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 .
Priority
The Instant Application, filed on 05/19/2025, claims priority to Provisional Application 63/648,960, filed on 05/17/2024; additionally, the Instant Application, filed on 05/19/2025, is a continuation in part US Application 18/511,054, filed on 11/16/2023, which claims priority to Provisional Application 63/425,708, filed on 11/16/2022. Claims 9, 10, 18, and 19 of the Instant Application are directed to subject matter that was introduced for the first time in the Provisional Application 63/648,960, filed on 05/17/2024 (i.e., the two bridge support). The earliest Provisional Application and U.S. Application 18/511,054 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for a “proximal bridge support” and a “distal bridge support” as recited by independent claims 9, 10, 18, and 19. Accordingly, claims 9, 10, 18, and 19 are not entitled to the benefit of the prior applications because the above terms are considered to be unsupported within the disclosures listed above. The earliest disclosure for the subject matter of claims 9, 10, 18, and 19 and thus the effective filing date for the subject matter of claims 9, 10, 18, and 19 is 05/17/2024.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because:
they include the following reference character(s) not mentioned in the description: “113” (Fig. 1);
lines extending from reference characters “111” and “106” in Fig. 2 are pointing to space and not to the actual designated structure;
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Page 14, paragraph [0063] recites “distal bridge tube 1704” in line 3 and “distal bridge tube 1703” in line 4.
Appropriate correction is required.
Claim Objections
Claims 1, 4, 8, 12, 14, 15, and 17 are objected to because of the following informalities:
Claim 1 recites “the external sheath retracted when the main catheter is at a leaflet to be cut”, although the line is understood by the Examiner to be a functional such that the limitation is not a method step and does not positively require the leaflet to be cut (i.e., a part of the body – 101 issue), the Examiner suggests the line be amended to read “the external sheath is configured to be retracted when the main catheter is a the leaflet to be cut” for the purpose of having consistent language throughout the claims;
Claims 1 (lines 5,6,9), 4 (lines 3,4), 14 (lines 6,8), 15 (line 1), and 17 (lines 3,4) recite “a distal bridge tube” in the lines listed, although the phrase is understood by the Examiner to mean “the distal bridge tube” as the “distal bridge tube” was previously defined and based on Applicant’s disclosure, which details only one “distal bridge tube”, the Examiner suggests each instance of the phrase in the lines above be amended to read “the distal bridge tube” for the purpose of maintaining consistent language throughout the claims;
Claim 8 recites “the catheter” in lines 2 and 3, although the line is understood by the Examiner to mean “the main catheter” as previously defined and repeated in every other instance, the Examiner suggests the lines be amended to read “the main catheter” for the purpose of maintaining consistent language throughout the claims;
Claims 9, 10, 18, and 19, recite “the cutter” in various lines, although this does not rise to the level of being indefinite as the phrase is understood by the Examiner to mean “the cutting wire” as previously defined and based off of Applicant’s disclosure where the cutting wire is the only cutter, the Examiner suggests the lines be amended to read “the cutting wire” for the purpose of maintaining consistent language throughout the claims;
Claims 11 and 20 recite “the patient’s body” in line 2, although the lines are understood by the Examiner to mean “a body of the patient” as “the body” was not previously defined, the Examiner suggests the line be amended to read “a body of the patient” for the purpose of maintaining consistent language throughout the claims;
Claim 12 recites “the commissure guidewire” in line 2, although the line is understood by the Examiner to mean “a commissure guidewire” as the “commissure guidewire” was not previously defined, the Examiner suggests the line be amended to read “a commissure guidewire” for the purpose of providing proper antecedent basis for the claimed terms;
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 6, 9, 10, and 17 – 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 5 and 6, the phrase "the device of Fig. 4" renders the claim indefinite because the claims can not be dependent on a Fig. and it is unclear whether Applicant is intending for claims to be dependent on claim 4 or if Applicant is intending for the claims to be dependent on an entirely different claims. For the purpose of examination, the Examiner will read the claims to be dependent on claim 4 as they include structure first introduced in claim 4.
Claim 17 recites the limitation "the undeployed configuration" in line 5. There is insufficient antecedent basis for this limitation in the claim. Additionally, the phrase " the undeployed configuration" renders the claim indefinite because it is unclear if Applicant is intending for claim 17 to provide the antecedent basis for the “undeployed configuration” or if Applicant is intending for claim 17 to be dependent on claim 15 which provides antecedent basis for the “undeployed configuration”. For the purpose of examination, the claim 17 will be read as providing antecedent basis for the “undeployed configuration” and as being dependent on claim 14.
Claims 9, 10, 18, and 19 recites the limitation "the cutter [wire] is in the deployed configuration" in line 3. There is insufficient antecedent basis for this limitation in the claim as Applicant has not previously defined a “deployed configuration” for the “cutting wire”. Additionally, the phrase renders the claim indefinite because it is unclear if Applicant is intending to define a “deployed configuration” for the cutting wire, or if Applicant is intending to refer to the “deployed configuration of the main catheter” which has been previously defined. For the purpose of examination, the Examiner will read the limitations to mean the latter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 – 3, 9, 10, 14 – 16, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al (US 6,743,228 B2).
Regarding claim 1, Lee discloses a device (tissue severing device 100) capable of being a cardiac cutting device (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88. With that said, the device of Lee is structurally similar to the claimed device and is therefore capable of functioning as a cardiac cutting device), the device comprising:
a main catheter (tubular shaft 150) (col. 6 lines 48 – 65 and Fig. 1A-C) configured to be threaded into a patient's vasculature (Examiner’s note: it should be understood that the preceding limitations are intended use, and only require the structure of the prior art be capable of functioning in the manner claimed. With that said, the device is capable of being threaded through a patient’s vasculature. Therefore, the device is configured to function as claimed), the main catheter comprising a retractable external sheath (tubular shaft 150), the external sheath retracted when the main catheter is in a deployed configuration (configuration shown in Fig. 1C) (Examiner’s note: as discussed in col. 6 lines 48 – 65 and shown through the Figs. 1A-1C, the guide lumens 104 / 106 is slid out of the tubular shaft 150, therefore, the tubular shaft 150 (i.e., the sheath) is retracted relative to the guide lumens and is considered a retractable sheath as it moves proximally relative to the distally moving guide lumens);
the external sheath [configured to be] retracted when the main catheter is at a leaflet to be cut (Examiner’s note: as stated above the tubular shaft 150 (i.e., the sheath) is retractable and is therefore capable of being retracted when the main catheter is at a leaflet);
a proximal bridge tube (distal segment 110) and a distal bridge tube (distal segment 108) retractable within the main catheter and covered by the external sheath when the main catheter is in an undeployed configuration (configuration shown in Fig. 1A) (Fig. 1A), the proximal bridge tube and a distal bridge tube projecting from the main catheter when the main catheter is in a deployed configuration (col. 7 line 66 – col. 8 line 24 and Fig. 1C), the proximal bridge tube and a distal bridge tube projecting radially from the main catheter in a same plane when the main catheter is in the deployed configuration (Fig. 1C); and
a cutting wire (cutting tool 120) extending between the proximal bridge tube and a distal bridge tube (col. 9 lines 51 – 65, col. 10 lines 1 – 5, and Figs. 1B/C), the cutting wire projecting outwardly from the main catheter when the main catheter is in the deployed configuration (Figs. 1B/C), the cutting wire, the proximal bridge tube and the distal bridge tube forming a bridge when the main catheter is in the deployed configuration (Figs. 1B/C).
Regarding claims 2 and 3, Lee further discloses wherein the cutting wire is operable to cut aortic valve leaflets by moving in a reciprocating motion and by moving in a rotating motion (Examiner’s note: it should be understood that the preceding limitations are intended use, and only require the structure of the prior art be capable of functioning in the manner claimed. With that said, the entire device can be reciprocated and rotated such that the cutting tool 120 (i.e., the cutting wire) is capable of cutting aortic leaflets via a reciprocating / rotating motion).
Regarding claims 9 and 10, Lee further discloses further comprising a proximal bridge support (guide lumen 106) affixed to the proximal bridge tube (distal segment 110) and a distal bridge support (guide lumen 104) affixed to the distal bridge tube (distal segment 108) (col. 6 line 25 – col. 7 line 13 and Fig. 1B/C), the proximal bridge support configured to support the proximal bridge tube when the cutter is in the deployed configuration and the distal bridge support configured to support the distal bridge tube when the cutter is in the deployed configuration (col. 6 line 25 – col. 7 line 13 and Fig. 1B/C) (Examiner’s note: the guide lumens support the respective bridge tubes by being coextensive with them, thereby providing structural support).
Regarding claim 14, Lee discloses a device (tissue severing device 100) capable of being a cardiac cutting device (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88. With that said, the device of Lee is structurally similar to the claimed device and is therefore capable of functioning as a cardiac cutting device), the device comprising:
a main catheter (tubular shaft 150) (col. 6 lines 48 – 65 and Fig. 1A-C) adapted for femoral insertion into a patient's vasculature in an over-the- wire method (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure be capable of functioning as claimed, with that said the tubular shaft 150 is capable of being used in an over-the-wire method as claimed),
the main catheter (tubular shaft 150) comprising a retractable external sheath (tubular shaft 150), the external sheath (tubular shaft 150) retracted when the main catheter is in a deployed configuration (configuration shown in Fig. 1C) (Examiner’s note: as discussed in col. 6 lines 48 – 65 and shown through the Figs. 1A-1C, the guide lumens 104 / 106 is slid out of the tubular shaft 150, therefore, the tubular shaft 150 (i.e., the sheath) is retracted relative to the guide lumens and is considered a retractable sheath as it moves proximally relative to the distally moving guide lumens);
a proximal bridge tube (distal segment 110) and a distal bridge tube (distal segment 108) extending radially from the main catheter (tubular shaft 150) when the main catheter is in the deployed configuration (configuration shown in Fig. 1C) (col. 6 line 25 – col. 7 line 13 and Fig. 1A/B/C), the proximal bridge tube and a distal bridge tube projecting radially from the main catheter in a same plane (Fig. 1C);
a cutting wire (cutting tool 120) extending between the proximal bridge tube and a distal bridge tube (col. 9 lines 51 – 65, col. 10 lines 1 – 5, and Figs. 1B/C).
Regarding claim 15, Lee discloses wherein the proximal bridge tube (distal segment 110) and a distal bridge tube (distal segment 108) are retractable within the main catheter and covered by the external sheath when the main catheter is in an undeployed configuration (configuration shown in Fig. 1A) (col. 7 line 66 – col. 8 line 24 and Figs. 1A/B/C).
Regarding claim 16, Lee further discloses wherein the cutting wire is operable to cut aortic valve leaflets by moving in a reciprocating motion (Examiner’s note: it should be understood that the preceding limitations are intended use, and only require the structure of the prior art be capable of functioning in the manner claimed. With that said, the entire device can be reciprocated such that the cutting tool 120 (i.e., the cutting wire) is capable of cutting aortic leaflets via a reciprocating).
Regarding claims 18 and 19, Lee further discloses further comprising a proximal bridge support (guide lumen 106) affixed to the proximal bridge tube (distal segment 110) and a distal bridge support (guide lumen 104) affixed to the distal bridge tube (distal segment 108) (col. 6 line 25 – col. 7 line 13 and Fig. 1B/C), the proximal bridge support configured to support the proximal bridge tube when the cutter is in the deployed configuration and the distal bridge support configured to support the distal bridge tube when the cutter is in the deployed configuration (col. 6 line 25 – col. 7 line 13 and Fig. 1B/C) (Examiner’s note: the guide lumens support the respective bridge tubes by being coextensive with them, thereby providing structural support).
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 3, 8, 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Woolfson et al (US 8,771,302 B2) and in view of Kheradvar et al (US 2017/0360557 A1).
Regarding claim 1, Woolfson discloses a cardiac cutting device (expandable resector 1025) (abstract, col. 23 line 63 – col. 24 line 13, and Fig. 23) comprising:
a main catheter (see annotated Fig. 23) configured to be threaded into a patient's vasculature (col. 22 lines 14 – 33);
a proximal bridge tube (proximal expandable arm 1030; designated in annotated Fig. 23) and a distal bridge tube (distal expandable arm 1030 with an opening that is longitudinally aligned with the proximal expandable arm; designated in annotated Fig. 23), the proximal bridge tube (proximal expandable arm 1030; designated in annotated Fig. 23) and the distal bridge tube (distal expandable arm 1030) projecting from the main catheter when the main catheter is in the deployed configuration (Fig. 23 and annotated Fig. 23), the proximal bridge tube and the distal bridge tube projecting radially from the main catheter in a same plane when the main catheter is in the deployed configuration (Examiners note: the designated the proximal bridge tube and the distal bridge tube have at least one plane in common as the cutting wire is shown as extending from designated the proximal bridge tube and the distal bridge tube and extending parallel to the longitudinal axis);
a cutting wire (recessing wire 1040; designated in annotated Fig. 23) extending between the proximal bridge tube and the distal bridge tube (col. 23 line 63 – col. 24 line 13, and Fig. 23), the cutting wire projecting outwardly from the main catheter when the main catheter is in a deployed configuration (configuration shown in Fig. 23) (Fig. 23 and annotated Fig. 23), the cutting wire, the proximal bridge tube and the distal bridge tube forming a bridge when the main catheter is in the deployed configuration (Figs. 1B/C).
However, the embodiment of Fig. 23 of Woolfson is silent regarding (i) the main catheter comprising a retractable external sheath, the external sheath retracted when the main catheter is in a deployed configuration and (ii) wherein proximal bridge tube and the distal bridge tube are retractable within the main catheter and covered by the external sheath when the main catheter is in an undeployed configuration.
As to the above, Kheradvar teaches a main catheter comprising a retractable sheath (sheath 104) for an expandable medical device (heat valve 101; which is equated to the expandable resector 1025 of Woolfson), for the purpose of allowing the user to selectively cover, uncover, or recover the expandable medical device which allows for the expandable medical device to traverse the vasculature without unintentionally damaging the vasculature and for the purpose of allowing the user to reposition the expandable medical device or remove it altogether if needed (paragraphs [0009], [0019], [0116], and Fig. 18).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the main catheter of Woolfson to incorporate the retractable sheath, as taught by Kheradvar, for the purpose of covering the expandable resector as the device traverses the vasculature, thereby preventing any unwanted damage to the vasculature, and for the purpose of being able to recover and reposition the expandable resector without causing undo harm to healthy tissue that could be damaged when reorienting the expandable resector when in the expanded state. With respect to (ii), the modified device is such that the main catheter comprises the external retractable sheath; additionally, it should be understood that the limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; and as discussed above, the sheath is retractable, therefore, the bridge tubes are retractable within the main catheter (i.e., the sheath, which is a part of the main catheter) and capable of being covered by the sheath when the main catheter is in an undeployed configuration. Thus the combination encompasses the limitation above.
Annotated Figure 23 of Woolfson
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Regarding claim 2, as discussed above, the combination of Woolfson and Kheradvar teaches the device of claim 1. Additionally, Woolfson discloses wherein the cutting wire (recessing wire 1040; designated in annotated Fig. 23) is operable to cut aortic valve leaflets by moving in a reciprocating motion (col. 23 line 63 – col. 24 line 13, and Fig. 23).
Regarding claim 3, as discussed above, the combination of Woolfson and Kheradvar teaches the device of claim 1. Additionally, Woolfson discloses wherein the cutting wire (recessing wire 1040; designated in annotated Fig. 23) is operable to cut aortic valve leaflets by moving in a rotating motion (col. 23 line 63 – col. 24 line 13, and Fig. 23).
Regarding claim 8, as discussed above, the combination of Woolfson and Kheradvar teaches the device of claim 1. Additionally, Woolfson discloses wherein:
the proximal bridge tube (proximal expandable arm 1030; designated in annotated Fig. 23) comprises a proximal bridge tube opening (designated in annotated Fig. 23) that faces towards the distal end of the catheter (Examiner’s note: the opening faces the distal end of the distal end of the “distal bridge tube” which is a part / distal end of the catheter) and
the distal bridge tube (distal expandable arm 1030 designated in annotated Fig. 23) comprises a distal bridge tube opening (designated in annotated Fig. 23) that faces the proximal end of the catheter (see annotated Fig. 23),
the cutting wire (recessing wire 1040; designated in annotated Fig. 23) extending between the proximal bridge tube opening and the distal bridge tube opening (see annotated Fig. 23).
Regarding claims 11 and 20, as discussed above, the combination of Woolfson and Kheradvar teaches the cardiac cutting device of claims 1 and 12. Additionally, Woolfson teaches, in col. 23 line 63 – col. 24 line 6, wherein the wire 1040 (i.e., the cutting wire) is reciprocally driven; and because the wire 1040 (i.e., the cutting wire) is reciprocally driven it would be obvious for the system to comprise a controller, actuatable by the operator, outside of the body, and wherein the cutting wire extends to said controller, for the purpose of having the operator be in full control of the device while the cutting wire is within the patient’s body. Therefore, the combination of Woolfson and Kheradvar makes obvious a controller for actuating the cutting wire.
Claims 7, 12, and 13 rejected under 35 U.S.C. 103 as being unpatentable over Woolfson et al (US 8,771,302 B2) in view of Kheradvar et al (US 2017/0360557 A1), as applied to claim 1 above, and further in view of McDonald (US 2017/0027600 A1).
Regarding claim 7, as discussed above, the combination of Woolfson and Kheradvar teach the cardiac cutting device of claim 1.
However, the combination is silent regarding (i) wherein the wherein the cutting wire comprises a diamond wire.
As to the above, McDonald teaches, in the same field of endeavor, a cardiac cutter (aortic cutter 10) comprising a cutting wire (cutting wire 19) comprising a diamond wire (diamond coated wire) (abstract and paragraphs [0023 – 0026]).
It should be understood that Woolfson and McDonald are known references in the art that teach a cardiac cutting device comprising cutting wire (abstract, col. 23 line 63 – col. 24 line 13, and Fig. 23 – Woolfson ; abstract and paragraphs [0023 – 0026] – McDonald); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one cutting wire material for another, and the results of the substitution would have been predictable and resulted in the modified wire of Woolfson being able to function as intended to properly cut the tissue. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Regarding claim 12, as discussed above, the combination of Woolfson and Kheradvar teach the cardiac cutting device of claim 11.
However, the combination is silent regarding (i) the controller further comprises a commissure guide control actuator configured to deploy and undeployed the commissure guidewire when the main catheter is in the deployed configuration.
As to the above, McDonald teaches, in the same field of endeavor, an aortic valve cutting device (aortic cutter 10), comprising a catheter (housing 9 – made out of the same material as a catheter – paragraph [0018]), a cutting wire (cutting wire 19), wherein the catheter comprises a commissure guidewire (upper and lower push wires 21 and 22) attached to the catheter and deployable via a commissure guide control actuator (thumb driven slide – paragraph [0022]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Woolfson in view of Kheradvar to incorporate the commissure guide wire(s), based on the teachings of McDonald, for the purpose of assisting in stabilizing the catheter during the cutting operation (paragraph [0027] – McDonald); furthermore, it would have been obvious to modify the controller system of Woolfson in view of Kheradvar to incorporate the commissure guide control actuator, as taught by McDonald, for the purpose of actuating the commissure guide wires.
Regarding claim 13, as discussed above, the combination of Woolfson, Kheradvar, and McDonald teach the cardiac cutting device of claim 12. Additionally, Kheradvar teaches a bridge control actuator (sheath controller) operable to partially or fully deploy the bridge (the combined bridge tubes of Woolfson) when the main catheter (main catheter of Woolfson) is in the deployed configuration (shown in Fig. 23 of Woolfson) (abstract and paragraph [0074] – Kheradvar) (Examiner’s note: the sheath controller of Kheradvar causes the sheath of the modified to extend and retract, and the retraction of the sheath deploys the bridge of the modified device; therefore, the sheath controller is a bridge control actuator).
Allowable Subject Matter
Claim 4 – 6 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Related Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fogarty et al (2004/0220604 A1), Dake (US 2016/0317174 A1) and Farin et al (US 2014/0243822 A1) teach tissue resection / cutting tools comprising extendable wires.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771