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 with respect to claim(s) 1-2, 4-18, and 20 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2, 4, 9-12, and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 fails to include all the limitations of the claim upon which it depends, it is contradictory in claiming “a measured pressurized inner diameter” and then overwriting it with “a measured pressurized outer diameter”.
Claim 4 fails to include all the limitations of the claim upon which it depends, it is contradictory in claiming “a measured pressurized inner diameter” and then overwriting it with “a measured pressurized outer diameter of the donor artery graft and a measured pressurized inner diameter”.
Claim 18 fails to include all the limitations of the claim upon which it depends, it is contradictory in claiming “a measured pressurized inner diameter” and then overwriting it with “a measured pressurized outer diameter”.
Dependent claims are likewise rejected/
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4-12, 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 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 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).
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, Ruoya further teaches wherein the measured pressurized diameter consists of 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 pressurized inner diameter of the donor artery graft (pg. 5, col 2, paragraph 2, internal pressurized lumen diameter is recorded).
Ruoya 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).
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 further teaches wherein the unpressurized diameter is an unpressurized 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 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).
Regarding claim 8 and 12, Ruoya further teaches wherein the measured unpressurized diameter consists of a measured unpressurized outer diameter of the donor artery graft (pg. 3, col 2, paragraph 2, outer diameter measured) and an unpressurized 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 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).
Regarding claim 15 and 20, Ruoya further teaches a method of processing an a donor artery graft, comprising (a) subjecting an 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 recorded).
Ruoya fails to teach wherein the 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).
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.
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.
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 7:30PM-5:00PM EST M-F (occasionally off Fridays).
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, Jerrah Edwards can be reached on (408) 918-7557. 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.
/H.L.P./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774