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 .
CLAIM INTERPRETATION
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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘capture member’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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.
Claims 1, 24, 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2 and 3 of U.S. Patent No. 11,234,727. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant claim is anticipated by the reference patent claim 1. Claim 1 of U.S. Patent No. 11,234,727 recites the distal segment being generally curved, the proximal segment being generally curved and concave, and capturing intraluminal tissue of the blood vessel with the proximal segment of the capture member and the and the instant claim does not. A person of ordinary skill in the art would have viewed omission the generally curved and concave description of the distal and proximal segments as being the same as the proximal and distal segments of the instant claim as having different curved profiles. Furthermore, the step of capturing the intraluminal tissue with the proximal segment would have been obvious to a person of ordinary skill in the art as a means to facilitating the modification of intraluminal tissue. Therefore, the instant claim is not patentably distinct.
Claims of Instant Application 19/086036
Corresponding Claims of Reference Patent 11,234,727
1
1
24
2
25
3
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 29 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wilson et al. (US 2016/0166243A1).
Regarding claim 29, Wilson discloses a method for modifying intraluminal tissue including intravascularly delivering a distal portion of a treatment system (900,1000; Figs. 9, 10) to a treatment site within a blood vessel [0094, 0097; Fig. 9, 10].The distal portion of the treatment system includes an outer shaft (904, 1004) and an inner shaft (906, 1006). Capture members (902, 1002) of the outer shaft are actuated [0094, 0097] from a low-profile state (Fig. 9A) to a deployed state (Fig. 9B). Each of the capture members includes a first portion extending between a proximal joint (1030c) and an intermediate joint (1030b) of the outer shaft and a second portion extending between the intermediate joint (1030b) and a distal joint (1030a) of the outer shaft. Wilson discloses capturing the intraluminal tissue of the blood vessel with the second portion of the capture members [0094, 0097].
Regarding claim 30, Wilson discloses actuating the capture members from the low-profile state to the deployed state includes moving the inner shaft proximally with respect to the outer shaft [0094, 0097].
Regarding claim 35, Wilson discloses deploying cutting elements (1021; Fig. 10) radially outwardly away from a longitudinal axis of the outer shaft. The cutting elements are moved relative to the capture members to cut the intraluminal tissue captured by the second portion of the capture members [0097].
Regarding claim 36, Wilson discloses moving the cutting elements relative to the capture members includes moving each of the cutting elements through a slot [0096] in a corresponding one of the capture members (Fig. 10).
Regarding claim 37, Wilson discloses that the capture members are deployed to cause each of the capture members to flex or bend at each of the distal, proximal and intermediate joints (Figs. 9a,b, 10; [0092]).
Regarding claim 29, Wilson discloses a method for modifying intraluminal tissue including intravascularly delivering a distal portion of a treatment system (2100; Figs. 21A) to a treatment site within a blood vessel [0143].The distal portion of the treatment system includes an outer shaft (2104) and an inner shaft (2106). Capture members (2102) of the outer shaft are actuated [0143] from a low-profile state to a deployed state. Each of the capture members includes a first portion extending between a proximal joint and an intermediate joint of the outer shaft and a second portion extending between the intermediate joint and a distal joint of the outer shaft (please see annotated figure below). Wilson discloses capturing the intraluminal tissue of the blood vessel with the second portion of the capture members [0143].
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Regarding claim 31, Wilson discloses actuating the capture members from the low-profile state to the deployed state includes moving the outer shaft distally with respect to the inner shaft [0143].
Regarding claim 34, Wilson discloses expanding tensioning arms (2182; Fig. 21) to extend outwardly away from the outer shaft. The tensioning arms are radially offset from the capture members to increase radial tension on the blood vessel [0134].
Regarding claim 38, Wilson discloses a method for modifying intraluminal tissue including intravascularly delivering a distal portion (Fig. 10) of a treatment system to a treatment site within a blood vessel. An inner shaft (1006) of the treatment system is moved proximally with respect to an outer shaft of the treatment system [0094, 0097]. The inner shaft is fixed to the outer shaft at a distal end (1014) of the inner shaft such that moving the inner shaft proximally with respect to the outer shaft causes capture members of the outer shaft to bend outwardly away from a longitudinal axis of the outer shaft into a deployed state (Fig. 9, Fig. 10; [0097]). In the deployed state, each of the capture members includes a proximal segment (1030c; Fig. 10) extending between a proximal joint and an intermediate joint (1030b) and a distal segment that extends between the intermediate joint (1030b) and a distal joint (1030a). A portion of the intraluminal tissue is engaged within a capture region formed by the distal segments of the capture members [0097].
Regarding claim 39, Wilson discloses deploying a cutting element (1021; Fig. 10) at the distal portion of the treatment system such that blades (1025) of the cutting element extend outwardly away from the longitudinal axis of the outer shaft to cut the portion of the intraluminal tissue engaged (tissue separated and used to create a dissection pocket) by the capture region.
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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. (US 2016/0166243A1, “Wilson”).
Regarding claim 21, Wilson discloses a method for modifying intraluminal tissue including intravascularly delivering a distal portion of an elongated shaft (904) to a treatment site within a blood vessel [0094; Fig. 9]. A capture member (903; [0091]) at the distal portion is deployed [0094] such that the capture member bends outwardly away from a longitudinal axis of the elongated shaft. The capture member includes a distal segment (901a) having a first curved profile between a distal joint (930a) of the capture member and an intermediate joint (930b) of the capture member. A proximal segment (901b) has a generally linear profile between the intermediate joint (930b) and a proximal joint (930c) of the capture member [0093]. Wilson does not expressly disclose that the proximal segment includes a second curved profile between the intermediate joint and a proximal joint of the capture member, wherein the second curved profile is different from the first curved profile.
Wilson teaches that the length of each segment (901; [0093]), the angle between the segments (901a,b) and/or the shape of each segment (e.g., linear, curved, etc.) can be varied along a single dissection arm to achieve a desired dissection pocket and/or leaflet shape. As seen in Wilson, the shape (linear/curved) of the proximal segment are disclosed as result effective variables in that changing the shape of the proximal segment such that the proximal segment includes a curved profile different from the curved profile of the distal segment which affects the ability to achieve a desired dissection pocket. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the proximal segment of Wilson to have a different curved profile than the distal segment, as it involves only adjusting the shape of the segments disclosed to require adjustment. Therefore, 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 proximal segment of Wilson by making the curved profile of the proximal segment different than the curved profile of the distal segment, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 22, Wilson discloses that the first curved profile is concave away from a proximal portion of the elongated shaft (Fig. 9B).
Regarding claim 23, Wilson discloses capturing a portion of the intraluminal tissue of the blood vessel with the distal segment of the capture member [0094].
Regarding claims 24 and 27, Wilson discloses that the capture member is one of a plurality of capture members (opposing side including proximal and distal segments of capture member in claim 21 above; Fig. 9B). The elongated shaft is an outer shaft (904). The plurality of capture members are deployed by moving an inner shaft (906) disposed within the outer shaft in a proximal direction (A; Fig. 9B) relative to the outer shaft. A distal end region (914) of the inner shaft is fixed to a distal end region of the outer shaft (Fig. 9B) such that proximal movement forces the plurality of capture members to bend outwardly [0091, 0094].
Regarding claim 25, Wilson discloses that the outer shaft includes a plurality of slots (Fig. 9a; removed regions) extending along a length of the distal portion [0096], e.g., within the proximal segment of the dissection arms (1002; Fig. 10). Portions of the outer shaft between the plurality of slots define the plurality of capture members. Moving the inner shaft in the proximal direction pulls distal portions of the plurality of capture members proximally to force the plurality of capture member to bend outwardly [0093-0094].
Allowable Subject Matter
Claims 26, 28, 32, 33, and 40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cox (US 2007/0005093A1) discloses a method for modifying intraluminal tissue including an inner and an outer shaft attached to capture members.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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