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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Notice of Amendment
In response to the amendment(s) filed on 12/16/25, amended claim(s) 62, 64-65, 67-69, and 71, and , and canceled claim(s) 63 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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(s) 62 and 64-73 is/are 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.
For claim 62, the claim language “determine a patch removal event of an allergen patch” does not appear to be 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., 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 invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites the function of determining a patch removal event of an allergen patch, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
For claim 70, the claim language “wherein the allergen test evaluation circuit is further structured to operate a neural network to perform at least one of determining the allergen test success value or the test execution adjustment” does not appear to be 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., 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 invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites the function of operating a neural network to perform at least one of determining the allergen test success value or the test execution adjustment, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. The term “neural network” is treated as a machine learning type black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. For example, how many and what types of layers are there? How is the data propagated? What logics are programmed to help the machine learning algorithm make a decision? Is the training supervised or unsupervised? What are the weightings? Are other training concepts sed such as regression? It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
For claim 71, the claim language “wherein the allergen test evaluation circuit is further structured to operate an expert system to perform at least one of determining the allergen test success value or the test execution adjustment” does not appear to be 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., 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 invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites the function of operating a neural network to perform at least one of determining the allergen test success value or the test execution adjustment, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. The term “expert system” is treated as a machine learning type black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. For example, how many and what types of layers are there? How is the data propagated? What logics are programmed to help the machine learning algorithm make a decision? Is the training supervised or unsupervised? What are the weightings? Are other training concepts sed such as regression? It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Dependent claim(s) 64-73 fail to cure the deficiencies of independent claim 62, thus claim(s) 62 and 64-73 is/are rejected under 35 U.S.C. 112(a).
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.
Claim(s) 62 and 64-73 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 62 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 62 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “determine a patch removal event of an allergen patch,” “capture a first test area image in response to the patch removal event, wherein the first test are image is high resolution,” “provide a user notification in response to an elapsed time value determined from the patch removal event,” “capture a second test area image in response to the elapsed time value, wherein the second test area image is high resolution,” and “determine an allergen test success value in response to at least one of the patch removal event, the first test area image, or the second test area image, wherein the allergen test success value comprises at least one value selected from the values consisting of: a patch displacement description; or a patch orientation description; and perform a test execution adjustment in response to the allergen test success value,” and “… transmit the first test area image and the second test area image to a provider device.” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “an allergen test execution circuit,” “an allergen test evaluation circuit,” and “a provider interaction circuit.” However, these elements are not “significantly more” because they are well-known, routine, and/or conventional since they are generic computer structure(s), which has been held to not add significantly more according to Bilski. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 62 fail to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 64-73 fail to cure the deficiencies of independent claim 62 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or more generic computer structure that has been held to not add significantly more according to Bilski. Thus, claim(s) 62 and 64-73 is/are rejected under 35 U.S.C. 101.
Allowable Subject Matter
Claim(s) 62 and 64-73 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) and 35 U.S.C. 101, set forth in this Office action.
Response to Arguments
Applicant’s arguments filed 12/16/25 have been fully considered.
With respect to the 112 rejections, para [0071] just parrots the same language in claim 63. Para [0071] doesn’t disclose the computer and the algorithm (i.e., 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 invented the claimed subject matter. That is, there is no written description, just a black box. With respect to claims 70 and 71, Applicant’s arguments suffer from the same deficiency. Pointing out in the specification where the exact same words are repeating in the specification as in the claim doesn’t provide an evidence that Applicant had possession. Specifically with claims 70 and 71, the claims recite a machine learning type black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. For example, how many and what types of layers are there? How is the data propagated? What logics are programmed to help the machine learning algorithm make a decision? Is the training supervised or unsupervised? What are the weightings? Are other training concepts sed such as regression? Therefore, written description is needed to demonstrate to a skilled artisan that Applicant actually had possession of these machine learning type algorithms and that they are not just black boxes.
With respect to the 101 rejection, all of the step recited in claim 62 are performed by different circuits. Therefore, they all embody abstract ideas that are automated into computer circuitry. The scope of the claim language is broad enough such that it encompasses subject matter that encompasses an abstract idea. The scope of the claim language is not specific enough that it could not be performed in the human mind. With respect to step 2A, prong two, allergen testing is not a technology, it is a diagnostic process. Maybe the flow process or the order that a diagnostic procedure is being performed is being improved, but that process is just a series of steps of an algorithm, not a technology such a computer screen or a sensor. With respect to step 2B, the only elements that were found to be additional elements that are not judicial exceptions are the claimed “an allergen test execution circuit,” “an allergen test evaluation circuit,” and “a provider interaction circuit.” There are no structure claimed for these circuits (i.e., the transistors, gates, capacitors, etchings, substrate(s), etc.) are not claimed and therefore they are considered generic computer structures. As a result, the claims still do not pass muster under 35 U.S.C. 101.
With respect to the 103 rejection(s), Applicant’s amendments and arguments are persuasive and thus the rejection(s) is/are withdrawn.
Conclusion
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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791