Notice of Pre-AIA Status
The present reissue application is being examined under the pre-AIA first to invent provisions. It is noted that while the examination of the current reissue application falls under the pre-AIA first to invent provisions due to the priority date of US Patent No. 8,292,850 (the ‘850 patent); the application for reissue filing date is after September 16, 2012 and therefore is subject to the reissue rule changes enacted under the Leahy-Smith American Invents Act (AIA ), see Federal Register, Vol. 77, No. 157, pg. 48820, August 16, 2012. For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Reissue Applications and Prosecution History
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 the ‘850 patent is or was involved. These proceedings would include interferences, reissues, reexaminations and litigations.
The present reissue application is a reissue of the ‘850 patent and a continuation reissue of reissue application 14/984,273 resulting in US Pat. No. RE47379 which is a continuation reissue of reissue application 14/195,435 resulting in US Pat. No. RE46116 which is a continuation reissue of reissue application 14/070,161 resulting in US Pat. No. RE45380 which is a reissue of the ‘850 patent. Reissue application 14/195,385 resulting in US Pat. No. RE45760 and reissue application 14/195,413 resulting in US Pat. No. RE45776 were filed contemporaneously to reissue application 14/195,435 as copending continuation reissue applications of reissue application 14/070,161, The ‘850 patent is a DIV of US Pat. No. 8,142,413 which is a DIV of US Pat. No. 8,048,032. US Pat. No. 8,048,032 is subject to Inter Partes Reviews IPR2020-00126 and IPR2020-00127 which were instituted and each include Final Decisions mailed on 6/17/21. A Notice of Appeal was filed in both reviews on 9/27/21. US Pat. No. 8,142,413 is subject to Inter Partes Reviews IPR2020-01341 and IPR2020-01342 which have been instituted and a Final Decision was mailed on 2/07/22 in both reviews. A Notice of Appeal was filed in both reviews on 4/06/22. RE45380 is subject to Inter Partes Reviews IPR2020-00128; IPR2020-00129; and IPR2020-00130 which were instituted and include respective Final Decisions mailed on 6/17/21. A Notice of Appeal was filed in all three reviews on 9/27/21. RE45760 is subject to IPR2020-00132 and IPR2020-00134 which were instituted and each include Final Decisions mailed on 6/17/21. A Notice of Appeal was filed in both reviews on 9/27/21. RE45776 is subject to IPR2020-00135 and IPR2020-00136 which were instituted and each include Final Decisions mailed on 6/17/21. A Notice of Appeal was filed in both reviews on 9/27/21. RE46116 is subject to Inter Partes Reviews IPR2020-001343 and IPR2020-01344 which have been instituted and a Final Decision was mailed on 2/23/22 in both reviews. A Notice of Appeal was filed in both reviews on 4/22/22. RE47379 is subject to Inter Partes Reviews IPR2020-00137 and IPR2020-00138 which were instituted and a Final Decision was mailed on 6/17/21 and 6/22/21, respectively. A Notice of Appeal was filed in both reviews on 9/27/21.
The CAFC Decision in the consolidated appeals in Nos. IPR2020-00126; IPR2020-00128; IPR2020-00132; IPR2020-00135; and IPR2020-00137 was decided on May 24, 2023 and the CAFC affirmed the PTAB’s Final Decision that Itou does not qualify as prior art to the challenged patents under 35 USC 102(e) and that the challenged claims are not unpatentable. The CAFC Decision in the Appeals in Nos. IPR2020-00129; IPR2020-00134; and IPR2020-00138 was decided on June 5, 2023 and the CAFC affirmed the PTAB’s Final Decision regarding the claims found not unpatentable and granting issuance of the substitute claims. The CAFC Decision in the Appeals in Nos. IPR2020-00127; IPR2020-00130; and IPR2020-00136 was decided on June 5, 2023 and the CAFC affirmed the PTAB’s Final Decision regarding the claims found not unpatentable and granting issuance of the substitute claims. The appeals of the Final Decisions in IPR2020-01341; IPR2020-01342; IPR2020-01343; and IPR2020-01344 are still pending at the CAFC as of the mailing of this office action.
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.
Oath/Declaration
The reissue oath/declaration filed with this application is defective because the error which is relied upon to support the reissue application is not an error upon which a reissue can be based. See 37 CFR 1.175and MPEP § 1414.
The Reissue Declaration by the Inventor filed 09/18/2020 sets forth that the limitations of "A system" and "a guide catheter having a continuous lumen extending for a predefined length from a proximal end at a hemostatic valve to a distal end adapted to be placed in the branch artery, the continuous lumen of the guide catheter having a circular cross-sectional inner diameter sized such that interventional cardiology devices are insertable into and through the continuous lumen of the guide catheter" from original claim 1 of the ‘850 patent caused the ‘850 patent to be in error. However, these limitations were previously relied upon in the error statements as the basis of a reissue proceeding in reissue applications 14/070,161; 14/195,385; 14/195,413; 14/195,435 and 14/984,273. Therefore, this error is considered to have already been corrected in the issuance of Reissue Pat. Nos. RE45380; RE45760; RE45776; RE46116 and RE47379. Specifically, each of these reissue patents issued with claims either amending or entirely eliminating the same limitations being relied upon again as causing an error as the basis for reissue of the ‘850 patent. Additionally, the same error, i.e. original claim limitations causing the error, is being relied upon in this reissue as is being relied upon in each of co-pending reissue applications 16/220,925; 16/220,951; 16/220,996 and 16/220,975.
While, the issuance of multiple reissue patents from a single original patent is permitted. See 37 CFR 1.177; once a reissue claim has gone to issuance, the error providing the basis for that reissue patent is considered to have been corrected. If the same error corrected in the parent, e.g. reissue application 14/070,161 resulting in Pat. No. RE45380, is also being corrected in a continuation reissue application, but the error is being corrected in a different way, a statement is needed to explain compliance with 37 CFR 1.175(f)(2) for a reissue application filed on or after September 16, 2012. Since the current error statement relies on the same limitations listed in each of applications 14/070,161; 14/195,385; 14/195,413; 14/195,435; 14/984,273; 16/220,925; 16/220,951; 16/220,996 and 16/220,975, the statement explaining that the error is being corrected in a different way would need to differentiate from each of these applications.
Claims 25-41 are rejected as being based upon a defective reissue declaration error statement under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the error statement is set forth in the discussion above in this Office action.
Double Patenting
The nonstatutory double patenting rejections have been withdrawn in light of the Terminal Disclaimer filed and approved 4/16/21.
Original Patent
The following is a quotation of 35 USC §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.
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(c) APPLICABILITY OF THIS TITLE.— The provisions of this title relating to applications for patent shall be applicable to applications for reissue of a patent, except that application for reissue may be made and sworn to by the assignee of the entire interest if the application does not seek to enlarge the scope of the claims of the original patent or the application for the original patent was filed by the assignee of the entire interest.
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 USC §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 invention, 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.
The structure without a lumen through which an interventional cardiology device is insertable imitation
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 the following throughout the ‘850 patent, see, e.g., col. 6, lines 47-49:
Rigid portion 20 may be formed from a hypotube or a section of stainless steel or Nitinol tubing.
However, the specification does not disclose that the rigid portion can be any “structure without a lumen through which an interventional cardiology device is insertable.” See claims 25 and 41. In their response filed 09/18/2020 on pages 19-20, applicant asserts
that [a]lthough a hypotube includes a central passage, it does not include a lumen through which an interventional cardiology device is insertable. As defined in the specification of the pending application, “[T]he term ‘interventional cardiology devices’ … include[s] … guidewires, balloon catheters, stents and stent catheters.” (U.S. Patent No. 8,292,850, referred to herein as “the ‘850 patent,” at col. 1, ln. 28-31.) It is well known to those of skill in the art that a hypotube’s inner diameter is too small to allow insertion of an interventional cardiology device as defined in the ‘850 patent.
While a hypotube is disclosed in the ‘850 patent specification; other structures meeting the claim limitation of “structure without a lumen through which an interventional cardiology device is insertable” are not. Therefore, the original patent does not support the full extent of a rail “structure without a lumen through which an interventional cardiology device is insertable.”
Therefore, independent claims 25 and 41 and dependent claims 26-40, which are directed to “structure without a lumen through which an interventional cardiology device is insertable”, are rejected under 35 USC §251 for not claiming subject matter directed to the invention disclosure in the original patent.
The tubular flexible portion defining a tubular structure limitation
The ‘850 patent specification never uses the term “tubular flexible portion.” “The tubular flexible portion” is also claimed to define “a tubular structure” and later “a flexible cylindrical distal tip portion.” Turning to the ‘850 patent specification, the coaxial guide catheter 12 discloses multiple tubular portions and structures including flexible bumper tip 33, reinforced portion 18 and the full circumferential portion of the rigid portion 20. See col. 6, ll. 21-56; and col. 7, ll. 21-34. The flexible bumper tip is the only portion disclosed as flexible. However, since “a flexible cylindrical distal tip portion” and “a flexible cylindrical portion with a braid or coil” are both later disclosed as being included in the “tubular flexible portion,” than the “tubular flexible portion” seems to be referring to the combination of the flexible tip 33 and the reinforced portion 18 which is referred to in the ‘850 patent specification as the substantially cylindrical structure. Therefore, the initial recitation of “a tubular structure” which is also part of the “tubular flexible portion” does not have support in the specification as its own structure in addition to the flexible tip 33 and the reinforced portion 18. The ‘850 patent specification and figures do not disclose an additional tubular structure aside from the flexible tip 33 and the reinforced portion 18 as being part of the substantially cylindrical structure.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The 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 25-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the rigid means being a hypotube, does not reasonably provide enablement for all rail structures “without a lumen through which an interventional cardiology device is insertable.” The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. The limitation of “a rail structure without a lumen through which an interventional cardiology device is insertable” includes structures, other than the disclosed hypotube, that haven’t been disclosed in the ‘850 patent specification.
Claims 25-41 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.
The ‘850 patent specification never uses the term “tubular flexible portion.” “The tubular flexible portion” is also claimed to define “a tubular structure” and later “a flexible cylindrical distal tip portion.” Turning to the ‘850 patent specification, the coaxial guide catheter 12 discloses multiple tubular portions and structures including flexible bumper tip 33, reinforced portion 18 and the full circumferential portion of the rigid portion 20. See col. 6, ll. 21-56; and col. 7, ll. 21-34. The flexible bumper tip is the only portion disclosed as flexible. However, since “a flexible cylindrical distal tip portion” and “a flexible cylindrical portion with a braid or coil” are both later disclosed as being included in the “tubular flexible portion,” than the “tubular flexible portion” seems to be referring to the combination of the flexible tip 33 and the reinforced portion 18 which is referred to in the ‘850 patent specification as the substantially cylindrical structure. Therefore, the initial recitation of “a tubular structure” which is also part of the “tubular flexible portion” does not have support in the specification as its own structure in addition to the flexible tip 33 and the reinforced portion 18. The ‘850 patent specification and figures do not disclose an additional tubular structure aside from the flexible tip 33 and the reinforced portion 18 as being part of the substantially cylindrical structure.
Claim Interpretation
Independent claims 25 and 41 both recite “a tubular flexible portion defining a tubular structure.” It is being interpreted, in light of the 112 rejection above, that this entire limitation indicates one flexible tube structure rather than a larger tubular flexible portion having a subset region of a tubular structure. The claim then recites that the tubular flexible portion, i.e. the flexible tube structure, includes a flexible cylindrical distal tip portion and a flexible cylindrical portion. In other words, it is understood that the flexible cylindrical distal tip portion and the flexible cylindrical portion make up the “tubular structure” of the “tubular flexible portion,” as understood above, and are not distinct sections from the tubular structure.
Regarding claim 26, the ‘850 patent specification never uses the term “proximal side opening.” However, it is clear from the figures and specification that the first full circumference portion, hemicylindrical portion / greater than 180 degree portion, and arcuate portion / less than 180 degree portion defines the “proximal side opening.” See col. 6, ll. 50-67; col. 7, ll. 32-38; and col. 8, ll. 47-56. The side opening is shown in figures 4 and 12-16. The ‘850 patent specification is consistent in its disclosure that the proximal side opening is considered to be part of the rigid portion 20.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/16/2021, with respect to the rejection(s) of claim(s) 25-31, 34, 36 and 38-41 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US Pat. No. 5,439,445 to Kontos (“Kontos”) in view of US Pub. No. 2004/0010280 to Adams (“Adams ‘280”) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kontos in view of Takahashi in view of the Knowledge in the Art as detailed below.
The rejection of claims 28-29 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Adams ‘280 in further view of US Pub. No. 2005/0015073 to Kataishi (“Kataishi”) has been withdrawn in light of the withdrawal of the rejection of claim 26 over Kontos in view of Adams ‘280. The rejection of claims 27-30 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Adams ‘280 and in further view of US Pat. No. 5,980,486 to Enger (“Enger”) has been withdrawn in light of the withdrawal of the previous rejection of claim 26 over Kontos in view of Adams ‘280.
The rejection of claims 32-33, 35 and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Adams ‘280 in further view of US Patent No. 7,604,612 to Ressemann et al. (“Ressemann”) has been withdrawn in light of the withdrawal of the rejection of claim 26 over Kontos in view of Adams ‘280. However, upon further consideration, a new ground(s) of rejection is made in view of Kontos in view of Takahashi in view of the Knowledge in the Art and further in view of Adams ‘292 as detailed below.
Applicant’s arguments, see Remarks, filed 04/16/2021, with respect to the rejection(s) of claim(s) 25-41 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Adams ‘280 and Ressemann have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kontos in view of Takahashi in view of the Knowledge in the Art as detailed below.
The rejection of claims 28-29 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Adams ‘280 and Ressemann in further view of Kataishi has been withdrawn in light of the withdrawal of the rejection of claim 26 over Kontos in view of Adams ‘280 and Ressemann.
The rejection of claims 27-30 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Adams ‘280 and Ressemann and in further view of Enger has been withdrawn in light of the withdrawal of the rejection of claim 26 over Kontos in view of Adams ‘280 and Ressemann.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 25, 36 and 38-41 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Takahashi in view of the Knowledge in the Art.
Regarding claims 25 and 41, Kontos discloses a guide extension catheter (10) (see also figs. 1 and 14 and col. 1, ll. 9-13 and col. 5, ll. 49-52) that includes a tubular flexible portion defining a tubular structure (12, 16); and having a circular cross-sectional outer diameter sized to be insertable through the lumen of a predefined length 6 Fr guide catheter. As stated in Kontos at col. 4, ll. 46-50,
The size and shape of the various elements of support assembly 10 may vary depending on the desired application. In the application depicted in FIGS. 1 to 4, tube 16 has a 0.055 inch outer diameter and lumen 22 has a 0.045 inch diameter. (See, e.g., FIG. 2).
It is noted that tube 16 having a 0.055 inch outer diameter is “sized to be insertable through the lumen of a predefined length 6 Fr guide catheter.” The tubular structure (12, 16) also defines a lumen (22) having a cross-sectional inner diameter (“These sizes generally are suitable for existing PTCA catheters, such as the INTEGRATM catheter marketed by datascope Corp., the assignee of the present invention. Of Course, other sizes may be used for other applications.” see col. 4, ll. 61-65) through which an interventional cardiology device (PTCA catheter 40) is insertable, and a substantially rigid portion (14) that is rigid enough to push the tubular flexible portion through the guide catheter and into a coronary artery (see figs. 6A-C and 14 and col. 1, ll. 30-38; col. 2, ll. 16-23; col. 5, ll. 25-30 and ll. 49-52), the substantially rigid portion being proximal of, operably connected to (see fig. 1), and more rigid along a longitudinal axis (stainless steel and “provides structure for inserting, manipulating, advancing and withdrawing the body portion 12, 112” col. 9, ll. 10-13) than the tubular flexible portion (12,16) made from pliable material such as polyethylene, see col. 4, ll. 1-4) and defining a rail structure (it is noted that rigid portion 14 is a rail structure in that it functions to push the tubular portion to a location within the vasculature through a guide catheter) without a lumen (14 is a wire) through which an interventional cardiology device is insertable (PTCA catheter 40), the substantially rigid portion having a maximal cross-sectional dimension at a proximal portion that is smaller than the cross-sectional outer diameter of the tubular flexible portion (See figs. 1, 5, 6A-C, 7, 8A-C and 9). Kontos does not explicitly disclose having a length that when combined with the length of the tubular flexible portion, which is distal to the substantially rigid portion, defines a length of the guide extension catheter along the longitudinal axis that is longer than the guide catheter where the proximal end of the substantially rigid portion would extend through a hemostatic valve in common with the interventional cardiology device. However, the length of the support assembly 10 being longer than the guide catheter 38 and extending proximally through a hemostatic valve while the distal end extends distally from the guide catheter is considered to be inherently necessary in order to function as disclosed (see 14). Kontos teaches that13Application No. Not Yet AssignedAttorney Docket No. 2005.86USRE18REISSUE APPLICATIONAdditionally, the tubular flexible portion includes a flexible cylindrical distal tip portion (28) which is more flexible than the flexible cylindrical portion (16) (col. 4, ll. 5-15).
Kontos does not teach that the tubular portion has a lumen having a cross-sectional inner diameter greater than or equal to 0.056 inches. Kontos does not explicitly disclose having a length that when combined with the length of the tubular flexible portion, which is distal to the substantially rigid portion, defines a length of the guide extension catheter along the longitudinal axis that is longer than the guide catheter where the proximal end of the substantially rigid portion would extend through a hemostatic valve in common with the interventional cardiology device.
The limitation of “a cross-sectional inner diameter greater than or equal to 0.056 inches.”
While Kontos does not explicitly teach that the body/tube (12/16) has in inner diameter grater than or equal to 0.056 inches; Kontos does state that
The size and shape of the various elements of support assembly 10 may vary depending on the desired application. Of Course, other sizes may be used for other applications.”
As noted, these sizes may vary depending upon the application to which the device is to be put. When it is to be used with a PTCA catheter, lumen 22 should be at least large enough to permit passage therethrough of the deflated PTCA balloon.
See Kontos at col. 4, ll. 46-50, 61-65 and col. 4, l. 66 through col. 5, l. 2.
Takahashi teaches the five-in-six system which is a method of inserting a 5 Fr guiding catheter (Heartrail, Terumo, Japan) into a 6 Fr guiding catheter to increase backup support. As the 5 Fr inner guiding catheter is inserted into the target artery through the outer 6 Fr guiding catheter, stronger backup support can be generated (Fig. 1A). Takahashi, p. 452. Takahashi explains that “[t]he five-in-six system is a method of inserting a 5 FR guiding catheter … into a 6 Fr guiding catheter to increase backup support.” Takahashi, p. 452. Takahashi states that the inner lumen of the 5 French and 6 French catheters are 0.059 inches and 0.071 inches, respectively. The 5 Fr Heartrail straight guiding catheter is 120 cm in length, whereas the 6 Fr guiding catheter is 100 cm. Takahashi, p. 452. The 5 Fr Heartrail catheter has a very soft 13 cm end portion. This soft end portion can easily negotiate the tortuous coronary artery with the minimal damage and then it can be inserted more deeply into the artery. Takahashi, p. 452.
At the time of the invention, it would have been obvious to incorporate the sizing of the system of Takahashi into the invention of Kontos. Both Kontos and Takahashi are PTCA procedure guidance systems; therefore, a combination is proper. Kontos teaches changing the size and shape of the various elements of support assembly 10 depending on the desired application. Additionally, 6 Fr guide catheters for PTCA procedures are standard in the art and Takahashi discloses a problem associate with this size, i.e. 6 Fr guide catheter’s backup support is not strong compared to a 7 or an 8 Fr catheter. Takahashi, p. 452. Furthermore, the solution Takahashi discloses, i.e. five-in-six system, is almost identical to the structural relationship, pushable tube within a guide catheter, as taught by Kontos. The change in size of the system of Kontos would have been a simple modification by one skilled in the art with predictable results, i.e., the system of Kontos would continue to function as disclosed. Additionally, Kontos provides the motivation for alterations in size in expressly stating, “The size and shape of the various elements of support assembly 10 may vary depending on the desired application … Of course, other sizes may be used for other applications.” Kontos, at col. 4, ll. 46-50, 61-65 and col. 4, l. 66 through col. 5, l. 2.
The limitations of “when combined with the length of the tubular flexible portion, defines a length of the guide catheter along the longitudinal axis that is longer than the length of the guide catheter, the substantially rigid portion extends proximally through a hemostatic valve in common with the interventional cardiology device”
As noted above, Kontos does not explicitly disclose having a length that when combined with the length of the tubular flexible portion, which is distal to the substantially rigid portion, defines a length of the guide extension catheter along the longitudinal axis that is longer than the guide catheter. If it is not considered to be inherently necessary for the length of the support assembly 10 to be longer than the guide catheter 38 and extend proximally from a hemostatic valve of the guide catheter, than this feature would have been obvious in light of Takahashi.
Fig. 1 of Takahashi depicts the entire five-in-six system. Shown is the entire 6Fr guide catheter including the hemostatic valve with inserted 5Fr catheter protruding from the distal end of the 6Fr guide catheter and extending proximally through the hemostatic valve. p. 452-453.
It would have been obvious to one skilled in the art that the support assembly 10 of Kontos would have to be longer than the entirety of the guide catheter used in order to function as disclosed. Takahashi Fig 1 shows the deployed inner catheter which is analogous to the operation of the support assembly of Kontos as shown in Figs. 6A-6C. Additionally, Takahashi shows how the proximal end of the inner catheter must extend from the proximal end of the outer guide catheter and through the hemostatic valve. This same arrangement would be necessitated in the system of Kontos in order to be able to advance the tubular portion (12/16) of the support assembly (10). Finally, incorporating a hemostatic valve, as shown in Takahashi, into the invention of Kontos would have been a necessity in order to prevent the patient from losing blood during the procedure. These modifications, if not inherently necessary, would have been obvious to one skilled in the art in order to safely carry out the procedure as disclosed in Kontos.
Kontos in view of Takahashi does not teach that the flexible cylindrical portion (16) includes a braid or coil that is proximal to the flexible cylindrical distal tip portion.
However, metallic braids or coils are ubiquitous in the prior art of guiding catheters for PTCA procedures. The guide catheter wall is typically constructed of "a lubricious, polymeric inner liner, a polymeric outer jacket, and a reinforcing structure disposed between the inner liner and outer jacket formed of woven, braided, or wound strands which are usually metallic, high strength polymers or combinations thereof. The lubricious inner liner serves to diminish the frictional forces generated from the passage of interventional devices within the inner lumen. The lubricious inner liner is commonly formed of polytetrafluoroethylene (PTFE) because of its low coefficient of friction." US Pat. No. 6,837,890 at Col. 2, ll. 10-21. See also sampling of guide catheters including braided or coiled elements including: US Pat. No. 6,837,890; US Pat. No. 6,245,053; US Pub. No. 2004/0087933; US Pat. No. 6,626,889; and US Pat. No. 5,755,704. Reasons for the use of braids or coils within the wall of the guide catheter include facilitating the incorporation of PTFE as an inner liner and reducing the wall thickness or inner diameter of the lumen. See US Pat. No. 6,245,053 for the incorporation of a flexible tip with a braid or coil proximal to the flexible tip. One skilled in the art would have been well aware of the use of braided or coiled elements in the walls of guide catheters for PTCA procedures. Additionally, Kontos discloses that "Body 12 [] may be viewed as a mini guide catheter, including a tube 16." Kontos col. 3, ll. 47-48.
Regarding claim 36, in Kontos the insertion wire (14) is made from stainless steel. See col. 4, l. 58.
Regarding claim 38, as shown in Kontos fig. 1 the substantially rigid portion (14) is eccentrically positioned relative to a circular cross-section of the tubular flexible portion.
Regarding claim 39, the lumen of the tubular flexible portion (12) is coaxial with the lumen of the guide catheter (38)(see Kontos, figs. 6A-C).
Regarding claim 40, the lumen of the tubular flexible portion is substantially uniform along its length (see Kontos fig. 1).
Claims 35 and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Takahashi in view of the Knowledge in the Art and further in view of US Pat. No. 5,527,292 to Adams et al. (“Adams ‘292”).
Kontos in view of Takahashi in view of the knowledge in the art meets the claim limintations for claim 25 as described above. However, Kontos does not disclose that the insertion wire (14) is a hypotube or made from nitinol.
The ‘850 patent does not provide any critically for the material or structure of rigid portion 20, i.e. stainless steel, nitinol or a hypotube. Rather, the ‘850 lists these materials and types of insertion wires interchangeably and further states that other substantially rigid materials may be used as well. See the ‘850 patent col. 6, ll. 46-50.
Adams ‘292 teaches a push rod (172) which extends proximally from a proximal end of the elongated flexible tube 32A outside the patient so that it is accessible to the user to continually adjust the extended length of the elongated flexible tube 32A relative to the guide catheter 12A. The tubular shaft member (172) is preferably formed from stainless steel hypotube. See Adams ‘292 col. 7, ll. 13-19. Adams ‘292 also teaches another push rod 262 which is preferably made from nitinol. See col. 15, ll. 8-9.
At the time of the invention, it would have been obvious to substitute the substantially rigid portion of Kontos with either a stainless hypotube or a rigid portion made from nitinol as taught by Adams ‘292 as simple substitution of one known element for another known element to obtain predictable results. Either of the push rods as taught by Adams ‘292 would perform as well as the substantially rigid segment as taught by Kontos.
Conclusion
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/CATHERINE S WILLIAMS/Reexamination Specialist, Art Unit 3993
Conferees:
/Patricia L Engle/Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/SPRS, Art Unit 3993
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