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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 23 March 2026 has been entered.
Claims 1 – 3, 6 – 13, 15 – 17 and 19 - 35 are pending in the instant application. The Examiner acknowledges the amendments to claims 1, 10 – 13, 23 and 29 – 32.
Drawings
The subject matter of this application admits of illustration by a drawing to facilitate understanding of the invention. Applicant is required to furnish a drawing under 37 CFR 1.81(c). No new matter may be introduced in the required drawing. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d).
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the matter in claims 1 – 3, 6 – 13, 15 – 17 and 19 - 35 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 – 3, 6 – 13, 15 – 17 and 19 - 35 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, 12 - 13, 23 and 31 - 32 is a relative term which renders the claim 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. It is unclear what “substantially” entails.
The term “about” in claim 20 is a relative term which renders the claim indefinite. The term “about” 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. It is unclear what “about” entails.
Claim Rejections - 35 USC § 103
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 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 – 3, 6, 9 – 13, 15 – 17 and 19 - 35 are rejected under 35 U.S.C. 103 as being unpatentable over Bloor et al (US 20100179639 A1, hereinafter “Bloor”) in view of Matheny (US 20160022407 A1, hereinafter “Math”) in further view of Rabaud et al (US 5416074 A, hereinafter “Rabaud”).
Regarding claim 1, Bloor teaches a method of manufacturing a vascular bioprosthetic graft for a host vessel in a subject ([0031] – [0032]), the method comprising:
obtaining a xenogeneic venous vessel from dorsum of a bovine ([0042]),
wherein the xenogenic venous vessel has an internal diameter ([0042], [0095], [0097]); and
subjecting the xenogeneic venous vessel to a fixation treatment to obtain a bioprosthetic graft ([0042], [0095], [0097]);
wherein the graft is substantially free of cuts, tears, or obvious deviations from the internal diameter ([0031] – [0032], [0042]; Bloor sets forth using a bovine vessel and any vein or artery, and subjecting the xenogeneic venous vessel to a fixation treatment to obtain a bioprosthetic graft, crosslinking as set forth in paragraph [0042].).
The limitation “wherein said the graft is configured to provide a substantial laminar flow and substantial endothelialization based on age, internal diameter, and elastin to collagen ratio once placed in the host vessel” does not require any specific structure for the vessel and therefore does not provide any limitations to the method of making the xenograft claimed.
Bloor does not teach obtaining the vessel from dorsum of a bovine up to 24 months old, the xenogenic venous vessel has an internal diameter of about 2.5-3.5 mm, and an elastin to collagen ratio of about 8:1.
However, Math discloses “methods and apparatus for reconstructing or replacing damaged or diseased cardiovascular vessels” (abstract) and teaches obtaining the vessel from dorsum of a bovine up to 24 months old ([0007], [0106], Examiner interprets the graft material from an adolescent mammal, such as a bovine, considering the age of a bovine’s adolescence is 6 – 24 months, according to Google see Final rejection of 22 September 2025.) and a bovine based graft having an outside diameter of between 3-10 mm ([0106]) thereby requiring the interior being 3-10 mm minus two wall thickness, the diameter of the graft is determined based on where the graft will be used.
It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to make the graft taught by Bloor having an internal diameter of about 3 mm when that is the size of the vessel being repaired and is within the known range of diameters as shown by Math, i.e. 3 mm.
Additionally, 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 method of Bloor by making the internal diameter range of about 2.5 mm - 3.5 mm to 3 mm - 3.5 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 (II)(A). Lastly, applicant appears to have placed no criticality on the claimed range.
The modified invention of Bloor and Math does not teach an elastin to collagen ratio of about 8:1.
However, Rabaud discloses “compositions of protein materials […] for the making of artificial biological membranes” (column 1, lines 8 - 12) and teaches graft material having an elastin to collagen ratio of about 10:1 (“the invention the elastin or solubilized elastin peptides/collagen ratio (p/p, in relation to the dry weight) is approximately 10 to 1” column 2, lines 28 - 31).
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 graft of Bloor by making the ratio ranging from about 10:1 to 8:1, as claimed, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 (II)(A). Lastly, applicant appears to have placed no criticality on the claimed ratio.
Regarding claim 2, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the xenogeneic venous vessel from the dorsum is a xenogeneic vein (Bloor: “any artery, vein or other, smaller, blood vessel” [0032]).
Regarding claim 3, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the xenogeneic venous vessel from the dorsum is a xenogeneic cranio-rectal vein (Bloor: “any artery, vein or other, smaller, blood vessel” [0032]).
Regarding claim 6, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the vascular bioprosthetic graft is used as a bypass graft for conducting coronary artery bypass grafting surgery or coronary artery bypass procedures (Bloor: [0004]).
Regarding claim 9, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches size of the graft matches the diameter of the host vessel (Math: “The vascular grafts can also have various diameters, e.g. 3.0-10.0 mm.” [0106]).
Regarding claim 10, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the graft (Bloor: [0013], [0031] – [0032], [0042]) is configured to prevent thrombosis (Bloor: “thrombosis” [0022], [0083]) based on age (Bloor: [0005]), internal diameter (Bloor: [0012], [0095] – [0096]), and elastin to collagen ratio (Bloor: [0027], [0053], [0080] – [0082], [0084] – [0085], [0088]) once placed in the host vessel (Bloor: [0013], [0031] – [0032], [0042]).
Regarding claim 11, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the graft (Bloor: [0013], [0031] – [0032], [0042]) is configured to prevent intimal hyperplasia (Bloor: “intimal hyperplasia” [0022] – [0023], [0078], [0083]) based on age (Bloor: [0005]), internal diameter (Bloor: [0012], [0095] – [0096]), and elastin to collagen ratio (Bloor: [0027], [0053], [0080] – [0082], [0084] – [0085], [0088]) once placed in the host vessel (Bloor: [0013], [0031] – [0032], [0042]).
Regarding claim 12, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the graft (Bloor: [0013], [0031] – [0032], [0042]) is configured to substantially prevent eddy currents or turbulent flow (Bloor: [0025], [0053], [0087], [0094] – [0100]) based on age (Bloor: [0005]), internal diameter (Bloor: [0012], [0095] – [0096]), and elastin to collagen ratio (Bloor: [0027], [0053], [0080] – [0082], [0084] – [0085], [0088]) once placed in the host vessel (Bloor: [0013], [0031] – [0032], [0042]).
Regarding claim 13, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the graft (Bloor: [0013], [0031] – [0032], [0042]) is configured to provide substantially similar pulsability (Bloor: [0094], [0100]) as the host vessel (Bloor: [0031] – [0032], [0042]) based on age (Bloor: [0005]), internal diameter (Bloor: [0012], [0095] – [0096]), and elastin to collagen ratio (Bloor: [0027], [0053], [0080] – [0082], [0084] – [0085], [0088]).
Regarding claim 15, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the method further comprising subjecting the vascular bioprosthetic graft to terminal gamma radiation sterilization (Bloor: [0072]).
Regarding claim 16, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the subject is human (Bloor: [0004]).
Regarding claim 17, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the host vessel is a coronary artery (Bloor: [0004]).
Regarding claim 19, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches a vascular bioprosthetic device (Bloor: [0001]) for a host vessel in a subject ([0031] – [0032]), comprising a vascular bioprosthetic graft (Bloor: [0031] – [0032], [0042]) manufactured by the method of claim 1 (see claim 1 rejection above).
Regarding claim 20, Bloor, Math and Rabaud teach all limitations of claim 19. The modified invention of Bloor, Math and Rabaud teaches the xenogeneic venous vessel from the dorsum (Bloor: [0031] – [0032], [0042]) is a xenogeneic cranio-rectal vein (Bloor: [0031] – [0032], [0042]) obtained from a bovine (Bloor: [0042]; Math: [0007], [0106]),
wherein the age of the bovine is about 18 - 24 months (Math: [0007], [0106], Examiner interprets the graft material from an adolescent mammal, such as a bovine, considering the age of a bovine’s adolescence is 6 – 24 months, according to Google see Final rejection of 22 September 2025.).
Regarding claim 21, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the vascular bioprosthetic graft is used as a bypass graft for conducting coronary artery bypass grafting surgery or coronary artery bypass procedures (Bloor: [0004], [0062]).
Regarding claim 22, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the vascular bioprosthetic graft is configured to have endothelialization after implementing the vascular bioprosthetic graft to the host vessel in a subject (Bloor: [0023 – [0025]; Examiner interprets the vascular bioprosthetic graft taught by Bloor is inherently capable of having “endothelialization after implementing the vascular bioprosthetic graft to the host vessel in a subject”).
Regarding claim 35, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the elastin to collagen ratio (Bloor: [0011], [0027], [0053], [0080] – [0082], [0084] – [0085], [0088]) of the graft (Bloor: [0013], [0031] – [0032], [0042]) is configured to provide improved retractile force (Bloor: [0011] – [0013], [0017] – [0020], [0024] – [0029], [0080] – [0082], [0085]) and oppose the development of dilatation and tortuosity of the graft (Bloor: [0011] – [0013], [0017] – [0020], [0024] – [0029], [0080] – [0082], [0085]).
Regarding claim 23, Bloor teaches a method for coronary artery bypass grafting surgery in a subject using a vascular bioprosthetic graft ([0031] – [0032]), the method comprising:
obtaining a xenogeneic venous vessel from dorsum of a bovine ([0042]),
wherein the xenogenic venous vessel has an internal diameter ([0042], [0095], [0097]);
subjecting the xenogeneic venous vessel to a fixation treatment to obtain a bioprosthetic graft; and attaching the graft in a coronary artery of said subject ([0042], [0095], [0097]),
wherein said graft is substantially free of cuts, tears, or obvious deviations from the internal diameter ([0031] – [0032], [0042]; Bloor sets forth using a bovine vessel and any vein or artery, and subjecting the xenogeneic venous vessel to a fixation treatment to obtain a bioprosthetic graft, crosslinking as set forth in paragraph [0042].).
The limitation “wherein said graft is configured to provide substantial endothelialization based on age, internal diameter, and elastin to collagen ratio after attaching the vascular bioprosthetic graft to the coronary artery of said subject” does not require any specific structure for the vessel and therefore does not provide any limitations to the method of making the xenograft claimed.
Bloor does not teach obtaining the vessel from dorsum of a bovine up to 24 months old, the xenogenic venous vessel has an internal diameter of about 2.5-3.5 mm, and an elastin to collagen ratio of about 8:1.
However, Math discloses “methods and apparatus for reconstructing or replacing damaged or diseased cardiovascular vessels” (abstract) and teaches obtaining the vessel from dorsum of a bovine up to 24 months old ([0007], [0106], Examiner interprets the graft material from an adolescent mammal, such as a bovine, considering the age of a bovine’s adolescence is 6 – 24 months, according to Google see Final rejection of 22 September 2025.) and a bovine based graft having an outside diameter of between 3-10 mm ([0106]) thereby requiring the interior being 3-10 mm minus two wall thickness, the diameter of the graft is determined based on where the graft will be used.
It would have been obvious to one of ordinary skill in the medical arts at the time the invention was effectively filed to make the graft taught by Bloor having an internal diameter of about 3 mm when that is the size of the vessel being repaired and is within the known range of diameters as shown by Math, i.e. 3 mm.
Additionally, 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 method of Bloor by making the internal diameter range of about 2.5 mm - 3.5 mm to 3 mm - 3.5 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 (II)(A). Lastly, applicant appears to have placed no criticality on the claimed range.
The modified invention of Bloor and Math does not teach an elastin to collagen ratio of about 8:1.
However, Rabaud discloses “compositions of protein materials […] for the making of artificial biological membranes” (column 1, lines 8 - 12) and teaches graft material having an elastin to collagen ratio of about 10:1 (“the invention the elastin or solubilized elastin peptides/collagen ratio (p/p, in relation to the dry weight) is approximately 10 to 1” column 2, lines 28 - 31).
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 graft of Bloor by making the ratio ranging from about 10:1 to 8:1, as claimed, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 (II)(A). Lastly, applicant appears to have placed no criticality on the claimed ratio.
Regarding claim 24, Bloor and Math teach all limitations of claim 23. The modified invention of Bloor and Math teaches the xenogeneic venous vessel from the dorsum is a xenogeneic vein (Bloor: [0032]).
Regarding claim 25, Bloor, Math and Rabaud teach all limitations of claim 23. The modified invention of Bloor, Math and Rabaud teaches the xenogeneic venous vessel from the dorsum is a xenogeneic cranio-rectal vein (Bloor: [0032]).
Regarding claim 26, Bloor, Math and Rabaud teach all limitations of claim 23. The modified invention of Bloor, Math and Rabaud teaches the xenogeneic venous vessel has an elastin to collagen ratio of about 8:1 (see claim 23 rejection; Rabaud: “the invention the elastin or solubilized elastin peptides/collagen ratio (p/p, in relation to the dry weight) is approximately 10 to 1” column 2, lines 28 - 31).
Regarding claim 27, Bloor, Math and Rabaud teach all limitations of claim 23. The modified invention of Bloor, Math and Rabaud teaches the xenogeneic venous vessel from the dorsum (Bloor: [0031] – [0032], [0042]) is obtained from a bovine (Bloor: [0031] – [0032], [0042]),
wherein the age of the bovine is up to 24 months old (Math: [0007], [0106], Examiner interprets the graft material from an adolescent mammal, such as a bovine, considering the age of a bovine’s adolescence is 6 – 24 months, according to Google see Final rejection of 22 September 2025.).
Regarding claim 28, Bloor, Math and Rabaud teach all limitations of claim 23. The modified invention of Bloor, Math and Rabaud teaches size of the graft matches the diameter of the host vessel (Math: “The vascular grafts can also have various diameters, e.g. 3.0-10.0 mm.” [0106]).
Regarding claim 29, Bloor, Math and Rabaud teach all limitations of claim 23. The modified invention of Bloor, Math and Rabaud teaches the graft (Bloor: [0013], [0031] – [0032], [0042]) is configured to prevent thrombosis (Bloor: “thrombosis” [0022], [0083]) based on age (Bloor: [0005]), internal diameter (Bloor: [0012], [0095] – [0096]), and elastin to collagen ratio (Bloor: [0027], [0053], [0080] – [0082], [0084] – [0085], [0088]) once attached to the coronary artery of said subject (Bloor: [0013], [0031] – [0032], [0042]; Bloor sets forth using a bovine vessel and any vein or artery, and subjecting the xenogeneic venous vessel to a fixation treatment to obtain a bioprosthetic graft, crosslinking as set forth in paragraph [0042].).
Regarding claim 30, Bloor, Math and Rabaud teach all limitations of claim 23. The modified invention of Bloor, Math and Rabaud teaches the graft (Bloor: [0013], [0031] – [0032], [0042]) is configured to prevent intimal hyperplasia (Bloor: “intimal hyperplasia” [0022] – [0023], [0078], [0083]) based on age (Bloor: [0005]), internal diameter (Bloor: [0012], [0095] – [0096]), and elastin to collagen ratio (Bloor: [0027], [0053], [0080] – [0082], [0084] – [0085], [0088]) once attached to the coronary artery of said subject (Bloor: [0013], [0031] – [0032], [0042]).
Regarding claim 31, Bloor, Math and Rabaud teach all limitations of claim 23. The modified invention of Bloor, Math and Rabaud teaches the graft (Bloor: [0013], [0031] – [0032], [0042]) substantially prevents eddy currents or turbulent flow (Bloor: [0025], [0053], [0087], [0094] – [0100]) based on age (Bloor: [0005]), internal diameter (Bloor: [0012], [0095] – [0096]), and elastin to collagen ratio (Bloor: [0027], [0053], [0080] – [0082], [0084] – [0085], [0088]) once attached to the coronary artery of said subject.
Regarding claim 32, Bloor, Math and Rabaud teach all limitations of claim 23. The modified invention of Bloor, Math and Rabaud teaches the graft (Bloor: [0013], [0031] – [0032], [0042]) is configured to provide substantially similar pulsability (Bloor: [0094], [0100]) as the coronary artery based on age (Bloor: [0005]), internal diameter (Bloor: [0012], [0095] – [0096]), and elastin to collagen ratio (Bloor: [0027], [0053], [0080] – [0082], [0084] – [0085], [0088]).
Regarding claim 33, Bloor, Math and Rabaud teach all limitations of claim 23. The modified invention of Bloor, Math and Rabaud teaches the method further comprising subjecting the vascular bioprosthetic graft to terminal gamma radiation sterilization (Bloor: “The vascular implant was gamma-irradiated” [0072]).
Regarding claim 34, Bloor, Math and Rabaud teach all limitations of claim 23. The modified invention of Bloor, Math and Rabaud teaches the subject is human (Bloor: [0007]).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Bloor, Math, and Rabaud, as applied in claim 1, in view of Dardik et al (US 5131908 A, hereinafter “Dar”).
Regarding claim 7, Bloor, Math and Rabaud teach all limitations of claim 1. The modified invention of Bloor, Math and Rabaud teaches the method as claimed.
The modified invention of Bloor, Math and Rabaud does not teach the use of mandrel (even indicates the graft should be formed without a mandrel even though the use of a mandrel is typical in the art, paragraph [0047]) and the method further comprising inserting a mandrel into an internal lumen of the xenogeneic venous vessel from the dorsum.
However, Dar teaches a method of making a graft using a mandrel to size, shape and remove valves in the graft, see Example I in column 8. In claim 1, section “d” Dar teaches the mandrel has an outer diameter equal to the minimum bore dimension of vessel to be formed into the graft. As set forth above the diameter of the vessel is between about 3 mm to about 10 mm (Math). Therefore, the mandrel will have a diameter between about 3 mm to about 0 mm based on the vessel being treated.
It would have been obvious to one of ordinary skill in the medical art at the time the invention was effectively filed to use a mandrel in the method of Bloor to size, shape and remove and structure/debris from within the vessel as taught by Dar to gain the advantage of a correctly shaped, sized and clear graft as taught by Dar. Such a modification would produce predictable results of the method of Bloor including the use of a mandrel and have a high expectation of success because the use of mandrels is beneficial and well known in the medical arts.
While Bloor teaches the use of a mandrel should be avoided, it is the position of the office that one of ordinary skill in the medical arts would use an mandrel in a process of making the graft to gain the advantage of sizing, shaping and removing any internal structure/debris from the vessel being made into the graft as is well known in the art as taught by Dar because Bloor does not provide any alternative method for sizing, shaping, or removing structure/debris from within the vessel being formed into a graft.
Regarding claim 8, Bloor, Math, Rabaud and Dar teach all limitations of claim 7. The modified invention of Bloor, Math, Rabaud and Dar teaches the mandrel has a diameter of about 3 mm (see claim 1 rejection; Math: “The vascular grafts can also have various diameters, e.g. 3.0-10.0 mm.” [0106]).
Response to Arguments
Applicant's arguments, page 6, filed 23 March 2026, with respect to 35 U.S.C. 112(d) rejections to claims 10 – 13 and 29 - 32 have been fully considered but they are not persuasive. Applicant amended the claims. However, the amendments do not overcome the rejection due to pertaining to method claim. Thus, the amendments do not provide any additional limitations to the method of making the graft, therefore they are rejected on the same basis as claims 1 and 23.
Applicant’s arguments, see pages 6 - 7, filed 23 March 2026, with respect to the rejection(s) of claim(s) 1 – 3, 6, 9 – 13, 15 – 17, 19 – 25 and 27 – 35 under 35 U.S.C. 103 have been fully considered and are persuasive in light of the amendments. Therefore, the rejections of 22 September 2025 have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bloor et al (US 20100179639 A1, hereinafter “Bloor”) in view of Matheny (US 20160022407 A1, hereinafter “Math”) in further view of Rabaud et al (US 5416074 A, hereinafter “Rabaud”). See rejections above.
Applicant's arguments, see page 7, filed 23 March 2026, have been fully considered but they are not persuasive. Applicant contends “the Examiner does not explain or discuss why a person skilled in the art would select bovine when Bloor at [0031] recites that it is preferable to use porcine vascular tissue as the starting material, and that the starting materials for the present invention may be obtained from any human or non-human mammal, including primates, cows, sheep, horses, and goats”.
However, Schlachtenberger et al (2020; NPL: U) discloses “bovine pericardium exhibit superior incorporation and biocompatibility, resulting in better clinical long-tern performance compared with porcine pericardium” (page 639, paragraph 2). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select bovine for the benefit of providing superior incorporation and biocompatibility for a desired treatment.
Applicant's arguments, see pages 8 - 9, filed 23 March 2026, have been fully considered but they are not persuasive. Applicant contends “Mathany discloses a graft is that is soured from decellularized fetal small intestine. See Mathany, for example, at [0077]- [0079]. Mathany teaches that this feature (e.g., the source of the graft) is essential, as it allows the graft to induce host tissue proliferation, biomodelling, and regeneration of tissue structures. Id. While Mathany discloses that the vascular graft can have an internal diameter within the range claimed, Mathany does not teach or suggest that a graft with the claimed internal diameter may be sourced from a bovine up to 24 months, and that the graft with the internal diameter has an elastin to collagen ratio of about 8:1” and “Mathany fails to teach or suggest a graft sourced from bovine up to 24 months with an internal diameter of about 2.5-3.5 mm and an elastin to collagen ratio of about 8:1, there is no basis in Mathany for a skilled person to expect any technical effect from the use of such graft.”.
However, Rabaud teaches graft material having an elastin to collagen ratio of about 10:1 (“the invention the elastin or solubilized elastin peptides/collagen ratio (p/p, in relation to the dry weight) is approximately 10 to 1” column 2, lines 28 - 31). 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 graft of Bloor by making the ratio ranging from about 10:1 to 8:1, as claimed, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 (II)(A). See rejection above.
Applicant's arguments, see page 9, filed 23 March 2026, have been fully considered but they are not persuasive. Applicant contends “Rabaud does not disclose or suggest a vascular graft derived from a bovine up to 24 months with an internal diameter of about 2.5-3.5 mm and an elastin to collagen ratio of about 8:1. As such, Rabuad does not demonstrate that a graft with a combination of features based on age, internal diameter, and elastin to collagen ratio provides substantial laminar flow or substantial endothelialization once placed in the host vessel.”.
However, the above rejections reject the amended claims. The limitation “based on age, internal diameter, and elastin to collagen ratio” does not provide any additional limitations to the method of making the graft, therefore they are rejected on the same basis as claims 1 and 23.
Applicant's arguments, see page 10, filed 23 March 2026, have been fully considered but they are not persuasive. Applicant contends “Dardick does not disclose or suggest a vascular graft that is configured to provide a substantial laminar flow or substantial endothelialization based on age, internal diameter, and collagen to elastin ratio once placed in the host vessel.”
However, the claims as written are method claims and the limitation “wherein said the graft is configured to provide a substantial laminar flow and substantial endothelialization based on age, internal diameter, and elastin to collagen ratio once placed in the host vessel”. Examiner suggests amending to recite the following limitation: “provide a substantial laminar flow and substantial endothelialization based on age, internal diameter, and elastin to collagen ratio once placed in the host vessel” by specifically reciting what is being configured, or essentially clearly reciting a method step.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE T TRAN whose telephone number is (703)756-4677. The examiner can normally be reached Monday - Friday from 8:30 am - 5:00 pm.
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, Alexander Valvis can be reached at (571) 272-4233. 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.
/JULIE THI TRAN/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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