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 .
Information Disclosure Statement
The information disclosure statement filed October 25, 2024 has been entered and the references cited therein have been considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: The vents 138 (para. 0035). 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: controller in claims 6 and 7.
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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (U.S. Patent Application Publication No. 2024/0189029) in view of Leuthardt et al. (U.S. Patent Application Publication No. 2017/0119467).
In regard to claims 1, 2, 8-13, 15, 17, 23, Schwartz et al. teach a therapeutic treatment system (see para. 0004) comprised of laser catheter assembly 101 with an illuminating system 200 including an optical fiber 202 and a laser source 203 and a cooling system 300 with a coolant reservoir 305, a coolant pump 307 and a coolant recovery bag 309 (see Fig. 1 and para. 0085). An introducer probe 113 encloses the illuminating system 200 and the cooling system 300 and the introducer probe 113 can be an elongated outer tubular section 114 with a sealed end 115 that can be clear, optically and/or infrared transparent and shaped to distribute light from the optical fiber 202 (see Figs. 2A and 2B and paras. 0100-0102). Schwartz et al. also teach that the optical fiber tip 204 can include a diffuser tip 223 integrally formed at the tip 204 and configured to diffuse optical energy received from the optical fiber 202 (see para. 0103). Schwartz et al. also teach that the introducer probe 113 can have a width (diameter) of less than or equal to about 2 mm, 1 mm, 0.5 mm or ranges including and/or spanning the aforementioned values (see para. 0124). Schwartz et al. are silent as to a depth stop configured to adjust an insertion length of the introducer probe 113 but do teach that the introducer probe 113 can be inserted into tissue using a trocar sleeve assembly 400 with a trocar 425 and a sleeve catheter 426 (see para. 0125) and that the introducer probe 113 has hash marks 121 and/or gradations to mark the depth of penetration of the probe into tissue (see para. 0112). Leuthardt et al. teach a similar probe system 100 for performing a thermoablation procedure on the brain 200 comprised of a probe 102 and a probe mount 106 where the probe mount 106 is a mechanism which is operable to manipulate the portion of the probe 102 inserted into the skull (see Fig. 1 and para. 0017). After the sheath 112 of probe 102 has been inserted into the skull 204 to a desired depth, the probe mount 106 is locked in order to fix the sheath 112 in position along the insertion axis A (see Figs. 4 and 5 and para. 0027). The interface between the sheath 112 and the probe mount 106 can be adjusted to selectively reposition and fix the sheath 112 in place such that the depth at which the sheath 112 is inserted into the skull 204 is selectable (see para. 0031). Leuthardt et al. thus demonstrate that the use of probe mounts to selectively fix a sheath and thereby act as a depth stop to adjust an insertion length of the sheath are well known in the art for the purpose of precisely and selectively controlling the insertion depth of the sheath. Since, as noted above, Schwarz et al. teach that the introducer probe 113 can be inserted into tissue using a trocar sleeve assembly 400 with a trocar 425 and a sleeve catheter 426 (see para. 0125) and that the introducer probe 113 has hash marks 121 and/or gradations to mark the depth of penetration of the probe into tissue (see para. 0112), it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Schwartz et al. with the probe mount 106 of Leuthardt et al. in order to precisely and selectively controlling the insertion depth of the introducer probe 113. In regard to claim 3, see paras. 0035 and 0163 of Schwartz et al. In regard to claims 4 and 5, see para. 0154 of Schwartz et al. In regard to claims 6 and 7, Leuthardt et al. teach a temperature sensing structure 118 comprised of a thermocouple 134 that gauges the temperature of the tip 126 where the temperature sensing structure 118 is connected to probe control unit 108 (see Fig. 1 and paras. 0022-0023). In addition, Schwartz et al. teach that the period of time that the laser is active at a given position can be equal to or at least about 15 minutes (see para. 0151) and that a coolant pump 307 controls the flow of coolant to control the temperature of the probe (see above). Furthermore, it is well known in the art, as evidenced by Leuthardt et al., that computer control of medical devices is both well-known and widely used. A proportional control algorithm, as broadly as claimed, would simply switch on either the laser or the coolant pump to control the temperature of the probe and this would be desirable in order to avoid overheating of the probe and/or inadvertent tissue damage. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Schwartz et al. with the probe control unit 108 of Leuthardt et al. that is connected to a temperature sensing structure 118 in the probe so that the temperature of the probe can be controlled using a proportional control algorithm and the active of time of the laser can also be controlled using a proportional control algorithm in order to avoid overheating of the probe and/or inadvertent tissue damage. In regard to claims 14, 16 and 18, Schwartz et al. teach that the probe 113 can include an internal tube 117 having a first lumen 116 and a second lumen 118 (see para. 0146). Figure 7L shows that these lumens are proximally offset from the distal end of the sealed end 115 by distances measure in millimeters (as the overall length of the probe 113 is multiple centimeters (see para. 0112). In regard to claim 19, see Figure 2A-1 of Schwartz et al. In regard to claim 20, inlet connector 104 constitutes a device to hold the coolant inlet conduit 306 in position (see Fig. 1 of Schwartz et al.). In regard to claim 21, as the outer diameter of probe 113 is less than or equal to about 2 mm, 1 mm, 0.5 mm or ranges including and/or spanning the aforementioned values (see para. 0124), it follows that the inner diameter of the inlet conduit 306 would be about 0.250 to 0.350 mm and the outer diameter would be about 0.400 to 0.650 mm as the conduit 306 needs to fit within the probe 113. In regard to claim 22, see Fig. 1 of Schwartz et al. showing conduits 127 and 132.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794