DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This action is in response to the amendment filed on 5/14/2026. In the amendment, claims 1, 3, and 10 have been amended. The amendments have corrected all minor informalities previously objected to in the Non-Final Rejection mailed on 2/17/2026.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-5, 7, 8, 10, 12, and 13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by St. Goar et al. (US Pat. No. 6,090,096).
Regarding claim 1, St. Goar et al. disclose an angioplasty device 20, 80 (Figs. 1, 2, 8, 9) configured for local widening of a narrowed segment of an internal lumen of a blood vessel including atheromatous deposits on walls of the blood vessel, the angioplasty device comprising a flexible tubular body 22, 82 (Figs. 1 & 8) extending along a longitudinal axis between a proximal end and a distal end, wherein the flexible tubular body 22, 82 comprises a proximal part that includes the proximal end, and a distal part that includes the distal end, the tubular body 22, 82 further comprising: an inflatable angioplasty balloon 28/84,110 arranged radially about the tubular body in the distal part, wherein the angioplasty balloon 28/84,110 is such that an inflation of the angioplasty balloon in the narrowed segment of the blood vessel causes the internal lumen of the blood vessel to widen, the atheromatous deposits to compress against the walls of the blood vessel and a stenosis to be durably rectified; a first internal conduit 44, 98 (Figs. 1 & 8) extending parallel to the longitudinal axis at least in the distal part, to enable an insertion of a guidewire having a predetermined external diameter into the first conduit and a sliding of the tubular body along a guide wire (conduit 44, 98 extends from a proximal conduit opening 46, 100 to a distal conduit opening 48, 102 which would allow for a guidewire to extend therethrough and allow the tubular body/catheter to be slide thereover; column 9, lines 63-67) ; a leaktight second internal conduit 50, 112 (Figs. 1, 2, 8, 9) extending parallel to the longitudinal axis and opening out at the proximal end 52 and opening out into the balloon 28, 110 (via port 54, 116) in such a way as to permit an injection of a fluid into the balloon; a third internal conduit 30, 86 (Figs. 1, 2, 8, 9) opening out at the proximal end and into one or more injection orifices 34, 90 (Figs. 1, 2, 8, 9) situated in the distal part, at least one of which is less than 5 cm away from the angioplasty balloon (column 6, lines 58-60), wherein the third conduit has a cross-section dimension based on an amount and a viscosity of a contrast agent to be injected therethrough and into a patient's blood (fluid intended to be delivered therethrough - column6, lines 63-64); a fourth internal conduit 38, 92 (Figs. 1, 2, 8, 9) for injecting medicaments or substances into the patient’s blood.
Regarding claim 2, St. Goar et al. further disclose wherein the first 44(98), second 50(112) and third conduits 30(86) are leaktight with respect to one another (Figs. 2 & 9).
Regarding claim 3, St. Goar et al. further disclose wherein the injection orifices 34 (90) (Figs. 1 & 8) are distributed radially about the tubular body 22,82 (on a radial location).
Regarding claim 4, St. Goar et al. further disclose wherein the one or more injection orifices 90 (Fig. 8) include at least one downstream injection orifice situated between the angioplasty balloon 110 and the distal end (Fig. 8).
Regarding claim 5, St. Goar et al. further disclose wherein the one or more injection orifices 34 (Fig. 1) include at least one upstream injection orifice situated between the proximal part and the angioplasty balloon 28 (Fig. 1).
Regarding claim 7, St. Goar et al. further disclose wherein the first 44(98), second 50(112) and third conduits 30(86) are arranged side by side (Figs. 2 & 9).
Regarding claim 8, St. Goar et al. further disclose wherein the first conduit 44 (98) has a circular cross section (at the proximal end where the ports link up to the tubular body 22 (82) and has a diameter substantially equal to that of the guide wire 68 (column 9, lines 63-67).
Regarding claim 10, St. Goar et al. further disclose wherein the first conduit 44 (98) opens out at the proximal end and at the distal end (conduit 44, 98 extends from a proximal conduit opening 46, 100 to a distal conduit opening 48, 102; column 9, lines 63-67).
Regarding claim 12, St. Goar et al. further disclose wherein each of the one or more injection orifices 34, 90 (Figs. 1, 2, 8, 9) is located less than 5 cm away from the angioplasty balloon (column 6, lines 58-60)
Regarding claim 13, St. Goar et al. further disclose further comprising a guide wire 68 (column 9, lines 63-67) of said predetermined external diameter.
Allowable Subject Matter
Claim 15 is allowed.
The following is an examiner’s statement of reasons for allowance: the following is a list of the most pertinent prior art with respect to the claims: US Pat. Nos. 6,723,070; 6,322,577*; 6,090,096*; 5,637,086*; 4,909,258*; 4,777,951*; 4,763,654*. (*IDS reference) The closest prior art to claim 15 is found to be US Pat. No. 6,322,577 which has a multipurpose conduit 16 and inflation conduit 13 as claimed in claim 15 (Fig. 1), but fails to further disclose, teach, or suggest an additional conduit for injecting medicaments or substances into a patient’s blood.
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.”
Response to Arguments
Applicant's arguments filed 5/14/2026 have been fully considered but they are not persuasive.
Applicant makes the following argument: “As is known to those of skill in the art, angioplasty balloons are configured to withstand a high inflation pressure without unduly increasing volume to perform the function assigned to it. More specifically, the angioplasty balloon is specifically configured to inflate while keeping a cylindrical shape and a maximum diameter that is not greater than the inner diameter of the blood vessel, all while being filled with a fluid at a pressure sufficient to compress atheromatous deposits against the walls of the blood vessel. Angioplasty devices are therefore high-pressure, non-compliant or semi-compliant tubes.”
Examiner argues that none of these structural specificities (underlined portions above as underlined for emphasis by examiner) are disclosed in the claims to differentiate the claimed ‘balloon’ from the prior art balloon. Claiming a ‘balloon’ by classifying it as an ‘angioplasty balloon’ and adding function of the balloon provides zero structural evidence that the balloon being claimed is any different than the balloon disclosed by the prior art. Based upon the minimal structure provided in the claim, it is considered that any balloon could perform the function in the right environment and control provided by a user. There is no discussion of the specific ‘structural requirements’ argued by applicant in applicant’s specification to further distinguish that the disclosed balloon has these structural specificities to define it over an occlusion balloon.
To reiterate, examiner finds no discussion of the following argued structural requirements of the ‘angioplasty balloon’ in applicant’s specification:
non-compliant or semi-compliant tube
the angioplasty balloon is specifically configured to inflate while keeping a cylindrical shape and a maximum diameter that is not greater than the inner diameter of the blood vessel
configured to withstand a high inflation pressure without unduly increasing volume to perform the function assigned to it
It is further argued that the prior art’s balloon is used to occlude blood flow, not to widen a narrowed vessel segment or compress atheromatous deposits. It is reminded that the intended use of a structure does not define a structure over an equivalent structure as claimed. However, if the prior art’s balloon were introduced to a narrowed vessel segment and inflated to a diameter greater than the narrowed segment, it would provide pressure to the segment to widen the area. The same application applies to the compression of atheromatous deposits. If the occlusion balloon were to enter a segment with deposits, and were to be inflated to a diameter greater than the segment with the deposits, it would push against the deposits and would compress them. If the occlusion balloon is capable of anchoring a catheter and stopping blood flow, it is considered that it possesses some sort of outward pressure that is strong enough to keep it in position against blood flow acting against it which could be capable of widening a vessel having an internal diameter less than the maximum inflated diameter of the balloon.
Conclusion
THIS ACTION IS MADE FINAL. 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 ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 August 2, 2026
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