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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/14/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 04/14/2026. As directed by the amendment: claims 1, 21-23, 31, 34, and 36 have been amended and claims 3 and 25-30 have been cancelled. Thus, claims 1-2, 4-24, and 31-7 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 8, filed 04/14/2026, with respect to the drawing objections have been fully considered and are persuasive. The applicant’s amendments to the claims have made the claims consistent with the illustration in Figs. 17 and 21. The drawing objections have been withdrawn.
Applicant’s arguments, see page 8, filed 04/14/2026, with respect to the claim objections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the minor informalities within the claims. The claim objections have been withdrawn.
Applicant’s arguments, see page 8, filed 04/14/2026, with respect to the USC 112(b) rejections have been fully considered and are persuasive. The applicant’s amendments overcome the issues of clarity within the claims. The USC 112(b) rejections of claims 23-34 have been withdrawn.
Applicant’s arguments, see pages 9-12, filed 04/14/2026, with respect to the rejection(s) of claim(s) 31 under 35 U.S.C. 102(a)(1) as being anticipated by Gandhi (US 20050113864 A1), herein referenced to as “Gandhi” have been fully considered and are persuasive.
The applicant has amended claim 31 to further recite: “body, wherein the main body comprises an inner catheter tube, and the detachable tip component includes a shaft that abuts a distal end of the inner catheter tube at a location in a proximal direction with respect to the detachment mechanism surrounding the shaft where the shaft extends entirely through the detachment mechanism in anon-detached state”.
The examiner agrees that Gandhi does not explicitly disclose the amended claim language.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rudakov et al (US 20160135984 A1).
Applicant’s arguments, see pages 9-12, filed 04/14/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 as being unpatentable over Gandhi (US 20050113864 A1), herein referenced to as “Gandhi” in view of Chen et al (US 20140277094 A1), herein referenced to as “Chen” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite: “coil surrounding the shaft, where the shaft extends entirely through the coil in a non-detached state”.
The examiner agrees that the combination of Gandhi and Chen does not teach the amended claim language.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rudakov et al (US 20160135984 A1).
Applicant’s arguments, see pages 9-12, filed 04/14/2026, with respect to the rejection(s) of claim(s) 22 under 35 U.S.C. 103 as being unpatentable over Gandhi in view of Chen and Sharkey have been fully considered and are persuasive.
The applicant has amended claim 22 to further recite: “coil surrounding the shaft, where the shaft extends entirely through the coil in a non-detached state”.
The examiner agrees that the combination of Gandhi, Chen, and Sharkey does not teach the amended claim language.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rudakov et al (US 20160135984 A1) in view of Sharkey.
Applicant’s arguments, see pages 9-12, filed 04/14/2026, with respect to the rejection(s) of claim(s) 34 under 35 U.S.C. 103 as being unpatentable over Gandhi in view of Chen, Sharkey, and Scribner have been fully considered and are persuasive.
The applicant has amended claim 22 to further recite: “wherein the detachable tip component includes a shaft that abuts a distal end of the inner catheter at a location in a proximal direction with respect to the coil surrounding the shaft where the shaft extends entirely through the coil in anon-detached state”.
The examiner agrees that the combination of Gandhi, Chen, and Sharkey does not teach the amended claim language.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rudakov et al (US 20160135984 A1) in view of Sharkey and Scribner.
Claim Objections
Claims 10-11, 21, and 36 are objected to because of the following informalities:
Claim #
Line #
Current
Suggested change
10
1
a shaft
the shaft
11
1
a coil
the coil
11
2
a shaft
the shaft
21
21
a shaft
the shaft
36
3
a second wire second that
a second wire that
Appropriate correction is required.
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: detachment mechanism in claim 31.
The limitation “detachment mechanism” invokes 112(f) because “mechanism” is a generic placeholder term with no specific structural meaning modified by the functional language “detachment” or for detachment and is not further modified by sufficient structure “a shape memory material” does not provide adequate structure. For the purpose of prior art examination this limitation will be interpreted as either “a wire” or “a coil” per applicant’s patent application publication (PGPUB) [0012].
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 33-37 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 33 recites the limitation "the coil" in line 3. There is insufficient antecedent basis for this limitation in the claim as “a coil” is not positively recited in claim 33 or claims 32 or 31, from which claim 33 depends on. For the purpose of prior art examination this limitation will be interpreted as “the detachment mechanism”. Appropriate correction is required.
Claim 34 recites the limitation “the detachable tip component includes a shaft that abuts a distal end of the inner catheter” and it is not clear if this is the same as the shaft in line 5 of claim 34, or a different shaft. For the purpose of prior art examination this limitation will be interpreted as “the detachable tip component includes the shaft”. Appropriate correction is required.
Claims 35-37 are rejected as being dependent on claim 34.
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.
Claim(s) 1-2, 4-5, 9, 11-13, 15-16, 20-21, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov et al (US 20160135984 A1), herein referenced to as “Rudakov”.
Claim 1
Rudakov discloses: An endovascular device 10 (see Figs. 6-8, [0158]) comprising: a catheter 38 + 40 (see Figs. 6-8, [0158]); a detachment mechanism 76 (see Figs. 6-8, [0158]) comprising a shape memory material nitinol (see [0210], 76 is formed of nitinol, [0087], or a shape memory material) formed as a coil 76 (see Figs. 8, 76 is a coil) located at a distal end the distal end of 40 (see Figs. 6-8, particularly Fig. 8, 76 is at the distal end of 40, [0158]) of the catheter 40; and a detachable tip component 14 (see Figs. 6-8, [0158]) that is detachably secured to the catheter 38 + 40 by the detachment mechanism 76 (see [0158]-[0165], 56 can swell to push 76 outwards, causing 76 to open to allow 14 to detach from the catheter 38 + 40), wherein the detachment mechanism 76 is configured such that application of electricity (see [0165], 56 swells with the application of electric signals in order open the coil 76 up to allow 14 to release and detach) to the detachment mechanism 76 causes the coil 76 to open and release the detachable tip component 14, and wherein the catheter 38 + 40 includes an inner catheter tube 40 (see Figs. 6-8, [0158]) and an outer catheter tube 38 (see Figs. 6-8, [0158]).
Rudakov does not explicitly disclose: and the detachable tip component includes a shaft that abuts a distal end of the inner catheter tube at a location in a proximal direction with respect to the coil surrounding the shaft where the shaft extends entirely through the coil in a non-detached state.
However, a variant embodiment (see Figs. 21 and 23-26) of Rudakov teaches an endovascular device 10 with a catheter 98 + retrieval device 68 + retrieval catheter (see Figs. 23-24, [0218]) with an outer catheter 98 and an inner catheter retrieval device 68 + retrieval catheter (see [0218] and Figs. 14A-14B, [0176], 68 is an exemplary showing of a retrieval device which includes a retrieval catheter, see [0176]) and a detachable tip component 14 (see Figs. 21 and 23-26) and a coil 76 (see Figs. 21 and 23-26). Rudakov further teaches: the detachable tip component 14 includes a shaft 95 + 96a (see Figs. 21 and 23-26, [0216]) that abuts a distal end distal end of retrieval device 68 + retrieval catheter (see [0218], 96a contacts the distal end of a retriever such as shown in with 68 in Figs. 14A-14B) of the inner catheter tube retrieval device 68 + retrieval catheter at a location in a proximal direction (see Figs. 23-24 and 26, 96a is proximal to 76 in the non-detached state shown in Fig. 23) with respect to the coil 76 surrounding the shaft 95 where the shaft 95 extends entirely through the coil 76 in a non-detached state (see Fig. 23, 95 extends entirely through 76).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified (Figs. 6-8) Rudakov to incorporate the teachings of a variant embodiment (Figs. 21 and 23-26) of Rudakov and teach an endovascular device with the detachable tip component includes a shaft that abuts a distal end of the inner catheter tube at a location in a proximal direction with respect to the coil surrounding the shaft where the shaft extends entirely through the coil in a non-detached state. Motivation for such can be found in Rudakov as this facilitates the grasping of a withdrawal component of the detachable tip component to be able to fully remove the tip component from the patient to restore flow to an occluded vessel (see [0218]-[0219]).
Claim 2
Rudakov teaches: The device of claim 1, see 103 rejection above. Rudakov further discloses: wherein the shape memory material nitinol (see [0210], 76 is formed of nitinol, [0087], or a shape memory material) is nitinol.
Claim 4
Rudakov teaches: The device of claim 1, see 103 rejection above. Rudakov (Figs. 21 and 23-26) further teaches: wherein the coil 76 surrounds the detachable tip component 14 + 95 (see Figs. 21 and 23-24, 76 surrounds the shaft of the detachable tip component) and is distally spaced from the catheter retrieval device 68 + retrieval catheter (see [0218], 96a contacts the distal end of a retriever such as shown in with 68 in Figs. 14A-14B, as such 76 is distal to 95 + 96a and distal from the retrieval catheter).
Claim 5
Rudakov teaches: The device of claim 4, see 103 rejection above. Rudakov further teaches: wherein in a rest position (see [0165], while electric signals are not applied, 56 does not swell and does not expand 76) of the detachment mechanism 76, when the shape memory material nitinol, including the coil 76, is not under influence of electricity, the coil 76 tightly grasps (see Fig. 23) the detachable tip component, which passes through an opening the lumen of 76 (as combined in Figs. 23, 95 part of 14 extends through 76) of the coil 76, and maintains coupling between the detachable tip component 14 and the catheter 38 + 40 and wherein in an actuated state when electricity is applied (see [0165], electric signals are applied, causing 56 to swell and expand 76, causing 76 to expand and open, and releasing 14), the coil expands and opens, thereby releasing the detachable tip component 14 and severing the coupling between the detachable tip component 14 and the catheter 38 + 40.
Claim 9
Rudakov teaches: The device of claim 1, see 103 rejection above. Rudakov further discloses: wherein in an at rest position when electricity is not applied to the shape memory material (see [0165], while electric signals are not applied, 56 does not swell and does not expand 76), the detachable tip component 14 abuts the catheter 38 + 40 and conversely in an actuated state (see [0165], electric signals are applied, causing 56 to swell and expand 76, causing 76 to expand and open, and releasing 14), when electricity is applied to the shape memory material, the detachable tip component 14 is free to separate from the catheter 38 + 40.
Claim 11
Rudakov teaches: The device of claim 1, see 103 rejection above. Rudakov further teaches: wherein the shape memory material nitinol comprises a coil 76 (see claim objection above, interpreted as “the coil”) that is tightly wound (see Fig. 23, 76 is tightly wound around 95, and is capable of expanding outwards) about a shaft 95 that is part of the detachable tip component 14.
Claim 12
Rudakov teaches: The device of claim 1, see 103 rejection above. Rudakov further discloses: wherein the detachable tip component 14 comprises an embolic device (see [0091], occlusion device).
Claim 13
Rudakov teaches: The device of claim 1, see 103 rejection above. Rudakov further teaches: wherein the shape memory material nitinol of the detachment mechanism 76 has: (1) a longitudinal portion 13 (see Fig. 8, [0168], a longitudinal portion that extends along the length of 38 + 40) that extends along a length a length of 38 + 40 of the catheter 38 + 40 and a length a length of 14 of the detachable tip component 14 and (2) a coil portion 76 (as modified, 76 only extends around 95, and not the retrieval catheter, see Fig. 23) that is only disposed about the detachable tip component 14.
Claim 15
Rudakov teaches: The device of claim 13, see 103 rejection above. Rudakov further discloses: wherein the coil portion 76 has at least one winding (see Fig. 8, 76 has at least one winding) disposed about the detachable tip component 14 in an at rest position prior to application of electricity (see Fig. 8, [0165], before the electrical signals).
Claim 16
Rudakov teaches: The device of claim 13, see 103 rejection above. Rudakov further discloses: wherein the coil portion 76 has two or more windings (see Fig. 8, 76 has at least two windings) disposed about the detachable tip component 14 in an at rest position prior to application of electricity (see Fig. 8, [0165], before the electrical signals).
Claim 20
Rudakov teaches: The device of claim 1, see 103 rejection above. Rudakov further teaches: wherein a proximal portion a proximal portion 76 (see Fig. 24) of the detachment mechanism 76 is disposed within an annular shaped lumen the lumen of 98 (see Fig. 24) formed in the catheter 98 and a distal end portion distal portion of 76 outside of 98 (see Fig. 24) of the detachment mechanism 76 comprises a coiled portion the distal portion of 76 outside of 98 is a coiled portion that is disposed about the detachable tip component 95 of 14 (see Fig. 24) and not the catheter 98.
Claim 21
Rudakov teaches: The device of claim 1, see 103 rejection above. Rudakov further teaches: wherein the detachable tip component 14 comprises a distal tip member 14 (see Fig. 23) with a shaft 95 that abuts a distal end distal end of retrieval device 68 + retrieval catheter (see [0218], 96a contacts the distal end of a retriever such as shown in with 68 in Figs. 14A-14B, as such 76 is distal to 95 + 96a and distal from the retrieval catheter) of the catheter retrieval device 68 + retrieval catheter in an at rest position when electricity is not applied to the shape memory material, and conversely in an actuated state, when electricity is applied to the shape memory material, the distal tip member 14 is free to separate from the distal end distal end of retrieval device 68 + retrieval catheter (see [0218], 96a contacts the distal end of a retriever such as shown in with 68 in Figs. 14A-14B, as such 76 is distal to 95 + 96a and distal from the retrieval catheter) of the catheter (as modified, the coil 76 is held to the retrieval catheter/inner catheter, until an electric signal is sent to expand 56 to expand 76 to allow 14 to detach).
Claim 31
Rudakov discloses: An endovascular device 10 (see Figs. 6-8, [0158]) comprising: a main body 38 + 40 (see Figs. 6-8, [0158]); a detachment mechanism 76 (see Figs. 6-8, [0158], see 112f interpretation above as a coil, 76 is a coil) comprising a shape memory material nitinol (see [0210], 76 is formed of nitinol, [0087], or a shape memory material) located at a distal end the distal end of 40 (see Figs. 6-8, particularly Fig. 8, 76 is at the distal end of 40, [0158]) of the main body 40; and a detachable tip component 76 that is detachably secured to the main body 38 + 40 by the detachment mechanism 76 (see [0158]-[0165], 56 can swell to push 76 outwards, causing 76 to open to allow 14 to detach from the catheter 38 + 40), wherein the detachment mechanism 76 is configured such that application of electricity (see [0165], 56 swells with the application of electric signals in order open the coil 76 up to allow 14 to release and detach) to the detachment mechanism 76 causes the detachment mechanism to the detachment mechanism 76 causes the coil 76 to open and release the detachable tip component 14 from the main body 38 + 40, wherein the main body 38 + 40 comprises an inner catheter tube 40 (see Figs. 6-8, [0158]).
Rudakov does not explicitly disclose: and the detachable tip component includes a shaft that abuts a distal end of the inner catheter tube at a location in a proximal direction with respect to the detachment mechanism surrounding the shaft where the shaft extends entirely through the detachment mechanism in a non-detached state.
However, a variant embodiment (see Figs. 21 and 23-26) of Rudakov teaches an endovascular device 10 with a main body 98 + retrieval device 68 + retrieval catheter (see Figs. 23-24, [0218]) with an outer catheter 98 and an inner catheter retrieval device 68 + retrieval catheter (see [0218] and Figs. 14A-14B, [0176], 68 is an exemplary showing of a retrieval device which includes a retrieval catheter, see [0176]) and a detachable tip component 14 (see Figs. 21 and 23-26) and a coil 76 (see Figs. 21 and 23-26). Rudakov further teaches: the detachable tip component 14 includes a shaft 95 + 96a (see Figs. 21 and 23-26, [0216]) that abuts a distal end distal end of retrieval device 68 + retrieval catheter (see [0218], 96a contacts the distal end of a retriever such as shown in with 68 in Figs. 14A-14B) of the inner catheter tube retrieval device 68 + retrieval catheter at a location in a proximal direction (see Figs. 23-24 and 26, 96a is proximal to 76 in the non-detached state shown in Fig. 23) with respect to the coil 76 surrounding the shaft 95 where the shaft 95 extends entirely through the coil 76 in a non-detached state (see Fig. 23, 95 extends entirely through 76).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified (Figs. 6-8) Rudakov to incorporate the teachings of a variant embodiment (Figs. 21 and 23-26) of Rudakov and teach an endovascular device with the detachable tip component includes a shaft that abuts a distal end of the inner catheter tube at a location in a proximal direction with respect to the coil surrounding the shaft where the shaft extends entirely through the coil in a non-detached state. Motivation for such can be found in Rudakov as this facilitates the grasping of a withdrawal component of the detachable tip component to be able to fully remove the tip component from the patient to restore flow to an occluded vessel (see [0218]-[0219]).
Claim(s) 6, 19, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov as applied to claim 1 above, and further in view of Sharkey et al (US 20060030881 A1), herein referenced to as “Sharkey”.
Claim 6
Rudakov teaches: The device of claim 1, see 103 rejection above. Rudakov does not explicitly teach: wherein the catheter comprises a balloon catheter including an outer catheter and an inner catheter that is disposed internally within the outer catheter, the inner catheter extending distal to the outer catheter and wherein a balloon is coupled to the outer catheter.
However, Sharkey in a similar field of invention teaches an endovascular device (see Fig. 5) with a catheter 43 with an inner catheter 48 and an outer catheter 43 and a detachable tip component 10 + 14 (see Fig. 5). Sharkey further teaches: wherein the catheter 43 comprises a balloon catheter 43 + 55 (see Fig. 5, [0034]) wherein the inner catheter 48 extends distally with respect to the outer catheter 43 (see Fig. 5, 48 extends distally past the distal end of 45) and wherein a balloon 55 is coupled to the outer catheter 43 (see [0034], 55 is sealingly secured to the distal end of 43).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter the endovascular device of Rudakov to incorporate the teachings of Sharkey and teach an endovascular device with the catheter comprises a balloon catheter and wherein the inner catheter extends distally with respect to the outer catheter and wherein a balloon is coupled to the outer catheter. Motivation for such can be found in Sharkey as the balloon can facilitate the deployment of the detachable tip component/partitioning device (see [0034]) by manually expanding the tip component, useful for occlusion of vasculature.
Claim 19
Rudakov teaches: The device of claim 1, see 103 rejection above. Rudakov does not explicitly teach: wherein the catheter comprises a balloon catheter with the detachable tip component being at least partially received within the balloon.
However, Sharkey in a similar field of invention teaches an endovascular device (see Fig. 5) with a catheter 43 and a detachable tip component 10 + 14 (see Fig. 5). Sharkey further teaches: wherein the catheter 43 comprises a balloon catheter 43 + 55 (see Fig. 5, [0034]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter the endovascular device of Rudakov to incorporate the teachings of Sharkey and teach an endovascular device with the catheter comprises a balloon catheter. Motivation for such can be found in Sharkey as the balloon can facilitate the deployment of the detachable tip component/partitioning device (see [0034]) by manually expanding the tip component, useful for occlusion of vasculature.
The combination of Rudakov and Sharkey further teaches: wherein the with the detachable tip component being at least partially received within the balloon (the combination of Rudakov and Sharkey teaches that the distal end of the catheter of Rudakov as shown Fig. 24 is modified to have a balloon that overlaps an inner catheter that extends distally past the outer catheter as shown in Sharkey Fig. 5, which would then surround the shape memory material which surrounds a portion of the detachable tip component).
Claim 32
Rudakov teaches: The endovascular device of claim 1, see 103 rejection above. Rudakov does not explicitly teach: wherein the catheter comprises a balloon catheter having an inflatable balloon and the shaft of the detachable tip component abuts the distal end of the inner catheter tube at a location at which the inflatable balloon is in a surrounding relationship.
However, Sharkey in a similar field of invention teaches an endovascular device (see Fig. 5) with a catheter 43 with an inner catheter 48 and an outer catheter 43 and a detachable tip component 10 + 14 (see Fig. 5). Sharkey further teaches: wherein the catheter 43 comprises a balloon catheter 43 + 55 (see Fig. 5, [0034]) having an inflatable balloon 55 (see [0034]) wherein the inner catheter 48 extends distally with respect to the outer catheter 43 (see Fig. 5, 48 extends distally past the distal end of 45) and wherein a balloon 55 is coupled to the outer catheter 43 (see [0034], 55 is sealingly secured to the distal end of 43).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter the endovascular device of Rudakov to incorporate the teachings of Sharkey and teach an endovascular device with the catheter comprises a balloon catheter having an inflatable balloon. Motivation for such can be found in Sharkey as the balloon can facilitate the deployment of the detachable tip component/partitioning device (see [0034]) by manually expanding the tip component, useful for occlusion of vasculature.
The combination of Rudakov and Sharkey further teaches: wherein the shaft of the detachable tip component abuts the distal end of the inner catheter tube at a location at which the inflatable balloon is in a surrounding relationship (the combination of Rudakov and Sharkey teaches that the distal end of the catheter of Rudakov as shown Fig. 24 is modified to have a balloon that overlaps an inner catheter that extends distally past the outer catheter as shown in Sharkey Fig. 5, which would then surround the shape memory material which surrounds the shaft 96 of the detachable tip component which is within the outer catheter).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Sharkey as applied to claim 6 above, and further in view of Sessions et al (US 4130119 A), herein referenced to as “Sessions”.
Claim 7
The combination of Rudakov and Sharkey teaches: the device of claim 6, see 103 rejection above. The combination of Rudakov and Sharkey does not explicitly teach: wherein the shape memory material is disposed between the outer catheter and the inner catheter in a lumen in which balloon inflation fluid is disposed.
However, Sessions in a similar field of invention teaches an endovascular device (see Figs. 1-2) with a coil/shape memory material 22 (see Figs. 1-3, as known in the art, coils are commonly made of shape memory materials, to be able to return to an uncompressed state after a force is removed from them), an outer catheter 5 (see Figs. 1-3), and an inner catheter 32 + 30 (see Figs. 1-3). Sessions further teaches: wherein the shape memory material 22 is disposed between (see Fig. 3, 22 is radially between 32 + 30 and 5) the outer catheter 5 and the inner catheter 32 in a lumen 14 (see col. 4, lines 12-21) in which balloon inflation fluid liquid (see col. 4, lines 12-21) is disposed.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endovascular device of Rudakov and Sharkey to incorporate the teachings of Sessions and teach an endovascular device wherein the shape memory material is disposed between the outer catheter and the inner catheter in a lumen in which balloon inflation fluid is disposed. Motivation for such can be found in Sessions the shape memory material can assist in sealing a valve for the balloon while the shape memory material is not compressed (see col. 3, lines 40-53).
Claim(s) 8 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov and Sharkey as applied to claim 6 and claim 33 above respectively, and further in view of Haarstad et al (US 6533753 B1), herein referenced to as “Haarstad”.
Claim 8
The combination of Rudakov and Sharkey teaches: the device of claim 6, see 103 rejection above. The combination of Rudakov and Sharkey further teaches: wherein the balloon 55 (Sharkey) is configured such that a distal end of the balloon that surrounds the detachable tip component (the combination of Rudakov and Sharkey teaches that the distal end of the catheter of Rudakov as shown in Fig. 24 is modified to have a balloon that overlaps an inner catheter that extends distally past the outer catheter as shown in Sharkey Fig. 5, which would then surround the shape memory material which surrounds a portion of the detachable tip component) and overlaps the catheter 43 + 48 (Sharkey, the balloon 55 overlaps the catheters 43 + 48, see Fig. 5).
The combination of Rudakov and Sharkey does not explicitly teach: the distal end of the balloon is inverted.
However, Haarstad in a similar field of invention teaches an endovascular device 10 (see Fig. 1) that is a catheter 11 + 12 (see Fig. 1) with an inner catheter 12 (see Fig. 1) which extends distally past the outer catheter 11 (see Fig. 1, 11 overlaps with and ends with the balloon 13) and a balloon 13 (see Fig. 1) with a distal end 18 (see Fig. 1) that overlaps the catheter 11 + 12 (see Fig. 1). Haarstad further teaches: the distal end 18 of the balloon 13 is inverted (see Figs. 1 and 11-14, col. 4 lines 62-67 and col. 5 lines 1-16, Figs. 11-14 show the process of creating a balloon shown in Fig. 1, including inversion of the balloon to a create an inverted balloon).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the balloon of the combination endovascular device of Rudakov and Sharkey to incorporate the teachings of Haarstad and teach an endovascular device with the distal end of the balloon is inverted. Motivation for such can be found in Haarstad as the balloon which assists in centering the endovascular device within the lumen of the device has an exit port that doesn’t extend past the balloon in order to ensure the distal end is centered by virtue of a fully expanded balloon in the blood vessel and stabilized within the lumen in order to function within the patient’s vasculature (see col. 2 lines 36-54).
Claim 33
The combination of Rudakov and Sharkey teaches: the device of claim 32, see 103 rejection above. The combination of Rudakov and Sharkey further teaches: wherein the balloon 55 (Sharkey) is configured such that a distal end of the balloon that surrounds the detachable tip component (the combination of Rudakov and Sharkey teaches that the distal end of the catheter of Rudakov as shown in Fig. 24 is modified to have a balloon that overlaps an inner catheter that extends distally past the outer catheter as shown in Sharkey Fig. 5, which would then surround the shape memory material which surrounds a portion of the detachable tip component) and overlaps the catheter 43 + 48 (Sharkey, the balloon 55 overlaps the catheters 43 + 48, see Fig. 5).
The combination of Rudakov and Sharkey does not explicitly teach: the distal end of the balloon is inverted.
However, Haarstad in a similar field of invention teaches an endovascular device 10 (see Fig. 1) that is a catheter 11 + 12 (see Fig. 1) with an inner catheter 12 (see Fig. 1) which extends distally past the outer catheter 11 (see Fig. 1, 11 overlaps with and ends with the balloon 13) and a balloon 13 (see Fig. 1) with a distal end 18 (see Fig. 1) that overlaps the catheter 11 + 12 (see Fig. 1). Haarstad further teaches: the distal end 18 of the balloon 13 is inverted (see Figs. 1 and 11-14, col. 4 lines 62-67 and col. 5 lines 1-16, Figs. 11-14 show the process of creating a balloon shown in Fig. 1, including inversion of the balloon to a create an inverted balloon).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the balloon of the combination endovascular device of Rudakov and Sharkey to incorporate the teachings of Haarstad and teach an endovascular device with the distal end of the balloon is inverted. Motivation for such can be found in Haarstad as the balloon which assists in centering the endovascular device within the lumen of the device has an exit port that doesn’t extend past the balloon in order to ensure the distal end is centered by virtue of a fully expanded balloon in the blood vessel and stabilized within the lumen in order to function within the patient’s vasculature (see col. 2 lines 36-54).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov as applied to claim 1 above, and further in view of Divino et al (US 20170367709 A1), herein referenced to as “Divino”.
Claim 10
Rudakov teaches: The device of claim 9, see 103 rejection above. Rudakov further teaches: wherein the detachable tip component 14 includes a shaft 95 + 96a (see claim objection above, interpreted as “the shaft) that abuts the catheter retrieval device 68 + retrieval catheter (see [0218], 96a contacts the distal end of a retriever such as shown in with 68 in Figs. 14A-14B, as such 76 is distal to 95 + 96a and distal from the retrieval catheter).
Rudakov does not explicitly teach: wherein a diameter of the shaft and a diameter of the catheter are approximately equal.
However, Divino in a similar field of invention teaches an endovascular device 122 (see Figs. 8A-8B) with a detachable tip component 92 (see Figs. 8A-8B) with a shaft 50 (see Figs. 8A-8B) and a catheter 140 (see Figs. 8A-8B) that the shaft 20 abuts. Divino further teaches: wherein a diameter of the shaft 59 (see Fig. 8B, [0088]) and a diameter 188 (see Fig. 8B, [0088], the diameter of 182 matches that of 140 as can be seen) of the catheter 140 are approximately equal (see [0088], the diameter of 182 is equal to that of 59).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endovascular device of Rudakov to incorporate the teachings of Divino and teach an endovascular device wherein a diameter of the shaft and a diameter of the catheter are approximately equal. Motivation for such can be found in Divino as this can create a bias which can provide a force of engagement with the shaft of the detachable tip component to limit or resist movement of the detachable tip component (see [0088]]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov as applied to claim 13 above, and further in view of Lim et al (US 20130138188 A1), herein referenced to as “Lim”.
Claim 14
Rudakov teaches: The device of claim 13, see 103 rejection above. Rudakov does not explicitly teach: wherein the longitudinal portion comprises a first longitudinal segment and a second longitudinal segment that is circumferentially spaced relative to the first longitudinal segment.
However, Lim in a similar field of invention teaches an endovascular device 10 (see Figs. 1A-2B) with a longitudinal portion 64 (see Figs. 2A-2B, 64 runs through 14) of shape memory material (see [0019], the cable is a nitinol wire). Lim further teaches: wherein the longitudinal portion 64 comprises a first longitudinal segment 64 (see Figs. 2A-2B, [0044]) and a second longitudinal segment 66 (see Figs. 2A-2B, [0044]) that is circumferentially spaced relative (see Fig. 2B, 64 is circumferentially spaced relative to 66) to the first longitudinal segment 64.
Rudakov teaches the claimed endovascular device except for wherein the longitudinal portion has a second longitudinal segment that is circumferentially spaced relative to the first longitudinal segment. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the longitudinal portion of the Rudakov to incorporate the teachings of Lim and teach the longitudinal portion has a second longitudinal segment corresponding to the first longitudinal segment, the second longitudinal is circumferentially spaced relative to the first longitudinal segment, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 (VI-B).
Furthermore, it would have been obvious to one of ordinary skill in the art to combine Rudakov with Lim as having a second longitudinal portion attached the coil at the distal end would prevent the coil from tilting in one direction as it is withdrawn by a single nitinol longitudinal portion by balancing with a second circumferentially spaced nitinol longitudinal portion.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov as applied to claim 1 above, and further in view of Giba et al (US 5997526 A), herein referenced to as “Giba”.
Claim 17
Rudakov teaches: the device of claim 1, see 103 rejection above. Rudakov further discloses: wherein the catheter 38 + 40 includes a handle 48 (see Fig. 6, [0159]) for applying the electricity (see [0165], electrical signal) to the detachment mechanism 76.
Rudakov does not explicitly teach: that contains an actuator for applying the electricity.
However, Giba in a similar field of invention teaches an endovascular device (see Figs. 1-2B) with a catheter 4 (see Fig. 1) and a handle 2. Giba further teaches: wherein the handle 2 (see Fig. 1, col. 4, lines 66-67) contains an actuator 46 (see Fig. 1, col. 6, lines 28-43) for applying the electricity (see col. 6, lines 28-43, can control electric power applied).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the endovascular device of Gandhi to incorporate the teachings of Giba and teach an endovascular device with the catheter includes a handle that contains an actuator for applying the electricity. Motivation for such can be found in Giba as this can control the electric power applied to various portions of the device, including increasing the electrical power flow (see col. 6, lines 28-43).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov as applied to claim 1 above, and further in view of Gandhi et al (US 20050113864 A1), herein referenced to as “Gandhi”.
Claim 18
Rudakov teaches: the device of claim 1, see 103 rejection above. Rudakov does not explicitly teach: further including a battery which provides electric current that flows through the shape memory material and causes expansion thereof and opening of a coil portion of the detachment mechanism that in a rest state is tightly wound about the detachable tip component.
However, Gandhi in a similar field of invention teaches an endovascular device 10 (see Figs. 1-2, [0031]) comprising: a catheter 12 (see Figs. 1-2, [0031]); a detachment mechanism 24 (see Figs. 1-2, [0031]) comprising a shape memory material (see [0034], shape memory alloy, such as nickel titanium alloy) formed as a coil (see [0034], shape memory alloy spring, a spring is a form of coil). Gandhi further teaches: further including a battery 30 (see Figs. 1-2, [0035], small battery) which provides electric current (see [0035], supply electrical current) that flows through the shape memory material (see [0034], current applied through the connector) and causes expansion thereof (see [0034]) and opening of a coil portion (see [0034], spring, a spring is a coil) of the detachment mechanism 24 that in a rest state (see Fig. 1) is tightly wound (see Figs. 1-2, [0031] and [0034], when the coil acts in the same way as shown in Fig. 1, it is tightly wound about 20 to hold it place to secure it tightly to the distal end of the catheter) about the detachable tip component 14.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rudakov to incorporate the teachings of Gandhi and teach an endovascular device with a battery which provides electric current that flows through the shape memory material and causes expansion thereof and opening of a coil portion of the detachment mechanism that in a rest state is tightly wound about the detachable tip component. Motivation for such can be found in Gandhi as a small battery can fit within the handle of a device yet sufficient to supply electrical current to expand the coil and release the device and avoid thermal damage of the surrounding tissues (see [0035]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Sharkey.
Claim 22
Rudakov discloses: An endovascular device 10 (see Figs. 6-8, [0158]) comprising: a catheter 38 + 40 (see Figs. 6-8, [0158]) having a distal end the distal end of 40 attached to 76 (see Fig. 8); a detachable tip component 14 (see Figs. 6-8, [0158]) that is disposed distal to the distal end the distal end of 40 attached to 76 (see Fig. 8, 14 is distal to the distal end of 40 attached to 76) of the catheter 40; a detachment mechanism 76 (see Figs. 6-8, [0158]) for detachably coupling (see [0158]-[0165], 56 can swell to push 76 outwards, causing 76 to open to allow 14 to detach from the catheter 38 + 40) the detachable tip component 14 to the catheter 38 + 40, the detachment mechanism 76 being in contact with the detachable tip component 14 (see Fig. 8, 76 is in contact with 14) at an attachment point (see Fig. 8) and comprising a wire 76 is a coiled formed of a wire (see Figs. 6-8, [0158]-[0165]) formed of a shape memory material nitinol (see [0210], 76 is formed of nitinol, [0087], or a shape memory material), the detachment mechanism 76 being configured such that application of electrical current (see [0165], 56 swells with the application of electric signals in order open the coil 76 up to allow 14 to release and detach) or heat (will not be examined here due to being an optional claim limitation) to the wire 76 causes a coil the coil 76 (see Fig. 8, [0158]-[0165]), that is formed at a distal end distal end comprises the coil 76 of the wire 76, to expand and open (see [0165]), thereby releasing the detachable tip component 14 from the detachment mechanism 76 (see [0165], 14 is released from 76, as action by 76, the definition of “from” according to the online Merriam-Webster dictionary being “used as a function word to indicate the source, cause, agent, or basis”, as in this case 76 is the cause of 14 releasing) and allowing separation (see [0165]) of the detachable tip component 14 from the catheter 38 + 40, and wherein the catheter 38 + 40 includes an inner catheter tube 40 (see Figs. 6-8, [0158]) and an outer catheter tube 38 (see Figs. 6-8, [0158])
Rudakov does not explicitly disclose: and the detachable tip component includes a shaft that abuts a distal end of the inner catheter tube at a location in a proximal direction with respect to the coil surrounding the shaft where the shaft extends entirely through the coil in a non-detached state; wherein the detachable tip component also comprises an expandable sheath disposed about the shaft of the detachable tip component and is configured to expand in response to inflation of a balloon of the catheter in an attached state between the catheter and the detachable tip component, the expandable sheath at least partially covering the balloon.
However, a variant embodiment (see Figs. 21 and 23-26) of Rudakov teaches an endovascular device 10 with a catheter 98 + retrieval device 68 + retrieval catheter (see Figs. 23-24, [0218]) with an outer catheter 98 and an inner catheter retrieval device 68 + retrieval catheter (see [0218] and Figs. 14A-14B, [0176], 68 is an exemplary showing of a retrieval device which includes a retrieval catheter, see [0176]) and a detachable tip component 14 (see Figs. 21 and 23-26) and a coil 76 (see Figs. 21 and 23-26). Rudakov further teaches: the detachable tip component 14 includes a shaft 95 + 96a (see Figs. 21 and 23-26, [0216]) that abuts a distal end distal end of retrieval device 68 + retrieval catheter (see [0218], 96a contacts the distal end of a retriever such as shown in with 68 in Figs. 14A-14B) of the inner catheter tube retrieval device 68 + retrieval catheter at a location in a proximal direction (see Figs. 23-24 and 26, 96a is proximal to 76 in the non-detached state shown in Fig. 23) with respect to the coil 76 surrounding the shaft 95 where the shaft 95 extends entirely through the coil 76 in a non-detached state (see Fig. 23, 95 extends entirely through 76).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified (Figs. 6-8) Rudakov to incorporate the teachings of a variant embodiment (Figs. 21 and 23-26) of Rudakov and teach an endovascular device with the detachable tip component includes a shaft that abuts a distal end of the inner catheter tube at a location in a proximal direction with respect to the coil surrounding the shaft where the shaft extends entirely through the coil in a non-detached state. Motivation for such can be found in Rudakov as this facilitates the grasping of a withdrawal component of the detachable tip component to be able to fully remove the tip component from the patient to restore flow to an occluded vessel (see [0218]-[0219]).
Rudakov does not explicitly teach: wherein the detachable tip component also comprises an expandable sheath disposed about the shaft of the detachable tip component and is configured to expand in response to inflation of a balloon of the catheter in an attached state between the catheter and the detachable tip component, the expandable sheath at least partially covering the balloon.
However, Sharkey in a similar field of invention teaches an endovascular device (see Fig. 5) with a catheter 43 and a detachable tip component 10 + 11 + 14 (see Fig. 5) with a shaft 48 (see Fig. 5). Sharkey further teaches: wherein the detachable tip component 10 + 11 + 14 also comprises an expandable sheath 11 (see Fig. 5, [0029]) disposed about the shaft 48 of the detachable tip component 10 + 11 + 14 and is configured to expand (see Figs. 8C-8D) in response to inflation (see Figs. 8C-8D, [0034]) of a balloon 55 (see Fig. 5, [0034]) of the catheter 43 in an attached state between the catheter 43 and the detachable tip component 10 + 11 + 14 (see Fig. 8D), the sheath 11 at least partially covering the balloon 55 (see Figs. 5 and 8C-8D).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter the endovascular device of Gandhi to incorporate the teachings of Sharkey and teach an endovascular device with the detachable tip component also comprises an expandable sheath disposed about the shaft of the detachable tip component and is configured to expand in response to inflation of a balloon of the catheter in an attached state between the catheter and the detachable tip component, the sheath at least partially covering the balloon. Motivation for such can be found in Sharkey as the balloon can facilitate the deployment of the detachable tip component/partitioning device (see [0034]) by manually expanding the tip component, useful for occlusion of vasculature.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Sharkey as applied to claim 22 above, and further in view of Scribner et al (US 5972015 A), herein referenced to as “Scribner”.
Claim 23
The combination of Rudakov and Sharkey teaches: The device of claim 22, see 103 rejection above. Rudakov further discloses: wherein the inner catheter tube 40 (see Fig. 8) is disposed inside a lumen the lumen of 38 (see Fig. 8) of the outer catheter tube 38.
Sharkey further teaches: the inner catheter tube 48 extends distally beyond the outer catheter tube 43 (see Fig. 5, 48 extends distally past the distal end of 45).
The combination of Rudakov and Sharkey does not explicitly teach: the balloon having a first end attached to the outer catheter tube and a second end attached to the inner catheter tube and an inverted portion that is located distal to a distal end of the inner catheter tube, the inverted portion having a center opening that is defined only by the inverted portion of the balloon for receiving the detachable tip component at a location distal to the distal end of the inner catheter tube.
However, Scribner in a similar field of invention teaches an endovascular medical device (see Fig. 20, col. 1, lines 20-24) with a balloon 110 (see Fig. 20), an inner catheter 120 (see Fig. 20) and an outer catheter 118 (see Fig. 20). Scribner further teaches: the inner catheter tube 120 extends distally beyond the outer catheter tube 118 (see Fig. 20, 120 extends distally beyond 118), the balloon 110 (see Fig. 5) having a first end proximal 116 (see Fig. 20, col. 11, lines 24-29) attached to the outer catheter tube 118 (see Fig. 20) and a second end distal 116 (see Fig. 20, col. 11, lines 24-29) attached to the inner catheter tube 120 (see Fig. 20) and an inverted portion distal 114 (see Fig. 20, col. 11, lines 24-29) that is located distal (see Fig. 20, the distal 114, is distal to the distal end of 120, col. 11, lines 60-64) to a distal end distal end of 120 of the inner catheter tube 120, the inverted portion distal 114 having a center opening (see annotated Fig. 20 below) that is defined only by the inverted portion distal 114 of the balloon 110.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rudakov and Sharkey to incorporate the teachings of Scribner and teach an endovascular device with the inner catheter tube extends distally beyond the outer catheter tube and the balloon having a first end attached to the outer catheter tube and a second end attached to the inner catheter tube and an inverted portion that is located distal to a distal end of the inner catheter tube, the inverted portion having a center opening that is defined only by the inverted portion of the balloon. Motivation for such can be found in Scribner as this prevents the catheter from extending past the expandable structure, thus preventing bone compaction or contact with tissue with the catheter (see col. 11, lines 60-64).
The language, "for receiving the detachable tip component at a location distal to the distal end of the inner catheter tube" constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Gandhi, Chen, Sharkey, and Scribner meets the structural limitations of the claim, and is capable of the central opening defined by the inverted portion of the balloon to receive a detachable tip component, as there is space before the detachable tip component would contact the inner catheter tube.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Sharkey, and Scribner as applied to claim 23 above, and further in view of Chin et al (US 20160278747 A1), herein referenced to as “Chin”.
Claim 24
The combination of Rudakov, Sharkey, and Scribner teaches: the device of claim 23, see 103 rejection above. The combination of Rudakov, Sharkey, and Scribner does not explicitly teach: wherein the coil of the wire is disposed around the inverted portion of the balloon, the balloon being disposed between the coil and a proximal section of the detachable tip component, wherein in an at rest position, the coil is tightly wound about the proximal section and in an open position, the expanded coil permits the proximal section to be released.
However, Chin in a similar field of invention teaches an endovascular device (see Fig. 21A) with an inverted balloon 120 (see Fig. 21, [0074], the balloon is inverted) and a coil 124 of the wire (see [0074], nitinol coil spring, a nitinol coil spring is a wound wire as known in the art). Chin further teaches: wherein the coil 120 (see [0073]) of the wire (a coil is a wound wire as known in the art) is disposed around the inverted portion of the balloon (see Fig. 21A, [0074], the coil is sheathed on the outside of the inverted portion of the balloon).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination endovascular device of Rudakov, Sharkey, and Scribner to incorporate the teachings of Chin and teach an endovascular device with the coil of the wire is disposed around the inverted portion of the balloon. Motivation for such can be found in Chin as the spring coil being at the distal end can assist in navigating the balloon catheter and pushing through vasculature without damaging the vasculature walls (see [0074]).
The combination of Rudakov, Sharkey, Scribner, and Chin further teaches: the balloon being disposed between the coil and a proximal section 95 + 96c (Rudakov, see Figs. 22-23 and 26, [0216]) of the detachable tip component (the combination of Rudakov and Haarstad teaches that the distal end of the catheter of Rudakov as shown Fig. 23 is modified to have a balloon that overlaps an inner catheter that extends distally past the outer catheter as shown in Sharkey Fig. 5, which would then surround the shape memory material which surrounds a portion of the detachable tip component, and combined with Chin, the coil is over a distal portion of the balloon, such as the balloon is now between the coil and the 95 + 96c of the detachable tip component of Rudakov), wherein in an at rest position (Rudakov, Fig. 23), the coil is tightly wound about the proximal section 95 and in an open position (Rudakov, Fig. 26), the expanded coil 76 (see Fig. 26, expanded coil 76, and released 95 from the catheter 98) permits the proximal section to be released.
Claim(s) 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Sharkey and Scribner.
Claim 34
Rudakov discloses: An endovascular device 10 (see Figs. 6-8, [0158]) comprising: a catheter 38 + 40 (see Figs. 6-8, [0158]) having an inner catheter 40 (see Figs. 6-8, [0158]), and outer catheter 38 (see Figs. 6-8, [0158]) that surrounds the inner catheter 40, a detachable tip component 14 (see Figs. 6-8, [0158]) that is disposed at least in part distal (see Fig. 8, 14 is distal to the distal end of 40) to the distal end the distal end of 40 (see Figs. 6-8, particularly Fig. 8, 76 is at the distal end of 40, [0158]) of the catheter 40; a detachment mechanism 76 (see Figs. 6-8, [0158]) comprising a shape memory material nitinol (see [0210], 76 is formed of nitinol, [0087], or a shape memory material) formed as a coil 76 (see Figs. 8, 76 is a coil) located at a distal end the distal end of 40 (see Figs. 6-8, particularly Fig. 8, 76 is at the distal end of 40, [0158]) of the catheter 40, wherein the detachment mechanism 76 is configured such that application of electricity (see [0165], 56 swells with the application of electric signals in order open the coil 76 up to allow 14 to release and detach) to the detachment mechanism 76 causes the coil 76 to open and release the detachable tip component 14.
Rudakov does not explicitly disclose: the catheter is a balloon catheter and an inflatable balloon; the detachable tip component having a shaft that, in a non-detached position, abuts the inner catheter of the balloon catheter; and wherein the inflatable balloon is coupled at a proximal end to the outer catheter and is free to inflate at a distal end in a manner that surrounds the catheter and expand the detachable tip component, wherein the detachable tip component includes a shaft that abuts a distal end of the inner catheter at a location in a proximal direction with respect to the coil surrounding the shaft where the shaft extends entirely through the coil in a non-detached state.
However, a variant embodiment (see Figs. 21 and 23-26) of Rudakov teaches an endovascular device 10 with a catheter 98 + retrieval device 68 + retrieval catheter (see Figs. 23-24, [0218]) with an outer catheter 98 and an inner catheter retrieval device 68 + retrieval catheter (see [0218] and Figs. 14A-14B, [0176], 68 is an exemplary showing of a retrieval device which includes a retrieval catheter, see [0176]) and a detachable tip component 14 (see Figs. 21 and 23-26) and a coil 76 (see Figs. 21 and 23-26). Rudakov further teaches: the detachable tip component 14 includes a shaft 95 + 96a (see Figs. 21 and 23-26, [0216]) that abuts a distal end distal end of retrieval device 68 + retrieval catheter (see [0218], 96a contacts the distal end of a retriever such as shown in with 68 in Figs. 14A-14B) of the inner catheter tube retrieval device 68 + retrieval catheter at a location in a proximal direction (see Figs. 23-24 and 26, 96a is proximal to 76 in the non-detached state shown in Fig. 23) with respect to the coil 76 surrounding the shaft 95 where the shaft 95 extends entirely through the coil 76 in a non-detached state (see Fig. 23, 95 extends entirely through 76).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified (Figs. 6-8) Rudakov to incorporate the teachings of a variant embodiment (Figs. 21 and 23-26) of Rudakov and teach an endovascular device with the detachable tip component includes a shaft that abuts a distal end of the inner catheter tube at a location in a proximal direction with respect to the coil surrounding the shaft where the shaft extends entirely through the coil in a non-detached state. Motivation for such can be found in Rudakov as this facilitates the grasping of a withdrawal component of the detachable tip component to be able to fully remove the tip component from the patient to restore flow to an occluded vessel (see [0218]-[0219]).
Rudakov does not explicitly teach: the catheter is a balloon catheter and an inflatable balloon; and wherein the inflatable balloon is coupled at a proximal end to the outer catheter and is free to inflate at a distal end in a manner that surrounds the catheter and expand the detachable tip component.
However, Sharkey in a similar field of invention teaches an endovascular device (see Fig. 5) with a catheter 43 and a detachable tip component 10 + 11 + 14 (see Fig. 5) with a shaft 48 (see Fig. 5). Sharkey further teaches: the catheter 43 is a balloon catheter 43 (see Figs. 5 and 8C-8D, [0034]) and an inflatable balloon 55 (see Figs. 5 and 8C-8D, [0034]); and wherein the inflatable balloon is free to inflate at a distal end distal end of 55 (see Figs. 5 and 8C-8D) and expand the detachable tip component 11 (see Figs. 5 and 8C-8D, [0029] and [0034]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter the endovascular device of Rudakov to incorporate the teachings of Sharkey and teach an endovascular device with the catheter is a balloon catheter and an inflatable balloon; and wherein the inflatable balloon is free to inflate at a distal end and expand the detachable tip component. Motivation for such can be found in Sharkey as the balloon can facilitate the deployment of the detachable tip component/partitioning device (see [0034]) by manually expanding the tip component, useful for occlusion of vasculature.
The combination of Rudakov and Sharkey does not explicitly teach: wherein the inflatable balloon is coupled at a proximal end to the outer catheter and is free to inflate at a distal end in a manner that surrounds the catheter.
However, Scribner in a similar field of invention teaches an endovascular medical device (see Fig. 20, col. 1, lines 20-24) with a balloon 110 (see Fig. 20), an inner catheter 120 (see Fig. 20) and an outer catheter 118 (see Fig. 20). Scribner further teaches: wherein the inflatable balloon 110 is coupled at a proximal end proximal 116 (see Fig. 20, col. 11, lines 24-29) to the outer catheter 118 and is free to inflate at a distal end 114 (see Fig. 20, lines 24-29) in a manner that surrounds the catheter 120 + 118 (see Fig. 20, when the balloon is inflated it surrounds the catheter).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rudakov and Sharkey to incorporate the teachings of Scribner and teach an endovascular device with the inflatable balloon is coupled at a proximal end to the outer catheter and is free to inflate at a distal end in a manner that surrounds the catheter. Motivation for such can be found in Scribner as this prevents the catheter from extending past the expandable structure, thus preventing bone compaction or contact with tissue with the catheter (see col. 11, lines 60-64).
Claim 35
The combination of Gandhi, Chen, Sharkey, and Scribner teaches: The endovascular device of claim 34, see 103 rejection above. Sharkey further teaches: wherein the detachable tip 10 + 11 + 14 comprises an expandable sheath 11 (see Figs. 5 and 8C-8D, [0029] and [0034]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter the endovascular device of Gandhi and Chen to incorporate the teachings of Sharkey and teach an endovascular device with the detachable tip comprises an expandable sheath. Motivation for such can be found in Sharkey as manually expanding the tip component is useful for occlusion of vasculature (see [0034]).
Claim(s) 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rudakov in view of Sharkey and Scribner as applied to claim 34 above, and further in view of Lim.
Claim 36
The combination of Rudakov, Sharkey, and Scribner teaches: The endovascular device of claim 34, see 103 rejection above. Rudakov further discloses: wherein the catheter 38 + 40 further includes a first wire section 13 + 58 (see Fig. 8, [0168], a longitudinal portion that extends along the length of 38 + 40) that extends longitudinally in a first region the space between 38 + 40 (see Fig. 8) between the inner catheter 40 and outer catheter 38 and wherein the coil 76 is coupled to the first wire section (see Fig. 8, [0168]) to receive electric current and is configured such that application of current to the coil through the first wire section causes the coil to expand (see [0165], 56 swells with the application of electric signals in order open the coil 76 up to allow 14 to release and detach), open and release the detachable tip component [0158]-[0165], 56 can swell to push 76 outwards, causing 76 to open to allow 14 to detach from the catheter 38 + 40).
Rudakov does not explicitly teach: and a second wire that extends longitudinally in a second region between the inner catheter and outer catheter.
However, Lim in a similar field of invention teaches an endovascular device 10 (see Figs. 1A-2B) with a first wire section 64 (see Figs. 2A-2B, 64 runs through 14) of shape memory material (see [0019], the cable is a nitinol wire). Lim further teaches: and a second wire segment 66 (see Figs. 2A-2B, [0044])
that is circumferentially spaced relative (see Fig. 2B, 64 is circumferentially spaced relative to 66) to the first longitudinal segment 64.
Rudakov teaches the claimed endovascular device except for wherein the longitudinal portion has a second longitudinal segment that is circumferentially spaced relative to the first longitudinal segment. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the longitudinal portion of the Rudakov to incorporate the teachings of Lim and teach the longitudinal portion has a second longitudinal segment corresponding to the first longitudinal segment, the second longitudinal is circumferentially spaced relative to the first longitudinal segment, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 (VI-B).
Furthermore, it would have been obvious to one of ordinary skill in the art to combine Rudakov with Lim as having a second longitudinal portion attached the coil at the distal end would prevent the coil from tilting in one direction as it is withdrawn by a single nitinol longitudinal portion by balancing with a second circumferentially spaced nitinol longitudinal portion.
The combination of Rudakov and Lim teaches: the second wire extends longitudinally in a second region (the second wire as modified by Lim is circumferentially spaced from the first wire of Rudakov, hence it would in a second region) between the inner catheter 40 and outer catheter 38.
Claim 37
The combination of Rudakov Sharkey, Scribner, and Lim teaches: The endovascular device of claim 36, see 103 rejection above. Scribner further teaches: wherein the inflatable balloon 110 is coupled at a proximal end proximal 116 (see Fig. 20, col. 11, lines 24-29) to the outer catheter 118 and is free to inflate at a distal end 114 (see Fig. 20, lines 24-29) in a manner that surrounds the catheter 120 + 118 (see Fig. 20, when the balloon is inflated it surrounds the catheter).
The combination of Sharkey and Scribner further teaches: and expand the detachable tip component (the combination of Sharkey and Scriber teaches expanding the detachable tip component with the balloon).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ken et al (US 6168615 B1) teaches an endovascular device with a coil with a shaft of a detachable tip component extending through the coil, with an outer catheter and an inner catheter, the coil at the distal end of the inner catheter with the outer catheter surrounding the coil
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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