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 19 May 2026. As directed by the amendment: claim 1 has been amended, claims 13-16 are cancelled, and claims 7-12 stand withdrawn. Claims 1-12 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the drawing objections presented in the previous Office Action, which are correspondingly withdrawn.
The amendments to the claims are sufficient to overcome the claim objections presented in the previous Office Action, which are correspondingly withdrawn. Further claim objections as necessitated by the claim amendments are presented below.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) listed in the previous action, which are correspondingly withdrawn. Further rejections under 35 U.S.C. 112(b) as necessitated by the claim amendments are presented below.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1) have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive. As to Shadeck (US 8,109,956), Applicant contends that the inner diameter of Shadeck’s retainer 144 and the increased diameter (i.e. sleeve 140) of the inner tube would not create an interference fit, and that a washer and seal 142 abut the proximal end of the sleeve 140 and include an outer diameter which would slide through the retainer 144 if pulled proximally. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Shadeck is modified in view of Oliver (US 9,737,322) for the relative diameters of the retainer and the portion of increased diameter. Examiner notes that FIGS. 3A and 6 of Shadeck appear to show that at least the washer (shown between 142 and 144 in FIG. 3A) has an outer diameter which would abut against an end of the retainer 144, so that the washer is disposed between the retainer 144 and the locking flange, shown in cross-hatch below the retainer 144 in FIG. 6 but disposed in the locking flange. It would not make sense for the washer to be able to slide through the retainer 144, i.e. to be smaller than an inner diameter of the retainer 144, since a washer is meant to be between two abutting surfaces and would not be floating within the retainer.
Applicant contends that it would not prevent unintentional dislodgement from the proximal hub when pulled proximally. Examiner respectfully submits, in view of the interpretation above, that the washer and portion of increased diameter would prevent unintentional dislodgement from the proximal hub when pulled proximally since the washer sits below the retainer. Modification in view of Oliver also meets this limitation.
Claim Interpretation
The limitation “the retainer is mechanically locked atop the inner tube” (claim 1 / lines 14-15) will be interpreted as components of the tool being mechanically secured together as parts of the assembled whole, i.e. the retainer is mechanically locked as part of the assembled whole atop or around the inner tube.
Claim Objections
Claims 1-6 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 1 / lines 15-16: “an outer diameter of the portion of increased diameter of the inner tube” (note that amendment as such would require further amendment to claim 2 / line 2: “[[an]] the outer diameter”)
Claim 1 / line 18: “the proximal hub connector.”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 1, the limitation “prevents the inner tube from becoming unintentionally dislodged from the proximal hub connector during removal of the proximal connector” (lines 17-18) renders the claims indefinite, because it is unclear how the inner tube is prevented from becoming unintentionally dislodged from the proximal hub connector while also the proximal connector is being removed. Further clarification to the claim language is required to, for example, define from what the proximal connector is being removed, if not from the inner tube, and how this relates to the preventing the inner tube from becoming unintentionally dislodged from the proximal hub connector. For examination purposes, the limitation will be interpreted as “prevents the inner tube from becoming unintentionally dislodged from the proximal hub connector during removal of the proximal hub connector from the cutting device.”
As to claim 2, the limitation “an inner diameter of the retainer” renders the claim indefinite because it is unclear if this refers to “the retainer including an inner diameter” previously recited in claim 1, or to a different inner diameter. For examination purposes, the limitation will be interpreted as the inner diameter of the retainer.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 8,109,956 to Shadeck in view of U.S. Patent No. US 9,737,322 to Oliver et al. (hereinafter, “Oliver”).
As to claim 1, Shadeck discloses a disposable cutting tool (interpreted as language of intended use; any tool is capable of disposal) configured for use with a cutting device for removing tissue or bone, comprising: an outer shaft (52) (col. 4 / line 63 – col. 5 / line 5) including a cutting head (66; cutting edge at 84) at a distal end thereof configured to cut tissue or bone (col. 5 / lines 49-52; col. 6 / lines 6-7), FIGS. 3A and 4A; a shaft assembly (33) configured to secure a proximal end of the outer shaft therein, FIGS. 3A and 5; an inner tube (56 and 140) concentrically disposed within the outer shaft (distal portion of 56 is disposed within 52) and extending proximally therethrough, FIGS. 3A and 5, the inner tube supporting a proximal hub connector (100) at a proximal end thereof (col. 6 / lines 33-39); a retainer (144) disposed atop the inner tube proximate a distal end of the proximal hub connector, FIG. 5, the retainer configured to cooperate with a locking flange (proximal end 108 of hub 60) disposed on a proximal end of the shaft assembly to secure the inner tube therein (col. 7 / lines 63-67), FIG. 6, the retainer including an inner diameter, FIG. 5; and a seal (142 and washer) disposed between the locking flange and the retainer configured to prevent fluid from leaking from the shaft assembly (col. 7 / lines 63-67), FIGS. 3A and 6, wherein the inner tube defines a portion of increased diameter (140) between the retainer and the proximal end of the outer shaft, FIG. 6, wherein, once assembled and the retainer is mechanically locked (mechanically locked in place in the locking flange) atop (over, surrounding) the inner tube proximate (i.e. near, and/or proximal to) the portion of increased diameter, FIG. 6, the inner tube is prevented from becoming unintentionally dislodged from the proximal hub connector during removal of the proximal connector (interpreted as language of intended use; the snug interfitting of all of the components would prevent the inner tube from becoming unintentionally dislodged from the proximal hub connector, at least as much as the instant invention).
As to claim 3, Shadeck discloses the disposable cutting tool according to claim 1, wherein the distal end of the proximal hub connector is tapered, FIG. 6, and cooperates with the portion of increased diameter to capture the retainer (since the retainer is between the proximal hub connector and the portion of increased diameter), FIG. 6.
As to claim 4, Shadeck discloses the disposable cutting tool according to claim 1, wherein a proximal end of the proximal hub connector includes a universal mechanical interface (mechanical interface that is universal to the cutting device disclosed and all others of complementary form) which is adapted to connect to a locking collar disposed within the cutting device to secure the cutting tool therein (interpreted as language of intended use; fully capable of connecting to a complementary locking collar disposed within the cutting device), FIG. 7B.
As to claim 6, Shadeck discloses the disposable cutting tool according to claim 1, wherein the retainer is mechanically secured to the portion of increased diameter after the retainer is engaged with the locking flange (the components, including the retainer and the portion of increased diameter, are mechanically secured to each other as parts of the assembled whole, FIG. 5).
Shadeck is silent as to the increased diameter of the inner tube relative to the inner diameter of the retainer prevents the inner tube from becoming unintentionally dislodged from the proximal hub connector during removal of the proximal connector (claim 1); and wherein an inner diameter of the retainer is smaller than an outer diameter of the portion of increased diameter when sealed atop the inner tube (claim 2).
Oliver teaches cutting tool, FIG. 3B, comprising an outer shaft (40); a shaft assembly (56) configured to secure a proximal end of the outer shaft therein; an inner tube (36) concentrically disposed within the outer shaft and extending proximally therethrough, the inner tube supporting a proximal hub connector (42) at a proximal end thereof (col. 5 / lines 42-46); a retainer (54) disposed atop the inner tube proximate a distal end of the proximal hub connector, FIG. 3B, the retainer configured to cooperate with a locking flange (proximal end of 56) disposed on a proximal end of the shaft assembly to secure the inner tube therein, the retainer including an inner diameter (the inner diameter taken at the distal opening through the retainer that closely receives the inner tube); and a seal (88) disposed between the locking flange and the retainer configured to prevent fluid from leaking from the shaft assembly, FIG. 3B.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the retainer in Shadeck to have a distal opening therethrough that closely fits around a portion of the inner tube that passes therethrough, as taught by Oliver, to contribute to the seal around the inner tube (as disclosed by Shadeck’s seals 142) and to stabilize the inner tube through the retainer so that the inner tube does not inadvertently extend off-axis through the retainer. Then, with the distal opening through the retainer closely fitting around the proximal portion of the inner tube that passes therethrough, an inner diameter of the retainer at its distal opening is the same as or only slightly larger than the outer diameter of the proximal portion of the inner tube. Then, because an outer diameter of the portion of increased diameter is greater than the outer diameter of the proximal portion of the inner tube that extends through the retainer, the outer diameter of the portion of increased diameter would also be greater than the inner diameter of the retainer at its distal opening, i.e. the inner diameter of the retainer is smaller than the outer diameter of the portion of increased diameter when sealed atop the inner tube. The increased diameter of the inner tube at the portion of increased diameter in Shadeck, relative to the inner diameter of the retainer as modified in view of Oliver, prevents the inner tube from becoming unintentionally dislodged from the proximal hub connector during removal of the proximal connector, as least as much as the claimed invention. When, for example, the proximal hub connector is removed from an instrument by pulling downwardly, it will take the retainer and the inner tube with it by virtue of the retainer abutting the portion of increased diameter, preventing the inner tube from becoming dislodged from the proximal hub connector.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shadeck in view of Oliver (hereinafter, “Shadeck/Oliver”), as applied to claims 1-4 and 6 above, and further in view of U.S. Patent No. US 10,527,230 to Stachulla et al. (hereinafter, “Stachulla”).
Shadeck/Oliver are silent as to wherein the portion of increased diameter includes at least one of a shrink wrap, curable adhesive, or swage.
Stachulla teaches that a cylinder can be formed by swaging (col. 10 / lines 65-67).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the cylindrical portion of increased diameter in Shadeck/Oliver by swaging, so that the portion of increased diameter includes swage since it is formed by swaging, since Stachulla teaches that a cylinder can be formed by swaging and swaging a blank into a cylindrical shape would allow for the use of a universal blank and therefore reduce production costs.
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY L KAMIKAWA/Examiner, Art Unit 3775
Prosecution Insights