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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 23-34, 43 and 44, drawn to a medical tracking fixture, classified in A61B17/3403.
II. Claims 45-50, drawn to a medical system, classified in A61B90/36.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because it does not require a curved member or a set of projections extending radially inward from the curved member. The subcombination has separate utility such as a protective cover for a surgical instrument or other device.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Newly submitted claims 45-50 are directed to an invention that is independent or distinct from the invention originally claimed for the above reasons.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 45-50 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the expandable member configured to be inflated with a fluid and extending from the elongate body (claim 25) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 23-27, 31-34 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Kleven (US 2011/0238043) in view of Carette et al. (US 2014/0105782).
Regarding claim 23, Kleven discloses a medical tracking fixture (1; Figure 6c; for attaching a tracking marker - ¶[0027]) comprising: an elongated body (2) configured to attach the elongated body to an imaging instrument to limit movement of the elongated body relative to the imaging instrument (¶[0028]), wherein the tracking fixture is attachable to a medical instrument of a teleoperated assembly (the tracking fixture could be gripped or fixed in enumerable ways to some form of medical instrument of a teleoperated assembly; furthermore coupling 20 can attach to a variety of instruments - ¶[0033] ,[0034]), wherein the elongated body comprises a curved member (formed by adjacent pairs of legs 4; the legs form a curved interior surface as evident from Figure 6c).
Kleven fails to disclose that the curved member has an engagement feature comprising a set of projections extending radially inward from the curved member. Kleven discloses that the inner surface of the legs (4) can be modified to increase friction (¶[0047]). Kleven depicts teeth on the inner surface of the legs in other embodiments (Figures 3a, 4 and 6a).
Carette et al. disclose a device for gripping various surgical instruments (¶[0002], [0009]; Figure 7) having a similar curved member (20/20) wherein the curved member comprises a set of projections extending radially inward from the curved member in order to improve grip while allowing sterilant to be washed over the instrument (¶[0022], [0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the set of projections of Carette et al. on the inner surface of the curved member of Kleven in order to improve grip while allowing sterilant to be washed over the instrument.
Regarding claim 24, the engagement feature includes a set of projections sized for receipt within a set of elongated grooves on the imaging instrument (the members 22 could seat within some form of elongated grooves on a imaging instrument).
Regarding claim 25, Examiner takes official notice that it is well-known in the art to attach tracking fixtures to balloon catheters (for example see US 2017/0120072 and tracking device 12). Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have attached the tracking fixture of Kleven to a balloon catheter in order help a surgical navigation system track the catheter. The balloon catheter can regarded as the expandable member as claimed.
Regarding claim 26, the tracking fixture further comprises a marker on the elongated body detectable in an image taken of the imaging instrument (tracking marker - ¶[0027]).
Regarding claim 27, the elongated body includes a coupling mechanism (20) for attaching the medical instrument to the tracking fixture (¶[0033] ,[0034]).
Regarding claim 31, the coupling mechanism includes a compliant joint mechanism (22; ¶[0037]).
Regarding claim 32, a sensor (tracking marker - ¶[0027], [0033]) is associated with the compliant joint mechanism for determining a pose of the tracking fixture with respect to the medical instrument.
Regarding claim 33, the engagement feature could attach to an appropriately structured ultrasound probe.
Regarding claim 34, the elongated body has a channel shape (see channel shape formed by opposing members 4 - Figures 1a or 6c).
Regarding claim 43, as claimed, the pair of members 4 of Kleven can be considered as the elongate member. The projections would extend along their entire length as shown in Figure 6 of Carette et al.
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Kleven (US 2011/0238043) in view of Carette et al. (US 2014/0105782), as applied to claim 27 above, and further in view of Fleig et al. (WO 2015/117665).
Regarding claims 28 and 29, Kleven fails to disclose that the coupling mechanism includes a magnet. Kleven discloses that the coupling mechanism can us a variety of means such as Velcro, bayonet, snap lock, tape, etc. (¶[0034]) to attach to an add-on instrument such as a tracking marker (¶[0027], [0033]).
Fleig et al. disclose that a tracking marker (1) can be attached to a medical instrument using a magnet (6; Figures 4 and 5; page 8, lines 4-18; page 9, lines 1-6; can be regarded as an active magnet).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Fleig et al. to have used a magnet as the coupling mechanism of Kleven as an alternative prior art coupling means suitable for the same or similar purpose.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Kleven (US 2011/0238043) in view of Carette et al. (US 2014/0105782), as applied to claim 27 above, and further in view of Zagorchev et al. (US 2011/0105896)
Regarding claim 30, Kleven fails to disclose that the coupling mechanism includes a suction mechanism. Kleven discloses that the coupling mechanism can us a variety of means such as Velcro, bayonet, snap lock, tape, etc. (¶[0034]) to attach to an add-on instrument such as a tracking marker (¶[0027], [0033]).
Zagorchev et al. teach that a suction cup or suction mechanism is a known in the art for attaching a tracking marker to a medical instrument (¶[0018]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Zagorchev et al. to have used a magnet as the coupling mechanism of Kleven as an alternative prior art coupling means known in the art for the same or similar purpose.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Kleven (US 2011/0238043) in view of Carette et al. (US 2014/0105782), as applied to claim 43 above, and further in view of Zhao et al. (US 2010/0168562).
Regarding claim 44, Kleven fails to disclose a plurality of markers circumferentially spaced about an external surface of the elongate body. Kleven intends for the fixture to be used for tracking medical instrumets but also discloses that the tracking device coupling (20) can also be used to attach to other instruments not used for tracking (¶[0027] and elsewhere).
Zhao et al. disclose a tracking fixture (sleeve at 146 in Figure 12C) having a plurality of markers (144) circumferentially spaced about the fixture (also see Figure 21B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the markers of Zhao et al. circumferentially about the surface of the elongate body of Kleven as claimed in order to allow the fixture to be used for tracking surgical instruments while also allowing the coupling (20) to be attached to a non-tracking device.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 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, please contact the examiner’s supervisor, Elizabeth Houston at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
Prosecution Insights