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 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.
No claim elements are interpreted under 112(f).
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 and 17 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) “determining and comparing the responses of the first and second acoustic stimuli to assess canal and otolith contributions to sound-evoked responses of the vestibular end organs.”
Under the first of the two-prong inquiry of step 2A for evaluating 101, this limitation is considered a mental process because the steps as claimed may be easily performed in the user’s mind. Since the claims do not specify what is meant by “determining” and “comparing,” a user may perform “determining and comparing the responses of the first and second acoustic stimuli to assess canal and otolith contributions to sound-evoked responses of the vestibular end organs” by simply observing the first and second acoustic stimuli and make mental assessments of canal and otolith contributions to sound-evoked responses of the vestibular end organs. Additionally, no structure is recited to perform said method, which further indicates the step as a mental process.
Under the second of the two-prong inquiry of step 2A, this judicial exception is not integrated into a practical application because there are no limitations that indicate improvements to the functioning of a computer or to the technology/technical field; effecting a particular treatment or prophylaxis for a disease/condition; applying the judicial exception with a particular machine; effecting a transformation or reduction of a particular article to a different state/thing; applying the judicial exception in a meaningful way beyond generally linking to a particular technological environment.
Since the second of the two-prong inquiry of step 2A is not satisfied, the claims are then evaluated under step 2B.
Under step 2B for evaluating 101, the claim(s) does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of “providing a first acoustic stimuli to the subject to activate otolith afferents to provide a response, the first acoustic stimuli being at a first predetermined frequency and a first set predetermined intensities” and “providing a second acoustic stimuli to the subject to activate both canal and otolith afferents to provide a response, the second acoustic stimuli being at a second predetermined frequency and a second set of predetermined intensities” constitute data gathering steps that are well-known, routine, and conventional in the VEMP art area. Additionally, no structure is recited, which also reinforces the nature of the mental process not being significantly more.
Claims 2-16, 18-19 and 21 do not provide any practical application or add significantly more to the abstract idea.
Claims 14 and 16 also recite an abstract idea in the form of a mathematical process as well as a mental process because the intensity-amplitude curve and a ratio of the slopes are determined mathematically and can also be calculated in a user’s mind, respectively. These are also not recited in a way that provides any practical application nor significantly more than the abstract idea.
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.
Claim 16 is 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.
The claim lacks proper antecedent basis for the recitation of “the high frequency and low frequency.” The claim cites dependency to Claim 14 but said claim also does not recite said limitations. Clarification is requested.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 6-10, 12-13, 15, 17, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kato et al (US Pub No. 20210205137) in view of Rosengren et al (The Contributions of Vestibular Evoked Myogenic Potentials and Acoustic Vestibular Stimulation to Our Understanding of the Vestibular System; Front Neurology, 2018 Jun 29; 9:481).
In regard to Claim 1, Kato et al disclose a method of discriminative vestibular-evoked myogenic potential testing (VEMP) in a subject in need thereof (0057), comprising:
providing a first acoustic stimuli to the subject to activate otolith afferents to provide a response – “tests conducted on persons confirmed that a sound stimulation having a sound volume level of 85 dB and a frequency in a range from 20 Hz and 140 Hz provides the benefit of activating the vestibular function via the ear stone of the subject person” (0073),
the first acoustic stimuli being at a first predetermined frequency – i.e. between 20 and 140 Hz (abst, 0073), for example 90 Hz as seen in Figure 7B (0056), and
a first set predetermined intensities – “If the amount of movement of the head is relatively great, for example, the sound volume level of the sound stimulation may be decreased within the range 70-85 dB, and, if the amount of movement of the head is relatively small, the sound volume level of the sound stimulation may be increased within the range 70-85 dB” (0085);
providing a second acoustic stimuli to the subject to activate both canal and otolith afferents to provide a response – “a frequency in a range from 20 Hz and 140 Hz provides the benefit of activating the vestibular function via the ear stone of the subject person… results shown in FIGS. 14-16 confirmed that the sound stimulation in the above range may also stimulate the semicircular canal” (0073),
the second acoustic stimuli being at a second predetermined frequency – i.e. between 20 and 140 Hz (abst, 0073), for example 100 Hz as seen in Figure 7B (0056) and
a second set of predetermined intensities – “If the amount of movement of the head is relatively great, for example, the sound volume level of the sound stimulation may be decreased within the range 70-85 dB, and, if the amount of movement of the head is relatively small, the sound volume level of the sound stimulation may be increased within the range 70-85 dB” (0085);
determining and comparing the responses such as in the form of the graph in Figure 7B (0056).
However, Kato et al do not expressly disclose determining and comparing the responses of the first and second acoustic stimuli to assess canal and otolith contributions to sound-evoked responses of the vestibular end organs.
Rosengren et al teach that it is well-known in the art to provide an analogous method of vestibular-evoked myogenic potential testing (VEMP) in a subject includes determining and comparing the responses of acoustic stimuli to assess canal and otolith contributions to sound-evoked responses of the vestibular end organs – “recorded AC click-evoked responses in the primary vestibular afferents of rats and found that clicks produced responses in twice as many otolith afferents (81%) as canal afferents (43%)”; “otolith afferents were in fact more sensitive to vibration: 83% of irregular otolith afferents compared to 16% of irregular canal afferents responded to vibration” (VEMP-inspired animal studies section).
Rosengren et al thus teach that determining and comparing the responses of acoustic stimuli can assess canal and otolith contributions to sound-evoked responses of the vestibular end organs provide useful information.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kato et al such that the method includes determining and comparing the responses of the first and second acoustic stimuli to assess canal and otolith contributions to sound-evoked responses of the vestibular end organs as taught by Rosengren et al to effectively investigate the contributes from the canal vs otolith to the sound-evoked responses of the vestibular end organs in Kato et al to provide useful information to better target the treatment to the patient (0007 of Kato et al).
2. Kato et al disclose the method of claim 1, wherein the first and second acoustic stimuli are series of at least three tone bursts, i.e. Figure 7B shows at least six VEMP responses to frequencies shown, and thus can be considered two series of three tone bursts (0056).
3. Kato et al disclose the method of claim 1, wherein the first predetermined frequency is below 500 Hz – 20-140 Hz – and the first set of predetermined intensities is a series of tone bursts up to about 100 dB HL – 70-85 dB sound volume level (abst).
6. Kato et al disclose the method of claim 1, wherein the first acoustic stimuli is a series of at least four tone bursts at a frequency below 500 Hz – Figure 7B shows at least five VEMP responses up to 200 Hz (0056) – and the intensity up to about 100 dB HL – 70-85 dB sound volume level (abst).
7. Kato et al disclose the method of claim 3, wherein the tone bursts are at increasing intensities up to about 100 dB HL, best seen in Figure 7B (0056).
8, 9. Kato et al disclose the method of claim 1, wherein the second intensity is a series of tone bursts up to 100 dB HL – 70-85 dB sound volume level HL (abst) but do not expressly disclose the second predetermined frequency is about 1500 Hz.
Rosengren et al teach that it is well-known in the art “saccular and utricular afferents had broad tuning to AC sound between frequencies 500 and 3,000 Hz” (VEMP-inspired animal studies section). Thus, Rosengren et al teach that using a frequency of about 1500 Hz would affect otolith afferents.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kato et al as modified by Rosengren et al such that the second predetermined frequency is about 1500 Hz as taught by Rosengren et al to effectively target the otolith afferents as desired by Kato et al.
10. Kato et al disclose the method of claim 9, wherein the tone bursts are at increasing intensities up to about 100 dB HL – “if the amount of movement of the head is relatively small, the sound volume level of the sound stimulation may be increased within the range 70-85 dB” (0085).
12. Kato et al in combination with Rosengren et al disclose the method of claim 6, wherein the first acoustic stimuli is capable of discriminately activates otolith afferents per the teachings of Rosengren et al.
13. Rosengren et al disclose the method of claim 1, where in the activation is measured by the peaks of VEMP responses, for example see caption of Figure 1, as a well-known, routine, and conventional measure of the VEMP response.
15. Kato et al disclose the method of claim 1, wherein the first predetermined frequency is 350 Hz or below – 20-140 Hz (abst).
In regard to Claim 17, Kato et al disclose a method of discriminative sound-evoked vestibular myogenic potential testing (VEMP) in a subject in need thereof (0057), comprising:
providing a first acoustic stimuli to the subject to activate otolith afferents to provide a response – “tests conducted on persons confirmed that a sound stimulation having a sound volume level of 85 dB and a frequency in a range from 20 Hz and 140 Hz provides the benefit of activating the vestibular function via the ear stone of the subject person” (0073),
the first acoustic stimuli being at a first predetermined frequency – i.e. between 20 and 140 Hz (abst, 0073), for example 90 Hz as seen in Figure 7B (0056), and
a first set predetermined intensities – “If the amount of movement of the head is relatively great, for example, the sound volume level of the sound stimulation may be decreased within the range 70-85 dB, and, if the amount of movement of the head is relatively small, the sound volume level of the sound stimulation may be increased within the range 70-85 dB” (0085);
providing a second acoustic stimuli to the subject to activate otolith afferents to provide a response (0073),
the second acoustic stimuli being at a second predetermined frequency – i.e. between 20 and 140 Hz (abst, 0073), for example 100 Hz as seen in Figure 7B (0056) and
a second set predetermined intensities – “If the amount of movement of the head is relatively great, for example, the sound volume level of the sound stimulation may be decreased within the range 70-85 dB, and, if the amount of movement of the head is relatively small, the sound volume level of the sound stimulation may be increased within the range 70-85 dB” (0085);
determining and comparing the responses such as in the form of the graph in Figure 7B (0056).
However, Kato et al do not expressly disclose determining and comparing the responses of the first and second acoustic stimuli to assess canal and otolith contributions to sound-evoked responses of the vestibular end organs.
Rosengren et al teach that it is well-known in the art to provide an analogous method of vestibular-evoked myogenic potential testing (VEMP) in a subject includes determining and comparing the responses of acoustic stimuli to assess canal and otolith contributions to sound-evoked responses of the vestibular end organs – “recorded AC click-evoked responses in the primary vestibular afferents of rats and found that clicks produced responses in twice as many otolith afferents (81%) as canal afferents (43%)”; “otolith afferents were in fact more sensitive to vibration: 83% of irregular otolith afferents compared to 16% of irregular canal afferents responded to vibration” (VEMP-inspired animal studies section).
Rosengren et al thus teach that determining and comparing the responses of acoustic stimuli can assess canal and otolith contributions to sound-evoked responses of the vestibular end organs provide useful information.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kato et al such that the method includes determining and comparing the responses of the first and second acoustic stimuli to assess canal and otolith contributions to sound-evoked responses of the vestibular end organs as taught by Rosengren et al to effectively investigate the contributes from the canal vs otolith to the sound-evoked responses of the vestibular end organs in Kato et al to provide useful information to better target the treatment to the patient (0007 of Kato et al).
19. Kato et al disclose the method of claim 17, wherein the first and second predetermined frequencies are below 500 Hz – 20-140 Hz (abst), best seen in Figure 7B (0056), and the first and second set of predetermined intensities are a series of tone bursts up to about 100 dB H – 70-85 dB sound volume level (abst), wherein it is noted that since applicant defines “about” as being within 20% (0036 filed spec) this includes 85 dB.
21. Kato et al disclose the method of claim 17, wherein the first and second acoustic stimuli are series of at least four tone bursts at frequency below 350 Hz – Figure 7B shows at least five VEMP responses up to 200 Hz (0056).
Claim(s) 4-5, 11, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kato et al (US Pub No. 20210205137) in view of Rosengren et al, further in view of Hu et al (US Pub No. 20220054640).
Kato et al in combination with Rosengren et al disclose the invention above but do not expressly disclose the series of tone bursts are at least four tone bursts in increasing intensity increments of about 10 to 30 dB HL. It is noted that Kato et al is considered to disclose at least four tone bursts, such as shown in Figure 7B, each result constituting a tone burst.
Hu et al teach that it is well-known in the art to provide an analogous sound-evoked response method comprising providing sounds that were increased in intensity increments of about 10 to 30 dB HL – “The same pure tone stimuli were repeated 512 times, the sound pressure levels were increased in a step of 10 dB SPL (5 dB around threshold) from 20 dB SPL to 90 dB SPL after every 512 repeated trials” to effectively test the sound evoked response of the user (0936).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kato et al as modified by Rosengren et al such that the intensity increments of Kato et al are such that there is at least four tone bursts in increasing intensity increments of about 10 to 30 dB HL as taught by Hu et al as an effective manner to test the sound-evoked responses of the vestibular end organs in Kato et al.
Claim(s) 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kato et al (US Pub No. 20210205137) in view of Rosengren et al, further in view of Gattie et al (“Weak vestibular response in persistent developmental stuttering and implications for own voice identification”; Front Integr Neurosci, 2021 Sept 1; 15:662127).
Kato in combination with Rosengren et al disclose the invention above but do not expressly disclose the peaks of the VEMP responses are plotted to form an intensity-amplitude curve wherein intensity and VEMP amplitude curves of the high frequency and low frequency are compared to obtain a ratio of the slopes of the two intensity-amplitude curves.
Gattie et al teach that plotting intensity-amplitude curves such as shown in Figures 10 and 13 along with a slope provide an effective measure of comparison of the desired VEMP response of the patient (see caption of Figure 10).
It is noted that Rosengren et al teach “it has now been shown that comparing the responses at these frequencies in the form of a ratio is helpful in distinguishing MD from other causes of vertigo” (Meniere’s disease section).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kato et al as modified by Rosengren et al such that the peaks of the VEMP responses are plotted to form an intensity-amplitude curve wherein intensity and VEMP as taught by Gattie et al and the amplitude curves of the high frequency and low frequency are compared to obtain a ratio of the slopes of the two intensity-amplitude curves as taught by Gattie et al along with Rosengren et al, to effectively provide a manner of analysis of the VEMP of the users, such as for effectively distinguishing MD from other causes, as would be pertinent in the treatment determination of Kato et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong Q NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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