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 .
Response to Amendments
The amendments to claims 11 and 20 are acknowledged and the previous claim objections are withdrawn.
The amendment to claim 7 stating that the indexing member “comprises a projection” is sufficient enough to overcome the 112(f) interpretation and the 112(f) interpretation is withdrawn. Regarding the 112(f) interpretation of the “engagement member”, the examiner acknowledges para. 0087 of the specification and included the structure provided in the 112(f) interpretation.
The amendments to claims 7-11, 14, and 15 are acknowledged and the 112(b) rejections are withdrawn.
Response to Arguments
Applicant's arguments filed 04/21/2026 have been fully considered but they are not persuasive.
Applicant argues that Clark fails to teach or suggest “wherein each template guide of the one or more template guides includes one or more applicator tip engagement position openings configured to receive a distal region of an applicator tip" as required in claims 1, 17, and 20.
The examiner respectfully acknowledges applicant’s argument. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, the Clark reference is not used to teach "wherein each template guide of the one or more template guides includes one or more applicator tip engagement position openings configured to receive a distal region of an applicator tip". Johnston already discloses this limitation. Johnston is relied upon as a primary reference to disclose "wherein each template guide of the one or more template guides includes one or more applicator tip engagement position openings configured to receive a distal region of an applicator tip" as required in the independent claims (see Figs. 23A-B for example, para. 0153 of Johnston: “ FIGS. 20-26B illustrate examples of targeting patches (e.g., targeting patch devices) that may be used to guide and/or to insulate a treatment tip and may be placed on the tissue to be treated prior to treatment”). Clark is a secondary reference only used to teach that it is known in the art to have a singular base frame with interchangeable template guides (Fig. 6B, para. 0125 of Clark). The combination of Johnston in view of Clark would result in a product wherein the one or more template guides of Johnston removably fit within the singular base frame. Therefore, the rejections are maintained.
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:
“engagement member” in claim 11. The limitation describing the engagement member in claim 11 (“configured to engage with each template guide to removably secure the template guide in the base frame and against tissue” in claim 11 fails to include sufficient structure to perform the recited function of "engaging". The specification describes the engagement member as a pocket, tab, or latch (para. 0021) or a notch or cut-out (para. 0087). Therefore, the engagement member is interpreted as a pocket, tab, latch, notch, cut-out or any structural equivalent thereof that is configured to engage with each template guide to removably secure the template guide in the base frame and against tissue.
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.
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) 1-9, 11-12, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston (WO 2020077019) [hereinafter Johnston] in view of Clark, III et al. (US 20190269429) [hereinafter Clark, III].
Regarding claim 1, Johnston discloses a template apparatus 2000, 2200, 2200’, 2200’’ (Figs. 20-26B, para. 0153) for guiding an application of electrical energy to a tissue (Figs. 21, 24A-B, para. 0153-0155), the apparatus comprising:
a plurality of base frames (interpreted as the body of the target guides 2200, 2200’, 2200’’ Figs. 22A-C and 2003 of patch 2000 shown in Fig. 20, para. 0153-0155); and
one or more template guides (interpreted as the face of the base frame 2000, 2200, 2200’, 2200’’ defining a space for receiving an applicator tip shown in Figs. 20, 22A-C, para. 0153-0155), wherein each template guide of the one or more template guides includes one or more applicator tip engagement position openings configured to receive a distal region of an applicator tip (Figs. 21, 23A-B, 24A-B, para. 0153-0155, see note below in regards to “configured to” language).
However, Johnston fails to disclose the singular base frame, the one or more template guides configured to removably fit into the singular base frame in one or more orientations and wherein the one or more applicator tip engagement position openings of the one or more template guides are configured to form an enlarged treatment pattern after at least one of the one or more template guides held within the base frame in more than one orientation.
Clark, III in the same field of endeavor of medical frames teaches a base frame 309 (Figs. 6A-6B, para. 0124-0125), one or more template guides 302 (see Fig. 6B) are configured to removably fit into the base frame 309 in one or more orientations (Fig. 6B, para. 0125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the plurality of base frames and the plurality of template guides in Johnston to be a single base frame and a plurality of template guides such that the plurality of template guides is removable and interchangeable from the singular base frame, as taught by Clark, III in order to allow the user to customize the template apparatus for the procedure (para. 0125 of Clark, III) such that the base frame can accommodate different template guides for different applicator tips, thereby increasing the ease of use and utility of the device (para. 0125 of Clark, III).
The combination of Johnston in view of Clark, III would result in a product wherein the one or more applicator tip engagement position openings of the one or more template guides of Johnston (Figs. 20, 22A-C, para. 0153-0155 of Johnston) are configured to form an enlarged treatment pattern (Figs. 20, 22A-24B, para. 0153-0155 of Johnston, see note below in regards to “configured to” language) after at least one of the one or more template guides held within the base frame in more than one orientation as taught by Clark, III (see annotated Fig. 6A of Clark, III below; Fig. 6B, para. 0125 of Clark, III; The examiner notes that since the plurality of template guides removably fit into the base frame in the one or more orientations, as taught by Clark, III, may be flipped over along a longitudinal axis, thereby oriented 180 degrees (as a second orientation relative to a first orientation), and placed within the base frame, thereby meeting the “more than one orientation” limitation).
Note: “wherein each template guide of the one or more template guides includes one or more applicator tip engagement position openings configured to receive a distal region of an applicator tip” is interpreted as functional language and intended use of the claimed invention and not interpreted as a structural component of the claimed invention. Therefore, “a distal region of an applicator tip” is not positively claimed and is interpreted as a functional component that the claimed invention is capable of receiving. Since Johnston discloses the structural components i.e. the one or more applicator tip engagement position openings to perform the functional limitation, Johnston thereby discloses the functional limitation of one or more applicator tip engagement position openings capable of receiving a distal region of an applicator tip and capable of forming an enlarged treatment pattern. For example, para. 0151-0153 of Johnston discloses that the one or more template guides are designed to receive a distal region of an applicator tip. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Note: “wherein the one or more applicator tip engagement position openings of the one or more template guides are configured to form an enlarged treatment pattern after at least one of the one or more template guides held within the base frame in more than one orientation” is interpreted as functional language and intended use of the claimed invention and not interpreted as a structural component of the claimed invention. Therefore, “an enlarged treatment pattern” is not positively claimed and is interpreted as a functional component that the claimed invention is capable of forming. Since Johnston discloses the structural components i.e. for the one or more applicator tip engagement position openings to perform the functional limitation, Johnston thereby discloses the functional limitation of one or more applicator tip engagement position openings capable of forming an enlarged treatment pattern after at least one of the one or more template guides held within the base frame in more than one orientation. For example, para. 0151-0153 of Johnston discloses that the one or more template guides are designed to receive a distal region of an applicator tip. If an applicator tip that is sized small enough to fit in multiple areas of the one or more applicator tip engagement position openings of the one or more template guides is used, the one or more applicator tip engagement position openings is capable of forming an enlarged treatment pattern such that the applicator tip can treat multiple areas within the one or more applicator tip engagement position openings in more than one orientation. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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Annotated Fig. 6A of Clark, III
Regarding claim 2, modified Johnston discloses wherein the base frame comprises an adhesive configured to secure the base frame to a treatment site (Fig. 25B, para. 0156, 0185 of Johnston).
Regarding claim 3, modified Johnston discloses further comprising attachment projections 2205, 2603 extending from the base frame and configured to attach the base frame to the tissue (Figs. 22A-C, 25B, para. 0155-0156 of Johnston).
Regarding claim 4, modified Johnston discloses wherein at least some of the applicator tip engagement position openings (see openings of guides 2200, 2200’ and 2200’’) include one or more rotational orientation indicators (interpreted as extensions 2205 of guides 2200, 2200’, and 2200’’, see Figs. 22A-C of Johnston and one or more fiducial marks 2005 of patch 2000, see Fig. 20, para. 0153 of Johnston) configured to rotationally align the applicator tip within the applicator tip engagement position openings (para. 0153 of Johnston discloses the one or more fiducial marks 2005 align and engage with the treatment tip; para. 0155 of Johnston discloses that the design of guides shown in Figs. 22A-C allow the applicator tip to align without the need for visual markings).
Regarding claim 5, modified Johnston discloses wherein the one or more rotational orientation indicators 2005 (see Figs. 20-21 of Johnston) comprise markings configured to match markings on the applicator tip (Figs. 20-21, para. 0153-0154 of Johnston).
Regarding claim 6, modified Johnston discloses wherein the one or more rotational orientation indicators comprise projections (see Figs. 22A-C of Johnston which illustrates the extensions 2205 as projections; Figs. 20-21, para. 0153 of Johnston discloses that the fiducial marks may be raised marks which are interpreted as projections) configured to engage with the applicator tip in a particular orientation (Figs. 20-21, para. 0153-0155 of Johnston).
Regarding claim 7, modified Johnston discloses all of the limitations set forth above in claim 1. However, modified Johnston fails to disclose further comprising an indexing member comprising a projection on the base frame and configured to engage each template guide of the one or more template guides and to releasably orient the template guide in the base frame.
Clark, III further teaches an indexing member comprising a projection 607 on the base frame 309 (Fig. 6A, para. 0125) and configured to engage each template guide of the plurality of template guides 302 and to releasably orient the template guide 302 in the base frame 309 (Fig. 6A, para. 0125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base frame in modified Johnston to include the indexing members of Clark, III in order to securely constrain the one or more template guides within the base frame (para. 0125 of Clark, III).
Regarding claim 8, modified Johnston discloses wherein the indexing member 607 comprises a tab (Fig. 6A, para. 0125 of Clark, III; The examiner notes that “a tab” is defined as a “short projecting device”, see Merriam-Webster dictionary definition attached) configured to engage with a tab receiver on each template guide of the plurality of template guides (Fig. 6A, para. 0125 of Clark, III, see note below).
Note: “configured to engage with a tab receiver on each template guide of the plurality of template guides” is interpreted as functional language due to the “configured to” language. Therefore, the tab receiver introduced in claim 8 is not positively claimed as a structural component of the device, but interpreted as a functional component that the tab is capable of engaging with. As claimed, modified Johnston discloses all of the structure provided in the limitation to necessitate the functional language i.e. the indexing member 607 comprising the tab (Fig. 6A, para. 0125 of Clark, III). Furthermore, modified Johnston discloses that the tab is designed to engage a top surface of the one or more template guides (Fig. 6A, para. 0125 of Clark, III). Therefore, the tab is capable of engaging with a tab surface positioned on the top surface of the one or more template guides. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 9, modified Johnston discloses wherein the one or more template guides is movably attached to the base frame 309 (Fig. 6B, para. 0125 of Clark, III teaches that the one or more template guides may be interchangeable with the base frame such that the template guides can be moved to and from the base frame, and thereby “movably attached”).
Regarding claim 11, modified Johnston discloses all of the limitations set forth above in claim 1. However, modified Johnston fails to disclose further comprising an engagement member on each base frame (interpreted as the base frame, see 112(b) rejection above) configured to engage with each template guide to removably secure the template guide in the base frame and against the tissue.
Clark, III further teaches an engagement member 607 on a base frame 309 configured to engage with each template guide 302 to removably secure the template guide 302 in the base frame 309 and against tissue. (Fig. 6A, para. 0125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the base frame in modified Johnston to include the engagement member of Clark, III in order to securely constrain the one or more template guides within the base frame (para. 0125 of Clark, III).
Regarding claim 12, modified Johnston discloses wherein the engagement member 607 comprises tab (para. 0125 of Clark, III; The examiner notes that “a tab” is defined as a “short projecting device”, see Merriam-Webster dictionary definition attached).
Regarding claim 14, modified Johnston discloses wherein the enlarged treatment pattern formed by the applicator tip engagement position openings of the one of the one or more template guides 2000, 2200, 2200’, 2200’’ is configured to provide continuous and non-overlapping coverage of the tissue (see Figs. 21, 25A which illustrates the enlarged pattern of the guides being sized to completely encircle the target lesion in a continuous pattern such that the enlarged pattern does not overlap the lesion para. 0154-0155 of Johnston).
Regarding claim 15, modified Johnston discloses wherein at least some of the one or more template guides 2200, 2200’, 2200’’ of Johnston are configured to removably fit into the base frame in two or more rotational orientations that are offset from each other (see note below in regards to functional language; Figs. 22A-C, para. 0155 of Johnston; Fig. 6B, para. 0125 of Clark, III).
Note: “configured to removably fit into the base frame in two or more rotational orientations that are offset from each other” is interpreted as functional language due to the “configured to” language. Therefore, the limitation is not positively claimed as a structural component of the device, but interpreted as a functional component that the one or more template guides are capable of doing. As claimed, modified Johnston discloses all of the structure provided in the limitation to necessitate the functional language i.e. one or more template guides (Figs. 22A-C, para. 0155 of Johnston designed to removably couple from the base frame as taught by Clark, III (Fig. 6B, para. 0125 of Clark, III)). Therefore, the one or more template guides are capable of being interchangeable such that a user can place a template guide that removably fits into the base frame in two or more rotational orientations that are offset from each other. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 16, modified Johnston discloses wherein the two or more rotational orientations are offset from each other by 90 degrees or 180 degrees (see note below in regards to functional language; Figs. 22A-C, para. 0155 of Johnston; Fig. 6B, para. 0125 of Clark, III).
Note: “wherein the two or more rotational orientations are offset from each other by 90 degrees or 180 degrees” is interpreted as functional language due to the “configured to” language of claim 15 above. Therefore, the two or more rotational orientations that are offset from each other introduced in claim 15 is not positively claimed as a structural component of the device, but interpreted as a functional component that the one or more template guides are capable of doing. As claimed, modified Johnston discloses all of the structure provided in the limitation to necessitate the functional language i.e. one or more template guides (Figs. 22A-C, para. 0155 of Johnston designed to removably couple from the base frame as taught by Clark, III (Fig. 6B, para. 0125 of Clark, III)). Therefore, the one or more template guides are capable of being interchangeable such that a user can place a template guide that removably fits into the base frame in two or more rotational orientations that are offset from each other by 90 degrees or 180 degrees. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 17, Johnston discloses a template apparatus 2000, 2200, 2200’, 2200’’ (Figs. 20-26B, para. 0153) for guiding an application of electrical energy to a tissue (Figs. 21, 24A-B, para. 0153-0155), the apparatus comprising:
a plurality of base frames (interpreted as the body of the target guides 2200, 2200’, 2200’’ Figs. 22A-C and 2003 of patch 2000 shown in Fig. 20, para. 0153-0155); and
a plurality of template guide (interpreted as the face of the base frame 2000, 2200, 2200’, 2200’’ defining a space for receiving an applicator tip shown in Figs. 20, 22A-C, para. 0153-0155), wherein each template guide of the plurality of template guides includes one or more applicator tip engagement position openings configured to receive a distal region of an applicator tip (Figs. 21, 23A-B, 24A-B, para. 0153-0155).
However, Johnston fails to disclose a singular base frame, the plurality of template guides configured to removably fit into the singular base frame in one or more orientations and further wherein the one or more applicator tip engagement position openings of a first template guide of the plurality of template guides forms an enlarged treatment pattern with: 2) the one or more applicator tip engagement position openings of the first template guide in a second orientation of the one or more orientations.
Clark, III in the same field of endeavor of medical frames teaches a base frame 309 (Figs. 6A-6B, para. 0124-0125) and a plurality of template guides 302 (see Fig. 6B) are configured to removably fit into the base frame 309 in one or more orientations (Fig. 6B, para. 0125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the plurality of base frames and the plurality of template guides in Johnston to be a single base frame and a plurality of template guides such that the plurality of template guides is removable and interchangeable from the singular base frame, as taught by Clark, III in order to allow the user to customize the template apparatus for the procedure (para. 0125 of Clark, III) such that the base frame can accommodate different template guides for different applicator tips, thereby increasing the ease of use and utility of the device (para. 0125 of Clark, III).
The combination of Johnston in view of Clark, III would result in a product wherein the one or more applicator tip engagement position openings of a first template guide of the plurality of template guides (Figs. 20, 22A-C, para. 0153-0155 of Johnston) forms an enlarged treatment pattern (Figs. 20, 22A-24B, para. 0153-0155 of Johnston) with: 2) the one or more applicator tip engagement position openings of the first template guide in a second orientation of the one or more orientations (see annotated Fig. 6A of Clark, III below; Fig. 6B, para. 0125 of Clark, III; The examiner notes that since the plurality of template guides removably fit into the base frame in the one or more orientations, as taught by Clark, III, may be flipped over along a longitudinal axis, thereby oriented 180 degrees (as a second orientation relative to a first orientation), and placed within the base frame, thereby meeting the “more than one orientation” limitation).
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Annotated Fig. 6A of Clark, III
Regarding claim 18, modified Johnston discloses wherein the second orientation is rotated by 180 degrees relative to a first orientation (see annotated Fig. 6A of Clark, III above; Fig. 6B, para. 0125 of Clark, III; The examiner notes that since the plurality of template guides removably fit into the base frame in the one or more orientations, as taught by Clark, III, may be flipped over along a longitudinal axis, thereby oriented 180 degrees (as a second orientation relative to a first orientation), and placed within the base frame, thereby meeting the “more than one orientation” limitation).
Note: Due to the “or” language in claim 17, the limitation “further wherein the one or more applicator tip engagement position openings of a first template guide of the plurality of template guides forms an enlarged treatment pattern with: 1) the one or more applicator tip engagement position openings of a second template guide of the plurality of template guides, or 2) the one or more applicator tip engagement position openings of the first template guide in a second orientation of the one or more orientations” becomes a conditional limitation. Since modified Johnston meets the requirement of “2) the one or more applicator tip engagement position openings of the first template guide in a second orientation of the one or more orientations”, claim 18 is rejected.
Regarding claim 19, due to the "or" language in claim 17, the limitation "1) the one or more applicator tip engagement position openings of a second template guide of the plurality of template guides, or 2) the one or more applicator tip engagement position openings of the first template guide in a second orientation of the one or more orientations." becomes a conditional limitation. As stated in claim 17, modified Jauregui Johnston meets the requirement of "1) the one or more applicator tip engagement position openings of a second template guide of the plurality of template guides". Therefore, claim 19 is moot because it falls under the first condition which was not chosen by the examiner.
Regarding claim 20, Johnston discloses a template apparatus 2200, 2200’, 2200’’ (Figs. 20-26B, para. 0153) for guiding an application of electrical energy to a tissue (Fig. 24A-B, para. 0155), the apparatus comprising:
a plurality of base frames (interpreted as the body of the target guides shown in Figs. 22A-C, para. 0155);
a plurality of template guides (interpreted as the face of the base frame 2200, 2200’, 2200’’ defining a space for receiving an applicator tip shown in Figs. 22A-C, para. 0155), wherein each template guide of the plurality template guides includes one or more applicator tip engagement position openings configured to receive a distal region of an applicator tip (Figs. 22A-C, 23A-B, 24A-B, para. 0155) and to hold the applicator tip in a fixed position and orientation relative to the tissue (Figs. 23A-B, 24A-B, para. 0155), further wherein at least some of the applicator tip engagement position openings (see openings of guides 2200, 2200’ and 2200’’) include a rotational orientation indicator (interpreted as one of the extensions 2205 of guides 2200, 2200’, and 2200’’, see Figs. 22A-C) configured to align with a complimentary indicator on the distal region of the applicator tip within the applicator tip engagement position openings (see Figs. 23A-B and 24A-B which illustrate the extensions aligning with complementary projections on the applicator tip; para. 0155 of Johnston discloses that the design of guides shown in Figs. 22A-C allow the applicator tip to align without the need for visual markings).
However, Johnston fails to disclose a singular base frame and the plurality of template guides configured to removably fit into the singular base frame in a predetermined orientation.
Clark, III in the same field of endeavor of medical frames teaches a base frame 309 (Figs. 6A-6B, para. 0124-0125), one or more template guides 302 (see Fig. 6B) are configured to removably fit into the base frame 309 in a predetermined orientation (Fig. 6B, para. 0125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the plurality of base frames and the plurality of template guides in Johnston to be a single base frame and a plurality of template guides such that the plurality of template guides is removable and interchangeable from the singular base frame, as taught by Clark, III in order to allow the user to customize the template apparatus for the procedure (para. 0125 of Clark, III) such that the base frame can accommodate different template guides for different applicator tips, thereby increasing the ease of use and utility of the device (para. 0125 of Clark, III).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Johnston (WO 2020077019) [hereinafter Johnston] in view of Clark, III et al. (US 20190269429) [hereinafter Clark, III] as applied to claim 9 above, and further in view of Sorensen et al. (US 20200282202) [hereinafter Sorensen].
Regarding claim 10, modified Johnston discloses all of the limitations set forth above in claim 9. However, modified Johnston fails to disclose wherein the one or more template guides is hinged to the base frame by one or more of: a dowel pin, a c-shaped, a ball joint, and a living hinge.
Sorensen teaches that it is known in the art to provide a hinge 35 such as a living hinge to connect a base frame 25 to another frame (Fig. 3, para. 0049, 0051-0052), as a known alternative to frames being formed separately and may be connected together (para. 0065).
The substitution of one known frame construction (frames with a hinged connection as shown in Sorensen) for another (separately formed frames as shown in modified Johnston) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the hinged connection shown in Sorensen would have yielded predictable results, namely, provide an alternative way to connect the base frame to the one or more template guides, as taught in Sorensen (para. 0065 of Sorensen) to prevent separation or disengagement of the base frame and the one or more template guides (Fig. 3, para. 0049, 0051-0052 of Sorensen); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Johnston (WO 2020077019) [hereinafter Johnston] in view of Clark, III et al. (US 20190269429) [hereinafter Clark, III] as applied to claim 1 above, and further in view of Fiorina et al. (US 20070088419) [hereinafter Fiorina].
Regarding claim 13, modified Johnston discloses all of the limitations set forth above in claim 1. However, modified Johnston wherein the base frame is flexible and configured to conform to a curved tissue surface.
Fiorina teaches a pad assembly configured to be applied to skin (para. 0021) comprising a base frame 12 (Fig. 1, para. 0019), wherein the base frame 12 is flexible and configured to conform to a curved tissue surface (para. 0019, 0021).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the base frame in modified Johnston to be flexible, as taught by Fiorina, in order to provide the base with the ability to conform to the skin without stiffness or resistance (para. 0021 of Fiorina).
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.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
