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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/19/11 has been entered.
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 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.
Claims 1, 3, 4, 9, 10, 14, 15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Oren Petel (US 20200225133), hereinafter ‘Petel’ in view of Stefan M. Duma et al. (US 20160021964), hereinafter ‘Duma’, in view Xianghao Zhan et al., “The relationship between brain injury criteria and brain strain across different types of head impacts can be different”, J. R. Soc. Interface 18: 2021, 14 p., https://doi.org/10.1098/rsif.2021.0260, further in view of Katherine M. Breedlove et al., “The effect of football helmet facemasks on impact behavior during linear drop tests”, Journal of Biomechanics 79 (2018) 227–231, hereinafter ‘Breedlove’, and in further view of Christopher R.P. Withnall et al. (US 20040074283), hereinafter ‘Withnall’.
With regards to Claim 1, Petel discloses
A method of evaluating a helmet using a system (evaluating helmet and helmet component performance through observation and measurement of their deformation [0004]; [0038]; Figs.1, 12), comprising:
applying a first impact configuration to the helmet (The impact force applied to the headform 102 or helmet 104 may come from a variety of sources, including drop impact events [0052]),
the first impact configuration comprising a plurality of impacts applied to the helmet via free fall drops of the helmet to a metal plate tilted at a first predetermined angle (dropping the headform on a drop tower, monorail, or guided twin wire onto an anvil or various materials [0052]; the impact force is imparted by dropping the helmet and headform onto an anvil, where said anvil may be flat or hemispherical and may be inclined at an angle or remain perpendicular to the direction of the drop, Claim 8; rigid surface);
generating a plurality of linear acceleration and angular velocity values associated with the first impact configuration (The accelerometer data is processed to determine the direction and magnitude of linear and rotational components of acceleration [0044]).
Petel also discloses that it is known in the art of biomechanics to study mechanical response to a rigid surface [0013] and discloses that the risk of brain injury is due to impact [0050].
However, Petel does not specifically disclose:
the plurality of impacts comprising a first impact to a front of the helmet, a second impact to a side of the helmet, and a third impact to a rear boss of the helmet
applying a second impact configuration to the helmet using the winch system,
the second impact configuration comprising a second plurality of impacts applied to the helmet via free fall drops of the helmet to the metal plate tilted at a second predetermined angle;
the second plurality of impacts comprising a fourth impact to the front of the helmet, a fifth impact to the side of the helmet, and a sixth impact to the rear boss of the helmet;
determining a plurality of injury risk values associated with the first and the second impact configurations based on the plurality of linear acceleration values and the plurality of angular velocity values, the plurality of linear acceleration values and the plurality of angular velocity values being separate inputs or components of an equation for determining the plurality of injury risk values;
determining a plurality of exposure values associated with the first and the second impact configurations; and
determining an overall injury risk metric based on the plurality of injury risk values and the plurality of exposure values.
Duma discloses determining a plurality of injury risk values associated with the first impact configurations (Tables 4 and 5, Column “Risk of injury”; [0052-0053]); determining a plurality of exposure values associated with the configurations (Tables 3-5) and determining an overall injury risk metric for the helmet based on the plurality of injury risk values and a plurality of exposure values (present invention provides an evaluation approach that is the Summation of Tests for the Analysis of Risk (STAR) formula, which combines head impact exposure with brain injury probability over the broad range of 227 head impacts that a hockey player is likely to experience during one season. These impact exposure data may be mapped to parameters using a series of 12 impact conditions comprised of three energy levels and four head impact locations, which include centric and non-centric directions of force. Injury risk is determined using a multivariate injury risk function that incorporates both linear and rotational head acceleration measurements. The methodology provides a framework to optimize hockey helmet design for injury risk reduction, as well as providing meaningful metrics to assess the relative performance of hockey helmets [0012]; Tables 3 and 4, STAR values; STAR values … rather an overall estimate of undiagnosed and diagnosed injuries combined. While these values are tied to concussion risk, ultimately the rating system identifies helmets that best reduce head acceleration throughout the range of head impacts that hockey player's experience [0072]).
Duma also discloses a plurality of impact configurations comprising a plurality of impacts between a helmet and a rigid surface at a plurality of predetermined angles ([0041], [0043], [0046]; [0048]; Figs. 5A, 5B).
Zhan discloses the plurality of linear acceleration values and the plurality of angular velocity values being separate inputs or components of an equation for determining the plurality of injury risk values (They are calculated by taking the maximum of the magnitude of the respective translational or rotational parameters, p.4; The critical values ωcr and αcr were design variables and decided by risk of diffuse axonal injury and the best linear fit between CSDM and the BRIC. Different ωcr and αcr were given in [39] and the parameters used were obtained by on-field football data (p.4):
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Petel in view of Duma, and Zhan to use separate inputs or components for plurality of linear acceleration values and the plurality of angular velocity values in equation (Equation 2.6, Zhan) for determining the plurality of injury risk values as they are reflective of different kinematics that human heads experience during impacts to correctly evaluate risk (Brain Injury Criteria, Zhan, Abstract) using rotational and translation movements (the peak values of head movement kinematics, such as the linear acceleration at the brain centre of gravity, angular velocity and angular acceleration, can also be used as a BIC, Abstract, Zhan).
Breedlove discloses the plurality of impacts comprising a (first) impact to a front of the helmet, a (second) impact to a side of the helmet, and a (third) impact to a rear boss of the helmet (Helmets were dropped in the six orientations prescribed by NOCSAE (NOCSAE, 2012, 2013a,b): Front, Right Front Boss, Top, Right Rear Boss, Rear, and Side (Fig. 2)., Breedlove, p.228).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Petel in view of Duma, Zhan, and Breedlove to apply a second impact configuration to the helmet comprising a plurality of impacts between the helmet and the metal plate (anvil, Petel) tilted at a second predetermined angle where the plurality of impacts comprising a (fourth) impact to a front of the helmet, a (fifth) impact to a side of the helmet, and a (sixth) impact to a rear boss of the helmet similarly to applying the first impact configuration at the first angle the plurality of impacts comprising a (first) impact to a front of the helmet, a (second) impact to a side of the helmet, and a (third) impact to a rear boss of the helmet (Breedlove, Duma) to apply the first and second impacts to same helmet locations all suggested by a standard to collect symmetrical data to compare responses/results accordingly and to produce representative results corresponding to different angles impacts experienced by players that affect severity of potential injuries as known in the art (These conditions were chosen to be representative of a span of impacts severities that encompass both sub-concussive and concussive head impacts, and are defined by pendulum arm angles of 40° (low), 65° (medium), and 90° (high), Duma [0050]).
Withnall discloses applying an impact configuration to the helmet using the winch system [0041].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Petel in view of Duma, Zhan, Breedlove, and Withnall to apply to both impact configurations winch system to manage a process of dropping weighs (helmets) as a known in the art of safety/control system.
With regards to Claims 3 and 4, Petel in view of Duma, Zhan, Breedlove, and Withnall discloses the invention as discussed above in Claim 1.
However, Petel does not explicitly disclose wherein identifying the plurality of linear acceleration and angular velocity values comprises identifying a respective linear acceleration value and angular acceleration value for each impact of the first and the second impact configurations and wherein determining the plurality of injury risk values comprises determining a respective injury risk value for each impact of the first and the second impact configurations.
Duma also discloses a plurality of impact configurations as discussed in Claim 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Petel in view of Duma, Zhan, Breedlove, and Withnall to identify a respective linear acceleration value and angular acceleration value and determine the respective plurality of injury risk values for each impact of the first and the second impact configurations to obtain a comprehensive assessment of probability of concussion (to define probability of concussion as a function of linear head acceleration, angular head acceleration, or both. Debates over the mechanisms of brain injury and the ability of metrics that include linear or angular head acceleration to predict injury risk are long-standing, Duma [0008]).
With regards to Claims 9 and 10, Petel in view of Duma, Zhan, Breedlove, and Withnall discloses the invention as discussed above in Claims 1 and 9.
Petel additionally disclose that the accelerometer data is processed to determine the direction and magnitude of linear and rotational components of acceleration [0013] using 3 accelerometers at the center of gravity and … 2 accelerometers mounted along the top and front anatomical mid-sagittal and the side coronal plane in a 3-2-2-2 configuration [0013].
However, Petel does not explicitly disclose wherein the plurality of linear acceleration and angular velocity values are generated by a six degrees of freedom (6DoF) sensor package located near a center of gravity of a headform, wherein the 6DoF sensor package comprises three accelerometers and a triaxial angular rate sensor.
Duma discloses the plurality of linear acceleration and angular velocity values are generated by a six degrees of freedom (6DoF) sensor package located near the center of gravity, the 6DoF sensor package comprises three accelerometers and a triaxial angular rate senso (Adaptor plate 100 is used to mate the headform 110 to neck 112 while keeping the relative locations of the occipital condyle pin and headform center of gravity (CG) as close as possible [0044]; headform 110 was instrumented with a 6 degrees of freedom sensor package consisting of 3 accelerometers and 3 angular rate sensors (6DX-Pro, DTS, Seal Beach, Calif.) [0045]; [0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Petel in view of Duma, Zhan, Breedlove, and Withnall to collect acceleration data using a six degrees of freedom (6DoF) sensor package located near a center of gravity of a headform comprising three accelerometers and a triaxial angular rate sensor to obtain enough linear and rotational acceleration data that characterize corresponding impacts (To measure the kinematics resulting from impact [0045]).
With regards to Claim 14, Petel in view of Duma, Zhan, Breedlove, and Withnall discloses the invention as discussed above in Claim 1.
Petel additionally discloses considering injury risk ([0008], [0050]).
However, Petel does not explicitly disclose wherein determining the overall injury risk metric comprises: multiplying an injury risk value among the plurality of injury risk values to a corresponding exposure value among the plurality of exposure values to determine a plurality of weighted injury risk values; and aggregating the plurality of weighted injury risk values.
Duma discloses determining the overall injury risk metric comprises: multiplying an injury risk value among the plurality of injury risk values to a corresponding exposure value among the plurality of exposure values and aggregating the plurality of (weighted) injury risk values (Concussion risks are multiplied by the exposure values for each impact condition to determine incidence values. All incidence values are aggregated to calculate a Hockey STAR value for each helmet. The Hockey STAR values for each helmet are averaged to determine a helmet model's overall Hockey STAR value [0032]).
Duma also discloses weighing exposure for each impact [0025].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Petel in view of Duma, Zhan, Breedlove, and Withnall to determine the overall injury risk metric comprises: multiplying an injury risk value among the plurality of injury risk values to a corresponding exposure value among the plurality of exposure values to determine a plurality of value (i.e. “weighted injury risk”) to aggregate them for each helmet (to determine a helmet model's overall Hockey STAR value, Duma [0032]).
With regards to Claim 15, Petel in view of Duma, Zhan, Breedlove, and Withnall discloses the claim limitations as discussed above in Claim 1.
With regards to Claims 19 and 20, Petel in view of Duma, Zhan, Breedlove, and Withnall discloses the claimed limitations as discussed in Claims 1 and 19.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Petel in view of Duma, Zhan, Breedlove, and Withnall, and further in view of Erin Linn Hanson et al. (US 20130174329), hereinafter ‘Hanson’.
With regards to Claim 21, Petel in view of Duma, Zhan, Breedlove, and Withnall discloses the invention as discussed above in Claim 1.
However, Petel does not specifically disclose wherein: wherein the helmet is a snow sport helmet.
Hanson discloses a snow sport helmet [0028].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Petel in view of Duma, Zhan, Breedlove, and Withnall, and Hanson to use a helmet that is a snow sport helmet used in sports with high risk of brain damage due to faults to evaluate corresponding injury risk (In order to combat concussions and other head injuries in sporting activities, protective helmets are commonly worn whenever there is a possibility of injury to the head. For example, protective helmets are commonly worn in football, hockey, baseball, lacrosse, motor sports, extreme sports, and winter snow sports, Hanson [0005]).
Response to Arguments
35 USC § 103
Applicant’s arguments with respect to claim(s) 1 (19) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
William PAYNE et al. (US 3331236) discloses a drop test using top surfaces that are shaped and angled as indicated and which is suitably secured to a rectangular metal base plate (Col.3, Lines 15-18).
Eric G. Takhounts “KINEMATIC ROTATIONAL BRAIN INJURY CRITERION (BRIC)”, TRB, 2011, 10 pages, https://www.nhtsa.gov/sites/nhtsa.gov/files/2022-09/ESV11-0263%20Takhounts.pdf, discloses combining BRIC and HIC injury criteria that use separate inputs for the plurality of linear acceleration values and the plurality of angular velocity values.
BROOKLYNN M. KNOWLES et al., “Predicting Cumulative and Maximum Brain Strain Measures From HybridIII Head Kinematics: A Combined Laboratory Study and Post-Hoc Regression Analysis”, Annals of Biomedical Engineering, Vol. 45, No. 9, September 2017, pp. 2146–2158, discloses using linear acceleration and angular velocity as inputs to an equation for determining the plurality of injury risk values.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER SATANOVSKY whose telephone number is (571)270-5819. The examiner can normally be reached on M-F: 9 am-5 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Catherine Rastovski can be reached on (571) 270-0349. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER SATANOVSKY/
Primary Examiner, Art Unit 2857
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