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 .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 5 August 2025 is acknowledged.
Claims 12-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5 August 2025.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1-11 are objected to because of the following informalities:
The claims filed 5 August 2025 fail to comply with 37 CFR 1.121.C. as the claims do not properly show all changes to the claims. Claim 1 is indicated as currently amended but shows no marked amendments; Applicant’s remarks indicate that an amendment has been made, and the last line of the claim as presented differs from the previous version of the claims despite not being marked as a change. As no other claims have been indicated as having been amended, they have not been checked against their previous versions and any unmarked amendments in claims 2-11 will not be treated as having changed, nor is there any indication of amendments in the withdrawn claims. In the interest of compact prosecution the current response with improperly amended claims will be accepted this one time, but future responses that fail to comply may be considered non-responsive. All future responses should be carefully checked to ensure that all claim amendments are properly presented and identified as required by 37 CFR 1.121.
Claim 1 is directed to a test kit which comprises an odor proctor and “an application on a computing device” – as presented, the computing device is not actually part of the claimed invention, only the application/instructions. It is unclear how this “test kit” could be assembled or provided to a user when half of the “kit” is programming code. At the least, it appears the intended assembly might be the combination of an odor proctor and a computing device comprising various instructions.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
odor proctor, first recited in claim 1 (odors printed on or embedded into a smell test card, or a collection of encapsulated scents, paragraphs [0043]-[0044] as filed).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 6-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 refers to “each of the plurality of odors on the printed test card”; there is no antecedent basis for this limitation in the claim as claim 1 merely sets forth delivery of one odor using a proctor, where that odor is one of a plurality of possible odors, but does not provide any constraint such that it encompasses delivery of any one odor from among any possible odors existing in the world; claim 2 defines a test card but does not call for the delivered odor, let alone any other odors, to be on the test card. Correction is required.
Claim 3 calls for using a cover associated with each odor “to encapsulate a scent of the plurality of odors” – is this some scent that is the result of a combination of all the odors? It appears it should refer to a scent of each odor of the plurality of odors; correction is required.
Claim 6 calls for calculating “a score for the odor intensity test”; per claim 1 the smell test can be an odor intensity test, but claim 1 calls for calculating “a score for the smell test” – if the score calculated in claim 6 is this same score, it should clearly set forth that the calculated smell test score is a score for the odor intensity test. If two separate scores it should be clearly defined as such. For the purposes of examination the claim will be treated as the former, but correction is required.
Claim 7 calls for increasing or decreasing “the score” based on an intensity rating; per claims 1 and 6 the score is generated based the user input. It is unclear how or why this score would then be subsequently increased or decreased based on the same information that was used to generate the score itself. It appears the intent may be to determine a cumulative score from a number of odor tests, but the claims do not call for performing any more than one test, nor does merely repeating the instructions result in this being feasible as each iteration of the instructions in claims 1 and 6 would simply generate a new score for that testing result, not a score that is then updated based on some subsequent testing result.
Claim 8 calls for calculating “a score for the odor identification test”; per claim 1 the smell test can be an odor identification test, but claim 1 calls for calculating “a score for the smell test” – if the score calculated in claim 6 is this same score, it should clearly set forth that the calculated smell test score is a score for the odor identification test. If two separate scores it should be clearly defined as such. For the purposes of examination the claim will be treated as the former, but correction is required.
Claim 9 calls for increasing or decreasing “the score” based on whether a response is correct or incorrect; per claims 1 and 8 the score is generated based on whether the response is correct or incorrect. It is unclear how or why this score would then be subsequently increased or decreased based on the same information that was used to generate the score itself. It appears the intent may be to determine a cumulative score from a number of odor tests, but the claims do not call for performing any more than one test, nor does merely repeating the instructions result in this being feasible as each iteration of the instructions in claims 1 and 8 would simply generate a new score for that testing result, not a score that is then updated based on some subsequent testing result.
Claim 10 recites “instruct the user of the computing device to smell a first odor, a second odor, and a third odor on the odor proctor”; as defined in claim 1 the odor proctor is only configured to deliver “an odor” such that there is no antecedent basis for the ability to smell first, second, and third odors; it is additionally unclear if the delivered odor is one of these odor which is smelled, or if smelling is separate from delivery and at least four odors are involved? Clarification is required.
Claim 10 further calls for the device to “calculate a score”; as in claims 6 and 8, if this score is the “score for the smell test” as defined in claim 1 it should be clearly defined as such. Correction is required.
Claim 11 calls for increasing or decreasing “the score” based on whether a response is correct or incorrect; per claims 1 and 10 the score is generated based on whether the response is correct or incorrect. It is unclear how or why this score would then be subsequently increased or decreased based on the same information that was used to generate the score itself. It appears the intent may be to determine a cumulative score from a number of odor tests, but the claims do not call for performing any more than one test, nor does merely repeating the instructions result in this being feasible as each iteration of the instructions in claims 1 and 10 would simply generate a new score for that testing result, not a score that is then updated based on some subsequent testing result.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) generating a report of symptoms linked with infection by scoring results of a test, which falls into the grouping of mental processes. This judicial exception is not integrated into a practical application because the generation of the report
does not present any improvement to the functioning of a computer or to any other technology, as it is merely a nonspecific correlation between a test score and symptoms of infection
does not apply or use a judicial exception to effect a particular treatment or as a prophylaxis for a disease or medical condition, as the generated report is not used in any manner
does not apply the judicial exception with, or by use of, a particular machine, as the generation of the report is performed only using “instructions” on a wholly nonspecific “computing device” (see MPEP 2106.05(d), Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."), showing that these computer functions are well-understood, routine, and conventional functions)
does not effect a transformation or reduction of a particular article to a different state or thing, as it is merely correlation of a score with some unidentified indication of symptoms
does not apply or use the judicial exception in some other meaningful way, as the report itself is not applied or used in any way and is not specifically output in any manner
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only element beyond the conventional and nonspecific “computing device” that is used for presenting instructions and receiving input of data for scoring is an “odor proctor”, a well-understood, routine, and conventional device for performance of smell testing that is recited at a high level of generality and only for the purpose of insignificant extrasolution data gathering (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional). As such, considered individually and as a whole, the claim elements do not amount to significantly more than the abstract idea itself.
The dependent claims also fail to provide anything significantly more, as claims 2-4 are directed to aspects of the device that is included only for of data gathering; claim 5 is directed to conventional computing devices for the execution of the abstract idea itself; claims 6-11 are directed to the performance of insignificant data gathering to provide input to the abstract idea itself.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 5, 8-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taherkhani (US 2016/0220165).
Regarding claim 1, Taherkhani discloses a test kit comprising:
an odor proctor configured to deliver an odor from among a plurality of odors (paragraphs [0042]-[0045]; the examiner notes that the claim does not call for the plurality of odors to be contained within/on/as part of a single proctor, only that the delivered odor is one of a plurality of odors that could be delivered);
an application on a computing device comprising instructions (paragraphs [0039], [0040]) that, when executed by a processor running on the computing device, cause the computing device to:
generate a user interface to be displayed on the computing device (paragraph [0040]);
receive, via the user interface, a user input for a smell test comprising at least one of an odor intensity test, an odor identification test, or an odor discrimination test (paragraph [0039], [0040]);
calculate, based on the user input for the smell test, a score for the smell test (paragraph [0047], [0048]); and
using the score for the smell test, generate a report indicating a user being affected with symptoms associated with an infection (paragraphs [0048], [0049]; per the disclosure of the instant invention, anosmia is a symptom associated with an infection, see paragraph [0111] and [0113] as filed).
Regarding claim 2, Taherkhani further discloses that the odor proctor includes a printed test card (paragraph [0043]).
Regarding claim 4, the Examiner notes that any object may be disposed of if so desired, including the odor proctor, such that it is thus “configured to be disposable”.
Regarding claim 5, Taherkhani further discloses that the computing device is one of a personal computer, tablet, or smart phone (paragraphs [0039], [0040]).
Regarding claim 8, Taherkhani further discloses that the instructions further include steps for administering the odor identification test that cause the computing device to:
instruct the user of the computing device to smell an odor on the odor proctor (step 101);
generate an odor identification user interface comprising an odor selection function (paragraphs [0039], [0040]);
receive from the user, via the odor selection function, a selection of an odor identification (paragraphs [0039], [0040]);
query a database to identify a correct response for the selection (paragraph [0047]); and
calculate a score for the odor identification test (paragraphs [0047], [0048]).
Regarding claim 9, Taherkhani further discloses that correct responses lead to higher scores (abstract).
Regarding claim 10, Taherkhani further discloses that the instructions include steps for administering the odor discrimination test that cause the computing device to:
instruct the user of the computing device to smell a first odor, a second odor, and a third odor on the odor proctor (step 101; paragraph [0072]);
generate an odor discrimination user interface comprising an odor discrimination function (paragraphs [0039]-[0040]);
receive from the user, via the odor discrimination function, a selection of one of the first odor, the second odor, or the third odor ()paragraphs [0039], [0040], [0072]);
query a database to identify a correct response for the selection (paragraph [0072], [0106]); and
calculate a score for the odor discrimination test (paragraphs [0106]-[0112]).
Regarding claim 11, Taherkhani further discloses that correct responses lead to higher scores (abstract).
Claim Rejections - 35 USC § 103
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taherkhani in view of Doty (US 6557394).
Regarding claim 3, Taherkhani does not explicitly disclose the printed test card including a plurality of odors including the delivered odor, each including a cover thereon configured to encapsulate its scent. Doty teaches a printed test card configured to deliver a plurality of odors, each of the plurality of odors including a cover thereon configured to encapsulate its scent (figure 24, elements 24a-l; column 4, lines 1-3). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Taherkhani with a plurality of odors on the test card, each odor with a cover, as taught by Doty, in order to allow easy testing of multiple samples.
Claim(s) 6, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taherkhani in view of Matsunami (US 2010/0143337).
Regarding claim 6, Taherkhani further discloses that the instructions include steps for administering the odor intensity test that cause the computing device to:
instruct the user of the computing device to smell an odor on the odor proctor (step 101);
generate an odor test user interface comprising an odor characteristic input function (paragraphs [0039]-[0040]);
receive from the user, via the input function, an odor characteristic evaluation (paragraphs [0039]-[0040]); and
calculate the score for the odor test (paragraphs [0047], [0048]).
Taherkhani does not disclose the interface comprising an intensity rating function or the received input being an intensity rating, where the score is calculated based on the odor intensity. Matsunami teaches a test kit comprising an odor proctor configured to deliver an odor (paragraph [0259]) and instructions configured to cause a computer device to generate an odor intensity user interface comprising an intensity rating function and receive from the user, via the intensity rating function, an intensity rating (paragraph [0037]; figure 7); and calculate a score for the odor intensity (paragraphs [0260]-[0279]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Taherkhani and configured the instructions for evaluating odor intensity, as taught by Matsunami, in order to provide an additional evaluation of the user’s condition.
Regarding claim 7, Taherkhani further discloses that correct responses lead to higher scores (abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2023/0119965 to Harrah, US 2022/0117541 to Dalton, US 2022/0054074 to Stodgell, US 2021/0391088 to Harrah, 2017/0290541 to Albers, 2017/0247145 to Reishacher, which disclose similar devices
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/KAREN E TOTH/Examiner, Art Unit 3791