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 .
This office action is in response to the claims filed 7/1/24. Claims 1-12 are pending in the instant application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the portable frame (claim 1).
Claim Objections
Claim 1 is objected to because of the following informalities: the language “the infrasound range” (line 4-5) lacks antecedent basis in the claim but does not rise to the level of indefiniteness as one would recognize the inherency of an infrasound range (with regards to humans to which the application is directed); Examiner suggests amending to read –an infrasound range--. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “vibration-inducing element” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Corresponding structure is set forth in para. 0028 to include a transducer for example.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 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.
The term "substantially against the skull" in claim 1 line 9 (emphasis added) is a relative term which renders the claim indefinite. The term "substantially" 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 known what qualifies, or does not qualify, as being held substantially against the skull.
Claim 6 recites the limitation "the user" in line 1. There is insufficient antecedent basis for this limitation in the claim.
The term "substantially against the fascia" in claim 9 line 2 (emphasis added) is a relative term which renders the claim indefinite. The term "substantially" 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 known what qualifies, or does not qualify, as being held substantially against the fascia.
Claims 2-5, 7-8, and 10-12 are rejected based on dependency on a rejected claim.
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.
Claim(s) 1-3, 5, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lattner (2013/0303953) in view of Doochin et al. (2014/0276193) and Erikson et al. (7,633,835).
Regarding claim 1, Lattner shows a device for disrupting a vestibular system (see Fig. 2-13 for example) including a power source 130 (see para. 0049); a signal generator connected to the power source and configured to generate a signal comprising a tone at a user-selectable frequency in the infrasound range (see para. 0049-0051, microprocessor 110 generating signals, see para. 0019 which teaches frequency range of 1-40 Hz, including infrasound frequencies, thus being obvious to provide such frequencies as 1-30 Hz, completely encompassed by the disclosed range and to provide desired frequency level to the treatment signal); a vibration-inducing element connected to the signal generator and configured to convert the signal into physical vibrations (vibrating-inducing element 20, see para. 0049); the power source, signal generator, and vibration-inducing element disposed in a portable frame capable of being held substantially against the skull of an animal near the animal's ear, the vibration-inducing element configured to transmit the physical vibrations to a vestibular system of the animal via the animal's skull (see Fig. 3-9 and para. 0056 for example; Fig. 9 and para. 0085 in particular which discloses that the device 10a is self-contained within a frame as shown in Fig. 9). Lattner is silent as to the signal generator explicitly delivering signals having a sine wave pattern; however, a sinusoidal waveform is well-known in the art. Furthermore, Doochin teaches a similar device which includes a signal generator producing signals having a sine wave pattern (see Doochin para. 0006 which discloses various types of waveform signals, including sine waveform) and it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the Lattner device's signal generator to produce a sine wave, as taught by Doochin, as this is a well-known type of signal waveform in the art and one would expect the modified Lattner device to perform equally as well utilizing a sine waveform. The now modified Lattner device is silent as to the signal having an average output power level of between 100 and 150 decibels; however, Erikson teaches that providing low frequency signals at high decibel levels (including 100-150 dB range) provides audible tones (see Erikson col. 1 ln. 62-67) and it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the modified Lattner device’s signal generator to produce an output power level of between 100 to 150 dB, as taught by Erikson in order to provide an audible tone treatment to provide a desired level of treatment to a particular user.
Regarding claim 2, the modified Lattner device's infrasound range includes frequency range of between 10 and 30 Hz (see Lattner para. 0019, it would have been obvious to choose values between 10 and 30 Hz in order to provide a particular treatment level/frequency).
Regarding claim 3, the modified Lattner device’s power source is a battery (see Lattner para. 0049).
Regarding claim 5, the modified Lattner device is silent as to the signal generator including an amplifier; however, amplifiers providing in such a device as modified Lattner device is well-known in the art. Furthermore, Doochin teaches a similar device which includes a signal generator having an amplifier (see Doochin para. 0023), and it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the modified Lattner device to further include an amplifier, as taught by Doochin, in order to amplify the signal provided by the signal generator.
Regarding claim 9, the modified Lattner device’s vibration-inducing element is configured to be implantable under the animal’s skin and held substantially against fascia covering the skull (see Lattner para. 0015 & 0056 and Fig. 12-13).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lattner, Doochin, and Erikson as applied to claim 1 above, and further in view of Shafieloo (2014/0350441).
Regarding claim 4, the modified Lattner device is silent as to the power source being a USB port; however, this is a well-known type of power supply device in the art. Furthermore, Shafieloo teaches a similar device which includes a power supply in the form of a USB port (see Shafieloo para. 0015 & 0034), and it would have been obvious to one of ordinary skill at the time the invention was filed to modify the modified Lattner device's power supply to be a USB port, as taught by Shafieloo, in order to provide the ability to both power the device and interface with a personal computer.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lattner, Doochin, and Erikson as applied to claim 1 above, and further in view of Veitl (2013/0237746).
Regarding claim 6, the modified Lattner device is silent as to the output power level explicitly being able to be adjusted by the user; however, adjustable volume/power level is well-known in the art. Furthermore, Veitl teaches a similar device which includes user adjustable power levels (see Veitl para. 0044 and 0050). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the modified Lattner device's output power level to be adjustable by the user, as taught by Veitl, in order to provide the user the ability to tailor the treatment to his/her requirements.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lattner, Doochin, and Erikson as applied to claim 1 above, and further in view of Kania (6,443,913).
Regarding claim 7, the modified Lattner device is silent as to providing an acceleration sensor in the portable frame such that the output level is varied in response to sensed acceleration/deceleration change. However, Kania teaches a similar treatment device which includes an acceleration sensor which is utilized in a feedback control of the therapy (see Kania col. 2 ln. 32-67 and col. 6 ln. 34-65 for example). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the modified Lattner device to further include an acceleration sensor for feedback control of the device, as taught by Kania, in order to provide the ability of the device to treat a user who is traveling.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lattner, Doochin, and Erikson as applied to claim 1 above, and further in view of Kania and Butnaru (5,966,680).
Regarding claim 8, the modified Lattner device is silent as to including an orientation sensor in the portable frame such that the output level is varied in response to sensed orientation change. However, Butnaru teaches a similar device which utilizes orientation sensors for control and Kania teaches a similar device which includes using positional sensors (acceleration sensor for example) for in a feedback control of the level of therapy (see Kania col. 2 ln. 32-67 and col. 6 ln. 34-65 for example). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the modified Lattner device to include an orientation sensor, as taught by Butnaru, to provide for feedback control of the level of therapy provided by the device, as taught by Kania, in order to provide treatment to a user who is traveling.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lattner, Doochin, and Erikson as applied to claim 1 above, and further in view of Mark (4,558,703).
Regarding claim 10, the modified Lattner device is silent as to providing the frame to be configured to attach to or incorporated into a vehicle, helmet, seat, or headrest; however, Mark teaches a similar device which is configured to attach to or be incorporated into a vehicle, helmet, seat, or headrest (see Mark col. 1 ln. 47-58 and col. 2 ln. 11-20). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the modified Lattner device to be attached/incorporated into a vehicle, helmet, seat, or headrest, as taught by Mark, in order to provide an alternative means of providing the therapy device to the patient (helmet of Mark versus the headset of Lattner).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lattner, Doochin, Erikson, and Mark as applied to claim 10 above, and further in view of Kania.
Regarding claim 11, the modified Lattner device is silent as to providing an acceleration sensor in the portable frame such that the output level is varied in response to sensed acceleration/deceleration change. However, Kania teaches a similar treatment device which includes an acceleration sensor which is utilized in a feedback control of the therapy (see Kania col. 2 ln. 32-67 and col. 6 ln. 34-65 for example). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the modified Lattner device to further include an acceleration sensor for feedback control of the device, as taught by Kania, in order to provide the ability of the device to treat a user who is traveling.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lattner, Doochin, Erikson, and Mark as applied to claim 10 above, and further in view of Kania and Butnaru.
Regarding claim 12, the modified Lattner device is silent as to including an orientation sensor in the portable frame such that the output level is varied in response to sensed orientation change. However, Butnaru teaches a similar device which utilizes orientation sensors for control and Kania teaches a similar device which includes using positional sensors (acceleration sensor for example) for in a feedback control of the level of therapy (see Kania col. 2 ln. 32-67 and col. 6 ln. 34-65 for example). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the modified Lattner device to include an orientation sensor, as taught by Butnaru, to provide for feedback control of the level of therapy provided by the device, as taught by Kania, in order to provide treatment to a user who is traveling.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 5-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,053,426 in view of Lattner and Doochin.
Regarding instant claim 1, patent claim 2 discloses each structural and functional limitation as claimed (see patent claim 2 which discloses infrasound range of the signal, patent claim 1 setting forth the power source, signal generation, and vibration inducing element to be secured to the skull and transmit physical vibrations to disrupt vestibular system), but is silent as to the signal having a sine wave pattern and to be user selectable frequency and the structural elements housed within a portable frame; however, Lattner and Doochin teach these features (see Lattner: para. 0049-0051, Fig. 3-9 and para. 0056 for example; Fig. 9 and para. 0085 in particular which discloses that the device 10a is self-contained within a frame as shown in Fig. 9; Doochin: para. 0006 which discloses various types of waveform signals, including sine waveform). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patent claim 2 device to include such features, as taught by Lattner and Doochin, in order to provide desired signal shape/waveform and structural element to house the components.
Also regarding instant claim 1, patent claim 1 discloses each structural and functional limitation as claimed (see patent claim 1 setting forth the power source, signal generation, and vibration inducing element to be secured to the skull and transmit physical vibrations to disrupt vestibular system), but is silent as to the signal having a sine wave pattern and to be user selectable frequency in the infrasound range and the structural elements housed within a portable frame; however, Lattner and Doochin teach these features (see Lattner: para. 0049-0051, para. 0019 which teaches frequency range of 1-40 Hz, including infrasound frequencies, Fig. 3-9 and para. 0056 for example; Fig. 9 and para. 0085 in particular which discloses that the device 10a is self-contained within a frame as shown in Fig. 9; Doochin: para. 0006 which discloses various types of waveform signals, including sine waveform). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patent claim 1 device to include such features, as taught by Lattner and Doochin, in order to provide desired signal shape/waveform and structural element to house the components.
Instant claims 2-3 correspond to patent claims 2-3, respectively. Instant claims 5-8 correspond to patent claims 5-8, respectively. Regarding instant claim 9, modified patent claim 2, in view of Lattner, discloses an implantable device (see Lattner para. 0015 & 0056 and Fig. 12-13). Instant claim 10 corresponds to patent claim 9.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,053,426 in view of Lattner, Doochin, and Shafieloo.
Regarding instant claim 4, patent claim 4 discloses the power source including an electrical port, but is silent as to the port explicitly being a USB port; however, this is a well-known type of power supply device in the art. Furthermore, Shafieloo teaches a similar device which includes a power supply in the form of a USB port (see Shafieloo para. 0015 & 0034), and it would have been obvious to one of ordinary skill at the time the invention was filed to modify the modified patent claim 4 device's power supply to be a USB port, as taught by Shafieloo, in order to provide the ability to both power the device and interface with a personal computer.
Claims 10-12 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Patent No. 12,053,426 in view of Lattner, Doochin, and Mark.
Regarding instant claim 10, patent claim 7 or 8 include an acceleration sensor and orientation sensor, respectively, for controlling the signal processor based thereon, but is silent as to providing the frame to be configured to attach to or incorporated into a vehicle, helmet, seat, or headrest; however, Mark teaches a similar device which is configured to attach to or be incorporated into a vehicle, helmet, seat, or headrest (see Mark col. 1 ln. 47-58 and col. 2 ln. 11-20). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the modified patent claim 7 or 8 device to be attached/incorporated into a vehicle, helmet, seat, or headrest, as taught by Mark, in order to provide an alternative means of providing the therapy device to the patient.
Instant claim 11 corresponds to patent claim 7. Instant claim 12 corresponds to patent claim 8.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Gibson-Horn (2016/0051793), Lenhardt (2005/0201574), and Snow (2017/0135896).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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/COLIN W STUART/Primary Examiner, Art Unit 3785
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