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.
Maintenance Fees
Review of the file indicates that applicant’s window for the 3.5 year maintenance fee for the ‘049 patent without surcharge opened 16 August 2025 and will close 16 February 2026. Payment of the maintenance fee with surcharge begins 17 February 2026 and will close 16 August 2026. If the last day for paying a maintenance fee with or without surcharge falls on a Saturday, Sunday, or a federal holiday within the District of Columbia, the fee plus surcharge if applicable may be paid on the next succeeding day which is not a Saturday, Sunday or federal holiday. Applicant is encouraged to ensure all payments are current and proper. See 37 CFR §1.362(d) and (e).
Drawings
The amended drawings are objected to under 37 CFR 1.173(b)(3). The drawing sheet must be labeled as “Replacement Sheet” and Fig. 2A must identified as “Amended” under the figure label.
Corrected drawing sheets in compliance with 37 CFR 1.173 are required in reply to the Office action. According to 37 CFR 1.173 (b)(3),
Drawings. One or more patent drawings shall be amended in the following manner: Any changes to a patent drawing must be submitted as a replacement sheet of drawings which shall be an attachment to the amendment document. Any replacement sheet of drawings must be in compliance with § 1.84 and shall include all of the figures appearing on the original version of the sheet, even if only one figure is amended. Amended figures must be identified as "Amended," and any added figure must be identified as "New." In the event that a figure is canceled, the figure must be surrounded by brackets and identified as "Canceled." All changes to the drawing(s) shall be explained, in detail, beginning on a separate sheet accompanying the papers including the amendment to the drawings.
Response to Amendment
The amendment to the claims filed on 06/17/2024 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 1 presented in the amendment filed 06/17/2024 does not include markings with respect to the original claims of the ‘049 patent. Specifically, claim 1 should be marked as (Amended) and the original claim language of “wherein the proximal port is in fluid communication with the first lumen” should be bracketed as now omitted with respect to original claim 1. Alternatively, if the omission of the claim language is in error, claim 1 should remain identified as (Original) and “wherein the proximal port is in fluid communication with the first lumen” should be reinserted into claim 1 without any marks since the limitation is original to the patented claim.
These corrections should be submitted with the next correspondence.
Reissue Oath/Declaration
The reissue oath/declaration filed on 10/30/2024 is defective (see 37 CFR § 1.175 and 1.4(d)(2) and MPEP § 1414) because of the following:
-the document is titled Declaration for Patent Application which is incorrect since this proceeding is a reissue application; and
-the signatures of the inventors are improper.
A new Reissue Application Declaration by the Inventor should be submitted. It is recommended that applicant use form PTO/AIA /06. Additionally, each signature should include forward slashes before and after the S-signature.
Therefore, claims 1-26 are rejected as being based upon a defective reissue declaration under 35 USC § 251 as set forth above. See 37 CFR § 1.175.
Improper Error
Additionally, the reissue oath/declaration filed with this application is defective (see 37 CFR § 1.175 and MPEP § 1414) because of the following: the basis for the reissue application as per the error statement filed on 10/30/2024 is an error directed to a subject matter surrendering limitation. See Recapture Rejection below.
As per MPEP 1412.02,
A reissue will not be granted to "recapture" claimed subject matter which was surrendered in an application to obtain the original patent. In re McDonald, 43 F.4th 1340, 1345, 2022 USPQ2d 745 (Fed. Cir. 2022); Greenliant Systems, Inc. v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Youman, 679 F.3d 1335, 102 USPQ2d 1862 (Fed. Cir. 2012); In re Mostafazadeh, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984); In re Wadlinger, 496 F.2d 1200, 181 USPQ 826 (CCPA 1974); In re Richman, 409 F.2d 269, 276, 161 USPQ 359, 363-364 (CCPA 1969); In re Willingham, 282 F.2d 353, 127 USPQ 211 (CCPA 1960).
See recapture rejection below. Therefore, claims 1-26 are rejected as being based upon a defective reissue declaration under 35 USC § 251 as set forth above. See 37 CFR § 1.175.
Applicant must provide a new signed Reissue Oath/Declaration with new error statement directed to a claim limitation that was not relied upon for allowance of the ‘670 application.
Failure to File a Continuing Application
As per MPEP 1412.01,
Where a restriction (or an election of species) requirement was made in an application and applicant permitted the elected invention to issue as a patent without filing a continuing application on the non-elected invention(s) or on non-claimed subject matter distinct from the elected invention, the non-elected invention(s) and non-claimed, distinct subject matter cannot be recovered by filing a reissue application. A reissue applicant’s failure to timely file a continuing application is not considered to be an error causing a patent granted on the elected claims to be partially inoperative by reason of claiming less than the applicant had a right to claim. Accordingly, this is not correctable by reissue of the original patent under 35 U.S.C. 251. See In re Watkinson, 900 F.2d 230, 14 USPQ2d 1407 (Fed. Cir. 1990); In re Weiler, 790 F.2d 1576, 229 USPQ 673 (Fed. Cir. 1986); In re Orita, 550 F.2d 1277, 1280, 193 USPQ 145, 148 (CCPA 1977); see also In re Mead, 581 F.2d 251, 198 USPQ 412 (CCPA 1978).
In this case, applicant is reminded that a requirement for an election of species was made in the ‘670 application which was mailed on 04/28/2021. Therefore, applicant is barred from pursuing another distinct invention from that which issued in the ‘049 patent.
Claim Interpretation
It is noted that the claims include the terms:
a flow restriction member (claims 1-6 and 18-26); and
a valve (7-17).
It is noted that the ‘049 patent consistently refers to the embodiment of Figs. 2A-3B as having a flow restriction member that is selectively actuatable. See col. 4, l. 44 through col. 5, l. 25. Additionally, this flow restriction member embodiment allows for the flow of embolic material 1) out the distal end of the catheter when the flow restriction member is not actuated or 2) out the proximal port when the flow restriction member is actuated by expansion of the expandible member. See col. 4, ll. 57-66.
Conversely, the ‘049 patent specification consistently refers to the embodiment of Figs. 4A-5B as having a valve being a one-way or check valve that is not disclosed as selectively actuatable and seals the lumen when a higher pressure occurs in the lumen and is open when a lower pressure is within the lumen. This embodiment is not configured to allow for the flow of embolic material out the distal end of the catheter since flow through the lumen will cause an increase of fluid pressure in the lumen and cause the valve to seal.
It is also noted that the ‘049 patent specification does use the term flow restriction member as a generic, genus, term to identify either the flow restriction member of the first embodiment or the valve of the second embodiment. However, the term valve is used throughout the specification as a species term and does not encompass the flow restriction member of the first embodiment.
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.
Claims 10-11 are 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.
Claims 10 and 11 depend from claim 7 which recites a valve member. The valve member is disclosed as being part of the second embodiment having a one-way or check valve. However, claim 10 recites that the valve member may be selectively closed. The valve is not disclosed as being selectively closed but rather is automatically closed if fluid pressure rises within the lumen. Conversely, the flow restriction member of the first embodiment can be selectively closed by either actuating the expandible member or not. Therefore, claims 10-11 are a mixing of embodiments that is not supported by the ‘049 patent specification.
Claim 17 depend from claim 15 which recites a valve member. The valve member is disclosed as being part of the second embodiment having a one-way or check valve. However, claim 17 recites “wherein the dispensing embolic material out of the elongate body is through the distal port of the first lumen.” The embodiment with the valve is not capable of dispensing the embolic material through the distal port since the flow of material will increase the pressure in the lumen and actuate/close the check valve. Additionally, even if the valve limitation is referencing the flow restriction member of the first embodiment, this embodiment does not allow for fluid flow out the distal end of the catheter when the expandable member is expanded as is the limitation in claim 15. Therefore, claim 17 is not supported by the ‘049 patent specification.
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 a duplicate limitation that was previously presented in claim 18. 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 following is a quotation of the first paragraph of 35 U.S.C. 251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
MPEP 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP 1412.01 further provides guidelines for determining whether the reissue claims are "for the invention disclosed in the original patent" as:
(A) the claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 U.S.C. 112, first paragraph is satisfied; and
(B) nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application.
The presence of some disclosure (description and enablement) in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be his or her invention.
Further, the Federal Circuit addressed the “original patent” requirement of 35 USC 251 in Antares Pharma, Inc. v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). In Antares the reissue claims covered embodiments of injection devices (not restricted to jet-injection devices) which the Applicant admitted was a different invention from what was originally claimed. Id. at 1356. The Federal Circuit adopted the Supreme Court's explanation of the “same invention” requirement as “if the original patent specification fully describes the claimed inventions, but not if the broader claims ‘are [] merely suggested or indicated in the original specification’ ”. Id. at 1359. The Federal Circuit further stated that although wording in 35 USC 251 was changed from “same invention” to “original patent” no change in substance was intended. Id. at 1360.
Based on Antares a review of the specification is necessary to determine whether the original specification adequately discloses the invention of the reissue claims. Like in Antares, the specification states that “the flow of fluid and/or embolic materials 102 is out the distal end 112 of the body 110 when the flow restriction member 130 is not actuated (such as shown in FIGS. 2A-2B) and is out the proximal port 115 when the flow restriction member 130 is actuated by expansion of the expandable member 150 (such as shown in FIGS. 3A-3B).” See col. 4, ll. 60-66. However, the specification does not disclose that the second embodiment of Figs. 4A-5C which includes the valve as recited in new claim 15 is capable of “dispensing embolic material out of the elongate body through the distal port of the first lumen” as claimed in dependent claim 17. Additionally, it is noted that the first embodiment, having a flow restriction member, also prevents flow of embolic material from flowing out the distal port once the expandible member is expanded.
Therefore, claim 17 which is directed to embolic material flowing out the elongate body through the distal port of the first lumen is neither supported by the first embodiment when the expandable member is expanded nor by the second embodiment when a valve is present and thereby does not satisfy the “original patent” requirement.
Claim 17 is rejected under 35 USC 251 for not claiming subject matter directed to the invention disclosed in the original patent.
Recapture
Claims 15-17 are rejected 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.
See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984). A broadening aspect is present in the reissue which was not present in the application for patent. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
As stated in M.P.E.P. § 1412.02,
In Clement, 131 F.3d at 1468-70, 45 USPQ2d at 1164-65, the Court of Appeals for the Federal Circuit set forth a three step test for recapture analysis. In North American Container, 415 F.3d at 1349, 75 USPQ2d at 1556, the court restated this test as follows:
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We apply the recapture rule as a three-step process:
(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims;
(2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; and
(3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.
In North American Container, the court cited Pannu, 258 F.3d at 1371, 59 USPQ2d at 1600; Hester, 142 F.3d at 1482-83, 46 USPQ2d at 1649-50; and Clement, 131 F.3d at 1468, 45 USPQ2d at 1164-65 as cases that lead to, and explain the language in, the North American Container recapture test.
Step 1: Broadening
New claim 15 does not include the claim limitations which were part of original patent claim 1 including:
“through the proximal port.”
New claim 15 is broader than original patent claim 13. Therefore step 1 of the three-step test is met for claims 15-17.
Step 2a: Surrendered Subject Matter
In the prosecution of US Application 16/366,354 (“the ‘354 application”), applicant amended independent claim 18 (issued as independent claim 13) in an amendment filed 07/28/2021 in order to define over the prior art. The added limitations included,
“wherein the valve member is disposed distal of the proximal port,” and “out of the elongate body” to the already existing recitation of “through the proximal port.”
Additionally, applicant also stated in their response filed 07/28/2021, p. 11 that with respect to claim 18, “Jalgaonkar fails to describe ‘wherein embolic material passes out of the elongate body through the proximal port’ as recited.”
Subsequent to this amendment, a Final Rejection was mailed 11/22/2021 withdrawing the previous art rejections. The step of amending the claims in the amendment of 07/28/2021 in order to overcome the previous rejection of the claims over prior art is the action that generated the surrender of claimed subject matter, i.e. the broader claim before the amendment is the surrendered subject matter. Therefore, the surrender generating limitation includes “wherein the valve member is disposed distal of the proximal port” and “dispensing embolic material out of the elongate body through the proximal port.”
Step 2b: Broadening of the Surrender Generating Limitation
As indicated in Step 1, claim 15 was broadened with respect to original claim 13. In comparison with Step 2a, the surrender generating limitation (SGL) that was broadened in new claim 15 includes:
“through the proximal port.”
Therefore, this is the claim language removed from claim 15 which resulted in the broadening of claim 15 and is part of the claim language or related claim language of the surrendered subject matter by applicant.
Therefore, step 2 of the three-step test is met for claims 15-17.
Step 3: Materially Narrowing and Avoiding Recapture
It is impermissible recapture for a reissue claim to be as broad as, or broader in scope than any claim that was canceled or amended in the original prosecution to define over the art. Claim scope that was canceled or amended is deemed surrendered and therefore barred from reissue. Clement, 131 F.3d at 1470, 45 USPQ2d at 1165. It must be determined whether the reissue claim omits or broadens any limitation that was added or argued during the original prosecution to overcome an art rejection. Such an omission in a reissue claim, even if it is accompanied by other limitations making the reissue claim narrower than the patent claim in other aspects, is impermissible recapture. Pannu, 258 F.3d at 1371-72, 59 USPQ2d at 1600. In any broadening reissue application, the examiner will determine, on a claim-by-claim basis, whether the broadening in the reissue application claim(s) relates to subject matter that was surrendered during the examination of the patent for which reissue is requested) by an amendment narrowing claim scope in order to overcome a rejection and/or argument relying on a claim limitation in order to overcome a rejection.
While the entire SGL has not been eliminated, new claim 15 is broader than patented claim 13. Additionally, neither the remaining part of the limitation nor an added amendment materially narrows this aspect of the limitation.
Therefore, step 3 of the three-step test is met for claims 15-17 and claims 15-17 are rejected under 35 U.S.C. 251 as indicated above.
Claim Rejections - 35 USC § 102 / Claim Rejections - 35 USC § 103
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.
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. 102(a)(1) as anticipated by or, in the alternative, 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”).
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.
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.
Claim(s) 3-5, 19 and 21 is/are rejected 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”).
Carmel with or without Kupiecki meets the claim limitations with respect to claim 1 above but fails to specifically disclose that the flow restriction member is a one-way valve; selectively closed; and closed by the pressure of the expandable member.
Regarding claims 3 and 21, Hedge discloses the use of a one way valve (40a) for sealing the lumen against fluid flow.
Regarding claims 4-5 and 19, Hedge discloses a single lumen balloon catheter that teaches all three flow restriction member limitations. 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 any one of the valve 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.
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carmel with or without Kupiecki in further view of US Pub. No. 2014/0364835 to Allen et al (“Allen”).
Carmel with or without Kupiecki 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 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.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carmel in view of Kupiecki and in further view of Hegde.
Carmel in view of Kupiecki meets the claim limitations with respect to claim 7 above but fails to specifically disclose that the flow restriction member is a one-way valve; selectively closed; and closed by the pressure of the expandable member.
Regarding claim 9, Hedge discloses the use of a one way valve (40a) for sealing the lumen against fluid flow.
Regarding claims 10-11, Hedge discloses a single lumen balloon catheter that teaches all three flow restriction member limitations. Hedge teaches that the flow restriction member (40) is activated upon inflation of balloon member 14. See Fig. 3. This activation is selective.
At the time of filing, it would have been obvious to substitute the flow restriction member of Carmel with any one of the valve 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.
Conclusion
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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