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 .
Claim Status
Claims 84, 88, 95, and 98-104 are under consideration in this office action.
New Objections/Rejections Necessitated by Amendment
Objection to the Specification
The amendment filed August 26, 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material that is not supported by the original disclosure is as follows: “a method for determining a prophylactic treatment of a patient.” It is noted that “prophylactic treatment” or any method related to determining such a treatment does not appear within the specification as filed. Applicant is required to cancel the new matter in the reply to this Office Action.
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 84, 88, 95, and 98-104 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 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 84 is directed to a method of “determining a prophylactic treatment of a patient” and “determining the prophylactic treatment.” It is noted that a method of determining a “prophylactic treatment” does not appear within the specification as filed. Rather, the specification discloses methods for determining T2R phenotypic expression ([0007], [0085]) and susceptibility to respiratory infection [0070] and the clinical course of respiratory infection [0071]. There is no support for determining a prophylactic treatment of a patient.
MPEP 2163.05 discusses changes to the scope of the claims, and states, “The failure to meet the written description requirement of 35 U.S.C. 112, first paragraph, commonly arises when the claims are changed after filing to either broaden or narrow the breadth of the claim limitations, or to alter a numerical range limitation or to use claim language which is not synonymous with the terminology used in the original disclosure.” To comply with the written description requirement of 35 U.S.C. 112(a) or to be entitled to an earlier priority date or filing date under 35 U.S.C. 119, 120, or 365(c), each claim limitation must be expressly, implicitly, or inherently supported in the originally filed disclosure. By adding the new method of “determining a prophylactic treatment of a patient,” applicant is attempting to alter the scope of the claims. Because the instant claims now recite a method that was not clearly disclosed in the specification as filed, this limitation introduces new concepts and violate the description requirement of 35 U.S.C. 112(a). To obviate the instant rejection of record, Applicant is invited to provide sufficient written support for the new limitation indicated above. See MPEP 714.02 and 2163.06.
Modified Rejections Necessitated by Amendment
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 84, 88, 95, and 98-104 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more. Based upon consideration of all of the relevant factors, the instant claims are determined to be directed to a natural phenomenon and an abstract idea. The rationale for this determination is explained below:
Under Step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance the claimed method is found to be drawn to one of the four statutory categories of inventions, a process.
Under Step 2A, prong 1, the claims have been determined to recite a natural phenomenon (detecting T2R stimulation) and an abstract idea (stratification into phenotypic categories based on response to stimulation).
The claims recite a method of determining a prophylactic treatment; the method steps comprising introducing T2R agonists, detecting perceived level of stimulation, identifying category of phenotypic expression, stratifying patients based on their phenotype category into a category of inferred risk of viral infection, and determining prophylactic treatment based on inferred risk of viral infection. The new limitation directed to a method of determining the prophylactic treatment is not sufficient to overcome the 35 U.S.C. 101 rejection, as it is recited at a high level of generality.
The claims involve the natural phenomenon whereby level of taste perception correlates with the risk for infection of an upper respiratory tract infection. Natural correlations are laws of nature that have been deemed ineligible subject matter because methods directed to the natural correlation without significantly more, preempt use of the natural correlation itself. The additional steps of the claims are directed to the natural binding of proteins to biological materials (e.g., a receptor and its agonist) as well as a naturally occurring correlation (determined by a mental process), which is the relationship between natural T2R signaling pathways, a level of perception, and a risk of viral infection. A claim recites a mental process if it is directed to collecting and comparing known information, which are steps that can be practically performed in the human mind [see Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011)].
It is well established that the mere physical or tangible nature of additional elements, such as the obtaining and detecting of steps, does not automatically confer eligibility on a claim directed to a natural phenomenon [see, e.g., Alice Corp v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59 (2014)]. The method for determining prophylactic treatment is recited at a high level of generality and is not sufficient to ensure that the claim amounts to significantly more than the natural phenomenon and naturally occurring correlation. The courts have found that arranging a hierarchy of groups is to be well-understood, routine, conventional activity when they are claimed at a high level of generality Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1331, 115 USPQ2d 1681, 1699 (Fed. Cir. 2015) (see MPEP 2106.05(d)). Therefore, the step does not relate to the natural principles in a significant way to impose a meaningful limit on the scope. Note that the Supreme Court in Mayo v. Prometheus has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the “apply it.” Essentially, appending conventional steps or at a high level of generality to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.
For all of these reasons, the claims recite the judicial exceptions natural phenomenon and abstract idea (STEP 2A, Prong One: YES). The invention as a whole is directed to a judicial exception and thus required further analysis at Step 2B to determine if the claims amount to significantly more than the exception itself.
Under Step 2A, prong 2, the claims have been determined to not recite additional elements that integrate the judicial exception into a practical application, i.e., the claims do not use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. The generic “determining”, introducing”, “detecting”, and “identifying” of claim 84 and “predicting” of claim 88 do not provide the required meaningful limit. There are no additional elements in the combination of elements in the claimed invention that add other meaningful limitations not already present when the elements are considered separately.
MPEP section 2106.04(d) recites further consideration for integration of a judicial exception to a practical application. Relevant considerations include an improvement in the technical field; applying the judicial exception to effect a particular treatment or prophylaxis for disease; implementing the judicial exception with a particular machine; effecting a transformation to a different state or thing; and, applying or using the judicial exception in some meaningful way beyond generally linking the use to a technological environment. In the instant case, the additional steps of stimulating chemosensory receptors and recording a discerned level of stimulation, whether it is the capacity for treatment by stimulating chemosensory receptors or taste perception, present no improvement in the technology. Since claims are not directed to a method of treatment, there is no application of a judicial exception to a particular treatment or prophylaxis. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because stimulating chemosensory receptors and stratifying patients based on response to chemosensory receptors require the steps of introducing, detecting, and stratifying that were well understood, routine, and conventional in the art at the time of filing.
The present claims do not require performing any steps that are not routine and conventional. For example, the claims do not require using a novel T2R agonist to detect the phenotypic expression of T2Rs nor do they require use of a particular machine, wherein the particular machine implements one or more of the judicial exceptions or integrates the judicial exception into a particular practical application. The active step of the claim is the step of detecting perceived level of T2R stimulation and identifying categories of phenotype expression of T2R and their correlation to risk of viral infection.
In Prometheus, the court found that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” Additionally, “conventional or obvious”” “[pre]solution activity” is normally not sufficient to transform unpatentable law of nature into a patent-eligible application of such a law”. Flook, 437, U.S., at 590; see also Bilski, 561 U.S., (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’…, adding ‘insignificant post-solution activity’” (quoting Diehr, supra, at 191-102).
The required steps are merely the extra solution activity that must be performed in order to observe the natural phenomenon itself. Thus, the claims as a whole, looking at the additional elements individually and in combination, do not integrate the judicial exception into a practical application.
Since the claims recite stimulating T2Rs, recording level of stimulating, and correlating the discerned level of T2R stimulation to predict inferred risk of infection of an upper respiratory tract interaction or determining a prophylactic treatment, they effect no transformation of the data collected to a different state. As a whole, the additional steps/elements do not apply the judicial exception in any meaningful way. (STEP 2A, Prong Two: NO).
Under final Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception encompassed by the method of the instant claims, i.e. the claims do not recite elements beyond the well-understood, routine, or conventional activities previously known to the field.
In the instant claims, the elements in addition to the correlation are stimulating chemoreceptors with an agonist and then detecting a level of stimulating. These steps are recited at a high level of generality, the breadth of which reads upon practices that are routinely performed, such as tasting a bitter stimulus. For example, if chemosensory receptors in the oral tissue are contacted with a bitter stimulus, like quinine, the perception of a bitter taste can be recorded; in this way, the subject expresses taste receptors responsible for bitter perception, namely T2Rs. Further, the categorization/stratification of subjects based on perception of taste is directed to a mental process that can be performed in the human mind.
Methods for stimulating T2Rs and recording a discerned level of taste perception in human patients via use of self-reporting was well established, routine, and conventional practices at the time the application was filed. The following prior art teaches methods relating to categorization of humans based on taste detection of the bitter compounds phenylthiocarbamide (PTC) (Bufe et al, see Summary, PTO-892 from 10/31/22; Lee et al, pg 4145, column 2 ln 11-15, PTO-892 from 10/31/22). The prior art reference teaches that PTC is useful for modulating taste perception and that detection of PTC (the phenotype) is linked to the genotype of a bitter taste receptor, TAS2R38 (Bufe et al, pg 325, columns 1-2). Further, US 2015/0017099 (“Cohen”; PTO-892 from 10/31/2022) teaches that polymorphisms of chemosensory receptors are linked to significant differences in the ability of upper respiratory cells to clear and kill bacteria [0152], which reads on predicting risk of infection and innate microbial activity. Thus, the prior art establishes that the steps and elements recited in addition to the judicial exception of the claims were all well understood, routine, and conventional prior to filing. For all of these reasons, the additional elements do not amount to significantly more than the exception itself (STEP 2B: NO).
The preponderance of evidence demonstrates that the claims are not directed to patent eligible subject matter, and claims 84, 88, 95, and 98-104 are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 84, 88, 95, and new claims 98-104 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0017099A1 (“Cohen”).
Claims 84 and 88 are directed to method for determining a prophylactic treatment by stratification of a patient into a category of current risk of viral infection based on stimulating T2Rs without reference to genotype testing, said method comprising the steps of administering a taste test kit comprising a plurality of agonists, detecting patient perceived level of stimulation, categorization of patient based on taste perception and risk for viral infection.
Cohen teaches a method for determining the susceptibility of a subject to a respiratory infection associated disease such as sinusitis or rhinisinusitis [0127]. Sinusitis or rhinosinusitis of the method can be caused by infection of viruses [0134], as in claim 84. Subjects are categorized as tasters or non-tasters based on the intensity of a taste upon presentation of a bitter tasting compound (a T2R agonist) [0137], which reads on the stratification of patients based on phenotypic expression in claim 84 and prediction of inferred risk of infection of claim 88. In this embodiment of Cohen, there is no reference to genotype testing, as in claim 84. Cohen teaches a method of treating a respiratory infection by administering an agent capable of activating better taste signal pathway, such as a T2R38 agonist [0018], wherein the term “treat” refers also to prophylactic or preventative measure [0140], as in the new limitation of instant claim 84.
Cohen teaches presenting a plurality of test compounds (includes at least one bitter receptor agonist and one non-bitter receptor agonist) and having the subject rate the intensity of the taste response to the test compounds; the intensity of the taste response is then compared with pre-calibrated intensities to determine susceptibility to a respiratory infection [0013]. Cohen teaches that the bitter test compounds used in the taste test may include phenylthiocarbamide, quinine, and denatonium benzoate [0120] and a pharmaceutically acceptable carrier [0142]. The teachings of the Cohen reference teaches all the components of the kit and therefore meet the requirements as set forth for the kit in the method of claim 84.
Cohen teaches that the subjects taste the bitter tasting compounds and rate the intensity [0013], which reads on the method of determining a prophylactic treatment further comprised of stratifying the patient at the time of administering the taste, as required by claim 98.
Cohen teaches that the taste test uses a plurality of bitter taste compounds and the rated intensities of the taste response are compared with pre-calibrated intensities to determine susceptibility to a respiratory infection [0013], which reads on the repeated stimulation in a predetermined sequence of plurality of agonists of instant claims 99-101. The pre-calibrated intensity of taste response does not reference genotype testing, as required by claim 102, and the genotype of the patients is not determined [0013], which reads on new claims 103-104.
Even though there is no expressed support in Cohen for the introduction of a plurality of T2R agonists in a “predetermined sequence established in relation to a statistically significant reference population”, as required by claim 84 and 99, Cohen teaches the method of testing, which inherently comprises a sequential delivery step. Without these steps, there is no delivery of the plurality of compounds.
Claim 95 is directed to a limitation comprising stratifying reference levels into ranges indicative of innate antiviral activity. Cohen teaches that response to a chemosensory receptor bitter taste test that relies on bitter taste sensitivity on the tongue can indicate bitter taste sensitivity of the upper respiratory tract [0112]. Less sensitive receptors “in the upper respiratory tract will provide a poor defense against microbes” [0112]. Cohen postulates that individuals will differ in how their innate immunity functions as a result of the expression of their bitter chemosensory receptor, and thus, those who are relatively less sensitive to bitter compounds are more prone to respiratory pathogen infection compared to those with more bitter chemosensory receptor sensitivity [0112].
Further, the court in Integra Life Sciences | Ltd. v. Merck KGaA, 50 USPQe2d 1846 (DC SCalif, 1999) held that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products. Because the only active method steps recited in claim 84 are introducing to T2Rs a plurality of agonists, detecting a level of stimulation, identifying a category by comparing said level of stimulation to a reference level, and stratifying the patients into categories of phenotypic expression of T2Rsand because Cohen teaches these steps, the reference inherently teaches the method of stratifying a patient into a category of phenotypic expression, without reference to genotype, as set forth in amended claims 84 and 103-104.
Therefore, Cohen anticipates claims 84, 88, 95, and 98-104.
Response to Arguments
Applicant's arguments filed August 26, 2025 regarding the rejection under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant asserts that the ordered combination of all claim elements requires or achieves significantly more than the judicial exception or transforms the claim elements into more than merely the elements themselves (remarks, pg 9). Claim 84 has been amended to specify that the method is directed to determining a prophylactic treatment, which applicant argues ties together and integrates the judicial exception in a manner than is concrete (remarks, pg 9). Note that the Supreme Court in Mayo. V Prometheus has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding “apply it.” Essentially, appending conventional steps at a high level of generality to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible. The present claims do not require performing any steps that are not routine and conventional. For example, the claims do not require using a novel reagent to detect the expression of T2R. The active steps of the claim are related to detecting the phenotype and categorizing the phenotype; the step of determining a prophylactic treatment is interpreted as an “apply it” style step of the judicial exception. In the instant case, it is not clear that one is determining a treatment based upon the judicial exception. Without recitation of additional elements demonstrating that the claim integrates the exception into a practical application, for example a method of preventing or treating a disease or medical condition, the claimed method is not directed to patent eligible subject matter. This rejection could be overcome if the claims were amended to include a step of treating a specific disease with a given therapeutic.
Applicant is directed to MPEP 2106.05(e): Classen Immunotherapies Inc. v. Biogen IDEC provides an example of claims that recited meaningful limitations. 659 F.3d 1057, 100 USPQ2d 1492 (Fed. Cir. 2011) (decision on remand from the Supreme Court, which had vacated the lower court’s prior holding of ineligibility in view of Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010)). In Classen, the claims recited methods that gathered and analyzed the effects of particular immunization schedules on the later development of chronic immune-mediated disorders in mammals in order to identify a lower risk immunization schedule, and then immunized mammalian subjects in accordance with the identified lower risk schedule (thereby lowering the risk that the immunized subject would later develop chronic immune-mediated diseases). 659 F.3d at 1060-61; 100 USPQ2d at 1495-96. Although the analysis step was an abstract mental process that collected and compared known information, the immunization step was meaningful because it integrated the results of the analysis into a specific and tangible method that resulted in the method "moving from abstract scientific principle to specific application." 659 F.3d at 1066-68; 100 USPQ2d at 1500-01. Regarding the instant claims, the abstract idea is the collection and comparison of taste response and the relationship to risk for viral infection; however, there is no meaningful step elevating the method to practical application. For the reasons detailed in the rejection above, the rejection under 35 U.S.C. 101 is maintained. The step of determining a prophylactic treatment is not sufficient.
Applicant asserts that the conclusory analysis of the 101 rejection is impermissible, because the rejection has failed to address the ordered combination of all claim elements (remarks, pg 8). Applicant is directed to Bufe et al, Lee et al, and Cohen, which were cited in the rejection to demonstrate that the sequence of steps recited by the claims for a taste test were already known in the art. Furthermore, these steps of identifying and stratifying, as claimed, are merely the extra-solution activity necessary to observe the natural phenomenon.
Applicant submits that it is not well understood, routine, or conventional to use phenotype, and not genotype, to predict risk of viral infection (remarks, pg 13). Although Cohen teaches the relationship between the taste test response and genotype, Cohen also teaches that an intervention to treat respiratory infection can be determined using a phenotype test [0137], which is what is claimed. There is clearly support in the prior art for phenotype predicting risk of viral infection. Further, arguments related to the examiner citing relevant art (remarks, pg 11) are not persuasive, as the reference disputed (US 2009/0274632A1), was not cited in any rejection of record or response to arguments in the previous office action mailed on February 26, 2025.
Regarding the rejection under 35 U.S.C. 102(a)(1), the amendment of claim 84 to include a method of determining a prophylactic treatment is anticipated by Cohen. Cohen teaches that the bitter taste test sensitivity of tongues is an indicator of bitter taste function in the upper respiratory tract [0112] and by extension a predictor of infection risk. Further, Cohen teaches administration of T2R agonists for the treatment of respiratory infection. Since the step of determining inherently precedes the step of administering, Cohen anticipated the determining a prophylactic treatment step. Because the only other active method steps recited in claim 84 are introducing to T2Rs a plurality of agonists, detecting a level of stimulation, identifying a category by comparing said level of stimulation to a reference level, and stratifying the patients into categories of phenotypic expression of T2Rs, and because Cohen teaches these steps, the reference inherently anticipates the method of amended claim 84.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675