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 .
Status of Claims
Claims 1-3 and 5-15 are pending and examined below
Response to Arguments
The remarks of 02/16/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art doesn't explicitly teach or disclose all of the elements of amended claims 1 and 15, in particular applicant argues the following claim language:
a porous layer or coating fabricated within, applied to, or deposited on the blood contacting surface, comprising one or more materials selected from the group consisting of synthetic biodegradable materials, synthetic nonbiodegradable materials, hybrid biomaterials, and biopolymers in a form of multi-layered, electrospun microfibers and/or electrospun nanofibers,
“wherein the medical device is configured for blood to pass through the porous layer or coating in one direction during a systolic phase of a cardiac cycle and subsequently out in a reverse direction during a diastole phase of the cardiac cycle as a result of intraluminal pressure changes in the systolic and diastolic phases”.
Regarding the first bullet point – Herbert discloses a porous layer or coating (Fig. 1, 12) comprising a synthetic nonbiodegradable material (¶0114, polyester) in a form of multi-layered microfibers (¶00114, wherein “filaments” of a “micrograft” corresponds to microfibers). Please note that “electrospun” is being treated as a product-by-process limitation per MPEP 2113. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference.
Regarding the second bullet point - Paragraph 0118 describes the capillary created by the micrograft 10. Because the micrograft can “form a conduit for transport of blood through the continuous inside lumen” it is configured for this intended use.
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 is 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.
Regarding claim 2, the claim reads “wherein the porous layer or coating comprises multiple layers”. This fails to further limit the claim because it depends from amended claim 1 which reads “in a form of multi-layered”. 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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 8, 11, 13, and 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2020/0138422 (Herbert)
Regarding claims 1, Herbert discloses a self-cleaning medical device (Fig. 1, 10), comprising:
a blood contacting surface (Fig. 1, 22, wherein 22 contacts blood once implanted), and
a porous layer or coating (Fig. 1, 12, ¶0112, wherein absorbent braided polymeric textile corresponds to porous layer) fabricated within, applied to, or deposited on the blood contacting surface (¶0143, wherein 12 is applied to 22), comprising one or more materials selected from the group consisting of synthetic biodegradable materials, synthetic nonbiodegradable materials, hybrid biomaterials, and biopolymers (¶0114, wherein polyester corresponds to a synthetic nonbiodegradable material) in a form of multi-layered electrospun microfibers (¶0114, wherein “multifilament interlaced yarns” corresponds to microfibers, please note that “electrospun” is being treated as a product-by-process limitation per MPEP 2113) and/or electrospun nanofibers,
wherein one or more properties of the porous layer or coating (¶0118, “close cell construction of 12”) control reversal fluid flow there through (¶0118, wherein the closed cell fashion of 12 forms a tube for flow and is capable of absorbing blood and generating a blood clot – which corresponds to control reversal fluid flow), and
wherein the medical device is configured for blood to pass through the porous layer or coating one direction during a systolic phase of a cardiac cycle and subsequently out in a reverse direction during a diastolic phase of the cardiac cycle as a result of intraluminal pressure changes in the systolic and diastolic phases (¶0115, wherein 10 is configured for this intended use because it can “form a conduit for transport of blood through the continuous inside lumen”).
Regarding claim 2, Herbert further discloses wherein the porous layer or coating (Fig. 1, 12) comprises multiple layers (¶0114, wherein the multifilament yarns are interlaced – corresponding to multiple layers)
Regarding claim 3, Herbert further discloses wherein the porous layer or coating is a fibrous layer or a fibrous coating (¶0114, wherein the layer is made up of 18 filament polyester multifilament yarns – corresponding to fibrous layer)
Regarding claim 5, Herbert further discloses wherein the electrospun fibers are in the form of a fiber mat or web (¶0128, wherein “braid” corresponds to a web).
Regarding claim 8, Herbert discloses a self-cleaning medical device comprising a porous layer or coating (see rejection of claim 1).
Please note that in the rejection of claim 1 - Examiner has chosen to examine the embodiment comprising one or more synthetic nonbiodegradable materials from the list of possible alternatives. Claim 8 further limits an alternate embodiment wherein the porous layer or coating is formed of or more hybrid biomaterials. Therefore, the rejection of claim 1 is also applied to claim 8.
Regarding claim 11, Herbert discloses wherein the one or more properties are selected from the group consisting of mechanical stiffness (¶0112, “reduce stiffness”), material type (¶0114, “polyester”), structural permeability, and geometrical thickness (¶0112, “wall thickness”)
Regarding claim 13, Herbert discloses wherein said device is selected from the group consisting of a tissue-engineered vascular graft and a synthetic graft (¶0114, wherein 10 corresponds to a synthetic graft because it is constructed of polyester)
Regarding claim 14, Herbert discloses a method of preparing a self-cleaning medical device (Fig. 1), comprising:
obtaining a medical device having a blood contacting surface (Fig. 1, wherein 22 contacts blood once implanted within a blood vessel);
fabricating within, applying to, or depositing on the blood contacting surface a porous layer or coating (¶0112, wherein 12 corresponds to a porous layer which is applied to 22) comprising one or more materials selected from the group consisting of synthetic biodegradable materials, synthetic nonbiodegradable materials, hybrid biomaterials including at least one synthetic biodegradable material and at least one synthetic nonbiodegradable material and biopolymers (¶0114, wherein polyester corresponds to a synthetic nonbiodegradable material), in a form of multi-layered electrospun microfibers (¶0114, wherein “multifilament interlaced yarns” corresponds to microfibers, please note that “electrospun” is being treated as a product-by-process limitation per MPEP 2113) and/or electrospun nanofibers; and
pre-selecting one or more properties of the porous layer or coating (¶0118, wherein the “closed cell construction” corresponds to one or more properties) to control reversal fluid flow there through (¶0118, wherein the closed cell fashion of 12 forms a tube for flow and is capable of absorbing blood and generating a blood clot – which corresponds to control reversal fluid flow)
wherein the medical device is configured for blood to pass through the porous layer or coating one direction during a systolic phase of a cardiac cycle and subsequently out in a reverse direction during a diastolic phase of the cardiac cycle as a result of intraluminal pressure changes in the systolic and diastolic phases (¶0115, wherein 10 is configured for this intended use because it can “form a conduit for transport of blood through the continuous inside lumen”).
Claim(s) 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 5,603,731 (Whitney)
Regarding claim 15, Whitney discloses a method of reducing platelet activation and aggregation on a blood contacting surface of a medical device (Column 4, Lines 57-64, “prevents the platelets in the blood from being attached to the site”), comprising:
obtaining a medical device (Fig. 4, 12) having a blood contacting surface (Fig. 4, end sections 31);
fabricating within, applying to, or depositing on the blood contacting surface a porous layer or coating (comprising one or more materials selected from the group consisting of synthetic biodegradable materials, synthetic nonbiodegradable materials, hybrid biomaterials including at least one synthetic biodegradable material and at least one synthetic nonbiodegradable material and biopolymers (Col. 3, Lines 41-58, wherein annealed metal wire mesh corresponds to a synthetic nonbiodegradable material) in a form of multi-layered electrospun microfibers (¶0114, wherein “multifilament interlaced yarns” corresponds to microfibers, please note that “electrospun” is being treated as a product-by-process limitation per MPEP 2113) and/or electrospun nanofibers;
pre-selecting one or more properties of the porous layer or coating (Col. 3, Lines 61-64, wherein “uninsulated” corresponds to one or more properties) to control reversal fluid flow there through (Col. 4, Line 57 – Col. 5, Line 4, wherein an electrical potential applied to the metal mesh controls reversal fluid flow);
wherein the medical device is configured for blood to pass through the porous layer or coating one direction during a systolic phase of a cardiac cycle and subsequently out in a reverse direction during a diastolic phase of the cardiac cycle as a result of intraluminal pressure changes in the systolic and diastolic phases (¶0115, wherein 10 is configured for this intended use because it can “form a conduit for transport of blood through the continuous inside lumen”), and
pushing platelets away from the blood contacting surface to reduce platelet activation and aggregation on said surface (Col. 4, Lines 57-64, wherein electrical potential prevents platelets from clotting on interior surface of end sections 31)
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0138422 (Herbert) in view of WO 2019/175341 (Andersson)
Regarding claim 6, Herbert discloses a discloses a self-cleaning medical device with a porous layer of coating (see rejection of claim 1) but doesn't explicitly teach or disclose that the porous layer or coating is formed of synthetic biodegradable materials are selected from the group consisting of polyurethanes, PLA, PLGA, PGA, PCL, PLLA, gelatin, tropoelastin and mixtures and combinations thereof.
Andersson discloses a medical device wherein the synthetic biodegradable materials are selected from the group consisting of polyurethanes, PLA, PLGA, PGA, PCL, PLLA, gelatin, tropoelastin and mixtures and combinations thereof (Page 19, Lines 16-19, “PLLA”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to form the porous layer of Herbert with PLLA, as taught by Andersson, to maintain a radially strong framework while still breaking down over time to be safely metabolized (Andersson, Page 19, Lines 16-19).
Claim(s) 7, 9, 10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0138422 (Herbert) in view of WO 93/21860 (De Goicoechea)
Regarding claim 7, Herbert discloses a discloses a self-cleaning medical device with a porous layer of coating (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the synthetic nonbiodegradable materials are selected from the group consisting of silicones, polyurethanes, ePTFE, and mixtures and combinations thereof.
De Goicoechea discloses a medical device wherein the synthetic nonbiodegradable materials are selected from the group consisting of silicones, polyurethanes, ePTFE, and mixtures and combinations thereof (Page 7, Lines 5, wherein the base material comprises “polyurethane”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the medical device of Herbert with a synthetic nonbiodegreable material such as polyurethane, as taught by De Goicoechea, in order to create a medical device that is both strong and easy to suture.
Regarding claim 9, Herbert discloses a self-cleaning medical device with a porous layer or coating (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the porous layer or coating is formed of one or more materials including biopolymers comprising collagen, gelatin and tropoelastin.
De Goicoechea discloses a medical device wherein the biopolymers comprise collagen, gelatin and tropoelastin (Page 7, Lines 2-3, “collagen”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the porous layer or coating of Herbert to be formed of collagen, as taught by De Goicoechea, in order to reduce the porosity of the vascular graft to blood or other body fluids (De Goicoechea, Page 6, Lines 25-27).
Regarding claim 10, Herbert discloses a self-cleaning medical device with a porous layer or coating (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the porous layer or coating is formed of one or more materials including biopolymers selected from the group consisting of fibrillary or nonfibrillar collagen, gelatin, tropoelastin, laminin, and mixtures and combinations thereof.
De Goicoechea discloses wherein the biopolymer is selected from the group consisting of fibrillary or nonfibrillar collagen, gelatin, tropoelastin, laminin, and mixtures and combinations thereof (Page 8, Lines 17-25, wherein the “collagen” is nonfibrillar).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the porous layer or coating of Herbert with nonfibrillar collagen, as taught by De Goicoechea, in order to reduce the porosity of the vascular graft to blood or other body fluids (De Goicoechea, Page 6, Lines 25-27).
Regarding claim 12, Hebert discloses a self-cleaning medical device with a fibrous layer (see rejection of claim 3) but doesn't explicitly teach or disclose wherein the fibrous layer is crosslinked with genipin or glutaraldehyde.
De Goicoechea discloses wherein the fibrous layer is crosslinked with genipin or glutaraldehyde (Page 9, Lines 1-6, “cross-linking the collagen with a cross-linking agent such as glutaraldehyde”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to crosslink the fibrous layer of Herbert with glutaraldehyde, as taught by De Goicoechea, in order to improve mechanical strength and thermal stability.
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 extension fee 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 date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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