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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 11/05/2025. As directed by the amendment: Claims 31-35 have been amended, claims 1-10, 12-13, and 18-30 have been cancelled, and no claims have been added. Claims 11 and 14-17 were previously withdrawn. Thus, claims 31-35 are presently under consideration in this application.
Response to Arguments
Applicant’s answers to Examiner’s arguments, see pages 10-15, filed 11/05/2025, have been considered. Applicant argues on page 11 that “original Claim 14 recites in relevant part:"...an energy source cooperating to simultaneously provide output information to a device user and end users whether said device user is at risk of a concussion." This establishes the concept of simultaneously presenting concussion-related information to users. Furthermore, the specification provides a clear written description. Paragraph [0021] describes the device's capability to conduct pressure and force impact measurements and to convert these into an electronic signal that is simultaneously displayed and transmitted. Paragraph [0034] describes a LED light source connected to the device, which is triggered to visually alert the end-user and others of a threshold level of a probability of a concussion. Taken together, these disclosures demonstrate that the device is configured to generate and transmit concussion-related alerts in real time, including via a visual signal (LED light source) that is responsive to impact events. The phrase "connected in series to said power source" is a structural clarification that does not introduce new matter but rather specifies the electrical configuration of the LED light source, which is inherently supported by the disclosure of the LED being "connected to the device" and "triggered" upon impact. Therefore, Applicants respectfully submit that the original disclosure fully supports the amended limitations in Claims 31 and 35 and does not introduce new matter.” Examiner disagrees because the claim recites that the force impact to the head occurs simultaneously with the visual signal showing the threshold level of probability of concussion, which is clearly not disclosed in Applicant’s citations, or anywhere in the instant specification. Original claim 14 and [0021]’s “simultaneous” usage are directed to the simultaneous output provided to a device user and end users, and not simultaneously outputting the output during impact, as claimed. Regarding [0034], the alert is triggered when the threshold of probability exceeded, which has nothing to do with the simultaneously outputting the output during impact.
Applicant then argues on page 13 that “the Examiner bears the initial burden of presenting evidence or reasons why a person skilled in the art would not recognize the written description as providing adequate support for the claimed invention. Applicants respectfully request that the Examiner clearly identify the specific claim limitations that are allegedly unsupported by the specification and explain why the specification fails to reasonably convey possession of those limitations to one of ordinary skill in the art. Absent such identification and reasoning, there is uncertainty procedurally and substantively as to the deficiency.” Applicant further asserts on page 14 that “While the precise form of the function is not explicitly defined, the disclosure of the input variables, their derivation, and their role in concussion probability modeling provides a sufficient level of detail to demonstrate possession. The specification further explains that a critical value of Y will trigger a notification to the user, indicating a practical application of the model.” Examiner disagrees. The function/equation for f(X1, X2, X3, X4, X5, X6) remains undefined as to what the “more complex function” is used to achieve the probability of concussion. Defining variables used without defining the equation does not show that Applicant has possession, rather, shows Applicant wants to use different variables but not showing how they are all combined together. This does not exceed the threshold set in Vasudevan as this crucial calculation required to determine the probability of concussion is missing.
Applicant then asserts on page 14 that “To further support this position, Applicants submit in the accompanying Appendix section the Expert Declaration of Troy Osman Uysal, a Medical Device Quality Engineer, who confirms that the variables and metrics were obtained through prototype testing and repeated experimentation. In the declaration, Mr. Uysal affirms that the specification provides sufficient information for a skilled artisan to understand and implement the invention, and that the claimed invention is enabled and demonstrates possession of the probability function and its application.” While the person skilled in the art has pointed that the prototype has been tested, performed, and analyzed, and that the metrics collected are valid. Applicant has failed to disclose the entire invention. As stated by the person skilled in the art, the patent provides sufficient information to understand the design of the device, the data acquisition and signal processing, and probability function inputs to be able to build a device to collect, process, and analyze the data, which Examiner accepts is true, however, the Declaration fails to address that one skilled in the art would know how to deduce this probability without the need for the Applicant to disclose the equation/formula. The Declaration has failed to provide facts as to how well known the equation f(X1, X2, X3, X4, X5, X6) is, for one skilled in the art to know that this equation produces a probability of concussion. Therefore, the Declaration is insufficient.
Applicant’s arguments, see page 16-18, filed 11/05/2025, under Claim Objections, with respect to claim(s) 31-35 have been considered. Applicant argues on page 16 that “Applicants have reviewed the claims as submitted in the most recent amendment filed on August 05, 2025, and verified via the USPTO Patent Center document history that claims 31 and 35 do not contain any underlined portions. Claims 31 and 35 were submitted in clean format, and no amendments were made to claims 31 or 35 in that submission. Moreover, the Office Action does not identify the specific text alleged to be underlined, and Applicant has no way of determining what portions are being referred to. Applicants believe the objection may be from a formatting artifact or a clerical error in the USPTO's internal processing system. In any event, the amended Claims 31 and 35, set forth in the latest Listing of Claims, do not contain unintended underlining.” Applicant further argues on pages 17-18 that the amendments to the claim should overcome these informalities. Examiner agrees. However, one last objection that has not been amended, that being lines 5-6 should be amended to recite “wherein said air-tight chamber”. Therefore, the objections to the claims have been withdrawn.
Applicant’s arguments, see pages 18-19, filed 11/05/2025, under 35 U.S.C. 112(a) new matter, with respect to claim(s) 31-35 have been considered but not persuasive. Applicant argues on page 19 that “original Claim 14 recites in relevant part:"...an energy source cooperating to simultaneously provide output information to a device user and end users whether said device user is at risk of a concussion." This establishes the concept of simultaneously presenting concussion-related information to users. Furthermore, the specification provides a clear written description. Paragraph [0021] describes the device's capability to conduct pressure and force impact measurements and to convert these into an electronic signal that is simultaneously displayed and transmitted. Paragraph [0034] describes a LED light source connected to the device, which is triggered to visually alert the end-user and others of a threshold level of a probability of a concussion. Taken together, these disclosures demonstrate that the device is configured to generate and transmit concussion- related alerts in real time, including via a visual signal (LED light source) that is responsive to impact events. The phrase "connected in series to said power source" is a structural clarification that does not introduce new matter but rather specifies the electrical configuration of the LED light source, which is inherently supported by the disclosure of the LED being "connected to the device" and "triggered" upon impact. Therefore, Applicants respectfully submit that the original disclosure fully supports the amended limitations in Claims 31 and 35 and does not introduce new matter.” Examiner disagrees because the claim recites that the force impact to the head occurs simultaneously with the visual signal showing the threshold level of probability of concussion, which is clearly not disclosed in Applicant’s citations, or anywhere in the instant specification. Original claim 14 and [0021]’s “simultaneous” usage are directed to the simultaneous output provided to a device user and end users, and not simultaneously outputting the output during impact, as claimed. Regarding [0034], the alert is triggered when the threshold of probability exceeded, which has nothing to do with the simultaneously outputting the output during impact.
Therefore, the rejections to the claims have been maintained.
Applicant’s arguments, see pages 20-23, filed 11/05/2025, under 35 U.S.C. 112(a) written description, with respect to claim(s) 31-35 have been considered but not persuasive. On page 20, Applicant cites what each variable is defined as, and the use of the sensors on page 21 used “to compute the probability of concussion in real-time and trigger alerts. This level of detail demonstrates how the claimed function is achieved, not merely that it could be achieved. The specification goes beyond a mere statement of function and provides a clear roadmap for implementation.” Applicant then asserts on page 21 that “This formula is used to calculate acceleration/deceleration forces, which are critical inputs to the concussion probability algorithm. The inclusion of this formula and its defined variables (v, vo, s, g) further supports the sufficiency of the written description.” Examiner disagrees because such a generic acceleration formula is insufficient in the determination of the probability, as one skilled in the art would not be able to determine probability from this acceleration formula alone.
Applicant lastly argues on pages 22-23 that
The Examiner cites Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671 (Fed. Cir. 2015), to argue that the specification must explain how the inventor intends to achieve the claimed function. As shown above, the specification does exactly that:
- It identifies the relevant metrics.
- It describes how those metrics are measured and calculated.
- It defines the variables used in the algorithm.
- It explains how the function is generated and used to determine concussion probability.
This level of detail satisfies the written description requirement under Vasudevan. Applicants respectfully assert that the Examiner's reliance on Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 114 USPQ2d 1349 (Fed. Cir. 2015), is misplaced and inapplicable to the present claims and specification. In Vasudevan, the Federal Circuit emphasized that a specification must convey to a person of ordinary skill in the art that the inventor had possession of the claimed invention at the time of filing. However, the facts of Vasudevan involved a situation where the patent specification failed to disclose any algorithm or method for achieving the claimed functionality, leaving the skilled artisan to guess how the invention might be implemented. In contrast, the present application provides a detailed, structured disclosure of the algorithm used to determine concussion probability. The specification includes:
- A defined set of measured and calculated variables (X1-Xn) used in the function f(X1, X2, X3, X4, X5, X6).
- A mathematical formula for acceleration/deceleration.
- A description of the hardware architecture, including sensors, integrator, and transmission devices.
- A clear explanation of how the data is processed, converted, and used to generate diagnostic metrics.
This level of detail exceeds the threshold set in Vasudevan and demonstrates that the inventors were in possession of the claimed invention. The specification does not merely state a desired result; it explains how the result is achieved through a combination of hardware, signal processing, and algorithmic computation. Therefore, the Examiner's citation of Vasudevan does not support the rejection and should not be applied to the present case.
Examiner disagrees. The function/equation for f(X1, X2, X3, X4, X5, X6) remains undefined as to what the “more complex function” is used to achieve the probability of concussion. Defining variables used without defining the equation does not show that Applicant has possession, rather, shows Applicant wants to use different variables but not showing how they are all combined together. This does not exceed the threshold set in Vasudevan as this crucial calculation required to determine the probability of concussion is missing.
Therefore, the rejections to the claims have been maintained.
Applicant’s arguments, see pages 23-25, filed 11/05/2025, under 35 U.S.C. 112(b), with respect to claim(s) 31-35 have been considered and are persuasive. Applicant states that the claims have been amended, and further argues that “the term "magnitude of force" refers to the sum of all the forces that are acting on an object. If all the forces are acting in the same direction, then the magnitude of the force increases. Claim 30 provides in relevant part:" transmission of an electrical output signal consisting of both pressure and a pressure-time derivative communication value that corresponds to magnitudes of an external physical or mechanical pressure, force, or impact,"…the claim is reasonably clear to people of ordinary skill in the art. Moreover, the use of "a magnitude" (or "a magnitudes) is not grammatically correct.” . Examiner agrees. Therefore, the rejection of the claims has been withdrawn.
The Declaration under 37 CFR 1.132 filed 11/05/2025 is insufficient to overcome the rejection of claims 31-35 based upon 35 U.S.C. 112(a) as set forth in the last Office action because:
The declaration simply asserts that 1) the prototype was tested, performed, and analyzed by a medical device quality engineer (one skilled in the art), 2) variables, functions, and metrics define pressure and acceleration profiles of impact, and 3) the patent provides sufficient information to understand the design of the device, the data acquisition and signal processing, and probability function inputs to be able to build a device to collect, process, and analyze the data. Examiner disagrees because the declaration fails to address the crux of the Examiner’s argument- that being the specification fails to provide facts as to how the determination of a probability of a concussion can be determined without a defined function for equation f(X1, X2, X3, X4, X5, X6).
In re Chilowsky, 306 F.2d 908, 134 USPQ 515 (CCPA 1962) (expert opinion that an application meets the requirements of 35 U.S.C. 112 is not entitled to any weight; however, facts supporting a basis for deciding that the specification complies with 35 U.S.C. 112 are entitled to some weight); In re Lindell, 385 F.2d 453, 155 USPQ 521 (CCPA 1967) (Although an affiant’s or declarant’s opinion on the ultimate legal issue is not evidence in the case, “some weight ought to be given to a persuasively supported statement of one skilled in the art on what was not obvious to him.” 385 F.2d at 456, 155 USPQ at 524 (emphasis in original)).
While the person skilled in the art has pointed that the prototype has been tested, performed, and analyzed, and that the metrics collected are valid. Applicant has failed to disclose the entire invention. As stated by the person skilled in the art, the patent provides sufficient information to understand the design of the device, the data acquisition and signal processing, and probability function inputs to be able to build a device to collect, process, and analyze the data, which Examiner accepts is true, however, the Declaration fails to address that one skilled in the art would know how to deduce this probability without the need for the Applicant to disclose the equation/formula. The Declaration has failed to provide facts as to how well known the equation f(X1, X2, X3, X4, X5, X6) is, for one skilled in the art to know that this equation produces a probability of concussion. Therefore, the Declaration is insufficient.
Claim Objections
Claim 32 objected to because of the following informalities: lines 5-6 should be amended to recite “wherein said air-tight chamber”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 30-35 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 31 and 35 have been amended to include the limitation, " a light source connected in series to said power source to visually signal end-users and others of a threshold level of a probability of a concussion simultaneously with said physical or mechanical impact applied to the surface of said membrane. ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for “A LED light source is connected to the device to be triggered to visually alert the end-user and others of the threshold level of a probability of a concussion” in [0034] of the instant specification. However, the specification does not provide support for the LED light triggered simultaneously with the applied impact to the surface. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " a light source connected in series to said power source to visually signal end-users and others of a threshold level of a probability of a concussion simultaneously with said physical or mechanical impact applied to the surface of said membrane”. Therefore, the new claim limitations introduce new matter.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may “express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted).It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015).
Claim 30-31 and 35 and the specification fail to sufficiently describe the usage of the predictive algorithm to calculate a probability of a concussion in enough detail for one skilled in the art to understand how the inventor intended the function to be performed. The mere statement and recitation of the determination of a probability of a concussion in claim 30-31 and 35, and the specification in pages 16-17 describes what each variable represents from the function f(X1, X2, X3, X4, X5, X6) but provides insufficient detail to what the equation is composed of to use all the variables used for determining the probability of concussion. In other words, the instant specification fails to detail the function/equation for f(X1, X2, X3, X4, X5, X6). Therefore, the claim and specification fail to described in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
Conclusion
Claims 30-35 overcome the prior art but are still rejected under 35 U.S.C. 112(a).
The following is a statement of reasons for the indication of the claims overcoming the prior art:
The air-tight chamber, storing incompressible pressure-sensitive fluid, formed within an interior wall of a membrane of the soft flexible headwear, which includes a pressure sensor transducer on the membrane for processing pressure and pressure-time derivative value corresponding to the magnitude of an impact force applied to the surface of the membrane are not conventionally relied upon in determining a probability of concussion for diagnostic evaluation and are therefore allowable over the prior art.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796