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
In light of Applicant’s amendment, claim(s) 1 is/are amended, claims 2, 9, and 16 are canceled and claim(s) 22-26 were previously canceled. Claims 27-29 are added. Claims 1, 3-8, 10-15, 17-21 and 27-29 are pending examination.
Response to Arguments
Applicant’s amendments, filed 9/12/2025, with respect to the rejection(s) of claim(s) 1 under U.S.C. 102 have been fully considered. Examiner agrees the additional limitation of “wherein the frame is divided into a proximal frame in a proximal area of the filtering unit and a distal frame in a distal area of the filtering unit, the distal frame separate from the proximal frame” overcomes the previous rejection. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Schumacher in view of Carpenter et al.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "feeding unit" in claim 1.
Claim 1 recites the limitation of a “feeding unit”. The term “unit” is used as a substitute for “means” and is modified by functional language “feeding”. There is no corresponding structure in the claim, therefore invoking 112(f). According to the specification, the corresponding structure for “a feeding unit” is “a wire, preferably a coil consisting of multiple thin wires” or equivalents thereof (Page 3).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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.
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, 20, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Schumacher et al. (WO 2018077458 A1) (noted on IDS) (paragraph citations correspond to attached Espacenet translation and figure citations correspond to original document submitted by applicant) (previously of record) in view of Carpenter et al. (US 20160317277 A1) (noted on IDS).
Regarding claim 1, Schumacher discloses an embolic protection device (1) for inserting into an aortic arch from a feeder vessel, the embolic protection device (Figure 1, 5A-B, 8; Paragraph 0010; 0122), comprising:
a feeding unit (7) (As indicated above, the limitation “a feeding unit” invokes 112f. The corresponding structure in Schumacher is a wire, which is equivalent to the wire disclosed in the present disclosure.) (Figure 1, 5A-B, 8; Paragraph 0036; 1048);
a filtering unit (3+5) coupled to the feeding unit (Paragraph 0122) comprising a frame (5) and at least one filter mesh (fibers of filter unit 3), the at least one filter mesh arranged on the frame (Figure 8; Paragraph 0122; 0149; 0155),
a support device (43) independent from the frame and coupled to the filtering unit (thread 43 secures distal form 4 to the filter unit 3, thus is a support device) (Figure 12; Paragraph 0162; 0223),
wherein the filtering unit is configured to exit a catheter (25) and be positioned at least partially in the aortic arch by the feeding unit (Figure 14; Paragraph 0153; 0166; 0170), and
wherein, once the filtering unit exits the catheter and is positioned by the feeding unit (the limitation “once the filtering unit exits the catheter and is positioned by the feeding unit” is seen as functional language and not necessarily required to be disclosed as a step if the claimed components are capable of performing the function of the claimed components), at least a portion of the support device extends proximally into the catheter and is operable independently from the feeding unit (Paragraph 0098; 0176), to allow a user to actively collapse a proximal area of the filtering unit toward the feeder vessel (Paragraph 0162) (Schumacher is provided with a thread, which corresponds to device 23 of the present disclosure, which is fully capable of functioning as claimed. If desired, the thread can be extended to deploy the device at any time, even once the filtering unit is positioned by the feeding unit. The thread can be actuatable independently as the distal end of the frame is deployable prior to the deployment of the proximal end (Paragraph 0179). Further, a delivery unit is fully capable of actuating the device to actively collapse a proximal area of the filtering unit toward the feeder vessel (Paragraph 0063; 0090)).
Schumacher fails to explicitly disclose the support device extending proximally from the filtering unit and wherein the frame is divided into a proximal frame in a proximal area of the filtering unit and a distal frame in a distal area of the filtering unit, the distal frame separate from the proximal frame.
However, Carpenter is directed to an embolic protection device and teaches a filtering unit (106) wherein the frame is divided into a proximal frame (134) in a proximal area of the filtering unit and a distal frame (132) in a distal area of the filtering unit, the distal frame separate from the proximal frame (Figure 6A; Paragraph 0086) and the support device (130) extending proximally from the filtering unit (Figure 6A, 8; Paragraph 0086; 0107) (junction 130 secures the wires 110, 120 of the frame, thus is a support device).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Schumacher such that the frame is divided into a proximal frame in a proximal area of the filtering unit and a distal frame in a distal area of the filtering unit, the distal frame separate from the proximal frame and the support device extending proximally from the filtering unit, as taught by Carpenter, as both references and the claimed invention are directed to embolic protection devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schumacher with the teachings of Carpenter by incorporating the frame is divided into a proximal frame in a proximal area of the filtering unit and a distal frame in a distal area of the filtering unit, the distal frame separate from the proximal frame in order to have the frame configured such that it is transformed from a first, low-profile reduced configuration during delivery to a second, expanded configuration while in use, and if necessary, back to the first low-profile reduced configuration for later removal (Carpenter Paragraph 0081) and the support device extending proximally from the filtering unit to allow for an attachment between the frame and a delivery device.
Regarding claim 3, Schumacher further discloses wherein haptic feedback is generated when the filtering unit is appropriately positioned to signal a final position to the user (Paragraph 0017; 0180).
Regarding claim 4, Schumacher further discloses wherein the proximal frame and the distal frame each comprise two ends (labeled in Annotated Figure 5A), extending in parallel to one another in an interior of the frame (Annotated Figure 5A; Paragraph 0072), and connected with the feeding unit (Paragraph 0072-73).
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Regarding claim 5, Schumacher further discloses wherein the distal area and/or the proximal areas comprise an anchorage (20), configured to increase a radial rigidity of the frame (Figure 5A-B; Paragraph 0133-134).
Regarding claim 6, Schumacher further discloses wherein the ends of the frame (labeled in Annotated Figure 5A) extending along and/or perpendicular to a direction of blood flow are configured to be bent (Figure 5A-B).
Regarding claim 7, Schumacher further discloses wherein the ends of the frame and/or sides of the frames can be given an angle (WI) of between 5° and 85°, in the direction of blood flow (Paragraph 0129).
Regarding claim 8, Schumacher further discloses wherein the proximal area is configured to be actively and/or passively collapsed, independently of the distal area, when the embolic protection device is removed (Paragraph 0185).
Regarding claim 11, Schumacher further discloses a single filter (3) expands over both the proximal and distal frames (the filter 3 is part of the filter unit and extends over both the distal and the proximal portions of the frame) (Figure 1, 8; Paragraph 0057).
Regarding claim 20, Schumacher discloses a medical device comprising the embolic protection device (1) of Claim 1 (see rejection to claim 1 above) and the catheter (25) (Figure 14; Paragraph 0166; 0170).
Regarding claim 27, Schumacher discloses an embolic protection device (1) for inserting into an aortic arch from a feeder vessel, the embolic protection device (Figure 1, 5A-B, 8; Paragraph 0010; 0122), comprising:
a feeding unit (7) (As indicated above, the limitation “a feeding unit” invokes 112f. The corresponding structure in Schumacher is a wire, which is equivalent to the wire disclosed in the present disclosure.) (Figure 1, 5A-B, 8; Paragraph 0036; 1048);
a filtering unit (3+5) coupled to the feeding unit (Paragraph 0122) comprising a frame (5) and at least one filter mesh (fibers of filter unit 3), the at least one filter mesh arranged on the frame (Figure 8; Paragraph 0122; 0149; 0155),
wherein the filtering unit is configured to be positioned at least partially in the aortic arch by the feeding unit (Figure 17; Paragraph 0063; 0074.
Schumacher fails to explicitly disclose wherein the frame is divided into a proximal frame in a proximal area of the filtering unit and a distal frame in a distal area of the filtering unit, the distal frame separate from the proximal frame, wherein a respective independent filter mesh is arranged on each of the proximal frame and the distal frame, and wherein the proximal frame and the distal frame each comprise two ends coupled to the feeding unit.
However, Carpenter is directed to an embolic protection device and teaches a filtering unit (106) wherein the frame is divided into a proximal frame (134) in a proximal area of the filtering unit and a distal frame (132) in a distal area of the filtering unit, the distal frame separate from the proximal frame (Figure 6A; Paragraph 0086), wherein a respective independent filter mesh (108) is arranged on each of the proximal frame and the distal frame (Figure 12; Paragraph 0077; 0117) , wherein the proximal frame and the distal frame each comprise two ends (ends of 110, 120 within junction 130) coupled to the feeding unit (300) ((Figure 6A, 8; Paragraph 0081; 0086; 0105; 0107). (As indicated above, the limitation “feeding unit” invokes 112(f). The corresponding structure in Carpenter is a deployment shaft, which is equivalent to a wire, as disclosed in the present disclosure.)
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Schumacher such that the frame is divided into a proximal frame in a proximal area of the filtering unit and a distal frame in a distal area of the filtering unit, the distal frame separate from the proximal frame, wherein a respective independent filter mesh is arranged on each of the proximal frame and the distal frame, and wherein the proximal frame and the distal frame each comprise two ends coupled to the feeding unit as taught by Carpenter, as both references and the claimed invention are directed to embolic protection devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schumacher with the teachings of Carpenter by incorporating the frame is divided into a proximal frame in a proximal area of the filtering unit and a distal frame in a distal area of the filtering unit, the distal frame separate from the proximal frame, wherein a respective independent filter mesh is arranged on each of the proximal frame and the distal frame, and wherein the proximal frame and the distal frame each comprise two ends coupled to the feeding unit in order to have the frame configured such that it is transformed from a first, low-profile reduced configuration during delivery to a second, expanded configuration while in use, and if necessary, back to the first low-profile reduced configuration for later removal ( Carpenter Paragraph 0081).
Regarding claim 28, Schumacher as modified by Carpenter teaches the embolic protection device of Claim 27, and Carpenter further teaches wherein the proximal frame is configured to be actively and/or passively collapsed toward the feeder vessel independently of the distal frame (the first lobe 132 and second lobe 134 are biased in opposing radially outwards directions, thus the proximal frame (134) is fully capable of being biased, i.e., collapsed towards the feeder vessel independently of the distal frame, as the two frames extend in opposing directions) (Paragraph 0086).
Regarding claim 29, the combination of Schumacher and Carpenter further teaches wherein the proximal frame and the distal frame each comprise an independent wire forming a loop (110, 120, respectfully) such that the frame comprises four wire ends (labeled in Annotated Figure 6A) coupled to the feeding unit (Figure 6A; Paragraph 0086).
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Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Schumacher in view of Carpenter and further in view of Lashinski (US 20110022076 A1) (previously of record).
Regarding claim 10, Schumacher as modified by Carpenter discloses the embolic protection device in accordance with Claim 1, but fails to specifically disclose that a respective independent filter is stretched over each of the proximal and distal frames.
However, Lashinski is directed to a filter device (100) and teaches two independent filters (115, 130) stretched over each of a proximal and distal frames (portions of 105 attached to 115, 130 respectively) (Figure 1; Paragraph 0015).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Schumacher as modified by Carpenter such that a respective independent filter is stretched over each of the proximal and distal frames, as taught by Lashinski, as both references and the claimed invention are directed to embolic protection devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schumacher as modified by Carpenter with the teachings of Lashinski by incorporating a respective independent filter is stretched over each of the proximal and distal frames in order to allow filtering of different sized particles if provided with different sized openings or to allow filtering of two different vessels simultaneously (Lashinski Paragraph 0017-18).
Claims 12-17, 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Schumacher in view of Carpenter, as applied to claim 1 above, and further in view of McNamara et al. (US 5624396 A) (previously of record) in view of Lenker et al. (US 20100114017 A1) (previously of record).
Regarding claim 12-17 and 19, Schumacher as modified by Carpenter discloses a medical device comprising the embolic protection device of claim 1 (see rejection to claim 1 above), but fails to specifically disclose a handle comprising a first connecting piece, a handle shell, a slide, and a second connecting piece; wherein the first connecting piece is configured to be actively secured to a catheter; wherein the first connecting piece comprises notches on an inside surface of the first connecting piece configured to receive blades of a catheter; wherein the second connecting piece is configured to reversibly clamp the feeding unit; wherein the slide is configured to exert a tractive and/or compression force for loading and positioning of the embolic protection device; wherein the slide comprises a locking device anchoring the slide such that a position of the slide is adjustable in relation to the handle shell and the handle shell comprises an interior guide tube insertable into the slide.
McNamara is directed to a medical device and teaches a handle (proximal portion of Figures 1-2) for a medical device, characterized in that the handle comprises a first connecting piece (34), a handle shell (66), and a second connecting piece (64) (Figure 1; Col 4, lines 33-48, lines 63-66); wherein the first connecting piece is configured to be actively secured to a catheter (26) (Figure 2; Col 4, lines 34-36), wherein the first connecting piece comprises notches on an inside surface of the first connecting piece configured to receive blades of a catheter (threads of catheter 26) (Figure 2; Col 4, lines 34-36); wherein the second connecting piece is configured to reversibly clamp the feeding unit (the second connecting piece 64 is a telescoping inner housing, which is moveable and thus is fully capable of being configured to reversibly clamp the feeding unit) (Figure 2; Col 5, lines 36-38); and the handle shell comprises an interior guide tube (30) insertable into the slide, (which is fully capable of being inserted into the slide if it were provided) (Figure 1-2; Col 4, lines 34-36).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Schumacher as modified by Carpenter such that the device includes a handle comprising a first connecting piece, a handle shell, a slide, and a second connecting piece; wherein the first connecting piece is configured to be actively secured to a catheter; wherein the first connecting piece comprises notches on an inside surface of the first connecting piece configured to receive blades of a catheter; wherein the second connecting piece is configured to reversibly clamp the feeding unit and the handle shell comprises an interior guide tube insertable into the slide, as taught by McNamara, as both references and the claimed invention are directed to medical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schumacher as modified by Carpenter with the teachings of McNamara by incorporating a handle comprising a first connecting piece, a handle shell, a slide, and a second connecting piece; wherein the first connecting piece is configured to be actively secured to a catheter; wherein the first connecting piece comprises notches on an inside surface of the first connecting piece configured to receive blades of a catheter; wherein the second connecting piece is configured to reversibly clamp the feeding unit and the handle shell comprises an interior guide tube insertable into the slide, as Schumacher is silent to any handle and such a modification to incorporate a known handle would have been obvious, namely to allow the user to hold and manipulate the device of Schumacher.
Furthermore, Lenker is directed to a medical device and teaches a handle (5) for a medical device, characterized in that the handle (5) comprises a first connecting piece (3604) (Figure 36A; Paragraph 0260), a handle shell (3602) (Figure 36A; Paragraph 0261), and a slide (3610) (Figure 36A; Paragraph 0260); wherein the slide is configured to exert a tractive force for loading and positioning of a device (Paragraph 0261); wherein the slide comprises a locking device (3612) anchoring the slide such that a position of the slide is adjustable in relation to the handle shell (Paragraph 0261).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Schumacher as modified by Carpenter as modified by McNamara to include a slide wherein the slide is configured to exert a tractive and/or compression force for loading and positioning of the embolic protection device; wherein the slide comprises a locking device anchoring the slide such that a position of the slide is adjustable in relation to the handle shell, as taught by Lenker, as both references and the claimed invention are directed to medical devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schumacher as modified by Carpenter as modified by McNamara with the teachings of Lenker by incorporating a slide wherein the slide is configured to exert a tractive and/or compression force for loading and positioning of the embolic protection device; wherein the slide comprises a locking device anchoring the slide such that a position of the slide is adjustable in relation to the handle shell in order to easily actuate the handle and control deployment of a device (Lenker Paragraph 0261).
Regarding claim 21, Schumacher as modified by Carpenter, McNamara and Lenker teaches the medical device of claim 12 and Schumacher further discloses the catheter (25) (Figure 14; Paragraph 0166; 0170).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Schumacher in view of Carpenter, McNamara and Lenker, as applied to claim 12 above, and further in view of Goldfarb et al. (US 20040049207 A1) (previously of record).
Regarding claim 18, Schumacher as modified by Carpenter, McNamara and Lenker discloses the medical device of Claim 12, but fails to specifically disclose that the handle comprises a hemostatic valve.
However, Goldfarb is directed to a catheter device and teaches a handle (1056) comprises a hemostatic valve (1090) (Figure 74; Paragraph 0286).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Schumacher as modified by Carpenter, McNamara and Lenker such that the handle comprises a hemostatic valve, as taught by Goldfarb, as both references and the claimed invention are directed to catheter devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schumacher as modified by Carpenter, McNamara and Lenker with the teachings of Goldfarb by incorporating the handle comprises a hemostatic valve in order to provide leak-free sealing, prevent back bleeding, and reduce the possibility of air introduction (Goldfarb Paragraph 0286).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11534284 B2 (Schumacher et al.) in view of Schuamcher et al (WO 2018077458 A1) (referred to as Schumacher ‘458) (noted on IDS) (paragraph citations correspond to attached Espacenet translation and figure citations correspond to original document submitted by applicant) and Carpenter et al (US 20160317277 A1).
Regarding claim 1, claim 1 of Schumacher et al. claims an embolic protection device (1) for inserting into an aortic arch (Col 18, lines 46-47),
comprising a feeding unit (7) (Col 18, lines 48-51);
a filtering unit (3+5) coupled to the feeding unit (Col 19, lines 20-24) and comprising a frame (5) and at least one filter mesh (filter unit 3) and the at least one filter mesh is arranged on the frame (Col 18, lines 49, 51),
a support device (4) (Col 18, lines 54-55),
wherein the filtering unit comprises a proximal area (9) and a distal area (2), wherein the filtering unit is designed in such a way that it can, at least partially, be positioned in the aortic arch by the feeding unit (Col 18, lines 46-47; 53-55).
Schumacher fails to explicitly claim a support device independent from the frame and coupled to the filtering unit, the support device extending proximally from the filtering unit, wherein the frame is divided into a proximal frame in a proximal area of the filtering unit and a distal frame in a distal area of the filtering unit, the distal frame separate from the proximal frame, wherein the filtering unit is configured to exit a catheter and be positioned at least partially in the aortic arch by the feeding unit, and wherein, once the filtering unit exits the catheter and is positioned by the feeding unit, at least a portion of the support device extends proximally into the catheter and is operable independently from the feeding unit to allow a user to actively collapse the proximal area of the filtering unit toward the feeder vessel
However, Schumacher ‘458 is directed to a similar device and teaches a support device (43) coupled to the filter mesh (Figure 2; Paragraph 0125), wherein the support device is operable independently from the feeding unit (Paragraph 0098; 0176), such that the support device is configured to actively draw the filter mesh towards a roof of the aortic arch (Paragraph 0090; 0176) (Schumacher is provided with a thread, which corresponds to device 23 of the present disclosure, which is fully capable of functioning as claimed. If desired, the thread can be extended to deploy the device at any time, even once the filtering unit is positioned by the feeding unit. The thread can be actuatable independently as the distal end of the frame is deployable prior to the deployment of the proximal end (Paragraph 0179). Further, a delivery unit is fully capable of actuating the device to actively draw the filter mesh towards a roof of the aortic arch (Paragraph 0063; 0090)), wherein the filtering unit is configured to exit a catheter (25) and be positioned at least partially in the aortic arch by the feeding unit (Figure 14; Paragraph 0153; 0166; 0170), and
wherein, once the filtering unit exits the catheter and is positioned by the feeding unit (the limitation “once the filtering unit exits the catheter and is positioned by the feeding unit” is seen as functional language and not necessarily required to be disclosed as a step if the claimed components are capable of performing the function of the claimed components), at least a portion of the support device extends proximally into the catheter and is operable independently from the feeding unit (Paragraph 0098; 0176), to allow a user to actively collapse a proximal area of the filtering unit toward the feeder vessel (Paragraph 0162) (Schumacher is provided with a thread, which corresponds to device 23 of the present disclosure, which is fully capable of functioning as claimed. If desired, the thread can be extended to deploy the device at any time, even once the filtering unit is positioned by the feeding unit. The thread can be actuatable independently as the distal end of the frame is deployable prior to the deployment of the proximal end (Paragraph 0179). Further, a delivery unit is fully capable of actuating the device to actively collapse a proximal area of the filtering unit toward the feeder vessel (Paragraph 0063; 0090)).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schumacher with the teachings of Schumacher ‘458 by incorporating the support device independent from the frame and coupled to the filter mesh wherein once the filtering unit is positioned by the feeding unit, the support device is operable independently from the feeding unit to allow a user to actively draw the filter mesh towards a roof of the aortic arch in order to secure the frame and filter and also control insertion of the device to position it according to the anatomy of the patient.
Further, Carpenter is directed to an embolic protection device and teaches a filtering unit (106) wherein the frame is divided into a proximal frame (134) in a proximal area of the filtering unit and a distal frame (132) in a distal area of the filtering unit, the distal frame separate from the proximal frame (Figure 6A; Paragraph 0086) and the support device (130) extending proximally from the filtering unit (Figure 6A, 8; Paragraph 0086; 0107) (junction 130 secures the wires 110, 120 of the frame, thus is a support device).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Schumacher such that the frame is divided into a proximal frame in a proximal area of the filtering unit and a distal frame in a distal area of the filtering unit, the distal frame separate from the proximal frame and the support device extending proximally from the filtering unit, as taught by Carpenter, as both references and the claimed invention are directed to embolic protection devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schumacher with the teachings of Carpenter by incorporating the frame is divided into a proximal frame in a proximal area of the filtering unit and a distal frame in a distal area of the filtering unit, the distal frame separate from the proximal frame in order to have the frame configured such that it is transformed from a first, low-profile reduced configuration during delivery to a second, expanded configuration while in use, and if necessary, back to the first low-profile reduced configuration for later removal (Carpenter Paragraph 0081) and the support device extending proximally from the filtering unit to allow for an attachment between the frame and a delivery device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771