DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on March 12, 2026. As directed by the amendment: claims 1, 28-29, 35, and 41 have been amended, no claims have been added, claim 4 has been canceled. Thus claims 1-3, 6, 8, 11-16, 21, 27-29, 34-37 and 41 are presently pending in this application. Applicant's amendments to the Claims have overcome each and every objection rejection previously set forth in the Non-Final Office Action mailed September 12, 2025. However, applicant’s amendments to the claims did not address the 35 U.S.C. 112(b) applied to claim 13, therefore this rejection is maintained.
Response to Arguments
Applicant’s arguments, see Remarks, filed March 12, 2026, have been fully considered.
Applicant’s arguments with respect to the interpretation of claim 16 under 35 U.S.C. 112(f), see pg. 6-7 of Remarks, have been fully considered but they are not persuasive. The fixation feature of claim 16 does invoke 35 U.S.C. 112(f) interpretation, as the claim language does not provide any structure for the feature. The examiner acknowledges that there are more known features in the art than what is listed in applicant specification, and these features would be considered "equivalents thereof" of the specification-listed features during the 112(f) interpretation.
Applicant’s arguments with respect to the rejections of claims 1-2 for non-statutory double patenting and the provisional rejections of claims 1-3 for non-statutory double patenting, see pg. 7 of the Remarks have been fully considered and are persuasive. The amendment to claim 1 overcomes these rejections/provisional rejections. The rejections of claims 1-2 and the provisional rejections of claims 1-3 have been withdrawn.
Applicant’s arguments with respect to the rejection(s) of claim(s) under 35 U.S.C. 102/103, see pgs. 8-9 of the Remarks, have been fully considered and are persuasive. None of the applied art discloses all the limitations of amended claim 1, namely the added limitation “wherein the first joint cannula section is configured to be connected to the second joint cannula section by a clinician”. Therefore, the rejection of claim 1 has been withdrawn. And due to their dependency on claim 1, the rejections of claims 2-3, 6, 8, 11-16, 21, 27-29, 34-37 and 41 are also withdrawn for similar reasons. However, upon further consideration, in light of the amendment, a new ground(s) of rejection is made below.
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: “a fixation feature” in claim 16.
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. “A fixation feature” in claim 16 is given the broadest reasonable interpretation of “a butterfly pad, a suture pad, or a suture ring” or equivalents thereof, as defined in [0052] of the instant specification.
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 13 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 13 recites the limitation "the second angle". There is insufficient antecedent basis for this limitation in the claim. Claim 13 is dependent from claim 11, however the “second angle” is not defined until claim 12, which claim 13 is not dependent on. Therefore, for examining purposes, “the second angle” is interpreted to be a new claim limitation. (The examiner notes: amending claim 12 to be dependent on claim 11, and amending claim 13 to be dependent on claim 13, would resolve all dependency issues for these claim limitations.)
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.
Claims 1-3, 8, 11-12, 14, 16, 27-29, 34-35, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi (US 20200289794), in view of Bonnette et al. (US 20080188831), hereinafter Bonnette.
Regarding claim 1, Fantuzzi discloses an access device (Fig. 2, sheath delivery system 200), comprising: a hub (Fig. 2, hub 220) configured to be coupled to a proximal end of a cannula (Fig. 2, hub 220 is configured to be coupled to proximal end 212 of sheath 210) having a proximal end (Fig. 3, hub 220 has a proximal end 232), a distal end (Fig. 3, hub 220 has a distal end at port 270) and a joint lumen therethrough (Fig. 3, hub 220 has a joint lumen region located at and downstream of the region where lumens 235 and 255 meet in hub 220 and the joint lumen extends into the sheath 210 to also form the sheath lumen), the hub comprising: a first arm (Fig. 3, arm 250) having a first lumen (Fig. 3, lumen 255) and a first hemostatic valve (Fig. 3 and [0028], valve 258, which may be a hemostasis valve), the first lumen operably connected to the joint lumen (Fig. 3, lumen 255 feeds into joint lumen region of hub 220), the first lumen and the first hemostatic valve configured for passage of an internally placeable medical device (Fig. 1, 6 and [0046], lumen 255 and valve 258 are configured for the passage of a medical device 160); a second arm (Fig. 3, arm 230) coupled to the first arm (Fig. 3, arm 250 and arm 230 are coupled together), the second arm having a second lumen (Fig. 3, lumen 235) operably connected to the joint lumen (Fig. 3, lumen 235 feeds into joint lumen region of hub 220), the second arm configured to be operably coupled to an external medical device (Fig. 3 and [0043], arm 230 is configured to be coupled to a medical device 140, such as a mechanical circulatory support device like an ECMO pump, thus medical device can be external to body).
Fantuzzi fails to disclose wherein the cannula is a joint cannula, the joint cannula comprising: a first joint cannula section having a proximal end and a distal end, the proximal end of the first joint cannula section being coupled to the hub; and a second joint cannula section having a proximal end and a distal end, the proximal end of the second joint cannula section being coupled to the distal end of the first joint cannula section; wherein the first joint cannula section is configured to be connected to the second joint cannula section by a clinician. However, Bonnette discloses wherein the cannula is a joint cannula (Fig. 1 and 6 and [0066], cannula 14 is a joint cannula comprised of proximal tube 30 and distal tube 32), the joint cannula comprising: a first joint cannula section (fig. 1, proximal tube 30) having a proximal end (Fig. 2, proximal end (end closest to manifold 12) of proximal tube 30) and a distal end (Fig. 1-2 and 6, distal end (end connected to distal tube 32) of proximal tube 30), the proximal end of the first joint cannula section being coupled to the hub (Fig. 2, proximal end of proximal tube 30 couples to manifold 12 (equivalent to hub 220 of Fantuzzi)); and a second joint cannula section (Fig. 2, distal tube 32) having a proximal end (Fig. 1-2 and 6, proximal end (end connected to proximal tube 30) of distal tube 32) and a distal end (Fig. 2, distal tip 34 of distal tube 32), the proximal end of the second joint cannula section being coupled to the distal end of the first joint cannula section (Fig. 6 and [0066], proximal end of distal tube 32 is coupled to distal end of proximal tube 30); wherein the first joint cannula section is configured to be connected to the second joint cannula section by a clinician (Examiner notes: The language "wherein… a clinician" constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by the structural limitations. The office submits that the device of Bonnette meets the structural limitations of the claim, as Fig. 6 and [0066] discloses that proximal end of distal tube 32 is sized to be inserted within the distal end of proximal tube 30, and then secured by suitable methods. This insertion may easily be done by a clinician and there for the joint cannula of Bonnette is capable of "the first joint cannula section is configured to be connected to the second joint cannula section by a clinician").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fantuzzi to incorporate the disclosures of Bonnette and modify the sheath cannula to be a joint cannula comprising: a first joint cannula section having a proximal end and a distal end, the proximal end of the first joint cannula section being coupled to the hub; and a second joint cannula section having a proximal end and a distal end, the proximal end of the second joint cannula section being coupled to the distal end of the first joint cannula section; wherein the first joint cannula section is configured to be connected to the second joint cannula section by a clinician. Doing so would provide a catheter tube which is formed of various component materials that provide desired pushability and torqueability and promote operator feel (Bonnette, [0024, 0066]).
Regarding claim 2 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses the access device according to claim 1, wherein the external medical device includes an extracorporeal membrane oxygenation (ECMO) device (Fig. 3 and [0043], arm 235 is configured to be coupled to a medical device, such as an ECMO pump).
Regarding claim 3 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses the access device according to claim 1, wherein the cannula is coupled to the hub via a threaded or a barbed connection (Figs. 1-2 and [0024], sheath 210 is coupled to hub 220 via the connection port 270 of hub 220 (equivalent to connection port 170 of Fig. 1), which may include a threaded interaction between the port 270 and the sheath 210).
Regarding claim 8 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses the access device according to claim 1.
However, Fantuzzi, in view of Bonnette, does not expressly disclose wherein the joint lumen has an inner-diameter ID, wherein 3 mm < ID < 36 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Fantuzzi, in view of Bonnette, to have an inner-diameter ID of the joint lumen, wherein 3 mm < ID < 36 mm, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Fantuzzi would not operate differently with the ID range and Fantuzzi shows in Figs. 1-2 and [0024] that the joint lumen of the hub and sheath is configured to receive at least one medical device therein, for delivery to the target site within the patient, similar to the intended purpose of the claimed joint lumen, therefore the device would function appropriately having the claimed diameter range. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the inner diameter "may" be within the claimed ranges (instant specification [0012]).
Regarding claim 11 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses the access device according to claim 1, wherein a first angle formed between a central axis of the first arm and a central axis of the second arm is less than 90 degrees (Fig. 3 and [0026, 0030], angle between central axis of arm 250 and central axis of arm 230 is less than 90 degrees).
Regarding claim 12 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses the access device according to claim 1, wherein a second angle formed between a central axis of the first lumen and a central axis of the second lumen is less than 90 degrees (Fig. 3 and [0026, 0030], angle between central axis of lumen 255 (which is aligned with central axis of arm 250) and central axis of lumen 235 (which is aligned with central axis of arm 230) is less than 90 degrees).
Regarding claim 14 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses the access device according to claim 1, wherein the first lumen and second lumen connect to form a junction (Fig. 3, lumens 250 and 230 connect at the joint lumen portion to form a junction).
Regarding claim 16 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses access device according to claim 1, further comprising a fixation feature (Fig. 3, hub 220 comprises a suture ring 225 as a fixation feature).
Regarding claim 27, Fantuzzi, in view of Bonnette, discloses the access device according to claim 1, as explained above. Fantuzzi is silent to wherein the cannula further comprises at least one lumen in a distal portion of the cannula, the at least one lumen extending from an outer surface of the cannula to the joint lumen through a wall of the cannula. However, Bonnette further discloses wherein the cannula further comprises at least one lumen in a distal portion of the cannula, the at least one lumen extending from an outer surface of the cannula to the joint lumen through a wall of the cannula (Fig. 2, 4, 6 and [0066], outflow orifice 36 extends through catheter wall to lumen of catheter (similar to wall of sheath and joint lumen of sheath of Fantuzzi)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fantuzzi, in view of Bonnette, to further incorporate the disclosures of Bonnette and modify the sheath cannula to have at least one lumen in a distal portion of the cannula, the at least one lumen extending from an outer surface of the cannula to the joint lumen through a wall of the cannula. Doing so would provide an outflow (and/or inflow if desired) opening(s) in the cannula, for directing fluid/other materials radially into/out of the device, while maintaining the structural integrity of the minimally sized distal portion of the cannula/catheter (Bonnette, [0066, 0072]).
Regarding claim 28 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses the access device according to claim 1, wherein the cannula is configured to receive a dilator assembly (Fig.2-3, sheath 210 is configured to receive a dilator 280).
Regarding claim 29 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses the access device according to claim 1, wherein the hub further comprises a third lumen (Fig. 3 and [0029], hub 230 comprises a side port 256, with its own lumen) operably connected to the first lumen, the second lumen, or both (Fig. 3 and [0029], side port lumen 256 is connected to the lumen 255).
Regarding claim 34 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses the access device according to claim 1, wherein the medical device is a guide wire, a balloon catheter, or a catheter-based heart pump (Fig. 3 and 6 and [0004, 0043], medical device 140 inserted into first arm 230 is a mechanical circulatory support device such as an intra-aortic balloon pump, which is a catheter based heart pump).
Regarding claim 35 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses the access device according to claim 1, further comprising a second hemostatic vale positioned in the first arm (Fig. 3, arm 230 has valve 238 positioned within its lumen, which may be a hemostasis valve).
Regarding claim 41 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses a kit (kit of components for system 200 of Figs. 2-4) comprising: an access device according to claim 1 (Figs. 2-4, system 200); an external medical device configured to be coupled to the second arm of the access device ( [0043], a mechanical circulatory support device like an ECMO pump (an external medical device) which can be configured to couple to arm 235); and a medical device configured to be inserted through the first hemostatic valve, the first lumen, and the joint lumen (Figs. 1-2 and [0046], a medical device 160 which is configured to be inserted through hemostasis valve 258, lumen 255, and the joint lumen region).
Claims 6, 13, 15, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi (US 20200289794), in view of Bonnette (US 20080188831), as applied to claims 1 and 11 above, and further in view of Schweikert et al. (US 20030088213), hereinafter Schweikert.
Regarding claim 6, Fantuzzi, in view of Bonnette, discloses the access device according to claim 1.
Fantuzzi, in view of Bonnette, fails to disclose wherein the second arm is configured to be operably coupled to an external medical device via an additional cannula. However, Schweikert discloses wherein the second arm is configured to be operably coupled to an external medical device via an additional cannula (Fig. 3, 5, and [0035, 0038], tube connection 156 of hub body 152 may comprise an extension tube 132, with a proximal end 132B which connects to an external device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fantuzzi, in view of Bonnette, to incorporate the disclosures of Schweikert and modify the second arm to be configured to be operably coupled to an external medical device via an additional cannula. Doing so would allow for a releasable connection to a device exterior to the catheter, such that the exterior device may be connected during use, but disconnected when not in use (Schweikert, [0035]).
Regarding claim 13, Fantuzzi, in view of Bonnette, discloses the access device according to claim 11.
Fantuzzi, in view of Bonnette, fails to disclose wherein the first angle, the second angle, or both are between 15 degrees and 60 degrees. However, Schweikert discloses wherein the first angle, the second angle, or both are between 15 degrees and 60 degrees (Figs. 2 and 5 and [0042], the angle of cannula lumens 162 and 164 of tube connections 156 and 158 (equivalent to the second angle) is approx. 20 deg. with respect to each other).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fantuzzi, in view of Bonnette, to incorporate the disclosures of Schweikert and modify the angle formed between the central axis of the first lumen and the central axis of the second lumen to be between 15 and 60 degrees. Doing so would arrange the hub cannulae away from each other, providing slight separation between the tube connections and their extension tubes, to help facilitate the manufacturing of the catheter device assembly (Schweikert, [0042]).
Regarding claim 15, Fantuzzi, in view of Bonnette, discloses the access device according to claim 1.
Fantuzzi, in view of Bonnette, fails to disclose a clamp configured to allow a user to clamp off the second arm. However, Schweikert discloses a clamp configured to allow a user to clamp off the second arm (Fig. 1 and [0036], the extension tube 132 of tube connection 156 in hub body 152 may comprise a clamp 140 for pinching flow of extension tube 132 to tube connection 156).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fantuzzi, in view of Bonnette, to incorporate the disclosures of Schweikert and modify the second arm to comprise an extension tube with a clamp configured to allow a user to clamp off the second arm. Doing so would allow for pinching off flow through the tube/tube connection in hub and during periods of non-use (Schweikert, [0036]).
Regarding claim 37 and Fantuzzi, in view of Bonnette, Fantuzzi further discloses a method for using a single access device (method of using system 200 of Figs. 2-4), comprising: providing an access device according to claim 1 (Figs. 2-4, system 200); connecting the hub of the access device to the cannula ([0045], hub 220 is connected to sheath 210 via connector port 270); and inserting a medical device into the first arm of the single access device and into a patient (Fig. 6 and [0046], a medical device 160 is inserted into arm 250, and advances through system 200 to be delivered into the patient); coupling an external medical device to the single access device (Fig. 6 and [0043-0045], a medical device 140, which may be an ECMO device, may be inserted/coupled to device) via an additional cannula.
Fantuzzi, in view of Bonnette, fails to disclose coupling an external medical device to the single access device via an additional cannula. However, Schweikert discloses coupling an external medical device to the single access device via an additional cannula (Fig. 3, 5, and [0035, 0038], tube connection 156 of hub body 152 may couple to an external device via an extension tube 132, with a proximal end 132B which connects to the external device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fantuzzi, in view of Bonnette, to incorporate the disclosures of Schweikert and modify the method to include coupling an external medical device to the single access device via an additional cannula. Doing so would allow for a releasable connection to a device exterior to the catheter, such that the exterior device may be connected during use, but disconnected when not in use (Schweikert, [0035]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi (US 20200289794), in view of Bonnette (US 20080188831), as applied to claim 1 above, and further in view of Elkins et al. (US 20060047266), hereinafter Elkins.
Regarding claim 21, Fantuzzi, in view of Bonnette, discloses the access device according to claim 1.
Fantuzzi, in view of Bonnette, fails to disclose wherein the cannula is reinforced with coiled wire, braided wire, or a precision-cut hypotube. However, Elkins discloses wherein the cannula is reinforced with coiled wire, braided wire, or a precision-cut hypotube (Fig. 22 and [0096, 0103], sheath 352 may be constructed with an inner-coiled wire reinforcement).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fantuzzi, in view of Bonnette, to incorporate the disclosures of Elkins and modify the sheath to be reinforced with coiled wire, braided wire, or a precision-cut hypotube. Doing so would provide reinforced support within the polymer walls of the sheath (Elkins, [0103]).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Fantuzzi (US 20200289794), in view of Bonnette (US 20080188831), as applied to claim 1 above, and further in view of Wells (US 20110166527).
Regarding claim 36, Fantuzzi, in view of Bonnette, discloses the access device according to claim 1.
Fantuzzi, in view of Bonnette, fails to disclose an inflatable valve disposed within the first lumen, second lumen, or joint lumen. However, Wells discloses an inflatable valve disposed within the first lumen, second lumen, or joint lumen (Fig. 3 and [0038], hub with hemostasis valve (like arm 250 of Fantuzzi) may comprise an additional sealing mechanism such as an inflatable valve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fantuzzi, in view of Bonnette, to incorporate the disclosures of Wells and modify the first arm/hemostasis valve additionally comprise an inflatable valve. Doing so would further prevent fluids from leaving or entering the body target site through the device (Wells, [0002]).
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 SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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, BHISMA MEHTA can be reached at (571) 272-3383. 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.
/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
Prosecution Insights