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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 (“RCE”), 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 December 2025 (“Reply) has been entered.
Response to Amendment
This Action is responsive to the RCE and Reply. As directed in the Reply:
Claims 1, 34, 36, and 40 have been amended;
Claims 2, 3, 9-33, 35, 39, and 41-45 have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 1, 4-8, 34, 36-38, and 40 are presently pending in this application.
Response to Arguments
Applicant' s arguments with respect to Claims 1 and 4-8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 34 is objected to because the word “contiguous” in lines 24 and 26 is misused, and appears should be “continuous” as discussed in the Interview conducted on 14 January 2026, which is how the word has been treated in the claims.
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 8 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.
Upon further review, it appears that all of the features of Claim 8 have already been incorporated into Claim 1, from which Claim 8 ultimately depends; thus, the scope of Claim 8 is indefinite, because it is unclear what additional subject matter it recites.
Claim 8 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.
As noted above, Claim 8 includes only features already in Claim 1, from which it ultimately depends, and therefore does not further limit Claim 4, which depends from Claim 1.
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
Claim 1 is rejected under 35 U.S.C. § 103(a) as being obvious over U.S. Patent App. Pub. No. 2011/0137225, by Feng et al. (“Feng”) in view of U.S. Patent App. Pub. No. 2008/0097350, by Bell et al. (“Bell”).
Feng discloses a catheter substantially as claimed by Applicant, as follows.
Claim 1: A catheter (Fig. 1: 10) for insertion into vasculature of a patient (Abstract), the catheter comprising:
a proximal portion including a hub (Fig. 1, catheter hub 30);
a withdrawal lumen wall (wall surrounding lumens 18, 20) extending around a withdrawal lumen (18, 20) in fluidic communication with a negative pressure withdrawal line (withdrawal line 32) that is connected to a negative pressure source providing a negative pressure in the withdrawal lumen (dialyzer 40; see [0036], describing withdrawal and infusion of fluid, and thus negative pressure in the withdrawal line), wherein:
the withdrawal lumen wall extends between the proximal portion and a withdrawal lumen tip (at 24),
the withdrawal lumen tip located and arranged for reception of blood into the withdrawal lumen from the vasculature (at ports holes 24; see [0036]); and
the withdrawal lumen has a withdrawal lumen profile (as shown, Fig. 4);
an infusion lumen wall coupled with the withdrawal lumen wall (wall surrounding lumen 20), the infusion lumen wall extending around an infusion lumen (20) in fluidic communication with a positive pressure infusion line (34) that is connected to a positive pressure source providing a positive pressure in the infusion lumen (dialyzer 40; see [0036], describing withdrawal and infusion of fluid, and thus positive pressure in the infusion line), wherein:
the infusion lumen wall extends between the proximal portion and an infusion lumen tip (Fig. 3, 25),
the infusion lumen tip located and arranged for discharge of blood into the vasculature from the infusion lumen ([0036]);
the infusion lumen has an infusion lumen profile smaller than the withdrawal lumen profile ([0037], the diameter D2 of each of withdrawal lumens 18, 22 is 50-100% of the diameter D1 of lumen 20, and thus the total cross-sectional area of lumens 18+22 is, at the upper limit, 200% that of infusion lumen 20, as there are two withdrawal lumens; accordingly, the infusion lumen’s cross-sectional area is 50% of the withdrawal lumens’);
a septum (21, 23) extending between the withdrawal lumen and the infusion lumen, wherein:
the septum is coupled with the withdrawal lumen wall and the infusion lumen wall (as shown, Fig. 4); and
the septum isolates the withdrawal lumen from the infusion lumen (id.); and
wherein the withdrawal lumen profile has a first cross-sectional area taken at a first longitudinal position along a length of the catheter (at the section of Fig. 4); and
the infusion lumen profile has a second cross-sectional area that is at least 10 percent smaller than the first cross-sectional area at laterally adjacent locations taken at the same first longitudinal position along a length of the catheter (id.).
Feng does not, however, describe that its septum is flexible such that, in use, the flexible septum deflects toward the infusion lumen to help equalize fluid flow between the infusion lumen and the withdrawal lumen during flexing of the flexible septum in response to a pressure differential between the infusion lumen and the withdrawal lumen.
Bell relates to multi-lumen, withdrawal and infusion catheters and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Bell teaches that the septum (18 in Fig. 1; passim) is such catheters can be made flexible ([0054]) so that the septum will flex during use of the catheter ([0021]), change the cross-sectional areas of the adjacent lumens, and thus change the fluid flow rate through these lumens (id.), and that only a single withdrawal lumen can be used, which simplifies the construction of the catheter and the fluid mechanics. Bell’s flexible septum between withdrawal and infusion lumens helps equalize fluid flow between the infusion lumen and the withdrawal lumen during flexing of the flexible septum in response to a pressure differential between the infusion lumen and the withdrawal lumen in the same manner as does Applicant’s.
It 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, to make Feng’s catheter’s septum flexible, and to use only a single withdrawal lumen, because Bell teaches doing so in a closely related catheter, in order to better control fluid flow through the catheter, and to simplify the construction of the catheter.
Claim 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Feng and Bell as applied to Claim 1 above, and further in view of U.S. Patent App. Pub. No. 2011/0004198, by Hoch (“Hoch”).
Feng and Bell together describe a device substantially as claimed by Applicant; see above. They do not, however, describe a transducer configured to measure one or more fluid flow characteristics of fluid flowing in the vasculature of the patient.
Hoch relates to monitoring a patient or subject's central venous pressure (CVP), while simultaneously administering medication, hydration fluids, nutrients, radiologic contrasts, or other fluids, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Hoch teaches that such catheters can be provided with a pressure transducer (160, Fig. 1A) which measures the pressure of the blood in the patient’s vessel, because “[k]nowledge of CVP is useful in the management of several disease states and injuries, including but not limited to shock, acute renal failure, hypotension, congestive heart failure, cerebral trauma, and spinal cord trauma.” Hoch, at [0005].
It 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, to include, in a Feng - Bell catheter, a transducer configured to measure one or more fluid flow characteristics of fluid flowing in the vasculature of the patient, because Hoch teaches doing so in a closely related catheter in order to monitor blood pressure which may be indicative of disease states and/or injuries.
Claim 5: (The catheter of claim 4,) wherein the transducer is sized and shaped for insertion into the vasculature of the patient (Hoch, Fig. 1A).
Claim 6: (The catheter of claim 4,) wherein the transducer is capable of measuring one or more fluid flow characteristics between the catheter and a vasculature wall of the patient (intended use feature; when placed near a vasculature wall, sensor 160 will sense the fluid pressure at that location).
Claim 7: (The catheter of claim 4,) wherein the transducer is capable of measuring one or more fluid flow characteristics around the catheter (pressure at the tip is a fluid flow characteristic).
Claim 8: (The catheter of claim 4,) wherein the catheter includes a withdrawal lumen wall extending around a withdrawal lumen (limitation is redundant of that of Claim 1), wherein:
the withdrawal lumen wall extends to a withdrawal lumen tip, the withdrawal lumen tip located and arranged for reception of blood into the withdrawal lumen from the vasculature (limitation is redundant of that of Claim 1).
Allowable Subject Matter
Claims 34, 36-38, and 40 include allowable subject matter and would be allowable if the objection to Claim 34, above, is overcome.
The following is an examiner’s statement of reasons the indication of allowable subject matter.
The prior art of record, taken both alone and in permissible combination, fails to identically disclose or fairly suggest the combinations of features recited in Claim 34. More specifically, there is not sufficient evidence in the record to support a conclusion that it would have been obvious to modify any of the devices described in the prior art, including that of O’Mahoney, to include a first trimming section in a plurality of trimming sections, which include a contiguous [sic: “continuous”] fluid-impervious outer wall section and which do not include the one or more structure supports. With respect to the O’Mahoney device, it’s opening 222 is critical to the design and function of its device, and the location of opening 222 is the only portion of that device which might be a ‘trimming section;’ removal of opening 222, to create a fluid-impervious outer wall section as claimed, would thus render the device not functional for its intended purpose, and thus such a modification would not have been obvious.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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 on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783