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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1-12, drawn to an electrode assembly, classified in A61B18/00.
II. Claim 13-20, drawn to method to direct irrigation fluid from a medical apparatus, classified in A61B18/1492.
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus as claimed can be used to practice another and materially different process that does not require directing the irrigation fluid from the axial channel through at least one trans-axial channel disposed at an oblique angle to the axial channel through the lumen of the electrode and leading to an exterior of the fluid-directing assembly while blocking the irrigation fluid from flowing axially in a forward direction beyond the at least one trans-axial channel.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Korbin M. Blunck on 08/19/2026 a provisional election was made without traverse to prosecute the invention of group I, claim 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claim 13-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Rejections - 35 USC § 102
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.
Claims 1-3 and 5-9 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Koblish (US 2009/0093811).
Regarding claim 1, Koblish discloses an electrode assembly for a medical apparatus, the electrode assembly (fig..2A; tip 20) comprising: an electrode in electrical communication with an energy source to apply ablative energy to tissue inside a body of a patient [0045], the electrode comprising an outer surface (see annotated figure below), a lumen, and a wall having a plurality of apertures formed therethrough (fig.2B); a fluid-directing assembly that mates to the electrode (the fluid-directing assembly mates to the electrode at anchor member 48, see also [0043]), the fluid-directing assembly comprising an axial channel (fluid lumen 44 and fluid path 50) that is in fluid communication with a fluid source and leading to an exterior of the fluid-directing assembly [0043] and into the lumen of the electrode (fig.2A), and one or more slots disposed radially about the axial channel of the fluid-directing assembly and extending through the fluid-directing assembly parallel to the axial channel (see annotated figure below); and a baffle fixed to the electrode and spaced apart from the fluid-directing assembly with a gap between the baffle and the fluid-directing assembly to deflect any flow of fluid transverse to the axial channel (see annotated figure below).
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Regarding claim 2, Koblish discloses the electrode assembly according to claim 1, wherein the electrode assembly is configured for attachment to a distal segment section of a probe for insertion into the body (fig.1; see also [0044]).
Regarding claim 3, Koblish discloses the electrode assembly according to claim 2, wherein the fluid-directing assembly is disposed between the distal segment section of the probe and the electrode, the fluid-directing assembly disposed at least partially within the lumen of the electrode (fig.2A).
Regarding claim 5, Koblish discloses the electrode assembly according to claim 1, wherein some of the plurality of apertures are oriented at a forward angle with respect to a longitudinal axis of symmetry to deliver the fluid diagonally forward and outward of the electrode (fig.2B).
Regarding claim 6, Koblish discloses the electrode assembly according to claim 1, wherein some of the plurality of apertures are oriented at a backward angle with respect to a longitudinal axis of symmetry to deliver the fluid that exits the fluid-directing assembly diagonally behind and outward of the electrode (fig.2B, the irrigation aperture 54 are positioned radially around the circumferential which includes backward angle with respect of the longitudinal axis).
Regarding claim 7, Koblish discloses the electrode assembly according to claim 1, wherein the fluid-directing assembly comprises between two and twelve trans-axial channels (see annotated figure above).
Regarding claim 8, Koblish discloses the electrode assembly according to claim 1, wherein the fluid-directing assembly comprises exactly one trans-axial channel (see annotated figure above).
Regarding claim 9, Koblish discloses the electrode assembly according to claim 8, wherein the exactly one trans-axial channel extends 360 degrees about the axial channel (see annotated figure above).
Claim Rejections - 35 USC § 103
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.
Claims 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Koblish (US 2009/0093811).
Regarding claim 4 and 10, Koblish does not disclose wherein the distal segment section comprises a diameter of 2.5 mm and wherein the plurality of apertures has diameters in a range of 0.05-0.2 mm. However, it would have been an obvious matter of design choice to the desired size including a diameter of 2.5 mm and apertures diameters in a range of 0.05-0.2 mm, since such a modification would have involved a mere change in the size of a component. A change in size is general recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Koblish (US 2009/0093811) in view of Messing (US 2003/0004506).
Regarding claim 11-12, Koblish does not disclose the medical apparatus further comprising one or more sensors, each sensor extending at least partially through one of the at one or more slots formed on the fluid-directing assembly and wherein the one or more sensors are configured to detect electrophysiological data of the body. Messing teaches catheter tip may be designed with multiple irrigation channels, multiple channel pathways, and/or exterior shapes to improve the cooling of the tip (abstract). The catheter includes a sensor 350, such as a thermistor, may be located at the distal end of the tip and the irrigation channel 335 may contain a 3D sensor (fig.3, see also [0035]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Koblish with a sensor that extending partially through one of the at one or more slots formed on the fluid-directing assembly as taught by Messing for the purpose of having feedback regarding the treatment.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9 of U.S. Patent No. 12,161,395. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of U.S. Patent No. 12,161,395 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
18/972,304
US 12,161,395
1. An electrode assembly for a medical apparatus, the electrode assembly comprising: at electrode in electrical communication with an energy source to apply ablative energy to tissue inside a body of a patient, the electrode comprising an outer surface, a lumen, and a wall having a plurality of apertures formed therethrough; a fluid-directing assembly that mates to the electrode, the fluid-directing assembly comprising an axial channel that is in fluid communication with a fluid source and leading to an exterior of the fluid-directing assembly and into the lumen of the electrode, and one or more slots disposed radially about the axial channel of the fluid-directing assembly and extending through the fluid-directing assembly parallel to the axial channel; and a baffle fixed to the electrode and spaced apart from the fluid-directing assembly with a gap between the baffle and the fluid-directing assembly to deflect any flow of fluid transverse to the axial channel.
1. A medical apparatus, comprising: a probe, having a distal segment section for insertion into a body of a subject and a longitudinal axis of symmetry; at least one electrode coupled to the distal segment section of the probe and coupled to an energy source to apply energy to tissue inside the body, the electrode comprising an outer surface, a lumen, and a wall having a plurality of apertures formed therethrough; a fluid-directing assembly that mates to the distal segment section of the probe and the at least one electrode, the fluid-directing assembly comprising an axial channel that is in fluid communication leading to an exterior of the fluid-directing assembly and into the lumen of the electrode, and at least three slots disposed radially about the axial channel of the fluid-directing assembly and extending through the fluid-directing assembly parallel to the axial channel; a baffle fixed to the electrode and spaced apart from the fluid-directing assembly with a gap between the baffle and the fluid-directing assembly to deflect any flow of fluid transverse to the axial channel; and at least three sensors, each sensor extending at least partially through one of the at least three slots formed on the fluid-directing assembly.
4. The electrode assembly according to claim 2, wherein the distal segment section comprises a diameter of 2.5 mm
7. The apparatus according to claim 1, wherein the distal segment section comprises a diameter of 2.5 mm.
5. The electrode assembly according to claim 1, wherein some of the plurality of apertures are oriented at a forward angle with respect to a longitudinal axis of symmetry to deliver the fluid diagonally forward and outward of the electrode.
8. The apparatus according to claim 1, wherein some of the plurality of apertures are oriented at a forward angle with respect to the longitudinal axis of symmetry to deliver the fluid diagonally forward and outward of the distal segment section.
6. The electrode assembly according to claim 1, wherein some of the plurality of apertures are oriented at a backward angle with respect to a longitudinal axis of symmetry to deliver the fluid that exits the fluid-directing assembly diagonally behind and outward of the electrode.
2. The apparatus according to claim 1, wherein some of the plurality of apertures are oriented at a backward angle with respect to the longitudinal axis of symmetry to deliver the fluid that exits the fluid-directing assembly diagonally behind and outward of the distal segment section.
7. The electrode assembly according to claim 1, wherein the fluid-directing assembly comprises between two and twelve trans-axial channels.
3. The apparatus according to claim 1, wherein the fluid-directing assembly comprises between two and twelve trans-axial channels.
8. The electrode assembly according to claim 1, wherein the fluid-directing assembly comprises exactly one trans-axial channel.
4. The apparatus according to claim 1, wherein the fluid-directing assembly comprises exactly one trans-axial channel.
9. The electrode assembly according to claim 8, wherein the exactly one trans-axial channel extends 360 degrees about the axial channel.
5. The apparatus according to claim 4, wherein the exactly one trans-axial channel extends 360 degrees about the axis of symmetry.
10. The electrode assembly according to claim 1, wherein the plurality of apertures has diameters in a range of 0.05-0.2 mm.
6. The apparatus according to claim 1, wherein the plurality of apertures has diameters in a range of 0.05-0.2 mm.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-2721213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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