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 .
Benefit
The application is a Continuation of 17/737126, filed 22 August 2021, which claims benefit as a Continuation to 16/763617, filed13 May 2020, issued as US 11,090,056, which is a National Stage entry under 35 USC 371 of PCT/US2018/061302, filed 15 November 2018, which claims benefit to US Provisional 62/587,149, filed 16 November 2017.
Formal Matters
Claims 1-20 are pending and under examination.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
The limitation “static mixing component” in claim 5 is treated under 112(f). Function: promote mixing of materials delivered through injection channels prior to exit at the outlet opening. Corresponding structure: the stationary baffle assembly shown in FIG and described at p. 10, ¶35 including and equivalents.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Obviousness-Type Double Patenting (Non-Provisional)
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent 11,090,056 (17 August 2021).
This is a non-provisional rejection. US Patent 11,090,056 has the same inventive entity and appears to be commonly owned. If so, a terminal disclaimer under 37 CFR 1.321 would overcome the Obviousness-Type Double Patenting rejection.
Although the claims at issue are not identical, they are not patentably distinct due to anticipation or obviousness of the claims of the ‘056 patent. Claims 9, 16, and 18 of the current application recite features from the end-of-claim clause in the ‘056 patent claim 1. These differences would have been obvious given their express inclusion in claim 1 of the ‘056 patent and because the patent’s specification teaches that the diaphragm of the third catheter body can occlude the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction (col 7, lines 56-62).
A chart is set forth below showing the side-by-side claim comparison. The obvious variations in the claims are distinguished by italics with the respective related claim numbers of the ‘135 application indicated.
US 11,090,056
18/939,135
1. A catheter assembly comprising:
a first catheter body having a proximal end portion,
a distal end portion having a distal tip, and a wall that circumferentially encloses a primary opening,
wherein the first catheter body further comprises at least one inflation channel within the wall of the first catheter body,
wherein the primary opening of the first catheter body extends along an entire length of the first catheter body;
a first balloon coupled to the distal end portion of the first catheter body and
positioned in fluid communication with the at least one inflation channel of the first catheter body,
the first balloon enclosing an interior space,
wherein the first catheter body extends through the interior space of the first balloon in a proximal-to-distal direction such that at least the distal tip of the first catheter body is positioned distal of the first balloon;
a second catheter body partially received within the primary opening of, and selectively moveable relative to, the first catheter body,
wherein the second catheter body has a proximal end portion, a distal end portion having a tip, and a wall that circumferentially encloses a primary opening,
wherein the second catheter body further comprises at least one inflation channel within the wall of the second catheter body, wherein the primary opening of the second catheter body extends along an entire length of the second catheter body;
a second balloon coupled to the distal end portion of the second catheter body and positioned in fluid communication with the at least one inflation channel of the second catheter body,
the second balloon enclosing an interior space,
wherein the second catheter body extends through the interior space of the second balloon in the proximal-to-distal direction such that at least the distal tip of the second catheter body is positioned distal of the second balloon; and
a third catheter body partially received within the primary opening of, and selectively moveable relative to, the second catheter body,
wherein the third catheter body has a proximal end portion, a distal end portion, and a wall structure that defines at least one injection channel extending from the proximal end portion toward the distal end portion,
wherein the distal end portion of the third catheter body further comprises at least one outlet opening positioned in fluid
communication with the at least one injection channel,
wherein the distal end portion of the third catheter body has a distal tip and a diaphragm that is secured to the distal tip, the diaphragm extending outwardly from the distal tip,
wherein the third catheter body is selectively retractable relative to the second catheter body, and
wherein when the third catheter body is retracted to be fully received within the primary opening of the second catheter body,
the diaphragm of the third catheter body occludes the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction.
A catheter assembly comprising:
a first catheter body having a proximal end portion,
a distal end portion having a distal tip, and
a wall that circumferentially encloses a primary opening,
wherein the first catheter body further comprises at least one inflation channel within the wall of the first catheter body,
wherein the primary opening of the first catheter body extends along an entire length of the first catheter body;
a first balloon coupled to the distal end portion of the first catheter body and
positioned in fluid communication with the at least one inflation channel of the first catheter body,
the first balloon enclosing an interior space,
wherein the first catheter body extends through the interior space of the first balloon in a proximal-to-distal direction such that at least the distal tip of the first catheter body is positioned distal of the first balloon;
a second catheter body partially received within the primary opening of, and selectively moveable relative to, the first catheter body,
wherein the second catheter body has a proximal end portion, a distal end portion having a tip, and a wall that circumferentially encloses a primary opening,
wherein the second catheter body further comprises at least one inflation channel within the wall of the second catheter body,
wherein the primary opening of the second catheter body extends along an entire length of the second catheter body;
a second balloon coupled to the distal end portion of the second catheter body and positioned in fluid communication with the at least one inflation channel of the second catheter body,
the second balloon enclosing an interior space,
wherein the second catheter body extends through the interior space of the second balloon in the proximal-to-distal direction such that at least the distal tip of the second catheter body is positioned distal of the second balloon; and
a third catheter body partially received within the primary opening of, and selectively moveable relative to, the second catheter body,
wherein the third catheter body has a proximal end portion, a distal end portion, and a wall structure that defines at least one injection channel extending from the proximal end portion toward the distal end portion,
wherein the distal end portion of the third catheter body further comprises at least one outlet opening positioned in fluid communication with the at least one injection channel.
9. wherein the distal end portion of the third catheter body has a distal tip and a diaphragm that is secured to the distal tip, the diaphragm extending outwardly from the distal tip.
16. withdrawing the third catheter body into the primary opening of the second catheter body.
18. withdrawing the third catheter body until the third catheter body is fully received within the primary opening of the second catheter body,
18. wherein a diaphragm secured to a distal tip of the third catheter body occludes the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction.
2. The catheter assembly of claim 1, wherein the at least one injection channel of the third catheter body comprises a plurality of injection channels.
2. The catheter assembly of claim 1, wherein the at least one injection channel of the third catheter body comprises a plurality of injection channels.
3. The catheter assembly of claim 1, wherein the at least one injection channel of the third catheter body comprises first and second injection channels, and wherein the wall structure of the third catheter body comprises an outer wall and an inner wall that extends between opposing portions of the outer wall to define the first and second injection channels.
3. The catheter assembly of claim 1, wherein the at least one injection channel of the third catheter body comprises first and second injection channels, and wherein the wall structure of the third catheter body comprises an outer wall and an inner wall that extends between opposing portions of the outer wall to define the first and second injection channels.
4. The catheter assembly of claim 1, wherein the at least one outlet opening of the distal end portion of the third catheter body comprises a plurality of outlet openings.
4. The catheter assembly of claim 1, wherein the at least one outlet opening of the distal end portion of the third catheter body comprises a plurality of outlet openings.
5. The catheter assembly of claim 1, Wherein the distal end portion of the third catheter body further comprises a static mixing component positioned between the at least one injection channel and the at least one outlet opening.
5. The catheter assembly of claim 1, wherein the distal end portion of the third catheter body further comprises a static mixing component positioned between the at least one injection channel and the at least one outlet opening.
6. The catheter assembly of claim 1, wherein, in an inflated position, the second balloon is larger than the first balloon.
6. The catheter assembly of claim 1, wherein, in an inflated position, the second balloon is larger than the first balloon.
7. The catheter assembly of claim 1, wherein the wall of the first catheter body defines at least one outlet opening to provide fluid communication between the at least one inflation channel and the interior space of the first balloon.
7. The catheter assembly of claim 1, wherein the wall of the first catheter body defines at least one outlet opening to provide fluid communication between the at least one inflation channel and the interior space of the first balloon.
8. The catheter assembly of claim 1, wherein the wall of the second catheter body defines at least one outlet opening to provide fluid communication between the at least one inflation channel and the interior space of the second balloon.
8. The catheter assembly of claim 1, wherein the wall of the second catheter body defines at least one outlet opening to provide fluid communication between the at least one inflation channel and the interior space of the second balloon.
9. The catheter assembly of claim 1, wherein the second catheter body is selectively retractable relative to the first catheter body.
10. The catheter assembly of claim 1, wherein the second catheter body is selectively retractable relative to the first catheter body.
10. The catheter assembly of claim 1, wherein the first and second catheter bodies are selectively lockable to maintain a desired position and orientation of the second catheter body relative to the first catheter body.
11. The catheter assembly of claim 1, wherein the first and second catheter bodies are selectively lockable to maintain a desired position and orientation of the second catheter body relative to the first catheter body.
11. A method comprising: deploying the catheter assembly of claim 1;
selectively inflating the first balloon to occlude a first opening;
selectively advancing the second catheter body relative to the first catheter body;
selectively inflating the second balloon to occlude a second opening;
selectively advancing the third catheter body relative to the second catheter body;
selectively delivering at least one injectable material to the at least one injection channel of the third catheter body; and
delivering the at least one injectable material to a selected delivery site through the at least one outlet opening of the third catheter body.
12. A method comprising: deploying the catheter assembly of claim 1;
selectively inflating the first balloon to occlude a first opening;
selectively advancing the second catheter body relative to the first catheter body;
selectively inflating the second balloon to occlude a second opening;
selectively advancing the third catheter body relative to the second catheter body;
selectively delivering at least one injectable material to the at least one injection channel of the third catheter body; and
delivering the at least one injectable material to a selected delivery site through the at least one outlet opening of the third catheter body.
12. The method of claim 11, wherein the first opening is an inter-atrial septum of a heart, wherein the second opening is an ostium of a left atrial appendage of the heart, and wherein the selected delivery site is the left atrial appendage of the heart.
13. The method of claim 12, wherein the first opening is an inter-atrial septum of a heart, wherein the second opening is an ostium of a left atrial appendage of the heart, and wherein the selected delivery site is the left atrial appendage of the heart.
13. The method of claim 12, wherein the first balloon is positioned on a left atrial septal side of the inter-atrial septum, wherein the second balloon is positioned proximally of the ostium of the left atrial appendage, and wherein the first balloon provides axial support for the second balloon to maintain occlusion of the left atrial appendage.
14. The method of claim 13, wherein the first balloon is positioned on a left atrial septal side of the inter-atrial septum, wherein the second balloon is positioned proximally of the ostium of the left atrial appendage, and wherein the first balloon provides axial support for the second balloon to maintain occlusion of the left atrial appendage.
14. The method of claim 13, further comprising: pulling the first catheter body in a proximal direction to press the first balloon against the inter-atrial septum; and pushing the second catheter body in a distal direction to press the second balloon against the ostium of the left atrial appendage.
15. The method of claim 14, further comprising: pulling the first catheter body in a proximal direction to press the first balloon against the inter-atrial septum; pushing the second catheter body in a distal direction to press the second balloon against the ostium of the left atrial appendage.
15. The method of claim 11, further comprising withdrawing the third catheter body into the primary opening of the second catheter body.
16. The method of claim 12, further comprising withdrawing the third catheter body into the primary opening of the second catheter body.
16. The method of claim 15, wherein the at least one injectable material is delivered to the selected delivery site through the at least one outlet opening of the third catheter body until the third catheter body is fully received within the primary opening of the second catheter body.
17. The method of claim 16, wherein the at least one injectable material is delivered to the selected delivery site through the at least one outlet opening of the third catheter body until the third catheter body is fully received within the primary opening of the second catheter body.
17. The method of claim 15, further comprising withdrawing the third catheter body until the third catheter body is fully received within the primary opening of the second catheter body, wherein a diaphragm secured to a distal tip of the third catheter body occludes the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction.
18. The method of claim 16, further comprising withdrawing the third catheter body until the third catheter body is fully received within the primary opening of the second catheter body, wherein a diaphragm secured to a distal tip of the third catheter body occludes the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction.
18. The method of claim 17, further comprising allowing the second balloon and the third catheter body to occlude the second opening and the primary opening of the second catheter body until the at least one injectable material is sufficiently hardened within the delivery site.
19. The method of claim 18, further comprising allowing the second balloon and the third catheter body to occlude the second opening and the primary opening of the second catheter body until the at least one injectable material is sufficiently hardened within the delivery site.
19. The method of claim 11, further comprising locking the first and second catheter bodies in position prior to the step of advancing the third catheter body relative to the second catheter body.
20. The method of claim 12, further comprising locking the first and second catheter bodies in position prior to the step of advancing the third catheter body relative to the second catheter body.
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, 2, 4-8, 10-17, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krishnan US 20160166242 (16 June 2016).
Regarding independent claim 1, Krishnan teaches a catheter assembly (FIG 1, 100) comprising:
a first catheter body (103) having a proximal end portion (FIG 1),
a distal end portion (FIG 1) having a distal tip (FIG 1; ¶144), and
a wall (FIG 1) that circumferentially encloses a primary opening (control port 110, ¶124),
wherein the first catheter body (103) further comprises at least one inflation channel (FIG 1, inflation port 112; ¶¶131-134) within the wall of the first catheter body (FIG 1; 100),
wherein the primary opening of the first catheter body (103) extends along an entire length of the first catheter body (FIG 1);
a first balloon (104) coupled to the distal end portion of the first catheter body (103) and
positioned in fluid communication (¶131) with the at least one inflation channel of the first catheter body (FIG 1; ¶124),
the first balloon (104) enclosing an interior space (FIG 1, ¶125),
wherein the first catheter body (103) extends through the interior space (FIG 1) of the first balloon (104) in a proximal-to-distal direction (FIG 1, ¶124) such that at least the distal tip (FIG 1) of the first catheter body (103) is positioned distal of the first balloon (FIGs 1, 2);
a second catheter body (FIG 1, inner sheath 101) partially received within the primary opening of (FIG 1), and selectively moveable (steerable, ¶144) relative to, the first catheter body (103),
wherein the second catheter body (101) has a proximal end portion (FIG 1), a distal end portion having a tip (FIG 1, ¶144), and a wall that circumferentially encloses a primary opening (FIG 1),
wherein the second catheter body (101) further comprises at least one inflation channel (FIG 1; ¶¶131-134) within the wall of the second catheter body (FIG 2),
wherein the primary opening (FIG 1) of the second catheter body (101) extends along an entire length of the second catheter body (FIG 1);
a second balloon (102) coupled to (FIG 1; ¶124) the distal end portion of the second catheter body (101) and positioned in fluid communication (¶131) with the at least one inflation channel (FIG 1; ¶124) of the second catheter body (101),
the second balloon (102) enclosing an interior space (FIG 1, ¶126),
wherein the second catheter body (101) extends through the interior space (FIG 1) of the second balloon (102) in the proximal-to-distal direction (FIG 1) such that at least the distal tip (FIG 1) of the second catheter body (101) is positioned distal of the second balloon (102); and
a third catheter body (FIG 1, inner catheter 117) partially received within the primary opening of (FIG 1), and selectively moveable (steerable, ¶144) relative to, the second catheter body (101),
wherein the third catheter body (117) has a proximal end portion, a distal end portion (FIGs 1, 34) and a wall structure (FIGs 1, 34) that defines at least one injection channel (FIGs 1, 34) extending from the proximal end portion toward the distal end portion (FIGs 1, 34),
wherein the distal end portion of the third catheter body (117) further comprises at least one outlet opening (120, ¶133) positioned in fluid communication with the at least one injection channel (FIG 1; ¶133).
The term “wall” in is broadly interpreted to include “a wall that circumferentially encloses a primary opening” (Specification, p. 2, ¶8). The specification describes walls that encompass the first catheter body (p. 2, ¶7), the second catheter body (p. 2, ¶8), defining at least one injection channel (p. 3, ¶9), wall 20 (p, 7, ¶32), wall 48 (pp. 8-9, ¶33-34), wall 82, wall 84, wall 86, wall defining the first and second injection channels 88 (pp. 9-10, ¶35). Krishnan’s terminology control port (110) is broadly interpreted as the claimed primary opening. Krishnan describes control port 110 as providing the portal for connection to catheter handling devices designed to control and navigate inner sheath 101, outer sheath 103, and inner catheter 117 to the desired locations (¶144). Control port (110) is also broadly interpreted as connecting the first (inner sheath 101), second (outer sheath 103), and third (inner catheter 117) catheter bodies over the entire length of the device (FIG 1, ¶144).
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Regarding claim 2, Krishnan teaches the catheter assembly of claim 1, as set forth above, wherein the at least one injection channel (FIG 1, ¶133) of the third catheter body (117) comprises a plurality of injection channels (FIG 34, 3102, ¶229).
Regarding claim 4, Krishnan teaches the catheter assembly of claim 1, as set forth above, wherein the at least one outlet opening (120, ¶133) of the distal end portion of the third catheter body (117) comprises a plurality of outlet openings (FIG 34, 3102, ¶229).
Regarding claim 5, Krishnan teaches the catheter assembly of claim 1, as set forth above, wherein the distal end portion of the third catheter body (117) further comprises a static mixing component (FIG 14, ¶165) positioned between the at least one injection channel (lumen) and the at least one outlet opening (120).
“A static mixing component” is interpreted as set forth above.
Regarding claim 6, Krishnan teaches the catheter assembly of claim 1, as set forth above, wherein, in an inflated position, the second balloon (102) is larger than the first balloon (104) (FIGs 1, 4, ¶¶125-126).
Regarding claim 7, Krishnan teaches the catheter assembly of claim 1, as set forth above, wherein the wall of the first catheter (103) body defines at least one outlet opening to provide fluid communication (¶131) between the at least one inflation channel (106a, 106b, 106c, ¶131) and the interior space of the first balloon (104).
Regarding claim 8, Krishnan teaches the catheter assembly of claim 1, as set forth above, wherein the wall (FIG 1) of the second catheter body (101) defines at least one outlet opening (116a, 116b, 116c; ¶132) to provide fluid communication (¶133) between the at least one inflation channel (lumen) and the interior space of the second balloon (102).
Regarding claim 10, Krishnan teaches the catheter assembly of claim 1, as set forth above, wherein the second catheter body (101) is selectively retractable (¶¶230-231) relative to the first catheter body (103).
Regarding claim 11, Krishnan teaches the catheter assembly of claim 1, as set forth above, wherein the first (103) and second catheter (101) bodies are selectively lockable (¶¶142-143: “locking means 109 is a spring-loaded device housed in inner sheath 101 [corresponding: first catheter] that, upon activation, the protrusions would bulge out through the corresponding protrusions slots on outer sheath 103, as shown in FIG 2” “an additional locking means can be present on the outer sheath 103 [corresponding: second catheter] (¶142)) to maintain a desired position and orientation of the second catheter body (101) relative to the first catheter body (103).
Regarding independent claim 12, Krishnan teaches a method (FIG 3) comprising: deploying the catheter assembly of claim 1 (301), as set forth above;
selectively inflating the first balloon (104) to occlude a first opening (303);
selectively advancing (302) the second catheter body (101) relative to the first catheter body (103);
selectively inflating (305) the second balloon (102) to occlude a second opening (LAA ostium);
selectively advancing (306) the third catheter body (117) relative to the second catheter body (101);
selectively delivering at least one injectable material to the at least one injection channel (FIGs 1, 34; “air or fluid may be delivered via port 112 to through inner catheter opening 120 or more than one catheter opening” ¶133) of the third catheter body (117); and
delivering the at least one injectable material (¶133) to a selected delivery site through the at least one outlet opening (120) of the third catheter body (117).
Regarding claim 13, Krishnan teaches the method of claim 12, wherein the first opening is an inter-atrial septum of a heart (FIG 4, ¶41), wherein the second opening is an ostium of a left atrial appendage of the heart (¶42), and wherein the selected delivery site is the left atrial appendage of the heart (¶42).
Regarding claim 14, Krishnan teaches the method of claim 13, as set forth above, wherein the first balloon (104) is positioned on a left atrial septal side of the inter-atrial septum (FIG 4), wherein the second balloon (102) is positioned proximally of the ostium of the left atrial appendage (FIG 4), and wherein the first balloon provides axial support for the second balloon to maintain occlusion of the left atrial appendage (FIG 3, 305; FIG 4).
Regarding claim 15, Krishnan teaches the method of claim 14, as set forth above, further comprising: pulling (FIG 3, 304) the first catheter body (103) in a proximal direction to press the first balloon against the inter-atrial septum (304); pushing (305) the second catheter body (101) in a distal direction to press the second balloon (102) against the ostium of the left atrial appendage (305).
Regarding claim 16, Krishnan teaches the method of claim 12, as set forth above, further comprising withdrawing (¶231) the third catheter body (117) into the primary opening of the second catheter body (101).
Regarding claim 17, Krishnan teaches the method of claim 16, as set forth above, wherein the at least one injectable material (¶133) is delivered to the selected delivery site through the at least one outlet opening (120) of the third catheter body (117) until the third catheter body (117) is fully received (¶231) within the primary opening of the second catheter body (101).
Regarding claim 20, Krishnan teaches the method of claim 12, as set forth above, further comprising locking (309) the first (103) and second catheter (101) bodies in position prior to the step of advancing (310) the third catheter body (117) relative to the second catheter body (101) (FIG 3).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Krishnan US 20160166242 (16 June 2016) in view of Kassab, US 20100286718 (11 November 2010).
Regarding claim 3, Krishnan teaches the catheter assembly of claim 1, as set forth above, wherein the at least one injection channel (FIG 1, ¶133) of the third catheter body (117) comprises first and second injection channels (FIG 34, 3102, ¶229), and wherein the wall structure of the third catheter body (117) comprises an outer wall and an inner wall (FIGs 1 and 34; lumen of catheter 117, ¶229).
Krishnan does not expressly teach that the third catheter body (117) extends between opposing portions of the outer wall to define the first and second injection channels.
Kassab teaches occlusion assembly 10 comprising lumen 44, 46 (FIG 1B). Kassab teaches that “the interior 34 of the catheter 16 comprises multiple lumens. In the embodiment shown in FIG. 1B, the occlusion assembly 10 comprises a triple-lumen pigtail catheter, comprising a first lumen 42, a second lumen 44, and a third lumen 46. In this embodiment, the first lumen 42 is disposed around the circumference of the catheter 16 and the second and third lumens 44, 46 are disposed centrally within the interior 34. The second and third lumens 44, 46 are wholly surrounded by the first lumen 42. While this specific configuration is shown with respect to FIG. 1B, it will be appreciated that the interior 34 may comprise any number of lumens and the lumens can be arranged in any configuration” (¶53). Kassab expressly provides a rationale and motivation for this configuration stating that “the multiple lumens enable the catheter 16 to perform multiple functions without withdrawing the catheter 16 from the body or employing more than one device. In this manner, the catheter 16 is capable of various functionalities including, without limitation, delivering suction to the cavity of the LAA, advancing the guidewire 18 to ensure accurate navigation throughout the body, and applying an adhesive to the LAA” (¶54).
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Krishnan and Kassab teach in the field of medical elongate catheters and methods of use. Although, Krishnan discloses the claimed base multi-catheter and balloon device comprising a third catheter body (117) and a distal tip (118), Krishnan does not disclose that the third catheter body (117) extends between opposing portions of the outer wall to define the first and second injection channels.
Kassab specifically addresses this by providing embodiments showing catheter 16 extending between opposing portions of the outer wall to define first and second injection channels (broadly interpreted as lumen 44 and 46 of Kassab). The motivation for this configuration is provided by Kassab in permitting a greater range of flexibility of functionality of delivering materials or providing suction the multi-channeled device.
A person of ordinary skill in the art, seeking improved functionality for delivery and evacuation of materials through Krishnan’s multi-catheter architecture would reasonably consult Kassab’s multi-lumen solution. Kassab’s multi lumen solution can be incorporated alongside Krishnan’s third catheter body (117) and distal tip (118) using known assembly methods without redesigning Krishnan’s core delivery path. Krishnan expressly teaches that it is contemplated that the number of catheter openings can vary depending on design needs (¶133). Similarly, Kassab teaches that it will be appreciated that the interior 34 may comprise any number of lumens and the lumens can be arranged in any configuration (¶54).
Because the references address the same engineering problem (improving functionality on multi-catheter systems) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (as expressly acknowledged by both references), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Krishnan US 20160166242 (16 June 2016) in view of Hartley et al., US 20080132937 (5 June 2008).
Regarding claim 9, Krishnan teaches the catheter assembly of claim 1, as set forth above, wherein the distal end portion of the third catheter body (117) has a distal tip (118).
Krishnan does not teach a diaphragm that is secured to the distal tip, the diaphragm extending outwardly from the distal tip.
Hartly teaches a device (2) comprising an elongate catheter comprising a nose cone dilator (8) that is secured to the distal tip (FIG 3), the diaphragm extending outwardly from the distal tip (FIG 3). Hartley teaches that “in its retracted position the nose cone dilator closes off the proximal end 5 of the elongate catheter” (¶23).
Krishnan and Hartly both teach elongate catheters for medical procedures. Although, Krishnan discloses the claimed base multi-catheter and balloon device comprising a third catheter body (117) and a distal tip (118), Krishnan does not disclose a diaphragm secured to the distal tip, the diaphragm extending outwardly from the distal tip. Hartly specifically addresses a distal device tip comprising a diaphragm as a nose cone dilator (8) where the catheter (10) is fastened to the nose cone dilator (8) (¶21). Hartley’s teaching that the nose cone dilator in its retracted position closes off the proximal end 5 of the elongate catheter at ¶23, corresponds to the claimed diaphragm occluding the primary opening to prevent distal-to-proximal entry. Krishnan’s third catheter body (117) and distal tip is taught as being a penetrating tip that can be blunt or sharpened (¶160). Krishnan discloses that upon puncturing the wall of the LAA apex, no significant blood will enter the pericardial cavity because of the tight hemostatic seal previously formed by the inflated balloons (¶160). Hartly teaches guidewire catheter (10) extends through the hemostatic seal 6 and is fastened to the nose cone dilator (8). In its retracted position, nose cone dilator closes off the proximal end (5) of the elongate catheter (¶23).
Both Krishnan and Hartly are concerned with hemostatic seals associated with the elongate catheters. A person of ordinary skill in the art, seeking a seal or closure of a proximal end of a catheter of Krishnan’s architecture would reasonably consult Hartley’s nose cone dilator solution. Hartley’s nose cone dilator solution can be incorporated alongside Krishnan’s third catheter body (117) and distal tip (118) using known assembly methods without redesigning Krishnan’s core delivery path.
Because the references address the same engineering problem (structural sealing of component catheters and biological structures) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a deflector adjacent to the existing tip), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 18, Krishnan teaches the method of claim 16, as set forth above, further comprising withdrawing the third catheter body (117) until the third catheter body (117) is fully received (¶231) within the primary opening of the second catheter body (101).
Krishnan does not teach wherein a diaphragm secured to a distal tip of the third catheter body occludes the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction.
Hartly teaches a device (2) comprising an elongate catheter comprising a nose cone dilator (8) that is secured to the distal tip (FIG 3), the diaphragm extending outwardly from the distal tip (FIG 3). Hartly teaches guidewire catheter (10) extends through the hemostatic seal 6 and is fastened to the nose cone dilator (8). In its retracted position, nose cone dilator closes off the proximal end (5) of the elongate catheter (¶23) so that the nose cone dilator occludes the primary opening of the second catheter body to prevent entry of material into the primary opening of the second catheter body in a distal-to-proximal direction.
Krishnan and Hartly both teach elongate catheters for medical procedures. Although, Krishnan discloses the claimed base multi-catheter and balloon device comprising a third catheter body (117) and a distal tip (118), Krishnan does not disclose a diaphragm secured to the distal tip, the diaphragm extending outwardly from the distal tip. Hartly specifically addresses a distal device tip comprising a diaphragm as a nose cone dilator (8) where the catheter (10) is fastened to the nose cone dilator (8) (¶21). Krishnan’s third catheter body (117) and distal tip is taught as being a penetrating tip that can be blunt or sharpened (¶160). Krishnan discloses that upon puncturing the wall of the LAA apex, no significant blood will enter the pericardial cavity because of the tight hemostatic seal previously formed by the inflated balloons (¶160). Both Krishnan and Hartly are concerned with hemostatic seals associated with the elongate catheters. A person of ordinary skill in the art, seeking a seal or closure of a proximal end of a catheter of Krishnan’s architecture would reasonably consult Hartley’s nose cone dilator solution. Hartley’s nose cone dilator solution can be incorporated alongside Krishnan’s third catheter body (117) and distal tip (118) using known assembly methods without redesigning Krishnan’s core delivery path.
Because the references address the same engineering problem (structural sealing of component catheters) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a deflector adjacent to the existing tip), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Krishnan US 20160166242 (16 June 2016) in view of Hartley et al., US 20080132937 (5 June 2008) and further in view of Kassab, US 20100286718 (11 November 2010).
Regarding claim 19, Krishnan modified by Hartly teaches the method of claim 18, as set forth above.
Krishnan modified by Hartly does not teach further comprising allowing the second balloon (102) and the third catheter body (117) to occlude the second opening and the primary opening of the second catheter body until the at least one injectable material is sufficiently hardened within the delivery site.
Kassab teaches using catheter 16 of occlusion assembly 10 to inject adhesive 47 into a collapsed LAA cavity (¶57). The adhesive biological glue is injected to achieve an adequate seal of the LAA ostium (FIG 3E; ¶69). Kassab teaches that “the inflation of balloon 14 is maintained during the requisite sealing time” ¶70 and “catheter 16 is withdrawn from the body through shaft 12 (¶70) after sealing.
Accordingly, Kassab at ¶69-70 teaches the method further comprising allowing the second balloon (14) and the third catheter body (16) to occlude the second opening (FIG 3E) and the primary opening of the second catheter body (12) until the at least one injectable material is sufficiently hardened within the delivery site (FIG 3F). These steps correspond to maintaining occlusion until material is hardened.
Krishnan, Hartly, and Kassab all teach in the field of medical elongate catheters and methods of use. Although, Krishnan discloses the claimed base multi-catheter and balloon device comprising a third catheter body (117) and a distal tip (118), Krishnan does not disclose a diaphragm secured to the distal tip, the diaphragm extending outwardly from the distal tip. Hartly specifically addresses a distal device tip comprising a diaphragm as a nose cone dilator (8) where the catheter (10) is fastened to the nose cone dilator (8) (¶21). Krishnan’s third catheter body (117) and distal tip is taught as being a penetrating tip that can be blunt or sharpened (¶160). Krishnan discloses that upon puncturing the wall of the LAA apex, no significant blood will enter the pericardial cavity because of the tight hemostatic seal previously formed by the inflated balloons (¶160). Both Krishnan and Hartly are concerned with hemostatic seals associated with the elongate catheters. A person of ordinary skill in the art, seeking a seal or closure of a proximal end of a catheter of Krishnan’s architecture would reasonably consult Hartley’s nose cone dilator solution. Hartley’s nose cone dilator solution can be incorporated alongside Krishnan’s third catheter body (117) and distal tip (118) using known assembly methods without redesigning Krishnan’s core delivery path.
All three references are concerned with generating or maintaining seals associated with procedures involving elongate catheters. A person of ordinary skill in the art, seeking a seal or closure of a proximal end of a catheter of Krishnan’s architecture would reasonably consult Hartley’s nose cone dilator solution. Hartley’s nose cone dilator solution can be incorporated alongside Krishnan’s third catheter body (117) and distal tip (118) using known assembly methods without redesigning Krishnan’s core delivery path. Additionally, Kassab discloses using catheter 16 of occlusion assembly 10 to inject adhesive 47 into a collapsed LAA cavity (¶57) to generate a seal of the LAA ostium (FIG 3E; ¶69). Kassab also teaches steps to maintain the occlusion until the material is hardened. Kassab teaches “Balloon 14 is maintained during the requisite sealing time,” (¶70) and “catheter 16 is withdrawn” after sealing (¶70). Kassab’s steps allow the balloon/catheter to remain in position during setting/hardening correspond to the instant limitation of allowing the second balloon and the third catheter body to occlude … until the injectable material is sufficiently hardened.
A person of ordinary skill in the art attempting to provide improved seals in Krishnan’s multi-catheter LAA ostium occlusion method in order to avoid compromised seals or improve or provide superior seals would look for established sealing mechanisms, designs, and methods to avoid creating a novel sealing structure that risks failure in vivo. Kassab’s biological glue adhesive are modular and can be adapted to the multi-balloon, multi-catheter device of Krishnan modified by Hartly to provide improved seals of the LAA ostium. Because the references address the same engineering problem (structural sealing of component catheters and biological structures) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a deflector adjacent to the existing tip), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kassab et al., US 20100222738 (2 September 2010) teaches devices and systems for selective auto-retroperfusion of the cerebral venous system.
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/CHERIE M POLAND/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771