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 .
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.
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.
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 limitation(s) is/are: “external rotational alignment element” in claims 44-47. The claim limitation is interpreted as an “indicator” stated in paragraph [0095] of the specification and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/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 this/these limitation(s) 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.
Claim Rejections - 35 USC § 103
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.
Claims 34-42, 48, 49, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Rudin (US2007/0021816) in view of Cohn (US2013/0096580).
Regarding claim 34, Rudin discloses a method comprising:
advancing a delivery system (catheter, [0047]) carrying a blood flow modification device to a first target artery (BV’, see Fig. 3A-B, where this artery is a main artery), the blood flow modification device comprising a frame (202) carrying a cover (200) that only partially surrounds a circumference of the frame (see Figs. 1A-B, 3A-3B);
rotationally aligning the cover with an ostium of an aneurysm (radiographic imaging is used for proper rotational orientation of the stent, [0054]);
deploying the blood flow modification device in the first target artery such that the cover is positioned across the ostium of the aneurysm ([0047]); and
occluding at least partial blood flow through the ostium of the aneurysm (partial obstruction, [0014]).
Rudin does not disclose inducing weight loss in a patient, and placing the blood modification device across the ostium of a second target artery. Cohn teaches an occlusion device that can be delivered into the vascular system of a patient for inducing weight loss (see Abstract). The device occludes the celiac artery (second artery) ([0048]). The device includes an exterior stent 45 that is deployed in the target blood vessel and then an interior occluding stent 60 is deployed within the exterior stent 45 ([0048]). Where the occluding stent 60 clots over time. It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have used the blood modification device of Rudin for inducing weight loss by positioning the device at an ostium of a second artery that provides blood flow to an organ of the gastrointestinal tract as taught by Cohn, since Rudin discloses a stent that occludes a cavity, and Cohn teaches it is known to use a stent in this manner for occlusion therapy for multiple purposes ([0069]). Examiner makes notice the stent of Rudin is placed in a main vessel (abdominal aorta) to meet the ostium of the aneurysm and would be placed at the junction of the celiac artery and abdominal aorta (main vessel) to perform as intended.
Rudin does not explicitly disclose gradually occluding blood flow. Cohn further teaches the occluding stent 60 gradually occluding blood flow, determined by the nature, design, and materials of the progressive occluding device ([0059]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the cover of the blood modification device of Rudin to have gradual occlusion determined by the nature, design, and materials of the progressive occluding device in order to induce hypoperfusion for a desired purpose ([0069]).
Regarding claim 35, Rudin/Cohn makes obvious the method of claim 34, Rudin further discloses further comprising partially deploying the blood flow modification device (partial deployment is when the stent is partially deployed out of catheter, [0047]).
Regarding claim 36, Rudin/Cohn makes obvious the method of claim 35, the modified invention further discloses further comprising confirming a radiopaque marker ([0044]) on a deployed section of the partially deployed blood flow modification device (the stent can be partially made of radiographic material, and therefore a partially deployed section would be partially made of radiographic material, [0044] of Rudin) is positioned opposite the ostium of the second target artery (the stent is partially made of radiographic material and therefore the part of the stent opposite to the ostium would include radiographic material).
Regarding claim 37, Rudin/Cohn makes obvious the method of claim 34, Rudin further discloses wherein deploying the blood flow modification device comprises unsheathing the blood flow modification device (unsheathing is interpreted as removing the device from the catheter, [0052]).
Regarding claim 38, Rudin/Cohn makes obvious the method of claim 34, the modified invention further discloses wherein deploying the blood flow modification device comprises positioning an end of the blood flow modification device between the second target artery (celiac artery as taught by Cohn) and a superior mesenteric artery (when the device is placed within the abdominal aorta to block the celiac artery as taught by the modified invention, it would be between the celiac artery and the superior mesenteric artery when looking down the vertical axis of the human body).
Regarding claim 39, Rudin/Cohn makes obvious the method of claim 34, the modified invention further teaches wherein gradually occluding at least partial blood flow through the ostium of the second target artery does not fully occlude blood flow through the ostium of the second target artery (Cohn teaches gradual occlusion and not complete occlusion over time but narrowing, [0058], [0059]).
Regarding claim 40, Rudin/Cohn makes obvious the method of claim 34; yet, does not explicitly disclose wherein gradually occluding at least partial blood flow through the ostium of the second target artery comprises occluding flow by at least 60% within one month. Cohn teaches partial occlusion taking place over a gradual period of time, and the length of time and amount of occlusion being a result effective variable, where the length of time of which is determined by the nature, design, and materials of the progressive occluding device ([0059]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have the gradual occlusion occlude flow by 60% after a month, based on the nature, design, and materials of the occluding device ([0059]). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
Regarding claim 41, Rudin/Cohn makes obvious the method of claim 34, the modified invention discloses further comprising, after gradually occluding at least partial blood flow through the ostium of the second target artery (gradual occlusion is interpreted as occurring after the first stent 202 is implanted), regaining access to the second target artery by advancing an instrument through the cover and the ostium of the second target artery (regaining access is performed by a second catheter to deliver a second stent 202’ and cover 200’ that is placed through the cover and ostium of the celiac artery as modified at least along the axis facing the intersection of the ostium and the components, see Fig. 3A-3B).
Regarding claim 42, Rudin/Cohn makes obvious the method of claim 41, the modified invention discloses wherein regaining access to the second target artery comprises advancing the instrument to the first target artery (second catheter advanced to the first artery) and through the cover to the second target artery (interpreted as advancing through the cover to the second target artery/celiac artery at least along the axis facing the intersection of the second catheter with the cover and target artery/celiac artery).
Regarding claim 48, Rudin/Cohn makes obvious the method of claim 34, the modified invention further teaches wherein the first target artery is an abdominal aorta and the second target artery is a celiac artery (where the device would be placed at the junction of the abdominal aorta and celiac artery by being positioned at the ostium of the celiac artery, [0048] of Cohn).
Regarding claim 49, Rudin/Cohn makes obvious the method of claim 34, Cohn further teaches wherein the second target artery is a superior mesenteric artery ([0036]).
Regarding claim 54, Rudin discloses a method comprising:
advancing a delivery system (catheter, [0047]) carrying a blood flow modification device (200/202) to a first artery (BV’, see Fig. 3A-Bk, the artery is a main artery), the blood flow modification device comprising a frame (202) carrying a cover (200);
rotationally aligning the cover with an ostium of an aneurysm (Rudin discloses catheter is rotated to correctly position the stent with visualization of the radiographic marker, [0054);
deploying the blood flow modification device in the first artery such that the cover is positioned across the ostium of the aneurysm (see Fig. 3A-B, [0047]);
occluding at least partial blood flow through the ostium of the aneurysm (partial obstruction, [0014]).
Rudin does not disclose inducing weight loss, and deploying the blood flow modification device in an abdominal artery, and positioning the frame cover across the ostium of a celiac artery. Cohn teaches an occlusion device that can be delivered into the vascular system of a patient for inducing weight loss (see Abstract). The device occludes the celiac artery (second artery) and therefore blocks blood to an organ of the gastrointestinal tract ([0048]). The device includes an exterior stent 45 that is deployed in the target blood vessel and then an interior occluding stent 60 is deployed within the exterior stent 45 ([0048]). Where the occluding stent 60 clots over time. It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have used the blood modification device of Rudin for inducing weight loss by positioning the device at an ostium of a second artery that provides blood flow to an organ of the gastrointestinal tract as taught by Cohn, since Rudin discloses a stent that occludes a cavity, and Cohn teaches it is known to use a stent in this manner for occlusion therapy for multiple purposes ([0069]). Examiner makes notice the stent of Rudin is placed in a main vessel to meet the ostium of the aneurysm and would be placed at the junction of the celiac artery and abdominal aorta (main vessel) to perform as intended.
Rudin does not explicitly disclose and gradually occluding at least partial blood flow through the ostium of the aneurysm. Cohn further teaches the occluding stent 60 gradually occluding blood flow, determined by the nature, design, and materials of the progressive occluding device ([0059]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the cover of the blood modification device of Rudin to have gradual occlusion determined by the nature, design, and materials of the progressive occluding device in order to induce hypoperfusion for a desired purpose ([0069]).
Claims 44-47, 50-53 are rejected under 35 U.S.C. 103 as being unpatentable over Rudin (US2007/0021816) in view of Cohn (US2013/0096580) as applied to claim 46, and further in view of Adams (US2004/0010280).
Regarding claim 44, Rudin/Cohn makes obvious the method of claim 34, Rudin further discloses further comprising confirming rotational alignment of the cover with the ostium of the second target artery (radiographic markers on the stent are used for alignment, [0044]); yet, is silent regarding using an external rotational alignment element on the delivery system for determining rotational alignment. Adams teaches using radiopaque markers (external rotational alignment element) on a catheter ([0056]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the delivery system of Rudin to include radiopaque markers on it to further assist in proper placement ([0056]). Where the markers of Adams are an equivalent structure to the “external rotational alignment element” interpreted under 112(f) by being a physical indicator on the system.
Regarding claim 45, Rudin/Cohn/Adams makes obvious the method of claim 44, the modified invention discloses further comprising rotating the delivery system until the external rotational alignment element is aligned with the ostium of the second target artery (Rudin discloses catheter is rotated to correctly position the stent with visualization of the radiographic marker, [0054]; where the modified invention would utilize the additional radiopaque markers in the same manner).
Regarding claim 46, Rudin discloses a method comprises steps of:
obtaining a delivery system (catheter, [0047]) comprising a blood flow modification device (200/202) and deploying the blood flow modification device within a first artery (BV’, see Fig. 3A-B, where this artery is a main artery),
wherein the blood flow modification device comprises a frame (200) and a frame cover (202) that partially surrounds a frame circumference (see Fig. 1A-B, 3A-B), and
wherein the frame cover is aligned within the delivery system ([0044]); and
positioning the frame cover adjacent an ostium of an aneurysm ([0047]) by rotating the delivery system (catheter is rotated to correctly position the stent with visualization of the radiographic marker, [0054]).
Rudin does not disclose inducing weight loss, and positioning the frame cover adjacent an ostium of a second artery that supplies blood to an organ of the gastrointestinal tract. Cohn teaches an occlusion device that can be delivered into the vascular system of a patient for inducing weight loss (see Abstract). The device occludes the celiac artery (second artery) and therefore blocks blood to an organ of the gastrointestinal tract ([0048]). The device includes an exterior stent 45 that is deployed in the target blood vessel and then an interior occluding stent 60 is deployed within the exterior stent 45 ([0048]). Where the occluding stent 60 clots over time. It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have used the blood modification device of Rudin for inducing weight loss by positioning the device at an ostium of a second artery that provides blood flow to an organ of the gastrointestinal tract as taught by Cohn, since Rudin discloses a stent that occludes a cavity, and Cohn teaches it is known to use a stent in this manner for occlusion therapy for multiple purposes ([0069]). Examiner makes notice the stent of Rudin is placed in a main vessel to meet the ostium of the aneurysm and would be placed at the junction of an artery extending from the abdominal aorta and abdominal aorta (main vessel) to perform as intended.
Rudin does not explicitly disclose wherein the delivery system comprises an external rotational alignment element. Rudin discloses radiographic markers on the stent as an alignment element ([0044]). Adams teaches using radiopaque markers (external rotational alignment element) on a catheter ([0056]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the delivery system of Rudin to include radiopaque markers on it to further assist in proper placement ([0056]). Where the frame cover and external rotational alignment element would be aligned within the delivery system during the delivery process ([0044] of Rudin). Where the markers of Adams are an equivalent structure to the “external rotational alignment element” interpreted under 112(f) by being a physical indicator on the system. Where the modified invention would be configured to rotate the delivery system so that the external rotational alignment element is aligned with the ostium of the aneurysm ([0044] of Rudin teaches rotational alignment using radiopaque markers, where the additional radiopaque markers as taught by Adams would be used in the same manner)
Regarding claim 47, Rudin/Cohn/Adams makes obvious the method of claim 46; yet, is silent regarding wherein the external rotational alignment element comprises a hemostasis valve "Y" connector comprising a Y port that is aligned with the frame cover in the delivery system, and wherein the hemostasis valve "Y" connector is in a rotationally locked position. Rudin discloses the catheter inserted into an introducer ([0018]). Adams teaches a system that includes a device to occlude blood flow and a distal protection device to remove embolic debris (see Abstract). The system having an introducer that includes a hemostasis valve “Y” connector comprising a Y port ([0060]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the introducer having a hemostasis valve and Y port as taught by Adams for the introducer of Rudin, since the substitution would have yielded the same predictable result of providing an introducer for the assembly while also preventing blood loss because of the hemostasis valve ([0060]). Where the modified invention of Rudin/Cohn/Adams is interpreted as having the connector in a rotationally locked position by the introducer being secured for introduction of the system into the body.
Regarding claim 50, Rudin/Cohn/Adams makes obvious the method of claim 46, the modified invention discloses wherein the first artery is an abdominal aorta (where the device would be placed at the junction of the abdominal aorta and celiac artery by being positioned at the ostium of the celiac artery, [0048] of Cohn).
Regarding claim 51, Rudin/Cohn/Adams makes obvious the method of claim 46, the modified invention discloses wherein the second target artery is a celiac artery or a superior mesenteric artery (where the device would be placed at the junction of the abdominal aorta and celiac artery by being positioned at the ostium of the celiac artery, [0048] of Cohn).
Regarding claim 52, Rudin/Cohn/Adams makes obvious the method of claim 46, Cohn further teaches wherein the second target artery is a left gastric artery, a right gastric artery, a left gastroepiploic artery, a right gastroepiploic artery, a common hepatic artery, an inferior pancreaticoduodenal artery, jejunal arteries, or ileal arteries ([0035]).
Regarding claim 53, Rudin/Cohn/Adams makes obvious the method of claim 46; yet, does not explicitly disclose further comprises reopening the second target artery after positioning the frame cover adjacent the ostium of the second target artery. Cohn further teaches reopening the artery completely after the occluder is within the artery ([0068]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have reopened the artery after occlusion as taught by Cohn in order to restore natural function of the artery if there is complication with the surgery ([0057])
Allowable Subject Matter
Claim 43 is 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:
No prior art of record teaches or discloses “wherein regaining access to the second target artery comprises advancing the instrument through a third target artery and into the second target artery and then through the cover into the first target artery.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799