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 Arguments
1. Applicant’s arguments, filed 07/17/2026, with respect to the rejection(s) of the claim(s) under U.S.C. 102/103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Khalaj (US 20200269018 A1).
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.
2. 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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
a first and second means for occluding a lumen in claim 1
a third means for processing the fluid in claim 1
a fourth means for controlling the fluid flow to and from the extracorporeal device in claim 4
a fifth means for oxygenating the fluid in claim 6
a sixth means for cooling and heating in claim 7
a seventh means for delivering and removing one or more compounds to the fluid in claim 8
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
3. Claim(s) 1-9, 21, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochareon (US 2018/0272104) in view of Khalaj (US 20200269018 A1).
Regarding claim 1, Hochareon discloses a system for the selective perfusion of one or more organs (Abstract; Fig. 1, isolation system 8), said system comprising:
a first catheter comprising a first means for occluding a first lumen downstream of the one or more organs; a second catheter comprising a second means for occluding a second lumen upstream of the one or more organs (first and second catheters 10, 30 with occlusion devices 14, 34; para. 51, 57); and
an extracorporeal device configured to deliver fluid through the first catheter and to receive fluid through the second catheter, the extracorporeal device including a third means for processing the fluid (blood conditioning apparatus 40 with extracorporeal therapy delivery; para. 53-54; para. 63 discloses conditioning blood by oxygenating, cooling, bioactive agent addition, etc.).
Hochareon does not disclose wherein the first and/or second catheter comprise a diffuser, wherein the diffuser comprises a plurality of apertures to allow the fluid to flow freely throughout. However, in the same field of endeavor, Khalaj teaches a multi-head catheter system for fluid delivery (Abstract) wherein the catheter comprises a diffusing means with exit holes [408] that allow the fluid to exit and flow (Par. 0074) in order to create a substantially uniform flow through substantially all of the exit holes; thus, the fluid is delivered at a substantially equal rate throughout the wound area of the anatomy (Par. 0074).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Hochareon and modified them by having the catheter comprise diffusion holes, as taught and suggested by Khalaj, in order to create a substantially uniform flow through substantially all of the exit holes; thus, the fluid is delivered at a substantially equal rate throughout the wound area of the anatomy (Par. 0074 of Khalaj).
Regarding claim 2, the combined teachings of Hochareon and Khalaj as applied to claim 1 discloses the first and second means for occluding each comprise an expandable structure (para. 60 of Hochareon discloses the first and second occlusion devices 14, 34 may each be inflatable balloons).
Regarding claim 3, the combined teachings of Hochareon and Khalaj as applied to claim 1 discloses the expandable structure comprises an inflatable balloon (para. 60 of Hochareon).
Regarding claim 4, the combined teachings of Hochareon and Khalaj as applied to claim 1 discloses a fourth means for controlling the fluid flow to and from the extracorporeal device (flow-volume adjustor 48; para. 59 of Hochareon).
Regarding claim 5, the combined teachings of Hochareon and Khalaj as applied to claim 1 discloses one or more fluid pressure sensors coupled near first ends of the first and second catheters, the first and second catheters being coupled to the extracorporeal device at the first ends (para. 72 of Hochareon discloses one or more catheters may be provided with a pressure sensor; para. 95 of Hochareon).
Regarding claim 6, the combined teachings of Hochareon and Khalaj as applied to claim 1 discloses the third means for processing includes a fifth means for oxygenating the fluid (para. 63 of Hochareon).
Regarding claim 7, the combined teachings of Hochareon and Khalaj as applied to claim 1 discloses the third means for processing includes a sixth means for heating and cooling (para. 63; para. 109 of Hochareon).
Regarding claim 8, the combined teachings of Hochareon and Khalaj as applied to claim 1 discloses the third means for processing includes a seventh means for delivering and removing one or more compounds to the fluid (para. 63 of Hochareon).
Regarding claim 9, the combined teachings of Hochareon and Khalaj as applied to claim 1 discloses the one or more organs include the brain (para. 71 of Hochareon).
Regarding claim 21, the combined teachings of Hochareon and Khalaj as applied to claim 1 discloses the expandable structure comprises a delivery configuration configured to fit within a delivery sheath and an occluding configuration (para. 60 of Hochareon discloses inflated and deflated states of occlusion devices; deflated state is the delivery configuration, inflated state is the occluding configuration).
Regarding claim 29, the combined teachings of Hochareon and Khalaj as applied to claim 1 discloses the system of claim 1 wherein the diffuser is configured to direct the flow of the fluid (Par. 0074 of Khalaj – see claim 1 rejection)
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.
4. Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochareon and Khalaj in view of Raulerson et al. (US 2004/0092863) (hereinafter Raulerson).
Regarding claim 22, the combined teachings of Hochareon and Khalaj as applied to claim 1 do not disclose the first and/or second catheter comprise a dilator with a guide wire slidably extending therethrough.
Raulerson, however, teaches a multiple catheter assembly (Abstract) wherein generally, to insert any catheter into a blood vessel, the vessel is identified by aspiration with a long hollow needle in accordance with the well-known Seldinger technique. When blood enters a syringe attached to the needle, indicating that the vessel has been found, a thin guide wire is then introduced, typically through a syringe needle or other introducer device into the interior of the vessel. The introducer device is then removed, leaving the guide wire within the vessel. The guide wire projects beyond the surface of the skin. At this point, several options are available to a surgeon for catheter placement. The simplest is to pass a catheter into the vessel directly over the guide wire. The guide wire is then removed, leaving the catheter in position within the vessel. However, this technique is only possible in cases where the catheter is of a relatively small diameter, made of a stiff material, and not significantly larger than the guide wire, for example, for insertion of small diameter dual lumen catheters. If the catheter to be inserted is significantly larger than the guide wire, a dilator device is passed over the guide wire to enlarge the hole. The dilator is removed and the catheter is then passed over the guide wire. After the catheter is inserted, the guide wire is removed (para. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Hochareon and Khalaj such that the first and/or second catheter comprise a dilator with a guide wire slidably extending therethrough. Making this modification would be useful for inserting larger catheters into blood vessels, as taught by Raulerson.
5. Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochareon and Khalaj in view of Ishida (WO 2019124422).
Regarding claim 24, the combined teachings of Hochareon and Khalaj as applied to claim 1 do not disclose the first and/or second catheter comprise a puncture component, wherein the puncture component comprises a flexible tip.
Ishida, however, teaches a catheter assembly (Fig. 9) wherein the catheter comprises a puncture component, wherein the puncture component comprises a flexible tip (flexible tip 106). The hardness of the flexible portion 106 (flexible portion single region 82B) is, for example, harder than 80A in JIS hardness (type A) and softer than the catheter main body 104 at 23 C., preferably 53D in JIS hardness (type D) It is -64D. The flexible portion 106 in the illustrated example is joined to the catheter body 104. By setting the axial length and the hardness of the flexible portion single-piece region 82B in the above-described range, it is possible to suppress the curling of the tip (flexible portion 106) of the catheter 82 at the time of puncturing. In addition, it is possible to preferably suppress the sticking on the blood vessel back wall when the catheter 82 is inserted. Furthermore, crushing of the tip of the catheter 82 at the time of blood suction can be suppressed (pg. 12, para. 6 of attached translation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Hochareon and Khalaj such that the first and/or second catheter comprise a puncture component, wherein the puncture component comprises a flexible tip. Making this modification would be useful for suppressing curling of the tip at the time of puncturing, suppressing sticking on the blood vessel back wall when the catheter is inserted, and suppressing crushing of the tip at the time of blood suction.
6. Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hochareon and Khalaj in view of Ishida, further in view of Greene (US 2002/0165497).
Regarding claim 25, Hochareon in view of Khalaj and Ishida does not teach the puncture component comprises a cover configured to maintain the puncture component in a puncture configuration.
Greene, however, teaches a safety intravenous catheter assembly includes a catheter hub, a needle cover attachable to and releasably lockable with the catheter hub, and a needle which extends through and is withdrawn into the needle cover. A stop assembly is attached to the needle and to the needle cover for maintaining a tip of the needle within the needle cover after catheter insertion. The stop assembly may include a first locking position whereby the catheter hub cannot disengage from the needle cover, and a second locking position whereby the catheter hub can disengage from the needle cover. The needle cover includes a notch clip which may be integrally formed as one-piece (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Hochareon in view of Khalaj and Ishida such that the puncture component comprises a cover configured to maintain the puncture component in a puncture configuration. Making this modification would be useful for maintaining a tip of the needle within a needle cover after catheter insertion, as taught by Greene.
7. Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Hochareon and Khalaj in view of Mafi et al. (US 2009/0264821) (hereinafter Mafi).
Regarding claim 26, the combined teachings of Hochareon and Khalaj as applied to claim 1 do not disclose the first and/or second catheter comprise a dilator and a puncture component, wherein the puncture component comprises a puncture tip and slidably extends through the dilator.
Mafi, however, teaches endoluminal sealant delivery apparatus (Abstract) wherein guide
catheter "GC" can be used to deliver a conventional puncture device, which includes a needle (hidden from view) and dilator 22 in which the needle is slidably mounted so that it can be extended therefrom (para. 52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Hochareon and Khalaj such that the first and/or second catheter comprise a dilator and a puncture component, wherein the puncture component comprises a puncture tip and slidably extends through the dilator. Making this modification would be useful for providing a conventional puncture device wherein the needle is extendable from the dilator, as taught by Mafi.
Allowable Subject Matter
8. Claim 27-28 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: In the closest prior art, Hochareon in view of Mafi does not teach the dilator comprises a distal opening, wherein the distal opening is configured to prevent the puncture tip from sliding into the dilator.
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 SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
