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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/12/2025 has been entered.
Election/Restrictions
Newly submitted claims 45-55 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
This application contains claims directed to the following patentably distinct species:
Species A: Figs. 1A-1C, 2A-2D, 3A-3C, and 4-5
Species B: Figs. 6A and 6C
Species C: Fig. 6B
Species D: Figs. 7A-7D
Species E: Figs. 8A-8B
The species are independent or distinct because Species A includes a first wire attached to a distal end of the lower surface of the filter/lateral structure and via a bead mechanism and a second collapsible wire attached to the proximal end of the filter/lateral structure, Species B includes a first wire attached at various attachment points along an upper surface of the filter and a second wire as a tube proximal to the filter through which the first wire passes, Species C includes two hollow tubes and two wires movable within the respective tubes on opposing sides of the filter/lateral structure, Species D includes a nonsymmetric design with detachable wires at both ends of the filter/lateral structure, including a first wire with a snare, and Species F includes a symmetric design with the first and second wires both attached to the filter at its distal and proximal ends in a relatively symmetrical manner. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claims are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the inventions have acquired a separate status in the art due to their recognized divergent subject matter (for example, a separate field of search would be necessary and the prior art applicable to one invention would not likely be applicable to another invention due to the mutually exclusive characteristics described above with respect to each embodiment as a first wire attached to a distal end of the lower surface of the filter/lateral structure and via a bead mechanism and a second collapsible wire attached to the proximal end of the filter/lateral structure requires a different search than two hollow tubes and two wires movable within the respective tubes on opposing sides of the filter/lateral structure).
Since applicant has received an action on the merits for the originally presented invention (Species C: Fig. 6B), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 45-55 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
The previous rejection of claim(s) 28-35 over 35 U.S.C. 112(a) as failing to comply with the written description requirement are moot as claims 28-35 have been canceled in the amendment filed 12/12/2025.
The previous rejection of claim(s) 35 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made by canceling claims 35 on 12/12/2025.
Applicant's arguments filed 12/12/2025 with respect to Krahbichler (US 2015/0313701 A1) have been fully considered but they are not persuasive. Applicant argues that the embodiment shown in Fig. 8 of Krahbichler only supports the filter at six points (the guiding units 320) which are spaced apart from each other; therefore, non-continuous. However, Fig. 8 was pointed to as a reference. Paragraph [0124] of Krahbichler states the at least one guiding unit 320, such as an eyelet (shown in Fig. 8), may alternatively be a tubular bent element i.e. a hollow tube. Therefore, the eyelets shown in Fig. 8 may instead be replaced with a single hollow tube and a single hollow tube extends continuously without interruption. Thus, arguments over Krahbichler are not found persuasive.
Claim Objections
Claim 36 is objected to because of the following informalities: Claim 36 recites “the position” in line 13 which should read “a position”. Appropriate correction is required.
Claim 41 is objected to because of the following informalities: Claim 41 recites “the walls” in line 2 which should read “walls”. Appropriate correction is required.
Claim 45 is objected to because of the following informalities: Claim 45 recites “the position” in lines 8-9 which should read “a position”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 36-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 36 recites “a one-piece hollow tube extending continuously without interruption along the entirety of a length of the lateral structure from a proximal end to a distal end of the filter; and a wire attached to a proximal end of the lateral structure or to the filter” in lines 8-11. On page 5 of the remarks filed 12/12/2025, applicant points to Fig. 6B to provide support for the amended claim language. Applicant annotates 600 along the upper surface of the filter as the claimed hollow tube and 203 along the lower surface of the filter as the claimed wire. However, there is nothing to suggest that the wire 203 is attached to a proximal end of the lateral structure or to the filter. Instead, the wire 203 extends through the hollow tube 600 on the lower surface of the filter and appears to move back and forth between stoppers 602, 603, similar to wire 202 (Fig. 6B; [0055]). While other embodiments show wire 203 attached to the proximal end of the lateral structure or to the filter (see for example, Figs. 1A-1C, 2A-2D, 3A-3C, and 4-5), doing so in the embodiment of Fig. 6B would prevent the wire 202 from moving back and forth. Therefore, mutually exclusive characteristics of different embodiments appear to have been claimed. Accordingly, applicant fails to possess the claimed invention.
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.
Claim 44 is 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.
Claim 44 recites the limitation "the retraction of the catheter" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 36-42 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krahbichler (US 2015/0313701 A1) in view of Lees et al. (US 9,888,994 B2).
Regarding claim 36, Krahbichler ‘701 discloses a system for deflecting emboli (Fig. 2; as device 200 is used for embolic deflection; [0019]), the system comprising: a catheter (catheter 7; Fig. 12) having an opening at its distal end (distal open end of catheter 7; Fig. 12); and a device (embolic protection device 200; Fig. 12) loadable into the catheter (the device may be deliverable via a side channel 7 of catheter 2; [0115]), the device comprising: a filter (blood permeable unit, generally noted as 132 in the figures) configured to prevent particles in a blood vessel from passing there through (as selectively permeable unit 132 is permeable for blood but impermeable for embolic material; [0102]); a lateral structure (frame, generally noted as first support member 133 in the figures) supporting the filter (see for example Fig. 3, in which the frame 133 encircles the filter 132); a one-piece hollow tube (guiding unit 320 that may be a tubular bent element i.e. one-piece “hollow tube”; [0038]; [0124]) extending continuously without interruption along a length of the lateral structure from a proximal end to a distal end of said filter (reference is made to Fig. 8 which shows a guiding element 320, as eyelets, along the length of the lateral structure and filter; because the guiding element may be eyelets or a tubular bent element, the tubular bent element would also extend continuously along the length of the lateral structure and filter from at least the distal eyelet 320 to the proximal eyelet 320 shown in Fig. 8); and a wire (130) attached to a proximal end of said lateral structure or to said filter (Fig. 12); wherein said hollow tube (320) and the wire (130) are both arranged to extend out of a distal end of the catheter (distal open end of catheter 7; Fig. 12; as the tether 300 may run in the same channel as the embolic protection device and delivery unit; [0115]) and are configured for controlling the position, orientation or deflection of said device (as the tethers are provided to control sealing of the periphery to aortic arch via push action; [0021]; Fig. 12).
Krahbichler ‘701 fails to explicitly disclose the hollow tube extending along the entirety of the length of the lateral structure and a guidewire extending out of the distal end of the catheter.
However, Krahibichler ‘701 teaches a tubular element (rib 135) may extend continuously without interruption along the entirety of a length of the lateral structure from a proximal end to a distal end of the filter (Fig. 7) for the purpose of permitting an operator to push, press or draw the device against certain features of the aortic arch ([0131]).
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 hollow tube of Krahibichler ‘701 to extend along the entirety of a length of the lateral structure from a proximal end to a distal end of the filter in order to both guide and protect the tether 300 therewithin for the entire length of the filter and to improve operation of the device with additional stability and control. Further, extending the hollow tube to the entirety of the length of the filter would prevent gaps between the tether and the tube, thereby preventing pinching of tissue therebetween.
Krahbichler ‘701 modified fails to disclose a guidewire extending out of the distal end of the catheter.
However, Lees teaches a system comprising a device (filter 310) for deflecting emboli in an aortic arch (Figs. 3A-3E) wherein the system further comprises a catheter (catheter 320) and a guide wire (guide wire) that is placed such that the catheter can be introduced into a patient (as the sheath is placed over the guide wire; column 12, lines 52-55).
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 catheter of modified Krahbichler ‘701 to further include a guide wire as taught by Lees to easily introduce the catheter to the treatment site via a standard percutaneous technique.
Regarding claim 37, Krahbichler ‘701 modified discloses the invention as claimed above, and Krahbichler ‘701 further discloses wherein said device is made from metal wire or Nitinol wire (as portions of the frame and/or permeable unit 132 can be constructed out of wire containing a core of tantalum and/or platinum and an outer material of Nitinol; [0125]).
Regarding claims 38-39, Krahbichler ‘701 modified discloses the invention as claimed above, and Krahbichler ‘701 further discloses wherein the device can be stiffened by the inclusion of heavier gauge wire or by multiple wires of a certain gauge being wound together, e.g., the device can include 2, 3, 4, 5, or more wires to increase the stiffness of the intra-vascular device i.e. two or more twists. Thus, the gauges of the wires result in differing stiffness of the device, but Krahbichler ‘701 fails to expressly disclose a diameter of said metal wire or Nitinol wire is substantially 0.5 mm or less.
However, Lees teaches a device for deflecting emboli in an aortic arch (Figs. 3A-E) with a frame and a filter or porous membrane having an integrated delivery device wire ranging from 0.014 inch to 0.035 inch (i.e. 0.3556 mm to 0.889 mm; column 12, lines 31-43).
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 diameter of the multiple wires of the frame of modified Krahbichler ‘701 to be less than substantially 0.5 mm as taught by Lees as the gauge of the wires, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 40, Krahbichler ‘701 modified discloses the invention as claimed above, and Krahbichler ‘701 further discloses wherein said device further comprises radiopaque markers (as one or more radiopaque fiducial markers may be provided on the device; [0125]).
Regarding claim 41, Krahbichler ‘701 modified discloses the invention as claimed above, and Krahbichler ‘701 further discloses wherein, upon installation in an aortic arch, the lateral structure is configured to form a seal with the walls of the aortic arch (Fig. 12; [0111]; [0131]).
Regarding claim 42, Krahbichler ‘701 modified discloses the invention as claimed above, and Krahbichler ‘701 further discloses a protected lip (wherein the distal end of the catheter 2 which extends past side channel 7 is considered a protected lip as it protrudes past the side channel 7; Figs. 9A-12) which is extendable distal to the catheter.
Regarding claim 44, Krahbichler ‘701 modified discloses the invention as claimed above, and Krahbichler ‘701 further discloses wherein the lateral structure and filter of the device expand upon the retraction of the catheter relative to the lateral structure and filter of the device (as the filter 200 expands; Figs. 9A-12).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krahbichler (US 2015/0313701 A1) in view of Lees et al. (US 9,888,994 B2), as applied to claim 29 above, and further in view of Krahbichler (US 2014/0194920 A1).
Regarding claim 30, Krahbichler ‘701 modified fails to disclose wherein said protected lip further comprises a dilator, and wherein the lateral structure and filter of the device is compressed within the catheter and positioned behind the dilator.
However, Krahbichler ‘920 teaches a device for deflecting emboli (Fig. 4B) comprising a filter (embolic protection unit 8), and a catheter (at 7) having a protected lip (extension of sheath 2 that extends past second channel 7), similar to the catheter of Krahbichler ‘701 (Fig. 12), that includes a dilator (radially expandable units 5; Fig. 4B) connected to the device (Fig. 4B) for the purpose of providing an accessible lumen or dilating septum punctures as well as accurate positioning and stabilization of the device ([0038]), wherein the lateral structure and filter of the device is compressed within the catheter and positioned behind said dilator (as filter 200 is compressed within channel 7 which is proximal the distal tip of the catheter 2 comprising the dilator of Krahbichler ‘920).
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 device of modified Krahbichler ‘701 to include a dilator connected to the protected lip, such that the lateral structure and filter of the device is compressed within the catheter and positioned behind the dilator as taught by Krahbichler ‘920 in order to dilate septum punctures as well as provide accurate positioning and stabilization of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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/SARAH A LONG/Primary Examiner, Art Unit 3771