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 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 1-12 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).
More specifically, claims 1, 9, and 10 are device claims that seem to encompass a human, particularly when referencing a user. Examiner suggests amending the claim language to recite the device elements being “configured to” interact with the user.
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 1-14 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.
Regarding claim 1, it is unclear in what way the inclined surface is “adjustably mounted on the frame.”
Regarding claims 13 and 14, it is unclear from where the force is measured, as there is no frame of reference provided for either claim. Further, claim 13 fails to disclose how bilateral hamstring function is measured, as two sensors would be required to evaluate bilateral hamstring function.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. More specifically, claim 4 recites claim limitations pertaining to a feature that was already disclosed in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blackburn et al. (Blackburn et al.; Influences of hamstring stiffness and strength on anterior knee joint stability; Clinical Biomechanics; March 2011; pp. 278-283; Vol. 26, Issue 3 – Cited by Applicant), hereinafter Blackburn.
Regarding claim 1, Blackburn discloses a device for the measurement of hamstring function [See Fig. 1; Custom-built perturbation device, see pg. 279, left column, last paragraph] comprising:
a base adapted to sit on the ground [wooden base, see in Fig. 1];
a frame extending vertically from the base [frame extending vertically from base, including cushioning where subject rests, see in Fig. 1];
a thigh support element having an inclined surface adjustably mounted on the frame [inclined cushioning where subject is resting thigh, connected to the frame, see in Fig. 1; Examiner notes that an arbitrary form of adjustability of the thigh support is assumed to be present to account for different leg dimensions of the 30 tested subjects]; and
at least one hook shaped element mounted adjacent the base of the device [attachment strap connected to foot of subject and is positioned adjacent to the base structure in Fig. 1; Examiner notes that the strap appears to be able to be hook shaped], the hook shaped element comprising at least one force sensor [load cell, see in Fig. 1] which senses the force applied either by one or both of the hamstrings of a user pushing their thighs against the thigh support element [The foot was secured to a loading device interfaced with a load cell which allowed measurement of isometric hamstrings contraction (knee flexion) force, see on pg. 279, left column, last paragraph], and which transmits the force which is sensed to a device which records and measures the force [Prior to perturbation, subjects activated the hamstrings to 30+/-5 %MVIC using real-time biofeedback in the form of load cell output displayed on a computer monitor in the subject's view, see on pg. 279, left column, last paragraph; Examiner notes that the “device which can record and measure the force” is not a positively claimed element in the hamstring function measurement device].
Regarding claim 2, Blackburn discloses the device of claim 1,wherein the frame comprises a planar element mounted substantially vertically on the frame [Planar element mounted vertically at area where subject rests foot, see in Fig. 1, left side].
Regarding claim 3, Blackburn discloses the device of claim 2, wherein the planar element has a front face and a rear face [see planar element where test foot is rested, planar element has front and rear face, see in Fig. 1], the thigh support element being adjustably mounted on the front face of the planar element [Examiner notes that the thigh support element is mounted on the front facing side of the planar element in reference to where it is connected on the frame].
Regarding claim 4, Blackburn discloses the device of claim 1, wherein the thigh support element is adjustably mounted on the frame [Thigh support appears to be connected to the frame, see in Fig. 1; Examiner notes that an arbitrary form of adjustability of the thigh support is assumed to be present to account for different leg dimensions of the 30 tested subjects].
Regarding claim 5, and substantially similar limitations in claims 6 and 7, Blackburn discloses the device of claim 1, wherein the inclined surface of the thigh support element is inclined at 27 to 33o to the horizontal [Subjects were positioned prone with the right hip and knee supported in 30 degrees of flexion, see on pg. 279, under Experimental procedures].
Regarding claim 8, Blackburn discloses the device of claim 1, wherein the force sensor is a loadcell [loadcell in Fig. 1].
Regarding claim 9, Blackburn discloses the device of claim 1, wherein the device is provided with two hook shaped elements, one for each ankle of the user [multiple hook shaped attachments in Fig. 1; Examiner notes that the attachments can be rearranged to secure both ankles].
Regarding claim 10, Blackburn discloses the device of claim 1, wherein the device is provided with a handle that the user grasps during use of the device [Examiner notes that the wooden frame on in Fig. 1 can be grasped on the side as a handle during the use of the perturbation device].
Regarding claim 11, Blackburn discloses the device of claim 1, further comprising a seat [seat included in Fig. 1]
Regarding claim 12, Blackburn discloses the device of claim 11, wherein the height of the seat is adjustable [Examiner notes that the seat in Fig. 1 can be manipulated so that its height is adjusted, such as being placed on a platform, or can be replaced with a different seat that has built in height adjustability].
Regarding claim 13, Blackburn discloses a method of measuring bilateral hamstring function the method comprising: sensing and measuring the force applied by a user pushing their thighs against a thigh support element [inclined cushioning where subject is resting thigh, connected to the frame, see in Fig. 1] having an inclined surface inclined at 27 to 33o to the horizontal [Subjects were positioned prone with the right hip and knee supported in 30 degrees of flexion, see on pg. 279, under Experimental procedures; see also in Fig. 1].
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Blackburn (Blackburn et al. Influences of hamstring stiffness and strength on anterior knee joint stability. Clinical Biomechanics. March 2011. pp. 278-283; Vol. 26, Issue 3 – Cited by Applicant) in view of Elson et al. (Elson RA, Aspinall GR. Measurement of hip range of flexion-extension and straight-leg raising. Clin Orthop Relat Res. 2008;466(2):281-286.), hereinafter Elson.
Regarding claim 14, Blackburn discloses a method of measuring unilateral hamstring function with the tested leg, the method comprising sensing and measuring the force applied by a user pushing their thighs against a thigh support element [inclined cushioning where subject is resting thigh, connected to the frame, see in Fig. 1] having an inclined surface inclined at 27 to 33o to the horizontal [Subjects were positioned prone with the right hip and knee supported in 30 degrees of flexion, see on pg. 279, under Experimental procedures; see also in Fig. 1].
Blackburn fails to disclose that the non-tested leg is in 10-30o of hip extension.
However, Elson discloses that 10-30 degrees is within normal range of hip extension [5-40 degrees range of motion found in a group of 200 healthy individuals, with an average of 25 degrees and a mode of 20 degrees, see in Table 1, pg. 285].
Blackburn and Elson are both analogous to the claimed invention because they are in the same field of testing lower extremity function. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Blackburn to incorporate the teachings of Elson and include that the non-tested leg is in 10-30o of hip extension, as this would test bilateral hamstring function during normal range of hip extension of the non-tested leg.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HY KHANH DOAN whose telephone number is (703)756-5434. The examiner can normally be reached Monday - Friday 8:00 a.m. - 5 p.m..
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/HY KHANH DOAN/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791