Since 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 .
Priority
The application claims priority as a National Stage Entry under 35 USC 371 to PCT/EP2022/061826 (3 May 2022) which claims priority to DE 102021114151.6 (1 June 2021).
Formal Matters
Claim 15 is cancelled. Claims 1-14 are pending and under examination. Preliminary amendments to the specification and abstract, filed on 9 November 2023, are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9 November 2023 and 21 October 2025 have been considered by the examiner. Signed copies are attached.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 102
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 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 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mah et al., US 6,109,270 (29 August 2000).
Regarding claim 1, teaches an instrument advancing apparatus (robotic instrument 16) for translationally and/or rotationally driving at least one first instrument (cannula probe assembly 27), the instrument advancing apparatus comprising:
a guide device (actuator mechanism 26) comprising at least one first axis body (cannula 22) extending in a translational driving direction (FIG 2; col 6, lines 31-39, A-A) of the at least one first instrument (27);
at least one first motor (28) configured to be motor-driven along the first axis body (FIG 2; col 6, lines 31-39, A-A); and
at least one second motor (30) configured to be motor-driven along the first axis body (FIG 2; col 6, lines 31-39, A-A) or along a second axis body of the guide device (FIG 2; col 6, lines 31-39, B-B)
the second axis body (probe 24) arranged aligned parallel to the first axis body (FIG 2) and wherein the first motor (28) is connected or configured to be connectable to a first holding means (col 6, lines 12-13, probe mounting plate 74) configured to hold and/or move the first instrument (col 7, lines 17-19, 74), and wherein the second motor (30) is connected or configured to be connectable to a second holding means (col 6, lines 31-32, mounting plate 76) configured to hold and/or move the first instrument or a second instrument (col 7, lines 17-19, 76).
A “holding means” is interpreted as set forth in the specification at ¶27 and ¶34 and equivalents thereof.
Regarding claim 12, Mah teaches the instrument advancing apparatus according to claim 1, as set forth above, wherein the first instrument and/or the second instrumentcol 1, lines 15-20).
Regarding claim 13, Mah teaches the instrument advancing apparatus according to claim 1, as set forth above, wherein the first instrument is a needle-shaped instrument (probe 24) and the second instrument is a tube-shaped instrument (cannula 22), and wherein the first instrument is configured and arranged to pass through the second instrument (cannula probe assembly 27).
Regarding claim 14, Mah teaches the instrument advancing apparatus according to claim 1, as set forth above, wherein the guide device comprises an instrument stabilizing device (base 81) configured to stabilize leading end of the first instrument and/or the second instrument (col 5, lines 60-67).
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.
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 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Mah et al., US 6,109,270 (29 August 2000) in view of in view of Vogele, WO 2019197056 (17 October 2019) (cited on Applicant’s IDS filed 9 November 2023).
Regarding claim 2, Mah teaches the instrument advancing apparatus according to claim 1, as set forth above.
Mah does not teach wherein the instrument advancing apparatus further comprises at least a third motor configured to be motor-driven along the first axis bod
Vogele teaches a medical robot (p. 6; 200) that provides guidance and actuation of medical instrument (p 6; 400), comprising a first motor, a second motor, and a third motor (p. 22, first paragraph, first linear actuator, second linear actuator, third linear actuator) configured to be motor-driven along the first axis bodp. 3, lines 7-8), or along a third axis body of the guide device, the third axis body being aligned parallel to the first axis body and the second axis body (p. 22, first paragraph, last sentence).
Mah and Vogele teach in the same field of endeavor, robotic surgical systems comprising instrument control units for surgical instruments. Mah teaches instrument advancing apparatus comprising two motors. Mah does not teach an instrument advancing apparatus or control unit comprising three motors. Vogele teaches a medical robot that provides guidance and actuation of medical instrument using a first, second, and third linear actuator (p. 22) with optional additions of a rotational actuator or additional linear actuators (p. 22). Vogele also teaches that the linear actuators may be connected to the guide tube (p. 22, line 23). Based on the teachings of Mah, one of ordinary skill in the art looking to add additional movement (degrees of freedom) to the surgical instrument would look for established designs for the modification. According to the teachings of Vogele, modifications may be made to robots with four degrees of freedom (p. 6, last line, to p. 7, lines 1-3) to provide robots with five or more degrees of freedom (Abstract). Additionally, Vogele provides motivation for the addition of linear actuators to improve movement of the base system of Mah at p. 22, lines 16-22 by explaining that the linear movement of the center solid cylindrical shaft relative to the inner hollow tubular shaft may be controlled by a third linear actuator which may be clamped onto the inner hollow tubular shaft. Vogele states that “[t]he rotation of the center solid cylindrical shaft relative to the inner hollow tubular shaft may be controlled by a third rotational actuator which may be clamped to the third linear actuator. That is, the capabilities of the medical robot as disclosed can be expanded by adding additional linear and/or rotational actuators in a cascading fashion.” Because Mah and Vogele address the same engineering problem (surgical apparatus comprising a plurality of motors for holding or moving surgical instruments) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a motor to the instrument control apparatus) as taught by Vogele, a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 3, Mah modified by Vogele teaches the instrument advancing apparatus according to claim 2, as set forth above, wherein the third motor (Vogele: p. 22, first paragraph, third linear actuator) comprises a third holding means (Vogele: p. 22, clamp) configured to hold and/or move the first instrument or the second instrument (Vogele: p. 22).
A “holding means” is interpreted as set forth in the specification at ¶27 and ¶34 and equivalents thereof.
Regarding claim 4, Mah modified by Vogele teaches the instrument advancing apparatus according to claim 1, as set forth above, wherein first motor (Vogele: p. 22, first linear actuator), the second motor (Vogele: p. 22, second linear actuator) and the third motor (Vogele: p. 22, first full paragraph, third linear actuator) are piezo motors (Vogele: p. 7, second full paragraph, last sentence).
Claims 5-7 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Mah et al., US 6,109,270 (29 August 2000) in view of in view of Vogele, WO 2019197056 (17 October 2019) (cited on Applicant’s IDS filed 9 November 2023) and further in view of Vogele US 20160278806 (hereinafter “Vogele ‘806”).
Regarding claim 5, Mah modified by Vogele teaches the instrument advancing apparatus according to claim 1, as set forth above.
Mah modified by Vogele does not teach wherein the instrument advancing apparatus comprises a spindle device configured to rotationally move the first instrument and the spindle device operatively connected to at least one of the first holding means, the second holding means, and a third holding means.
Vogele ‘806 teaches wherein the instrument advancing apparatus comprises a spindle device (FIG 2, drives (e.g. fine thread spindles); ¶20) configured to rotationally move the first instrument and the spindle device operatively connected to at least one of the first holding means, the second holding means, and a third holding means (FIG 2, base body 2).
Mah, Vogele, and Vogele ‘806 teach in the same field of endeavor, robotic surgical systems comprising instrument control units for surgical instruments. Mah teaches instrument advancing apparatus comprising two motors. Mah does not teach a spindle device configured to rotationally move the first instrument. Vogele teaches a medical robot that provides guidance and actuation of medical instrument using a first, second, and third linear actuator (p. 22) with optional additions of a rotational actuator or additional linear actuators (p. 22). A rotational actuator taught by Vogele would meet the definition of a spindle apparatus taught by Vogele ‘806. Vogele ‘806 also specifically teaches rotational drives as fine thread spindles (FIG 2,¶20) configured to rotationally move the first instrument and the spindle device operatively connected to at least one of the first holding means, the second holding means, and a third holding means (FIG 2, base body 2).
Based on the teachings of Mah, one of ordinary skill in the art looking to add additional movement (degrees of freedom) to the surgical instrument would look for established designs for the modification. According to the teachings of Vogele, modifications may be made to robots with four degrees of freedom (p. 6, last line to p. 7, lines 1-3) to provide robots with five or more degrees of freedom (Abstract). Additionally, Vogele teaches linear actuators to provide degrees of freedom, gimble mounts to provide additional degrees of freedom, and rotational actuators to provide additional degrees of freedom, as set forth above, all of which improve movement of the base system of Mah. Vogele also expressly teaches that the capabilities of the medical robot as disclosed can be expanded by adding additional linear and/or rotational actuators in a cascading fashion (p. 22). Adding a spindle drive to the base device of Mah, modified by the device components of Vogele, and further modified by the spindle drive of Vogele ‘806 would be predictable because they all address the same engineering problem (optimizing movement for moving surgical instruments) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding additional motors, actuators, and drive devices to the instrument control apparatus) taught by Mah, as modified by Vogele, and as taught as being further modifiable as taught by Vogele at p. 22, and Vogele ‘806 using a spindle apparatus (¶20), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
A “holding means” is interpreted as set forth in the specification at ¶27 and ¶34 and equivalents thereof.
Regarding claim 6, Mah modified by Vogele and Vogele ‘806 teaches the instrument advancing apparatus according to claim 5, as set forth above, wherein the spindle device is configured to interact with the first holding means and the second holding means (Vogele ‘806: FIG 2,¶20, interaction with base body 2 (FIG 2) and guide jaws 5).
Regarding claim 7, Mah modified by Vogele and Vogele ‘806 teaches the instrument advancing apparatus according to claim 5, as set forth above, wherein the spindle device comprises a hollow body including a cavity and at least one thread (Vogele ‘806: FIG 2, ¶20, fine thread spindles), wherein the first instrument (Vogele ‘806: needle 6) is configured to be arranged and fixed in the cavity (Vogele ‘806: FIG 2,¶20).
Regarding claim 9, Mah modified by Vogele and Vogele ‘806 teaches the instrument advancing apparatus according to claim 7, as set forth above, wherein the first holding means and/or the second holding means-comprises a guide member (Vogele ‘ 806: FIGs 2, 3; ¶20, guide jaws 5) configured to be guided in the at least one thread (Vogele ‘806, rotational drives as fine thread spindles, FIG 2,¶20)
Regarding claim 10, Mah modified by Vogele and Vogele ‘806 teaches the instrument advancing apparatus according to claim 1, as set forth above, wherein the first motor, the second motor and the third motor each comprise a fastening means configured to releasably fasten the first holding means, the second holding means and the third holding means (Vogele ‘806: ¶18 guide jaws 5 as a releasable clamp).
Regarding claim 11, Mah modified by Vogele and Vogele ‘806 teaches the instrument advancing apparatus according to claim 10, wherein the fastening means comprise a fastening unit configured to interact with a complementarily shaped counter unit of the first holding means, the second holding means and the third holding means (Vogele ‘806: FIG 2, extension 5f; ¶18, guide jaw 5 designed as a releasable clamp).
Allowable Subject Matter
Claims 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art does not teach or reasonably suggest the instrument advancing apparatus wherein the spindle device comprises two counter-rotating threads.
Conclusion
Claims 1-7 and 9-14 are rejected. Claim 8 is objected to.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Grover et al., WO 2015175200 (19 November 2015) (cited on Applicant’s IDS filed 9 November 2023) teaches an instrument control unit (FIG 2B; ¶42, 100) for control of a surgical instrument (10) configured to be used during a medical procedure (¶2) wherein the instrument advancing apparatus further comprises at least a third motor (¶10) configured to be motor-driven along the first axis body (¶10), along the second axis body or along a third axis body of the guide device, the third axis body being aligned parallel to the first axis body and the second axis body (¶10).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771