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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to parent Application No. KR10-2021-0061981, filed on 13 May 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6 November 2023, 18 March 2025, & 15 December 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Species I in the reply filed on 10 December 2025 is acknowledged. The traversal is on the ground(s) that “Species I and II both pertain to the same field of search, contrary to the Examiner's assertion” AND a lack of explanation as to “why there would be a serious search and/or examination burden on the examiner.”
This is not found persuasive. Firstly, the species do not belong to the field of search of “used in the medical field for the diagnosis and treatment of affected areas as well as for skin care.” As detailed in the Restriction Requirement of 11 September 2025, the field of the inventive concept would be variable focal depth in HIFU applications (see ¶ [0002] of the instant specification). The divergent field of searches of the different species of focal depth adjustment would include an expanding tube versus a variable shaft focal depth adjustment means. Secondly, the Office met their burden of explaining the different fields of search when identifying the different species: the expanding tube and the variable shaft focal depth adjustment means.
Moreover, the instant specification explicitly that “unlike the one embodiment of the inventive concept, the ultrasonic wave generating apparatus capable of adjusting a focus depth of ultrasonic waves according to another embodiment of the inventive concept further includes a variable shaft 120 and a manipulation part 130” (emphasis added) (see ¶ [0074]). More specifically, the instant specification clearly admits that the embodiments of mutually exclusive.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the drawings illegible. More specifically, it difficult to identify which parts the various reference numerals are pointing to. For example, elements 33, 33a, 33b all appear to be pointing at the same element. Similarly, elements 41, 100, & 110 are indistinguishable from one another. Applicant is suggested to employ a landscape arrangement and a larger, zoomed-in view which clearly distinguishes the various elements.
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "50" and "52" have both been used to designate the “guide shaft” or the “guide part,” which is also unclear. Similarly, reference characters "80" and "90" appear to be designating the same tube instead of a first and second tube. 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. 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 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:
Claim 1 recites “a guide part provided in the cartridge housing, and configured to guide the ultrasonic wave generating unit such that the ultrasonic wave generating unit is movable in the vertical direction and an axial line direction of the movable shaft” which includes the generic placeholder “guide part” coupled to functional language “to guide the ultrasonic wave generating unit such that the ultrasonic wave generating unit is movable in the vertical direction and an axial line direction of the movable shaft ” without reciting sufficient structure to achieve the function. For the purpose of this Examination, the broadest reasonable interpretation of the claim limitation is the structure, material or act described in the specification as performing the entire claimed function and equivalents to the disclosed structure, material or act. In particular, while paragraph ¶ [0036] of the instant specification discloses that “the guide part 50 functions to guide the ultrasonic wave generating unit 30 such that the ultrasonic wave generating unit 30 may be moved in the vertical direction of the transducer 32 and the axial line direction of the movable shaft 40”, neither the instant specification nor the drawings explicitly describe the structure associated with the guide part.
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.
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(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for “guide shaft”, does not reasonably provide enablement for “guide part”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. In particular, the instant specification discloses in ¶ [0036] that “the guide part 50 functions to guide the ultrasonic wave generating unit 30 such that the ultrasonic wave generating unit 30 may be moved in the vertical direction of the transducer 32 and the axial line direction of the movable shaft 40.” However, since the instant specification labels the guide part 50 and the guide shaft 52 as the same element in FIGS 1-5, one of ordinary skill in the art cannot discern the enabling structure associated with the guide part. It should be appreciated that one of ordinary skill in the art would understand that the outer housing of the connector 31 translates both vertically and horizontally about bushing 70. But, it is not clear what structure is associated with the guide part. Accordingly, the instant specification does not teach those skilled in the art how to use the full scope of the claimed invention without undue experimentation; therefore, the instant specification is not commensurate with the scope of protection sought by the claims.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7 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.
In particular, Claim 1 recites a “guide part”; however, since FIGS. all indicate that the guide part 50 and the guide shaft 52 are the same element, one of ordinary skill in the art would not be able to discern the structure associated with the guide part apart from the functional language of “functions to guide the ultrasonic wave generating unit 30 such that the ultrasonic wave generating unit 30 may be moved in the vertical direction of the transducer 32 and the axial line direction of the movable shaft 40” (see ¶ [0036]).
Dependent claims are rejected by virtue of their dependency to abovementioned claims.
Allowable Subject Matter
Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) and 35 U.S.C. 112(b), set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art Lee (KR20150115432A; hereinafter "Lee1") teaches of:
An ultrasonic wave generating apparatus capable of adjusting a focus depth of ultrasonic waves (ultrasonic handpiece 100 capable of adjusting the height {i.e. vertically movable} of the ultrasonic transducer 150 via elevating means 160; see pg. 5, ¶ 1), the ultrasonic wave generating apparatus comprising:
a handpiece (handle 110);
a cartridge housing separably mounted on the handpiece (cartridge 120 with divided {i.e. separable} from the handle 110; see FIG. 2 & pg. 5, ¶ 1-2);
an ultrasonic wave generating unit provided in the cartridge housing and including a transducer configured to generate the ultrasonic waves (transducer 150; see FIG. FIG. 5);
a movable shaft configured to be movable in an axial line direction (shaft 171 can be linearly reciprocated in a horizontal direction; see pg. 4, ¶ 18); and
a guide part (shuttle 140) provided in the cartridge housing, and configured to guide the ultrasonic wave generating unit such that the ultrasonic wave generating unit is movable in the vertical direction and an axial line direction of the movable shaft (shuttle 140 translates horizontally with shaft 171 and vertically with lifting bar 163; see pg. 5, ¶ 6 & 9-10), and
wherein the guide part includes:
a guide shaft passing through the ultrasonic wave generating unit (lifting bar 163 acts as guide shaft passing through shuttle 140 as illustrated in FIG. 5).
While Lee teaches of a vertically and horizontally translatable transducer, Lee does not teach of the shaft 171 moving in both the horizontal and vertical directions, only in the horizontal direction as illustrated in the various figures.
Similarly, Lee et al. (KR20140009052A; hereinafter "Lee2") also teaches ultrasonic beauty device with a variable height transducer 610. Lee2 teaches of a handpiece 550, cartridge 500, moveable shaft 820, and guide part M through which guide shaft 540 is disposed. Like Lee1, Lee2’s moveable shaft 820 only translates horizontally and not vertically. The guide part M includes an adjustable screw mechanism 621/622 which adjust the height of the transducer 610.
Accordingly, neither Lee1 nor Lee2, alone or in combination, teaches of the recited limitations of Claim 1.
Dependent claims are allowable by virtue of their dependency to abovementioned Claim
Branson et al. (US PGPUB 20150321026) which teaches of a cartridge style HIFU device with a height adjustable lens 800 (see FIG. 20c).
Jeong (KR20120040909A) teaches of second lead screw 27 for vertical translation; however, first lead screw 22 for horizontal translation does not move as it is lead screw and not a linear actuator and does not move horizontally.
Lee3 (KR20170095549A) teaches of a height adjusting method in which the transducer 126 height is adjusted relative to the coupling member 125 via screw arrangement. However, linear actuating rod 113 only actuates horizontally and not vertically.
Kang et al. (KR20180015095A) teaches of a cartridge style HIFU handpiece with a screw-like adjustment means utilizing adjusting wheel 221 which rotates to vertically translate rotation axis 225 which is attached to transducer 215. However, the horizontal moving body 131/431 only moves horizontally and not vertically.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571) 272-6402. The examiner can normally be reached M-F 9:00 am - 5:00 pm (CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798