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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
For purposes of examination, the priority date for claims 1-14 and 16-18 is deemed to be July 12, 2024 as the certified copy is not in the English language.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 and 16-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites that “the coupling unit is arranged in the torque limiter so that the output element can be replaced”, but the instant application states:
“the invention is based on the problem of disclosing a torque limiter with which the service life of surgical instruments can be increased” (page 2, line 5-7);
“wherein the coupling unit is arranged replaceable in the torque limiter. In this way, after reaching a defined lifetime …, the coupling unit can be replaced for a new, calibrated coupling unit” (page 2, lines 26-32); and
“In this way, the assembly that is essential for defining an actual torque limit can be replaced without having to dispose of the entire torque limiter or the entire surgical instrument” (page 2, line 32-page 3, line 2).
Thus, one of ordinary skill in the art reading the instant specification would have understood that the “coupling unit” is replaced. The coupling unit is between the input element and the output element as per claim 1. Thus, the output element may not be a part of the coupling unit in claim 1.
While claim 1, as amended, is an originally-filed claim, the description in the specification does not support the notion or reasonably convey to one of ordinary skill in the art that applicant has possession of the claimed invention. The root “replac” is used 19 times in the specification, but in each occurrence, the coupling unit is being replaced. The root “remov” is used 4 times and is used directed to coupling elements to prevent unintentional removal of the coupling unit (e.g., page 8, line 15- page 9, line 15). Consequently, the written description of the instant specification fails to describe how the output element can be replaced.
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 3-4, 6-7, 8/5, 8/6, 8/7, 14, and 17 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites that the coupling unit has a first coupling element which can be coupled … on one side with the coupling body and on an opposite side with the input element. It is unclear what has “one side: the first coupling element or the coupling unit? Also, what has “an opposite side”?
Claim 4 recites that the coupling unit has a second coupling element which can be coupled … on one side with the coupling body and an opposite side with the input element. It is unclear what has “one side: the first coupling element or the coupling unit? Also, what has “an opposite side”?
Claim 8 recites “according to one of claim” (singular), but also recites a plural number of claims “5-7”. Since the term “claim” was amended to be singular from its plural form, it is unclear to which claim of the recited “5-7” claim 8 is intended to depend from.
Claim 17 depends from claim 3 and recites that the coupling unit has a second coupling element which can be coupled on the opposite side with the output element. It is unclear how the recitation in claim 3 provides support for the recitation in claim 17 directed to a second coupling element that is not present in claim 3.
Claim 14, line 3, includes the connector “such that” that renders the phrase following the connector indefinite as “such” connotes “of the kind, character, degree” which does not mean that the phrase following the connector is required for the claim. The Examiner suggests the connector “so that”.
Claims 6-7, 8/6, and 8/7 are rejected because they depend from an indefinite claim.
Claim Rejections - 35 USC § 102
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 1-5, 8/5, 12-14, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DE 20 2013 104656 (cited by Applicant and hereinafter referred to as “DE ‘656”).
Regarding claim 1, DE ‘656 discloses a torque limiter, especially for a surgical instrument with an axis of rotation (see Fig. 4 and English translated abstract of DE ‘656 provided/cited by Applicant), the torque limiter comprising: an input element to input torque into the torque limiter (e.g., Fig. 4, handle part 106; and page 8, lines 1-6 of the English machine translation of DE ‘656: A second embodiment of a tool with a torque limiter has a handle part 106 to which a torque is applied and transmitted to the torque limiter via rolling element cage 29 as a drive member of the torque limiter), an output element for the output of torque from the torque limiter (e.g., Fig. 4, output member/ rod 25 with area 28 and page 8, lines 6-12 of the English machine translation of DE ‘656: from the drive member 29 of the torque limiter, the torque is applied to the output member in the form a rod 25 with area 28), and a coupling unit (e.g., Fig. 4, 21 including cap 22, rolling element cage 29, bearing pins 33 and rolling elements 32 and page 8, lines 13-30 of the English machine translation of DE ‘656: In its assembled state, the area 28 of the rod 25 extends into a sleeve of the rolling element cage 29 [which is connected to the input element]) having a coupling body (e.g., Fig. 4, drive member 29, rolling elements 32, bearing pins 33), by means of which the input element can be coupled with the output element (e.g., page 8, lines 6-30 of the English machine translation of the DE ‘656), the coupling unit is arranged in the torque limiter so that the output element can be replaced (e.g., Fig. 4, cap 22, where the coupling unit including the output element would be capable of being removed from the handle when the cap is unscrewed).
Referring to claim 13, DE ‘656 discloses a handle unit (e.g., Fig. 4), especially for a surgical instrument (e.g., English-language abstract: A tool, in particular a surgical
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instrument), the handle unit comprising: a distal end (see annotated Fig. 4), a proximal end (see annotated Fig. 4), a handle longitudinal axis connecting the distal end and the proximal end (e.g., Fig. 4, rotation axis D), and a torque limiter having an input element to input torque into the torque limiter (e.g., Fig. 4, handle part 106; and page 8, lines 1-6 of the English machine translation of DE ‘656: A second embodiment of a tool with a torque limiter has a handle part 106 to which a torque is applied and transmitted to the torque limiter via rolling element cage 29 as a drive member of the torque limiter), an output element (e.g., Fig. 4, output member/ rod 25 with area 28 and page 8, lines 6-12 of the English machine translation of DE ‘656: from the drive member 29 of the torque limiter, the torque is applied to the output member in the form a rod 25 with area 28) and a coupling unit (e.g., Fig. 4, 21 including cap 22, rolling element cage 29, bearing pins 33 and rolling elements 32 and page 8, lines 13-30 of the English machine translation of DE ‘656: In its assembled state, the area 28 of the rod 25 extends into a sleeve of the rolling element cage 29 [which is connected to the input element]), wherein the input element has a gripping surface (e.g., Fig. 4, the surface of the handle part 106 and page 8, lines 26-32: torque is applied to grip part 106) and the coupling unit is arranged one of in and on the proximal end (see annotated Fig. 4 when in the assembled state, the hexagonal end 107of the output element 25 would be in the proximal end).
With respect to claims 2 and 14, DE ‘656 discloses the torque limiter according to claim 1 and the handle unit of claim 13, characterized in that the coupling unit is arranged along the axis of rotation in and on the torque limiter (e.g., Fig. 4, rotation axis D in the assembled state).
As to claim 3, DE ‘656 discloses the torque limiter according to claim 1, characterized in that the coupling unit has a first coupling element (e.g., Fig. 4, rolling element cage 29) which can be one of coupled, rotationally locked and directly connected on one side with the coupling body (e.g., Fig. 4, drive member 29, rolling elements 32, bearing pins 33) and on an opposite side with the input element (e.g., page 8, lines 6-30 – opposite side: rolling elements 32 of coupling unit).
With respect to claim 4, DE ‘656 discloses the torque limiter according to claim 3, characterized in that the coupling unit has a second coupling element (e.g., Figs. 4-5, rolling elements), which can be coupled on one side with the coupling body and on an opposite side with the input element (e.g., Fig. 5, rolling element 32 and page 8, lines 26-27 of the English machine translation of DE ‘656: torque is applied from grip part 106 via rolling elements 32).
As to claim 5, DE ‘656 discloses the torque limiter according to claim 1, characterized in that the coupling body has a pressing element constructed as a spring arm (e.g., Fig. 4, bearing pin 33 and page 8, lines 17-19: in a normal position parallel to the axis of rotation D extending trunnions 33 with a bearing pin 33 made of resilient material).
With respect to claim 8, DE 656 discloses the torque limiter according to claim 5, characterized in that the pressing element is formed by a plurality of pressing elements that are all oriented in a same circumferential direction about the axis of rotation (see Fig. 4, elements 33 are oriented in a same direction about the axis of rotation D).
As to claim 12, DE ‘656 discloses the torque limiter according to claim 1, characterized in that the coupling unit is configured to be one of latched and screwed into the input element (e.g., Fig. 4, cap 22 is screwed into the handle part 106 via threads).
With respect to claim 16, DE 656 discloses the torque limiter of claim 1, characterized in that the coupling unit has a first coupling element (e.g., Fig. 4, rolling element cage 29) which can be one of coupled, rotationally locked and directly connected on one side with the coupling body (outer side of rolling element cage 29) and on an opposite side with the output element (inner side of rolling element cage 29).
As to claim 17, DE ‘656 discloses the torque limiter of claim 3, characterized in that the coupling unit has a second coupling element which can be coupled on the opposite side with the output element (e.g., Fig. 5, rolling element 32 and page 8, lines 26-37 of the English machine translation of DE ‘656: torque is applied from grip part 106 via rolling elements 32 to the output element 25 + 28).
With respect to claim 18, DE ‘656 discloses the torque limiter of claim 1, characterized in that the coupling unit is configured to be one of latched and screwed into the output element (e.g., page 8, lines 7-9: rolling element cage 29 is rotationally fixed in an open cavity of handle part 106 via a hexagonal screw connection 107; Figs. 4 and 6, 107 of rod 25 has a cross-section that differs from the circular shape and the coupling unit can be screwed into the output element at 107).
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.
Claims 6-7, 8/6, and 8/7 are rejected under 35 U.S.C. 103 as being unpatentable over DE 656 in view of US Patent Application Publication No. 2011/0092295 to Wernz et al. (hereinafter referred to as “Wernz”).
With respect to claim 6, DE ‘656 discloses the torque limiter according to claim 4, but does not expressly disclose that the second coupling element has a latching element for interacting with a pressing element of the coupling body. However, Wernz, in a related art: torque limiter for a surgical instrument, teaches that it was well known to those skilled in the art to have a coupling unit (Figs. 1-2) with a cage 8 (Fig. 3, 8 - first coupling element) that forms a drive input shaft of the torque limiter (e.g., paragraph [0022]) and has a second coupling element (Figs. 1-2, rolling bodies 6), which has a latching element for interacting with a pressing element of the coupling body (e.g., paragraph [0023]: rolling bodies are held in rolling body holders 7 by pressure-exerting elements, such as rubber rings 9 and spring washers 10; Figs. 1-2, latching element 6 and pressure element 9, 10). Accordingly, one of ordinary skill in the art would have recognized the benefits of such a structure for a torque limiter surgical tool in view of the teachings of Wernz. Consequently, one of ordinary skill in the art would have modified the torque limiter of DE ‘656 so that its rolling element 32 is arranged in a recess of a shaft adjacent the rolling element cage 29 using rubber rings and spring washers to hold the rolling elements in view of the teachings of Wernz, and because the combination would have yielded a predictable result.
As to claim 7, DE ‘656 in view of Wernz teaches the torque limiter according to claim 6, characterized in that the latching element is constructed as a roller body (e.g., Figs. 1-2, 6) that is arranged in a recess of the second coupling element (DE ‘656, as modified by Wernz above would have a shaft with a recess attached to rolling element cage). Accordingly, one of ordinary skill in the art would have recognized the benefits of such a structure for a torque limiter surgical tool in view of the teachings of Wernz. Consequently, one of ordinary skill in the art would have modified the torque limiter of DE ‘656 so that its rolling element 32 is arranged in a recess of a shaft adjacent the rolling element cage 29 using rubber rings and spring washers to hold the rolling elements in view of the teachings of Wernz, and because the combination would have yielded a predictable result.
With respect to claim 8, DE ‘656 in view of Wernz teaches the torque limiter according to one of claim 6 to 7, characterized in that the pressing element is formed by a plurality of pressing elements that are all oriented in a same circumferential direction about the axis of rotation (see Figs. 1-2 where the pressing elements are all oriented in a circumferential direction about the axis of rotation). Accordingly, one of ordinary skill in the art would have recognized the benefits of such a structure for a torque limiter surgical tool in view of the teachings of Wernz. Consequently, one of ordinary skill in the art would have modified the torque limiter of DE ‘656 so that its rolling element 32 is arranged in a recess of a shaft adjacent the rolling element cage 29 using rubber rings and spring washers arranged in a same circumferential direction to hold the rolling elements in view of the teachings of Wernz, and because the combination would have yielded a predictable result.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over DE 656 in view of US Patent No. 11,787,026 to Ou.
DE ‘656 discloses the torque limiter according to claim 1, but does not expressly disclose that the coupling body is formed by multiple coupling bodies that are arranged one after the other along the axis of rotation. However, Ou, in a related art: screwdriver with torque control, teaches two sleeve members are disposed around and rotatable about the driver body 10 one after the other along an axis of rotation so that when a relative torque greater than a predetermined torque occurs between the sleeve member and the driver body, a blocking structure deforms (e.g., column 2, lines 11-33 and Fig. 1). Accordingly, one of ordinary skill in the art would have recognized the benefits of multiple coupling bodies arranged one after the other along the axis of rotation in view of the teachings of Ou. Consequently, one of ordinary skill in the art would have modified the torque limiter of DE ‘656 to have multiple coupling bodies that are arranged one after the other along the axis of rotation to enable torque control in both directions in view of the teachings of Ou, and because the combination would have yielded a predictable result.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over DE ‘656 in view of Ou as applied to claim 9 above, and further in view of Wernz.
DE ‘656 in view of Ou teaches the torque limiter according to claim 9, teach that the coupling unit comprises a spacer element that is constructed as a rubber ring and is arranged along the axis of rotation adjacent to one of the multiple coupling bodies. However, Wernz, in a related art, teaches the use of rubber rings 9 in a coupling unit for transferring torque that serves as a spacer and is arranged along the axis of rotation adjacent to one of the multiple coupling bodies. Accordingly, one of ordinary skill in the art would have recognized the benefits of such a structure for a torque limiter surgical tool in view of the teachings of Wernz. Consequently, one of ordinary skill in the art would have modified the torque limiter of DE ‘656 so that the coupling unit has a spacer element/rubber rings arranged along the axis of rotation adjacent one of the multiple coupling bodies in view of the teachings of Wernz that such structure was a well-known engineering expedient in the art, and because the combination would have yielded a predictable result.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over DE ‘656 in view of US Patent Application Publication No. 2019/0022833 to Macke et al. (hereinafter referred to as “Macke”).
DE ‘656 discloses the torque limiter according to claim 1, but does not expressly disclose that the coupling unit has an essentially mushroom-shaped outer contour. However, DE ‘656 does disclose that the coupling unit has a cap 22 which has a mushroom-like stem shape, but does not clearly show the top shape of its cap. In a related art: disposable surgical screwdriver, Macke teaches that it was known in the art to provide the cap of the torque control with a mushroom-shaped outer contour (e.g., Fig. 2B, 118 and paragraph [0044]). Moreover, since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See In re Dailey, 149 USPQ 47 (CCPA 1976). It appears that the disclosed device would perform equally well shaped as disclosed by Macke.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2024/0023946 to Wolf et al. is directed to a surgical tool adapter having a torque limiting device (e.g., paragraphs [0009] and [0067]-[0070]).
US Patent Application Publication No. 2019/0178301 to Witte is directed to a torque limiter for a surgical screwdriver.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792