FINAL REJECTION
Notice of Pre-AIA or AIA Status
The present reissue application 18/745,670 (“the ‘670 application”) of US Pat. No. 11,413,049 (“the ‘049 patent”), filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Reissue Applications
Applicant is reminded of the continuing obligation under 37 CFR § 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which US Pat. No. 8,900,322 (“the ‘049 patent”) is or was involved. These proceedings would include interferences, reissues, reexaminations and litigations.
Applicant is further reminded of the continuing obligation under 37 CFR § 1.56 to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Drawings
The amended drawings filed 06/08/2026 comply with 37 CFR 1.173(b)(3) and have been entered.
Response to Amendment
The amendment to the claims filed on 06/08/2026 is objected to as not complying with the requirements of 37 CFR 1.173(b)(2) and (d)(1)&(2) because each change relative to the ‘049 patent has not been properly marked. 37 CFR 1.173(b)(2) and (d)(1)&(2) state:
(b) Making amendments in a reissue application. An amendment in a reissue application is made either by physically incorporating the changes into the specification when the application is filed, or by a separate amendment paper. If amendment is made by incorporation, markings pursuant to paragraph (d) of this section must be used. If amendment is made by an amendment paper, the paper must direct that specified changes be made, as follows:
(2) Claims. An amendment paper must include the entire text of each claim being changed by such amendment paper and of each claim being added by such amendment paper. For any claim changed by the amendment paper, a parenthetical expression “amended,” “twice amended,” etc., should follow the claim number. Each changed patent claim and each added claim must include markings pursuant to paragraph (d) of this section, except that a patent claim or added claim should be canceled by a statement canceling the claim without presentation of the text of the claim.
(d) Changes shown by markings. Any changes relative to the patent being reissued which are made to the specification, including the claims, upon filing, or by an amendment paper in the reissue application, must include the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets; and
(2) The matter to be added by reissue must be underlined, except for amendments submitted on compact discs (§§ 1.96 and 1.821(c)). Matter added by reissue on compact discs must be preceded with “<U>” and end with “</U>” to properly identify the material being added.
Claim 8 presented in the amendment filed 06/08/2028 includes the use of double brackets; however, in reissue prosecution only single brackets are used to indicated deleted claim language from an original patent claim. Claim 15 includes brackets to indicate omitted claim language; however, claim 15 is new with respect to the original patent and therefore should only be underlined in its entirety with deleted claim language removed without any markings.
These corrections should be submitted with the next correspondence.
Reissue Oath/Declaration
The previous rejection of claims 1-26 as being based upon a defective reissue declaration under 35 USC § 251 has been withdrawn in light of the new oath filed 06/08/2026 and applicant’s remarks.
Claim Interpretation
Please see previous non-final rejection for claim interpretation of a flow restriction member versus a valve.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The previous rejection of claims 10-11 and 17 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement has been withdrawn in light of the amendment to the claims filed 06/08/2026.
Claim 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 17 has been amended to now recite “wherein the dispending embolic material out of the elongate body is through the distal port of the first lumen when the expandable member is not fully expanded.” The ‘049 patent specification clearly establishes at col. 4, ll. 60-63 that when the expandable member has not been inflated (shown in Figs. 2A-2B), the flow restriction member is not actuated and fluid flow occurs out the distal end. The ‘049 patent specification also clearly established at col. 4, ll. 63-66 that when the expandable member has been expanded (as shown in Figs. 3A-3B), the flow restriction member is actuated and fluid flow occurs out the proximal port. The ‘049 patent specification is silent as to the condition of the flow restriction member with respect to the expandable member in between no inflation (as shown in Figs. 2A-2B) and expansion (as shown in Figs. 3A-3B). By using the negative claim language the claim limitation now imparts a condition of the expandable member that is not disclosed in the ‘049 patent specification, i.e., somewhere between the uninflated condition of Figs. 2A-2B and the expanded condition of Figs. 3A-3B which is neither described or shown.
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 20 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. Claim 20 recites, “the proximal port is disposed proximal of the expandable member such that the proximal port is in communication with blood flow from the proximal direction when the expandable member is expanded” which does not further limit the recitation of “the proximal port is disposed proximal of the expandable member such that the proximal port is in communication with blood flow from a proximal direction when the expandable member is expanded” already claimed in claim 18 from which claim 20 depends. 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.
Original Patent
The previous rejection of claim 17 under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent has been withdrawn in light of the amendment to the claims filed 06/08/2026.
Recapture
The previous rejection of claims 15-17 under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based has been withdrawn in light of applicant’s remarks filed 06/08/2026.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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(s) 1, 2, 6, 18 and 22 is/are rejected under 35 U.S.C. 103 as obvious over US Pub. No. 2015/0359998 to Carmel et al. (“Carmel”) in view of US Pat. No. 6,440,097 to Kupiecki (“Kupiecki”) in further view of US Pat. No. 6,231,543 to Hegde et al (“Hedge”).
Regarding claims 1 and 18, Carmel teaches a catheter that is disclosed as being an infusion catheter for both fluid transfer and dispersion as well as guidewire passage; therefore, the catheter is capable of infusing an embolic material and functioning as an embolization catheter, comprising: an elongate body (1100), comprising: a first lumen (1114); a second lumen (1124); and a proximal port (1116) in fluid communication with the first lumen (see para. [0044] stating “Infusion lumen 1114 is further opened with a lateral infusion opening 1116”); an expandable member (1200) in fluid communication with the second lumen (see para. [0045] stating “An inflation lumen 1124, sealed to infusion lumen 1114, extends between a proximal inflation opening 1122, at shaft's 1100 proximal end, and a distal inflation port 1126, opened to an interior of inflatable member 1200”); and a flow restriction member / valve (2320/3320) configured to occlude a distal portion of the first lumen (see para. [0058] stating “Distally to lateral infusion opening 2116 in infusion lumen 2114 there is provided a proximal valving mechanism 2300 comprising a septum seal 2320, optionally made of a highly elastic and/or a viscoelastic material, allowing distal sealing either if guide wire 2310 is absent (not shown) or passes therethrough (as shown).” and para. [0059} stating “Distally to lateral infusion opening 3116 in infusion lumen 3114 there is provided a distal valving mechanism 3300 comprising a normally closed seal 3320 adapted to maintain sealing therethrough to infusion fluids either if guide wire 3310 passes therethrough or is absent.”), wherein the flow restriction member is disposed distal of the proximal port (see Figs. 2B and 3A), wherein the proximal port is disposed proximal of the expandable member (see Figs. 2B and 3A). Regarding the functional language of “such that the proximal port is in communication with blood flow from a proximal direction when the expandable member is expanded, and wherein embolic material passes out of the elongate body through the proximal port when the flow restriction member occludes the first lumen;” Carmel is capable of achieving these functions since Carmel is disclosed for use within a blood vessel that will necessarily expose the proximal port in communication with blood flow from a proximal direction when the expandable member is expanded. Furthermore, Carmel discloses at para. [0009] that “A method for operating the catheter includes at least one of the following steps (not necessarily in same order): [0010] 1. inserting a guidewire in a luminal vessel; [0011] 2. delivering the catheter in the luminal vessel over the guidewire to a chosen target; [0012] 3. inflating the inflatable member to occlude the luminal vessel at the target; and [0013] 4. infusing a fluid through the lateral infusion opening proximal to the inflatable member such that no fluid passes beyond the inflatable member.” It is also noted that the expandable member (1200) is concentric around the elongate member (1100) and therefore will inherently center the distal end of the catheter in the lumen of the blood vessel. See Fig. 3A.
In the alternative, that Carmel is found to not teach wherein embolic material passes out of the elongate body through the proximal port when the flow restriction member occludes the first lumen, Kupiecki teaches such a balloon catheter with delivery side hole. Kupiecki discloses at col. 13, ll. 39-48, “During delivery of the vaso-occlusive agent, the inflated balloon (162) seals the vessel (190) against flow distally of the delivery site. The tendency for the vaso-occlusive agent (202) to migrate distal to the target site is therefore eliminated or significantly reduced. Rather, the vaso-occlusive agent (202) has an increased propensity to enter the target vessel proximally of the balloon, shown here at sidebranch (195), and forms the desired artificial vaso-occlusion shown at (197).”
At the time of filing, it would have been obvious to incorporate the teaching of introducing embolic material through the infusion lumen and out the proximal port when the flow restriction member occludes the first lumen as taught by Kupiecki into the invention of Carmel since both devices are analogous in the art of infusion catheters; therefore, a combination is proper. Additionally, it would have been desirable in light of the fact that both catheters have similar structure and administer infusion flow out of the same region of the catheter. The motivation for the incorporation would have included a desire to expand the applications of the catheter of Carmel.
Carmel with or without Kupiecki meet(s) the claim limitations as described above but fails to include that inflation of the expandable member selectively closes the flow restriction member to occlude the first lumen. However, Hedge discloses a single lumen balloon catheter that teaches a selectively closeable flow restriction member upon inflation of an expandable member. Hedge teaches that the flow restriction member (40) is activated upon inflation of balloon member 14. See Fig. 3. This activation is selective and simultaneous.
At the time of filing, it would have been obvious to substitute the flow restriction member of Carmel with the flow restriction member (40 as taught above by Hedge. Both devices are analogous in the art of balloon catheters; therefore, a combination is proper. Additionally, one would have been motivated to make the substitutions in order to provide a restriction member that allows the guidewire to freely pass through the lumen; thereby providing additionally control to the medical technician using the device of Carmel.
Regarding claim 2, Carmel teaches that the expandable member is a balloon (1200).
Regarding claim 6, Carmel discloses that the balloon occludes a vessel. Carmel discloses at para. [0009] that “A method for operating the catheter includes at least one of the following steps (not necessarily in same order): [0010] 1. inserting a guidewire in a luminal vessel; [0011] 2. delivering the catheter in the luminal vessel over the guidewire to a chosen target; [0012] 3. inflating the inflatable member to occlude the luminal vessel at the target; and [0013] 4. infusing a fluid through the lateral infusion opening proximal to the inflatable member such that no fluid passes beyond the inflatable member.”
Regarding claim 22, Carmel shows a taper (3118) at the distal end of the elongate body. See Fig. 3A.
The previous rejection of claim(s) 3-5, 19 and 21 under 35 U.S.C. 103 as being unpatentable over Carmel with or without Kupiecki in further view of US Pat. No. 6,231,543 to Hegde et al (“Hedge”) has been withdrawn in light of the cancellation of the claims.
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carmel with or without Kupiecki in view of Hedge and in further view of US Pub. No. 2014/0364835 to Allen et al (“Allen”).
Carmel with or without Kupiecki in view of Hedge meets the claim limitations with respect to claim 18 above but fails to specifically disclose that the elongate body has a braid or coil.
However, braid and coil reinforcements are well known in the catheter art as evidenced by Allen. See para. [0135].
At the time of the invention, it would have been obvious to incorporate a braid or coil into the elongate body of Carmel with or without Kupiecki in order to enhance the rigidity or maneuverability of the catheter of Carmel.
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carmel with or without Kupiecki in view of Hedge and in further view of US Pub. No. 2013/0096604 to Hanson et al (“Hanson”).
Carmel with or without Kupiecki meets the claim limitations with respect to claim 18 above but fails to specifically disclose that the first lumen has a lubricious PTFE liner.
However, PTFE liners and coatings are well known in the catheter art to allow easy insertion of other instrument, including guidewires, into an introducer/larger catheter. See Hanson para. [0038].
At the time of the invention, it would have been obvious to incorporate a PTFE liner as taught by Hanson into the first lumen of the elongate body of Carmel with or without Kupiecki in order to enhance the ease of insertion of the guidewire of Carmel.
Claim(s) 7-8 and 12-16 is/are rejected under 35 U.S.C. 103 as obvious over Carmel in view of Kupiecki.
Regarding claims 7-8 and 12-16, Carmel teaches a catheter that is disclosed as being an infusion catheter for both fluid transfer and dispersion as well as guidewire passage; therefore, the catheter is capable of infusing an embolic material and functioning as an embolization catheter, comprising: an elongate body (1100), comprising: a first lumen (1114); a second lumen (1124); and a proximal port (1116) in fluid communication with the first lumen (see para. [0044] stating “Infusion lumen 1114 is further opened with a lateral infusion opening 1116”); an expandable member (1200) in fluid communication with the second lumen (see para. [0045] stating “An inflation lumen 1124, sealed to infusion lumen 1114, extends between a proximal inflation opening 1122, at shaft's 1100 proximal end, and a distal inflation port 1126, opened to an interior of inflatable member 1200”); a guidewire (2310/3310); and a flow restriction member / valve (2320/3320) configured to occlude a distal portion of the first lumen (see para. [0058] stating “Distally to lateral infusion opening 2116 in infusion lumen 2114 there is provided a proximal valving mechanism 2300 comprising a septum seal 2320, optionally made of a highly elastic and/or a viscoelastic material, allowing distal sealing either if guide wire 2310 is absent (not shown) or passes therethrough (as shown).” and para. [0059} stating “Distally to lateral infusion opening 3116 in infusion lumen 3114 there is provided a distal valving mechanism 3300 comprising a normally closed seal 3320 adapted to maintain sealing therethrough to infusion fluids either if guide wire 3310 passes therethrough or is absent.”), wherein the flow restriction member is disposed distal of the proximal port (see Figs. 2B and 3A), wherein the proximal port is disposed proximal of the expandable member (see Figs. 2B and 3A). Regarding the functional language of “such that the proximal port is in communication with blood flow from a proximal direction when the expandable member is expanded, and wherein embolic material passes out of the elongate body through the proximal port when the flow restriction member occludes the first lumen;” Carmel is capable of achieving these functions since Carmel is disclosed for use within a blood vessel that will necessarily expose the proximal port in communication with blood flow from a proximal direction when the expandable member is expanded. Furthermore, Carmel discloses at para. [0009] that “A method for operating the catheter includes at least one of the following steps (not necessarily in same order): [0010] 1. inserting a guidewire in a luminal vessel; [0011] 2. delivering the catheter in the luminal vessel over the guidewire to a chosen target; [0012] 3. inflating the inflatable member to occlude the luminal vessel at the target; and [0013] 4. infusing a fluid through the lateral infusion opening proximal to the inflatable member such that no fluid passes beyond the inflatable member.”
Carmel does not teach embolic material or the embolic material passes out of the elongate body through the proximal port when the flow restriction member occludes the first lumen. Kupiecki teaches such a balloon catheter with delivery side hole. Kupiecki discloses at col. 13, ll. 39-48, “During delivery of the vaso-occlusive agent, the inflated balloon (162) seals the vessel (190) against flow distally of the delivery site. The tendency for the vaso-occlusive agent (202) to migrate distal to the target site is therefore eliminated or significantly reduced. Rather, the vaso-occlusive agent (202) has an increased propensity to enter the target vessel proximally of the balloon, shown here at sidebranch (195), and forms the desired artificial vaso-occlusion shown at (197).”
At the time of filing, it would have been obvious to incorporate the teaching of embolic material and introducing embolic material through the infusion lumen and out the proximal port when the flow restriction member occludes the first lumen as taught by Kupiecki into the invention of Carmel since both devices are analogous in the art of infusion catheters; therefore, a combination is proper. Additionally, it would have been desirable in light of the fact that both catheters have similar structure and administer infusion flow out of the same region of the catheter. The motivation for the incorporation would have included a desire to expand the applications of the catheter of Carmel.
Carmel in view of Kupiecki meet(s) the claim limitations as described above but fails to include that inflation of the expandable member selectively closes the flow restriction member to occlude the first lumen. However, Hedge discloses a single lumen balloon catheter that teaches a selectively closeable flow restriction member upon inflation of an expandable member. Hedge teaches that the flow restriction member (40) is activated upon inflation of balloon member 14. See Fig. 3. This activation is selective and simultaneous.
At the time of filing, it would have been obvious to substitute the flow restriction member of Carmel with the flow restriction member (40 as taught above by Hedge. Both devices are analogous in the art of balloon catheters; therefore, a combination is proper. Additionally, one would have been motivated to make the substitutions in order to provide a restriction member that allows the guidewire to freely pass through the lumen; thereby providing additionally control to the medical technician using the device of Carmel.
The previous rejection of claim(s) 9-11 under 35 U.S.C. 103 as being unpatentable over Carmel in view of Kupiecki and in further view of Hegde has been withdrawn in light of the cancellation of the claims.
Response to Arguments
Applicant's arguments filed 06/08/2026 have been fully considered but they are not persuasive.
Regarding applicant’s arguments with respect to claims 1-2, 6, 18 and 22 and Hegde; Hedge is not being relied upon in the rejection to teach the first and second lumens. Rather, Hegde is only being relied upon to teach a flow restriction member that is selectively closable.
Regarding independent claims 13 and 15, the rejection of the claims above now relied upon Hegde to teach the a flow restriction member that is selectively closable. Applicant’s remarks regarding claims 13 and 15 with respect to Hegde do not specifically argue the combination of reference but rather the references individually.
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 CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/Reexamination Specialist, Art Unit 3993
Conferees:
/WILLIAM V GILBERT/ Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/SPRS, Art Unit 3993
Prosecution Insights