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 .
Drawings
The drawings are objected to because the drawings are blurry and or in grey scale (See Figs. 3 – 7). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 3, 4, 7, and 16 are objected to because of the following informalities:
Claim 3 recites “the branch vessel”, “a patient”, “a magnetic field”, “a guidewire” in various lines, although the phrases are understood by the Examiner to mean “a branch vessel”, “the patient”, “the magnetic field”, and “the guidewire”, as they were either not previously defined or were previously defined, the Examiner suggests the lines be amended to read “a branch vessel”, “the patient”, “the magnetic field”, and “the guidewire” for the purpose of maintaining consistent language throughout the claims;
Claim 4 recites “a magnetic field” and “electrical current” in various lines, although the phrases are understood by the Examiner to mean “the magnetic field” and “the electrical current” as both have been previously defined, the Examiner suggests the lines be amended to read “the magnetic field” and “the electrical current” for the purpose of maintaining consistent language throughout the claims;
Claim 7 recites “electrical current” in line 2, although the line is understood by the Examiner to mean “the electrical current” as the electrical current was previously defined, the Examiner suggests the line be amended to read “the electrical current” for the purpose of maintaining consistent language throughout the claims;
Claim 16 recites “a patient’s body” in line 1-2, although the line is understood by the Examiner to mean “a body of the patient” or “the patient’s body” as the “patient” was previously introduced in claim 15, the Examiner suggests the line be amended to read “a body of the patient” or “the patient’s body” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 20, the phrase "a battery coupled to the electromagnetic coil" renders the claim indefinite because it is unclear if Applicant is intending for the battery to be electrically coupled to both of the first and second electromagnetic coils or if Applicant is intending for the battery to be electrically coupled to only one of the first and second electromagnetic coils. For the purpose of examination, the Examiner will read the claim to mean the former, such that the battery is electrically coupled to both of the first and second electromagnetic coils.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 3, 5, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Quadri (US 2005/0154444 A1), and in view of Houser (US 2003/0014063 A1) and Mayberry et al (US 8,945,202 B2).
Regarding claims 1 and 2, Quadri discloses an apparatus (endoaortic graft 100) (abstract, paragraphs [0035 – 0037], [0067], and Figs. 1A/B, 2A, 8A/B, 10A-10DD) comprising:
a tubular main body (graft 100) configured to be implanted within a patient (paragraph [0035]), the tubular main body being radially collapsible and expandable between a collapsed state (shown in Fig. 2A) and an expanded state (shown in Fig. 10P) (paragraphs [0069] and Figs. 2A and Fig. 10P) ;
a fenestration (branch openings 114) (paragraph [0067] and Fig. 1B) in a wall (pliable tube 110) (paragraph [0067]) of the tubular body (graft 100);
[claim 2] the tubular main body (graft 100) comprises a stent graft (graft 100) configured to be implanted within a blood vessel to treat an aneurysm or injury of the blood vessel (paragraphs [0031], [0033], [0035 – 0036], and [0075]);
wherein in the collapsed state after introduction into a patient’s body and prior to expansion in the patient’s body the fenestration (branch opening 114) is uncannulated and guide wire free (Examiner’s note: it should be understood that “prior to” does not limit the claim to any point in time prior to the expansion within a patient’s body; and as stated in paragraph [0069] when the endoaortic graft is loaded within the delivery system 200, the compresses state, the branch guide wires are positioned within and traverse the branch openings 114 / the fenestrations, this means that there is a moment in time prior to the expansion of the graft, that the graft is compressed and the guide wire has yet to traverse / cannulate the fenestrations; therefore, at some point in time, the fenestrations will be uncannulated prior to expansion of the graft);
Quadri further teaches a magnet (magnetic ring 120) positioned around the fenestration (branch openings 114) (paragraph [0067] and Fig. 1A/B), such that the magnet is operable to magnetically guide another device (branch graft delivery system 400) to or through the fenestration (branch openings 114) (Examiner’s note: as stated in paragraph [0080] and shown in Figs. 10O – 10U the delivery system 400 and the magnet 440 are guided through the graft 100 to the magnet 120 on the graft 100 to deliver the branch graft 300).
However, Quadri is silent regarding (i) a tubular gate portion extending outwardly from the tubular main body, the tubular gate portion being in fluid communication with the tubular main body through the fenestration and shaped and sized to receive a separately delivered stented branch through the tubular gate portion, (ii) wherein the magnet is an electromagnetic coil wound on the tubular gate portion and positioned around the fenestration, the electromagnetic coil being switchable between an activated state and a deactivated state, the electromagnetic coil being operable to generate a magnetic field when electrical current flows through the electromagnetic coil in the activated state such that the electromagnetic coil is operable to magnetically guide another device to or through the fenestration, and (iii) wherein the electromagnetic coil is activatable after expansion of the tubular main body within the patient to cannulate the fenestration with a guide wire.
As to (i), Mayberry teaches, in the same field of endeavor, an apparatus comprising a tubular main body (prosthesis 1200) configured to be implanted within a patient (abstract, column 54 lines 19 – 35, and Figs. 62 – 63), a fenestration (fenestrations 1202) in a wall of the tubular main body (prosthesis 1200) (Fig. 62), and a tubular gate portion (tubular member 1210) extending outwardly from the tubular main body (prosthesis 1200) (Figs. 62 – 63), the tubular gate portion (tubular member 1210) being in fluid communication with the tubular main body (prosthesis 1200) through the fenestrations (Fig. 63), and shaped and sized to receive a separately delivered stented branch through the tubular gate portion (Examiner’s note: as recited in column 54 lines 19 – 35, the tubular gate portions are shaped and sized to receive separately delivered branch grafts and stents deployed within the fenestrations). Furthermore, Mayberry teaches, in col. 54 lines 19 – 35, the tubular member(s) 1210 (i.e., the tubular gate portions) improve the tear resistance and sealability of the fenestrations.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the tubular main body of Quadri, to incorporate the tubular gate portions, based on the teachings of Mayberry, for the purpose of improving the tear resistance of the fenestration and improving the sealability between the fenestration and the branch grafts and stents (col. 54 lines 19 – 35 – Mayberry).
As to (ii) and (iii), Houser, which is also cited by Quadri in paragraph [0021 – 0022] of Quadri teaches an apparatus (bypass graft and securing system) using magnets to further assist positioning of the delivery system within the body, the magnets are formed by winding conductive coils around a dilator to form electromagnets when current is supplied, and wherein the electromagnets on the dilator are used in conjunction with magnetically attracted guidewires such that when the current is applied the electromagnet on the dilator draws the guidewire to the dilator (paragraphs [0074 – 0075] of Houser).
It should be understood that Quadri and Houser are known references in the art that teach a deployment system for graft fixation comprising magnets to assist in the positioning of the system within the body (abstract, paragraphs [0067 – 0068], [0080], and Figs. 1A/B, 8A/B – Quadri ; paragraphs [0074 – 0075] – Houser); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one magnet / magnetic element for another, and the results of the substitution would have been predictable and resulted in the modified system of Quadri being able to function as intended to properly to attract the endograft branch. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. Additionally, with respect to (ii), the limitation is intended use which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the modified device of Quadri comprising electromagnetic coils are activatable after the implant has been expanded within the patient to cannulate the fenestration with a guidewire (Examiner’s note: as stated in paragraph [0075] of Houser the electromagnetic coils are activated when a current is suppled and the coil electromagnets are strong enough to pull a metal guidewire; thus the metal guidewires of Quadri are capable of being pulled, to some degree, through or to the fenestrations when the electromagnetic coil is activated). Thus, the limitation is said to be encompassed by Quadri in view of Houser.
Additionally, it should be understood that the prior art combination makes obvious wherein the modification made would result in the electromagnetic coil being wrapped around the outside of the tubular member 1210 (i.e., the tubular gate portions), as this would be where side branch graft would attach and thus where the side branch graft would need to be magnetically drawn to.
Regarding claim 3, as discussed above, it would have been obvious to modify the endograft system of Quadri to incorporate the electromagnetic coils of Houser and the tubular gate portions of Mayberry. Additionally, Quadri discloses the fenestration (branch openings 114) is configured to align with a branch vessel of the aorta so that fluid can flow between the tubular main body and the branch vessel through the fenestration when the apparatus is implanted in a patient (Examiner’s note: the preceding limitation is intended use which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the endograft 100 of Quadri is structurally capable of aligning with a branch vessel of the aorta, and thus is configured as claimed). Furthermore, the combination teaches wherein the electromagnetic coil is operable to generate a magnetic field that is sufficient to draw a guidewire or other transvascular device to the fenestration from within the tubular main body (Examiner’s note: as stated in paragraphs [0074 – 0075] of Houser the electromagnetic coils, when current is applied, attract a metal guidewire. Therefore, the electromagnetic coils generates a magnetic field and is configured to sufficiently operate as claimed as claimed).
Regarding claim 5, as discussed above, it would have been obvious to modify the endograft system of Quadri to incorporate the electromagnetic coils of Houser and the tubular gate portions of Mayberry. Additionally, Quadri discloses further comprising a magnetically tipped guidewire sheath (delivery system 400) (Examiner’s note: the delivery system 400 has magnet 440 at the tip – paragraph [0071]) positionable inside the tubular main body and magnetically couplable to the electromagnetic coil when the electromagnetic coil is in the activated state (paragraphs [0071] and [0080]).
Regarding claim 11, as discussed above, it would have been obvious to modify the endograft system of Quadri to incorporate the electromagnetic coils of Houser and the tubular gate portions of Mayberry. Additionally, the combination further teaches comprising a stented branch (branch graft 300 – Quadri) deployable through the tubular gate portion (tubular member 1210 – Mayberry) and the electromagnetic coil (magnets 120 – Quadri in view of Houser) of the fenestration (branched openings 114 – Quadri) (Examiner’s note: as stated in the rejection of claim 1, the combination makes obvious the electromagnetic coil being positioned around the gate portion, and as stated in paragraph [0070] of Quadri, the stented branch (branch graft 300) is delivered through the fenestrations, therefore, the modified device would encompass the stented branch (branch graft 300) being delivered through the tubular gate portions and the electromagnetic coil).
Regarding claim 13, as discussed above, it would have been obvious to modify the endograft system of Quadri to incorporate the electromagnetic coils of Houser and the tubular gate portions of Mayberry. Additionally, the combination makes obvious wherein the electromagnetic coil is collapsible with the tubular main body for transvascular delivery (Examiner’s note: as stated in paragraph [0084] of Quadri the magnetic rings 120 are flexible, as shown in Fig. 2A of Quadri the rings 120 (along with the graft 100) are compressed within the delivery device, and as shown in the sequential Figs. 10L to 10P of Quadri the rings 120 expand radially outward when deployed; and because the magnetic rings 120 of Quadri were substituted for electromagnetic coils, based on the teachings of Houser, it would be obvious to one of ordinary skill in the art to have the electromagnetic coils be collapsible, in the same manner in which the magnetic rings are, for the purpose of being able to fully collapse the entire endograft within the delivery device). Therefore, the prior art makes obvious the limitations above.
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Quadri (US 2005/0154444 A1) in view of Houser (US 20030014063 A1) and Mayberry et al (US 8,945,202 B2), as applied to claim 1 above, and further in view of Garibaldi (US 6,401,723).
Regarding claims 4 and 8, as discussed above, it would have been obvious to modify the endograft system of Quadri to incorporate the electromagnetic coils of Houser and the tubular gate portions of Mayberry. Additionally, the combination further teaches a portion of [claim 4] wherein the electromagnetic coil is operable to generate a magnetic field when electrical current flows through the electromagnetic coil (paragraphs [0074 – 0075] of Houser); a portion of [claim 8] wherein the fenestration (branched window 114 – Quadri) comprises a first fenestration (left sided window 114 when looking at Fig. 1B of Quadri), the electromagnetic coil (magnetic ring 120 on the left side modified to be an electromagnetic coil based on the teachings of Houser) comprises a first electromagnetic coil, a first tubular gate portion (left most fenestration of Quadri modified to include a tubular member 1210 based on the teachings of Mayberry) and the apparatus further comprises a second fenestration (right sided branched window 114 when looking at Fig. 1B of Quadri) in the tubular body (endoaortic graft 100 – Quadri), a second electromagnetic coil (magnetic ring 120 on the right side modified to be an electromagnetic coil based on the teachings of Houser), and a second tubular gate portion (right most fenestration of Quadri modified to include a tubular member 1210 based on the teachings of Mayberry) the second electromagnetic coil being operable to generate a magnetic field when electrical current flows through the second electromagnetic coil (Examiner’s note: it should be understood that the modification made by the Examiner in claim 1 above, was such that each of the ring magnets 120 of Quadri was modified to be an electromagnetic coil based on the teachings of Houser, thus the modified device comprises two electromagnetic coils in the location of the two ring magnets 120 as seen in Fig. 1B of Quadri; furthermore, as stated above each of the coils is operable to generate a sufficient magnetic field when induced with a current – paragraphs [0074 – 0075] of Houser). Thus, the claimed limitations above are considered obvious over the teachings of the prior art.
However, the combination of Quadri, Mayberry, and Houser is silent regarding [claims 4 and 8] (i) wherein the electromagnetic coil(s) include(s) first and second leads that are couplable to an electrical power source to supply electrical current in the coil.
As to the above, Garibaldi teaches, in a similar field of endeavor, an apparatus (magnetic medical device 20) (column 3 lines 51 – 60) comprising a first coil and a second coil (coils 26 and 30) (column 4, lines 20 – 30, and Fig. 5), being operable to generate a magnetic field when an electrical field is applied (column 4, lines 35 – 67), wherein the coils (coils 26 and 30) each have their own leads (Examiner’s note: as stated in column 4, lines 22 – 30, the coil 26 is coupled to / powered by leads 36 and 38, and the coil 30 is coupled to / powered by leads 44 and 46) that are coupled to the an electrical power source to generate electrical current in the coil (column 4 lines 25 – 35).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the coil magnets of Quadri in view of Houser and Mayberry to incorporate the leads and power supply, based on the teachings of Garibaldi, because the modified device of Quadri in view of Houser and the device of Garibaldi teach the use of sending an electrical current to electromagnetic coils used within the body, and Garibaldi simply further teaches the means of sending the electrical current to said coils. Thus, it would have been obvious to apply the known technique of using lead wires to stimulate said electromagnetic coil(s) as taught by Garibaldi for the predictable results of enabling the electromagnetic coil(s) to generate the intended magnetic field.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Quadri (US 2005/0154444 A1) in view of Houser (US 2003/0014063 A1) and Mayberry et al (US 8,945,202 B2), as applied to claim 1 above, and further in view of Schaer (US 2019/0167407 A1).
Regarding claim 7, as discussed above, it would have been obvious to modify the endograft system of Quadri to incorporate the electromagnetic coils of Houser and the tubular gate portions of Mayberry.
However, the combination of Quadri, Houser, and Mayberry is silent regarding (i) a transcutaneous induction charger to generate the electrical current in the electromagnetic coil.
As to the above, Schaer teaches an apparatus (delivery catheter system 11130 for delivery of an implant within the body - paragraph [0179]) comprising an electromagnet on said implant (implants 11140 and 11160 are coupled with magnetic elements – paragraph [0182]) wherein the electrical current is induced by a transcutaneous induction means to enable coupling of the two implants via a remote control (paragraphs [0182 – 0183]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the coil magnets of Quadri in view of Houser and Mayberry to incorporate a transcutaneous induction charger as taught by Schaer, because the modified device of Quadri in view of Houser and the device of Schaer teach the use of sending an electrical current to electromagnetic coils used within the body, and Schaer simply further teaches the means of sending the electrical current to said coils. Thus, it would have been obvious to apply the known technique of using the transcutaneous induction means to stimulate said coils as taught by Schaer for the predictable results of enabling the magnetic coils to generate the intended magnetic field. Furthermore, it would have been obvious to use the transcutaneous induction charger as taught by Schaer to generate the electrical current to the electromagnetic coil of Quadri in view of Houser for the purpose of providing a means of controlling the device remotely (paragraph [0183] – Schaer).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Quadri (US 2005/0154444 A1) in view of Houser (US 2003/0014063 A1), Mayberry et al (US 8,945,202 B2), and Garibaldi (US 6,401,723), as applied to claim 8 above, and further in view of Ogle (US 2017/0143938 A1).
Regarding claim 9, as discussed above, it would have been obvious to modify the endograft system of Quadri to incorporate the electromagnetic coils of Houser, the tubular gate portions of Mayberry, and the electrical leads of Garibaldi. Additionally, Garibaldi makes obvious to one of ordinary skill in the art to further modify the device of Quadri in view of Houser, Mayberry, and Garibaldi, to further incorporate wherein the electromagnetic coils (magnetic coils - Houser) are selectively energized such that the location of the magnetic field is controlled for the purpose of only having to energize one coil at a time so that the electromagnetic coil not being utilized does not have to have a current running therethrough thereby preventing overheating of the coil and damage to the tissue (col 9 line 55 – col. 10 line 3 – Garibaldi).
However, the combination of Quadri, Houser, Mayberry, and Garibaldi is silent regarding (i) a switch.
As to the above, Ogle teaches an apparatus (catheter 370) comprising a coil (metal coil 372) coupled to leads (wires 374 and 376) and a switch (switch 380) for the purpose of optionally generating a magnetic field (paragraph [0088]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Quadri in view of Houser, Mayberry, and Garibaldi to incorporate a switch because a switching device would be required for selectively energizing the coils which allows for controlling the location of the magnetic field, which could be useful when orienting the secondary branch to the correct fenestration, and used for switching off any of the electromagnetic coils in order to prevent overheating and damage to the tissue.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Quadri (US 2005/0154444 A1) in view of Houser (US 2003/0014063 A1), Mayberry et al (US 8,945,202 B2), and Garibaldi (US 6,401,723), as applied to claim 8 above, and further in view of Greenan et al (US 2008/0171934 A1).
Regarding claim 10, as discussed above, it would have been obvious to modify the endograft system of Quadri to incorporate the electromagnetic coils of Houser, the tubular gate portions of Mayberry, and the electrical leads of Garibaldi. Additionally, Garibaldi makes obvious to one of ordinary skill in the art to modify the device of Quadri in view of Houser, Mayberry, and Garibaldi, to further incorporate wherein the electromagnetic coils (magnetic coils - Houser) are selectively energized such that the location of the magnetic field is controlled for the purpose of only having to energize one coil at a time so that the electromagnetic coil not being utilized does not have to have a current running therethrough thereby preventing overheating of the coil and damage to the tissue (col 9 line 55 – col. 10 line 3 – Garibaldi).
However, the combination of is silent regarding (i) a controller electrically coupled to the first electromagnetic coil and to the second electromagnetic coil and operable to selectively activate each of the first and second electromagnetic coils one at a time to magnetically guide another device to or through the activated electromagnetic coil.
As to the above, Greenan teaches a vascular graft positioning system (abstract) comprising a controller 506 for directing electrical current to drive magnetic field generating coils one at a time, for the purpose of controlling the electromagnetic coils (abstract and paragraph [0081]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Quadri in view of Houser, Mayberry, and Garibaldi to incorporate a controller, based on the teachings Greenan, for the purpose of allowing the user to control the current flowing to the electromagnetic coils individually.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Quadri (US 2005/0154444 A1) in view of Houser (US 2003/0014063 A1) and Mayberry et al (US 8,945,202 B2), as applied to claim 1 above, and further in view of Marmur et al (US 10,485,684 B2).
Regarding claim 12, as discussed above, it would have been obvious to use the medical device of Quadri in view of Houser and Mayberry.
However, the combination of Quadri, Houser, and Mayberry is silent regarding (i) wherein the tubular gate portion comprises a stent frame.
As to the above, Marmur teaches, in the same field of endeavor, an apparatus comprising a main tubular body (main tube 40), a fenestration (opening within the lateral wall 56 from which the lateral tube 50 extends), and a tubular gate portion (lateral tube 50) wherein the tubular gate portion has a stent frame (Examiner’s note: the later tube is made up of strut members as recited in column 17, line 65 to column 18 line 16). Furthermore, Marmur teaches, in column 2 lines 5 – 25, the structural stent members of the lateral tube increases the fatigue resistance of the lateral tube during long-term implantation of the stent graft.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the tubular members of Quadri in view of Houser and Mayberry to incorporate the stent frame into the tubular gate portions, as taught by Marmur, for the purpose of increasing the fatigue resistance of the tubular member (column 2 lines 5 – 25 of Marmur).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Quadri (US 2005/0154444 A1) in view of Houser (US 2003/0014063 A1), and Mayberry et al (US 8,945,202 B2), as applied to claim 13 above, and further in view of Roeder et al (US 9,855,130 B2).
Regarding claim 14, as discussed above, the combination of Quadri, Houser, and Mayberry teach the device of claim 13.
However, the combination above is silent regarding (i) the shape of the electromagnetic coil.
As to the above, Roeder teaches, in the same field of endeavor, an apparatus (endoluminal prosthesis 20) comprising a tubular main body (prothesis 20) and first and second fenestrations (fenestrations 27A/B) disposed in a wall of the tubular main body (prosthesis 20) (abstract, col. 6 lines 1 – 40, and Fig. 1) wherein the fenestrations (fenestrations 27A/B) are oval shaped (col. 5 lines 63 – 67) for the purpose of matching the geometry of opening of the branching vasculature.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the fenestrations of Quadri to be oval shaped, based on the teachings of Roeder, as an oval shape is a known shape for fenestrations in endoprosthesis in order to match the geometry of the opening of the branching vasculature, and such a modification would have been predictable and resulted in the device being operable for its intended use. Furthermore, it would have been obvious to one of ordinary skill in the art to match the shape of the electromagnetic coils to the oval shape of the fenestrations for the purpose of creating a tight / friction fit attachment between the electromagnetic coils and the fenestrations. Therefore, the prior art combination makes obvious having an oval shaped electromagnetic coils.
Claim 15, 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Quadri (US 2005/0154444 A1) and in view of Houser (US 2003/0014063 A1), Mayberry et al (US 8,945,202 B2), Garibaldi (US 6,401,723), and Greenan et al (US 2008/0171934 A1).
Regarding claims 15, 16, 17, 18, Quadri discloses an apparatus (endoaortic graft 100) (abstract, paragraphs [0035 – 0037], [0067], and Figs. 1A/B, 2A, 8A/B, 10A-10DD) comprising:
a tubular main body (graft 100) configured to be implanted within a patient (paragraph [0035]), the tubular main body being radially collapsible and expandable between a collapsed state (shown in Fig. 2A) and an expanded state (shown in Fig. 10P) (paragraphs [0069] and Figs. 2A and Fig. 10P) ;
a first and second fenestration (left and right branch openings 114) (paragraph [0067] and Fig. 1B) in a wall (pliable tube 110) (paragraph [0067]) of the tubular body (graft 100);
[claim 16] wherein in the collapsed state after introduction into a patient’s body and prior to expansion in the patient’s body the fenestration (branch opening 114) is uncannulated and guide wire free (Examiner’s note: it should be understood that “prior to” is broad does not limit the claim to any specific point in time prior to the expansion within a patient’s body; and as stated in paragraph [0069] when the endoaortic graft is loaded within the delivery system 200, the compresses state, the branch guide wires are positioned within and traverse the branch openings 114 / the fenestrations, this means that there is a moment in time prior to the expansion of the graft, that the graft is compressed and the guide wire has yet to traverse / cannulate the fenestrations; therefore, at some point in time, the fenestrations will be uncannulated prior to expansion of the graft);
Quadri further teaches a first and second magnet (left and right magnetic rings 120) positioned around the fenestrations (branch openings 114) (paragraph [0067] and Fig. 1A/B), such that the magnets are operable to magnetically guide another device (branch graft delivery system 400) to or through the fenestration (branch openings 114) (Examiner’s note: as stated in paragraph [0080] and shown in Figs. 10O – 10U the delivery system 400 and the magnet 440 are guided through the graft 100 to the magnet 120 on the graft 100 to deliver the branch graft 300).
However, Quadri is silent regarding [claim 15] (i) wherein the first and second magnets are first and second electromagnetic coils wound on the tubular gate portion and positioned around each of the first and second fenestrations, respectively, the first and second electromagnetic coils being switchable between an activated state and a deactivated state, the first and second electromagnetic coils being operable to generate a magnetic field when electrical current flows through the electromagnetic coils in the activated state such that the electromagnetic coils are operable to magnetically guide another device to or through the fenestration, (ii) a controller electrically coupled to the first electromagnetic coil and to the second electromagnetic coil and operable to selectively activate each of the first and second electromagnetic coils one at a time to magnetically guide another device to or through the activated electromagnetic coil, [claim 16] (iii) wherein the electromagnetic coils are activatable after expansion of the tubular main body within the patient to cannulate the fenestration with a guide wire, and [claim 17] (iv) the tubular main body comprising a tubular gate portion extending outwardly from the tubular main body, the tubular gate portion being in fluid communication with the tubular main body through the fenestration and shaped and sized to receive a separately delivered stented branch through the tubular gate portion, wherein the first electromagnetic coil is wound around the tubular gate portion.
As to (i) and (iii), Houser, which is also cited by Quadri in paragraph [0021 – 0022] of Quadri teaches an apparatus (bypass graft and securing system) using magnets to further assist positioning of the delivery system within the body, the magnets are formed by winding conductive coils around a dilator to form electromagnets when current is supplied, and wherein the electromagnets on the dilator are used in conjunction with magnetically attracted guidewires such that when the current is applied the electromagnet on the dilator draws the guidewire to the dilator (paragraphs [0074 – 0075] of Houser).
It should be understood that Quadri and Houser are known references in the art that teach a deployment system for graft fixation comprising magnets to assist in the positioning of the system within the body (abstract, paragraphs [0067 – 0068], [0080], and Figs. 1A/B, 8A/B – Quadri ; paragraphs [0074 – 0075] – Houser); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one magnet / magnetic element for another (each of the magnets for a respective electromagnetic coil), and the results of the substitution would have been predictable and resulted in the modified system of Quadri being able to function as intended to properly to attract the endograft branch. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. Additionally, with respect to (iii), the limitation is intended use which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the modified device of Quadri comprising electromagnetic coils are activatable after the implant has been expanded within the patient to cannulate the fenestration with a guidewire (Examiner’s note: as stated in paragraph [0075] of Houser the electromagnetic coils are activated when a current is suppled and the coil electromagnets are strong enough to pull a metal guidewire; thus the metal guidewires of Quadri are capable of being pulled, to some degree, through or to the fenestrations when the electromagnetic coil is activated). Thus, the limitation is said to be encompassed by Quadri in view of Houser.
As to (ii), Garibaldi teaches, in a similar field of endeavor, an apparatus (magnetic medical device 20) (column 3 lines 51 – 60) comprising a first coil and a second coil (coils 26 and 30) (column 4, lines 20 – 30, and Fig. 5), being operable to generate a magnetic field when an electrical field is applied (column 4, lines 35 – 67), wherein the coils (coils 26 and 30) each have their own leads (Examiner’s note: as stated in column 4, lines 22 – 30, the coil 26 is coupled to / powered by leads 36 and 38, and the coil 30 is coupled to / powered by leads 44 and 46) that are coupled to the an electrical power source to generate electrical current in the coil (column 4 lines 25 – 35) and wherein the electromagnetic coils (magnetic coils - Houser) are selectively energized such that the location of the magnetic field is controlled for the purpose of only having to energize one coil at a time so that the electromagnetic coil not being utilized does not have to have a current running therethrough thereby preventing overheating of the coil and damage to the tissue (col 9 line 55 – col. 10 line 3 – Garibaldi). Additionally, Greenan teaches a vascular graft positioning system (abstract) comprising a controller 506 for directing electrical current to drive magnetic field generating coils one at a time, for the purpose of controlling the electromagnetic coils (abstract and paragraph [0081]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Quadri in view of Houser, to incorporate individual leads for each of the electromagnetic coils and a controller to control the current flow to said coils, based on the teachings of Garibaldi and Greenan, respectively, for the purpose of allowing the user to control the current flowing to the electromagnetic coils individually so that the electromagnetic coil not being utilized does not have to have a current running therethrough thereby preventing overheating of the coil and damage to the tissue (col 9 line 55 – col. 10 line 3 – Garibaldi; paragraph [0081] – Greenan)
As to (iv), Mayberry teaches, in the same field of endeavor, an apparatus comprising a tubular main body (prosthesis 1200) configured to be implanted within a patient (abstract, column 54 lines 19 – 35, and Figs. 62 – 63), a fenestration (fenestrations 1202) in a wall of the tubular main body (prosthesis 1200) (Fig. 62), and a tubular gate portion (tubular member 1210) extending outwardly from the tubular main body (prosthesis 1200) (Figs. 62 – 63), the tubular gate portion (tubular member 1210) being in fluid communication with the tubular main body (prosthesis 1200) through the fenestrations (Fig. 63), and shaped and sized to receive a separately delivered stented branch through the tubular gate portion (Examiner’s note: as recited in column 54 lines 19 – 35, the tubular gate portions are shaped and sized to receive separately delivered branch grafts and stents deployed within the fenestrations). Furthermore, Mayberry teaches, in col. 54 lines 19 – 35, the tubular member(s) 1210 (i.e., the tubular gate portions) improve the tear resistance and sealability of the fenestrations.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the tubular main body of Quadri in view of Houser, Garibaldi, and Greenan, to incorporate the tubular gate portions, based on the teachings of Mayberry, for the purpose of improving the tear resistance of the fenestration and improving the sealability between the fenestration and the branch grafts and stents (col. 54 lines 19 – 35 – Mayberry). Additionally, it should be understood that the prior art combination makes obvious wherein the modification made would result in the electromagnetic coil being wrapped around the outside of the tubular member 1210 (i.e., the tubular gate portions), as this would be where the side branch graft would attach and thus where the side branch graft would need to be magnetically drawn to.
Regarding claim 18, as discussed above, it would have been obvious to modify the endograft system of Quadri in view of Greenan and Garibaldi to incorporate the electromagnetic coils of Houser and the tubular gate portions of Mayberry. Additionally, the combination makes obvious wherein the electromagnetic coil is collapsible with the tubular main body for transvascular delivery (Examiner’s note: as stated in paragraph [0084] of Quadri the magnetic rings 120 are flexible, as shown in Fig. 2A of Quadri the rings 120 (along with the graft 100) are compressed within the delivery device, and as shown in the sequential Figs. 10L to 10P of Quadri the rings 120 expand radially outward when deployed; and because the magnetic rings 120 of Quadri were substituted for electromagnetic coils, based on the teachings of Houser, it would be obvious to one of ordinary skill in the art to have the electromagnetic coils be collapsible, in the same manner in which the magnetic rings are, for the purpose of being able to fully collapse the entire endograft within the delivery device). Therefore, the prior art makes obvious the limitations above.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Quadri (US 2005/0154444 A1) in view of Houser (US 2003/0014063 A1), Mayberry et al (US 8,945,202 B2), Garibaldi (US 6,401,723), and Greenan et al (US 2008/0171934 A1), as applied to claim 15 above, and further in view of Roeder et al (US 9,855,130 B2).
Regarding claim 19, as discussed above, the combination of Quadri, Houser, Mayberry, Garibaldi, and Greenan teach the device of claim 15.
However, the combination above is silent regarding (i) the shape of the electromagnetic coil.
As to the above, Roeder teaches, in the same field of endeavor, an apparatus (endoluminal prosthesis 20) comprising a tubular main body (prothesis 20) and first and second fenestrations (fenestrations 27A/B) disposed in a wall of the tubular main body (prosthesis 20) (abstract, col. 6 lines 1 – 40, and Fig. 1) wherein the fenestrations (fenestrations 27A/B) are oval shaped (col. 5 lines 63 – 67) for the purpose of matching the geometry of opening of the branching vasculature.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the fenestrations of Quadri to be oval shaped, based on the teachings of Roeder, as an oval shape is a known shape for fenestrations in endoprosthesis in order to match the geometry of the opening of the branching vasculature, and such a modification would have been predictable and resulted in the device being operable for its intended use. Furthermore, it would have been obvious to one of ordinary skill in the art to match the shape of the electromagnetic coils to the oval shape of the fenestrations for the purpose of creating a tight / friction fit attachment between the electromagnetic coils and the fenestrations. Therefore, the prior art combination makes obvious having an oval shaped electromagnetic coils.
Allowable Subject Matter
Claims 6 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art alone or in combination with fails to disclose or make obvious the device of claims 6 or claim 20, wherein the devices of claims 6 and 20 comprise the structure of claims 1 and 15, respectively, and further comprise a detachable nosecone on the tubular graft main body, wherein the nosecone houses a battery electrically coupled to the electromagnetic coil(s).
The closest prior art, Quadri in view of Houser and Mayberry (cited above), teach the devices of claims 1 and 15, as detailed in the rejection above. However, the combination fails to disclose or make obvious a detachable nosecone with a battery electrically coupled to the electromagnetic coils. Furthermore, although it would have been obvious to couple the electromagnetic coils to a battery for the purpose of suppling the electromagnetic coils with the electrical current needed to produce the intended magnetic field, it would not have been obvious to one of ordinary skill in the art to place the battery in a nosecone of the delivery system as there is no motivation, absent hindsight, to do so. Additionally, no other references, or reasonable combination thereof, could be found which discloses or suggests these features in combination with other limitations in the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Mciff et al (US 2008/0147173 A1) teaches a magnet on a endoprosthesis / tubular graft and a magnetic marker on a guidewire.
Wright et al (US 2008/0167704 A1) teaches a magnet on a fenestration of an endoprosthesis / tubular graft for connecting branch grafts.
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/Andrew Restaino/Primary Examiner, Art Unit 3771