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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/23/2026 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, 3-10, 13-16, 18-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over 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, in view of Katherine M. Breedlove et al., “The Ability of an Aftermarket Helmet Add-On Device to Reduce Impact-Force Accelerations During Drop Tests”, Journal of Athletic Training 2017;52(9): pp.802–808, hereinafter ‘Breedlove’, in view of, in further view of Óscar Juste-Lorente et al., “The Influence of Headform/Helmet Friction on Head Impact Biomechanics in Oblique Impacts at Different Tangential Velocities”, Appl. Sci. 2021, 11, 11318, https://doi.org/10.3390/app112311318, hereinafter ‘Influence’.
With regards to Claim 1, Duma discloses
A method of evaluating a helmet (the present invention provides a new evaluation system for hockey helmets. The evaluation system provides a quantitative measure of the ability of individual helmets to reduce the risk of concussion [0011], a framework to optimize hockey helmet design for injury risk reduction [0012]), comprising:
positioning the helmet on a bare headform, the bare headform being mounted on a neck using an adaptor to locate a center of gravity of the bare headform (positioning the helmet on a headform, the headform being mounted on a neck using an adaptor to locate a center of gravity of the headform [0038]; Figs.1B-1C; Claim 3);
applying a first impact configuration to the helmet with a first impact velocity, the first impact configuration comprising impacts to a front of the helmet, and a rear of the helmet at the first impact velocity; applying a second impact configuration to the helmet with a second impact velocity, the second impact configuration comprising impacts to the front of the helmet, and the rear of the helmet at the second impact velocity (The custom impact pendulum device was used to strike a NOCSAE headform mounted on a Hybrid III 50th percentile neck [0021]; Figs. 3A-3D; Tables 2-3; [0022, 0040-0044]; the Examiner interpreted impacts at different angles in Tables 2 and 3 as first and second impact configurations);
generating a plurality of linear acceleration values and a plurality of angular velocity values associated with the first impact configuration and the second impact configuration, the plurality of linear acceleration values and the plurality of angular velocity values comprising a respective linear acceleration value and a respective angular acceleration value for each impact of the first impact configuration and the second impact configuration (The linear acceleration and angular rate data were collected [0048]; [0052]; Tables 4 and 5);
determining a plurality of injury risk values associated with the first impact configuration and the second impact configuration based on the plurality of linear acceleration values and the plurality of angular velocity values (Tables 4 and 5, Column “Risk of injury”; [0052-0053]); and
determining an overall injury risk metric for the helmet based on plurality of injury risk values and the 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 additionally discloses comparing helmets [0014, 0062].
Duma additionally discloses an equation for determining the plurality of injury risk values (STAR equation [0010]).
However, Duma does not specifically disclose 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 and applying a first and second impact configuration to the helmet with a first and second impact velocities comprising impacts to a front boss of the helmet and a rear boss of the helmet.
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 Duma in view of Breedlove, 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 applying impact configurations to the helmet to a front boss of the helmet and a rear boss of the helmet (We dropped the helmets at 3 velocities on 6 helmet locations (front, side, right front boss, top, rear right boss, and rear) as prescribed by the National Operating Committee on Standards for Athletic Equipment, p.802).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Duma in view of Breedlove, and Knowles to also apply impacts to a front boss of the helmet and a rear boss of the helmet as known in the art (Breedlove) to meet the certification requirements (When evaluating protective headgear,13–15 the NOCSAE standards state that, for each helmet to meet the certification requirement, it must be dropped (without the facemask affixed) at 6 drop locations (front, side, right front boss, right rear boss, rear, and top, Breedlove, p.803).
Duma also does not disclose determining a plurality of exposure values associated with the first impact configuration and the second impact configuration;
applying a first impact configuration to the bare headform with the first impact velocity, the first impact configuration comprising impacts to a front of the bare headform, a front boss of the bare headform, a rear boss of the bare headform, and a rear of the bare headform at the first impact velocity;
applying a second impact configuration to the bare headform with the second impact velocity, the second impact configuration comprising impacts to the front of the bare headform, the front boss of the bare headform, the rear boss of the bare headform, and the rear of the bare headform at the second impact velocity:
determining a second plurality of injury risk values and a second plurality of exposure values associated with the first impact configuration to the bare headform and the second impact configuration to the bare headform; and
determining an overall injury risk metric for the helmet based on a comparison of the plurality of injury risk values and the plurality of exposure values with the second plurality of injury risk values and the second plurality of exposure values.
Lorente discloses comparing acceleration, velocity, and impact values of a helmeted headform with a second plurality of acceleration, velocity, and impact values for a bare headform (Table 1; Figs. 2-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Duma in view of Breedlove, Knowles, and Lorente to determine an overall injury risk metric for the helmet based on a comparison of the plurality of injury risk values and the plurality of exposure values with the second plurality of injury risk values and the second plurality of exposure values to assess and appreciate the differences between covered (helmet) and bare headforms as known in the art to demonstrate advantages of wearing a helmet (Lorente, Fig.2) while executing similar steps used for the covered helmet (similar headform locations, velocity, impact configurations, calculating plurality of injury risk values and the plurality of exposure values) as discussed above but applied to the bare headform as a comparison benchmark.
With regards to Claim 3, Duma further discloses mounting the headform on a sliding mass that simulates an effective torso mass of a human during a head impact, the sliding mass being mounted to an adjustable table [0021].
With regards to Claims 4 and 5, Duma further 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]).
With regards to Claim 6, Duma further discloses wherein the first velocity and the second velocity range from 3 meters per second (m/s) to 4.5 m/s (Pendulum arm angles of 40°, 65°, and 90° were tested, which equate to impact velocity of 3, 4.6, and 6.1 m/s [0055]).
With regards to Claims 7 and 8, Duma further discloses the first impact configuration and the second impact configuration are applied using a pendulum impactor, wherein the pendulum impactor comprises an arm, a pivot point, and an impactor surface (pendulum arm [0059]; impact pendulum with a surface [0015]; [0021, 0029, 0030, 0043], Claim 3; Impact pendulum 200 includes movable arm 210 [0041], Fig. 2B, pivot point).
With regards to Claim 9, Duma further discloses categorizing the overall injury metric into a rating system, the rating system comprising a numerical range with a plurality of numerical threshold levels (comparing the results … [0070]; Table 6).
With regards to Claim 10, Duma further discloses the claim limitations as discussed with regards to Claim 1 where the “third impact configuration” with a “third impact velocity” would correspond to another (third) angle shown in Figs. 2 and 3 as discussed above.
With regards to Claim 13, Duma in view of Breedlove, Knowles, and Lorente discloses the claim limitations as discussed above with regards to Claims 1 and 10.
With regards to Claim 14, Duma further discloses determining a plurality of exposure values to weight a relative frequency that an impact would occur at an impact location on the helmet ([0032, 0050]; Equation 2.
With regards to Claim 15, Duma further discloses wherein determining the overall injury risk metric for the helmet comprises determining the overall injury risk metric based further on the plurality of exposure values ([0034, 0055]; STAR value, Tables 4 and 5).
With regards to Claim 16, Duma further discloses wherein the plurality of exposure values are weighted so that each impact location of the first plurality of impact configurations contributes equally in the overall injury risk metric (The gray lines represent impact energy CDFs for each population and the black line is the equal-weight average of the four populations. The dashed lines show the bounds used to determine the percentage of impacts at each location associated with the low, medium, and high-energy impact conditions. This analysis was used to define the exposure weightings for each impact configuration in the Hockey STAR formula [0025]; The exposure for each impact location was weighted by how often they occur in data collected in the literature. The front, side (left and right combined), and back were approximately 30% each, with the remaining 10% of impacts to the top of the head. These values were used to weight exposure by impact location [0036]).
With regards to Claim 18, Duma in view of Breedlove, Knowles, and Lorente discloses the claim limitations as discussed above with regards to Claims 1, 13, and 15.
In addition, Duma discloses a second helmet (using two helmets [0031]).
With regards to Claim 19, Duma in view of Breedlove, Knowles, and Lorente discloses the claim limitations as discussed above with regards to Claim 18.
Duma also discloses using two similar model helmets for testing (In preferred embodiment, the testing methodology includes using two helmets of every model tested [0031]).
With regards to Claim 21, Duma in view of Breedlove, Knowles, and Lorente discloses the claimed limitations as discussed in Claims 18, 1, and 10.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Duma in view of Breedlove, Knowles, and Lorente, and further in view of Oren Petel et al. (US 20200225133), hereinafter ‘Petel’.
With regards to Claim 11, Duma in view of Breedlove, Knowles, and Lorente discloses the claimed invention as discussed above in Claim 1 including applying the first impact configuration and the second impact configuration to a headform and determining a plurality of injury risk values associated with the headform, wherein determining the overall injury risk metric for the helmet comprises determining the overall injury risk metric based further on the plurality of injury risk values associated with the headform.
However, Duma does not specifically disclose applying the first impact configuration and the second impact configuration to a bare headform; and determining a plurality of injury risk values associated with the bare headform, wherein determining the overall injury risk metric for the helmet comprises determining the overall injury risk metric based further on the plurality of injury risk values associated with the bare headform.
Petel discloses applying the first impact configuration and the second impact configuration to a bare headform (the impact load is applied to either the bare or helmeted headform 138 and the displacement of the markers 148 within the impact plane is recorded [0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Duma in view of Breedlove, Knowles, and Lorente, in further view of Petel applying the first impact configuration and the second impact configuration to a bare headform to collect corresponding acceleration data not influenced by a helmet padding as known in the art.
Claims 12, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Duma in view of Breedlove, Knowles, and Lorente, and further in view of Larry E. Jinkins (US 20150128332), hereinafter ‘Jinkins’.
With regards to Claim 12, Duma in view of Breedlove, Knowles, and Lorente discloses the claimed invention as discussed in Claim 1.
However, Duma does not specifically disclose rugby helmet.
Jinkins discloses a rugby helmet [0058].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Duma in view of Breedlove, Knowles, and Lorente, in further view of Jinkins to evaluate head impacts relayed to using a rugby helmet as an optional helmet used in sports and characterized by “risk of concussion, head injury” (Jinkins [0003]).
With regards to Claim 17, Duma in view of Breedlove, Knowles, and Lorente, and Jinkins discloses the claimed limitations as discussed in Claims 13 and 12.
With regards to Claim 20, Duma in view of Breedlove, and Lorente, and Jinkins discloses the claimed limitations as discussed in Claims 19 and 18.
Response to Arguments
35 USC § 103
Applicant’s arguments with respect to claim(s) 1 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.
STEVEN ROWSON et al., “Development of the STAR Evaluation System for Football Helmets: Integrating Player Head Impact Exposure and Risk of Concussion”, Annals of Biomedical Engineering, Vol. 39, No. 8, August 2011 ( 2011) pp. 2130–2140.
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.
Conclusion
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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