DETAILED ACTION
Applicant' s arguments, filed 01/29/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 08/05/2024, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-2, 4, 10, 37-47, and 50-65 are the current claims hereby under examination.
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.
The claim limitations being interpreted under 35 USC 112(f) include:
Claim 52 recites “step for obtaining first reactions of a recipient of a hearing prosthesis” Paragraph 0143 provides non-limiting examples of the first reactions relating to the threshold and comfort hearing levels of a patient. Paragraph 0143 details that in these non-limiting examples the obtained reactions may be “typical reactions” of whether the user can hear anything and whether what they hear is comfortable. Paragraph 0143 describes this step in purely functional language. In particular, the specific reactions obtained are not limited and their respective methods of obtainment are not explicitly described. Paragraphs 0028, 0075, and 0104 make reference to a comfort level and threshold level that is established for the patient but the specification does not appear to explicitly describe what the “first signals” may entail and how they are obtained. Furthermore, paragraphs 0047-0048 do not define either the first or second reactions and provide only non-limiting examples of what signals may be received. Furthermore, no particular method of obtaining the signals is provided. Paragraph 0075 relates to mixing ratios and does not describe either the first or second reaction signals nor how they are obtained. Fig. 13 element 1320 provides a mere statement of functionality and does not define the first reactions or describe how such reactions are obtained.
Claim 55 “a means for obtaining the respective second reactions” Paragraph 0143 recites that the second reactions may be biometric parameters. Paragraph 0088 recites that a system of sensors may be used to monitor different physiological signals. Paragraph 0094 recites a number of different physiological parameters which may be monitored and recites that one or more sensors may be used to detect these parameters. Paragraph 0096 provides exemplary embodiments in which a video camera or accelerometer may be used to track body movements. The specification does not describe the structure and composition of the array of sensors which may be used to capture the second signals. In particular, the structures of paragraph 0096 of a camera and accelerometer are sufficient support for the means of capturing their respective second reaction signals but the scope of second reaction signals is not limited to only those captured from the camera and accelerometer. The specification does not describe the particular structure or array of sensors that may be used as the means for capturing the full scope of the second reactions.
0094 0096
Claim 60 “a step for obtaining first reactions of the recipient of the hearing prosthesis” is interpreted in the same manner as the similar limitation of claim 52 described above.
Claim 61 recites “a step for obtaining the second reactions” Paragraph 0143 describes this step as obtaining biometric parameters. Paragraphs 0094 and 0096 provide a list of biometric parameters which may be acquired by the system. The specification does not describe the particular method used to obtain each of the listed parameters. For example, the specification does not describe the particular algorithm used to determine eye parameters such as pupil dilation, or describe how saliva composition is determined. Paragraph 0134 does not define the second reaction signals and merely provides a statement of functionality that the input biometric signals are related to a subject’s cognitive load. Paragraph 0129 does not relate to obtaining the second reactions and mere states that the subject’s average cognitive load is monitored and used to adjust operation of the device. Paragraphs 0087 and 0089 further merely state that biometric signals are input to determine cognitive load. These paragraphs do not specifically define “second reactions” nor do they describe how each of the potential biometric signals listed in paragraphs 0094 and 0096 are obtained. Fig. 13 element 1330 provides a mere statement of functionality and does not define the second reactions or describe how such reactions are obtained.
Claim Rejections - 35 USC § 112(b)
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 40-42, 44-47, 51-52, 55, 60-62, and 63-65 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 40 and its dependents are rejected as claim 40 recites “obtaining respective fourth reactions of the recipient to the second series of sounds to which the recipient reacted for the obtained third reactions, the fourth reactions being different in kind than the third reactions” but it is unclear if the fourth reactions are obtained using the first map, the second map, or some other map. In particular, each of the first through third reaction signals are clearly associated with a first or second map but the fourth reaction signal is not directly affiliated with a map and thus it is unclear whether it is obtained using either map. For the purposes of this examination, this limitation will be interpreted as being affiliated with the second map. This rejection is further applied to the similar recitations of claims 41 and 64 and their dependents.
Claim 40 recites “comparing an ability of the recipient to hear based on the first reactions and the third reactions and comparing a cognitive load of the recipient based on the second reactions and the fourth reactions” but it is unclear how the “ability of the recipient to hear” and “cognitive load” of the subject are being compared when neither of these metrics have been calculated or otherwise determined. It is further unclear what each of these metrics is being compared to since the claim appears to indicate that each metrics is determined from both of the affiliated signals. The recitations indicates that the “ability of the recipient to hear” and “cognitive load” of the subject are compared “based on” the first and third and second and fourth signals respectively. The comparison of the “ability of the recipient to hear” and “cognitive load” is considered distinct from a comparison of the signals from which these metrics are “based on”. No recitation of determining these metrics has been established and thus it is unclear how they are compared and what they are being compared to. For the purposes of this examination, these limitations will be interpreted as a comparison between a first ability to hear determined using the first signals and a second ability to hear determined using the third signals and a comparison between a first cognitive load determined using the second signals and a second cognitive load determined using the fourth signals. This rejection is further applied to the similar recitations of claim 64.
Claim 42 recites “an ability of the recipient to hear” but it is unclear if this limitation is the same as, related to, or different from “an ability of the recipient to hear” of claim 40. For the purposes of this examination, the two limitations are interpreted as different hearing metrics. This rejection is similarly applied to claim 46.
Claim 42 recites “based on an ability of the recipient to hear using the first map, determining that the recipient can hear using the first map at least the same or better than the ability of the recipient to hear using the second map” but it is unclear how this determination takes place since the recipient’s ability to hear using the first and/or second map has not yet been determined. It is further unclear if this recitation is the same as, related to, a subset of, or different from “comparing an ability of the recipient to hear based on the first and third reactions” of claim 40. For the purposes of this examination, the limitation will be interpreted as requiring the recipient’s ability to hear using the second map to also be determined. This rejection is further applied to the similar limitations of claim 44.
Claim 44 recites “an ability of the recipient to hear using the first map” but it is unclear if this limitation is the same as, related to, a subset of, or different from “a first ability of the recipient to hear determined using the first reactions” of claim 41. For the purposes of this examination, the limitations will be interpreted as referring to the same hearing ability. This rejection is further applied to claim 51 which recites similar limitations for an ability to hear using the second map and also depends from claim 41.
Claim 46 recites “based on the determined ability of the recipient to hear using the second map, determining that the recipient can hear using the second map at least the same or better than the ability of the recipient to hear using the first map” but it is unclear how this determination takes place since the recipient’s ability to hear using the first map has not yet been determined. For the purposes of this examination, the limitation will be interpreted as requiring the recipient’s ability to hear using the first map to also be determined. This rejection is further applied to the similar limitations of claim 51.
Claim 52 the limitation “step for obtaining first reactions of a recipient of a hearing prosthesis”; Claim 55 the limitation “a means for obtaining the respective second reactions”; claim 60 the limitation “a step for obtaining first reactions of a recipient of a hearing prosthesis”; and claim 61 the limitation “a step for obtaining second reactions” each invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. In particular, the specification does not explicitly describe the method in which each of these signals are obtained or the particular structure for performing the obtaining as described in the above presented claim interpretation section. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For the purposes of this examination, these limitations will be interpreted in the same manner as the corresponding obtaining limitations of claim 1.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 61-62 are rejected by virtue of their dependence on claim 52.
Claim 63 recites “the ability of the recipient to hear based on the second reactions and fourth reactions” but it is unclear what ability to hear has been determined from the second and fourth reactions. Claim 40 from which claim 63 depends recites that the second and fourth reactions are compared with respect to the cognitive load rather than the ability to hear. For the purposes of this examination, the limitation will be interpreted as the determination that the subject can hear at least the same or better using the second map over the first map is interpreted as considering each of the first through fourth reactions.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 40-42, 44, 46, 51-52, 55, 60-61, and 63-65 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 claim(s) 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.
Claim 1 recites “obtaining respective second reactions of the recipient to the series of sounds, the second reactions being different in kind than the first reactions”, paragraph 0143 describes this step as obtaining biometric parameters. Paragraphs 0094 and 0096 provide a list of biometric parameters which may be acquired by the system. Thus it would seem that the specification does not support the full scope of any and all “second reactions” which are different from the first reactions. This rejection is further applied to claim 52. This rejection is similarly applied to obtainment of the fourth reaction of claims 40, 41, and 64.
Claim 1 recites “fitting the hearing prosthesis based at least in part on both the first reactions and the second reactions”, paragraph 0143 describes this step in purely functional language. Paragraph 0141 describes how biometric parameters are indicative of cognitive load but the biometric parameters themselves are not considered in the fitting process. Rather the cognitive load indicated by the biometric parameters is utilized to determine the settings of the implant. Paragraphs 0060-0063 describe that fitting may utilize the recipient’s cognitive auditory ability but this analysis does not appear to utilize “first” and “second” reactions. Paragraph 0072 describes how cognitive load may be utilized in establishing an appropriate map for the user but the cognitive load is distinct from the raw input signals or “second reactions”. The specification does not appear to explicitly describe the “fitting” process which occurs when using first and second reaction signals including the meets and bounds of each signal type and how they are combined, processed, or otherwise considered to carry out the fitting process. This rejection is further applied to the similar limitations in claim 52.
Claim 4 recites “rating the recipient's ability to hear based on the obtained respective first reactions”, paragraphs 0144-0145 recite this step in purely functional language but do not describe how the “rating” is performed. Paragraph 0144 states that “any rating method can be used” but such a statement is considered insufficient to provide support for the claimed any and all possible methods of rating the subject’s ability to hear based on the first reactions. In particular, the specification does not appear to provide any thresholds, comparisons, or other metrics by which rating can take place. The exemplary ratings provided in paragraph 0145 do not describe how they are obtained from the input signals.
Claim 4 recites “rating a cognitive load of the recipient based on the obtained respective second reactions”, paragraphs 0144-0145 recite this step in purely functional language but do not describe how the “rating” is performed. Paragraph 0144 states that “any rating method can be used” but such a statement is considered insufficient to provide support for the claimed any and all possible methods of rating the subject’s cognitive load based on the second reactions. In particular, the specification does not appear to provide any thresholds, comparisons, or other metrics by which rating can take place. The exemplary ratings provided in paragraph 0145 do not describe how they are obtained from the input signals. Further, the recitations of paragraphs 0094-0095 that the variety of input parameters can be compared to a baseline to determine cognitive load is not considered sufficient to support the determination and/or rating of cognitive load because no particular method or metrics of the comparisons are provided and thus the statement that the received inputs are compared to a baseline is considered a mere statement of functionality. Furthermore, the articles incorporated by reference in paragraph 0093 do not describe how cognitive load may be determined for each of the parameters listed in paragraph 0094. It is further noted that the determination of cognitive load is considered essential subject matter for the claimed invention and thus if the disclosure as to how the cognitive load is determined for the variety of input types is to be incorporated by reference then it must be incorporated by reference to a U.S. patent or U.S. patent application publication as required by R – 1.57(d) which recites “(d) "Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. "Essential material" is material that is necessary to: (1) Provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a); (2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or (3) Describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f)”
Claim 4 recites “determining whether the rating of the recipient's ability to hear is acceptable relative to the rating of the cognitive load,” paragraph 0145 provides examples of possible ratings of both hearing ability and cognitive load and further recites for each example how the relationship between the two may be “utilitarian” or not. The specification does not describe any particular method or rationale to make the comparisons between the ratings. The examples provided do not fully support the claimed determination of acceptability because there are no specified relationships, ratios, or other comparisons to determine what ratings are “acceptable” when compared to the other ratings.
Claim 40 recites “comparing an ability of the recipient to hear based on the first reactions and the third reactions” but the specification does not provide a particular method of determining or rating the subject’s ability to hear. Paragraphs 0143-0146 provide a mere statement of functionality that the first and third reactions can be used to rate the subject’s ability to hear but do not describe how the input signals are processed to provide an “ability to hear”. While these paragraphs recite that the first and third reactions are “directly related to” the subject’s ability to hear, they do not describe how the input signals are converted into a “subject’s ability to hear” metric. The comparison of first and third signals is considered distinct from a comparison of “an ability to hear” based on those signals. This rejection is further applied to the similar recitation of comparing a subject’s ability to hear of claim 64.
Claim 40 recites “comparing a cognitive load of the recipient based on the second reactions and the fourth reactions” but the specification does not provide a particular method of determining or comparing a cognitive load between any two “reaction” signals. The comparison of second and fourth signals is considered distinct from a comparison of “a cognitive load” based on those signals. In particular, paragraph 0141 and Figs. 11 and 12 describe comparing biometric signals during a fitting session. Paragraph 0141 describes Fig. 11 as “calm” and that it is used as a reference to compare against another response illustrated in Fig. 12 which is described as “erratic”. Paragraph 0141 then states that the erratic response of Fig. 12 indicates that the cognitive load is “not stable, and likely higher”. The specification does not explicitly recite how the signals are compared. The specification indicates one signal as calm and the other as erratic but does not describe any metric by which these decisions are made. The specification does not explicitly describe how each of the various possible input signals can be compared to one another and what metrics, threshold, or other parameters are used in the comparison to determine a relative cognitive load between the two reaction signals. Paragraph 0146 further provides a mere statement of functionality and does not describe how the comparison takes place. Paragraphs 0097-0098 provide a mere statement of functionality and do not detail how a cognitive load comparison is carried out. Further, the recitations of paragraphs 0094-0095 that the variety of input parameters can be compared to a baseline to determine cognitive load is not considered sufficient to support the determination and/or comparison of cognitive load because no particular method or metrics of the comparisons are provided and thus the statement that the received inputs are compared to a baseline is considered a mere statement of functionality. Furthermore, the articles incorporated by reference in paragraph 0093 do not describe how cognitive load may be determined for each of the parameters listed in paragraph 0094. It is further noted that the determination of cognitive load is considered essential subject matter for the claimed invention and thus if the disclosure as to how the cognitive load is determined for the variety of input types is to be incorporated by reference then it must be incorporated by reference to a U.S. patent or U.S. patent application publication as required by R – 1.57(d). This rejection is further applied to the similar recitation of comparing a cognitive load of claim 64.
Claim 41 recites “a first ability of the recipient to hear determined using the first reactions to a second ability of the recipient to hear determined using the third reactions” but the specification does not provide a particular method of determining or rating the subject’s ability to hear. Paragraphs 0143-0146 provide a mere statement of functionality that the first and third reactions can be used to rate the subject’s ability to hear but do not describe how the input signals are processed to provide an “ability to hear”. While these paragraphs recite that the first and third reactions are “directly related to” the subject’s ability to hear, they do not describe how the input signals are converted into a “ability to hear” metric. This rejection is further applied to the recitations of determining respective abilities of the recipient to hear from the first and third reactions of claim 65.
Claim 41 recites “a first cognitive load of the recipient determined using the second reactions to a second cognitive load of the recipient determined using the fourth reactions” but the specification does not provide a particular method of determining a cognitive load using any “reaction” signal. In particular, paragraph 0141 and Figs. 11 and 12 describe comparing biometric signals during a fitting session. Paragraph 0141 describes Fig. 11 as “calm” and that it is used as a reference to compare against another response illustrated in Fig. 12 which is described as “erratic”. Paragraph 0141 then states that the erratic response of Fig. 12 indicates that the cognitive load is “not stable, and likely higher”. The specification does not explicitly recite how the signals are processed to determine the cognitive load. The specification indicates one signal as calm and the other as erratic but does not describe any metric by which these decisions are made. The specification does not explicitly describe how each of the various possible input signals can be processed to determine a cognitive load. Paragraphs 0097-0098 provide a mere statement of functionality and do not detail how a cognitive load determination is carried out. Further, the recitations of paragraphs 0094-0095 that the variety of input parameters can be compared to a baseline to determine cognitive load is not considered sufficient to support the determination of cognitive load because no particular method or metrics of the determination are provided and thus the statement that the received inputs are compared to a baseline is considered a mere statement of functionality. Furthermore, the articles incorporated by reference in paragraph 0093 do not describe how cognitive load may be determined for each of the parameters listed in paragraph 0094. It is further noted that the determination of cognitive load is considered essential subject matter for the claimed invention and thus if the disclosure as to how the cognitive load is determined for the variety of input types is to be incorporated by reference then it must be incorporated by reference to a U.S. patent or U.S. patent application publication as required by R – 1.57(d). This rejection is further applied to the recitations of determining respective cognitive loads from the second and fourth reactions of claim 65.
Claim 42 recites “based on an ability of the recipient to hear using the first map” which implicitly requires that said ability to hear using the first map is determined or calculated in some manner. Paragraphs 0147-0148 recite this step in purely functional language but do not describe how the “determining” is performed. These paragraphs do not describe what input signals are used to make such a determination. The specification does not appear to describe the particular processed used in determining the ability of the recipient to hear including the particular inputs, processing steps, and the output.
Claim 44 recites “determining an ability of the recipient to hear using the first map”, paragraphs 0147-0148 recite this step in purely functional language but do not describe how the “determining” is performed. These paragraphs do not describe what input signals are used to make such a determination. The specification does not appear to describe the particular process used in determining the ability of the recipient to hear including the particular inputs, processing steps, and the output. This rejection is further applied to the determination of an ability to hear steps of claims 46, and 51.
Claim 52 the limitation “step for obtaining first reactions of a recipient of a hearing prosthesis”; Claim 55 the limitation “a means for obtaining the respective second reactions”; claim 60 the limitation “a step for obtaining first reactions of a recipient of a hearing prosthesis”; and claim 61 the limitation “a step for obtaining second reactions” each invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. In particular, the specification does not explicitly describe the method in which each of these signals are obtained or the particular structure for performing the obtaining as described in the above presented claim interpretation section. Therefore, the claim lacks sufficient written description and is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
Claim 59 recites “obtaining third reactions of a recipient to the series of sounds, the third reactions being indicative of the recipient being under stress” but the specification does not appear to describe what “third reactions” which are “indicative of the recipient being under stress” may entail. Paragraphs 0141-0142 and 0152 discuss how stress may be applied during a fitting session to find parameters that reduce cognitive load in a stressful environment but does not details what parameters may indicate this stress. Paragraph 0146 recites the limitation of obtaining a third reaction indicative of the user under stress but further recites that the third reactions are directly related to the recipient’s ability to hear the series of sounds. The present third reactions are not limited to the subject’s ability to hear and may seemingly be any reaction to sounds while stressed. Thus it would seem that the specification does not support the full scope of any and all “third reactions” which are indicative of the recipient being under stress
Claim 63 recites “the ability of the recipient to hear based on the first reactions and third reactions as compared to the ability of the recipient to hear based on the second reactions and fourth reactions” but the specification does not provide a particular method of determining or rating the subject’s ability to hear. Paragraphs 0143-0146 provide a mere statement of functionality that the first and third reactions can be used to rate the subject’s ability to hear but do not describe how the input signals are processed to provide an “ability to hear”. While these paragraphs recite that the first and third reactions are “directly related to” the subject’s ability to hear, they do not describe how the input signals are converted into a “subject’s ability to hear” metric. The comparison of first and third signals is considered distinct from a comparison of “an ability to hear” based on those signals. Additionally, the specification does not recite that the second and fourth reactions may be used to determine an ability to hear. Rather these reactions are related to the cognitive load of the subject as described in paragraphs 0093-0095, 0097-0098, 0141, and 0146. The specification does not describe how the second and/or fourth reactions relate to the subject’s ability to hear or how such an ability to hear metric may be determined from these reactions.
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 52 and 61-62 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 52 and 61-62 are directed to a method of processing sound signals using a computational algorithm, which is an abstract idea. Claims 52 and 61-62 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 52 is as follows:
Step 1: Claim 52 is drawn to a process
Step 2A — Prong One: Claim 52 recites an abstract idea. In particular, claim 52 recites the following limitations:
[A1] step for obtaining respective first reactions of a recipient of a hearing prosthesis;
[B1] obtaining respective second reactions of the recipient of the hearing prosthesis
These elements [A1]-[B1] of claim 52 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A — Prong Two: Claim 52 recites the following limitations that are beyond the judicial exception:
[A2] a hearing prosthesis
[B2] fitting a hearing prosthesis based at least in part on both the first reactions and the second reactions.
The element [A2] of claim 52 does not integrate the exception into a practical application of the exception. In particular, the element [A2] merely generally links the use of the judicial exception to a particular technological environment or field of use— see MPEP 2106.05(h). Furthermore, the element [B2] merely adds the words “apply it” (or an equivalent) with the judicial exception.
Examiner’s Note: The element [B2] does not qualify as significantly more than the abstract idea because what “fitting” the hearing prosthesis entails is not particularly limited and thus may be considered as simply adjusting how the prosthesis fits within the ear. It would seem that if such a “fitting” process were to be limited to making specific operational changes to the hearing prosthesis, such as changing stimulation rate, compression ratio, etc., then the limitation may qualify as significantly more than the abstract idea.
Step 2B: Claim 52 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations “obtaining respective first/second reactions of a recipient of a hearing prosthesis” does not qualify as significantly more because this limitation merely further defines the recipient and does not incorporate the hearing prosthesis as part of the claimed invention. Also, in another interpretation, if the recitations “obtaining respective first/second reactions of a recipient of a hearing prosthesis” did positively recite the hearing prosthesis then it is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the hearing prosthesis is nothing more than a generic hearing aid. Such hearing aids are conventional as evidenced by:
U.S. Patent Application Publication No. US 2018/0125415 A1 (Reed) discloses that hearing aids are conventional (paragraph 0065 of Reed);
U.S. Patent Application Publication No. US 2016/0100796 A1 (Lineaweaver) discloses that hearing aids are conventional (paragraph 0004 of Lineaweaver);
U.S. Patent No. US 5842967 A (Krull) discloses that hearing aids are conventional (Col 3 Lines 34-47 of Krull); and
U.S. Patent Application Publication No. US 2013/0116746 A1 (Polak) discloses that hearing aids are conventional (paragraph 0004 of Polak).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 61-62 depend from claim 52, and recite the same abstract idea as claim 52. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm). In particular, claims 61 and 62 only serve to further limit the abstract idea and describe the nature of the collected data.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above -judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-2, 4-5, 10, 37, 39, 40, 42, 46-50, and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Boretzki US Patent Application Publication Number US 2013/0121496 A1 hereinafter Boretzki in view of Smith US Patent Application Publication Number US 2014/0052217 A1 hereinafter Smith
Regarding claim 1 Boretzki discloses a method (Abstract), comprising:
obtaining respective second reactions of the recipient to the series of sounds, the second reactions being different in kind than the first reactions (Paragraph 0088: the presented test signals may include speech-containing sounds; Paragraph 0096: it is preferable to sequentially present several test signals to the user so that settings for several parameters may be found; Paragraphs 0097-0102: the system captures images of the user in response to the test sounds); and
Boretzki further suggests the limitations of: obtaining respective first reactions of a recipient to a series of sounds subjected to the recipient of a hearing device, the first reactions being directly related to the recipient's ability to hear the series of sounds, and adjusting a setting of the hearing device based at least in part on both the first reactions and the second reactions. These recitations are at least suggested in paragraph 0108 where Boretzki discloses that the system may be used as a supporting and complimenting constituent in hearing device fitting. Boretzki provides examples that show the system may be used in conjunction with manually entered data and/or conventional dialog based fitting by comparing the results of the computer vision algorithm to the input results of the manually entered data and/or conventional dialog-based fitting. Thus the manual input by an audiologist and/or the patient’s response to a particular signal acquired through conventional dialog-based fitting is considered to at least suggest the limitation of obtaining first reaction signals and the comparison between the manual and/or conventional fitting modality to the computer-vision results to fit the device are considered to at least suggest fitting the hearing device based at least in part on both the first and second reactions.
Smith teaches a method includes sending a signal to a first hearing prosthesis and a second hearing prosthesis. The signal causes the first hearing prosthesis to deliver a first stimulus to a body part in a left auditory pathway of a user. The signal also causes the second hearing prosthesis to deliver a second stimulus to a body part in a right auditory pathway of the user. The first stimulus and the second stimulus cause the user to perceive a sound and are delivered simultaneously. The method also includes receiving an indication of a perception of the sound by the user. The method further includes determining an adjustment to at least one of the first stimulus or the second stimulus based on the perception of the sound by the user (Abstract). Thus, Smith falls within the same field of endeavor as the Applicant’s invention.
Smith teaches a fitting method where the test signals are applied to a user and feedback is received in order to determine a comfort and threshold level used to fit the hearing prosthesis (Paragraphs 0030-0031). The user input may be received through a variety of input mechanisms and the input signals allow the user or an audiologist to adjust the stimulus currents applied to each electrode of the hearing prosthesis (Paragraphs 0051-0052). The user may provide input for when they can barely hear a tone to determine a T-level or threshold hearing level (Paragraphs 0069-0070). The user may further provide input to determine when the stimulus becomes too load to determine a C-level or comfort level (Paragraphs 0077-0079). The determined C-level and T-level set the stimulation bounds, or dynamic range, of the map and the user can then request to “fine-tune” their mapping curves to more closely match the user’s ability to perceive sound at one or more frequencies (Paragraphs 0028-0029 and 0080-0081; Figs. 5A and 7A-C).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the dynamic range fitting method of Smith into the method Boretzki as the hearing device fitting method to which the method of Boretzki is used as a “supporting and complimenting constituent” because Boretzki explicitly contemplates using the fitting method described therein in conjunction with another fitting method (Boretzki: Paragraph 0108) and utilizing the method of Smith to establish a dynamic range of the user while carrying out the particular mapping method of Boretzki may reduce the time required to complete the mapping and reduce patient discomfort by establishing minimum and maximum amplitudes between which mapping needs to occur. This effectively provides the mapping method of Boretzki in view of Smith with a method to establishing a range of stimuli to more thoroughly test and map for “fine tuning” while quickly eliminating the need to test stimuli outside of the dynamic range once it has been established. This allows the method to produce a device with particularly good fitting results by minimizing cognitive stress and discomfort (Boretzki: Paragraphs 0104-0107) and may reduce the time required to produce such a result by establishing a dynamic range as taught by Smith (Smith: Paragraphs 0028-0030 and 0080-0081; Figs. 5A and 7A-C). Boretzki further teaches that the method is well suited for fine-tuning the parameters of a worn hearing prosthesis (Boretzki: Paragraph 0098)
Regarding claim 2 Boretzki in view of Smith teaches the method of claim 1. Modified Boretzki further teaches the method wherein: the second reactions are reactions indicative of a cognitive load of the recipient (Paragraph 0048-0052: estimating cognitive stress from the recorded reaction. Cognitive stress can originate from trying to understand hard-to-understand speech in noise).
Regarding claim 4 Boretzki in view of Smith teaches the method of claim 1. Modified Boretzki further teaches the method comprising:;
rating a cognitive load of the recipient based on the obtained respective second reactions (Paragraphs 0101-0102: determining the users cognitive stress in response to a test sound) and;
wherein the hearing device is a hearing prosthesis and the adjusting of the setting is part of an action of fitting the hearing prosthesis (Paragraphs 0103-0108: the hearing devices and the invention being used to fit the hearing devices)
Boretzki further suggests the method comprising: rating the recipient's ability to hear based on the obtained respective first reactions determining whether the rating of the recipient's ability to hear is acceptable relative to the rating of the cognitive load; wherein fitting the hearing prosthesis is based at least in part on the determination. These limitations are at least suggested in paragraphs 0103-0108 where Boretzki discloses that the method may be used to support and compliment another fitting method and wherein Boretzki teaches that the device operational parameters are optimized until better settings to reduce mental stress and/or discomfort cannot be found.
Smith teaches a fitting method where the test signals are applied to a user and feedback is received in order to determine a comfort and threshold level used to fit the hearing prosthesis (Paragraphs 0030-0031). The user input may be received through a variety of input mechanisms and the input signals allow the user or an audiologist to adjust the stimulus currents applied to each electrode of the hearing prosthesis (Paragraphs 0051-0052). The user may provide input for when they can barely hear a tone to determine a T-level or threshold hearing level (Paragraphs 0069-0070). The user may further provide input to determine when the stimulus becomes too load to determine a C-level or comfort level (Paragraphs 0077-0079). The determined C-level and T-level set the stimulation bounds, or dynamic range, of the map and the user can then request to “fine-tune” their mapping curves to more closely match the user’s ability to perceive sound at one or more frequencies (Paragraphs 0028-0029 and 0080-0081; Figs. 5A and 7A-C).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the dynamic range fitting method of Smith into the method Boretzki as the hearing device fitting method to which the method of Boretzki is used as a “supporting and complimenting constituent” because Boretzki explicitly contemplates using the fitting method described therein in conjunction with another fitting method (Boretzki: Paragraph 0108) and first establishing the dynamic range of the user prior to carrying out the particular mapping method of Boretzki may reduce the time required to complete the mapping and reduce patient discomfort by establishing minimum and maximum amplitudes between which mapping needs to occur. Such a combination teaches or at least suggests:
rating the recipient's ability to hear based on the obtained respective first reactions (Smith Paragraphs 0028-0030 and 0080-0081; Figs. 5A and 7A-C: establishing the dynamic range of the user’s ability to hear);
rating a cognitive load of the recipient based on the obtained respective second reactions (Boretzki: Paragraphs 0101-0102: determining the users cognitive stress in response to a test sound)
determining whether the rating of the recipient's ability to hear is acceptable relative to the rating of the cognitive load; wherein the hearing device is a hearing prosthesis and adjusting the setting is part of an action of fitting the hearing prosthesis is based at least in part on the determination (Boretzki: Paragraphs 0103-0108: the hearing device’s operational parameters are optimized, within the determined dynamic range of Smith, until better settings to reduce mental stress and/or discomfort cannot be found. Thus any parameter settings and their associated cognitive load of Boretzki that falls within the dynamic range of smith may be considered “acceptable” and are used by Boretzki in view of Smith to continue fitting/optimizing the hearing prosthesis parameters)
Regarding claims 10 and 37 Boretzki in view of Smith teaches the method of claim 1. Modified Boretzki further suggests the method wherein: background noise is not purposely applied in the series of sounds (Paragraphs 0048-0052, 0094, 0101, and 0104, at least suggest that the test signals applied include both test signals with and without background noise. In particular, paragraphs 0048-0052 and 0094 explicitly mention that one source of stress may be induced by embedding the test signals of speech in a lot of noise. These recitations at least suggest presenting signals with background noise. Paragraphs 0101 and 0104 describe how the system begins testing with non-challenging sounds that are not expected to produce high mental stress. The system then gradually increases the difficulty of the test signals as parameter optimization occurs. These recitations in combination with the recitations of paragraphs 0048-0052 and 0092 at least suggest that the testing begins with signals where no noise is applied, not-challenging with respect to mental stress, and then add background noise as the testing signals to induce more mental stress and select parameters accordingly.)
Regarding claim 39 Boretzki in view of Smith teaches the method of claim 1. Modified Boretzki further teaches the method, wherein: the device is a hearing prosthesis and adjusting the setting of the device is part of an action of fitting the hearing prosthesis (Paragraphs 0103-0108: the hearing devices and the invention being used to fit the hearing devices); and the fitting of the hearing prosthesis overcomes at least in part a hearing abnormally of the recipient (Paragraphs 0002 and 0088: hearing devices improve the individual’s audiological perception; the method serves to fit the hearing device to best suit the individual)
Regarding claim 40 Boretzki in view of Smith teaches the method of claim 1. Modified Boretzki further teaches the method wherein:
the device is a hearing prosthesis and adjusting the setting of the device is part of an action of fitting the hearing prosthesis (Paragraphs 0103-0108: the hearing devices and the invention being used to fit the hearing devices)
the obtained respective first reactions and the obtained respective second reactions are obtained with the hearing prosthesis utilizing a first map (Paragraphs 0100-0105: the “first map” is considered the device settings during the initial presentation of test sounds where the first and second reactions are obtained as taught by Boretzki in view of Smith described in claim 1 above); and
the method further comprises:
obtaining respective fourth reactions of the recipient to the series of sounds/ the second series of sounds, the fourth reactions being different in kind than the third reactions (Paragraphs 0100-0105: the stimulus presentation may be repeated until the facial parameters indicate cognitive stress and/or discomfort disappear, the method may move to a different stimulus of higher estimated difficulty and repeat the process );
comparing a cognitive load of the recipient based on the second reactions and the fourth reactions (Paragraphs 0100-0105: the testing an adjustment of parameters continue until no further adjustments can be made to improve the mental stress dimension or discomfort dimension. A comparison between each test is implicitly disclosed since the best settings may only be found when compared to other iterations of settings)
fitting the hearing prosthesis using the first map based on a determination that the first map requires a lower cognitive load than the second map (Paragraphs 0101-0105: the procedure is finished when no further optimizations can be made to reduce cognitive stress. Thus the map with the lowest cognitive load, or mental stress, is selected)
Boretzki further suggests the method including: obtaining respective third reactions of the recipient to a series of sounds/ a second series of sounds subjected to the recipient of the hearing prosthesis with the hearing prosthesis utilizing a second map, the third reactions being directly related to the recipient's ability to hear the series of sounds; and comparing an ability of the recipient to hear based on the first reactions and third reactions. These limitations are at least suggested in paragraphs 0103-0108 where Boretzki discloses that the method may be used to support and compliment another fitting method and wherein Boretzki teaches that the device operational parameters are optimized until better settings to reduce mental stress and/or discomfort cannot be found.
Smith teaches a fitting method where the test signals are applied to a user and feedback is received in order to determine a comfort and threshold level used to fit the hearing prosthesis (Paragraphs 0030-0031). The user input may be received through a variety of input mechanisms and the input signals allow the user or an audiologist to adjust the stimulus currents applied to each electrode of the hearing prosthesis (Paragraphs 0051-0052). The user may provide input for when they can barely hear a tone to determine a T-level or threshold hearing level (Paragraphs 0069-0070). The user may further provide input to determine when the stimulus becomes too loud to determine a C-level or comfort level (Paragraphs 0077-0079). The determined C-level and T-level set the stimulation bounds, or dynamic range, of the map and the user can then request to “fine-tune” their mapping curves to more closely match the user’s ability to perceive sound at one or more frequencies (Paragraphs 0028-0029 and 0080-0081; Figs. 5A and 7A-C).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the dynamic range fitting method of Smith into the method Boretzki as the hearing device fitting method to which the method of Boretzki is used as a “supporting and complimenting constituent” because Boretzki explicitly contemplates using the fitting method described therein in conjunction with another fitting method (Boretzki: Paragraph 0108) and because incorporating the user input from Smith would allow the system to compare the user’s hearing ability between different stimuli and the same stimuli when using different device settings. Such a comparison may result in the identification of settings that increase and/or decrease the T-level and C-level of the patient which may help optimize the device settings.
Regarding claim 42 Boretzki in view of Smith teaches the method of claim 40. Modified Boretzki further teaches the method further comprising: based on an ability of the recipient to hear using the first map, determining that the recipient can hear using the first map at least the same or better than the ability of the recipient to hear using the second map (Paragraphs 0101-0105: the settings, or map, with the lowest mental stress and discomfort/unpleasantness is selected; the subjects mental stress and unpleasantness in combination are considered to be “an ability to hear” and are determined for each stimuli and each parameter settings, or map).
Regarding claim 46 Boretzki in view of Smith teaches the method of claim 40. Modified Boretzki further teaches the method further comprising: determining an ability of the recipient to hear using the second map (Paragraphs 0101-0104: the subjects mental stress and unpleasantness in combination are considered to be “an ability to hear” and are determined for each stimuli and each parameter settings, or map); and based on the determined ability of the recipient to hear using the second map, determining that the recipient can hear using the second map at least the same or better than the ability of the recipient to hear using the first map (Paragraphs 0101-0105: the settings, or map, with the lowest mental stress and discomfort/unpleasantness is selected.)
Regarding claim 50 Boretzki in view of Smith teaches the method of claim 1. Modified Boretzki further teaches the method, wherein: the device is a hearing prosthesis and adjusting the setting of the device is part of an action of fitting the hearing prosthesis (Paragraphs 0103-0108: the hearing devices and the invention being used to fit the hearing devices); and the fitting of the hearing prosthesis is executed automatically (Paragraphs 0025, 0030-0034, 0047, 0053, and 0057-0058: the steps of the method and overall method itself may be carried out in an automated fashion),
Regarding claim 53 Boretzki in view of Smith teaches the method of claim 50. Modified Boretzki further teaches the method, wherein: the second reactions are reactions indicative of a cognitive load of the recipient (Paragraph 0048-0052: estimating cognitive stress from the recorded reaction. Cognitive stress can originate from trying to understand hard-to-understand speech in noise).
Regarding claim 54 Boretzki in view of Smith teaches the method of claim 1. Modified Boretzki further teaches the method, wherein: the device is a hearing prosthesis and adjusting the setting of the device is part of an action of fitting the hearing prosthesis (Paragraphs 0103-0108: the hearing devices and the invention being used to fit the hearing devices).
Boretzki further suggests the limitations of: the hearing prosthesis is fitted based at least in part on both the first reactions and the second reactions. This recitations are at least suggested in paragraph 0108 where Boretzki discloses that the system may be used as a supporting and complimenting constituent in hearing device fitting. Boretzki provides examples that show the system may be used in conjunction with manually entered data and/or conventional dialog based fitting by comparing the results of the computer vision algorithm to the input results of the manually entered data and/or conventional dialog-based fitting. Thus the manual input by an audiologist and/or the patient’s response to a particular signal acquired through conventional dialog-based fitting is considered to at least suggest the limitation of obtaining first reaction signals and the comparison between the manual and/or conventional fitting modality to the computer-vision results to fit the device are considered to at least suggest fitting the hearing device based at least in part on both the first and second reactions.
Smith teaches a fitting method where the test signals are applied to a user with cochlear implants and feedback is received in order to determine a comfort and threshold level used to fit the hearing prosthesis (Paragraphs 0030-0031). The user input may be received through a variety of input mechanisms and the input signals allow the user or an audiologist to adjust the stimulus currents applied to each electrode of the hearing prosthesis (Paragraphs 0051-0052). The user may provide input for when they can barely hear a tone to determine a T-level or threshold hearing level (Paragraphs 0069-0070). The user may further provide input to determine when the stimulus becomes too load to determine a C-level or comfort level (Paragraphs 0077-0079). The determined C-level and T-level set the stimulation bounds, or dynamic range, of the map and the user can then request to “fine-tune” their mapping curves to more closely match the user’s ability to perceive sound at one or more frequencies (Paragraphs 0028-0029 and 0080-0081; Figs. 5A and 7A-C).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the dynamic range fitting method of Smith into the method modified Boretzki as the hearing device fitting method to which the method of Boretzki is used as a “supporting and complimenting constituent” because Boretzki explicitly contemplates using the fitting method described therein in conjunction with another fitting method (Boretzki: Paragraph 0108) and utilizing the method of Smith to establish a dynamic range of the user while carrying out the particular mapping method of Boretzki may reduce the time required to complete the mapping and reduce patient discomfort by establishing minimum and maximum amplitudes between which mapping needs to occur. Thus the fitting is performed using both the first and second reaction signals.
Regarding claim 55 Boretzki in view of Smith teaches the method of claim 1. Modified Boretzki further teaches the method wherein: the action of obtaining respective second reactions is executed with a means for obtaining the respective second reactions (Paragraphs 0089-0092: the second reactions may be obtained from image analysis from images taken from an imaging unit; Paragraph 0100: the imaging unit may be a camera).
Regarding claim 56 Boretzki in view of Smith teaches the method of claim 54. Modified Boretzki further suggests the method, wherein: the method includes subjecting the recipient to the series of sounds by way of direct electrical or electromagnetic signals to the hearing prosthesis (Paragraph 0027: the auditory test signal is a signal for auditory perception. The signal may be delivered through sound waves or through electrical stimulation for hearing devices such as cochlear implants).
Smith teaches a fitting method where the test signals are applied to a user of a cochlear implant device and feedback is received in order to determine a comfort and threshold level used to fit the hearing prosthesis. The test signals are applied via electrical stimulation at each of the electrode sites on the implant (Paragraphs 0030-0031 and 0047).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of modified Boretzki to operate using a cochlear implant device which delivers stimuli via electrical or electromagnetic stimulation because Boretzki explicitly contemplates the method for use with a cochlear implant delivering electrical stimulation (Boretzki: Paragraph 0027).
Regarding claim 59 Boretzki in view of Smith teaches the method of claim 2. Modified Boretzki further teaches the method further comprising: obtaining third reactions of the recipient to the series of sounds, the third reactions being indicative of the recipient being under stress. (Paragraphs 0048-0052 and 0094: one source of stress may be induced by embedding the test signals of speech in a lot of noise. Thus the signals collected when noise is applied are indicative of the recipient being under stress. Paragraphs 0101 and 0104 describe how the system begins testing with non-challenging sounds that are not expected to produce high mental stress. The system then gradually increases the difficulty of the test signals as parameter optimization occurs.)
Regarding claim 60 Boretzki in view of Smith teaches the method of claim 54. Modified Boretzki further suggests the method wherein: the action of obtaining respective first reactions is a step for obtaining first reactions of the recipient of the hearing prosthesis. This recitation is at least suggested in paragraph 0108 where Boretzki discloses that the system may be used as a supporting and complimenting constituent in hearing device fitting. Boretzki provides examples that show the system may be used in conjunction with manually entered data and/or conventional dialog based fitting by comparing the results of the computer vision algorithm to the input results of the manually entered data and/or conventional dialog-based fitting. Thus the manual input by an audiologist and/or the patient’s response to a particular signal acquired through conventional dialog-based fitting is considered to at least suggest the limitation of obtaining first reaction signals
Smith teaches a fitting method where the test signals are applied to a user and feedback is received in order to determine a comfort and threshold level used to fit the hearing prosthesis (Paragraphs 0030-0031). The user input may be received through a variety of input mechanisms and the input signals allow the user or an audiologist to adjust the stimulus currents applied to each electrode of the hearing prosthesis (Paragraphs 0051-0052). The user may provide input for when they can barely hear a tone to determine a T-level or threshold hearing level (Paragraphs 0069-0070). The user may further provide input to determine when the stimulus becomes too load to determine a C-level or comfort level (Paragraphs 0077-0079). The determined C-level and T-level set the stimulation bounds, or dynamic range, of the map and the user can then request to “fine-tune” their mapping curves to more closely match the user’s ability to perceive sound at one or more frequencies (Paragraphs 0028-0029 and 0080-0081; Figs. 5A and 7A-C).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the dynamic range fitting method of Smith into the method of modified Boretzki as the hearing device fitting method to which the method of Boretzki is used as a “supporting and complimenting constituent” because Boretzki explicitly contemplates using the fitting method described therein in conjunction with another fitting method (Boretzki: Paragraph 0108) and utilizing the method of Smith to establish a dynamic range of the user while carrying out the particular mapping method of Boretzki may reduce the time required to complete the mapping and reduce patient discomfort by establishing minimum and maximum amplitudes between which mapping needs to occur.
Regarding claim 63 Boretzki in view of Smith teaches the method of claim 2. Modified Boretzki further teaches the method further comprising: the ability of the recipient to hear based on the second reactions and fourth reactions, determining that the recipient can hear using the second map at least the same or better than the ability of the recipient to hear using the first map (Paragraphs 0100-0105: the testing an adjustment of parameters continue until no further adjustments can be made to improve the mental stress dimension or discomfort dimension. A comparison between each test is implicitly disclosed since the best settings may only be found when compared to other iterations of settings and the method selects the map with the lowest cognitive load ).
Modified Boretzki further suggests the determination being further based on a comparison with the ability of the recipient to hear based on the first reactions and third reactions. These limitations are at least suggested in paragraphs 0103-0108 where Boretzki discloses that the method may be used to support and compliment another fitting method and wherein Boretzki teaches that the device operational parameters are optimized until better settings to reduce mental stress and/or discomfort cannot be found.
Smith teaches a fitting method where the test signals are applied to a user and feedback is received in order to determine a comfort and threshold level used to fit the hearing prosthesis (Paragraphs 0030-0031). The user input may be received through a variety of input mechanisms and the input signals allow the user or an audiologist to adjust the stimulus currents applied to each electrode of the hearing prosthesis (Paragraphs 0051-0052). The user may provide input for when they can barely hear a tone to determine a T-level or threshold hearing level (Paragraphs 0069-0070). The user may further provide input to determine when the stimulus becomes too loud to determine a C-level or comfort level (Paragraphs 0077-0079). The determined C-level and T-level set the stimulation bounds, or dynamic range, of the map and the user can then request to “fine-tune” their mapping curves to more closely match the user’s ability to perceive sound at one or more frequencies (Paragraphs 0028-0029 and 0080-0081; Figs. 5A and 7A-C).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the dynamic range fitting method of Smith into the method Boretzki as the hearing device fitting method to which the method of Boretzki is used as a “supporting and complimenting constituent” because Boretzki explicitly contemplates using the fitting method described therein in conjunction with another fitting method (Boretzki: Paragraph 0108) and because incorporating the user input from Smith would allow the system to compare the user’s hearing ability between different stimuli and the same stimuli when using different device settings. Such a comparison may result in the identification of settings that increase and/or decrease the T-level and C-level of the patient which may help optimize the device settings and would allow the user to have direct input in the final selection of the operational parameters which may allow the user to generate a more personalized map that provides them a better experience than one generated without their input.
Regarding claim 52 Boretzki discloses a method (Abstract), comprising:
Step for obtaining first reactions of a recipient of a hearing prosthesis (Paragraph 0088: the presented test signals may include speech-containing sounds; Paragraph 0096: it is preferable to sequentially present several test signals to the user so that settings for several parameters may be found; Paragraphs 0097-0102: the system captures images of the user in response to the test sounds); and
Boretzki further suggests the limitations of: obtaining second reactions of the recipient of the hearing prosthesis, and fitting a hearing prosthesis based at least in part on both the first reactions and the second reactions. These recitations are at least suggested in paragraph 0108 where Boretzki discloses that the system may be used as a supporting and complimenting constituent in hearing device fitting. Boretzki provides examples that show the system may be used in conjunction with manually entered data and/or conventional dialog based fitting by comparing the results of the computer vision algorithm to the input results of the manually entered data and/or conventional dialog-based fitting. Thus the manual input by an audiologist and/or the patient’s response to a particular signal acquired through conventional dialog-based fitting is considered to at least suggest the limitation of obtaining first reaction signals and the comparison between the manual and/or conventional fitting modality to the computer-vision results to fit the device are considered to at least suggest fitting the hearing prosthesis based at least in part on both the first and second reactions.
Smith teaches a fitting method where the test signals are applied to a user and feedback is received in order to determine a comfort and threshold level used to fit the hearing prosthesis (Paragraphs 0030-0031). The user input may be received through a variety of input mechanisms and the input signals allow the user or an audiologist to adjust the stimulus currents applied to each electrode of the hearing prosthesis (Paragraphs 0051-0052). The user may provide input for when they can barely hear a tone to determine a T-level or threshold hearing level (Paragraphs 0069-0070). The user may further provide input to determine when the stimulus becomes too loud to determine a C-level or comfort level (Paragraphs 0077-0079). The determined C-level and T-level set the stimulation bounds, or dynamic range, of the map and the user can then request to “fine-tune” their mapping curves to more closely match the user’s ability to perceive sound at one or more frequencies (Paragraphs 0028-0029 and 0080-0081; Figs. 5A and 7A-C).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the dynamic range fitting method of Smith into the method Boretzki as the hearing device fitting method to which the method of Boretzki is used as a “supporting and complimenting constituent” because Boretzki explicitly contemplates using the fitting method described therein in conjunction with another fitting method (Boretzki: Paragraph 0108) and utilizing the method of Smith to establish a dynamic range of the user while carrying out the particular mapping method of Boretzki may reduce the time required to complete the mapping and reduce patient discomfort by establishing minimum and maximum amplitudes between which mapping needs to occur. This effectively provides the mapping method of Boretzki in view of Smith with a method to establishing a range of stimuli to more thoroughly test and map for “fine tuning” while quickly eliminating the need to test stimuli outside of the dynamic range once it has been established. This allows the method to produce a device with particularly good fitting results by minimizing cognitive stress and discomfort (Boretzki: Paragraphs 0104-0107) and may reduce the time required to produce such a result by establishing a dynamic range as taught by Smith (Smith: Paragraphs 0028-0030 and 0080-0081; Figs. 5A and 7A-C). Boretzki further teaches that the method is well suited for fine-tuning the parameters of a worn hearing prosthesis (Boretzki: Paragraph 0098)
Regarding claim 61 Boretzki in view of Smith teaches the method of claim 52. Modified Boretzki further suggests the method, wherein: the action of obtaining second reactions is a step for obtaining the second reactions. This recitation is at least suggested in paragraph 0108 where Boretzki discloses that the system may be used as a supporting and complimenting constituent in hearing device fitting. Boretzki provides examples that show the system may be used in conjunction with manually entered data and/or conventional dialog based fitting by comparing the results of the computer vision algorithm to the input results of the manually entered data and/or conventional dialog-based fitting. Thus the manual input by an audiologist and/or the patient’s response to a particular signal acquired through conventional dialog-based fitting is considered to at least suggest the limitation of obtaining second reaction signals
Smith teaches a fitting method where the test signals are applied to a user and feedback is received in order to determine a comfort and threshold level used to fit the hearing prosthesis (Paragraphs 0030-0031). The user input may be received through a variety of input mechanisms and the input signals allow the user or an audiologist to adjust the stimulus currents applied to each electrode of the hearing prosthesis (Paragraphs 0051-0052). The user may provide input for when they can barely hear a tone to determine a T-level or threshold hearing level (Paragraphs 0069-0070). The user may further provide input to determine when the stimulus becomes too load to determine a C-level or comfort level (Paragraphs 0077-0079). The determined C-level and T-level set the stimulation bounds, or dynamic range, of the map and the user can then request to “fine-tune” their mapping curves to more closely match the user’s ability to perceive sound at one or more frequencies (Paragraphs 0028-0029 and 0080-0081; Figs. 5A and 7A-C).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the dynamic range fitting method of Smith into the method of modified Boretzki as the hearing device fitting method to which the method of Boretzki is used as a “supporting and complimenting constituent” because Boretzki explicitly contemplates using the fitting method described therein in conjunction with another fitting method (Boretzki: Paragraph 0108) and utilizing the method of Smith to establish a dynamic range of the user while carrying out the particular mapping method of Boretzki may reduce the time required to complete the mapping and reduce patient discomfort by establishing minimum and maximum amplitudes between which mapping needs to occur.
Claims 38 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Boretzki US Patent Application Publication Number US 2013/0121496 A1 hereinafter Boretzki in view of Smith US Patent Application Publication Number US 2014/0052217 A1 hereinafter Smith as applied to claims 1 and 4 above and further in view of Fung US Patent Application Publication Number US 2018/0234776 A1 hereinafter Fung.
Regarding claims 38, and 43 Boretzki in view of Smith teaches the method of claims 1 and 4 respectively. Modified Boretzki fails to further teach the method wherein: the method is part of a hearing rehabilitation or habilitation method.
Fung teaches a cochlear implant such that the cochlear implant evokes a hearing percept based on first input; and receiving second input from the virtual reality system in temporal proximity with the evocation of the hearing percept based on the first input, wherein the cochlear implant evokes a hearing percept based on the first input, and the second input is correlated with the first input (Abstract). Thus, Fung falls within the same field of endeavor as Applicant’s invention.
Fung teaches that cochlear implants may be used in certain rehabilitation and habilitation processes (Paragraph 0042).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to utilize the fitting method taught by modified Boretzki in the rehabilitation and habilitation processes taught by Fung because Fung utilizes cochlear implants to carry out the habilitation and rehabilitation process and utilizing the cochlear implant fitting method of modified Boretzki is a simple substitution of one known method (the fitting method of cochlear implant utilized by Fung paragraph 0031) for another known method (the fitting method of modified Boretzki) with no surprising technical effect (the cochlear implant is still fitted to the patient and capable of use in the subsequent habilitation/rehabilitation method.
Claims 57 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Boretzki US Patent Application Publication Number US 2013/0121496 A1 hereinafter Boretzki in view of Smith US Patent Application Publication Number US 2014/0052217 A1 hereinafter Smith as applied to claim 54 above and further in view of Heuvel US Patent Application Publication Number US 2011/0093039 A1 hereinafter Heuvel.
Regarding claims 57 and 58 Boretzki in view of Smith teaches the method of claim 54. Modified Boretzki further suggests the method wherein: the recipient can only hear by way of electric hearing and wherein: the recipient has never heard before receiving the hearing prosthesis. These limitations are at least suggested by paragraph 0027 of Boretzki which indicates that the method may be applied to patients who hear via electrical stimulation such as patients with cochlear implants.
Heuvel teaches a hearing prosthesis for use by a recipient. The hearing prosthesis includes a receiver configured to receive sounds external to the recipient, a stimulator configured to stimulate tissue of the recipient to enhance recipient hearing, a sound analyzer configured to analyze the sounds received by the receiver, the sound analyzer further being configured to output a sound analysis signal indicative of the analyzed sounds, an information signal generator configured to output an information signal upon which an inputted indication that is provided to the recipient via the stimulator may be based, and an information scheduler configured to control the time at which the information signal is delivered to the stimulator based on the sound analysis signal (Abstract). Thus, Heuvel falls within the same field of endeavor as Applicant’s invention.
Heuvel teaches that cochlear implants may be used in patients who are completely deaf (Paragraphs 0005 and 0058).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of modified Boretzki to be used in patients who can only hear using electric hearing and/or who have never heard before because modified Boretzki and Smith each teach that the method may be used on cochlear implant (Boretzki: Paragraph 0027; Smith: Paragraphs 0030-0031 and 0047), and Heuvel teaches that cochlear implants may be used in patients who are completely deaf. Thus it would be obvious to configure the method of Boretzki in view of Smith to be implemented on a 100% naturally deaf person who has never heard before receiving their cochlear implant as Heuvel teaches that cochlear implants are suitable for totally deaf patients and the method of Boretzki in view of Smith provides a rapid and effective stimulation adjustment technique for the implant which would improve the patient’s ability to hear and the speed at which the implant is adjusted to their desired parameters.
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Boretzki US Patent Application Publication Number US 2013/0121496 A1 hereinafter Boretzki in view of Smith US Patent Application Publication Number US 2014/0052217 A1 hereinafter Smith as applied to claim 52 above and further in view of Li US Patent Application Publication Number US 2019/0151661 A1 hereinafter Li.
Regarding claim 62 Boretzki in view of Smith teaches the method of claim 52. Modified Boretzki further suggests the method, wherein: the obtained second reactions are based on data obtained during real life usage of the hearing device outside of a clinical environment.
Smith teaches a fitting method where the test signals are applied to a user and feedback is received in order to determine a comfort and threshold level used to fit the hearing prosthesis (Paragraphs 0030-0031). The user input may be received through a variety of input mechanisms and the input signals allow the user to adjust the stimulus currents applied to each electrode of the hearing prosthesis (Paragraphs 0051-0055). The user may provide input for when they can barely hear a tone to determine a T-level or threshold hearing level (Paragraphs 0069-0070). The user may further provide input to determine when the stimulus becomes too loud to determine a C-level or comfort level (Paragraphs 0077-0079). The determined C-level and T-level set the stimulation bounds, or dynamic range, of the map and the user can then request to “fine-tune” their mapping curves to more closely match the user’s ability to perceive sound at one or more frequencies (Paragraphs 0028-0029 and 0080-0081; Figs. 5A and 7A-C).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the dynamic range fitting method of Smith into the method Boretzki as the hearing device fitting method to which the method of Boretzki is used as a “supporting and complimenting constituent” because Boretzki explicitly contemplates using the fitting method described therein in conjunction with another fitting method (Boretzki: Paragraph 0108) and utilizing the method of Smith to establish a dynamic range of the user while carrying out the particular mapping method of Boretzki may reduce the time required to complete the mapping and reduce patient discomfort by establishing minimum and maximum amplitudes between which mapping needs to occur.
Boretzki in view of Smith fails to further teach the method, wherein: the obtained second reactions are based on data obtained during real life usage of the hearing device outside of a clinical environment.
Li teaches that Arrangements are described for fitting an implanted patient and a hearing implant system having an implanted electrode array of electrode contacts. Objective response measurements are performed following delivery of preliminary electrical stimulation signals to the electrode contacts to determine a preliminary fit map that characterizes preliminary patient-specific operating parameters for the hearing implant system. Then an adjusted fit map is produced that characterizes adjusted patient-specific operating parameters for the hearing implant system based on using the preliminary fit map to constrain an implant neural response model to best fit a normal hearing neural response model (Abstract). Thus, Li falls within the same field of endeavor as Applicant’s invention.
Li teaches that cochlear implants may have different fit maps for different listening environments and that the closer the fit map is for a particular environment, the closer the experience for the user is to natural acoustic hearing (Paragraphs 0025-0037). Thus, Li teaches that it is desirable to generate multiple fit maps for multiple listening environments.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the method of Boretzki in view of Smith to be performed in multiple listening environments in order to generate multiple fit maps which each correspond to a respective environment because Li teaches that having multiple fit maps for multiple environments provides the user with a hearing experience closer to natural hearing. Furthermore, it is noted that Boretzki in view of Smith is well suited to be performed in multiple environments as Boretzki teaches that the imaging method may be implemented using a generic computer with a camera (Boretzki: Paragraphs 0111-0115) and Smith teaches that the user input, or second signals, may also be entered by the user using a computer (Smith: Paragraphs 0051-0055) and thus neither method requires specific equipment which necessitate a clinical environment and may be performed at any location where a user can bring a computer such as a library or coffee shop. The teachings of Li (Li: Paragraphs 0025-0037) show that performing the fitting method of Boretzki in view of Smith in various environments would be beneficial to the user’s experience.
Claims 41, 44-45, 47, 51, and 64-65 are not rejected over the prior art because claims 41 and 64 each include the distinguishing feature of fitting the hearing prosthesis using a map with a higher cognitive load than another map. The prior art of record is directed towards minimizing cognitive load/stress and Applicant’s specification paragraphs 0056-0058 and 0069 teaches that selecting a map with a higher cognitive load produces the technical effect of facilitating habilitation/rehabilitation of the user since it is desirable to challenge the user’s brain to a certain degree to facilitate habilitation/rehabilitation.
This selection of a map with a higher cognitive load is considered distinct from previously cited Lineaweaver (US 2017/0056655 A1) hereinafter Lineaweaver because Lineaweaver teaches that the assessment of a user’s auditory ability profile, which is related to but distinct from cognitive load, is used to help determine the stimulation parameters of the implant (Paragraph 0035-0037). However the parameters are not selected in order to produce a desired cognitive load. Rather the parameters are selected to optimize the amount of electrical audio information presented to the recipient in view of the recipient's cognitive auditory ability (Paragraphs 0042-0043 and 0066). The stimulation parameters are not directly determined by an induced cognitive load and thus the particular parameters, or map, selected is not selected on the basis of producing a higher/lower cognitive load.
Claims 44-45, 47, 51, and 65 are not rejected by virtue of their dependence upon claims 41 or 64.
Response to Arguments
Applicant asserts that the Examiner is not one of ordinary skill in the art due to the interpretation of what “fitting” may entail and lacks sufficient knowledge to examine the application and thus all rejections are moot because the level of one of ordinary skill in the art has not been established.
Applicant’s arguments are not found to be persuasive because the examiner has been assigned the application to perform the examination. Additionally, Applicant’s arguments that fitting can only mean the adjustment of stimulation parameters in a hearing prosthesis is not found to be persuasive because it is not commensurate in scope with the claim language. The claims require only a generic hearing device which is “fit” based on two generic reactions. Such a fitting may be, for example, a clinician aiding an elderly or disabled individual to properly insert their hearing aid based on the patient’s feedback and body language. Applicant attempts to define “fitting” as a term of the art for cochlear implants in the provided references but again the claims are not limited to cochlear implants and thus the broadest reasonably interpretation of “fitting” includes more than the adjustment of stimulation parameters.
In regards to the rejections previously presented under 35 USC 112:
Applicant alleges that Examiner does not address the content of the specification or the teachings of the prior art in the above presented clarity rejections and that no prima facie case has been established.
Applicant’s arguments are not found to be persuasive because the above presented clarity rejections set forth why the cited claim language is indefinite. Applicant has not set forth arguments or explanations as to why the claim language has clear and distinct meanings. Applicant’s arguments are directs towards claims 5 and 8 which have been cancelled.
Applicant alleges that paragraph 0088 has not been addressed in the rejection of claim 1 and thus the rejections are improper.
Applicant’s arguments are not found to be persuasive because Applicant does not explain how paragraph 0088 provides sufficient written description for each of the limitations of claim 1. In particular, paragraph 0088 provides only a generic statement regarding the presence of sensors which has already been addressed in the content of paragraph 0094 which also recites the presence of generic sensors for capturing the listed physiological parameters. Applicant’s specification does not support the claimed scope of claim 1.
Applicant asserts that all claims have not been properly examined under 35 USC 112(a). This argument is not found persuasive.
In regards to the rejections previously presented under 35 USC 102/103:
Applicant argues that the level of ordinary skill in the art has not been established because the Examiner is not one of ordinary skill in the art and thus the rejections are improper.
Applicant’s arguments are not found to be persuasive because the Examiner has been assigned the case and is thus considered a person of ordinary skill in the art.
Applicant argues that the cited paragraphs of Boretzki do not teach a system/method which captures images of the user in response to test sounds.
This argument is not found to be persuasive because paragraphs 0097-0102 explicitly recite “The user (user 6) is instructed to look at a camera (imaging unit 2) and listen to sounds (test sounds 1a) which are going to be presented” (Paragraph 0100), “Then, the system (or apparatus) presents a test sound” (Paragraph 0101), and “The system checks, using image analysis unit 3 and parameter setting unit 4 and possibly also storage unit 5, if facial expression or width of pupillae indicate cognitive stress or sensual unpleasantness, the latter indicating hearing discomfort” (Paragraph 0102) which clearly indicates that test sounds are presented to the user and image analysis (described in paragraph 0097) is performed from their reaction to the sounds.
In regards to the rejections previously presented under 35 USC 101:
Applicant asserts that the level of skill in the art has not been established or addressed because Applicant asserts that the Examiner is not one of ordinary skill in the art and thus all rejections are improper.
Applicant’s arguments are not found to be persuasive because the Examiner has been assigned the case and is thus considered a person of ordinary skill in the art.
Applicant asserts that claim 52 is not directed to an abstract idea.
This argument is not found to be persuasive because, as described above, the term fitting is not considered to limit the claims to only making adjustments to the operational settings of the hearing prosthesis. Applicant does not elaborate on how Examiner’s interpretation of fitting applied in the above rejection could not be considered an abstract idea.
Applicant further argues that the claimed method is an improvement in the functioning of technology, that the claim includes additional elements that use the alleged exception in a particular treatment, that the claim includes additional elements that are used in conjunction with a particular machine which is integral to the claim, that the claim reduces a typical sense protheses to a different thing, and that there are additional elements that as a whole amount to significantly more than the abstract idea.
Applicant’s arguments are not found to be persuasive because there are mere allegations that the claim should not be rejected under 35 USC 101 without any analysis as to how the presented claim language meets these criteria.
Conclusion
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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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791