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.
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:
expandable structure in claim 1 and claim 13
guiding structure in claim 10
collecting element in claim 11
capturing element in claim 21.
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 § 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.
Claim(s) 1-7 and 10-21 is/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.
Claim 1 recites the limitation "the inflatable balloons" in line 7. There is insufficient antecedent basis for this limitation in the claim.
The term “substantially” in claim 2 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Conical has been rendered indefinite by the use of the term substantially.
Regarding claim 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 recites the limitation "a lumen for fluid flow and fragment passage" in line 2. It is not clear if this is referring to the lumen disclosed in claim 1. For the purposes of art rejection the lumens in both claims will be considered to be the same lumen.
Claim 17 recites the limitation "the occlusion fragments" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the occlusion fragments" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Objections
Claims 14 and 19 are objected to because of the following informalities: please change “the expandable structure is a non-expanded configuration” to “the expandable structure in a non-expanded configuration”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: please change “the step of expanding” to “expanding”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: please change “the step of expanding” to “expanding”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: please change “the step of guiding” to “guiding”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: please change “the step of collecting” to “collecting”. Appropriate correction is required.
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) 1-7, 10-12 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leon-Yip (US 2021/0085360A1) in view of Eidenschink (US 2013/0345796A1).
Leon-Yip discloses a catheter device for extracting an occlusion from a blood vessel including a shaft (320; Fig. 2) having proximal and distal ends. An expandable structure (30; [0054]) includes a proximal portion and a distal portion and is coupled to or adjacent the distal end of the shaft (Fig. 2). The expandable structure is capable of expanding radially around the shaft. A lumen disposed within tube (20) for fluid flow and fragment passage (Fig. 6). A single inflatable balloon is positioned circumferentially around the lumen. The proximal portion of the expandable structure includes one or more fragmentors (306; Fig. 2; [0059-0062]). However, Leon-Yip does not disclose inflatable balloons, a plurality of balloons positioned circumferentially around the lumen.
In the same field of endeavor, inflatable balloons around a lumen, Eidenschink teaches an embodiment in which a balloon has a single annular compartment (Fig. 8c) and an embodiment in which a balloon is formed of a plurality of inflatable compartments (542; [0066]; Fig. 8d) that are disposed circumferentially around a lumen. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the balloon of Leon-Yip with a balloon formed of a plurality of inflatable balloons, as taught by Eidenschink, as this modification involves the simple substitution of one type of balloon for another for the predictable result of providing an inflatable balloon.
Regarding claim 2, the combination of Leon-Yip and Eidenschink discloses that the proximal portion of the expandable structure is tapered (Fig. 2; Leon-Yip).
Regarding claim 3, the combination of Leon-Yip and Eidenschink discloses that the proximal portion includes a plurality of tethers (one or more struts of the expandable structure; Fig. 2; Leon-Yip).
Regarding claim 4, the combination of Leon-Yip and Eidenschink discloses that the one or more fragmentors include cutters in the form of cutting edges [0060; Leon-Yip].
Regarding claims 5 and 6, the combination of Leon-Yip and Eidenschink discloses that the one or more fragmentors are aligned with the proximal portion of the expandable structure [0060; Leon-Yip] and are capable of guiding occlusion fragments towards the lumen by utilizing the profiled and oriented fragmentors.
Regarding claims 7 and 10-12, the combination of Leon-Yip and Eidenschink discloses that the expandable structure is an expandable scaffold (Fig.1, 2; Leon-Yip). The distal portion of the expandable structure includes a collecting element (380; Leon-Yip) that is capable of allowing fluid flow therethrough. The device includes a lumen about which the inflatable balloons are disposed and a guiding structure in the form of a suction tube that is capable of guiding fragments towards the lumen [0080; Leon-Yip].
Claim(s) 13-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leon-Yip (US 2021/0085360A1) in view of Eidenschink (US 2013/0345796A1) in view of Garrison et al. (US 2022/0287817A1, Garrison”).
Regarding claim 13, the combination of Leon-Yip and Eidenschink as disclosed above in claim 1, teaches advancing the device through the occlusion until the proximal portion of the device protrudes partially or completely beyond the occlusion (Fig. 9; Leon-Yip). The expandable structure is expanded (Fig. 10; [0085-0089]).
However, the combination of Leon-Yip and Eidenschink does not disclose advancing a catheter along the vessel, advancing a device of claim 1 through the catheter and the device is retrieved so as to fragment the occlusion. In the same field of endeavor, devices for removing obstructive material, Garrison teaches a method including a catheter (103; [0164]) that is advanced along the vessel and the device is advanced through the catheter. A device is advanced through the occlusion until the proximal portion of the device protrudes partially or completely beyond the occlusion [0164]. The device is retrieved so as to fragment the occlusion [0166, 0168, 0169, 0173, 0174]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the method of the combination of Leon-Yip and Eidenschink with the method, as taught by Garrison, to provide means for safely delivering the device of the combination of Leon-Yip and Eidenschink and efficiently removing fragments of the occlusion to reduce the risk of embolization.
Regarding claims 14-16, the combination of Leon-Yip, Eidenschink and Garrison discloses that the device is advanced through the catheter or occlusion in a non-expanded configuration [0165; Garrison] and the when expanded the expandable structure is a scaffold (Fig. 10; Garrison). Expanding the expandable structure includes inflating a plurality of inflatable balloons (Fig. 8D; [0066]; Leon-Yip).
Regarding claims 17 and 18, the combination of Leon-Yip, Eidenschink and Garrison discloses guiding occlusion fragments towards the lumen and collecting occlusion fragments [0166; Garrison].
Regarding claims 19-21, the combination of Leon-Yip, Eidenschink and Garrison discloses retrieving the device through the occlusion or through the catheter with the expandable structure in a non-expanded configuration [0166-0168; Garrison]. The system further includes a capturing element (380; Leon-Yip).
Claim(s) 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwartz (US 2004/0199191A1).
Regarding claim 22, Schwartz discloses a catheter device for extracting an occlusion from a blood vessel including a shaft having a proximal end and a distal end. An expandable balloon (18; Fig. 1) has a proximal portion (34) and a distal portion (38) and is coupled to or adjacent the distal end of the shaft [(16);0020]. The expandable balloon is capable of expanding radially around the shaft [0022]. The proximal portion of the balloon includes one or more cutters (26a,b).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sanchez Garcia (US 2018/0318560A1) discloses an expandable structure including multiple inflatable balloon encompassing a catheter shaft. The expandable structure includes a substantially conical or tapered portion and a lumen through which fluid may flow (Fig. 1).
Tilson et al. (US 2015/0141917A1) discloses an inflatable balloon formed of a plurality of inflatable flutes (84; Fig. 21, 22) that are positioned circumferentially around a lumen and vanes (186) that are capable of cutting tissue, but does not disclose that fluid or fragments may pass through the lumen. Tilson also discloses another embodiment in which a balloon (20; Fig. 16, 18) includes multiple balloon segments and a lumen (160) through which fluid and fragments may flow.
Spencer et al. (US 2013/0041391A1, “Spencer”) discloses a catheter device for extracting an occlusion from a blood vessel including a shaft (30; Fig. 1) having proximal and distal ends. An expandable structure (14) includes a proximal portion and a distal portion and is coupled to or adjacent the distal end of the shaft (Fig. 1). The expandable structure is capable of expanding radially around the shaft. A lumen through which the shaft extends is capable of passing fluid and fragments. The proximal portion of the expandable structure includes one or more fragmentors (20). The proximal portion is tapered or substantially conical (Fig. 1). The proximal portion includes a plurality of tethers (22). The one or more fragmentors includes a blade (20) and are aligned with the proximal portion of the expandable structure. The expandable structure is an expandable scaffold (Fig.1 ).
Barath (US 5,196,024) discloses an expandable structure disposed on a catheter shaft and including one or more cutters.
Rousu (US 2018/0099126A1) discloses an expandable structure disposed around a balloon formed of a plurality of inflatable balloons.
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