DETAILED ACTION
This Office Action is in response to the Amendment filed 1 June 2026. Claim(s) 1-2, 7-11, 18-35 are currently pending. The Examiner acknowledges the amendments to claim(s) 1-2, 8-11, 20, cancelled claim(s) 3-6, 12-17 and new claim(s) 21-35.
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 .
Claim Interpretation
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:
The limitation ‘treatment device’ in claims 1, 21 and 29 is construed under 35 U.S.C. 112(f).
Claims 1, 21 and 29 function: to engage a tissue and sever or disrupt the tissue.
Corresponding structure: first and second links, Figs. 3B, 5; [0015, 0017, 0054, 0065]; (310).
The limitation ‘actuating assembly’ in claims 1, 21 and 29 is construed under 35 U.S.C. 112(f).
Claims 1, 21 and 29 function: to control transition of the treatment device between the first configuration, the second configuration and the third configuration.
Corresponding structure: Figs. 3, 4; (304, 305, 307, 306); [0059,0064 0065].
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.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0061], lines 8, 10 and 11: please change “pusher” to “push rod”.
Appropriate correction is required.
Paragraph [0061], line 18: please change “1405” to “1407”.
Appropriate correction 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.
Claim(s) 1 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clark, III et al. (US 2014/0277027A1, “Clark”).
Regarding claims 1 and 19, Clark discloses an aesthetic treatment system including an elongate member (1801, Figs. 19, 20; [0135, 0137]) extending from a handle (Fig. 18;1804; [0146]) and is capable of being inserted through the skin. A pushrod (2002) is coupled to the handle and extends through the elongate member (Fig. 20). A treatment device (1802/1902) is attached to a distal portion of the elongate member via fixed pivot location (1903; [0137]). The treatment device has a first configuration when stowed (constrained position; [0135]), a second configuration capable of engaging a tissue (intermediate configuration between constrained and deployed, wherein pushing distal portion and distal ends of treatment device into tissue would result in engagement thereof and a central portion of the treatment device is radially expanded relative to the elongate member), and a third configuration capable of severing or disrupting the tissue (deployed configuration; Fig. 20; [0139]). An actuating assembly (1805; [0146]) is capable of controlling the transition of the treatment device between the first, second and third configurations [0146]. The actuating assembly is capable of holding the treatment device in the second configuration by utilizing a locking mechanism which selectively locks support member (2004) in place one it has extended the treatment device to the desired configuration [0138, 0140]. The treatment device includes a first link and a second link (1902).
Claim(s) 29-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Halloran et al. (US 2016/0166262A1, “O’Halloran”).
Regarding claims 29-31, O’Halloran discloses an aesthetic treatment system including an elongate member (398; Fig. 27-29; [0073]) extending from a handle (Fig. 26;404]) and is capable of being inserted through the skin. The handle having a body (Fig. 26) and an actuating assembly (405). A treatment device (388; Fig. 27-29) is attached to a distal portion of the elongate member. The treatment device has a first configuration when stowed (Fig. 27), a second configuration capable of engaging a tissue (wherein pushing distal portion and distal ends of treatment device into tissue would result in engagement thereof and a central portion of the treatment device is radially expanded relative to the elongate member; Fig. 29), and a third configuration capable of severing or disrupting the tissue (deployed configuration; Fig. 28; [0073-0074]). The treatment device includes a first link having a blade (401) and a second link that is capable of shielding the blade in the second configuration. The blade is exposed in the third configuration. A pushrod (402; [0074]) is coupled to the handle and extends through the elongate member (Fig. 27). The first link is attached to the distal portion of the elongate member. The second link is attached to the distal portion of the pushrod. The first and second links are capable of radially expanding relative to the elongate member in the second configuration (Figs. 27-29). The actuating assembly is capable of controlling the transition of the treatment device between the first, second and third configurations [0074]. Please see annotated figure below.
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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) 10, 11, 21, 22, 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Clark, III et al. (US 2014/0277027A1, “Clark”) in view of Gannoe et al. (US 2002/0002376A1, “Gannoe”).
Regarding claims 10, 11, 21, 22 and 27, Clark discloses an aesthetic treatment system including an elongate member (1801, Figs. 19, 20; [0135, 0137]) extending from a handle (Fig. 18;1804; [0146]) and is capable of being inserted through the skin. A pushrod (2002) is coupled to the handle and extends through the elongate member (Fig. 20). A treatment device (1802/1902) is attached to a distal portion of the elongate member via fixed pivot location (1903; [0137]). The treatment device has a first configuration when stowed (constrained position; [0135]), a second configuration capable of engaging a tissue (intermediate configuration between constrained and deployed, wherein pushing distal portion and distal ends of treatment device into tissue would result in engagement thereof and a central portion of the treatment device is radially expanded relative to the elongate member), and a third configuration capable of severing or disrupting the tissue (deployed configuration; Fig. 20; [0139]). An actuating assembly (1805; [0146]) is capable of controlling the transition of the treatment device between the first, second and third configurations [0146]. The actuating assembly is capable of holding the treatment device in the second configuration by utilizing a locking mechanism which selectively locks support member (2004) in place one it has extended the treatment device to the desired configuration [0138, 0140]. The actuating assembly is capable of holding the treatment device in the second configuration by utilizing a locking mechanism which selectively locks support member (2004) in place one it has extended the treatment device to the desired configuration [0138, 0140]. The treatment device includes a first link and a second link (1902). However, Clark does not disclose a spring that is capable of biasing the pushrod to transition the treatment device to the first configuration.
In the same field of endeavor, biased pushrods, Gannoe teaches a device including a push rod (48, 50) disposed within a lumen. The lumen includes a spring (60) that biases the push rod such that the surgical element (40) is biased in the retracted position [0053]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the elongate member of Clark with a spring, as taught by Gannoe, to automatically bias the pushrod to proximal, retracted position such that the treatment device is in the first configuration. With this modification, the inadvertent harm from the extended blade of the treatment device of the combination of Clark and Gannoe would be prevented from occurring.
Regarding claim 26, the combination of Clark and Gannoe discloses that the treatment device has a distal portion attached to a distal portion of the elongate member, a proximal portion attached to a distal portion of the pushrod and a central portion capable of radially expanding relative to the elongate member in the second configuration. Please see annotated figure below.
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Allowable Subject Matter
Claims 2, 7-9, 18, 20, 23-25, 28, and 32-35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 2, 7-11 and 18-35 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Greer (US 2008/0109023A1) discloses a treatment device (Fig. 8) having first and second links.
THIS ACTION IS MADE FINAL. 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 JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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