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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9, in the reply filed on 11/25/2025 is acknowledged. Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/2025.
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 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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hochareon (US 2018/0272104).
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.).
Regarding claim 2, Hochareon discloses the first and second means for occluding each comprise an expandable structure (para. 60 discloses the first and second occlusion devices 14, 34 may each be inflatable balloons).
Regarding claim 3, Hochareon discloses the expandable structure comprises an inflatable balloon (para. 60).
Regarding claim 4, Hochareon discloses a fourth means for controlling the fluid flow to and from the extracorporeal device (flow-volume adjustor 48; para. 59).
Regarding claim 5, Hochareon 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 discloses one or more catheters may be provided with a pressure sensor; para. 95).
Regarding claim 6, Hochareon discloses the third means for processing includes a fifth means for oxygenating the fluid (para. 63).
Regarding claim 7, Hochareon discloses the third means for processing includes a sixth means for heating and cooling (para. 63; para. 109).
Regarding claim 8, Hochareon discloses the third means for processing includes a seventh means for delivering and removing one or more compounds to the fluid (para. 63).
Regarding claim 9, Hochareon discloses the one or more organs include the brain (para. 71).
Regarding claim 21, Hochareon discloses the expandable structure comprises a delivery configuration configured to fit within a delivery sheath and an occluding configuration (para. 60 discloses inflated and deflated states of occlusion devices; deflated state is the delivery configuration, inflated state is the occluding configuration).
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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Hochareon in view of Raulerson et al. (US 2004/0092863) (hereinafter Raulerson).
Regarding claim 22, Hochareon does 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 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.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hochareon in view of Nilsson et al. (US 6132405) (hereinafter Nilsson).
Regarding claim 23, Hochareon does not disclose the first and/or second catheter comprise a diffusor.
Nilsson, however, teaches a catheter for peritoneal dialysis (Abstract; Fig. 3) wherein the catheter may comprise an insert 18, which further comprises a restriction 19, as well as an enlarging portion 20, for example in the form of a diffusor with even cross-sectional enlargement 23 (conical) and concludes in a tip opening 17. The inner diameter of the restriction may be 1.5 mm and the diffusor's conicity may be about 8 degrees which, with a length of about 9 mm, results in a final opening diameter of about 2.7 mm, i.e. the same as the original inner diameter of the catheter. The insert 18 can preferably be dimensioned so that the flow speed through the tip opening is approximately the same as the flow speed through the holes in the catheter's sidewall. With the aforementioned dimensions the flow through the tip opening is about 20% of the flow through the side holes, which has shown itself to be a suitable value. By means of this dimensioning, the advantage is obtained that the force which the flow exerts on the catheter tip is not too large and does not cause the catheter to move to too large a degree, i.e. catheter migration is avoided. (Col. 4-5, ll. 62-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Hochareon such that the first and/or second catheter comprise a diffusor. Making this modification would be useful so that the flow speed through the tip opening is approximately the same as the flow speed through the holes in the catheter's sidewall in order to avoid catheter migration, as taught by Nilsson.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Hochareon in view of Ishida (WO 2019124422).
Regarding claim 24, Hochareon does 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 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.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hochareon in view of Ishida, further in view of Greene (US 2002/0165497).
Regarding claim 25, Hochareon in view of 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 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.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Hochareon in view of Mafi et al. (US 2009/0264821) (hereinafter Mafi).
Regarding claim 26, Hochareon does 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 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
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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sterman et al. (US 6699231) discloses method and apparatus for perfusion of isolated tissue structure (Abstract).
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/A.A.G./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792