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 .
Response to Arguments
Regarding 35 U.S.C. 112
Examiner notes that the previously set forth 112(b) rejections are withdrawn in view of the amendments to the claims, however, new 112(b) rejections are necessitated by amendment.
Regarding prior art
Applicant's arguments filed 08/27/2025 have been fully considered but they are not persuasive. For example, applicant argues “the ultrasound transduction unit maintains a horizontal orientation while moving along an opposite direction, thereby keeping the ultrasound irradiation position (height) constant. For this purpose, Park employs an additional component referred to as a horizontal maintaining movement guide to control the ultrasound focus so that the focus moves at uniform desired depth” (REMARKS pg. 6). Examiner respectfully disagrees in that as can be seen by at least fig. 4 of Park, the transducer component moves along a curved path in pendulum movements (see where the transducer portion moves upward as it moves outward from the center) and is disclosed as moving along a curve which would necessarily occur when moved by a ball joint. Furthermore, the horizontal-maintaining movement guide unit is not directed to maintaining a horizontal height, but rather maintaining the ultrasound transducers orientation such that it remains horizontal see for example fig. 4 and [0018] which discloses a horizontal-maintaining movement guide unit allowing the transducer unit to move along the curve while maintaining horizontality. Such horizontality does not refer to the plane along which the transducer unit moves, but rather the orientation of the transducer itself as shown in the figures where the transducer unit still moves in pendulum movements as shown in the figures and disclosed as moving along a curve. See also [0021] which discloses the transducer unit may be moved along a curved line in a state in which horizontality is maintained and [0084] which discloses in this case, the pivot guide shaft portion 240 positioned in parallel with the pivot shaft portion 230 pivots in the same direction as the pivot shaft portion 230 and maintains the planar state of the ultrasonic transducer portion 220, so that the upper surface of the planar surface or the lower surface of the planar surface of the ultrasonic transducer portion 220 moves in a state in which the ultrasonic transducer portion 220 maintains the horizontal state during the pivot motion. For at least the reasons listed above, applicant’s arguments against the teachings of Park are not found persuasive.
Applicant further argues “In addition, the ultrasound transmission portion in park is formed as a flat planar surface” (REMARKS pg. 6). Examiner respectfully disagrees in that although the most distal portion appears to be a flat planar surface, it is noted that the ultrasound transmission portion has been interpreted to include the entire surface of the lower portion which is curved from the middle portion towards the side and thus is considered “gently curved” as recited by the claim. See at least figs. 3 and 4 depicting the gently curved shape of the ultrasound transmission portion. For at least these reasons, applicant’s arguments against the teachings of Park are not found persuasive.
Applicant further argues regarding the claimed invention “the ultrasound transmission portion is formed in a convex curved shape toward the bottom, the ultrasound transduction unit is designed to perform a pendulum-like curved movement along this shape. Furthermore, in the claimed invention, the ultrasound transduction unit does not maintain a horizontal orientation; rather, its irradiation direction and height vary as it moves along the curved surface of the ultrasound transmission portion (see fig. 7 of the current application reproduced below)” and concludes that “park fails to anticipated amended claim 1) (REMARKS pg. 7) In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a convex curved shape toward the bottom”, “a pendulum-liked curved movement along this shape”, “the ultrasound transduction unit does not maintain a horizontal orientation”, and “its irradiation direction and height vary as it moves along the curved surface of the ultrasound transmission portion”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, while applicant asserts that the claimed invention is directed to the above elements, it is noted that none of said elements are implicitly nor explicitly recited by the claims. For example, there is no requirement for a convex curved shape toward the bottom (rather the claim recites a gently curved shape with a shape raised toward the outside) , a pendulum-like curved movement along this shape (rather the claim recites pendulum movements to correspond with a gently curved inner surface), and an ultrasound transduction unit which does not maintain a horizontal orientation and has an irradiation direction and height that varies as it moves along the curved surface. For at least the reasons listed above, applicant’s arguments regarding the nature of the claimed invention are not found persuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “gently curved” in claim 1 is a relative term which renders the claim indefinite. The term “gently” 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. Examiner notes that while the specification describes that the ultrasound transmission portion may be formed in a gently curved shape and discloses a gently curved inner surface, there is no description/disclosure of what is meant by gently such that a person having ordinary skill in the art would readily understand how curved (or not curved) something would need to be to be considered gently curved. For examination purposes any amount of curvature has been considered to be gently curved, however, clarification is required.
Claim 1 recites the limitation “a gently curved shape with a shape raised toward the outside”. Examiner first notes that it is unclear if the shape raised towards the outside is considered the same as the gently curved shape, thus is intending to further define the gently curved shape as meaning it is “raised toward the outside”. Furthermore, the outside lacks sufficient antecedent basis in the claim, therefore it is unclear what is meant by “the outside” and “a shape raised toward the outside”. In other words, the limitation is unclear as to what the shape is raised from and which “outside” the shape is raised toward.
Claim 1 recites the limitation “the gently curved inner surface of the ultrasound transmission portion”. There is insufficient antecedent basis for the limitation “the gently curved inner surface” in the claim. It is unclear if the claim is attempting to define the gently curved shape as corresponding to or being an inner surface or if the claim is attempting to set forth a different/distinct gently curved inner surface. For examination purposes, it has been interpreted to mean any gently curved inner surface and may be the same as the gently curved shape or different, however, clarification is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Foreign Park (KR 20190115188 A), hereinafter Park. Examiner notes that citations to park are with respect to the translated copy provided herein.
Regarding claim 1,
Park discloses a head for ultrasound therapy (at least fig. 1 (10) and corresponding disclosure in at least [0036]), the head (10) comprising:
An upper portion (at least fig. 3 (110, 120, 220, 230, and 240) and corresponding disclosure in at least [0085]-[0095]); and
A lower portion (at least fig. 3 (210) and corresponding disclosure in at least [0040]),
Wherein the upper portion comprises a first axial movement portion (at least fig. 3 (120) and corresponding disclosure in at least [0095-[0096]) moving in a back and forth direction ([0096] which discloses the second operating body member 122 linearly reciprocates in the front and rear directions (thus in a back and forth direction));
A second axial movement portion (at least fig. 3 (110) and corresponding disclosure in at least [0095]-[0096]) that is connected to the first axial movement portion (see at least fig. 3 in which the second axial movement portion 112 is connected to the first axial movement portion and [0117] which discloses the second actuating body member 122 connected to the first actuating body member (i.e. 112)) and moves the first axial movement portion (122) in a left and right direction ([0115] which discloses when the first operation body member 112 (part of second axial movement portion 110) linearly reciprocates in the X-axis direction by the operation of the first rotation motor 111 ,the second operation body member linearly reciprocates together with the first operation body member 112 and [0096] which discloses the first operating body 112 linearly reciprocation the left and right directions (i.e. in the X-axis) and [0119] which discloses linearly reciprocating the first operating body member 112 in the X-axis direction and linearly reciprocating the second operating body member 122 connected to the first operating body member 112 in the X-direction. Furthermore, examiner notes that movement of the second axial movement portion 110 would necessarily cause the first axial movement portion in the left and right direction would thereby cause the first axial movement portion 120 to move in the left and right direction accordingly);
A ball joint (at least fig. 3 (232a) and corresponding disclosure in at least connected to the first axial movement portion (122) (see at least fig. 3 and [0096] which discloses a second operation body member 122… to which an operation ball joint portion 232a of the operation shaft portion 130 is pivotally coupled); and
An ultrasound transducer portion (at least fig. 3 (220) and corresponding disclosure in at least [0044] and [0065]) that is connected to the ball joint (232a) (see at least fig. 3 depicting the ultrasound transducer portion connected to the ball joint 232a at least via pivot shaft part 230) and is moved by both the first axial movement portion (120) and the second axial movement portion (110) ([0045] which discloses the first actuator 110 and the second actuator 120 move the ultrasonic transducer part in different directions. See also [0119] which discloses the pivot shaft part 230 is pivoted in the left-right direction, that is, in the X-direction by linearly reciprocating the first operating body member 112 in the X-axis direction by the operation of the first actuator 110 and linearly reciprocating the second operating body member 122 connected to the first operating body member in the X-axis direction and the first guide shaft member and second guide shaft member thus pivot together and the ultrasonic transducer part 220 moves along a curve while maintaining horizontality see also [0085] which discloses linearly moving the first actuator 110 in the Y-axis direction to pivot shaft portion 230 (thus the ultrasonic transducer portion 220 attached thereto) in the Y-axis direction).
Wherein the first axial movement portion (120) comprises:
a first axial skeleton portion (see annotated fig. 4 below);
a first axial shaft portion (at least fig. 2 (125a) and corresponding disclosure in at least [0109]) disposed across the first axial skeleton portion (see annotated fig. 4 below in which the guide rail is disposed across the first axial skeleton portion. See also fig. 3 depicting the first axial shaft portion disposed across the skeleton portion); and
A first axial drive portion (at least fig. 2 (122) and corresponding disclosure in at least [0108]) that is connected to the first axial shaft portion and moves along the first axial shaft portion (at least fig. 2 and [0109] which discloses the second operating body member 122 and movably coupled to the second guide rail 125a to guide a linear reciprocating motion of the second operating body member 122 while moving along the second guide rail 125a)
Wherein the second axial movement portion (110) comprises:
A second axial skeleton portion (see annotated fig. 5 below. See also 111a of fig. 5 and 110a of fig. 2);
A second axial shaft portion (at least fig. 5 (115a) and corresponding disclosure in at least [0102]) disposed across the second axial skeleton portion ; and
A second axial drive portion (at least fig. 2 and 5 (112) and corresponding disclosure in at least [0099]) that is connected to the second axial shaft portion (115a) and moves along the second axial shaft portion ([0102] which discloses the first operation body member 112 and movably coupled to the first guide rail 115a to guide a linear reciprocating motion of the first operation body member 112 while moving along the first guide rail 115a), wherein the second axial drive portion (112) is coupled to the first axial skeleton portion (see at least annotated fig. 4 above depicting the second axial drive portion 112 coupled to the first axial skeleton portion)
Wherein the second axial movement portion (110) is coupled to the first axial skeleton portion (see at least annotated fig. 4 above in which the second axial portion 110 (including portion 112) is coupled to the first axial skeleton portion) and moves the first axial movement portion (120) in a left and right direction ([0017] which discloses the first actuating body member 112 is linearly reciprocated in the X-axis direction by the operation of the first actuator 110 and the second actuating body member 122 connected to the first actuating body member 112 is linearly reciprocated in the X-axis direction by the operation of the first actuator 110 and [0117] which discloses the second actuating body member 122 connected to the first actuating body member (i.e. 112)) and moves the first axial movement portion (122) in a left and right direction ([0115] which discloses when the first operation body member 112 (part of second axial movement portion 110) linearly reciprocates in the X-axis direction by the operation of the first rotation motor 111 ,the second operation body member linearly reciprocates together with the first operation body member 112 and [0096] which discloses the first operating body 112 linearly reciprocation the left and right directions (i.e. in the X-axis) and [0119] which discloses linearly reciprocating the first operating body member 112 in the X-axis direction and linearly reciprocating the second operating body member 122 connected to the first operating body member 112 in the X-direction. Furthermore, examiner notes that movement of the second axial movement portion 110 would necessarily cause the first axial movement portion in the left and right direction would thereby cause the first axial movement portion 120 to move in the left and right direction accordingly)
wherein the first axial drive portion (at least fig. 2 (122) and corresponding disclosure in at least [0096]) of the first axial movement portion (120) is connected to the ball joint (232a) (see at least fig. 2 and [0095] which discloses a second operation body member 122 linearly reciprocating in a direction different from the direction of rotation of the second rotation motor 121 and to which an operation ball joint portion 232a of the operation shaft portion 130 is pivotally coupled), and
wherein the lower portion comprises an ultrasound transmission portion (at least fig. 2 (212) and corresponding disclosure in at least [0054] where the lower surface portion is considered an ultrasound transmission portion as ultrasound is transmitted therethrough to the patient) is disposed in the lower portion (210) (see at least fig. 2-4)
and wherein the ultrasound transmission portion is formed in a gently curved shape with a shape raised toward the outside (see at least figs. 3 and 4 depicting a gently curved shape with a shape raised toward the outside (e.g. the bottom surface raises toward the outside therefore forming a gently curved shape), and the ultrasound transducer portion (220) moves in a back and forth and left and right directions via the ball joint in a path of pendulum movements (see at least fig. 4 depicting pendulum movements and [0016] which discloses the transducer moves along a curved line and [0065] which discloses pivot shaft portion 230 is connected to the operating portion to pivot by the operation of the operating portion and is connected to the ultrasonic transducer portion 220 to move the ultrasonic transducer portion 220 along a curve, thus in a pendulum movement as depicted in at least fig. 4) in order to correspond to the gently curved inner surface of the ultrasound transmission surface (see at least annotated fig. 4 in which the movement corresponds to the gently curved inner surface of the ultrasound transmission portion in its broadest reasonable interpretation where corresponds to is broadly recited and since the movement of the transducer portion follows along the inner surface and curved portions thereof it necessarily corresponds thereto).
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Annotated fig. 4
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Annotated fig. 5
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bockenstedt et al. (US 20090171252 A1) teaches an ultrasound therapy head having a transmission portion which is gently curved and an ultrasound transducer portion that moves in back and forth and left and right directions via a ball join in a path of pendulum movements in order to correspond to the gently curved inner surface of the ultrasound transmission portion (See at least figs. 3-4 and fig. 13 and [0064] The use of the joystick like control arm also allows for the calculation of the Z-elevation change in the focal point of the transducer for any position of the control arm. An effect of the pendulum design is that as the transducer swings about the pivot point, the transducer focal point Z depth will change relative to a flat plane)
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 5712700552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LYN KLEIN/Examiner, Art Unit 3797