DETAILED ACTION
The following is a Final Office Action on the merits.
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 .
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 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.
Response to Amendment
Acknowledgment is made to the amendment received 4/15/2026.
Applicant’s amendments to the abstract are sufficient to overcome the specification objection set forth in the previous office action.
Applicant’s amendments to the specification are sufficient to overcome the specification new matter objection set forth in the previous office action. The Examiner notes that the specification can still contain reference to the priority chain of the PCT and Korean application, but cannot state they are incorporated by reference.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome 35 USC 112(b)/second paragraph rejection to claim 1 set forth in the previous office action.
Terminal Disclaimer
The terminal disclaimer filed on 4/15/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of co-pending application nos. 18/684411 & 19/034080 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “the other end” to -another end- in ll. 16. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: amend “rail through” to -rail and through- in ll. 4. Appropriate correction is required.
Claim Interpretation
Claims 3-5, 9 & 11 all recite “when” phrases which are interpreted as functional language/intended use.
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: “electrode unit”, “electrode guide”, “electrode guide driving unit”, “electrode driving unit”, “a moving unit” and “reducer” 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. Specifically: “electrode unit 120 may include a base unit 121, an electrode unit 122 and a sensor unit 123…electrode unit 122 may be composed of two electrodes extending parallel to each other on the base unit 121 on the base unit 121”; “electrode guide 130 includes a plurality of joint units 131 …the electrode guide 130 may further include a tip joint 132 and a wire 133”, “electrode guide driving unit 140 may be configured to move the electrode guide 130 in forward and backward directions, and may include a frame 141, a motor unit 142, a rod block 143, a wire block 144 and a variable connection unit 145”; “electrode driving unit 150 may include a tensile force maintaining unit 151, a moving unit 152, a reducer 153, a forward movement rail 154, a backward movement rail 155, a connection rail 156 connecting the forward movement rail 154 and the backward movement rail 155, and a second stopper 157”; and “moving unit 152 may include a connection portion 152a for connection to the tensile force maintaining unit 151, the pin 152b, a support 152c and a hinge 152d”. See 35 USC 112(b)/second paragraph rejection regarding the “reducer”.
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, 3 & 5-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations of “an end of the electrode unit”, “an opposite end of the electrode unit” and “the other end of the electrode unit”. It is unclear how many “ends” are being claimed for the electrode unit. For purposes of examination, the “an opposite end of the electrode unit” and “the other end of the electrode unit” will be interpreted as being the same.
Claim 1 recites the limitation “a reducer that is configured to gradually decrease a length of the first spring to a predetermined length to reduce a speed of the electrode connection portion moved in the backward direction by the tensile force of the first spring when the tensile force maintaining unit and the moving unit are disconnected from each other” which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (“reducer” is a generic placeholder modified by the functional limitation of “that is configured to gradually decrease a length of the first spring to a predetermined length to reduce a speed of the electrode connection portion moved in the backward direction by the tensile force of the first spring when the tensile force maintaining unit and the moving unit are disconnected from each other” and not further modified by sufficient structure or material for performing the claimed function). The originally filed disclosure is devoid of adequate structure to perform the claimed function. In particular, the specification states: “The reducer 153 may reduce the tensile force of the first spring 151a when the tensile force maintaining unit 151 and the moving unit 152 are disconnected from each other…. Therefore, in the present disclosure, the reducer 153 gradually reduces the tensile force of the first spring 151a so that damage to the tube V can be suppressed…. Here, when the tensile force maintaining unit 151 and the moving unit 152 are disconnected from each other, the electrode driving unit 150 may gradually reduce the tensile force of the first spring 151a by means of the reducer 153. That is, the length of the first spring 151a may be gradually decreased to a predetermined length (D2.fwdarw.D3) by means of the reducer 153.” The drawings illustrate a box as “reducer 153”. Thus, the disclosure is devoid of any specific structure that performs the function in the claim and lacks description for one of ordinary skill in the art to understand the structure or structures that perform(s) the claimed function.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, 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 and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should 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.
Claims 3 & 5-11 depend from claim 1 and are thus also rejected.
Allowable Subject Matter
Claims 1, 3 & 5-11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The closest prior art is regarded as: Joeng et al. (KR10-2244131, using US2023/0157747 as translation, cited in IDS, having two common inventors, previously cited) teaches an electrode device comprising a main body, an electrode unit and an electrode guide configured to enclose a circumference of a tube in a body, but fail to disclose the structure (as invoked under 35 USC 112(f)/sixth paragraph) of “a tensile force maintaining unit” and “a maintaining unit” in combination with the limitations of claim 1. Elmouelhi et al. (2006/0079883, previously cited) disclose an electrode device comprising a main body including a shaft, an electrode unit (30), an electrode guide (38A), an electrode guide driving unit (110), an electrode driving unit (108), a tensile maintaining unit (112), and a moving unit (118) that disconnects from the tensile maintaining unit (112), but fails to disclose the structure (as invoked under 35 USC 112(f)/sixth paragraph) of “an electrode guide”, “an electrode guide driving unit”, “a tensile force maintaining unit” and “a maintaining unit”. Park et al. (KR 10-2015-0021632, cited in IDS, previously cited) disclose a medical device comprising a guide driving unit (300, 310, 311, 315, 312, 365, 362, 340) configured to move a guide (140) in a forward and backward direction and a driving unit (200, 210, 220, 271, 262, 215, 250) configured to move a unit that includes a tensile force maintaining unit (250) and a moving unit (200), but fails to disclose all elements of the structure (as invoked under 35 USC 112(f)/sixth paragraph) of “an electrode guide”, “an electrode guide driving unit”, “a tensile force maintaining unit” and “a maintaining unit”.
Response to Arguments
Applicant's arguments filed 4/15/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that the term “reducer” is “well understood by a person of ordinary skill in the art as a mechanical component that reduces the magnitude of speed or force—in this case, a structure that physically limits the displacement of the first spring to a predetermined length to prevent the electrode connection portion from moving too rapidly in the backward direction” and “a person of ordinary skill in the art would readily understand the structure of the reducer from the description in the specification and the drawings, and the amended claim language clearly and distinctly claims the subject matter of the invention”, the Examiner respectfully disagrees. MPEP 2181 states: “ The disclosure of the structure (or material or acts) may be implicit or inherent in the specification if it would have been clear to those skilled in the art what structure (or material or acts) corresponds to the means- (or step-) plus-function claim limitation. See id. at 1380, 53 USPQ2d at 1229; In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir. 1997).” And “disclosure of structure corresponding to a means-plus-function limitation may be implicit in the written description if it would have been clear to those skilled in the art what structure must perform the function recited in the means-plus-function limitation. See Atmel Corp. v. Information Storage Devices Inc., 198 F.3d 1374, 1379, 53 USPQ2d 1225, 1228 (Fed. Cir. 1999)” First, 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., “mechanical reducer”) 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). Second, the specification fails to explicitly disclose the structure of the claimed “reducer”. Third, the specification fails to implicitly disclose the structure of the claimed “reducer”. Since the “reducer” can be one of various structures that gradually decreases the length of the first spring (e.g., gear reducer, weight/load reducer, extension spring reducer), it is also not implicitly clear to one of ordinary skill in the art at the time the invention was effectively filed the specific structure of the claimed “reducer”.
In response to Applicant’s arguments that the claims do not invoke 35 USC 112(f) since the claim language lacks the terms “means for” or “step for”, the Examiner respectfully disagrees. The 3-prong analysis is presented in the table below for each limitation:
(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 [AltContent: rect]
(C) the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
(A)
(B)
(C)
“electrode unit”
“… configured to denervate or modulate at least some nerves on a tube in a body”
“formed to be drawn out form one end of the shaft” does not denote structure, material, or acts for performing the claimed function is recited.
“denervate or modulate at least some nerves on a tube in a body” does not denote structure, material, or acts for performing the claimed function is recited.
“electrode guide”
“configured to guide the electrode unit to be brought into contact with the tube in the body”
“coupled to an end of the electrode unit” does not denote structure, material, or acts for performing the claimed function is recited.
“guide the electrode unit to be brought into contact with the tube in the body” does not denote structure, material, or acts for performing the claimed function is recited.
“electrode guide driving unit”
“configured to move the electrode guide in forward and backward directions”
“move the electrode guide in forward and backward directions” does not denote structure, material, or acts for performing the claimed function is recited.
“electrode driving unit”
“configured to move the electrode unit in the forward and backward directions in conjunction with the electrode guide driving unit”
“move the electrode unit in the forward and backward directions in conjunction with the electrode guide driving unit “does not denote structure, material, or acts for performing the claimed function is recited.
“a moving unit”
“that is configured to move the tensile force maintaining unit in the forward direction until the electrode guide encloses a circumference of the tube in the body in a state where the moving unit is connected to the tensile force maintaining unit, and then is disconnected from the tensile force maintaining unit
“move the tensile force maintaining unit in the forward direction until the electrode guide encloses a circumference of the tube in the body in a state where the moving unit is connected to the tensile force maintaining unit, and then is disconnected from the tensile force maintaining unit” does not denote structure, material, or acts for performing the claimed function is recited.
“reducer”
“that is configured to gradually decrease a length of the first spring to a predetermined length to reduce a speed of the electrode connection portion moved in the backward direction by the tensile force of the first spring when the tensile force maintaining unit and the moving unit are disconnected from each other”
“gradually decrease a length of the first spring to a predetermined length to reduce a speed of the electrode connection portion moved in the backward direction by the tensile force of the first spring when the tensile force maintaining unit and the moving unit are disconnected from each other” does not denote structure, material, or acts for performing the claimed function is recited.
In response to Applicant’s request the claims not be interpreted under 35 USC 112(f), the Examiner notes that if Applicant does not want to have the claim limitation interpreted under 35 U.S.C. 112(f), Applicant may:
(1) present a sufficient showing to establish that the claim limitation recites sufficient structure to perform the claimed function so as to avoid interpretation under 35 U.S.C. 112(f); or
(2) amend the claim limitation in a way that avoids interpretation under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function). (See MPEP 2181)
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 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 JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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