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 .
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 04/15/2024, 07/17/2024, and 12/06/2025, have been considered by the examiner.
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 14 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. The claim, which depends directly from claim 13, does not recite any additional limitations which are not already recited in claim 13. 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 § 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.
Claims 1-8, 12-18, and 20, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Macoviak et al. (USPN 6,508,777).
[Claims 1, 2, and 12] Macoviak teaches a method of extracorporeal blood oxygenation (figure 38; column 37, lines 53-64), comprising:
inserting a drainage cannula (figure 38, items 3899/3897) into a first site of a vasculature of a patient (figure 38; column 38, lines 25-31);
inserting an infusion cannula (figure 38, items 3802/3820) into a second site of the vasculature of the patient (figure 38; column 37, lines 65-67; column 38, lines 1-24), the infusion cannula comprising:
a main tube (figure 38, item 3820) having a proximal end, a distal end, and a tubular sidewall extending between the proximal end and the distal end (figure 38; column 37, lines 65-67; column 38, lines 1-24); and
an expandable balloon (figures 36/38; item 3608 or 3808) (the examiner notes figures 36-38 are taught as the same embodiment; column 36, lines 24-28) disposed on a portion of the tubular sidewall (figure 37), wherein the expandable balloon (figures 36/38; item 3608 or 3808) is configured to expand radially outward from the tubular sidewall to an expanded configuration (as best shown in figures 36 and 37);
expanding the expandable balloon (figures 36/38; item 3608 or 3808) radially outward from the tubular sidewall to engage an inner wall of the vasculature of the patient (figure 38; column 37, lines 65-67; column 38, lines 1-12);
wherein when the expandable balloon (figures 36/38; item 3608 or 3808) is engaged with the inner wall of the patient’s vasculature in the expanded configuration (figure 38), blood within the patient’s vasculature is permitted to flow from proximal of the expandable balloon (figures 36/38; item 3608 or 3808) to distal of the expandable balloon (figures 36/38; item 3608 or 3808) (via conduit 3612/3812; column 38, lines 46-51);
draining blood through the drainage cannula (figure 38, items 3899/3897) to a blood pump (figure 38, item 3857; column 38, lines 25-46);
pumping, via the blood pump (figure 38, item 3857), drained blood through an oxygenator (figure 38; “oxygenator”) to oxygenate the drained blood (figure 38; column 38, lines 25-46); and
returning oxygenated blood to the vasculature of the patient through the infusion cannula (figure 38, items 3802/3820) (figure 38; column 38, lines 25-46).
[Claims 3, 13, and 14] Macoviak teaches the limitations of claims 1 and 12, upon which claims 3, 13, and 14, depend. In addition, Macoviak discloses when the expandable balloon (figures 36/38; item 3608 or 3808) is engaged with the inner wall of the patient’s vasculature (figure 38), blood within the patient’s vasculature is permitted to flow around (the examiner notes flowing through the center of the balloon meets the limitation of “around”) the expandable balloon (figures 36/38; item 3608 or 3808) from proximal of the expandable balloon (figures 36/38; item 3608 or 3808) to distal of the expandable balloon (figures 36/38; item 3608 or 3808) externally of the main tube (figure 38, item 3820) (via conduit 3612/3812; column 38, lines 46-51).
[Claims 4, 15, and 16] Macoviak teaches the limitations of claims 1 and 12, upon which claims 4, 15, and 16, depend. Macoviak further discloses the infusion cannula (figure 38, items 3802/3820) comprises an aperture (figures 36-38, items 3626/3826), proximate the expandable balloon (figures 36/38; item 3608 or 3808) (as shown in figures 36-38), extending through the tubular sidewall at a location disposed between the proximal end of the tubular sidewall and the distal end of the tubular sidewall (figures 36-38; column 36, lines 63-67; column 37, line 1).
[Claim 17] Macoviak teaches the limitations of claim 16, upon which claim 17 depends. Macoviak also teaches expanding the expandable balloon (figures 36/38; item 3608 or 3808) radially outward from the tubular sidewall to engage the inner wall of the vasculature of the patient increases a spacing between the aperture (figures 36-38, items 3626/3826) and the inner wall of the vasculature of the patient (figures 36-38) (the examiner notes that inflation of the balloon would increase spacing from the wall of the vasculature which is diametrically opposed from the apertures).
[Claims 5 and 18] Macoviak teaches the limitations of claims 4 and 17, upon which claims 5 and 18 depend. In addition, Macoviak discloses when the expandable balloon (figures 36/38; item 3608 or 3808) is engaged with the inner wall of the patient’s vasculature in the expanded configuration (figure 38), infused blood is permitted to flow from within the infusion cannula (figure 38, items 3802/3820) outward through the aperture (figures 36-38, items 3626/3826) (figure 38; column 38, lines 19-24).
[Claims 6-8] Macoviak teaches the limitations of claim 1, upon which claims 6-8 depend. Macoviak further teaches the infusion cannula (figure 38, items 3802/3820) comprises an inflator tube (lumen) (figure 38, item 3888) in fluid communication with the expandable balloon (figures 36/38; item 3608 or 3808) and extending along at least a portion of the tubular sidewall (figure 38; column 38, lines 7-12); wherein the inflator tube (figure 38, item 3888) is configured to supply liquid or gas to the expandable balloon (figures 36/38; item 3608 or 3808) to cause expansion of the expandable balloon (figures 36/38; item 3608 or 3808) (figure 38; column 38, lines 7-12), wherein the liquid or gas is at least one of air, helium, or saline (although teaching “a syringe or balloon inflation device” (column 37, lines 29-33) the examiner notes the “liquid or gas” is only functionally recited and is not a positively recited claim method step; as such, the structure taught by Macoviak is fully capable of delivering “at least one of air, helium, or saline).
[Claim 20] Macoviak teaches the limitations of claim 1, upon which claim 20 depends. Macoviak also discloses an entirety of the expandable balloon (figures 36/38; item 3608 or 3808) extends only partially around a circumference of the tubular sidewall (figure 37; the balloon is not in full contact with the entire circumference of the tubular sidewall).
Claim Rejections - 35 USC § 103
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 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.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Macoviak et al. (USPN 6,508,777), in view of Legum et al. (PGPub 2020/0360670).
[Claims 9-11] Macoviak teaches the limitations of claim 1, upon which claims 9-11 depend. Macoviak does not specifically disclose an absorbent material at least partially filling the expandable balloon.
However, Legum teaches a catheter system utilizing an expandable balloon (“inflatable plug”) (figure 10b, item 54) which comprises an absorbent material (salt) (sodium salt-graft-poly(ethylene oxide)) (paragraph [0160]) at least partially filling the expandable balloon, wherein the absorbent material is configured to absorb water from an environment surrounding the expandable balloon (semipermeable membrane) (“the plug is made from a hydrogel or expandable material that grows when exposed to a hydrating environment. In some embodiments, the expandable material is a water swellable polymer or a superexpandable polymer”) (paragraph [0160]) to cause expansion of the expandable balloon (paragraphs [0154], [0160], [0161]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the expandable balloon taught by Macoviak, with the use of an absorbent material for balloon expansion, as taught by Legum, in order to provide an alternative, yet equivalent means, for expanding the balloon radially outward from the sidewall of the cannula. Furthermore, such a feature would allow for an automated means of expansion, as would occur upon exposure with the vasculature.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 12-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,931,496. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited patent claims. For example, all of the elements of claim 1 of the instant application can be found in claim 17 of the patent. The difference between claim 1 of the instant application and claim 17 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of claim 17 of the patent is in effect a “species” of the "generic” invention of claim 1 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the instant application is anticipated by claim 17 of the patent, it is not patentably distinct from claim 17 of the patent.
Allowable Subject Matter
Claim 19 is 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 07/19/2026
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