DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
Response to Arguments
Independent Claims 1 and 11
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
Regarding claim 1, applicant argues that Suzuki teaches away from the required limitation of amended claim 1 “wherein the lumen of the delivery catheter prevents the detach mechanism from transitioning from the first configuration to the second configuration when the detach mechanism is positioned within the lumen of the delivery catheter”. Applicant explains that para. 0051 discloses that the forceps are arranged so as to protrude from the distal end of the sheath 40 so that the forceps “may be made to be the same in the full-opened state and the half-opened state at all times” and that para. 0052 of Suzuki notes the importance of a lack of interaction between the sheath and the forceps such that the forceps may open fully without being restricted by the sheath.
The examiner respectfully disagrees that Suzuki teaches away from the newly added limitation of claim 1. The examiner notes that the sheath 40 is structurally analogous to the claimed delivery element 410 of applicant such that the forceps are arranged to protrude from a distal end of the sheath 40 since the sheath 40 is like a shaft to the forceps (see Fig. 2 of Suzuki). However, the claim requires “a delivery catheter comprising a lumen, wherein the lumen of the delivery catheter prevents the detach mechanism from transitioning from the first configuration to the second configuration when the detach mechanism is positioned within the lumen of the delivery catheter”. As stated in the previous office action, Suzuki discloses forceps being delivered through an endoscope (para. 0003, 0005-0006), but fails to disclose a delivery catheter. Marks is used as a secondary reference to teach the delivery catheter as claimed and further teaches the newly added limitation wherein the lumen 18 of the delivery catheter 12 prevents a detach mechanism 30 from transitioning from a first configuration (Fig. 2) to a second configuration (Fig. 4) when the detach mechanism 30 is positioned within the lumen 18 of the delivery catheter 12 (col. 4 lines 51-62 of Marks). Finger was used as a supporting reference to teach that a delivery catheter is a known alternative delivery device to an endoscope (para. 0101 of Finger) such that the combination would yield the use of the claimed delivery catheter as an alternative to the endoscope discussed in Suzuki. Therefore, the rejection of claim 1 is maintained.
Regarding claim 11, applicant argues that there is no suggestion or motivation to make the modification of Davidson with Echarri as proposed by the Office because such modification would render Davidson unsatisfactory for its intended purpose. Applicant explains that in Davidson, the intended purpose of the medical device is utilized to remove a thrombus for blood flow restoration. Applicant submits that inclusion of the fluid-impermeable membrane of Echarri would not only interfere with the ability of the medical device in Davidson to restore blood flow because the flow restricting member would prevent the cells from penetrating the thrombus and would only serve to make an occlusion worse.
The examiner respectfully disagrees. In response to applicant's argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F .2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. V. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the main intention of the Davidson reference is for occlusion removal within vasculature (para. 0001) since vasculature occlusions disrupts blood flow and prevents oxygen and nutrients from being delivered to tissues downstream of the occlusion (para. 0001). Echarri in the related art of clot retrieval devices is also intended for occlusion removal within vasculature (para. 0002 of Echarri) to achieve blood flow restoration in the vasculature (para. 0002, 0006 of Echarri). Therefore, the intended purposes of the devices are the same. Echarri further teaches that it is advantageous to utilize a fluid-impermeable membrane in clot retrieval devices because the membrane can capture and trap debris from the occlusion to prevent the debris from the captured clot from traveling to other parts of the body (para. 0006, 0064, 0071 of Echarri) which is beneficial and aligned with the intended purpose of the device of Davidson.
Furthermore, Echarri teaches and illustrates the flow restricting layer 308 mounted on a proximal end of the self-expandable skeleton 304, thereby only covering the plurality of cells on the proximal end of the device (see Figs. 4-5, para. 0066 of Echarri) and specifically Fig. 4 of Echarri illustrates the self-expandable skeleton 304 penetrating the clot while using the flow restricting layer (para. 0061 of Echarri) and not interfering with the cells' ability to penetrate into the thrombus (para. 0061 of Echarri). Therefore, the rejection of claim 11 is maintained.
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:
“detach mechanism” in claims 1 and 2. The limitation introducing the detach mechanism in claim 1 fails to include sufficient structure to perform the recited function of “detaching". In the specification, the elected detach mechanism shown in Figs. 12A-13B is described as comprising a pair of gripping elements hingedly mounted to delivery element (see para. 0152 of the PGPUB of the instant application US 2022/0218357). Therefore, the limitation will be interpreted as the pair of gripping elements hingedly mounted to the delivery element or any structural equivalent thereof capable of gripping and releasing an implant.
“gripping elements” in claim 2. The limitation introducing the gripping elements in claim 2 fails to include sufficient structure to perform the recited function of “gripping". In the specification, the gripping elements are described as claws comprising inwardly facing teeth in order to assist in gripping the embolization device (see para. 0153 of the PGPUB of the instant application US 2022/0218357). Therefore, the limitation will be interpreted as claws comprising inwardly facing teeth or any structural equivalent thereof capable of assisting in gripping the embolization device.
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(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 25 recites “wherein the detach mechanism is prevented from moving to the second configuration when the detach mechanism is within the lumen of the delivery catheter”. Claim 1 includes a limitation that recites “wherein the lumen of the delivery catheter prevents the detach mechanism from transitioning from the first configuration to the second configuration when the detach mechanism is positioned within the lumen of the delivery catheter”. Therefore, claim 25 fails to further limit the subject matter of claim 1 and is rejected under 112(d).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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) 1-6 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki et al. (US 20120158043) in view of Marks (US 5217484) and Finger et al. (US 20180161142) [hereinafter Finger].
Regarding claim 1, Suzuki discloses a delivery system 10 (Figs. 1-4, para. 0026) for delivering and deploying an implant to a bodily lumen (see note below), comprising:
a delivery element (interpreted as tubular element comprising sheath 40, cover member 50, and cover 55, Fig. 2, para. 0026, 0028) defining an inner lumen (interpreted as lumen defined by sheath 40 and cover which retains closing wire 30 and pin member 32, Fig. 2), the delivery element 40, 50 comprising a first stopping element 52 within the inner lumen (Fig. 2, para. 0034), wherein the first stopping element 52 comprises an internally projecting surface that partially protrudes into the inner lumen (Fig. 2, para. 0034);
a detach mechanism (interpreted as treatment section 20 and link members 33-34, Fig, 2, para. 0026-0027, 0030) fixedly connected to a distal portion of the delivery element 40, 50 (see Figs. 2-3 which illustrates the detach mechanism 20 fixed to cover 55 which is a distal portion of the delivery element 40, 50, para. 0028-0031), the detach mechanism 20 having a first configuration (interpreted as the detach mechanism in a closed configuration, see Fig. 2) in which the detach mechanism is configured to grip the implant (Fig. 2, para. 0043) and a second configuration (interpreted as the detach mechanism in an open configuration, Fig. 3) in which the detach mechanism is configured to release the implant (Fig. 3, para. 0044); and
an actuating mechanism (interpreted as opening and closing wire 30 and pin member 32) comprising a second stopping element 60 comprising a radially projecting surface (Figs. 2-3, para. 0026, 0035), the actuating mechanism configured to extend through the lumen of the delivery catheter (see para. 0027 of Suzuki ‘287) to the detach mechanism 20 (Figs. 2-3, para. 0029-0030), the actuating mechanism movable between a first position (Fig. 2) and a second position (Fig. 3), wherein moving the actuating mechanism from the first position to the second position changes the detach mechanism from the first configuration to the second configuration (Figs. 2-3, para. 0043-0044), wherein the first stopping element 52 of the delivery element 40, 50, 55 abuts with the second stopping element 60 of the actuating mechanism 30, 32 at a predetermined relative position of the actuating mechanism and delivery element (Fig. 3, para. 0036), to prevent movement of the actuation mechanism relative to the delivery element beyond a most distal position (Fig. 3, para. 0046).
Suzuki further discloses that the delivery element 40, 50 configured to extend through a lumen of a delivery catheter (Fig. 1, para. 0003, 0005-0006; note: “configured to extend through a lumen of a delivery catheter’ is interpreted as functional language due to the “configured to language”; see note below which describes how functional language is interpreted. Suzuki incorporates Suzuki (JP 4197983) [associated with Suzuki US 20040225287) therein which discloses that the delivery element extends through a lumen of an endoscope, as evidenced by Suzuki ‘287 in para. 0027). Therefore, the delivery element is capable of extending through a lumen of a delivery catheter).
However, Suzuki fails to disclose a delivery catheter comprising a lumen, wherein the lumen of the delivery catheter prevents the detach mechanism from transitioning from the first configuration to the second configuration when the detach mechanism is positioned within the lumen of the delivery catheter.
Marks in the same field of endeavor of implant delivery devices teaches that it is known in the art to use a delivery catheter 12 comprising a lumen 18, wherein a delivery element 22 is configured to extend through the lumen of the delivery catheter (Figs. 1-2, col. 3 lines 46-54 and col. 4 lines 33-42), wherein the lumen 18 of the delivery catheter 12 prevents a detach mechanism 30 from transitioning from a first configuration (Fig. 2) to a second configuration (Fig. 4) when the detach mechanism 30 is positioned within the lumen 18 of the delivery catheter 12 (col. 4 lines 51-62).
Finger in the same field of endeavor of delivery devices further teaches that a delivery catheter (Fig. 12, para. 0101) is a known alternative in the art to an endoscope (para. 0101).
In light of these teachings, the substitution of one known delivery device (delivery catheter as taught in Marks) for another (endoscope as disclosed in Suzuki) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the delivery catheter as taught Marks would have yielded predictable results, namely, an alternative way to introduce and delivery the implant to a target site as taught by Finger (para. 0101 of Finger); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Note: “for delivering and deploying an implant to a bodily lumen” is interpreted as functional language and intended use of the claimed invention. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Since Suzuki discloses all of the structural components required for the functional limitation, Suzuki thereby discloses the functional limitation such that the delivery system is capable of delivering and deploying an implant to a bodily lumen a. As evidenced by Domingo, the reference in the same field of endeavor teaches a biopsy forceps used as an implant delivery device (Figs. 1-3, para. 0004, 0058 of Domingo) for delivering and deploying an implant to a bodily lumen (Figs. 1-4, para. 0058-0060 of Domingo). The Domingo reference supports the argument that meeting the structural limitations of the claim, also meets the functional limitation of the claim; such that a delivery system designed to grip an object (see Fig. 2, para. 0043 of Suzuki) has the capability of gripping an implant for delivering and deploying the implant to a bodily lumen through as well. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 2, modified Suzuki discloses wherein the detach mechanism 20, 33, 34 comprises a pair of gripping elements 21, 22 (Figs. 2-3, para. 0027 of Suzuki).
Regarding claim 3, modified Suzuki discloses wherein the gripping elements 21, 22 are claws comprising inwardly facing teeth to grip the implant (see Figs. 2-3 which illustrate the inwardly facing teeth of the gripping element, para. 0027 of Suzuki).
Regarding claim 4, modified Suzuki discloses wherein the gripping elements 21, 22 are hingedly connected to the delivery element 40, 50, 55 (via. forceps rotary shaft 23, Figs. 2-3, para. 0028 of Suzuki);
Regarding claim 5, modified Suzuki discloses wherein the actuating mechanism 30, 32 comprises an elongate element 32 connected to both of the pair of gripping elements 21, 22 for simultaneously actuating both of the pair of gripping elements 21, 22 (Figs. 2-3, para. 0047-0048 of Suzuki).
Regarding claim 6, modified Suzuki discloses wherein the actuating mechanism 30, 32 is slidably received within one or more lumens of the delivery element 40, 50, 55 (see Figs. 2-3, para. 0042 of Suzuki).
Regarding claim 25, modified Suzuki discloses all of the limitations set forth above in claim 1. However, modified Suzuki fails to disclose wherein the detach mechanism is prevented from moving to the second configuration when the detach mechanism is within the lumen of the delivery catheter.
Marks further teaches that it is known in the art for a detach mechanism 34, 36 to be prevented from moving to a second configuration (interpreted as an open jaw configuration) when the detach mechanism 34, 36 is within the lumen of the delivery catheter 12(Fig. 2, col. 4 lines 36-40 of Marks).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Marks (i.e. known to prevent a jawed detach mechanism from moving to an open configuration when the detach mechanism is within a lumen of a delivery catheter) to the delivery system of modified Suzuki would have yielded predicable results and resulted in an improved system, namely, a system that would allow the detach mechanism to be easily inserted and maneuvered through the lumen of the delivery catheter by maintaining the detach mechanism in a low profile configuration (Fig. 2, col. 4 lines 36-40 of Marks) and would allow effective securement of the implant from delivery to deployment (Figs. 2, 4, col. 4 lines 37-46 of Marks); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 26, modified Suzuki discloses all of the limitations set forth above in claim 1. However, modified Suzuki fails to disclose wherein the detach mechanism abuts the lumen of the delivery catheter when the detach mechanism extends through the lumen of the delivery catheter.
Marks further teaches that it is known in the art for a detach mechanism 34, 36 to abut the lumen of the delivery catheter 12 when the detach mechanism 34, 36 extends through the lumen of the delivery catheter (Fig. 2, col. 4 lines 36-40).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Marks (i.e. known for jawed detach mechanism to abut a lumen of a delivery catheter when extending therethrough) to the delivery system of modified Suzuki would have yielded predicable results and resulted in an improved system, namely, a system that would allow the detach mechanism to be easily inserted and maneuvered through the lumen of the delivery catheter by maintaining the detach mechanism in a low profile configuration (Fig. 2, col. 4 lines 36-40 of Marks) and would allow effective securement of the implant from delivery to deployment (Figs. 2, 4, col. 4 lines 37-46 of Marks); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 11-12, 18, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson et al. (US 20170112512) [hereinafter Davidson] in view of Echarri et al. (US 20210298773) [hereinafter Echarri] and Wallace et al. (US 20060135986) [hereinafter Wallace].
Regarding claim 11, Davidson discloses an embolization system (Fig. 6), comprising:
an embolization device 102 (Fig. 6), comprising a self-expandable skeleton 118 (Fig. 6, para. 0089-0090), the embolization device having a collapsed delivery configuration in which the embolization device is configured to fit inside a delivery catheter 107 (Fig. 31, para. 0117), and an expanded deployed configuration in which the skeleton is configured to anchor the embolization device to a bodily lumen (Figs. 32-33, para. 0118);
a detach mechanism (interpreted as the detachment portion described in para. 0087) for connecting the embolization device 102 to a delivery element 104 and actuatable to release the embolization device from the delivery element (Fig. 6, para. 0087); and
a flexible joint 106 having a higher flexibility than the embolization device, the flexible joint for allowing the embolization device to tilt with respect to the delivery element when the delivery element is connected to the embolization device (Fig. 6, para. 0088, 0105).
However, Davidson fails to disclose a flow restricting layer mounted on the skeleton, wherein in the expanded deployed configuration the flow restricting layer is configured to extend over an entire diameter of the skeleton to restrict blood flow through the bodily lumen.
Echarri in the same field of endeavor of embolization devices 300 teaches that it is known in the art to include a flow restricting layer 308 mounted on a self-expandable skeleton 304 (Fig. 6, para. 0061, 0065, 0071), wherein in the expanded deployed configuration the flow restricting layer 308 is configured to extend over an entire diameter of the skeleton to restrict blood flow through the bodily lumen (Figs. 4, 6, para. 0071, 0075).
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 embolization device in Davidson to include the flow restricting layer, as taught by Echarri, since it is known in the art to trap thromboemboli and prevent said emboli from traveling to other parts of the body (para. 0006, 0064, 0071 of Echarri).
Davidson further discloses “Depending on the procedure and intended use of the medical device 100, it optionally may be advantageous to have a connection mechanism that permits intentional release of the intervention member 102…the medical device 100 can comprise a portion, located proximally or distally of the connection 106, that is configured for selective detachment of the intervention member 102 from the manipulation member 104. For example, such a portion can comprise an electrolytically severable or mechanically detachable segment of the manipulation member” (para. 0087). However, Davidson in view of Teitelbaum fails to disclose wherein the detach mechanism comprises a breakable detachment element comprising an electrolytic element operable to disintegrate by electrolysis in the bodily lumen, wherein the breakable detachment element breaks when a predetermined electric current is applied.
Wallace in the same field of endeavor teaches an implant delivery system 10 comprising a delivery element 18 comprising a detach mechanism 24 and a flexible joint 36 (Figs. 1-2, para. 0035), wherein the detach mechanism 24 comprises a breakable detachment element 24 comprising an electrolytic element operable to disintegrate by electrolysis in the bodily lumen (Figs. 1-2, para. 0028-0029), wherein the breakable detachment element 24 breaks when a predetermined electric current is applied (Figs. 1-2, para. 0028-0029).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrolytic breakable detachment element of Wallace for the breakable detachment element of modified Davidson, since such a substitution is a modification for one detachment element for another and would yield the predictable result of a way to detach the implant from the rest of the device such that the breakable detachment element disintegrates when electrically charged (para. 0028-0029 of Wallace); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 12, modified Davidson discloses wherein the flexible joint is provided proximally to the detach mechanism; or wherein the flexible joint is provided distally to the detach mechanism (para. 0087 of Davidson).
Regarding claim 18, modified Davidson discloses wherein the flexible joint comprises two or more connected loops (Fig. 6, para. 0087-0088 and 0105 of Davidson).
Regarding claim 24, modified Davidson discloses wherein in the expanded deployed configuration, the flow restricting layer 308 extends across the entire diameter of the bodily lumen (Fig. 4, para. 0061, 0075 of Echarri).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson et al. (US 20170112512) [hereinafter Davidson] in view of Echarri et al. (US 20210298773) [hereinafter Echarri] and Wallace et al. (US 20060135986) [hereinafter Wallace] as applied to claim 11 above, and further in view of Tsugita et al. (US 20020095174).
Regarding claim 15, modified Davidson discloses all of the limitations set forth above in claim 11. However, modified Davidson fails to disclose wherein the detach mechanism comprises a screw thread.
Tsugita in the same field of endeavor teaches a detach mechanism 136 (Figs. 10A-B), wherein the detach mechanism comprises a screw thread (Figs. 10A-B, para. 0086).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the detachment mechanism in modified Davidson for the thread/screw detachment mechanism of Tsugita, since Davidson discloses that a detachment mechanism comprising a mechanically detachable segment is a known alternative to an electrolytically severable detachment mechanism (para. 0087 of Davidson), since such a modification is a substitution of one known detachment mechanism for another, and would yield a predictable result of a way of detaching the embolization device from the delivery element (Figs. 10A-B, para. 0086 of Tsugita); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson et al. (US 20170112512) [hereinafter Davidson] in view of Echarri et al. (US 20210298773) [hereinafter Echarri] and Wallace et al. (US 20060135986) [hereinafter Wallace] as applied to claim 11 above, and further in view of Ramzipoor et al. (US 20060271097) [hereinafter Ramzipoor].
Regarding claim 17, modified Davidson discloses all of the limitations set forth above in claim 11. Davidson further discloses “the medical device 100 can comprise a portion, located proximally or distally of the connection 106, that is configured for selective detachment of the intervention member 102 from the manipulation member 104. For example, such a portion can comprise an electrolytically severable or mechanically detachable segment of the manipulation member” (para. 0087). However, modified Davidson fails to disclose wherein the breakable detachment element is also the flexible joint.
Ramzipoor in the same field of endeavor teaches a detach mechanism comprising a flexible joint 20, 30 comprising an interlocking loop structure (Fig. 11, para. 0039, 0048, 0066) and a breakable detachment element 27, wherein the breakable detachment element 27 is also the flexible joint (Fig. 11, para. 0066 discloses that the second loop 30 of the flexible joint comprises an electrolytically erodible region).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the location of breakable detachment element such that the breakable detachment element is formed as a part of the flexible joint, as taught by Ramzipoor, instead of the breakable detachment element being positioned either proximally or distally from the flexible joint, as stated in modified Davidson, since such a modification is a substitution of one known location for another, and would yield a predictable result of a way of detaching the embolization device from the delivery element (Fig. 11, para. 0066 of Ramzipoor); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771