DETAILED ACTION
Notice of 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 .
Response to Arguments
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive & moot in view of the new grounds of rejection made in response to the altered scope of claim 1.
The 112a and 112b rejections in view of 112f interpretation of “communication means” is maintained because “communication unit” and “wireless communication means” are not considered to be sufficient structure.
Concerning the propriety of Hynynen’s teachings combined with the cited references, the Examiner respectfully submits that the claim does not recite an “in situ” determination. While the goal of Hynynen may be different from that of Chandraratna, the teaching relied upon is directed to a physical attachment interface, which may be used under various applications and goals as would be conventionally known by one skilled in the art.
Claim Objections
Claims 14 and 15 are objected to because of the following informalities: It’s unclear as to whether “the ultrasonic stimulation” is referring to the previously set forth “acoustic wave stimulation” of claim 1.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f), 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f), 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), 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) 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) 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.
Claim limitation(s):
means for determining a geometric property
means for determining a shape
has/have been interpreted under 35 U.S.C. 112(f) because it uses/they use generic placeholder(s):
means
means
coupled with functional language:
determining
determining
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder(s) is/are not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) claim(s) 1 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f):
one or more processors of the computerized devices, plurality of sensors
one or more processors of the computerized devices, plurality of sensors
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f), applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
Claim element(s):
1. communication means configured to receive
is/are a means (or step) plus function limitation that invokes 35 U.S.C. 112(f). However, the written description fails to disclose the corresponding structure, material, or acts for the claimed function:
1. receive
Applicant is required to:
(a) Amend the claim so that the claim limitation will no longer be a means (or step) plus function limitation under 35 U.S.C. 112(f); or
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the claimed function 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 so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant is required to 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.
Claim Rejections - 35 USC § 112
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.
Claim(s) 1, 3-5, and 7-21 is/are rejected under 35 U.S.C. 112(a) 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, “communication means” is indefinite as per 112(f) above.
The following is a quotation of the first paragraph 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.
Claim(s) 1, 3-5, and 7-21 is/are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 1, “communication means” is indefinite as per 112(f) above.
Regarding claim 7, it is unclear as to whether “an active detectable element” is being claimed in addition to or in substitution to the “passive detectable element” previously set forth in claim 1.
Regarding claim 16, “the geometric property” lacks proper antecedent basis.
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, 8, 9, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandraratna (US 20060241522, of record) in view of Guenther (US 2011/0190629).
Regarding claim 1 Chandraratna discloses a treatment device for acoustic wave stimulation to cells of a body portion comprising a carrier element and at least one transducer capable to stimulate the body portion by an acoustic wave when arranged on the body portion, wherein the treatment device is portable and the treatment device comprises communication means configured to receive operating parameters for the at least one transducer from a remote computerized device (Fig. 1: “generator unit 22” is a remote computerized device; [0030]: “device 10” is portable). Chandraratna discloses that the treatment device allows for the determination of a position of the at least one transducer relative to the body portion when the carrier element is fastened on the body portion (Fig. 1 shows that the transducers are accessible when fastened onto the body and thus they allow for their general position to be determined whether visually or tactilely) and that the at least one transducer comprises a passive detectable element (Fig. 1: “transmission lines 20” are passive and detectable visually or tactilely). Chandraratna does not explicitly disclose that the treatment device is configured to transmit the position of the at least one transducer relative to the body portion to the remote computerized device. However, Guenther teaches a transducer position detection system ([0053]; [0095]…[0107]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the position detection of Guenther to the transducers of Chandraratna, as to provide robust position tracking.
Regarding claim 7, Chandraratna does not explicitly disclose that the at least one transducer comprises an active detectable element. However, Guenther teaches a transducer position detection system which include active elements ([0053]; [0095]…[0107]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the position detection of Guenther to the transducers of Chandraratna, as to provide robust position tracking.
Regarding claim 8, Chandraratna discloses that the carrier element has a shape that is specific to the body portion of an individual subject ([0030]).
Regarding claim 9, while Chandraratna does not explicitly disclose that the carrier element comprises rigid material that is formed according to at least a portion of the body portion to be treated. However, Chandraratna does teach the use of preformed rigid elements in certain embodiments ([0049]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the rigid elements as taught by Chandraratna, as to provide materials of varying rigidity for achieve an optimal fit.
Regarding claim 21, Chandraratna discloses a system comprising a treatment device according to claim 1, comprising communication means and a computer program comprising instructions which, when executed by a computerized device, cause the computerized device to exchange data with the communication means (Fig. 1, [0029]).
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandraratna (US 20060241522, of record) in view of Guenther (US 2011/0190629), as applied to claim 1 above, in view of Calzi (US 20190021629, of record).
Regarding claim 3, neither Chandraratna nor Guenther explicitly disclose that the means for determining a geometric property of the body portion comprise means for determining a shape of the body portion to be stimulated. However, Calzi teaches a vest equipped with an array of reference sensors that emit a detected output that is used to calculate the contour of a patient’s body ([0132]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the contour detection sensors of Calzi to the flexible device of Chandraratna, as to provide known contour data on the body being examined.
Regarding claim 4, neither Chandraratna nor Guenther explicitly disclose that the carrier element comprises the means for determining a geometric property of the body portion. However, Calzi teaches a vest equipped with an array of reference sensors that emit a detected output that is used to calculate the contour of a patient’s body ([0132]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the contour detection sensors of Calzi to the flexible device of Chandraratna, as to provide known contour data on the body being examined.
Regarding claim 5, neither Chandraratna nor Guenther explicitly disclose a plurality of sensors, wherein the sensors are arranged on the carrier element and wherein an output of the sensors depends on the arrangement of the sensors on the carrier element. However, Calzi teaches a vest equipped with an array of reference sensors that emit a detected output that is used to calculate the contour of a patient’s body ([0132]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the contour detection sensors of Calzi to the flexible device of Chandraratna, as to provide known contour data on the body being examined.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandraratna (US 20060241522, of record) in view of Guenther (US 2011/0190629), as applied to claim 1 above, in view Marquet (US 20170281984, of record).
Regarding claim 13, neither Chandraratna nor Guenther explicitly disclose that the device is configured for validating a configuration of the device with respect to a set of treatment parameters by comparing a measured parameter of the treatment device with a related parameter of the set of treatment parameters. However, Marquet teaches cross referencing data to calibrate ultrasound elements for a procedure ([0029]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the comparison of Marquet to the devices of Chandraratna and Guenther, as to provide a well-calibrated system.
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandraratna (US 20060241522, of record) in view of Guenther (US 2011/0190629), as applied to claim 1 above, in view Scott (US 20140163644, of record).
Regarding claims 14-16, neither Chandraratna nor Guenther explicitly disclose that the device comprises:
a) an input element for receiving a user feedback related to an effect of the ultrasonic stimulation.
b) the device comprises an input element for receiving information related to an effect of the ultrasonic stimulation, wherein the communication means are configured to transmit the information to a library that is available for other users.
c) the device comprises a sensor for generating subject specific information other than the geometric property of the body portion.
However, Scott teaches a hand-held device for capturing (thus sensing) feedback from a patient during a therapeutic stimulation procedure ([0090]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the input device of Scott to the system of Chandraratna, as to provide conventional input means.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandraratna (US 20060241522, of record) in view of Guenther (US 2011/0190629), as applied to claim 1 above, in view Schulz (US 20120029352, of record).
Regarding claim 17, neither Chandraratna nor Guenther explicitly disclose a transducer for exciting acoustic waves in the body portion and a transducer for detecting acoustic waves that are transmitted through and/or scattered in the body portion. However, Schulz teaches the use of ultrasound transceivers ([0010], [0014]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the transceivers of Schulz to the array of Chandraratna and Guenther, as to provide emitting and receiving capabilities.
Claim(s) 10-12, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chandraratna (US 20060241522, of record) in view of Guenther (US 2011/0190629), as applied to claim 1 above, in view Hynynen (US 2018/0177491, of record).
Regarding claim 10, neither Chandraratna nor Guenther explicitly disclose that the carrier element comprises a fixation element per transducer needed for a specific application, wherein each fixation element is arranged on the carrier element at a target position for the specific application. However, Hynynen teaches a plurality of attachment interfaces for receiving and supporting ultrasound transducer array elements ([0064]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the fixation element of Hynynen to the array of Chandraratna, as to provide selective attachment and removability of discrete transducer elements.
Regarding claim 11, neither Chandraratna nor Guenther explicitly disclose that the carrier element comprises an arrangement of a plurality of fixation elements that allows fixation of the at least one transducer at target positions of various applications. However, Hynynen teaches a plurality of attachment interfaces for receiving and supporting ultrasound transducer array elements ([0064]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the fixation element of Hynynen to the array of Chandraratna, as to provide selective attachment and removability of discrete transducer elements.
Regarding claim 12, neither Chandraratna nor Guenther explicitly disclose that the carrier element comprises position marks that help to arrange the at least one transducer at the target position. However, Hynynen teaches a plurality of visible, and thus marked, attachment interfaces for receiving and supporting ultrasound transducer array elements ([0064]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the fixation element of Hynynen to the array of Chandraratna, as to provide selective attachment and removability of discrete transducer elements.
Regarding claim 18, neither Chandraratna nor Guenther explicitly disclose that the carrier element for a treatment device according to claim 1, is formed according to at least a portion of the body portion to be treated, and wherein the carrier element comprises a fixation element for at least one transducer, wherein the number of fixation elements and the arrangement of the fixation elements are adapted to a specific acoustic wave stimulation; or the carrier element comprises an arrangement of a plurality of fixation elements that allows fixation of at least one transducer at target positions of various acoustic wave stimulations. However, Hynynen teaches a plurality of attachment interfaces for receiving and supporting ultrasound transducer array elements ([0064]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the fixation element of Hynynen to the array of Chandraratna, as to provide selective attachment and removability of discrete transducer elements.
Regarding claim 19, Chandraratna discloses that the carrier element is formed according to at least a portion of the body portion of an individual subject, said body portion being the body portion to be treated (Figs. 1 and 3-5).
Regarding claim 20, Chandraratna does not explicitly disclose that the carrier element comprises rigid material that is formed according to at least a portion of the body portion to be treated. However, Chandraratna does teach the use of preformed rigid elements in certain embodiments ([0049]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the rigid elements as taught by Chandraratna, as to provide materials of varying rigidity for achieve an optimal fit.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Ip whose telephone number is (571) 270-5387. The examiner can normally be reached Monday - Friday 9a-5p PST.
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/JASON M IP/Primary Examiner, Art Unit 3793