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 36-43 objected to because of the following informalities: “A method” should be “The method”. Appropriate correction is required.
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.
Claims 35-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 35 follows.
STEP 1
Regarding claim 35, the claim recites a series of steps or acts, including calculating a likelihood that the patient suffers from a blast brain injury based on at least one of age, gender, and eye conjugacy. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of calculating a likelihood that the patient suffers from a blast brain injury based on at least one of age, gender, and eye conjugacy sets forth a judicial exception. This step describes a mathematical concept. Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. The calculation of the likelihood that the patient suffers from a blast brain injury does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the calculated likelihood, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Claim 35 recites a step of analyzing eye movement of the at least one eye of the patient in response to the visual stimulus on the display and comparing to a baseline which is another abstract idea in the form of a mental process. Besides the Abstract Ideas, the claim recites additional steps of providing a display for presenting a visual stimulus and a camera; seating the patient a predetermined distance away from the display; presenting a video on the display to the patient; and tracking eye movement of at least one eye of the patient using the camera as the subject watches the video on the display and responds to the visual stimulus. Obtaining wye tracking data using a video display is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the presenting, seating, and tracking steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and Abstract Ideas. Claims 36-37 recite mere data gathering steps necessary to perform the Abstract Idea. Claims 38-43 are abstract ideas in the form of mental processes or mathematical concepts. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
(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) 35-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Samadani (US 20160278716 A1).
In regards to claim 35 Samadani teaches a method for identifying whether a patient has been exposed to a blast or a pressure wave or a sonic wave by ([0148]):
(a) providing a display for presenting a visual stimulus and a camera ([0191][0264]);
(b) seating the patient a predetermined distance away from the display ([0372]);
(c) presenting a video on the display to the patient ([0265]);
(d) tracking eye movement of at least one eye of the patient using the camera as the subject watches the video on the display and responds to the visual stimulus ([0262]);
(e) analyzing eye movement of the at least one eye of the patient in response to the visual stimulus on the display and comparing to a baseline ([0030]);
(f) calculating a likelihood that the patient suffers from a blast brain injury based on at least one of age, gender, and eye conjugacy ([0147-0148]).
In regards to claim 36 Samadani teaches the method according to claim 35,wherein at least about 100,000 samples of eye position are obtained ([0154]).
In regards to claim 37 Samadani teaches the method according to claim 35, wherein eye movement is tracked for a period of from about 30 to about 500 seconds ([0154]).
In regards to claim 38 Samadani teaches the method according to claim 35,wherein analyzing eye movement of the at least one eye comprises generating and plotting pairs of (x,y) values representing two components of instantaneous angle of pupil reflection (horizontal, vertical) over a period of time ([0200]).
In regards to claim 39 Samadani teaches the method according to claim 35,wherein analyzing eye movement of the at least one eye comprises generating a figure that reflects a trajectory traveled by the at least one eye ([0193]).
In regards to claim 40 Samadani teaches the method according to claim 35. further comprising identifying the patient as having eye movement of a first eye that is significantly different from eye movement of a second eye by identifying patients having a movement measure outlying the bell curve of normal ([0293] and claim 7).
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(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samadani (US 20160278716 A1) as applied to claim 35, in view of Rennaker (US 20150245766 A1).
In regards to claim 41 Samadani teaches the method according to claim 35. Samdani fails to teach further comprising calculating a blast impact score, and wherein a blast impact score of greater than or equal to 10.75 indicates the presence of a blast brain injury. Rennaker teaches calculating a blast impact score based on the movement of a user’s pupil ([0011] “numeric score indicative of a level of impairment” is a blast impact score). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Samdani to include a step of calculating a score indicative of a level of impairment in order to track subtle changes in neurophysiological status (Rennaker [0005]).
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samadani (US 20160278716 A1) as applied to claim 35, in view of Rennaker (US 20150245766 A1) as applied to claim 41, in view of Kirk (Generation and Analysis of Blast Waves from a Compressed Air-Driven Shock Tube).
In regards to claim 42 Samadani in view of teaches the method according to claim 41. Samadani fails to explicitly teach correlating the blast impact score with the patient's distance from a blast epicenter. Inherently the higher the blast impact score, the higher the impact the patient suffered. Kirk teaches that intensity of a blast wave’s shock front decays exponentially with distance to the explosion (Figure 1). Therefore it would have been prima facie obvious to one of ordinary kill in the art, to determine that the blast impact score of modified Samadani correlates to the distance from the blast epicenter as the blast epicenter outputs the highest force and it decays the further the distance is from the epicenter.
Examiner’s Note
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Baxter (Pituitary Dysfunction after Blast Traumatic Brain Injury: The UK BIOSAP Study) teaches a blast impact score, and wherein a blast impact score of greater than 10.75 indicates the presence of a blast brain injury (table 2 ISS in blast related TBI patients is 20-45).
In regards to claim 43, none of the prior art teaches or suggests, either alone or in combination, a device or method wherein the blast impact score is calculated to be equal to exp(y)/(1+exp(y))*100, where y=-2.569133882+0.01245639*age-0.517373229*gender 16.57131011*conjvarXtop+0.057694955*age*gender-2060.801989*gender*conjvarXtop, where gender is 1 if male, and 0 if female, in combination with the other steps. While claim 43 contains no prior art rejections, it is not in condition for allowance due to its rejection under 35 U.S.C. 101.
Conclusion
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/LUCY EPPERT/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791