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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
Priority
This application claims priority to U.S. Provisional Application No. 63/022,874 filed on 05/11/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/22/2025 has been received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and all references are considered except where they were lined through.
Claim Status
Claim 1 is amended and the Applicant notes that no new matter is added. Claims 2-3, 5-6 and 8-13 are original. The Applicant cancelled claims 4 and 7. Claims 14 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim as noted in the Office action of 11/13/2023. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/08/2023.
Thus, claims 1-3, 5-6 and 8-13 are pending and are under examination.
Withdrawn Rejections
The previous rejections of claims 1-3, 5-6 and 8-13 under 35 U.S.C. 103, regarding obviousness, is withdrawn in light of Applicant’s amendments and arguments of 12/22/2025.
While the Applicant amended claim 1 to overcome the previous rejections of claims 1-3, 5-6 and 8-13 under 35 U.S.C. 103, the Applicant introduced amendments that contradict prior art. The Applicant amended claim 1 to recite “a lipid portion of the tears originating primarily from goblet cells of the conjunctiva and composed primarily of lipid”, whereas prior art teaches that Goblet cells within the conjunctival epithelium are specialized cells that secrete mucins onto the surface of the eye as noted by Gipson et al. (Progress in Retinal and Eye Research 54 (2016) 49-63).
New Rejections
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-3, 5-6 and 8-13 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 claims contain 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.
Regarding claim 1, the claim recites “a lipid portion of the tears originating primarily from goblet cells of the conjunctiva and composed primarily of lipid” which is not supported by the disclosure of the instant application. The specification of the instant application teaches that “The mucin that forms the mucin layer, nearest the cornea, is secreted by goblet cells in the conjunctiva” (Page 12, lines 17-18). The specification further teaches that goblet cells are expected to attract and hold cannabinoids because the cells are lipophilic (Page 15, lines 13-14). The specification does not teach that the lipid portion of the tears originates primarily from goblet cells of the conjunctiva, and this teaching is in clear contradiction with prior art. Prior art teaches that Goblet cells within the conjunctival epithelium are specialized cells that secrete mucins onto the surface of the eye as noted by Gipson et al. (Progress in Retinal and Eye Research 54 (2016) 49-63).
Maintained Rejections
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 1-3, 5-6 and 8-13 are rejected under 35 U.S.C. 101 because the claimed invention is for a process or a method that is directed to at least one judicial exception without significantly more. The claims recite a mere collection of information in the form of data from which the applicant or doctor may draw an inference in light of the correlations. Such an inference is not sufficient to transform a law of nature (the correlation of selected cannabinoids levels with its presence in a subject) into a patentable application.
The claims are ineligible because the claims recite a judicial exception, i.e., a law of nature (the correlation of selected cannabinoids levels with its presence in a subject). Moreover, the claims as a whole do not integrate the judicial exception into a practical application nor do they provide an inventive concept. This judicial exception is not integrated into a practical application because the additional limitations of the claims amount to insignificant extra-solution activity. The claims do not include additional elements that are sufficient to significantly amount to any added inventive concept to the judicial exception as recognized by the court decisions listed in MPEP § 2106.05(d).
Step 1: Is the claim to a process, machine, manufacture or composition of matter?)
This part of the eligibility analysis evaluates whether the claim falls within any statutory category per MPEP 2106.03.
Claim 1 of the instant application is directed to a statutory class of a minimally invasive method of obtaining and processing a tear sample from an individual to identify cannabinoids within the sample of tears (Step 1: YES).
(Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature or natural phenomenon?)
Claim 1 of the instant application recites a judicial exception of a law of nature of correlating selected cannabinoids levels with its presence in a subject.
Accordingly, because claim 1 of the instant application recites a law of nature, the analysis must therefore proceed to Step 2A Prong Two.
(Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?)
This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application.
Claim 1 of the instant application does not have additional elements that would integrate the judicial exception cited above into a practical application. The claim has steps of measuring cannabinoids levels in tears and assessing the presence of cannabinoids in an individual by comparing values based on the measurements, and these steps do not integrate the judicial exception into a practical application because they are data gathering steps to use in the detection of cannabinoids, which do not add a meaningful limitation to the method as they are insignificant extra-solution activity. These steps do not integrate the judicial exception into a practical application because they do not amount to more than the judicial exception itself, analogous to Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012). Furthermore, the claims do not act on or use the judicial exceptions in any further steps as required by MPEP 2106.04(d).
Therefore, claim 1 does not integrate the judicial exception into a practical application.
(Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?)
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05.
Claim 1 of the instant application simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, such as measuring the levels of cannabinoids by using high-performance or high-pressure liquid chromatography (Specification, page 19, lines 18-22). Furthermore, the claim itself is recited at a high level of generality in which any assay can be used as the measurement method for claim 1.
Thus, claim 1 is not eligible and is rejected under 35 USC 101.
Regarding claims 2-3, the claims further select the sample type which does not integrate the judicial exception into a practical application because they do not amount to more than the judicial exception itself, nor do they amount to significantly more.
Regarding claims 5-6, and 8-12, the claims further select the method of detection to use for analyzing a sample for cannabinoids which does not integrate the judicial exception into a practical application because they do not amount to more than the judicial exception itself, nor do they amount to significantly more.
Regarding claim 13, the claim defines separating the lipid fraction of the tear sample from aqueous components which does not integrate the judicial exception into a practical application because they do not amount to more than the judicial exception itself, nor do they amount to significantly more.
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive regarding the rejection of claims 1-3, 5-6 and 8-13 under 35 U.S.C. 101, regarding the claims being directed to a judicial exception without significantly more.
Rejection of Claims under 35 U.S.C. 101:
The Applicant traversed to the rejection of claims 1-3, 5-6 and 8-13 under 35 U.S.C. 101 regarding the claimed invention being a process or a method that is directed to a judicial exception of a law of nature (the correlation of selected cannabinoids levels with its presence in a subject) without significantly more.
The Applicant alleged in the interview of 06/17/2025 that cannabinoids are not naturally occurring substances in the subjects that they are being tested in. The Applicant renewed these allegations in the response of 12/22/2025 and even stated that a rejection of claims 1-3, 5-6 and 8-13 under 35 U.S.C. 101 is a violation of compact prosecution.
These arguments are not persuasive because the presence of selected cannabinoids in a subject is a result of introducing such a substance by ingestion, inhalation or injection for example. Claim 1 simply recites a judicial exception of a law of nature because it is correlating the level of selected cannabinoids with its presence in a subject without adding any additional elements that are sufficient to amount to significantly more that the judicial exception itself. This judicial exception is still not integrated into a practical application because the additional limitations of claim 1 and its dependent claims amount to insignificant extra-solution activity. The claims do not include additional elements that are sufficient to significantly amount to any added inventive concept to the judicial exception as recognized by the court decisions listed in MPEP § 2106.05(d).
The Applicant alleged that this is the first time that a section 101 rejection has been presented in relation to this application which violates the principle of compact prosecution. The Applicant further questioned the amendments that necessitated such a rejection.
This argument is not persuasive because the 101 rejection was brought up after the amendments of 05/08/2024 that the Applicant introduced to claim 1. The amendments of claim 1 of 05/08/2024 recited “analyzing the sample to identify the cannabinoids by application of high performance or high pressure liquid chromatography”. The first action in an RCE application on 01/02/2025 vacated the Office action of 06/03/2024 to account for the 101 rejection. Also, it was noted in the Office actions of 06/03/2024 and 01/02/2025 that the Art Unit location of this application has been changed. Thus, every step was followed to ensure compliance with compact prosecution. As of today, no practical application nor inventive step has been introduced to overcome the judicial exception of a law of nature.
The Applicant alleged that the steps of claim 1 are meaningful limitations because they sufficiently limit the use of the alleged law of nature to the practical application of identifying the presence of cannabinoids in the lipid fraction of a tear sample. The Applicant alleged that this information can then be used to assess whether the individual whose tears are analyzed may be impaired from ingestion of the substances, and this is a very practical application.
This argument is not persuasive because the claim has steps of measuring cannabinoids levels in tears and assessing the presence of cannabinoids in an individual by comparing values based on the measurements. These steps do not integrate the judicial exceptions into a practical application because they do not amount to more than the judicial exceptions themselves, analogous to Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012). Furthermore, the claim does not act on or use the judicial exception in any further steps as required by MPEP 2106.04(d).
The Applicant alleged that claim 1 as a whole is far more than a drafting effort designed to monopolize the exception. The Applicant further alleged that claim 1 does not monopolize any law of nature.
This argument is not persuasive because the Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980 (quoting Myriad, 569 U.S. at 589, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena, even if the judicial exception is narrow (e.g., a particular mathematical formula such as the Arrhenius equation). See, e.g., Mayo, 566 U.S. at 79-80, 86-87, 101 USPQ2d at 1968-69, 1971 (claims directed to "narrow laws that may have limited applications" held ineligible).
In the instant case, the claims are attempting to claim the judicial exception of a natural law; and the measurement steps in the claims are simply data gathering steps to use in making the judicial exception without any integration of the judicial exception into a practical application nor significantly more.
Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court; in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). In the instant case, the method of claim 1 is not asking the doctor or skilled artisan of any action beyond detecting the presence of cannabinoids in a sample of tears.
Furthermore, Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 67, 101 USPQ2d 1961, 1964 (2010) provides an example of additional elements that were not an inventive concept because they were merely well-understood, routine, conventional activity previously known to the industry, which were not by themselves sufficient to transform a judicial exception into a patent eligible invention. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79-80, 101 USPQ2d 1969 (2012). Similarly, in the instant case, there are no additional elements that would add an inventive concept to the judicial exception because it is measuring the levels of cannabinoids by a well-understood, routine, and conventional method of high-performance or high-pressure liquid chromatography (Specification, page 19, lines 18-22). Furthermore, regarding claim 1, the claim itself is recited at a high level of generality in which any assay can be used as the detection method for cannabinoids.
Thus, the previous rejection of claims 1-3, 5-6 and 8-13 under 35 U.S.C. 101 is maintained.
Conclusion
No claims are allowed.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678