosure, Rubin et al. discloses (see claim 9) “wherein each protrusion is in sealing contact against the inner surface of the second sleeve.” The examiner has updated the rejections above to reflect this finding. In view of this, in combination with paragraph 0042, it is the examiner’s position that Rubin et al. disclose the claimed limitation.
On numbered pages 6 and 7, the applicant argues that “Perez fails to disclose that "an annular space between each respective fluid exit cutout at the end of the irrigation pathway is sealed between adjacent fluid exit cutouts." The examiner respectfully disagrees. After further review of the disclosure, Perez et al. discloses (see column 3, lines 47-58) “the bearing sleeves 33 and 34 which rotatably support the inner member 22 and cutting tool 24 inside the outer member 11 would tend to block the flow of irrigation liquid toward the distal end and the opening 12 thereat were it not for the plural elongated grooves 13 (FIG. 6) in the inside surface 14 of the outer member 11. That is, the irrigation liquid will flow through the gap 29 into the respective grooves 13 as indicated by the arrow B in FIG. 6” The examiner has updated the rejection above to reflect this finding. In view of this, it is the examiner’s position that Perez et al. disclose the claimed limitation.
The specifics of Brunnett et al., as used in the rejections above, were not addressed.
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 LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
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