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 . Claims 12-15, 64-73 are pending and examined below.
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 04/22/2025, with respect to claims 12-15 and 64-70 have been fully considered and are persuasive. The §103 rejection of claims 12-15 and 64-70 have been withdrawn.
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.
Claims 12-15, 64-73 are 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 claims 12, 67, and 68 the phrase "restricting portion" renders the claim(s) indefinite because it is unclear if the “restriction portion” is a technical feature of the implantable medical device or if the “restriction portion” is just a section of the graft after it has been twisted into a second configuration. The dependent claims are likewise rejected.
Regarding claims 12, 67, and 68 the phrase "adjustable portion" renders the claim(s) indefinite because it is unclear if the “adjustable portion” is a technical feature of the implantable medical device or if the “adjustable portion” is just a section of the graft that can be twisted into a second configuration. The dependent claims are likewise rejected.
Regarding claim 72 the phrase "substantially straight" renders the claim(s) indefinite because it is unclear what is required for the graft to be considered “substantially straight”.
Regarding claim 72 the phrase "substantially similar" renders the claim(s) indefinite because it is unclear what is required for the graft length to be considered “substantially similar”.
Claim 72 recites the limitation "the first length" in line two. There is insufficient antecedent basis for this limitation in the claim.
Claim limitation “restricting portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. For instance, it is unclear what structure or material would be required for a material to be considered a restricting portion. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim limitation “adjustable portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. For instance, it is unclear what structure or material would be required for a material to be considered an adjustable portion. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 12-15, 64-73 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bodewadt et al (US 2015/0374383 A1).
Regarding claim 12, Bodewadt et al discloses an implantable medical device for altering blood flow in a vessel of a patient (abstract), the device comprising: a stent element including a first stent and a second stent longitudinally spaced from each other (Fig. 1: first end element (16) and second end element (18), paragraph 0036); and a graft component attached to at least a portion of the stent element (Fig. 1: sleeve (30), paragraph 0039), the stent element and the graft component having: a restricting portion configured to direct flow into one or more side branches off the vessel (Fig. 1: coil (15), paragraph 0037; which is able to restrict the flow of blood and would be capable of altering the flow of blood downstream to other branched vessels in the body, paragraphs 0034 and 0037; also see MPEP 2114(II)), and an adjustable portion configured to alter an amount of directed blood flow by the restricting portion (Fig. 1: intermediate element (20), paragraph 0037), the adjustable portion including a membrane (the intermediate portion (20) is made of an expandable material, which can be considered a membrane, paragraph 0037)
Regarding claim 13, Bodewadt et al discloses the implantable medical device of claim 12, wherein the adjustable portion includes a first adjustable section and a second adjustable section (see annotated fig. 2a below, also see paragraph 0044), and at least one of the first adjustable section and the second adjustable section is configured to rotate to alter the amount of directed blood flow by the restricting portion (Fig. 2: the device is able to rotate along longitudinal axis (22) by the arrow (42 and 44), paragraph 0044; also see MPEP 2114(II)).
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Regarding claim 14, Bodewadt et al discloses the implantable medical device of claim 13, wherein the first adjustable section having an outlet and a second adjustable section having an outlet (see annotated fig. 2b below), and the directed blood flow increases in response to alignment of the outlet of the first adjustable section (Fig. 1: when the first section and the second section are aligned, meaning not twisted, the blood flow would be capable of increasing due to there being no obstruction to reduce the blood flow, paragraphs, 0008, 0035 and 0041; also see MPEP 2114(II)) and the outlet of the second adjustable section and decreases in response to misalignment of the outlet of the first adjustable section and the outlet of the second adjustable section (Fig. 2: when the first section and the second section are misaligned, meaning twisted, the blood flow would then decrease, paragraph , paragraphs 0008, 0035 and 0042, also see MPEP 2114(II)).
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Regarding claim 15, Bodewadt et al discloses the implantable medical device of claim 12, wherein the adjustable portion includes a multi-layer stent-structure having a membrane (the intermediate portion (20), in combination with a portion of the stent, is made of an expandable material, which can be considered a membrane, paragraph 0037) and the membrane is configured to restrict blood flow in response to increased blood pressure during the cardiac output phase (paragraph 0037, also see MPEP 2114(II)).
Regarding claim 64, Bodewadt et al discloses the implantable medical device of claim 12, wherein the adjustable portion is configured to be twisted to constrict a lumen extending therethrough (Fig. 2: paragraph 0041, also see MPEP 2114(II)).
Regarding claim 65, Bodewadt et al discloses the implantable medical device of claim 12, wherein the stent element includes a first body portion coupled to a first end of the adjustable portion (Fig. 2: end member (16) is connected to a portion of the adjustable portion (20), paragraph 0037), and a second body portion coupled to a second end of the adjustable portion (Fig. 2: end member (18) is connected to a portion of the adjustable portion (20), paragraph 0037),
Regarding claim 66, Bodewadt et al discloses the implantable medical device of claim 65, wherein first and second end are operable to rotate relative to each other (Fig. 2: paragraph 0041, also see MPEP 2114(II)).
Regarding claim 67, Bodewadt et al discloses an implantable medical device for altering blood flow in a vessel of a patient (abstract), the device comprising: a stent element and a graft component attached to at least a portion of the stent element (Fig. 1: an expandable sent (14) and sleeve (30), paragraphs 0035 and 0039), the stent element and the graft component having: a restricting portion configured to direct flow into one or more side branches off the vessel (Fig. 1: coil (15), paragraph 0037; which is able to restrict the flow of blood and would be capable of altering the flow of blood downstream to other branched vessels in the body, paragraphs 0034 and 0037; also see MPEP 2114(II)), and an adjustable portion configured to alter an amount of directed blood flow by the restricting portion (Fig. 1: intermediate element (20), paragraph 0037), wherein the adjustable portion is configured to be twisted to constrict a lumen extending therethrough (Fig. 2: the device is able to rotate along longitudinal axis (22) by the arrow (42 and 44), paragraph 0044; also see MPEP 2114(II)), wherein the graft component defines a lumen (the sleeve (30) includes a lumen, paragraph 0043), wherein the lumen has a first diameter when the stent element is in a first configuration (the lumen would have a diameter when the graft is not twisted, as seen in Fig. 1; paragraph 0043), and wherein the lumen has a second diameter that is smaller than the first diameter when the stent element is rotated (the lumen would then have a smaller second diameter when the graft is twisted, as seen in fig. 2, paragraph 0043)
Regarding claim 68, Bodewadt et al discloses an implantable medical device for altering blood flow in a vessel of a patient (abstract), the device comprising: a stent element including a first body portion defining first and second ends (see annotated fig. 2c below) and a second body portion including third and fourth ends (see annotated fig. 2c below) and a graft component including a first end coupled to the first body portion at a second end of the first body portion (see annotated fig. 2c below: sleeve (30), paragraph 0039)and a second end of the graft component coupled to the third end of the second body portion (see annotated fig. 2c below: sleeve (30), paragraph 0039), the stent element and the graft component having: a restricting portion configured to direct flow into one or more side branches off the vessel, (Figs. 1 and 2: coil (15), paragraph 0037; which is able to restrict the flow of blood and would be capable of altering the flow of blood downstream to other branched vessels in the body, paragraphs 0034 and 0037; also see MPEP 2114(II)) and an adjustable portion configured to alter an amount of directed blood flow by the restricting portion (Figs. 1 and 2: intermediate element (20), paragraph 0037), wherein the adjustable portion is configured to be twisted to constrict a lumen extending therethrough (Fig. 2: the device is able to rotate along longitudinal axis (22) by the arrow (42 and 44), paragraph 0044; also see MPEP 2114(II)).
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Regarding claim 69, Bodewadt et al discloses the implantable medical device of claim 12, wherein the graft component extends between the first and second stents (Fig. 1: sleeve (30) is between the first stent and the second stent, paragraphs 0040-0042).
Regarding claim 70, Bodewadt et al discloses the implantable medical device of claim 12, wherein the graft component defines a lumen (the sleeve (30) includes a lumen, paragraph 0043), wherein the lumen has a first diameter when the first and second stent are in a first configuration (the lumen would have a diameter when the first and second stents are not twisted, as seen in Fig. 1; paragraph 0043), and wherein the lumen has a second diameter that is smaller than the first diameter when the first stent is rotated relative to the second stent (the lumen would then have a smaller second diameter when the first and second stents are twisted, as seen in fig. 2, paragraph 0043) .
Regarding claim 71, Bodewadt et al discloses the implantable device of claim 12, wherein each of the first stent and the second stent have a first longitudinal length (see annotated fig. 2d below; the first stent length and the second stent length combined will be considered a first longitudinal length) and the graft component has a second longitudinal length that is shorter than the first longitudinal length (see annotated fig. 2d below, where the first longitudinal length, the first stent length and the second stent length, is longer compared to the twisted graft; also see paragraph 0063).
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Regarding claim 72, Bodewadt et al discloses the implantable medical device of claim 71, wherein, when the graft component is in a substantially straight configuration (the graft has an annular cylindrical configuration, which can be considered to be a straight configuration, paragraph 0036), the first length is substantially similar to a diameter of the graft component (paragraph 0054)
Regarding claim 73, Bodewadt et al discloses the implantable medical device of claim 12, wherein the graft component is continuous (Figs. 1 and 2: sleeve (30) is seen to be made from a single component, paragraphs 0039-0042).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE H TREVINO III whose telephone number is (703)756-4678. The examiner can normally be reached Monday - Friday: 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.T./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
