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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The examiner makes a note that all references from the IDS were considered, but wanted to inform the applicant that there appears to be a typographical error pertaining to the foreign reference currently presented as “JP-56139740-A” instead of the correct recitation “JP-S56139740-A”.
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 1-20 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.
Regarding Claim 1, the limitation “determination of a theoretical Rinne” is indefinite. It is unclear how a type of test such as a “Rinne” could be “theoretical”. For this examination, the phrase is being interpreted as “determination of a theoretical Rinne value”.
Additionally, the limitation “determination of a theoretical transcranial transfer” is indefinite. It is unclear how a type of process such as a “transcranial transfer” could be “theoretical”. For this examination, the phrase is being interpreted as “determination of a theoretical transcranial transfer value”.
Regarding Claim 2, the limitation “the patient comprising a transcranial transfer” recited between lines two and three is indefinite. It is unclear how a patient can “comprise” a transcranial transfer. Transcranial transfer is the physical transmission of sound waves experienced by a subject. For this examination, the phrase is being interpreted as “the patient experiencing a transcranial transfer”.
Additionally, the limitation “determining a current Rinne” recited in line 6 is indefinite. It is unclear how a person would “determine” a process. For this examination, the phrase is being interpreted as “performing a current Rinne”.
Furthermore, the limitation “determination of a current transcranial transfer” recited in lines 17-18 is indefinite. It is unclear how a person would “determine” a process. For this examination, the phrase is being interpreted as “performing a current transcranial transfer”.
Regarding Claim 3, the limitation “determining a current Rinne” recited in line 3 is indefinite. It is unclear how a person would “determine” a process. For this examination, the phrase is being interpreted as “performing a current Rinne”.
Additionally, the limitation “the step of determining a current Rinne comprises a step of decrementing the current Rinne by one step” is indefinite. It is unclear how decrementing a current Rinne results in that same current Rinne. Furthermore, it is also unclear what “decrementing…by one step” even comprises or what this all entails given that the applicant has recite a plurality of “steps”. Is the “step” recited within this portion of the limitation a value or is it a part of the method/process. The indefiniteness issues within the claim have rendered a proper prior art search unable to be performed. The same applies for Claims 13, 14, 16, and 19, which depend on Claim 3.
Regarding Claim 10, the term “better” recited in the fourth line of the claim is a relative term which renders the claim indefinite. The term “better” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what constitutes as a “better” ear? Does the “better” ear experience more or less of the effects of tests applied to a user? Does the “better” ear respond more less to the applied masking intensities? It is unclear what parameters are relied upon to determine a “better” ear.
Regarding Claim 11, the claim is indefinite in that it fails to recite any physical/structural elements of the claimed electronic audiometry testing device. For this examination, Claim 11 is being interpreted such that the claimed device comprises any physical element configured to implement the steps of the test method according to claim 1 (e.g., a processor).
Claims not explicitly rejected above are rejected due to their dependence on the above claims
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of Claim 9 follows.
STEP 1
Regarding Claim 1, the claim recites a series of steps or acts, including simultaneous application of a test sound to a test ear of a patient and a masking sound to a contralateral ear, determination of a theoretical Rinne from a theoretical transcranial transfer, determination of masking intensity from the theoretical Rinne, determination of a theoretical transcranial transfer from a theoretical Rinne, and determination of masking intensity from the theoretical transcranial transfer. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of determination of a theoretical Rinne from a theoretical transcranial transfer, determination of masking intensity from the theoretical Rinne, determination of a theoretical transcranial transfer from a theoretical Rinne, and determination of masking intensity from the theoretical transcranial transfer set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 fails to recite any application of determination of a theoretical Rinne from a theoretical transcranial transfer, determination of masking intensity from the theoretical Rinne, determination of a theoretical transcranial transfer from a theoretical Rinne, and determination of masking intensity from the theoretical transcranial transfer in a manner that imposes a meaningful limitation on the Abstract Idea. The Abstract Idea alone does not provide an improvement to the technological field, the method does not affect a particular treatment or effect a particular change based on a determination of a theoretical Rinne from a theoretical transcranial transfer, determination of masking intensity from the theoretical Rinne, determination of a theoretical transcranial transfer from a theoretical Rinne, or determination of masking intensity from the theoretical transcranial transfer, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, Claim 1 recites additional steps of simultaneous application of a test sound to a test ear of a patient and a masking sound to a contralateral ear. The application step is recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the application step does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Dependent Claims 2-19 fail to add something more to the abstract independent claims as they generally recite steps pertaining to data gathering and processing. Regarding Claims 4 and 13, the step of sending a message is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). Regarding Claims 11 and 12, the claimed device and “computer program” are generically claimed computers. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The application and determination steps recited in the independent claim, Claim 1, maintain a high level of generality even when considered in combination with the dependent claims.
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.
Claims 1, 2, 5-9, 11-12, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thornton et. al.'649 (U.S. Patent Publication 20070129649).
Regarding Claim 1, Thornton et. al.'649 discloses an audiometry test method comprising the following steps: simultaneous application of a test sound to a test ear of a patient comprising a test intensity, and of a masking sound, comprising a masking intensity, to a contralateral ear to mask the test sound (Paragraph [0028] - As mentioned above, the present invention is directed to a method and system for automated testing of a patient's hearing; Paragraph [0029] - The automated hearing test includes air and bone conduction testing with masking), wherein
the method comprises determination of a theoretical transcranial transfer value from a theoretical Rinne (Table 1; Paragraph [0080] - If unmasked bone is not being tested, then at step 902, the set pure tone masking levels module calculates the amount of crossover expected for the frequency being tested; Paragraph [0081] - entire paragraph - Using the mean values from Table 1 above, the amount of attenuation expected for a 500 Hz tone is about 59 dB; Paragraph [0082] - entire paragraph - The crossover can be determined from the inter-aural attenuation tables as described above. The non-test ear air-bone gap, at least initially, is assumed to be 0 dB. In some embodiments, a margin of 5 dB may be added to the minimum masking level in order to ensure there is sufficient masking, although the masking margin may be adjusted higher or lower as needed); and
determination of masking intensity from the theoretical transcranial transfer (Table 1; Paragraph [0082] - entire paragraph - The non-test ear air-bone gap, at least initially, is assumed to be 0 dB. In some embodiments, a margin of 5 dB may be added to the minimum masking level in order to ensure there is sufficient masking, although the masking margin may be adjusted higher or lower as needed. The maximum masking level is the level beyond which masking in the non-test ear will be heard in the test ear at a level sufficient to mask the test signal being presented. In some embodiments, the maximum masking level may be defined as that level which, when one subtracts the masking inter-aural attenuation, results in the effective presentation level. The effective presentation level is the intensity level of the tone as it is received at the inner ear).
Regarding Claim 2, Thornton et. al.'649 discloses the method outlined in Claim 1 above as well as determining a current Rinne (Paragraph [0058] - At step 612, the pure tone threshold module determines whether the air-bone gap for either ear is greater than or equal to a minimum significant air-bone gap, which might indicate that a masked bone threshold is needed to establish the bone conduction of each ear);
determining that the current Rinne is compatible, if there is a current intensity, such that if the masking intensity is equal to the current intensity and the Rinne of the test ear or contralateral ear is equal to the current Rinne, then the test sound is not perceived by the contralateral ear and the masking sound does not prevent perception of the test sound by the test ear (Paragraph [0082] -Once the crossover values have been calculated for the frequency being tested, the set pure tone masking levels module calculates at step 903 the minimum required masking level and the maximum allowable masking level for the frequency being tested; Paragraphs [0082-0087] ; Paragraph [0085] - the set pure tone masking levels module determines whether the new masking level is audible in the non-test (masked) ear at step 918. If the new masking level is not audible in the non-test ear, then in some embodiments, masking is simply turned off at this point); and
determination of a masking intensity from a maximum compatible current Rinne determined during the repetition step (Paragraph [0058] - At step 611, the pure tone threshold module again calls the pure tone intensity module to obtain the air threshold for the poorer ear. At step 612, the pure tone threshold module determines whether the air-bone gap for either ear is greater than or equal to a minimum significant air-bone gap, which might indicate that a masked bone threshold is needed to establish the bone conduction of each ear. The minimum significant air-bone gap is about 10 dB according to some audiologists; Paragraph [0059] - If, however, the air-bone gap for either ear is greater than or equal to the minimum significant air-bone gap, then the pure tone threshold module proceeds to obtain masked bone thresholds, beginning with the poorer ear at step 613 (by calling the pure tone intensity module); Paragraph [0082] - The maximum masking level is the level beyond which masking in the non-test ear will be heard in the test ear at a level sufficient to mask the test signal being presented. In some embodiments, the maximum masking level may be defined as that level which, when one subtracts the masking inter-aural attenuation, results in the effective presentation level. The effective presentation level is the intensity level of the tone as it is received at the inner ear. For air testing, the effective presentation level is the air conduction intensity level minus the air-bone gap. For bone testing, the effective presentation level is about equal to the bone conduction level).
Regarding Claim 5, Thornton et. al.'649 discloses the method outlined in Claim 2 above as well as wherein the audiometry test method comprises the first double steps (Paragraph [0039] - Finally, the pure tone intensity module calls the threshold detection module in order to establish whether a threshold intensity has been reached; Paragraph [0082] - the minimum masking level is defined as a sum of the crossover plus the non-test ear air-bone gap…For air testing, the effective presentation level is the air conduction intensity level minus the air-bone gap; Paragraphs [0083-0087] - entire paragraphs) and wherein the step of determining that the current Rinne is compatible comprises the following steps:
calculation of an efficacy threshold for the masking intensity above which the test sound cannot be perceived by the contralateral ear, based on the test intensity (Paragraph [0082] -The minimum masking level, in general, is the lowest level of masking that can still mask any crossover in the non-test ear…The non-test ear air-bone gap, at least initially, is assumed to be 0 dB. In some embodiments, a margin of 5 dB may be added to the minimum masking level in order to ensure there is sufficient masking, although the masking margin may be adjusted higher or lower as needed);
calculation of a no-overmasking threshold for the masking intensity below which the masking sound does not prevent perception of the test sound by the ear under test, based on the test intensity (Paragraph [0082] - The maximum masking level is the level beyond which masking in the non-test ear will be heard in the test ear at a level sufficient to mask the test signal being presented); and
a step to compare the efficacy threshold and the no-overmasking threshold, wherein the current Rinne is compatible if the efficacy threshold is less than or equal to the no-overmasking threshold (Paragraph [0059] - The pure tone threshold module thereafter determines whether the masked bone and unmasked bone difference for that ear is less than or equal to a maximum central masking effect; Paragraph [0074] - As can be seen from the exemplary flowchart 800, the first step is to determine whether a threshold intensity already exists for a particular transducer (e.g., bone or air conduction), frequency and ear being tested at step 801…; Paragraph [0084] - At step 910, the set for tone masking levels module determines whether the new masking level is so loud as to mask the test ear. If it is, then the set pure tone masking levels module sets the new masking level just below the maximum masking level at step 911, and determines whether this new masking level provides a sufficient amount of masking at step 912, that is, whether the new masking level is greater than or equal to the minimum masking level calculated at step 903).
Regarding Claim 6, Thornton et. al.'649 discloses the method outlined in Claim 2 above as well as the audiometry test being performed in air-conduction, wherein the audiometry test method comprises the first double steps, and wherein the calculation of the efficacy threshold is performed from the current Rinne (Paragraph [0082] - the minimum masking level is defined as a sum of the crossover plus the non-test ear air-bone gap…For air testing, the effective presentation level is the air conduction intensity level minus the air-bone gap; Paragraph [0084] - If the minimum masking level determined in step 903 is louder than the current masking level (step 906), or if the minimum masking level is much softer than the current masking level (step 907), then at step 909, the set pure tone masking level module sets the new masking level equal to the minimum masking level…determines whether this new masking level provides a sufficient amount of masking at step 912, that is, whether the new masking level is greater than or equal to the minimum masking level calculated at step 903. If the new masking level is not loud enough, then the set pure tone masking levels module raises an indication that there is a masking dilemma at step 913).
Regarding Claim 7, Thornton et. al.'649 discloses the method outlined in Claim 2 above as well as wherein the audiometry test method comprises the first double steps, and wherein the threshold calculation is performed on the basis of the current Rinne (Paragraph [0039] - Finally, the pure tone intensity module calls the threshold detection module in order to establish whether a threshold intensity has been reached; Paragraph [0082] - the minimum masking level is defined as a sum of the crossover plus the non-test ear air-bone gap…For air testing, the effective presentation level is the air conduction intensity level minus the air-bone gap; Paragraphs [0083-0087] - entire paragraphs).
Regarding Claim 8, Thornton et al. discloses the method outlined in Claim 5 above as well as wherein the audiometry test method comprises the first double steps (Paragraph [0039] - Finally, the pure tone intensity module calls the threshold detection module in order to establish whether a threshold intensity has been reached; Paragraph [0082] - the minimum masking level is defined as a sum of the crossover plus the non-test ear air-bone gap…For air testing, the effective presentation level is the air conduction intensity level minus the air-bone gap; Paragraphs [0083-0087] - entire paragraphs). Regarding the conditional "if” statements in the claim, Applicant is reminded that in a method claim, the steps following and dependent from a conditional limitation (i.e. when an assessment report indicates a particular condition) do not have to be performed in the method, if the condition precedent recited is not met. An examiner does not have to provide evidence for the method steps that are not required to be performed. According to a Patent Trial and Appeal Board decision mailed 04/28/2016 for application number 12/184,020 - “It is of course true that method steps may be contingent. If the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed.” Cybersettle, Inc. v. National Arbitration Forum, Inc., 243 Fed.Appx. 603, 606–07 (Fed.Cir.2007). As such, Thornton et al. need not disclose the conditional if limitations recited in the claim.
Regarding Claim 9, Thornton et. al.'649 discloses as described above, “the method according to claim 2”. For the remainder of Claim 9, “the second double steps” are not required to be analyzed from Claim 2 (from which this claim depends) due to the recitation of the limitation “at least one of the following two double steps”. The limitations of that claim do not require that there is necessarily “second double steps” present, therefore in the absence of “second double steps”, there is no antecedent basis for “comprises the second double steps” of Claim 6. As the limitations of Claim 6 concern the “comprises the second double steps”, which is not required for Claim 2, the limitations of the claim are satisfied without the application of additional art, as the claimed invention does not require the “the second double steps”.
Regarding Claim 11, Thornton et. al.'649 discloses the method outlined in Claim 1 above as well as an electronic audiometry testing device (100) configured to implement the steps of the test method according to claim 1 (Paragraph [0031] - The system 100 has three main components, namely, a computer 102, a display screen 104, and at least one transducer 106).
Regarding Claim 12, Thornton et. al.'649 discloses the method outlined in Claim 1 above as well as a computer program embodied on a non-transitory computer readable medium and comprising instructions, executable by a microprocessor or microcontroller, for implementing the test method according to claim 1 (Paragraph [0028] - The term "automated testing" as used herein refers to testing that is performed primarily by a computer; Paragraph [0034] - The central processing unit 202 is responsible for the overall operation of the computer 102, including execution of the operating system and any software applications residing on the computer 102. In some embodiments, the central processing unit 202 may be any one of several commercially available microprocessors).
Regarding Claim 18, Thornton et. al.'649 discloses the method outlined in Claim 5 above as well as the audiometry test being performed in air-conduction, wherein the audiometry test method comprises the first double steps, and wherein the calculation of the efficacy threshold is performed from the current Rinne (Paragraph [0082] - the minimum masking level is defined as a sum of the crossover plus the non-test ear air-bone gap…For air testing, the effective presentation level is the air conduction intensity level minus the air-bone gap; Paragraph [0084] - If the minimum masking level determined in step 903 is louder than the current masking level (step 906), or if the minimum masking level is much softer than the current masking level (step 907), then at step 909, the set pure tone masking level module sets the new masking level equal to the minimum masking level…determines whether this new masking level provides a sufficient amount of masking at step 912, that is, whether the new masking level is greater than or equal to the minimum masking level calculated at step 903. If the new masking level is not loud enough, then the set pure tone masking levels module raises an indication that there is a masking dilemma at step 913).
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.
Claims 4, 15, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Thornton et. al.'649 (U.S. Patent Publication 20070129649) as applied to Claim 2 above, in view of Margolis'398 (U.S. Patent Publication 20070179398).
Regarding Claim 4, Thornton et. al.'649 discloses the method outlined in Claim 2 above as well as sending an indication for improper readings (Paragraph [0058] - At step 611, the pure tone threshold module again calls the pure tone intensity module to obtain the air threshold for the poorer ear. At step 612, the pure tone threshold module determines whether the air-bone gap for either ear is greater than or equal to a minimum significant air-bone gap, which might indicate that a masked bone threshold is needed to establish the bone conduction of each ear. The minimum significant air-bone gap is about 10 dB according to some audiologists; Paragraph [0059] - If, however, the air-bone gap for either ear is greater than or equal to the minimum significant air-bone gap, then the pure tone threshold module proceeds to obtain masked bone thresholds, beginning with the poorer ear at step 613 (by calling the pure tone intensity module); Paragraph [0084] - determines whether this new masking level provides a sufficient amount of masking at step 912, that is, whether the new masking level is greater than or equal to the minimum masking level calculated at step 903. If the new masking level is not loud enough, then the set pure tone masking levels module raises an indication that there is a masking dilemma at step 913), but fails to explicitly disclose wherein if the maximum compatible current Rinne is below a minimum threshold, an alarm message is sent. Margolis’398 teaches issuing alerts based on achieved Rinne threshold values (Paragraph [0063] - After determination of air-conduction and bone-conduction thresholds, the program determines threshold measurements for which masking levels may not have been appropriate. The program alerts the examiner of these threshold measurements and these are known as masking alerts). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Thornton et. al.'649 to include alarms indicative of Rinne based threshold values in order to alert a user that measurements may not be appropriate as seen in Margolis’398.
Regarding Claim 15, Thornton et. al.'649 in view of Margolis'398 discloses the method outlined in Claim 4 above. Thornton et. al.'649 further discloses wherein the audiometry test method comprises the first double steps (Paragraph [0039] - Finally, the pure tone intensity module calls the threshold detection module in order to establish whether a threshold intensity has been reached; Paragraph [0082] - the minimum masking level is defined as a sum of the crossover plus the non-test ear air-bone gap…For air testing, the effective presentation level is the air conduction intensity level minus the air-bone gap; Paragraphs [0083-0087] - entire paragraphs) and wherein the step of determining that the current Rinne is compatible comprises the following steps:
calculation of an efficacy threshold for the masking intensity above which the test sound cannot be perceived by the contralateral ear, based on the test intensity (Paragraph [0082] -The minimum masking level, in general, is the lowest level of masking that can still mask any crossover in the non-test ear…The non-test ear air-bone gap, at least initially, is assumed to be 0 dB. In some embodiments, a margin of 5 dB may be added to the minimum masking level in order to ensure there is sufficient masking, although the masking margin may be adjusted higher or lower as needed);
calculation of a no-overmasking threshold for the masking intensity below which the masking sound does not prevent perception of the test sound by the ear under test, based on the test intensity (Paragraph [0082] - The maximum masking level is the level beyond which masking in the non-test ear will be heard in the test ear at a level sufficient to mask the test signal being presented); and
a step to compare the efficacy threshold and the no-overmasking threshold, wherein the current Rinne is compatible if the efficacy threshold is less than or equal to the no-overmasking threshold (Paragraph [0059] - The pure tone threshold module thereafter determines whether the masked bone and unmasked bone difference for that ear is less than or equal to a maximum central masking effect; Paragraph [0074] - As can be seen from the exemplary flowchart 800, the first step is to determine whether a threshold intensity already exists for a particular transducer (e.g., bone or air conduction), frequency and ear being tested at step 801…; Paragraph [0084] - At step 910, the set for tone masking levels module determines whether the new masking level is so loud as to mask the test ear. If it is, then the set pure tone masking levels module sets the new masking level just below the maximum masking level at step 911, and determines whether this new masking level provides a sufficient amount of masking at step 912, that is, whether the new masking level is greater than or equal to the minimum masking level calculated at step 903).
Regarding Claim 17, Thornton et. al.'649 in view of Margolis'398 discloses the method outlined in Claim 4 above. Thornton et. al.'649 further discloses the audiometry test being performed in air-conduction, wherein the audiometry test method comprises the first double steps, and wherein the calculation of the efficacy threshold is performed from the current Rinne (Paragraph [0082] - the minimum masking level is defined as a sum of the crossover plus the non-test ear air-bone gap…For air testing, the effective presentation level is the air conduction intensity level minus the air-bone gap; Paragraph [0084] - If the minimum masking level determined in step 903 is louder than the current masking level (step 906), or if the minimum masking level is much softer than the current masking level (step 907), then at step 909, the set pure tone masking level module sets the new masking level equal to the minimum masking level…determines whether this new masking level provides a sufficient amount of masking at step 912, that is, whether the new masking level is greater than or equal to the minimum masking level calculated at step 903. If the new masking level is not loud enough, then the set pure tone masking levels module raises an indication that there is a masking dilemma at step 913).
Regarding Claim 20, Thornton et. al.'649 in view of Margolis'398 discloses the method outlined in Claim 4 above. Thornton et. al.'649 further discloses wherein the audiometry test method comprises the first double steps, and wherein the threshold calculation is performed on the basis of the current Rinne (Paragraph [0039] - Finally, the pure tone intensity module calls the threshold detection module in order to establish whether a threshold intensity has been reached; Paragraph [0082] - the minimum masking level is defined as a sum of the crossover plus the non-test ear air-bone gap…For air testing, the effective presentation level is the air conduction intensity level minus the air-bone gap; Paragraphs [0083-0087] - entire paragraphs).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Thornton et. al.'649 (U.S. Patent Publication 20070129649) as applied to Claim 1 above, in view of Dyhrfjeld-Johnsen'503 (U.S. Patent Publication 20190083503).
Regarding Claim 10, Thornton et. al.'649 discloses the method outlined in Claim 1 above as well as the audiometry test is performed in air-conduction, and the tested ear is the targeted ear, the test method then comprising an audiometry test of the opposite ear to the tested ear in air-conduction (Paragraph [0033] - the transducer 106, this component may be an ear insert, earphones, and the like for air conduction; Paragraph [0057] - At step 607, for whichever ear was denoted as the better ear, the pure tone threshold module obtains an air threshold for that ear by again calling the pure tone intensity module…the pure tone threshold module proceeds to step 611 to obtain the air threshold for the other, poorer ear), where the audiometry test is carried out in bone-conduction, and the tested ear is the ear towards which a test was lateralized to, the test method then comprising an audiometry test of the opposite ear to the tested ear in bone-conduction (Paragraph [0033] - For bone conduction, the transducer 106 may be a vibrator or other similar devices…the bone conduction transducer is arranged in such a way as to allow testing of either ear; Paragraph [0055] - The pure tone threshold module thereafter uses the unmasked bone threshold to determine whether the left ear or the right ear is louder).
Thornton et. al.'649 fails to explicitly disclose applying a Weber test. Dyhrfjeld-Johnsen'503 teaches applying a Weber test as part of conductive hearing loss exam protocol (Paragraph [0083] - Sensorineural hearing loss and conductive hearing loss may be distinguished according to tests well known of the skilled artisan, including, without limitation, Weber and Rinne tests, otoscopy, audiograms, audiometry, auditory brainstem recordings, optoacoustic emissions recordings, word recognition tests and speech-in-noise tests). Since the prior art of Dyhrfjeld-Johnsen'503 recognizes the equivalency of audiometry and Weber tests in the field of conductive hearing loss testing, it would have been obvious to one of ordinary skill in the art at the time of the invention to replace the preliminary audiometry exam of Thornton et. al.'649 with the Weber test of Dyhrfjeld-Johnsen'503 as it is merely the selection of functionally equivalent conductive hearing loss examination protocols recognized in the art and one of ordinary skill in the art would have a reasonable expectation of success in doing so. According to MPEP Section 2143 I.B. Example 2 as well as the simple substitution of one known element for another is likely to be obvious when predictable results are achieved KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Keller’428 (U.S. Patent Publication 20040037428), Saly’940 (U.S. Patent Publication 20130303940), O’Neill et. al.’739 (U.S. Patent Publication 20170042739), and Frieding et. al.’730 (U.S. Patent Publication 20200252730) disclose hearing measurement devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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