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 Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims 21-25 have been renumbered 21-26 used in this action; applicant presented two claims 22.
Response to Arguments
Applicant's arguments filed 9/11/2025 have been fully considered but they are not persuasive. Applicant argues that the device for placement within a blood vessel of Papp et al fails to teach the stent elements spacing equation wherein D is a diameter of a stent element.
The distance/spacing between each stent is greater than or equal to
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.
Claim 14 has been amended claiming theta = 8.473 degrees. The cos(8.473) = 0.989. (1-0.989) = 0.0109 which is almost zero. The spacing equation using a very small diameter stent results in a near zero spacing. Without knowing the diameter D the equation cannot be solved.
Also, applicant claims “a device” and not a method using said device. The distance after expansion does not equal the unclaimed spacing on the balloon.
Finally, most of the claim limitations, including the stent elements spacing equation, are considered directed to functional language of using said device.
Papp et al teaches a device for placement within a blood vessel to maintain or enhance blood flow through the blood vessel, the device comprising multiple, balloon-expandable, stent elements (at least 351, 352, 353 and figures 15A-15B) configured to be implanted in the blood vessel as a multi-element stent;
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wherein the stent elements are positioned serially along a longitudinal length of a balloon (as shown and par. 0134) and do not touch one another in an unexpanded state. This alone fulfills claim 14. Pappa et al further teaches the following wherein the underlined and bolded portion maybe what applicant maybe believes to be inventive:
[0134] FIG. 5 depicts a projection of axial segments 351, 352, and 353 disposed over a balloon 350 in a deflated configuration. Axial segments are crimped tightly over the balloon in a reduced diameter configuration. A crimped configuration generally may correspond to the inner surface of the segments in contact with the outer surface of a balloon. The axial segments are spaced apart by a distance, size, or width Lg, which is the gap between segments. Lg can change during inflation and deployment of the segments to a deployed diameter due to movement of the segments and axial contraction or shortening of the segments. Lg at deployment should be large enough to avoid interference or contact of the segment ends during bodily movements.
Lines 7-16 of applicant’s claim 14 is considered functional language which device of Pappa et al is fully capable of.
The examiner removes the rejection under 35 U.S.C. 103 as being unpatentable over Papp et al (2013/0268045) to simplify the appeal process.
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.
Claims 14-17, 19-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Papp et al (2013/0268045).
Papp et al teaches a device for placement within a blood vessel to maintain or enhance blood flow through the blood vessel, the device comprising:
multiple, balloon-expandable, stent elements (at least 351, 352, 353 and figures 15A-15B) configured to be implanted in the blood vessel as a multi-element stent;
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wherein the stent elements are positioned serially along a longitudinal length of a balloon (as shown and par. 0134) and do not touch one another in an unexpanded state. Also, see figures 5, 8A-19D. The above fulfills claim 14.
The remainder of the claim is functional language. Regarding, “wherein the stent elements are spaced such that after implantation the stent elements do not touch one another at a targe vessel location during skeletal movement”, Pappa et al teaches:
[0134] FIG. 5 depicts a projection of axial segments 351, 352, and 353 disposed over a balloon 350 in a deflated configuration. Axial segments are crimped tightly over the balloon in a reduced diameter configuration. A crimped configuration generally may correspond to the inner surface of the segments in contact with the outer surface of a balloon. The axial segments are spaced apart by a distance, size, or width Lg, which is the gap between segments. Lg can change during inflation and deployment of the segments to a deployed diameter due to movement of the segments and axial contraction or shortening of the segments. Lg at deployment should be large enough to avoid interference or contact of the segment ends during bodily movements. Lg at deployment should be large enough so that there is axial stability and the support of the vessel is continuous. In exemplary embodiments, the segments when deployed are spaced apart by 0.5 to 2 mm, or more narrowly, 0.5 to 1 mm, 1 to 2 mm, 2 to 3 mm. The required Lg is determined by the anatomy that the segmented scaffold will be deployed in to, i.e., in the SFA it will need to be greater than for the Iliac where vessel compression and bending are virtually zero. In general, Lg is higher for anatomies with higher vessel compression and bending.
Therefore, Pappa et al teaches the stent elements are spaced such that after implantation, in an expanded state, the stent elements do not touch one another at a target vessel location during skeletal movement at a Spacing distance Lg. This is applicant’s supposed invention.
Pappa et al inherently fulfills (and is fully capable of) the said Spacing distance equation and even teaches the spacing of 3 mm (claimed in applicant’s claim 17) stated par. 0134 above. The claim language wherein a distance greater than or equal to
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does not limit the claim without knowing the diameter (D) and is still only functional language describing the stent element in an expanded state at a target vessel.
Regarding claim 14, the following is interpreted as functional language only which the device of Pappa et al is fully capable of fulfilling.
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Regarding claim 21, the following is interpreted as functional language only which the device of Pappa et al is fully capable of fulfilling.
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Claims 15 and 22, referring to figures 5, 8A-19D, the drawings show the stent element are the same length Ls. Note at least par. 0122. See MPEP 2125.
Claims 16 and 23, referring to figures 5, 7-19D, the drawings show the stent element are equally spaced. Note at least par. 0147 teaching the pre-pillowed sections have a width and par. 0134. See MPEP 2125.
Claims 17 and 24, par. 0134 teaches each of the stent elements are separated a distance of at least 2 to 3 mm while mounted on the ballon. After implantation, the stent elements are fully capable of being space at least 3 mm after implantation. This claim is functional language which device of Papp et al is fully capable of fulfilling. Also, see par. 0201 teaching a spacing of 2-5 mm fully capable of being separated greater than 3 mm after implantation.
Claim 18 is functional language which the device of Pappa is fully capable of fulfilling. See at least par. 0122 teaching varying stent element lengths.
Claims 19 and 25 claims the distance between each stent element is greater than or equal to ((LEC+GEC-GC)/(E-1))+G. This equation comprises numerous undefined variable L, E, G, D and is considered functional language which does not further limit the independent claim from which they depend. Pappa et al teaches stent elements of similar lengths, number of elements, materials such as PLLA. The device of Pappa et al is fully capable of fulfilling this function language equation.
Claims 20 and 26, see par. 0201 teaching a spacing of 2-5 mm fulfilling greater than 3 mm.
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 19-20 and 25-26 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.
Claims 19 and 25 claim the distance between each stent element greater than or equal to ((LEC+GEC-GC)/(E-1))+G comprises numerous undefined variable L, E, G, D and is considered indefinite. It is unclear how this limitation further limits claim 14.
Claims 20 and 26 claim the distance between each stent element is greater than 3 mm. It is ambiguous if this is defining the stent elements in the unexpanded state on the balloon or in an expanded state at a target vessel.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774