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 .
Response to Arguments
Applicant's arguments filed 4/20/2026 have been fully considered but they are not persuasive. Applicant argues that Ruoya does not disclose that the donor vessel is used as a graft. For clarification, the prior art is not required to disclose the intended use of the claimed graft as “arterial” graft, but merely have the capability of being used for that purpose. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As well known in the art, the particular anatomy of arteries varies widely based on numerous factors such as patient age, height, health, location in the body, occlusions, injuries, and species. The harvested vessel of Ruoya has all the claimed structures and is capable of being used as an arterial graft in at least some existing patient.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 21 and 22 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 21 and 22 clearly recite a claim to a human organ.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-12, 15, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ruoya ("A Novel Approach to Assess the In Situ Versus Ex Vivo Mechanical Behaviors of the Coronary Artery" ) In view of Lian ("In Vivo and in Vitro Measurements of Pulmonary Arterial Stiffness: A Brief Review ") and Heaton (US 2010/0114292).
Regarding claim 1, Ruoya teaches a donor artery graft (see abstract, porcine donor) and a first record (pg. 3, col 2, paragraph 2, an ex vivo measurement), wherein the first record provides a measured pressurized diameter of the donor artery graft (pg. 3, col 2, paragraph 2, pressure cycle between 0-90 mm Hg with diameter measured), and wherein the measured pressurized diameter has been determined ex vivo under a pressure (pg. 3, col 2, paragraph 2, an ex vivo measurement), wherein the measured pressurized diameter provides a pressurized inner diameter of the donor artery graft (pg. 5, col 2, paragraph 2, internal pressurized lumen diameter is recorded).
Ruoya discloses a measured pressurized outer diameter of the donor artery graft (pg. 3, col 2, paragraph 2, pressure cycle between 0-90 mm Hg with outer diameter measured) but fails to teach wherein a pressurized inner diameter is measured. Lian teaches ex vivo testing of an artery graft (abstract) wherein a pressurized inner diameter is measured (pg. 513, col 1, paragraph 3, see inner diameter measured simultaneously). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processed artery graft as taught by Ruoya by including a measurement of an inner diameter, as taught by Lian, in order to complete a simple substitution of one known element, a calculated inner diameter, for another, a measured inner diameter, to obtain predictable results of accurate identification of artery dimensions (MPEP 2143).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Ruoya pressure range to be 100 – 160 mm Hg, as Applicant appears to have placed no criticality on the claimed range (the range of 100-160 mm Hg is merely listed as an option in a list of possible ranges on page 9, lines 1-4) and since it has been held that “[in]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Although Ruoya discloses a range of pressurizing the donor graft of (pg. 3, col 2, paragraph 2, pressure cycle between 0-90 mm Hg), it is considered to be within an ordinary level of skill in the art before the effective filing date of the claimed invention to raise a pressure during measurement of a graft.
Ruoya in view of Lian fails to teach a package comprising a graft and record. Heaton teaches a vessel package ([0210]) comprising a vessel implant ([0209], vessel extender) and a first record ([0210]), wherein the first record provides a diameter of the vessel implant ([0210], [0150], and [0249], note label can include inner and outer diameter). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processed artery graft as taught by Ruoya in view of Lian by including the vessel packaging, as taught by Heaton, in order to yield predictable results of safely packaging and identifying a processed graft prior to surgery [0209].
Regarding claim 2, Ruoya further teaches wherein the measured pressurized diameter is a measured pressurized outer diameter of the donor artery graft (pg. 3, col 2, paragraph 2, pressure cycle between 0-90 with outer diameter measured).
Regarding claim 4, modified Ruoya discloses both a measured pressurized outer diameter of the donor artery graft (pg. 3, col 2, paragraph 2, pressure cycle between 0-90 with outer diameter measured) and a measured pressurized inner diameter taught by Lian (pg. 513, col 1, paragraph 3, see inner diameter measured simultaneously).
Regarding claim 5 and 9, Ruoya further teaches a second record (pg. 3, col 2, paragraph 2, an ex vivo measurement), wherein the second record provides a measured unpressurized diameter of the donor artery graft (pg. 3, col 2, paragraph 2, pressure cycle includes 0), wherein the measured unpressurized diameter has been determined ex vivo during processing (pg. 3, col 2, paragraph 2, an ex vivo measurement).
Regarding claim 6 and 10, Ruoya further teaches wherein the measured unpressurized diameter (pg. 3, col 2, paragraph 2, pressure cycle includes 0), is a measured unpressurized outer diameter of the donor artery graft (pg. 3, col 2, paragraph 2, pressure cycle between 0-90 with outer diameter measured).
Regarding claim 7 and 11, Ruoya fails to teach wherein the inner diameter is measured in an unpressurized state. Lian teaches ex vivo testing of an artery graft (abstract) wherein an inner diameter is measured (pg. 513, col 1, paragraph 3, see inner diameter measured simultaneously). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention have further modified the package of Ruoya by including a to include a measurement of an unpressurized inner diameter, as taught by Lian, in order to complete a simple substitution of one known element, a calculated inner diameter, for another, a measured inner diameter, to obtain predictable results of accurate identification of artery dimensions (MPEP 2143).
Regarding claim 8 and 12, Ruoya further teaches measurement of the outer diameter of the donor artery graft (pg. 3, col 2, paragraph 2, outer diameter measured) and an inner diameter of the donor artery graft (pg. 5, col 2, paragraph 2, internal lumen diameter is recorded). Ruoya fails to teach wherein the inner and outer diameters are measured in an unpressurized state. Lian teaches ex vivo testing of an artery graft (abstract) wherein an inner diameter is measured (pg. 513, col 1, paragraph 3, see inner diameter measured simultaneously). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processed artery graft as taught by Ruoya by including a measurement of an inner diameter in an unpressurized state, as taught by Lian, in order to obtain predictable results of accurate identification of artery dimensions (MPEP 2143).
Regarding claim 15 and 20, Ruoya further teaches a method of processing a donor artery graft, comprising (a) subjecting a donor artery graft to a pressure ex vivo during processing (pg. 3, col 2, paragraph 2), and (b) determining a measured pressurized diameter of the donor artery graft under the pressure (pg. 3, col 2, paragraph 2), whereby a processed donor artery graft is obtained (once the vessel undergoes step a and b, it becomes processed), wherein the pressurized diameter is a pressurized inner diameter of the donor artery graft (pg. 5, col 2, paragraph 2, internal lumen diameter is calculated).
Ruoya fails to teach wherein the pressurized inner diameter is measured. Lian teaches ex vivo testing of an artery graft (abstract) wherein an inner diameter is measured (pg. 513, col 1, paragraph 3, see inner diameter measured simultaneously). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processed artery graft as taught by Ruoya by including a measurement of an inner diameter, as taught by Lian, in order to complete a simple substitution of one known element, a calculated inner diameter, for another, a measured inner diameter, to obtain predictable results of accurate identification of artery dimensions (MPEP 2143).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Ruoya pressure range to be 100 – 160 mm Hg, as Applicant appears to have placed no criticality on the claimed range (the range of 100-160 mm Hg is merely listed as an option in a list of possible ranges on page 9, lines 1-4) and since it has been held that “[in]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Although Ruoya discloses a range of pressurizing the donor graft of (pg. 3, col 2, paragraph 2, pressure cycle between 0-90 mm Hg), it is considered to be within an ordinary level of skill in the art before the effective filing date of the claimed invention to raise a pressure during measurement of a graft.
Regarding claim 18, Ruoya further teaches wherein the pressurized diameter is a measured pressurized outer diameter of the donor artery graft (pg. 3, col 2, paragraph 2).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ruoya ("A Novel Approach to Assess the In Situ Versus Ex Vivo Mechanical Behaviors of the Coronary Artery" ) In view of Lian ("In Vivo and in Vitro Measurements of Pulmonary Arterial Stiffness: A Brief Review ") and Heaton (US 2010/0114292) and in further view of Kassab (US 20080194996).
Regarding claim 13, Ruoya in view of Lian and Heaton fails to teach the specific artery type. Kassab teaches a method for measuring a luminal structure (ABSTRACT) that further comprises the measurement selected from a major artery from the group consisting of celiac, superior and inferior mesenteric and renal arteries ([0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processed artery graft as taught by Ruoya in view of Lian and Heaton by including the artery selection, as taught by Kassab, in order to yield predictable results of processing the appropriate artery needed for a surgical procedure based on varying patient needs.
Regarding claim 14, Ruoya in view of Lian and Heaton fails to teach the specific artery type. Kassab teaches a method for measuring a luminal structure (ABSTRACT) that further comprises the measurement selected from a minor artery ([0069]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processed artery graft as taught by Ruoya in view of Lian and Heaton by including the artery selection, as taught by Kassab, in order to yield predictable results of processing the appropriate artery needed for a surgical procedure based on varying patient needs.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ruoya ("A Novel Approach to Assess the In Situ Versus Ex Vivo Mechanical Behaviors of the Coronary Artery" ) In view of Lian ("In Vivo and in Vitro Measurements of Pulmonary Arterial Stiffness: A Brief Review ") and Heaton (US 2010/0114292) and in further view of Weitzel (US 20050124892).
Regarding claim 16, Ruoya in view of Lian and Heaton doesn't exactly teach wherein the pressure is controlled by using a pressure relief valve or a calibrated syringe. Weitzel teaches a method for measuring properties of a vascular structure (ABSTRACT) wherein the pressure is controlled by using a pressure relief valve or a calibrated syringe ([0113], syringe).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processed artery graft as taught by Ruoya in view of Lian and Heaton by substituting the method of pressure, as taught by Weitzel, it would be obvious to try a known method that results in a finite number of solutions with reasonable success (MPEP 2143).
Regarding claim 17, Ruoya in view of Lian and Heaton doesn't exactly teach wherein the measured pressurized diameter is determined by using a tool selected from the group consisting of a ruler, a caliper, an umbilical tape, a laser micrometer and ultrasound. Weitzel teaches a method for measuring properties of a vascular structure (ABSTRACT) wherein the measured pressurized diameter is determined by using a tool selected from the group consisting of a ruler, a caliper, an umbilical tape, a laser micrometer and ultrasound ([0114], ultrasound). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processed artery graft as taught by Ruoya in view of Lian and Heaton by substituting the method of measurement, as taught by Weitzel, it would be obvious to try a known method that results in a finite number of solutions with reasonable success (MPEP 2143).
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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
