DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species A-1 and Species B-1-a in the reply filed on 12 December 2025 is acknowledged.
Claims 10, 12, and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 December 2025. The Examiner notes that Applicant’s identification of claims belonging to the non-elected species omitted claim 10, which falls into unelected species B-2 directed to an arrangement configured to deliver both constant and varying pressure.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the acoustic muffler must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-9, 11, 14-19 are objected to because of the following informalities:
As previously noted, the claims as currently presented are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. For example, these include but are not limited to:
Claim 1: “wherein at least part of said acoustic measurement device being configured”
Claim 1: “wherein… said acoustic measurement device comprising”
Claim 1: “characterized in that said air-pump arrangement comprising at least two pumps”
Claim 4: “wherein said at least one flow regulating component being configured”
Claim 5: “wherein said at least two pumps comprising”
Claim 7: “wherein said air-pump arrangement being configured”
Claim 7: “said first and said second piezo-electric membrane pump”
Claim 9: “wherein said air-pump arrangement…being configured to apply”
Claim 9: “wherein said air pressure level lying in the range”
And so forth.
Claim 16 presents a list of limitations which does not include an “and” before the final clause; it is unclear if this is a grammatical error or if an additional limitation has been omitted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 11, 14-19 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 1 recites that “said at least two pumps comprise a movable element in the form of a membrane”; it is unclear if the two pumps share a membrane or if each pump has its own respective membrane. Clarification is required.
Claim 7 defines “said air-pump arrangement providing a first piezo-electric membrane pump fluidically in series with a first flow resistor and a second piezo-electric membrane pump fluidically in series with a second flow resistor”; per claim 1 the air-pump arrangement already includes at least two pumps with membranes (that is, membrane pumps), and per claim 6 these pumps are piezo-electric membrane pumps. It is unclear if the piezo pumps of claim 7 are in addition to these, for a total of at least four piezo pumps, or if these are further defining the two pumps already present in the system. Clarification is required.
Claim 8 recites “said flow regulating components”; there is no antecedent basis for this limitation in the claim as neither claim 3 nor claim 1 define flow regulating components. It appears claim 8 should depend from claim 4; for the purposes of examination it will be treated as such but correction is required.
The term “essentially” in claim 9 is a relative term which renders the claim indefinite. The term “essentially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what amount of variability is permitted when maintaining “essentially” a single pressure, particularly as this is presented in contrast with the device also providing variable pressures which are also within the same range as the “essentially” single pressure. This limitation is also found in claim 10.
Claim 11 contains two clauses which end with a period, such that it is unclear if the second clause should be part of the claimed invention or if this has been inadvertently included. For the purposes of examination the claim will be treated as though the first period is a comma, but correction is required.
Claim 18 is rejected as it merely attempts to claim a process without setting forth any steps involved in the process, raising an issue of indefiniteness. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. It is entirely unclear what the scope of the claim might be without reciting any aspect of the claimed method.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 is directed only to “a diagnostic instrumental arrangement according to claim 16”, where claim 16 already defines “A diagnostic instrumental arrangement”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newman (US 2003/0171655).
Regarding claim 1, Newman discloses an acoustic measurement device configured to provide acoustic property values for objective ear-condition evaluation of a patient's ear, wherein:
- at least part of said acoustic measurement device is configured to be positioned within an ear canal of said patient and configured to take a resting position within said ear canal (figure 2),
- said acoustic measurement device comprises an ear probe (element 40),
- said acoustic measurement device comprises an air-pump arrangement (element 68), said air-pump arrangement, at least in said resting position, is in fluid connection with said ear canal through at least one tube running via said ear probe (element 70),
- said air-pump arrangement, in said resting position, is configured to apply an air- pressure control procedure, consisting of at least one air-pressure level, across said patient's tympanic membrane of said ear (paragraph [0056]), wherein:
- said acoustic measurement device, in said resting position, is configured to provide acoustic property values in reaction to said air pressure control procedure applied by said air-pump arrangement across said patient's tympanic membrane of said ear (paragraph [0056]),
characterized in that,
- said air-pump arrangement comprises a movable element in the form of a membrane (paragraph [0056]).
Newman does not disclose the air-pump arrangement comprising at least two membrane pumps, but In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. As there is no recited purpose for adding an additional pump to perform any function not already performed by a single pump, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have also included an additional pump for backup purposes.
Regarding claim 2, Newman further discloses that said pumps are configured to act as membrane pumps for applying said air-pressure control procedure (paragraph [0056]).
Regarding claim 3, Newman further discloses an acoustic input unit configured to capture acoustic signals representative for said air-pressure levels within said ear canal (element 60), a control device configured to control said air-pump arrangement (“circuit means” in element 40; paragraph [0056]), and a processing device configured to further process said captured acoustic signals (“circuit means” in element 40, paragraph [0056]).
Regarding claim 15, Newman further discloses that the acoustic measurement device comprises a control device configured to control said air-pump arrangement (paragraph [0056], “control means” in element 40).
Regarding claims 16 and 19, Newman further discloses a diagnostic instrumental arrangement configured to provide at least one objective ear-condition parameter of a patient's ear comprising:
- an acoustic measurement device according to claim 1 (see above),
- a processing device configured to further process said captured acoustic signals to an evaluation device, said evaluation device being configured to execute an evaluation process to said processed acoustic signals associated to said air-pressure control procedure to obtain said at least one objective ear-condition parameter for said patient's ear (“control means”, paragraph [0056]).
Regarding claim 17, Newman further discloses that said diagnostic instrumental arrangement being mechanically connectable to a stand-alone device or being operated via a mobile end device (paragraph [0054]).
Regarding claim 18, Newman further discloses an objective ear-condition evaluation method using an acoustic measurement device according to claim 1 (see entire document, for example paragraphs [0009], [0056], [0057]).
Claim(s) 1-8, 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lantz (US 2015/0342504) in view of George (US 2015/0003644).
Regarding claim 1, Lantz discloses an acoustic measurement device configured to provide acoustic property values for objective ear-condition evaluation of a patient's ear, wherein:
- at least part of said acoustic measurement device is configured to be positioned within an ear canal of said patient and configured to take a resting position within said ear canal (element 10; paragraph [0081]),
- said acoustic measurement device comprises an ear probe (paragraph [0065]),
- said acoustic measurement device comprises an air-pump arrangement (elements 16, 16’), said air-pump arrangement, at least in said resting position, is in fluid connection with said ear canal through at least one tube running via said ear probe (element18; figure 2),
- said air-pump arrangement, in said resting position, being configured to apply an air- pressure control procedure, consisting of at least one air-pressure level, across said patient's tympanic membrane of said ear (paragraph [0007]), wherein:
- said acoustic measurement device, in said resting position, being configured to provide acoustic property values in reaction to said air pressure control procedure applied by said air-pump arrangement across said patient's tympanic membrane of said ear (paragraph [0009]),
characterized in that,
- said air-pump arrangement comprising at least two pumps (figure 5; paragraphs [0052], [0083]).
Lantz does not disclose specifics of the type of pumps, including wherein said at least two pumps comprising a movable element in the form of a membrane.
George teaches a device configured to control delivery of pressures to a patient's ear, wherein:
- said device comprises an air-pump arrangement, said air-pump arrangement, at least in a resting position, being in fluid connection with an ear canal through at least one tube running via an ear probe (paragraphs [0091], [0092]),
- said air-pump arrangement, in said resting position, being configured to apply an air- pressure control procedure, consisting of at least one air-pressure level, across said patient's tympanic membrane of said ear (paragraph [0091], [0098]);
characterized in that,
- said air-pump arrangement comprising a movable element in the form of a membrane (paragraph [0092]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Lantz with membrane pumps, as taught by George, as Lantz does not specify a preferred type of pump and George teaches use of a membrane pump for controlling pressure within an ear canal and across a tympanic membrane.
Regarding claim 2, Lantz further discloses that said at least two pumps are configured to act as pumps for applying said air-pressure control procedure (paragraph [0083]); as modified by Newman above these membrane pumps would act as membrane pumps.
Regarding claim 3, Lantz further teaches an acoustic input unit configured to capture acoustic signals representative for said air- pressure levels within said ear canal (element 40), a control device configured to control said air-pump arrangement (element 54), and a processing device configured to further process said captured acoustic signals (element 7).
Regarding claim 4, Lantz further discloses that said at least two pumps are each arranged fluidically in series with at least one flow-regulating component (elements 18, 20; tube cross-section inherently provides some amount of flow regulation), wherein the two piezo-electric membrane pumps are arranged parallel to each other (figure 5),
wherein:
- said at least one flow regulating component being configured and arranged within said air-pump arrangement such that said two piezo-electric membrane pumps is capable of working bidirectional when applying said air-pressure control procedure (figure 5).
Further, George further teaches that the membrane pumps are piezo-electric membrane pumps (paragraph [0092]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Lantz and George with piezoelectric membrane pumps, as further taught by George, in order to provide precise pressure control.
Regarding claim 5, Lantz further discloses that said air-pump arrangement is configured such that said at least two pumps can work simultaneously to control said air pressure level within said air pressure control procedure in said ear canal (paragraph [0083]; simultaneous operation of both pumps still allows control of pressure via each probe).
Regarding claim 6, Lantz further discloses that said at least two pumps are each fluidically arranged in series with at least one flow resistor, wherein the two piezo-electric membrane pumps are arranged parallel to each other (figure 5).
Further, George further teaches that the membrane pumps are piezo-electric membrane pumps (paragraph [0092]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Lantz and George with piezoelectric membrane pumps, as further taught by George, in order to provide precise pressure control.
Regarding claim 7, Lantz further discloses said air-pump arrangement providing the first pump fluidically in series with a first flow resistor (element 18, the size of the tube impacts flow) and the second pump fluidically in series with a second flow resistor (element 20, as above), wherein said first pump and said second pump are arranged parallel to each other (figure 5),
wherein:
- said air-pump arrangement being configured and arranged such that pressure between said first flow resistor and said second flow resistor can be controlled in said ear-canal of said ear (via element 54),
- said air-pump arrangement thereby acting in a manner analogous to a voltage divider, by maintaining and adjusting an inlet pressure and an outlet pressure at said first and said second pumps (paragraph [0083]).
Regarding claim 8, Lantz further discloses a network of narrow tubes and cavities arranged at said ear probe (see elements 18 or 20); as defined herein these thus are an “acoustic muffler” as they have the defined configuration of such and act “in a manner of a flow resistor” where flow is inherently at least in part controlled by tube size, and inherently also attenuate noise at least partially by providing distance between a pump and the ear canal.
Regarding claim 14, Lantz further discloses said at least two pumps comprising a first pump and a second pump, wherein said first pump and said second pump being poled in opposing directions to each other (figure 5),
and
- said air-pump arrangement being configured such that said at least two pumps can work simultaneously to control said air pressure level within said air pressure control procedure in said ear canal (figure 5; paragraph [0083]; simultaneous operation of both pumps still allows control of pressure via each probe).
Further, George further teaches that the membrane pumps are piezo-electric membrane pumps (paragraph [0092]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Lantz and George with piezoelectric membrane pumps, as further taught by George, in order to provide precise pressure control.
Regarding claim 15, Lantz further discloses that the acoustic measurement device comprises a control device configured to control said air-pump arrangement (element 7).
Regarding claims 16 and 19, Lantz further discloses a diagnostic instrumental arrangement configured to provide at least one objective ear-condition parameter of a patient's ear comprising:
- an acoustic measurement device according to claim 1 (see above),
- a processing device configured to further process said captured acoustic signals to an evaluation device, said evaluation device being configured to execute an evaluation process to said processed acoustic signals associated to said air-pressure control procedure to obtain said at least one objective ear-condition parameter for said patient's ear (paragraphs [0063], [0064]).
Regarding claim 17, Lantz further discloses that said diagnostic instrumental arrangement being mechanically connectable to a stand-alone device (paragraph [0042], the device is “connectable” via output ports).
Regarding claim 18, Lantz further discloses an objective ear-condition evaluation method using an acoustic measurement device according to claim 1 (paragraph [0010]).
Claim(s) 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lantz as modified by George, as applied above, and further in view of Bojesen (US 2016/0220155).
Regarding claim 9, Lantz, as modified above, does not disclose specifics of the pressures being applied during use beyond that the pressure is varied during use (paragraphs [0007], [0076], [0083]), particularly being configured to apply said air pressure control procedure in the form of maintaining essentially a single air pressure level during said procedure, in the range of -600 to +400 daPa, or being configured to apply said air pressure control procedure in the form of performing varying air pressure levels during said procedure, wherein said varying air pressure levels during said procedure range between around -600 daPa to +400 daPa, and configured to perform said varying air-pressure levels with an adjustable air-pressure sweep rate.
Bojesen teaches an acoustic measurement device configured to provide acoustic property values for objective ear-condition evaluation of a patient's ear, wherein:
- at least part of said acoustic measurement device is configured to be positioned within an ear canal of said patient and configured to take a resting position within said ear canal (element 4; paragraphs [0003], [0073]),
- said acoustic measurement device comprising an ear probe (element 4),
- said acoustic measurement device comprising an air-pump arrangement (paragraph [0041]), said air-pump arrangement, at least in said resting position, being in fluid connection with said ear canal through at least one tube running via said ear probe (paragraph [0041], [0072], [0073]),
- said air-pump arrangement, in said resting position, is configured to apply an air- pressure control procedure, across said patient's tympanic membrane of said ear (paragraph [0041]), said air pressure control procedure having the form of performing varying air pressure levels during said procedure, wherein said varying air pressure levels during said procedure range between around -600 daPa to +400 daPa, and performed with an adjustable air-pressure sweep rate (paragraph [0009], [0021], [0022], [0053])
wherein:
- said acoustic measurement device, in said resting position, is configured to provide acoustic property values in reaction to said air pressure control procedure applied by said air-pump arrangement across said patient's tympanic membrane of said ear (paragraph [0009]).
It would have been obvious to one of ordinary skill in the art at the time the invention as filed to have made the system of Lantz, as modified above, with the pressure control procedure comprising varying air pressure levels during the procedure in the range of between around -600 daPa to +400 daPa with an adjustable air-pressure sweep rate, as taught by Bojesen, as Lantz does not set forth specifics of the pressures to be applied and Bojesen teaches that these applied pressures are useful for acoustic measurements.
Regarding claim 11, Lantz further discloses that said acoustic measurement device is configured to provide acoustic property values representative for said patient's middle-ear in reaction to a first pressure control procedure of said air pressure control procedure, applied by said air-pump arrangement across said patient's tympanic membrane of said ear (paragraph [0007], [0076], [0083]), wherein:
- said first pressure control procedure in particular contains performing varying air pressure levels during said procedure (paragraphs [0007], [0076], [0083]), and said acoustic measurement device being configured to act as a tympanometer (paragraph [0044]).
Lantz, as modified, does not disclose varying the air pressure levels during said first pressure control procedure between around -600 daPa to +400 daPa, with said air-pump arrangement being configured to perform said varying air-pressure levels with an adjustable air pressure sweep rate.
Bojesen teaches an acoustic measurement device configured to provide acoustic property values for objective ear-condition evaluation of a patient's ear, wherein:
- at least part of said acoustic measurement device is configured to be positioned within an ear canal of said patient and configured to take a resting position within said ear canal (element 4; paragraphs [0003], [0073]),
- said acoustic measurement device comprising an ear probe (element 4),
- said acoustic measurement device comprising an air-pump arrangement (paragraph [0041]), said air-pump arrangement, at least in said resting position, being in fluid connection with said ear canal through at least one tube running via said ear probe (paragraph [0041], [0072], [0073]),
- said air-pump arrangement, in said resting position, is configured to apply an air- pressure control procedure, across said patient's tympanic membrane of said ear (paragraph [0041]), said air pressure control procedure having the form of performing varying air pressure levels during said procedure, wherein said varying air pressure levels during said procedure range between around -600 daPa to +400 daPa, and performed with an adjustable air-pressure sweep rate (paragraph [0009], [0021], [0022], [0053])
wherein:
- said acoustic measurement device, in said resting position, is configured to provide acoustic property values in reaction to said air pressure control procedure applied by said air-pump arrangement across said patient's tympanic membrane of said ear (paragraph [0009]).
It would have been obvious to one of ordinary skill in the art at the time the invention as filed to have made the system of Lantz, as modified above, with the pressure control procedure comprising varying air pressure levels during the procedure in the range of between around -600 daPa to +400 daPa with an adjustable air-pressure sweep rate, as taught by Bojesen, as Lantz does not set forth specifics of the pressures to be applied and Bojesen teaches that these applied pressures are useful for acoustic measurements.
Conclusion
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/KAREN E TOTH/Examiner, Art Unit 3791