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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/09/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 06/23/2025. As directed by the amendment: claims 1, 6 and 13 have been amended, claims 3 and 63 have been cancelled and new claims 64-72 have been added. Thus, claims 1, 2, 4, 6, 7, 12-14 and 64-72 are presently pending in this application, and currently examined in the Office Action.
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.
Claims 64-72 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 last two lines of claim 64 set forth the parameter of “the spring is configured to cause more deformation to the arterial wall during diastole than during systole”; however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed specification never discloses an expandable structure comprising first and second elongate rigid elements which are linear along a longitudinal axis and curved along an axis orthogonal to the longitudinal axis and a spring extending between the first and second elongate rigid elements, wherein “the spring is configured to cause more deformation to the arterial wall during diastole than during systole”, as set forth in claim 64.
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 1, 2, 4, 6, 7, 12-14, 67 and 68 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 claim 1, which recites the limitation “the first and second rigid elements”, on the 2nd and last lines; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection and keep claim terminology consistent, it is suggested the word “elongate” be added between the words “second” and “rigid”.
Regarding claims 7 and 68, which recite the limitation “the aorta”, on the last line of both claims; there is insufficient antecedent basis for this limitation in the claims. In order to overcome this rejection it is suggested the word “the” be deleted and replaced with the word “an”.
Regarding claim 67, which recites the limitation “the plurality of springs”, on lines 1-2; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection and keep claim terminology consistent, it is suggested the words “plurality of springs” be deleted and replaced with the word “spring”.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 102
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)(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 64-71 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Karapetian (US PG Pub. 2022/0008188).
Regarding claims 64, 65 and 67, Karapetian discloses a device, for treating an artery, comprising an expandable structure configured to be intravascularly positioned within a lumen of the artery at a treatment site, wherein the artery has a substantially circular cross- sectional shape at the treatment site prior to deployment of the expandable structure therein, and wherein the expandable structure is configured to be positioned in an expanded state in apposition with an arterial wall at the treatment site, and wherein, under diastolic pressure, the expandable structure is configured to force the artery into a non-circular cross-sectional shape having a cross-sectional area less than a cross-sectional area of the artery in the substantially circular cross-sectional shape, and wherein the expandable structure is configured to deform towards a more circular cross-sectional shape in response to deformation of the arterial wall during systole ([0061]; [0062] & [0064]); and further wherein the expandable structure (90), illustrated in Figure 15A, comprises first and second elongate rigid elements (97) configured to be positioned against opposing portions of the arterial wall (98), each of the first and second elongate rigid elements (97) being linear along its respective longitudinal axis and curved along a dimension orthogonal to the longitudinal axis, and a spring (92) extending between the first and second elongate rigid elements (97) and holding them apart, wherein a preload and geometry of the spring (92) cause a force holding the first and second elongate rigid elements (97) apart to decrease as the first and second elongate rigid elements are pressed closer together, and wherein the spring is configured to cause more deformation to the arterial wall during diastole than during systole, illustrated in Figure 15A ([0106]).
Regarding claim 66, Karapetian discloses the device of Claim 64, wherein the non-circular cross-sectional shape is one of an oval, an ellipse, or an hourglass ([0064], Lines 4-5).
Regarding claim 68, Karapetian discloses the device of Claim 64, wherein the device is configured to be positioned in the aorta ([0063], 2nd to Last Line).
Regarding claim 69, Karapetian discloses the device of Claim 64, wherein the expandable structure comprises a superelastic material ([0067], Lines 1-3).
Regarding claims 70 and 71, Karapetian discloses the device of Claim 64, wherein the expandable structure is non-circular when positioned in the arterial lumen in the expanded state in the absence of an external constraint ([0064], Lines 5-7).
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 1, 2, 4, 6, 7, 12-14 and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Karapetian.
Regarding claims 1, 2 and 6, Karapetian discloses a device, for treating an artery, comprising an expandable structure configured to be intravascularly positioned within a lumen of the artery at a treatment site, wherein the artery has a substantially circular cross- sectional shape at the treatment site prior to deployment of the expandable structure therein, and wherein the expandable structure is configured to be positioned in an expanded state in apposition with an arterial wall at the treatment site, and wherein, under diastolic pressure, the expandable structure is configured to force the artery into a non-circular cross-sectional shape having a cross-sectional area less than a cross-sectional area of the artery in the substantially circular cross-sectional shape, and wherein the expandable structure is configured to deform towards a more circular cross-sectional shape in response to deformation of the arterial wall during systole ([0061]; [0062] & [0064]); and further wherein the expandable structure (90), illustrated in Figures 15A, 15B and modified figure 15B, below, first and second elongate rigid elements (97) configured to be positioned against opposing portions of the arterial wall (98), each of the first and second elongate rigid elements (97) being linear along its respective longitudinal axis and curved along a dimension orthogonal to the longitudinal axis, and a plurality of springs (92&92S) extending between the first and second rigid elements (97) and holding them apart, wherein a preload and geometry of the spring (92) cause a force holding the first and second elongate rigid elements (97) apart to decrease as the first and second elongate rigid elements are pressed closer together, and wherein the spring is configured to cause more deformation to the arterial wall during diastole than during systole, illustrated in Figures 15A, 15B and modified figure 15B, below ([0106]; [0124], Lines 9-11 & [0125], Lines 1-3); thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the first and second elongate rigid elements (97) with the embodiment illustrated in Figure 15B and modified figure 15B, below, which have a plurality of springs (92&92S), since Karapetian states that components/elements of any embodiment can be used with any other embodiment, and in order to protect the vessel walls from the spring structures, as also disclosed by Karapetian.
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Regarding claim 4, Karapetian discloses the device of Claim 1, wherein the non-circular cross-sectional shape is one of an oval, an ellipse, or an hourglass ([0064], Lines 4-5).
Regarding claim 7, Karapetian discloses the device of Claim 1, wherein the device is configured to be positioned in the aorta ([0063], 2nd to Last Line).
Regarding claim 12, Karapetian discloses the device of Claim 1, wherein the expandable structure comprises a superelastic material ([0067], Lines 1-3).
Regarding claims 13 and 14, Karapetian discloses the device of Claim 1, wherein the expandable structure is non-circular when positioned in the arterial lumen in the expanded state in the absence of an external constraint ([0064], Lines 5-7).
Regarding claim 72, Karapetian discloses the device of Claim 64, wherein the spring (92) is a first spring and the expandable structure (90) further includes a second spring (92S) extending between the first and second elongate rigid elements (97), illustrated in Figures 15A, 15B and modified figure 15B, above ([0106]; [0124], Lines 9-11 & [0125], Lines 1-3); thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the first and second elongate rigid elements (97) with the embodiment illustrated in Figure 15B and modified figure 15B, above, having first and second springs (92&92S), since Karapetian states that components/elements of any embodiment can be used with any other embodiment, and in order to protect the vessel walls from the spring structures, as also disclosed by Karapetian.
Response to Arguments
Applicant’s arguments with respect to independent claims 1 and 64 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774