Prosecution Insights
Last updated: August 06, 2026
Application No. 18/708,453

VASCULAR GRAFT WITH PULSATION DAMPING

Non-Final OA §102§103§112
Filed
May 08, 2024
Priority
Nov 09, 2021 — provisional 63/277,379 +1 more
Examiner
BLASS, PARIS MARIE
Art Unit
Tech Center
Assignee
Atrium Medical Corporation
OA Round
1 (Non-Final)
55%
Grant Probability
Moderate
1-2
OA Rounds
1y 4m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 55% of resolved cases
55%
Career Allowance Rate
17 granted / 31 resolved
-5.2% vs TC avg
Strong +54% interview lift
Without
With
+53.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
38 currently pending
Career history
75
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
51.2%
+11.2% vs TC avg
§102
31.2%
-8.8% vs TC avg
§112
16.3%
-23.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 31 resolved cases

Office Action

§102 §103 §112
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 . 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. Information Disclosure Statement The references cited in the PCT international search report have been considered, but will not be listed on any patent resulting from this application because they were not provided on a separate list in compliance with 37 CFR 1.98(a)(1). In order to have the references printed on such resulting patent, a separate listing, preferably on a PTO/SB/08 form, must be filed within the set period for reply to this Office action. 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 1-19, 22 and 24-31 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. The term “substantially” in claims 1-2, 5-6, and 18 is a relative term which renders the claims indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In regards to claim 1, it is unclear what amounts of change would fall within the scope of “substantially unchanged.” Claims 2-19, 22 and 24-31 depend from claim 1 and are indefinite for the same reason. In regards to claim 2, it is unclear what amount of a difference in perimeter would fall within the scope of “substantially equivalent.” In regards to claim 5, it is unclear what amount falls within the scope of “substantially great than a minor dimension of the shape.” 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)(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 1-4, 7-11, 12-19, 22, 24, and 28-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9579187 B1 (hereafter --Zukowski--). Regarding Claim 1, Zukowski discloses a vascular graft comprising: an implantable tubular body (40, 20) defining a lumen and at least one support frame (62) engaged to the tubular body for modifying a shape of a cross-section of at least a portion of the lumen (see column 10, lines 24-28, see annotated support frame 62 and portion of the lumen in Figure 31 below). The limitation “wherein the tubular body and the at least one support frame are configured to receive pulsatile blood flow so that as pressure of blood flowing through the lumen increases, a cross-sectional area of the portion of the lumen increases while a perimeter of the portion of the lumen remains substantially unchanged in order to dampen pulsation of the blood flow” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the graft being able to be compressed and expanded, as well as constricted in expansion by the support frame (see Figure 31, showing that the area of the device that lacks the support frame 62 increases in diameter, see also column 10, lines 24-44), and due to the graft/implant being capable of being implanted into a vessel/lumen that is not perfectly circular (oval shaped vessel), the device is able to be compressed by external pressures, in turn altering its starting shape to oval. The term “substantially unchanged” is read upon by the claim as it is not defined in the claim and unclear. The term is being given its broadest reasonable interpretation, to include small minute changes still falling under the umbrella of “substantially unchanged”. Looking deeper into the application, the term is indirectly further defined in claim 8 confirming that from the first state to the second state the perimeter still increases minutely, specifically that it preferably increases no more than about a 5% from the first to the second state. As shown in the rejections of claims 7-9 below, the numbers pan out relative to the prior art. Additionally, since the term “portion of the lumen” could include any portion of the stent graft, the portion of the lumen is interpreted to be the edge of the support frame 62 compressing a portion of the stent and graft that expands out from the connection, therefore the frame 62 is “modifying the shape of the cross section” at the part that it is connected to, all whilst the cross section beyond the connection of the support frame is increasing during expansion. PNG media_image1.png 235 462 media_image1.png Greyscale Regarding Claim 7, Zukowski discloses the vascular graft of claim 2, wherein the second cross-sectional area is at least about 10% greater than the first cross-sectional area (see column 10, lines 53-65 denoting that the stent graft is radially compliant in expansion from the free stent graft diameter up to 3 to 30% increase in diameter from the free stent graft diameter, including 3% or more, 5% or more, 10% or more, 15% or more, 20% or more, or 30% or more). Looking at an at least 10% increase of the cross sectional area, to find the least % amount of diameter it would take to end up at this difference. I looked at the formula A= pi*(d^2)/4, and solved for the diameter in the following equation: [1.1*( pi*(d^2)/4) ≤ ( pi*(x*d)^2)/4)]. Solving for x in this equation, I found ≈ 1.05, resulting in the fact that the diameter would at least need to increase by about 5% to increase the cross sectional area of the cylindrical graft by at least 10%. Since Zukowski specifically discloses 5% being a possible diameter increase percentage, Zukowski reads on the claim. Regarding Claim 8, Zukowski discloses the vascular graft of claim 7, wherein the second perimeter is no more than about 5%, preferably about 2% to about 3%, greater than the first perimeter (see column 10, lines 53-65 denoting that the stent graft is radially compliant in expansion from the free stent graft diameter up to 3 to 30% increase in diameter from the free stent graft diameter, including 3% or more, 5% or more, 10% or more, 15% or more, 20% or more, or 30% or more). Looking at an at least 10% increase of the cross sectional area, to find the least % amount of diameter it would take to end up at this difference. I looked at the formula C=pi*d and equaled it to 1.05*pi*d ≥ x*pi*d. Solving for x in this equation, I found 1.05, resulting in the fact that the diameter would at least need to increase by about 5% to increase the perimeter of the cylindrical graft by at most 5%. The perimeter and the diameter are directly proportional to the diameter, so if the diameter increased by 3%, so would the perimeter. Since Zukowski specifically discloses both 3% and 5% being a possible diameter increase percentages, Zukowski reads on the claim. Regarding Claim 9, Zukowski discloses the vascular graft of claim 2, wherein the second cross-sectional area is from about 10% greater to about 15% greater than the first cross-sectional area (see column 10, lines 53-65 denoting that the stent graft is radially compliant in expansion from the free stent graft diameter up to 3 to 30% increase in diameter from the free stent graft diameter, including 3% or more, 5% or more, 10% or more, 15% or more, 20% or more, or 30% or more). Looking at an at least 10% increase of the cross sectional area, to find the least % amount of diameter it would take to end up at this difference. I looked at the formula A= pi*(d^2)/4, and solved for the diameter in the following equation: [1.1*( pi*(d^2)/4) ≤ ( pi*(x*d)^2)/4)]. Solving for x in this equation, I found ≈ 1.05, resulting in the fact that the diameter would at least need to increase by about 5% to increase the cross sectional area of the cylindrical graft by at least 10%. Since Zukowski specifically discloses 5% or more being a possible diameter increase percentage range, Zukowski reads on the claim. PNG media_image2.png 545 665 media_image2.png Greyscale Regarding Claim 2, Zukowski discloses the vascular graft of claim 1, wherein the tubular body and the at least one support frame are configured to transition between a first state, in which the portion of the lumen has a first cross-sectional area and a first perimeter and a second state, in which the portion of the lumen has a second cross-sectional area and a second perimeter, and wherein the second cross-sectional area is greater than the first cross-sectional area and the second perimeter is substantially equivalent to the first perimeter, and radial compliance of the tubular body permits transition between the first state and the second state (see annotated Figure 30 below in the first state, see annotated Figure 31 below in the second state, showing that the area of the device that lacks the support frame 62 increases in diameter, see also column 10, lines 24-44). PNG media_image3.png 282 460 media_image3.png Greyscale PNG media_image4.png 245 462 media_image4.png Greyscale Regarding Claim 3, Zukowski discloses the vascular graft of claim 2, wherein the tubular body and the at least one support frame are configured to be in the first state when pressure of fluid flowing through the lumen is diastolic pressure for a patient in which the vascular graft is implanted, and the tubular body and the at least one support frame are configured to transition to the second state when pressure of the fluid flowing through the lumen increases to systolic pressure for the patient in which the vascular graft is implanted (see column 10, lines 24-44, see also column 7, lines 53-56 denoting that the changes in diameter are due to systolic and diastolic blood pressure changes, see also first and second state in Figures 30 and 31 above). Regarding Claim 4, Zukowski discloses the vascular graft of claim 2, wherein the tubular body and at least one support frame are configured to be in the first state when the pressure is less than a threshold pressure, and in the second state when the pressure is greater than or equal to the threshold pressure (see column 10, lines 24-44, see also column 7, lines 53-56 denoting that the changes in diameter are due to systolic and diastolic blood pressure changes, see also first and second state in Figures 30 and 31 above, the “threshold pressure” being the pressure that the graft starts to expand to the second state at). Regarding Claim 10, Zukowski discloses the vascular graft of claim 1, wherein the tubular body and the at least one support frame are configured to dampen pulsation of the blood flow through the lumen of the tubular body compared to when no support frame is present (see column 7, lines 40-45 denoting that blood flow to the aneurysmal sack has been excluded and therefore the pressure within the stent graft Pd is greater than the pressure within the aneurysmal sack Pv resulting in the radially compliant stent graft expanding within the aneurysmal sack to an expanded diameter, the sack being the portion without the support frame 60). Regarding Claim 11, Zukowski discloses the vascular graft of claim 10, wherein a pressure change for the pulsatile blood flow through the vascular graft is reduced by 5% to 20%, or by 5% to 50%, or by 20% to 50%, or by 20% to 90%, or by 50% to 90% compared to when no support frame is present (see column 10, lines 53-65 denoting that the stent graft is radially compliant in expansion from the free stent graft diameter up to 3 to 30% increase in diameter from the free stent graft diameter, including 3% or more, 5% or more, 10% or more, 15% or more, 20% or more, or 30% or more, see column 7, lines 40-45 denoting that blood flow to the aneurysmal sack has been excluded and therefore the pressure within the stent graft Pd is greater than the pressure within the aneurysmal sack Pv resulting in the radially compliant stent graft expanding within the aneurysmal sack to an expanded diameter, the sack being the portion without the support frame 60, see also column 10, lines 38-43). Looking at an at least 5% increase of the pressure, to find the % amount of diameter it would take to end up at this difference. Using Poiseuille’s law and assuming constant blood flow, graft length, constant blood viscosity, and constant laminar flow, pressure changes according to ∆ P 2 ∆ P 1 = ( d 1 d 2 ) 4 . Making d1=1 and d2=1.05 to account for a 5% increase of diameter, ∆ P 2 ∆ P 1 = 0.823, resulting in the pressure change decreasing by 17.7% which is within the claimed range of 5% to 20%. Regarding Claim 12, Zukowski discloses the vascular graft of claim 1, wherein an outer surface of the tubular body comprises a low-friction material (see column 2, lines 26-46 denoting that the graft can be made of ePTFE). Regarding Claim 13, Zukowski discloses the vascular graft of claim 1, wherein the tubular body comprises at least one of ePTFE or silicone (see column 2, lines 26-46 denoting that the graft can be made of ePTFE). Regarding Claim 14, Zukowski discloses the vascular graft of claim 1. The intended use recited in the claim (“wherein the graft is an arterio-venous shunt graft”) has been considered but deemed not to impose any structural difference between the claimed invention and Zukowski’s device. Zukowski’s device is structured as claimed and is therefore capable of being used as an arterio-venous shunt graft. Regarding Claim 15, Zukowski discloses the vascular graft of claim 1, wherein the at least one support frame comprises at least one of a band, a spring, a clip, or a helical coil configured to compress one or more portions of the tubular body when pressure of blood in the lumen is low, and wherein as the pressure of blood in the lumen increases these one or more portions of the tubular body expand radially outwardly against compression exerted by the at least one support frame (see annotated support frame in Figure 31 above, being a helical round of tape around the graft). Regarding Claim 16, Zukowski discloses the vascular graft of claim 1, wherein the at least one support frame comprises at least one of a band, a spring, a clip, or a helical coil configured to radially expand one or more portions of the tubular body when pressure of blood in the lumen is low causing the shape of the cross-section of the lumen to be oblong, and wherein as the pressure of blood in the lumen increases other portions of the tubular body expand radially outwardly causing the shape of the cross-section of the lumen to become more round (see annotated support frame in Figure 31 below, being a helical round of tape around the graft, the tape configured to expand the device starting at the portion that it ends, as it will compress the stent graft so that the portion that it’s lacking will expand, and due to the graft/implant being capable of being implanted into a vessel/lumen that is not perfectly circular (oval shaped vessel), the device is able to be compressed by external pressures, in turn altering it’s starting shape to an oval/oblong). Regarding Claim 17, Zukowski discloses the vascular graft of claim 1, wherein the at least one support frame comprises axially extending members forming an interconnected first helix and second helix (see annotated first and second helix in Figure 31 above). Regarding Claim 18, Zukowski discloses the vascular graft of claim 1, wherein the at least one support frame comprises a heat-set metallic coil (see column 7, lines 25-27) defining a lumen with one of [an oval cross-section or] a substantially circular cross-section at body temperature, in an unbiased state (see Figure 18 below, see also column 9, lines 6-12), and configured to engage portions of an outer surface of the tubular body to compress the tubular body at body temperature (see column 10, lines 25-31). PNG media_image5.png 264 689 media_image5.png Greyscale Regarding Claim 19, Zukowski discloses the vascular graft of claim 18, wherein as pressure of blood flow through the lumen of the tubular body increases, the shape of the cross-section of the tubular body becomes more round, causing the cross-section of the lumen of the metallic coil to become more round (see Figure 18 above, see also column 10, lines 31-38 denoting that the implant expands, which can be interpreted as becoming “more round,” in which when the graft expands against the support structure 62, the helical structure becomes “more round” since it would have a pressure against it and would be in less of a relaxed shape). Regarding Claim 22, Zukowski discloses the vascular graft of claim 1, wherein the at least one support frame is fused to portions of an outer surface of the tubular body or fixedly connected to the outer surface of the tubular body by an adhesive (see column 7, lines 25-27). Regarding Claim 24, Zukowski discloses the vascular graft of claim 1, wherein the at least one support frame connects to the tubular body along a major dimension of the tubular body, and wherein the outer surface of the tubular body is spaced apart from the at least one support frame at other portions of the outer surface (see annotated portions of outer surface with the support frame 62 and "other portions" of outer surface in Figure 31 below). PNG media_image6.png 644 575 media_image6.png Greyscale Regarding Claim 28, Zukowski discloses the vascular graft of claim 1, wherein the tubular body comprises an extruded tube (20, 40) and the at least one support frame comprises one or more polymeric layers fused to an outer surface of the tubular body (see column 7, lines 25-27, denoting that the support frame 62 can be fused to both the graft 20 and stent 40). Regarding Claim 29, Zukowski discloses the vascular graft of claim 1, wherein the tubular body comprises at least one raised ridge extending axially along at least a portion of the tubular body defining a channel of the lumen that spirals about a central longitudinal axis of the tubular body (see annotated raised ridge in Figure 30 above). Regarding Claim 30, Zukowski discloses the vascular graft of claim 29, wherein the tubular body comprises multiple raised ridges extending axially along the portion of the tubular body defining multiple channels of the lumen (see annotated raised ridges in Figure 30 above). Claims 1, 12-13, and 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20010025131 A1 (hereafter –Edwin--). Regarding Claim 1, Edwin discloses a vascular graft (10) comprising: an implantable tubular body (12) defining a lumen (13) (see annotated lumen, tubular body in Figures 1-3 below); and at least one support frame (14) engaged to the tubular body for modifying a shape of a cross- section of at least a portion of the lumen (see paragraph [0039] denoting that the support frame 14 can be made of a shape memory alloy, configured to transform shape in the body, and see paragraph [0034 denoting that the support frame is wrapped around the graft, thereby the support frame would be capable of modifying the shape of a cross-section of at least a portion of the lumen). The limitation “wherein the tubular body and the at least one support frame are configured to receive pulsatile blood flow so that as pressure of blood flowing through the lumen increases, a cross-sectional area of the portion of the lumen increases while a perimeter of the portion of the lumen remains substantially unchanged in order to dampen pulsation of the blood flow” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the graft of Edwin being capable of receiving blood flow, any blood flow in the lumen would increase the pressure in the lumen and therefore increase the cross-sectional area, at least minutely as it would not be in a position of rest, as well as, due to the graft/implant being capable of being implanted into a vessel/lumen that is not perfectly circular (for example, an oval shaped vessel), (there being more external pressure on portions of the graft that have the support frame surrounding it) the device is able to be compressed by external pressures, in turn altering it’s starting shape to an oval. The term “substantially unchanged” is read upon by the claim as it is not defined in the claim and unclear. The term is being given its broadest reasonable interpretation, to include small minute changes still falling under the umbrella of “substantially unchanged”. Looking deeper into the application, the term is indirectly further defined in claim 8 confirming that from the first state to the second state the perimeter still increases minutely, specifically that it preferably increases no more than about a 5% from the first to the second state. Additionally, since the term “portion of the lumen” could include any portion of the stent graft, the portion of the lumen is interpreted to be the edge of a portion of the support frame 14 compressing a portion of the graft that expands out from the connection, therefore the frame 14 is “modifying the shape of the cross section” at the part that it is connected to, all whilst the cross section beyond the connection of the support frame is increasing during expansion as the support frame compresses the graft it is around to an extent. PNG media_image7.png 473 975 media_image7.png Greyscale Regarding Claim 12, Edwin discloses the vascular graft of claim 1, wherein an outer surface of the tubular body comprises a low-friction material (see paragraph [0035]). Regarding Claim 13, Edwin discloses the vascular graft of claim 1, wherein the tubular body comprises at least one of ePTFE (see paragraph [0035]). Regarding Claim 14, Edwin discloses the vascular graft of claim 1, wherein the graft is an arterio-venous shunt graft (see claim 29 of Edwin). Regarding Claim 25, Edwin discloses the vascular graft of claim 1, wherein the at least one support frame comprises an elastomeric sleeve, and wherein the tubular body is inserted in and directly or indirectly connected to an inner surface of the elastomeric sleeve (see paragraph [0039]). Regarding Claim 26, Edwin discloses the vascular graft of claim 25, wherein the elastomeric sleeve defines a lumen, and wherein a shape of a cross-section of at least a portion of the lumen of the elastomeric sleeve is an oval at low pressure and becomes increasingly round as pressure increases in the lumen of the tubular body, which causes the cross-section of the lumen of the elastomeric sleeve to become round. (see paragraph [0039] denoting that the support frame 14 can be made of elastic material, and therefore would be capable of moving from a round to an oval shape as pressure changes). Regarding Claim 27, Edwin discloses the vascular graft of claim 25, wherein the elastomeric sleeve is connected to the tubular body by at least one of adhesive bonding, solvent bonding, hot melt bonding, or sintering (see paragraph [0043]). 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. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. 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. Claims 5-6 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over US 9579187 B1 (hereafter --Zukowski--). Regarding Claim 5, Zukowski discloses the vascular graft of claim 2. Zukowski fails to disclose wherein in the first state, the shape of the cross- section of the lumen is elongated having a major dimension that is substantially greater than a minor dimension of the shape, and wherein in the second state, the shape of the cross-section of the lumen is substantially round with the minor dimension approaching or being substantially equivalent in length to the major dimension. The Instant Application does not disclose wherein in the first state, the shape of the cross- section of the lumen is elongated having a major dimension that is substantially greater than a minor dimension of the shape, and wherein in the second state, the shape of the cross-section of the lumen is substantially round with the minor dimension approaching or being substantially equivalent in length to the major dimension solves any problem or is for any particular purpose, nor does it place criticality on the limitation. It appears that Zukowski’s graft would perform equally and function as intended with the wherein in the first state, the shape of the cross- section of the lumen is elongated having a major dimension that is substantially greater than a minor dimension of the shape, and wherein in the second state, the shape of the cross-section of the lumen is substantially round with the minor dimension approaching or being substantially equivalent in length to the major dimension (see paragraph [0075] describing the dimension equivalency, in that said disclosure lacks criticality or reasoning, see also paragraph [0079 denoting that wherein in the first state, the shape of the cross-section of the lumen is selected from the group consisting of a triangle, star, diamond, rectangle, square, polygon, trapezoid, crescent, oval, or elongated pill shape). Therefore, it would have been obvious to one having ordinary skill in the art to make wherein in the first state, the shape of the cross- section of the lumen is elongated having a major dimension that is substantially greater than a minor dimension of the shape, and wherein in the second state, the shape of the cross-section of the lumen is substantially round with the minor dimension approaching or being substantially equivalent in length to the major dimension, as an obvious matter of design choice within the skill of the art. Regarding Claim 5, Zukowski discloses the vascular graft of claim 2. Zukowski fails to disclose wherein in the first state, the shape of the cross- section of the lumen is an oval, and in the second state, the shape of the cross-section of the lumen is substantially circular. The Instant Application does not disclose wherein in the first state, the shape of the cross- section of the lumen is an oval, and in the second state, the shape of the cross-section of the lumen is substantially circular solves any problem or is for any particular purpose, nor does it place criticality on the limitation. It appears that Zukowski’s graft would perform equally and function as intended with the disclose wherein in the first state, the shape of the cross- section of the lumen is an oval, and in the second state, the shape of the cross-section of the lumen is substantially circular (see paragraph [0079 denoting that wherein in the first state, the shape of the cross-section of the lumen is selected from the group consisting of a triangle, star, diamond, rectangle, square, polygon, trapezoid, crescent, oval, or elongated pill shape). Therefore, it would have been obvious to one having ordinary skill in the art to make disclose wherein in the first state, the shape of the cross- section of the lumen is an oval, and in the second state, the shape of the cross-section of the lumen is substantially circular, as an obvious matter of design choice within the skill of the art. Additionally, it would have been obvious to one having ordinary skill in the art to make disclose wherein in the first state, the shape of the cross- section of the lumen is an oval, and in the second state, the shape of the cross-section of the lumen is substantially circular, since such a modification would have involved a mere change in the shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Regarding Claim 31, Zukowski discloses the vascular graft of claim 4. Zukowski fails to disclose wherein the threshold pressure is about 90 mmHg. The Instant Application does not disclose wherein the threshold pressure is about 90 mmHg solves any problem or is for any particular purpose, nor does it place criticality on the limitation. It appears that Zukowski’s graft would perform equally and function as intended with wherein the threshold pressure is about 90 mmHg (see paragraph [00151] describing the threshold pressure, in that said disclosure lacks criticality or reasoning). Therefore, it would have been obvious to one having ordinary skill in the art to make wherein the threshold pressure is about 90 mmHg, as an obvious matter of design choice within the skill of the art. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20060229710 A1: This reference discloses a vascular graft defining a lumen with a support frame. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /PARIS MARIE BLASS/Examiner, Art Unit 3774 /SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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Prosecution Timeline

May 08, 2024
Application Filed
Jul 28, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
55%
Grant Probability
99%
With Interview (+53.8%)
3y 7m (~1y 4m remaining)
Median Time to Grant
Low
PTA Risk
Based on 31 resolved cases by this examiner. Grant probability derived from career allowance rate.

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