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 Amendment
This Office Action is in response to the Applicant’s amendment filed 29 April 2026 wherein Claims 1, 6, 14, and 15 are amended, Claims 9 – 13 are or previously were cancelled, Claims 18 – 20 were previously withdrawn, and Claims 21 – 25 are newly added. Therefore, Claims 1 – 8 and 14 – 25 are currently pending.
The Applicant’s amendment to the Claims dated 29 April 2026 has been fully considered. These amendments have overcome each Claim Objection set forth in the Non-Final Rejection dated 11 February 2026 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Claim Objection set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant's arguments filed 29 April 2026 have been fully considered but they are not persuasive.
Altmann et al. (US 9,308,041 B2).
Govari et al. (US 2014/0163546).
The Applicant alleges that the prior art of record does not disclose or suggest an apparatus that includes “an injectrode attached to the shaft, the injectrode comprising: a lumen configured to deliver a therapeutic agent; and one or more electrodes disposed on the lumen” as recited in Claim 1. See page 8 of the Applicant’s Remarks dated 29 April 2026. The Applicant is correct that electrode contact arm of Altmann is not an injectrode comprising a lumen configured to deliver a therapeutic agent; and one or more electrodes disposed on the lumen, and to address this deficiency the Office relied upon the teaching of Govari. Id. However, the Examiner respectfully disagrees with the Applicant’s argument that Govari does not teach an injectrode comprising a lumen configured to deliver a therapeutic agent; and one or more electrodes disposed on the lumen because the electrodes 58, 60 of Govari are fluidly coupled to but not disposed on the lumens 82, 84 as alleged by the Applicant. Id.
During patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the specification.” MPEP 2111. Under a broadest reasonable interpretation (BRI), words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. MPEP 2111.01 The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. Id. The ordinary and customary meaning of a term may be evidenced by a variety of sources, including the words of the claims themselves, the specification, drawings, and prior art. Id. However, the best source for determining the meaning of a claim term is the specification - the greatest clarity is obtained when the specification serves as a glossary for the claim terms. Phillips v. AWH Corp., 415 F.3d 1303, 1315, 75 USPQ2d 1321, 1327 (Fed. Cir. 2005) (en banc); MPEP 2111.01.
Claim 1 recites:
…
an injectrode attached to the shaft, the injectrode comprising:
a lumen configured to deliver a therapeutic agent; and
one or more electrodes disposed on the lumen,
…
The Applicant’s specification dated 25 March 2022 has disclosed that the injectrode 1520 is attached to the shaft 310, the injectrode comprising: a lumen 1520 configured to deliver a therapeutic agent; and one or more electrodes 1530 disposed on the lumen. See Figures 15 – 16 and [0082] – [0087]. The Applicant’s recitation of the term “lumen” is contrary to its common understanding in the prior art. Within the medical device context, a “lumen” means the bore of a hollow tube such as a hollow needle or catheter. Here, the recited “lumen” in Claim 1 is referring to the hollow tube labeled at 1520 in Figures 15 and 16 of the Drawings dated 25 March 2022. Under the broadest reasonable interpretation in view of the Applicant’s specification and drawings, the term “lumen” within the claims is equated to be a hollow, tubular structure.
Turning to the claim phrase “one or more electrodes disposed on the lumen,” the broadest reasonable interpretation of this phrase depends on the broadest reasonable interpretation of the term “on” and the aforementioned broadest reasonable interpretation of the term “lumen.” The term “on” is defined to mean being in physical contact with and supported by an outer surface. This definition of the term “on” corresponds to the Applicant’s use of the term within the Specification and shown in the Drawings. For example, [0082] of the Specification dated 25 March 2022 recites “The injectrode 1510 includes a lumen 1520 through which a therapeutic agent can be delivered and one or more electrical contacts 1530 (e.g., electrode(s)) disposed on the lumen 1520). The electrical contact(s) 1530 can be located near the distal open end 1522 of lumen 1520 and/or along the shaft of the lumen 1520.” Figures 15 – 16 of the Drawings dated 25 March 2022 further show the electrodes 1530 “on” the lumen 1520. Based on what is shown in Figures 15 – 16 the electrodes 1530 are on the outer surface of the tubular structure of the lumen.
Combining the broadest reasonable interpretation of the term “lumen” and the term “on,” it is the Office’s position that “one or more electrodes disposed on the lumen” means that the electrodes can be on the outer surface of the lumen wherein the lumen is a hollow, tubular structure.
In view of the broadest reasonable interpretation for the claimed structure of the injectrode (i.e., the injectrode comprising: a lumen configured to deliver a therapeutic agent; and one or more electrodes disposed on the lumen), it is the Office’s position that Govari teaches this claim language. Figure 5 of Govari teaches one or more electrodes 58, 60 being disposed on the lumen 82, 84. Here, Govari teaches the electrodes 58 are along the lumen 82 while the electrode 60 is along the lumen 84. Either the electrodes 58 or electrode 60 meets the claim language as recited in Claim 1.
For at least the foregoing reasons, the prior art of record does disclose or suggest each and every limitation of Claim 1. Therefore, the Applicant’s arguments are found to be unpersuasive.
If it was the intent of the Applicant that the one or more electrodes are located “in” or “inside” the lumen then the Examiner suggests further clarifying the claim language when referring to the injectrode. Claim language reciting “one or more electrodes disposed on the lumen” versus “one or more electrodes disposed in the lumen” corresponds to different structures. Furthermore, the Examiner suggests reviewing the use of the term “lumen” within the claim language when referring to the structure of the injectrode to further clarify the broadest reasonable interpretation for what “lumen” means given the context of the Applicant’s Specification and Drawings.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni et al. (US 2009/0099516 A1) (hereinafter referred to as “Gildoni”), Zarembinski (US 2017/0135723 A1), Altmann et al. (US 9,308,041 B2) (hereinafter referred to as “Altmann”), and Govari et al. (US 2014/0163546 A1) (hereinafter referred to as “Govari”).
With regards to claim 1, Gildoni discloses (Figs. 2A – 2C) an apparatus (see [0053] “the balloon catheter”) comprising:
a shaft (13) (see [0081]) having proximal and distal ends (see Examiner annotated Fig. 2A below hereinafter referred to as “Fig. A”);
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a double balloon (20, 21, 23) (see [0081]) attached to the distal end of the shaft (see Fig. 2A), the double balloon comprising:
a first balloon (23) (see [0081]);
a second balloon (21) (see [0081]); and
a bridge (20) (see [0081]) extending between the first and second balloons (see Figure 2A);
one or more fluid lines (see [0081] “The lumen of the inflation/deflation channel off catheter 13” and [0082]) disposed in the shaft, the one or more fluid lines fluidly coupled to the double balloon and configured to change an inflation state of the double balloon (see [0081] and [0082]); and
wherein:
the second balloon (21) is located between the bridge (20) and the shaft (13), and
when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening (the language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g) and 2114. The claim is an apparatus claim and is to be limited by the structural limitations of the claim. The Office submits that the apparatus of Gildoni meets the structural limitations of the claim wherein the first balloon is capable of securing the double balloon to the anatomical opening. Support for the apparatus being capable of securing the double balloon to the anatomical opening can be found within [0082] – [0086] wherein when the distal balloon 23 occludes the vessel walls it also secures the double balloon in place. Gildoni also describes using the balloon catheter within the brain see [0127]).
However if it is determined that Gildoni is silent with regards to the functional claim language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” then the Examiner turns to the teachings of Zarembinski.
Zarembinski, which is within the analogous art of pear-shaped balloons (see [0069] and Fig. 8G), teaches when the first balloon (502) (see [0069]) is inflated on a distal side of an anatomical opening (see [0007] and [0069] “The balloon 502 can have any desired configuration, and can be pear-shaped in some embodiments. A pear-shaped balloon may, in some cases, improve outcome and correspond to the inner anatomy of the Meckel cave – the distal protrusion surrounding the trigeminal ganglion 302 and the distal part of the trigeminal root 304 as previously described.” Wherein the anatomical opening is the Meckel cave.),
the first balloon is configured to secure the double balloon to the anatomical opening (see [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first balloon of the apparatus of Gildoni in view of a teaching of Zarembinski such that when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening. One of ordinary skill in the art would have been motivated to make this modification because Zarembinski teaches that a pear-shaped balloon improves the treatment outcome and correspond to the inner anatomy of the Meckel cave (see [0069] of Zarembinski). Zarembinski further teaches that balloon rhizotomy is a low cost, simple therapeutic modality that reduces sensory neuronal input thereby turning off the trigger for neuropathic trigeminal pain for treating trigeminal neuralgia (see [0048] of Zarembinski).
The apparatus of Gildoni modified in view of a teaching of Zarembinski will hereinafter be referred to as the apparatus of Gildoni and Zarembinski.
However, neither Gildoni nor Zarembinski teaches:
an injectrode attached to the shaft, the injectrode comprising:
a lumen configured to deliver a therapeutic agent; and
one or more electrodes disposed on the lumen.
Nonetheless Altmann, which is within the analogous art of electrode contact arms (see Fig. 2A), teaches the apparatus (24; see Col. 4, lines 53 – 61 “catheter 24”) further comprising an injectrode/electrode contact arm (52; see Col. 4, line 62 – Col. 5, line 6 “End section 52”) attached to the shaft (54; see Col. 4, line 62 – Col. 5, line 6 “an insertion shaft 54, and an end section 52 that is connected to the distal end of the insertion shaft”), the electrode arm including a plurality of electrical contacts (56, 58; see Col. 5, lines 33 – 39 “End section 52 comprises an array of electrodes along its length, including, in this example, a tip electrode 56”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shaft of the apparatus of Gildoni and Zarembinski in view of a teaching of Altmann such that the apparatus further comprising an electrode contact arm attached to the shaft, the electrode arm including a plurality of electrical contacts. One of ordinary skill in the art would have been motivated to make this modification because the electrode contact arm can be used for ablating tissue when the end section is positioned against the tissue (see Col. 1, lines 61 – 67).
The apparatus of Gildoni and Zarembinski modified in view of Altmann will hereinafter be referred to as the apparatus of Gildoni, Zarembinski, and Altmann.
However, the apparatus of Gildoni, Zarembinski, and Altmann is silent with regards to the injectrode comprising:
a lumen configured to deliver a therapeutic agent; and
one or more electrodes disposed on the lumen.
Nonetheless Govari, which is within the analogous art of perforated electrodes (see [0013] and Fig. 5), further teaches the injectrode comprising:
a lumen (82, 84; see [0041] “supplies irrigation fluid to catheter 24 via both of lumens 82 and 84”) configured to deliver a therapeutic agent (see [0041] “irrigation fluid”); and
one or more electrodes (58, 60; see [0039] “electrodes 58 and 60”) disposed on the lumen (see Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the apparatus of Gildoni, Zarembinski, and Altmann in view of a teaching of Govari such that the injectrode comprises a lumen configured to deliver a therapeutic agent; and one or more electrodes disposed on the lumen. One of ordinary skill in the art would have been motivated to make this modification because Govari teaches that modifying the electrode contact arm such that it can provide an injection provides for local cooling and prevents adhesion during ablation (see [0032] of Govari).
The apparatus of Gildoni, Zarembinski, and Altmann modified in view of a teaching of Govari will hereinafter be referred to as the apparatus of Gildoni, Zarembinski, Altmann, and Govari.
Claim(s) 2, 3, and 5 – 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni, Zarembinski, Altmann, and Govari as applied to claim 1 above, and further in view of Jang (US 4,990,139 A).
With regards to claim 2, the apparatus of Gildoni, Zarembinski, Altmann, and Govari teaches the claimed invention of claim 1, however, none of Gildoni, Zarembinski, Altmann, or Govari teaches the apparatus further comprising a fluid coupling tube disposed in the double balloon, the fluid coupling tube including first and second ports,
wherein the one or more fluid lines include:
a first fluid line fluidly coupled to the first balloon through the first port, and
a second fluid line fluidly coupled to the second balloon through the second port.
Nonetheless Jang, which is within the analogous art of tandem independently inflatable/deflatable multiple diameter balloon angioplasty catheter systems (see abstract and title), teaches (see Fig. 21) the apparatus further comprising a fluid coupling tube (see Examiner annotated Fig. 21 below; hereinafter referred to as “Fig. B”) disposed in the double balloon (see Fig. B below wherein the annotated fluid coupling tube is located in the double balloon 16, 21), the fluid coupling tube including first and second ports (see at 28 and 24 respectively in Fig. 21),
wherein the one or more fluid lines (24, 26, 28; see Col. 21, lines 55 – 65) include:
a first fluid line (28; see Col. 21, lines 55 – 65) fluidly coupled to the first balloon (21; see Col. 21, lines 21 – 44) through the first port (see at 28 in Fig. 21), and
a second fluid line (24; see Col. 21, lines 55 – 65) fluidly coupled to the second balloon (16; see Col. 21, lines 21 – 44) through the second port (see at 24 in Fig. 21).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the apparatus of Gildoni, Zarembinski, Altmann, and Govari in view of a teaching of Jang such that the apparatus further comprises a fluid coupling tube disposed in the double balloon, the fluid coupling tube including first and second ports, wherein the one or more fluid lines include: a first fluid line fluidly coupled to the first balloon through the first port, and a second fluid line fluidly coupled to the second balloon through the second port. One of ordinary skill in the art would have been motivated to make this modification because Jang teaches the first and second fluid lines provide for the independent inflation and deflation of the first and second balloons (see Col. 21, lines 55 – 65 of Jang).
The apparatus of Gildoni, Zarembinski, Altmann, and Govari modified in view of a teaching of Jang will hereinafter be referred to as the apparatus of Gildoni, Zarembinski, Altmann, Govari and Jang.
With regards to claim 3, the apparatus of Gildoni, Zarembinski, Altmann, Govari, and Jang teaches the claimed invention of claim 2, however Gildoni is silent with regards to wherein the first balloon and the second balloon are fluidly isolated from each other, whereby an inflation state of the first balloon is independent from an inflation state of the second balloon.
Nonetheless Jang, which is within the analogous art of tandem independently inflatable/deflatable multiple diameter balloon angioplasty catheter systems (see abstract and title), further teaches (see Fig. 21) wherein the first balloon (21; see Col. 21, lines 21 – 44) and the second balloon (16; see Col. 21, lines 21 – 44) are fluidly isolated from each other (see Col. 21, lines 55 – 65), whereby an inflation state of the first balloon is independent from an inflation state of the second balloon (see Col. 21, lines 55 – 65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first and second balloon of the apparatus of Gildoni, Zarembinski, Altmann, Govari, and Jang in view of a further teaching of Jang such that the first balloon and the second balloon are fluidly isolated from each other, whereby an inflation state of the first balloon is independent from an inflation state of the second balloon. One of ordinary skill in the art would have been motivated to make this modification because Jang teaches the first and second fluid lines provide for the independent inflation and deflation of the first and second balloons (see Col. 21, lines 55 – 65 of Jang).
With regards to claim 5, the apparatus of Gildoni, Zarembinski, Altmann, Govari, and Jang teaches the claimed invention of claim 3, and Gildoni further teaches (see Figs. 2A – 2C) wherein:
the bridge (20) comprises a bridge balloon having a bridge inflation state (see [0081] and [0082]), and the bridge balloon is fluidly coupled to the first balloon (23) or the second balloon (see [0081]), whereby:
when the bridge balloon is fluidly coupled to the first balloon, the bridge inflation state is the same as the inflation state of the first balloon (see [0081] and [0082] where the described inflation state of the first balloon is the inflation state of the bridge balloon), and when the bridge balloon is fluidly coupled to the second balloon, the bridge inflation state is the same as the inflation state of the second balloon.
With regards to claim 6, the apparatus of Gildoni, Zarembinski, Altmann, Govari, and Jang teaches the claimed invention of claim 3, however, Gildoni is silent with regards to wherein:
the bridge comprises a bridge balloon, the fluid coupling tube includes a third port,
the one or more fluid lines include a third fluid line fluidly coupled to the bridge balloon through the third port,
the first balloon, the second balloon, and the third balloon are fluidly isolated from each other,
whereby the inflation state of the first balloon, the inflation state of the second balloon, and an inflation state of the bridge balloon are independent from each other.
Nonetheless Jang, which is within the analogous art of tandem independently inflatable/deflatable multiple diameter balloon angioplasty catheter systems (see abstract and title), teaches (see Fig. 21) wherein:
the bridge (20) comprises a bridge balloon (see [0081] and [0082]),
fluid coupling tube (see Fig. B reiterated below) includes a third port (see at 26 in Fig. 21),
the one or more fluid lines (24, 26, 28; see Col. 21, lines 55 – 65 “the first lumen 24 for inflating and deflating the first balloon 16 and the second lumen 26 for inflating the second balloon 20, it should also be provided with a third lumen 28 for inflating and deflating the third balloon 21.”) include a third fluid line (26) fluidly coupled to the bridge balloon (see Col. 21, lines 55 – 65) through the third port (see at 26 in Fig. 21),
the first balloon (21), the second balloon (16), and the third balloon (20) are fluidly isolated from each other (see Col. 21, lines 55 – 65),
whereby the inflation state of the first balloon, the inflation state of the second balloon, and an inflation state of the bridge balloon are independent from each other (see Col. 21, lines 55 – 65).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the apparatus of Gildoni, Zarembinski, Altmann, and Govari and Jang in view of a further teaching of Jang such that the bridge comprises a bridge balloon, fluid coupling tube includes a third port, the one or more fluid lines include a third fluid line fluidly coupled to the bridge balloon through the third port, the first balloon, the second balloon, and the third balloon are fluidly isolated from each other, whereby the inflation state of the first balloon, the inflation state of the second balloon, and an inflation state of the bridge balloon are independent from each other. One of ordinary skill in the art would have been motivated to make this modification because Jang teaches the first and second fluid lines provide for the independent inflation and deflation of the first and second balloons (see Col. 21, lines 55 – 65 of Jang).
With regards to claim 7, the apparatus of Gildoni, Zarembinski, Altmann, and Govari teaches the claimed invention of Claim 1, however Gildoni is silent with regards to wherein when the first and second balloons are inflated, a first dimension of the first balloon is larger than a corresponding second dimension of the second balloon.
Nonetheless Jang, which is within the analogous art of tandem independently inflatable/deflatable multiple diameter balloon angioplasty catheter systems (see abstract and title), teaches (see Fig. 21) when the first and second balloons (21, 16; see Col. 21, lines 21 – 44) are inflated, a first dimension of the first balloon (21) is larger than a corresponding second dimension of the second balloon (16) (see Col. 21, lines 41 – 44 “The first balloon 16 has the smallest maximum inflated diameter, the second balloon 20 has the next largest diameter, and the third balloon 21 has the largest inflated maximum inflated diameter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to the apparatus of Gildoni, Zarembinski, Altmann, and Govari in view of a teaching of Jang such that the first and second balloons are inflated, a first dimension of the first balloon is larger than a corresponding second dimension of the second balloon. One of ordinary skill in the art would have been motivated to make this modification because Jang teaches that the size of the balloon matches the size of the anatomy the balloon is intended to engage with (see Col. 3, lines 6 – 25 of Jang).
The apparatus of Gildoni, Zarembinski, Altmann, and Govari modified in view of Jang will hereinafter be referred to as the apparatus of Gildoni, Zarembinski, Altmann, Govari, and Jang.
With regards to claim 8, the apparatus of Gildoni, Zarembinski, Altmann, Govari, and Jang teaches the claimed invention of claim 7, however, Gildoni is silent with regards to wherein when the first and second balloons are inflated, the first balloon has a larger diameter than the second balloon.
Nonetheless Jang, which is within the analogous art of tandem independently inflatable/deflatable multiple diameter balloon angioplasty catheter systems (see abstract and title), teaches (see Fig. 21) wherein when the first and second balloons (21, 16; see Col. 21, lines 21 – 44) are inflated, the first balloon (21) has a larger diameter than the second balloon (16) (see Fig. 21 and see Col. 21, lines 41 – 44 “The first balloon 16 has the smallest maximum inflated diameter, the second balloon 20 has the next largest diameter, and the third balloon 21 has the largest inflated maximum inflated diameter.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first and second balloons of the apparatus of Gildoni, Zarembinski, Altmann, Govari, and Jang in view of a further teaching of Jang such that when the first and second balloons are inflated, the first balloon has a larger diameter than the second balloon. One of ordinary skill in the art would have been motivated to make this modification because Jang teaches that the size of the balloon matches the size of the anatomy in which the balloon is intended to engage with (see Col. 3, lines 6 – 25 of Jang).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni, Zarembinski, Altmann, Govari and Jang as applied to claim 3 above, and further in view of Ishibashi et al. (US 2013/0165823 A1 hereinafter referred to as “Ishibashi”).
With regards to claim 4, the apparatus of Gildoni, Zarembinski, Altmann, Govari, and Jang teaches the claimed invention of claim 3, however Gildoni is silent with regards to wherein:
the first balloon has a first cavity to receive fluid from the first fluid line,
the second balloon has a second cavity to receive fluid from the second fluid line, and
the apparatus further comprises:
a first pressure sensor in fluid communication with the first cavity; and
a second pressure sensor in fluid communication with the second cavity.
Nonetheless Ishibashi, which is within the analogous art of balloons with pressure sensors (see Fig. 10 and [0024]), teaches (see Fig. 10) the first balloon (210) has a first cavity (see at 210 in Fig. 10) to receive fluid from the first fluid line (230) (see [0024]), the second balloon (220) has a second cavity (see at 220 in Fig. 10) to receive fluid from the second fluid line (235) (see [0024]), and the apparatus further comprises:
a first pressure sensor (240) (see [0024]) in fluid communication with the first cavity (see at 210 in Fig. 10 and [0024] “a first pressure sensor 240 is disposed to measure a pressure of the liquid in the first balloon 210”); and
a second pressure sensor (245) (see [0024]) in fluid communication with the second cavity (see at 220 in Fig. 10 and [0024] “a second pressure sensor 245 is disposed to measure a pressure of the liquid in the second balloon 220”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first and second ballons of the apparatus of Gildoni, Zarembinski, Altmann, Govari, and Jang in view of a teaching of Ishibashi such that the first balloon has a first cavity to receive fluid from the first fluid line, the second balloon has a second cavity to receive fluid from the second fluid line, and the apparatus further comprises: a first pressure sensor in fluid communication with the first cavity; and a second pressure sensor in fluid communication with the second cavity. One of ordinary skill in the art would have been motivated to make this modification because Ishibashi teaches incorporating a first pressure sensor and a second pressure sensor within the first and second balloons, respectively, provides a means to measure the pressure of the liquid in the first and second balloons, respectively (see [0024] of Ishibashi). The pump control receives output values of the first and second pressure sensors and then controls the pump so that these pressure values are maintained (see [0033] of Ishibashi).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni, Zarembinski, Altmann, and Govari as applied to claim 1 above, and further in view of Corvi et al. (US 2013/0110104 A1 hereinafter referred to as “Corvi”).
With regards to claim 14, the apparatus of Gildoni, Zarembinski, Altmann, and Govari teaches the claimed invention of claim 1, however, Gildoni is silent with regards to further comprising one or more wires mechanically coupled to the lumen to steer the injectrode independently of the shaft.
Nonetheless Corvi, which is within the analogous art of electrode contact arms (see Fig. 2), teaches the apparatus further comprising one or more wires (see [0031] “One or more internal push/pull wires may also be provided in the medical device 16, and in particular, coupled to the handle assembly 22…a full length pull wire (or double pull wires such as in the case with bi-directional steering, neither of which is shown) may be secured to the a distal portion of the end of the shaft 42 and/or carrier assembly 36” and [0037]) mechanically coupled to the lumen to steer the injectrode (36) independently of the shaft (18; see [0020] “flexible catheter body 18”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the apparatus of Gildoni, Zarembinski, Altmann, and Govari in view of a teaching of Corvi such that the apparatus further comprises one or more wires mechanically coupled to the lumen to steer the injectrode independently of the shaft. One of ordinary skill in the art would have been motivated to make this modification because Corvi teaches the incorporation of one or more wires facilitates single or bi-directional steering and control of the distal treatment assembly (see [0031] of Corvi).
Claim(s) 15, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni, Zarembinski, Altmann, and Edwards (US 2002/0143324 A1).
With regards to claim 15, Gildoni discloses a system (see Fig. 2A) comprising:
a shaft (13) (see [0081]) having proximal and distal ends (see Fig. A reiterated below);
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a double balloon (20, 21, 23) (see [0081]) attached to the distal end of the shaft (see Fig. 2A), the double balloon comprising:
a first balloon (23) (see [0081]);
a second balloon (21) (see [0081]); and
a bridge (20) (see [0081]) extending between the first and second balloons (see Fig. 2A);
one or more fluid lines (see [0081] “The lumen of the inflation/deflation channel off catheter 13” and [0082]) disposed in the shaft, the one or more fluid lines fluidly coupled to the double balloon and configured to change an inflation state of the double balloon (see [0081] and [0082]);
a fluid reservoir (14) (see [0081]) fluidly coupled to the one or more fluid lines (see Fig. 2A and [0081] – [0082]);
wherein:
the second balloon (21) is located between the bridge (20) and the shaft (13) (see Fig. 2A), and
when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening (the language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g) and 2114. The claim is an apparatus claim and is to be limited by the structural limitations of the claim. The Office submits that the apparatus of Gildoni meets the structural limitations of the claim wherein the first balloon is capable of securing the double balloon to the anatomical opening. Support for the apparatus being capable of securing the double balloon to the anatomical opening can be found within [0082] – [0086] wherein when the distal balloon 23 occludes the vessel walls it also secures the double balloon in place. Gildoni also describes using the balloon catheter within the brain see [0127]).
However if it is determined that Gildoni is silent with regards to the functional claim language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” then the Examiner turns to the teachings of Zarembinski.
Zarembinski, which is within the analogous art of pear-shaped balloons (see [0069] and Fig. 8G), teaches when the first balloon (502) (see [0069]) is inflated on a distal side of an anatomical opening (see [0007] and [0069] “The balloon 502 can have any desired configuration, and can be pear-shaped in some embodiments. A pear-shaped balloon may, in some cases, improve outcome and correspond to the inner anatomy of the Meckel cave – the distal protrusion surrounding the trigeminal ganglion 302 and the distal part of the trigeminal root 304 as previously described.” Wherein the anatomical opening is the Meckel cave.),
the first balloon is configured to secure the double balloon to the anatomical opening (see [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first balloon of the system of Gildoni in view of a teaching of Zarembinski such that when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening. One of ordinary skill in the art would have been motivated to make this modification because Zarembinski teaches that a pear-shaped balloon improves the treatment outcome and correspond to the inner anatomy of the Meckel cave (see [0069] of Zarembinski). Zarembinski further teaches that balloon rhizotomy is a low cost, simple therapeutic modality that reduces sensory neuronal input thereby turning off the trigger for neuropathic trigeminal pain for treating trigeminal neuralgia (see [0048] of Zarembinski).
The system of Gildoni modified in view of a teaching of Zarembinski will hereinafter be referred to as the system of Gildoni and Zarembinski.
Neither Gildoni nor Zarembinski teaches:
an injectrode attached to the shaft, the injectrode comprising:
a lumen configured to deliver a therapeutic agent; and
one or more electrodes disposed on the lumen; and
a therapeutic agent reservoir fluidly coupled to the lumen, the therapeutic agent reservoir storing the therapeutic agent.
Nonetheless Altmann, which is within the analogous art of electrode contact arms (see Fig. 2A), teaches an injectrode/electrode contact arm (52; see Col. 4, line 62 – Col. 5, line 6 “End section 52”) attached to the shaft (54; see Col. 4, line 62 – Col. 5, line 6 “an insertion shaft 54, and an end section 52 that is connected to the distal end of the insertion shaft”), the electrode arm including a plurality of electrical contacts (56, 58; see Col. 5, lines 33 – 39 “End section 52 comprises an array of electrodes along its length, including, in this example, a tip electrode 56”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shaft of the system of Gildoni and Zarembinski in view of a teaching of Altmann such that the system further comprises an electrode contact arm attached to the shaft, the electrode arm including a plurality of electrical contacts. One of ordinary skill in the art would have been motivated to make this modification because the electrode contact arm can be used for ablating tissue when the end section is positioned against the tissue (see Col. 1, lines 61 – 67).
The system of Gildoni and Zarembinski modified in view of Altmann will hereinafter be referred to as the system of Gildoni, Zarembinski, and Altmann.
However, the system of Gildoni, Zarembinski, and Altmann is silent with regards to the injectrode comprising:
a lumen configured to deliver a therapeutic agent; and
one or more electrodes disposed on the lumen; and
a therapeutic agent reservoir fluidly coupled to the lumen, the therapeutic agent reservoir storing the therapeutic agent.
Nonetheless Edwards, which is within the analogous art of electropotential mapping devices (see abstract and title), teaches (see Fig. 6A) the injectrode (44) (see [0076]) comprising:
a lumen (58) (see [0076]) configured to deliver a therapeutic agent (70) (see [0076] “with arm lumens 58 and shaft lumens 36 may be used for the delivery of cooling solution 70 or electrolytic solution 72 to treatment site 12 as described herein”); and
one or more electrodes (22, 88) (see [0072] and [0076]) disposed on the lumen (see Fig. 6A, Fig. 7, [0072], and [0076]); and
a therapeutic agent reservoir (134) (see [0099] and Fig. 28) fluidly coupled to the lumen (see [0076]), the therapeutic agent reservoir storing the therapeutic agent (see Fig. 28 and [0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Gildoni, Zarembinski, and Altmann in view of a teaching of Edwards such that the injectrode comprising: a lumen configured to deliver a therapeutic agent; and one or more electrodes disposed on the lumen; and a therapeutic agent reservoir fluidly coupled to the lumen, the therapeutic agent reservoir storing the therapeutic agent. One of ordinary skill in the art would have been motivated to make this modification because Edwards teaches constructing the injectrode with this structure allows for the delivery of cooling solution or electrolytic solution to the treatment site (see [0076] of Edwards).
The system of Gildoni, Zarembinski, and Altmann modified in view of a teaching of Edwards will hereinafter be referred to as the system of Gildoni, Zarembinski, Altmann, and Edwards.
With regards to claim 21, Gildoni discloses (Figs. 2A – 2C) an apparatus (see [0053] “the balloon catheter”) comprising:
a shaft (13) (see [0081]) having proximal and distal ends (see Examiner annotated Fig. 2A below hereinafter referred to as “Fig. A”);
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a double balloon (20, 21, 23) (see [0081]) attached to the distal end of the shaft (see Fig. 2A), the double balloon comprising:
a first balloon (23) (see [0081]);
a second balloon (21) (see [0081]); and
a bridge (20) (see [0081]) extending between the first and second balloons (see Figure 2A);
one or more fluid lines (see [0081] “The lumen of the inflation/deflation channel off catheter 13” and [0082]) disposed in the shaft, the one or more fluid lines fluidly coupled to the double balloon and configured to change an inflation state of the double balloon (see [0081] and [0082]); and
wherein:
the second balloon (21) is located between the bridge (20) and the shaft (13), and
when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening (the language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. MPEP 2173.05(g) and 2114. The claim is an apparatus claim and is to be limited by the structural limitations of the claim. The Office submits that the apparatus of Gildoni meets the structural limitations of the claim wherein the first balloon is capable of securing the double balloon to the anatomical opening. Support for the apparatus being capable of securing the double balloon to the anatomical opening can be found within [0082] – [0086] wherein when the distal balloon 23 occludes the vessel walls it also secures the double balloon in place. Gildoni also describes using the balloon catheter within the brain see [0127]).
However if it is determined that Gildoni is silent with regards to the functional claim language of “when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening” then the Examiner turns to the teachings of Zarembinski.
Zarembinski, which is within the analogous art of pear-shaped balloons (see [0069] and Fig. 8G), teaches when the first balloon (502) (see [0069]) is inflated on a distal side of an anatomical opening (see [0007] and [0069] “The balloon 502 can have any desired configuration, and can be pear-shaped in some embodiments. A pear-shaped balloon may, in some cases, improve outcome and correspond to the inner anatomy of the Meckel cave – the distal protrusion surrounding the trigeminal ganglion 302 and the distal part of the trigeminal root 304 as previously described.” Wherein the anatomical opening is the Meckel cave.),
the first balloon is configured to secure the double balloon to the anatomical opening (see [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the first balloon of the apparatus of Gildoni in view of a teaching of Zarembinski such that when the first balloon is inflated on a distal side of an anatomical opening, the first balloon is configured to secure the double balloon to the anatomical opening. One of ordinary skill in the art would have been motivated to make this modification because Zarembinski teaches that a pear-shaped balloon improves the treatment outcome and correspond to the inner anatomy of the Meckel cave (see [0069] of Zarembinski). Zarembinski further teaches that balloon rhizotomy is a low cost, simple therapeutic modality that reduces sensory neuronal input thereby turning off the trigger for neuropathic trigeminal pain for treating trigeminal neuralgia (see [0048] of Zarembinski).
The apparatus of Gildoni modified in view of a teaching of Zarembinski will hereinafter be referred to as the apparatus of Gildoni and Zarembinski.
However, neither Gildoni nor Zarembinski teaches:
an injectrode attached to the shaft, the injectrode comprising:
a lumen configured to deliver a therapeutic agent; and
one or more electrodes disposed on the lumen,
wherein the lumen is configured to deliver the therapeutic agent through an open end of the lumen.
Nonetheless Altmann, which is within the analogous art of electrode contact arms (see Fig. 2A), teaches the apparatus (24; see Col. 4, lines 53 – 61 “catheter 24”) further comprising an injectrode/electrode contact arm (52; see Col. 4, line 62 – Col. 5, line 6 “End section 52”) attached to the shaft (54; see Col. 4, line 62 – Col. 5, line 6 “an insertion shaft 54, and an end section 52 that is connected to the distal end of the insertion shaft”), the electrode arm including a plurality of electrical contacts (56, 58; see Col. 5, lines 33 – 39 “End section 52 comprises an array of electrodes along its length, including, in this example, a tip electrode 56”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the shaft of the apparatus of Gildoni and Zarembinski in view of a teaching of Altmann such that the apparatus further comprising an electrode contact arm attached to the shaft, the electrode arm including a plurality of electrical contacts. One of ordinary skill in the art would have been motivated to make this modification because the electrode contact arm can be used for ablating tissue when the end section is positioned against the tissue (see Col. 1, lines 61 – 67).
The apparatus of Gildoni and Zarembinski modified in view of Altmann will hereinafter be referred to as the apparatus of Gildoni, Zarembinski, and Altmann.
However, none of Gildoni, Zarembinski, nor Altmann teaches the injectrode comprising:
a lumen configured to deliver a therapeutic agent; and
one or more electrodes disposed on the lumen,
wherein the lumen is configured to deliver the therapeutic agent through an open end of the lumen.
Nonetheless Edwards, which is within the analogous art of electropotential mapping devices (see abstract and title), teaches (see Fig. 6A) the injectrode (44) (see [0076]) comprising:
a lumen (58) (see [0076]) configured to deliver a therapeutic agent (70) (see [0076] “with arm lumens 58 and shaft lumens 36 may be used for the delivery of cooling solution 70 or electrolytic solution 72 to treatment site 12 as described herein”); and
one or more electrodes (22, 88) (see [0072] and [0076]) disposed on the lumen (see Fig. 6A, Fig. 7, [0072], and [0076]);
wherein the lumen is configured to deliver the therapeutic agent through an open end of the lumen (see Figure 6A at 58 and [0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Gildoni, Zarembinski, and Altmann in view of a teaching of Edwards such that the injectrode comprises a lumen configured to deliver a therapeutic agent; and one or more electrodes disposed on the lumen; and wherein the lumen is configured to deliver the therapeutic agent through an open end of the lumen. One of ordinary skill in the art would have been motivated to make this modification because Edwards teaches constructing the injectrode with this structure allows for the delivery of cooling solution or electrolytic solution to the treatment site (see [0076] of Edwards).
With regards to claim 22, the system of Gildoni, Zarembinski, Altmann, and Edwards teaches the claimed invention of claim 15, however, Gildoni is silent with regards to wherein the lumen is configured to deliver the therapeutic agent through an open end of the lumen.
Nonetheless Edwards, which is within the analogous art of electropotential mapping devices (see abstract and title), teaches (see Fig. 6A) wherein the lumen (58) is configured to deliver the therapeutic agent (70) through an open end of the lumen (see Figure 6A at 58 and [0076]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Gildoni, Zarembinski, Altmann, and Edwards in view of a further teaching of Edwards such that the lumen is configured to deliver the therapeutic agent through an open end of the lumen. One of ordinary skill in the art would have been motivated to make this modification because Edwards teaches constructing the injectrode with this structure allows for the delivery of cooling solution or electrolytic solution to the treatment site (see [0076] of Edwards).
Claim(s) 16 – 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni, Zarembinski, Altmann, and Edwards as applied to claim 15 above, and further in view of Ishibashi.
With regards to claim 16, the system of Gildoni, Zarembinski, Altmann, and Edwards teaches the claimed invention of claim 15, however, Gildoni is silent with regards to the system further comprising a pressure sensor configured to measure a pressure of the one or more fluid lines.
Nonetheless Ishibashi, which is within the analogous art of balloons with pressure sensors (see Figs. 1 and 10 and [0024]), teaches the system (see Fig. 1) further comprising a pressure sensor (240; see [0024] “a first pressure sensor 240 is disposed to measure a pressure of the liquid in the first balloon 210”) configured to measure a pressure of the one or more fluid lines (230; see [0024] “a first tube 230” and [0043] “It is to be noted that the first pressure sensor 240 does not have to be present in the first balloon 210, and may be disposed, for example, in the vicinity of the first three-way valve 180 of the first tube 230”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Gildoni, Zarembinski, Altmann, and Edwards in view of a further teaching of Ishibashi such that the system further comprising a pressure sensor configured to measure a pressure of the one or more fluid lines. One of ordinary skill in the art would have been motivated to make this modification because incorporating a first pressure sensor within the first balloon provides a means to measure the pressure of the liquid in the first balloon (see [0024] of Ishibashi). The pump control receives output values of the first pressure sensor and then controls the pump so that these pressure value is maintained within the first balloon (see [0033] of Ishibashi).
The system of Gildoni, Zarembinski, Altmann, and Edwards modified in view of a teaching of Ishibashi will hereinafter be referred to as the system of Gildoni, Zarembinski, Altmann, Edwards, and Ishibashi.
With regards to claim 17, the system of Gildoni, Zarembinski, Altmann, Edwards, and Ishibashi teaches the claimed invention of claim 16, however Gildoni is silent with regards to the system further comprising:
a pump fluidly coupled to the fluid reservoir; and
a controller in electrical communication with the pressure sensor and the pump, the controller configured to control the pump to inflate the first and second balloons while using the pressure of the one or more fluid lines as feedback.
Nonetheless Ishibashi, which is within the analogous art of balloons with pressure sensors (see Figs. 1 and 10 and [0024]), further teaches the system (see Fig. 1) further comprising:
a pump (170; see [0028] “the first pump 170 feeds the liquid from the liquid tank 190 toward the first tube 230 and the second tube 235”) fluidly coupled to the fluid reservoir (190); and
a controller (160; see [0026] “The pump control section 160 controls operations of the first pump 170…the pump control section 160 is connected to the first pressure sensor 240”) in electrical communication with the pressure sensor (240) and the pump (170), the controller configured to control the pump to inflate the first and second balloons (210, 220; see [0026] “first balloon 210…second balloon 220”) while using the pressure of the one or more fluid lines as feedback (see [0024], [0026], and [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Gildoni, Zarembinski, Altmann, Edwards, and Ishibashi in view of a further teaching of Ishibashi such that the system further comprising: a pump fluidly coupled to the fluid reservoir; and a controller in electrical communication with the pressure sensor and the pump, the controller configured to control the pump to inflate the first and second balloons while using the pressure of the one or more fluid lines as feedback. One of ordinary skill in the art would have been motivated to make this modification because incorporating a pressure sensor within the first balloon provides for a means to measure the pressure of the liquid in the first balloon (see [0024] of Ishibashi). The pump control receives output values of the first pressure sensor and then controls the pump so that these pressure value is maintained within the first balloon (see [0033] of Ishibashi).
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni, Zarembinski, Altmann, and Edwards as applied to claim 15 above, and further in view of Rubin (US 2020/0163904 A1).
With regards to claim 23, the system of Gildoni, Zarembinski, Altmann, and Edwards teaches the claimed invention of claim 15, however, Gildoni is silent with regards to wherein the therapeutic agent is configured to cause damage to at least a portion of a target structure.
Nonetheless Rubin, which is within the analogous art of liquid injectable pharmaceutical drug products (see abstract and title), teaches the therapeutic agent is configured to cause damage to at least a portion of a target structure (see [0009] “The ethanol drug product causes direct damage to nerve cells via dehydration, necrosis of cells, and leaking of protoplasm, leading to neuritis and a pattern of anterograde degeneration” and [0010]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the therapeutic agent of the system of Gildoni, Zarembinski, Altmann, and Edwards in view of a teaching of Rubin such that the therapeutic agent is configured to cause damage to at least a portion of a target structure. One of ordinary skill in the art would have been motivated to make this modification because Rubin teaches that this drug product is useful for treating intractable pain associated with cancer or a terminal illness and even for trigeminal neuraligia (see [0010] of Rubin).
The system of Gildoni, Zarembinski, Altmann, and Edwards modified in view of a teaching of Rubin will hereinafter be referred to as the system of Gildoni, Zarembinski, Altmann, Edwards and Rubin.
With regards to claim 24, the system of Gildoni, Zarembinski, Altmann, Edwards, and Rubin teaches the claimed invention of claim 23, however, Gildoni is silent with regards to wherein the target structure comprises a target nerve.
Nonetheless Rubin, which is within the analogous art of liquid injectable pharmaceutical drug products (see abstract and title), further teaches wherein the target structure comprises a target nerve (see [0009] “The ethanol drug product causes direct damage to nerve cells via dehydration, necrosis of cells, and leaking of protoplasm, leading to neuritis and a pattern of anterograde degeneration” and [0010]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the target structure of the system of Gildoni, Zarembinski, Altmann, Edwards, and Rubin in view of a further teaching of Rubin such that wherein the target structure comprises a target nerve. One of ordinary skill in the art would have been motivated to make this modification because Rubin teaches that this drug product is useful for treating intractable pain associated with cancer or a terminal illness and even for trigeminal neuraligia (see [0010] of Rubin).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gildoni, Zarembinski, Altmann, and Edwards as applied to claim 15 above, and further in view of Corvi.
With regards to claim 25, the system of Gildoni, Zarembinski, Altmann, and Edwards teaches the claimed invention of claim 15, however, Gildoni is silent with regards to the system further comprising one or more wires mechanically coupled to the lumen to steer the injectrode independently of the shaft.
Nonetheless Corvi, which is within the analogous art of electrode contact arms (see Fig. 2), teaches the apparatus further comprising one or more wires (see [0031] “One or more internal push/pull wires may also be provided in the medical device 16, and in particular, coupled to the handle assembly 22…a full length pull wire (or double pull wires such as in the case with bi-directional steering, neither of which is shown) may be secured to the a distal portion of the end of the shaft 42 and/or carrier assembly 36” and [0037]) mechanically coupled to the lumen to steer the injectrode (36) independently of the shaft (18; see [0020] “flexible catheter body 18”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Gildoni, Zarembinski, Altmann, and Edwards in view of a teaching of Corvi such that the system further comprises one or more wires mechanically coupled to the lumen to steer the injectrode independently of the shaft. One of ordinary skill in the art would have been motivated to make this modification because Corvi teaches the incorporation of one or more wires facilitates single or bi-directional steering and control of the distal treatment assembly (see [0031] of Corvi).
Conclusion
THIS ACTION IS MADE FINAL. Additionally, 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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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
07/14/2026
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