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 .
Status of Claims
Claims 1-20 are pending in this application. Claims 15-20 are withdrawn, claims 1, 3, 6, 9, 10, 15, and 17 have been amended, and Claims 1-14 have been examined on the merits.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-8 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Tuma (US20190142401A1) in view of Frederick (CN111655167A).
Regarding Claim 1,
Tuma teaches a handheld instrument assembly for use in a surgical environment (corresponding disclosure in at least [0043] and Figure 8, where the user can hold the device as the device is portable “The mounting portion 71 forms a framework into which the portable navigation system 75 can be inserted” and further in [0043] and Figure 7, where the device is used also as a surgical instrument “a combination of a navigation system 75 (comprising a display 73), 85 and a surgical instrument 70 in a sterile environment, wherein in the embodiment according to FIG. 7, the holding means 71 and/or the tip 79 are (individually or both) formed as disposable items”), the assembly comprising:
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Figure 8 of Tuma
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Figure 7 of Tuma
a non-sterile handle (corresponding disclosure in at least [0007], where there is a handle portion, which unless covered by a sterile device, would be non-sterile “a surgical instrument comprising a handle portion”); a treatment tool having a proximal end and a handheld instrument assembly (corresponding disclosure in at least [0007] and Figure 7, where there is a function portion/tip, which extends from the handle “ a surgical instrument comprising a handle portion or mounting portion and a functional portion and/or tip”),
wherein the treatment tool comprises a releasable portion which is releasably attached or attachable to the handle or to an adjoining portion of the treatment tool (corresponding disclosure in at least [0043], where the tip portion can be detached as it is a disposable item “the holding means 71 and/or the tip 79 are (individually or both) formed as disposable items (which can be used once), which can themselves also bear navigation reference markers 72”);
and a sterile envelope enveloping the non-sterile handle for being gripped by a user of the handheld instrument assembly (corresponding disclosure in at least [0044], where the device has a sterile drape it’s covered in prior to being gripped using the mounting “ the portable navigation system 75 comprising the display 73 has been wrapped in a sterile drape (covering of film) before being inserted into the mounting 71”).
Tuason does not teach the treatment tool having a proximal end being directly attached to, directly attachable to, or integral with a distal end of the non-sterile handle, the treatment tool extending from the distal end of the non-sterile handle in a distal direction of the handheld instrument assembly and the sterile envelope enveloping an overall outer contour of the non-sterile handle.Frederick, in a similar field of endeavor, teaches a similar concept (sterile surgical instruments) of the treatment tool having a proximal end being directly attached to, directly attachable to, or integral with a distal end of the non-sterile handle, the treatment tool extending from the distal end of the non-sterile handle in a distal direction of the handheld instrument assembly (corresponding disclosure in at least Figure 1 and [pg. 27, ln. 1558-ln1559], where the treatment tool proximal end is attached to the distal end of the handle “The end effector 1300 includes a shaft portion 1310 that includes an end effector connector 1390 that is configured to be engageable with the distal connector 1290 to couple the end effector 1300 to the shaft Components”).
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Figure 1 of Frederick
and the sterile envelope enveloping an overall outer contour of the non-sterile handle (corresponding disclosure in at least [pg. 51, ln. 2988-3000], where a sterile barrier covers the overall contour of the handle “In order to create a sterile environment for the surgical instrument 100, a sterile barrier 190 is covered on the handle 1500”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the proximal end being attachable to the distal end of the handle and have the envelope enveloping an outer contour of the handle as taught by Frederick. One of the ordinary skill in the art would have been motivated to incorporate this because the outer envelope allows for the handle and parts of the instrument to be easily sterilized and reused for procedures.
Regarding Claim 2, Tuma and Frederick teach the limitations of Claim 1, and Tuma further teaches the assembly comprising one or more tracking elements (corresponding disclosure in at least [0004], where tracking markers are used “the instruments—i.e. including the pointer—are spatially tracked by optical tracking systems, wherein markings (tracking markers) attached to the instruments are tracked by cameras”), wherein the sterile envelope is arranged to envelop the one or more tracking elements (corresponding disclosure in at least [0045] and Figure 8, where the entirety of the device, including the markers are covered in the sterile covering “the holding means can also comprise a holding plate 81 comprising navigation markers 82, on which a navigation system (comprising a display 85) is placed and which is covered with a sterile, rigid covering”).
Regarding Claim 3, Tuma and Frederick teach the limitations of Claim 2, and Tuma further teaches wherein the one or more tracking elements comprise one or more active tracking elements (corresponding disclosure in at least [0036], where the type of marker includes active markers “ use reflective tracking markers 12, 22, 32 which can be detected by a tracking system (for example, an infrared camera system). It is possible to use other tracking technologies, for example tracking active LED markers, electromagnetic tracking or acoustic tracking”),
and wherein the sterile envelope is transparent with regard to at least part of a spectrum of the light emitted by the active tracking elements (corresponding disclosure in at least [0045], where the envelope is transparent, which would allow for light to go through from the tracker “a navigation system (comprising a display 85) is placed and which is covered with a sterile, rigid covering (for example, a cover made of a transparent plastic material)”).
Regarding Claim 4, Tuma and Frederick teach the limitations of Claim 1, and Tuma further teaches wherein the releasable portion forms a distal portion of the treatment tool and is releasably attached or attachable to a proximal portion of the treatment tool, the proximal portion of the treatment tool being enveloped by the sterile envelope (corresponding disclosure in at least [0043] and Figure 7, where the tip portion can be disposed of, thus attachable to the proximal portion “the holding means 71 and/or the tip 79 are (individually or both) formed as disposable items”, and further in [0045], where the device is within a sterile covering “the holding means can also comprise a holding plate 81 comprising navigation markers 82, on which a navigation system (comprising a display 85) is placed and which is covered with a sterile, rigid covering”).
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Figure 7 of Tuma
Regarding Claim 5, Tuma and Frederick teach the limitations of Claim 1, and Tuma further teaches wherein the releasable portion is fixed to or integral with the sterile envelope (corresponding disclosure in at least [0045] and Figure 7, where the portion for release (releasable portion) is where the envelope is around and fixed to “ a navigation system (comprising a display 85) is placed and which is covered with a sterile, rigid covering (for example, a cover made of a transparent plastic material)”).
Regarding Claim 6, Tuma and Frederick teach the limitations of Claim 1, and Tuma further teaches wherein the releasable portion forms the treatment tool which is releasably attached or attachable at a proximal end to the handle enveloped by the sterile envelope (corresponding disclosure in at least [0043] and Figure 7, where the proximal section attaches to the handle of the device, which is enveloped by the sterile envelope “the holding means 71 and/or the tip 79 are (individually or both) formed as disposable items”), wherein the treatment tool is not enveloped by the sterile envelope (corresponding disclosure in at least Figure 7, where it’s shown that the treatment tool is not within the sterile envelope).
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Figure 7 of Tuma
Regarding Claim 7, Tuma and Frederick teach the limitations of Claim 1, and Tuma further teaches wherein the releasable portion forms a sharp tip of the treatment tool (corresponding disclosure in at least Figure 7, where the end of the tool forms a sharp tip)
Regarding Claim 8, Tuma and Frederick teach the limitations of Claim 1, and Tuma further teaches wherein the releasable portion is sterile (corresponding disclosure in at least [0044], where although the releasable portion 79 is not within the sterile envelope, it is still sterile (other sterile elements) “ this drape is indicated by a broken line and has been given the reference sign 74. In this way, the navigation system 75 (comprising the display 73) is thus likewise sterilely provided and can be directly used together with the other sterile elements of the instrument”).
Regarding Claim 11, Tuma and Frederick teach the limitations of Claim 1, and Tuma further teaches wherein the sterile envelope has, or can be formed to define, an opening for inserting the non-sterile handle and, optionally, the treatment tool or a proximal portion of the treatment tool, wherein the opening is sealingly closed in an assembled state of the handheld instrument assembly (corresponding disclosure in at least [0044] and Figure 7, where the sterile envelope (drape) can be wrapped around as a covering for the device into a closed state “the portable navigation system 75 comprising the display 73 has been wrapped in a sterile drape (covering of film) before being inserted into the mounting 71; this drape is indicated by a broken line and has been given the reference sign”).
Regarding Claim 12,
Tuma further teaches wherein the sterile envelope has an inner non- sterile surface side and an outer sterile surface side, and wherein the outer sterile surface side is configured to be gripped by the user of the handheld instrument assembly (corresponding disclosure in at least [0045], where there is a holding area to be gripped on the outer part of the envelope; the device on the inside may or may not be sterile “the holding means can also comprise a holding plate 81 comprising navigation markers 82, on which a navigation system (comprising a display 85) is placed and which is covered with a sterile, rigid covering (for example, a cover made of a transparent plastic material)”.
Regarding Claim 13, Tuma and Frederick teach the limitations of Claim 1, and Tuma further teaches wherein at least one of the releasable portion and the sterile envelope is a disposable item (corresponding disclosure in at least [0043], where the releasable portion (tip) can be disposed of “the holding means 71 and/or the tip 79 are (individually or both) formed as disposable items”).
Regarding Claim 14, Tuma and Frederick teach the limitations of Claim 1, and Tuma further teaches wherein the handheld instrument assembly is a navigation pointer (corresponding disclosure in at least [0036] and Figure 7, where the assembly has a pointer used for navigation (tracking) “The pointer instruments shown in FIGS. 1 to 3 use reflective tracking markers 12, 22, 32 which can be detected by a tracking system”).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tuma (US20190142401A1) and Frederick (CN111655167A) as applied in Claim 1 and in further view of Harle (US20200206462A1).
Regarding Claim 9, Tuma and Frederick teach the limitations of claim 1 and the releasable portion ([0044]), but does not teach the portion being releasably attached or attachable by a plug connection.
Harle, in a similar field of endeavor, teaches a similar concept (disposable medical device), where a releasable portion plugs into the handle or the adjoining portion of the treatment tool.
(corresponding disclosure in at least [0027], where there is a releasable portion (catheter), which can be attached via plug connection “Towards proximal, the handling element ends in a cylindrical section 39, on which by means of a plug connection 40 a catheter container can be connected, whose connector part 41 intervenes in the plug connection”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a plug connection as taught by Harle. One of the ordinary skill in the art would have been motivated to incorporate this because the plug connection provides a way to securely connect two pieces together, particularly when having to remove and reattach a portion.
Regarding Claim 10, Tuma and Frederick teach the limitations of Claim 1 and the releasable portion, but does not teach wherein the releasable portion comprises a blunt shaped cap hiding a sharp distal end of the treatment tool, wherein the treatment tool and the releasable portion are enveloped by the sterile envelope.
Harle, in a similar field of endeavor, teaches a similar concept of a blunt shaped cap hiding a sharp distal end of the treatment tool (corresponding disclosure in at least [0024], where there is a protection cap at the end of the sharp distal end (distal cannula) “ the distal cannula protection cap 27”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the blunt shaped cap as taught by Harle. One of the ordinary skill in the art would have been motivated to incorporate this because the cap is a protective covering for a sharp end to avoid injuries.
Response to Arguments
Applicant’s arguments filed 01/22/2026 in regards to the Drawings and Claim objections have been considered and are withdrawn in light of the amendments.
Applicant’s arguments filed 01/22/2026 in regards to the 35 U.S.C 112b rejections have been considered and are withdrawn in light of the amendments.
Applicant’s arguments with respect to claims 1-14 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.
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/K.E.K./ Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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