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 .
Claim Objections
Claims 1-4 are objected to because of the following informalities:
Claim 1 recites the limitation “to support a patient’s limb” in line 1. This limitation should be amended to include configured to language, and recite “a limb of a patient” to properly present both the limb, and the patient.
Claim 2 recites the limitation “another end portion”. This limitation should be amended to recite “a second end portion” or similar to avoid a lack of clarity.
Claim 3 recites the limitation “a patient’s leg side”. This limitation should be amended to recite “a leg side of the patient” to avoid reciting “a patient” twice. Claim 3 should be amended similarly.
Claim 4 recites the limitation “a patient’s head side”. This limitation should be amended to recite “a leg side of the patient” to avoid reciting “a patient” twice. Claim 3 should be amended similarly.
Appropriate correction is required.
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.
Claims 1-6 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 1 recites the limitations “a patient’s limb” in lines 1 and 3. The second recitation renders the claim indefinite because it is unclear if the second recitation is the same limb, or a new limb of the patient. For the purpose of examination, Examiner will interpret this limitation as being the same limb.
Claim 5 recites the limitations “a patient’s leg” in line 5. This limitation renders the claim indefinite because it is unclear if the patient’s leg recited in claim 5 is the same limb, or a new limb of the patient. For the purpose of examination, Examiner will interpret this limitation as being the same limb.
Claim 6 recites the limitation “one end portion in a longitudinal direction”. This limitation renders the claim indefinite because it is unclear if the end recited in claim 6 is the same “one end” recited in claim 1, or a new end. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claims 2-4 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim and thus, contain the same offending limitations.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 3 and 5 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In regards to claim 3, the limitation “on a patient's leg side” positively recites part of the human body.
In regards to claim 5, the limitation “toward a patient's leg” positively recites part of the human body.
To obviate a rejection under 35 USC 101, the Office suggests that any claim that would include a human being, or part thereof, within its scope should use “adapted to___” or “adapted for ___” or “configured to” or configured for” to define the metes and bounds of the claimed subject matter which is a permissible form of expression.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schuerch (US 2021/0145684 A1).
In regards to claim 1, Schuerch discloses A limb support tool (405; see [0137]; see figure 30) attached to a surgical table (Leg holder 405 is constructed so that it may be easily mounted to a surgical table; see [0137]) to support a patient's limb, the limb support tool comprising:
an arm member (415; see [0137]; see figure 30) that supports a patient's limb, the arm member being supported turnably in any direction centered on a base thereof (base of 415 attached to 625; see [0144]; see figure 30; ]; 415 can articulate with respect to 455 (see [0139])) and in a restrainable manner at any position (see [0162]); and
a gas cylinder (680; see [0146]; see figure 32) having one end portion in a longitudinal direction (690; see [0146]; see figure 32) turnably coupled to the arm member (see figure 32), the gas cylinder being supported turnably in any direction together with the arm member (see [0146]), wherein
an upper limit position of the arm member is restricted when a piston rod of the gas cylinder is in a most extended state, while a lower limit position of the arm member is restricted when the piston rod of the gas cylinder is in a most shrunk state (gas cylinder 680 may also be used to limit the travel in the lithotomy dimension, in the sense that clamping assembly 455 can move in the high lithotomy direction until gas cylinder 680 reaches its full extension length and clamping assembly 455 can move in the low lithotomy dimension until it reaches its full compression length; see [0146]).
In regards to claim 2, Schuerch discloses the invention as discussed above.
Schuerch further discloses wherein another end portion in a longitudinal direction (685; see [0146]; see figure 32) of the gas cylinder is turnably supported on a spherical portion (see figure 29 that 20 (and thus, similarly structured 420) comprises a spherical portion extending therefrom for engaging 685) disposed to protrude from a surface of a base plate (420; see [0146]; see figure 31) fixed to the surgical table (420 is used for attachment to the surgical table; see [0180]).
In regards to claim 5, Schuerch discloses the invention as discussed above.
Schuerch further discloses wherein the arm member (415) is supported turnably along a horizontal direction relative to a front-back direction of the surgical table (420 engages the side rails of the surgical table (see [0030]), and thus, 415 is supported turnably (i.e. positionable) relative to a front-back direction defined by the side rails of the surgical table), within a range of an identical angle each to an inner side and an outer side of the surgical table centered on a reference line, the reference line being inclined to an outer side in a right-left direction of the surgical table toward a patient's leg (see [0127-0128] in reference to the device being positionable in 9 degrees of adduction (i.e. 9 degrees inward from neutral), and 25 degrees of abduction (i.e. 25 degrees outward from neutral); thus, the reference angle which splits the range of 9 degrees of adduction to 25 degrees of abduction is at 9 degrees abduction (i.e. 9 degrees outward from neutral defined by the outer side of the surgical table) which is inclined with respect to the outer side of the surgical table).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuerch.
In regards to claim 3, Schuerch discloses the invention as discussed above.
Schuerch further discloses wherein a turning center (turning center defined by connection of 685) at the other end portion in the longitudinal direction of the gas cylinder (685 of 680) is positioned below a turning center (turning center defined by 625) at the base of the arm member and on a patient's leg side (see figures 31, 39, and 40), and
a straight line connecting the turning center at the other end portion in the longitudinal direction of the gas cylinder and the turning center at the base of the arm member is set with an inclination angle relative to a vertical direction (see annotated figure 31 below).
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Schuerch does not explicitly disclose the inclination angle is a range between 15° and 30°.
However, Schuerch teaches the gas cylinder is of a length which is intended to limit the travel in the lithotomy direction during surgical procedures. Thus, the inclination angle between the turning centers of the gas cylinder and the base of the arm affects the distance in which the gas cylinder can allow for travel in the lithotomy direction (i.e. a smaller inclination angle positions 685 closer to the surgical table and allows for more movement in the low lithotomy direction and less movement in the high lithotomy direction and a larger inclination angle would have the opposite effect) and is considered to be a result effective variable in that changing the inclination angle between the turning centers of the gas cylinder and the base of the arm affects the ability of the gas cylinder to limit the positioning of the arm support assembly. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the angle of inclination of the turning centers of the gas cylinder and the base of the arm as it involves only adjusting the angle of a component which is seen to have an undisclosed acute angle between the claimed structures.
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 modified the angle of inclination between the turning centers of the gas cylinder and the base of the arm of Schuerch by forming the angle between 15° and 30° as claimed as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of allowing the gas cylinder to allow for a desired amount of movement of the arm support in the lithotomy direction.
In regards to claim 6, Schuerch discloses the invention as discussed above.
Schuerch further discloses wherein one end portion in a longitudinal direction of the gas cylinder (690 of 680) is coupled to the arm member (415) via a bracket (see figure 32 that 690 is coupled to 415 by a bracket).
Schuerch does not disclose the bracket is formed in an approximate L-shape in side view.
However, Schuerch also teaches the bracket 690 can be in the form of an approximate L shape in side view (see figure 60 that 690 comprises 1300 which forms an approximate L shape in side view).
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 substituted the bracket as disclosed by Schuerch and for the bracket formed from an approximate L shape in side view as taught by the second embodiment of the bracket which connects the gas cylinder to the arm member since it has been held that “(w)here a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509 (BPAI, 2007) (citing KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1396 (2007) (see MPEP 2143 I B). Accordingly, Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results. In the instant case a substitution of the first bracket of the first embodiment for the approximate L-shape bracket of the second embodiment yields the predictable results of fastening the gas cylinder to the arm member.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schuerch in view of Soto et al. (US 2012/0124748 A1) (hereinafter Soto).
In regards to claim 4, Schuerch discloses the invention as discussed above.
Schuerch further discloses wherein the base plate (420) is disposed upright to be approximately parallel to a front-back direction of the surgical table (see figure 31 that 420 is parallel to the bracket which mounts 420 to the side rail of the surgical table and thus, 420 is parallel to the front-back direction of the surgical table),
Schuerch does not disclose the spherical portion is inclined at a predetermined inclination angle to a patient's head side relative to a direction perpendicular to a surface of the base plate.
However, Soto teaches an analogous limb support tool (10; see [0026]; see figure 1) which is utilized for the analogous purpose of supporting and positioning a patient’s limb (see [0026]); further comprising an analogous spherical portion (72; see [0033]; see figure 2) supported by an analogous base plate (76; see [0033]; see figure 2); wherein the spherical portion (72) is inclined at a predetermined inclination angle (angle beta; see [0033]; see figure 4) to a patient's head side relative to a direction perpendicular to a surface of the base plate (see [0033]; see figure 4).
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 modified the spherical portion of the base plate as disclosed by Schuerch and to have positioned the spherical portion at an inclination angle relative to a direction perpendicular to a surface of the base plate as taught by Soto in order to have provided an improved spherical portion that would add the benefit of providing an angled connection which is capable of increasing the customizable positioning for different medical procedures.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
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