DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 27 January 2026.
Notice of 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 .
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 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.
Response to Arguments
In the response filed 27 January 2026, Applicant argues that Adams’143 does not teach both the distal guide and the proximal guide are configured to constrain translation of a surgical instrument through both guides to a single axis of intervention.
This argument is persuasive. Examiner maintains the distal guide (12) is aligned with an axis (i.e. the central axis of distal guide 12, which is the axis of intervention) and an instrument having a diameter about equal to the diameter of distal guide 12 would be constrained to the axis of intervention. However, Examiner agrees this theoretical instrument could not pass through both the proximal guide 46 and the distal guide 12 while being constrained to the axis of intervention, as required by amended claim 1. The instrument would be too wide to pass through proximal guide 46. Therefore, Adams’143 is withdrawn as a reference in the rejection. However, upon further search and consideration, a new primary reference, Namba’039 is relied upon to teach this feature. See the updated rejection below.
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.
Claim 22 is 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 pre-AIA the applicant regards as the invention.
Claim 22 recites the limitation "the distal section" and “the proximal section”. There is insufficient antecedent basis for these limitations in the claim. For the purpose of examination, the Office will assume these limitations were intended to refer to the “the distal guide” and “the proximal guide”, respectively. Correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 8, 9, 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Namba (US Patent 6,613,039) in view of Court et al. (US Patent Publication 2007/0250006) in view of Onuma et al. (US Patent Publication 2017/0020557).
Claim 1: Namba’039 teaches a surgical guide (2) including a fixed portion (6, 8) having a distal guide (10) aligned with an axis of intervention and a movable portion (4, 14) having a proximal guide (16). The movable portion (64, 14) is attached to the fixed portion by a pivot (the two tubes 4, 6 are connected and rotate about the axis of the tubes – column 4, lines 56-67) which allows rotation of the movable portion (4, 14) about an axis of the pivot (longitudinal axis of 4, 6) parallel to and offset from the axis of intervention (axis of 10, 16, as seen in Figure 1). The movable portion (38) is configured to move between:
(i) a first position in which the proximal guide is aligned with the distal guide and the axis of intervention (Figure 1) and
(ii) a second position in which the proximal guide is not aligned with the distal guide and the axis of intervention (column 4, lines 56-67 states 4, 6 can be round but advises against this arrangement because tubes 4, 6 will rotate relative to each other).
Namba’039 proximal and distal guides (16, 10 respectively) are configured to constrain translation to the axis of intervention (see Figures 3-4).
Namba’039 does not teach the movable portion includes a sensor.
Court’006 also teaches a guide (10; paragraph [0007]) having openings (18a, 18b). The guide (10) includes a sensor for measuring translation and rotation of an instrument passing through the guide (paragraph [0030} in order to allow more accurate tracking of the instrument’s movement (paragraph [0005]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the guide taught by Namba’039, with a sensor, as taught by Court’006, in order to allow for more accurate tracking of instrument movement into the body.
In the combination of Namba’039 in view of Court’006, the sensor is not necessarily on the movable portion.
Onuma’557 teaches a surgical guide (Figure 1) having a movable portion (5) and a fixed portion (7). The movable portion (5) is provided with a sensor (52; Figure 4c) for measuring the translation of the instrument along an axis of intervention (i.e. the axis of movement through 5) in order to prevent the instrument from inadvertently reaching the target (paragraph [0041]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Namba’039 such that the movable portion includes a sensor, as taught by Onuma’557, in order to measure the translation of the instrument through the guide.
Claim 2: Court’006 teaches the sensor is an optical sensor (paragraph [0038]).
Claims 8, 9: The fixed portion and the movable portions are disposable because anything can be thrown away.
Claim 21: In Namba’039, the distal guide (10) is configured to receive a cannula when the moveable portion is in the second position so that translation of the cannula is constrained to the axis of intervention (the distal guide 10 can receive an instrument when the proximal guide 16 is moved away from the axis of intervention because distal guide 10 is a tubular element; the cannula will be constrained to the axis of intervention if it has a diameter close to the diameter of element 10. The cannula is not positively recited.);
The proximal guide (16) is configured to receive a surgical instrument when the movable portion is in the first position so the surgical instrument translates along the axis of intervention and through the received cannula (an instrument can be passed through the proximal guide 16 and then inserted into a cannula held within distal guide 10 such that the instrument moves along the axis of intervention. The instrument is not positively recited).
Claim 22: In Namba’039, an inner diameter of a through hole of the distal guide (10) is equal to an outer diameter of a cannula (the cannula is not a positively recited element, the distal guide has lumen/through hole with an inner diameter and this inner diameter could be equal to the size of a cannula); and
a through hole of the proximal guide (16) is equal to or slightly larger than an inner diameter of the cannula to accommodate the surgical instrument as it is inserted through the cannula (the cannula is not a positively recited element, the proximal guide guide has lumen/through hole with an inner diameter and this inner diameter could be equal to or slightly larger than the size of a cannula).
Claim 23: In Namba’039, an inner diameter of the distal guide (10) is sized such that the surgical instrument translates along the distal guide in a straight line (Figures 3, 4; note the surgical instrument is not positively recited).
Claim 24: In Namba’039, the distal guide (10) is sized such that the surgical instrument translates along the distal guide without wobbling or moving at an angle that is not parallel to the axis of intervention (Figures 3, 4; note: the surgical instrument is not positively recited).
Claim 25: In Namba’039, the distal guide is configured to constrain translation of the surgical instrument by applying pressure to the surgical instrument (the walls of distal guide 10 will apply pressure to an instrument when the instrument contacts the walls of the tube – for example, when the instrument tries to tilt out of the axis of intervention).
Claims 3, 4 are rejected under 35 U.S.C. 103 as being unpatentable over Namba’039 in view of Court’006 in view of Onuma’557, as applied to claim 1, further in view of Applicant’s admitted prior art.
Namba’039, as modified, teaches the limitations of claim 3 and 4 but does not teach the optical sensor includes a picture element array, an infrared LED and a pair of lenses.
Namba’039 in view of Court’006 teach the use of an optical sensor to detect translation and rotation of an instrument (Court’006 at paragraph [0038]).
Applicant’s specification discloses Pixart’s PMW3360 is a known optical sensor for measuring displacement and rotation which has the claimed features: a picture element array, an infrared LED, a first lens to align light from the LED and a second lens to focus a surface image on the picture element array. See specification at paragraphs [0090]-[0092].
It would have been obvious to modify the device taught by Namba’039 in view of Court’006 with a different optical sensor, such as Pixart’s PMW3360 which includes a picture element array, an infrared LED and a pair of lenses, because this is a known sensor and one of ordinary skill in the art would have expected this optical sensor, which is known to detect translation and rotation, would have performed equally as well as the optical sensor taught by Namba’039 in view of Court’006. Further, the substitution of one known element (the optical sensor taught by Court) for another (Pixart’s PMW3360) would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention because the substitution of one optical sensor for another would yield predictable results of sensing translation and rotation of an object.
Claims 5 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Namba’039 in view of Court’006 in view of Onuma’557, as applied to claim 1 and 25, respectively, further in view of Churchill et al. (US Patent Publication 2009/0059206).
Claim 5: Namba’039 in view of Court’006 in view of Onuma’557 teaches the invention substantially as claimed, but do not teach the sensor is a magnetic sensor.
Churchill’206 teaches displacement and rotation sensors are well known to be either optical sensors or magnetic sensors (paragraphs [0003]-[0006]).
In light of this teaching, the substitution of one known element (optical displacement sensor) for another (magnetic displacement sensor) would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention since the substitution of the optical sensor for a magnetic sensor would have yielded predictable results, namely, a measurement of displacement and/or rotation of the instrument that was not dependent on the type of sensor used.
Claim 26: Namba’039 does not disclose the distal guide applies pressure to the instrument using ball bearings on an inner surface of a through hole of the distal guide.
It is old and well known to provide a through hole of a guide with ball bearings. For example, Churchill’206 teaches a guide (22) with a through hole (lumen through which element 24 is passing). The through hole is provided with ball bearings (42) to permit the instrument (24) to slide through the lumen with low friction (paragraph [0035]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Namba’039 by providing the distal guide with ball bearings, as taught by Churchill’206, in order to allow the instrument to slide through the guide with low friction.
Claims 6, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Namba’039 in view of Court’006 in view of Onuma’557, as applied to claim 1, further in view of Butcher et al. (US Patent Publication 2010/0125283).
Claim 6, 7: Namba’039, as modified, teaches the limitations of claim 6, including a cannula 18. Namba’039 does not teach a bushing.
Providing adjustable means on instrument guides is old and well known. For example, Butcher’283 teaches an instrument guide (Figure 1) comprising a cannula (20; paragraph [0025]) and a proximal opening 26 having a first size. The proximal opening (26) is provided with a bushing (48) having an opening (44) with a second, smaller size. Depending on the size of the instrument, the user can choose to pass the instrument through the first, larger opening (26) or the smaller opening (44) of bushing (48) so the instrument more closely matches the size of the opening (paragraph [0019]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Namba’039 cannula to have an interchangeable bushing, as taught by Butcher’283, in order to provide additional support to the instrument passing through the guide and so the guide is compatible with differently sized instruments.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Namba’039 in view of Court’006 in view of Onuma’557, as applied to claim 1, further in view of Furst et al. (US Patent 6,245,028).
Namba’039, as modified, teaches the limitations of claim 10 except for a threshold release mechanism to disconnect the surgical instrument from a robot when a patient moves.
Like Namba’039, Furst’028 is directed towards a device (Figure 2) including a guide (Figure 3) for a surgical instrument (210).
Furst’028 teaches providing the guide with a threshold release mechanism (column 10, lines 30-38; this term is interpreted under 112f to include a magnetic coupling that separates when a threshold force is applied and its equivalents) to allow the guide (280) to separate from the rest of the device (at connections 270, 284) when the patient moves and a threshold force or pressure is applied to the needle. This is considered to be equivalent to the magnetic coupling because Furst’028 teaches a coupling that automatically releases when a threshold force is applied to the needle (column 10, lines 30-38).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Namba’039 with a threshold release mechanism, as taught by Furst’028, in order to prevent injury to the patient when the patient moves unexpectedly.
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 extension fee 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 date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 6 March 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771