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 8/19/25 have been fully considered but they are not persuasive. Applicant contends that The Action did not consider paragraph [0120], which states:
“De-gas of ePTFE: De-gassing was performed by immersing ePTFE in acetone for 3 hours and then washing the acetone-treated ePTFE with 70% Ethanol for 30 minutes (repeated 3 times). The de-gassed ePTFE was rinsed in distilled water for 30 minutes (repeated 3 times). From this time point, ePTFE needs to be immersed in distilled water or phosphate buffered saline (PBS) to avoid re-gas.
Paragraph [0120] (emphasis added). Based on paragraph [0120], a skilled person would understand that the claimed de-gassed polymer substrate of the pending claims was de-gassed, as described, but was also kept in a de-gassed state by immersion in distilled water or PBS.
These arguments are not commensurate with the claims. The applicant appears to be arguing component of the specification into the claims. MPEP 2111 (II) states in part:
II. IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION
"….Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment." Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004). See also Liebel-Flarsheim Co. v. Medrad Inc., 358 F.3d 898, 906, 69 USPQ2d 1801, 1807 (Fed. Cir. 2004)….”
Current claim 24 recites:
“Claim 25 (Previously presented} A method of treating a blood vessel defect in a subject in need thereof comprising implanting a vascular graft in a subject, wherein the vascular graft comprises (a) a de-gassed polymeric substrate at least partially coated by an endothelial cell attachment agent and (b) human arterial endothelial cells adhered to the coated, de-gassed polymeric substrate.”
It is clear from the limitations of claim 25 that there is no mention of “De-gassing was performed by immersing ePTFE in acetone for 3 hours and then washing the acetone-treated ePTFE with 70% Ethanol for 30 minutes (repeated 3 times). The de-gassed ePTFE was rinsed in distilled water for 30 minutes (repeated 3 times). From this time point, ePTFE needs to be immersed in distilled water or phosphate buffered saline (PBS) to avoid re-gas”.
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.
Claim(s) 25-26, 33, 39-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McAuslan et al. 5,077,215.
McAuslan et al. discloses the invention as claimed comprising: A method of treating a blood vessel defect in a subject in need thereof comprising implanting a vascular graft (here McAuslan et al. discloses a graft as recited in the abstract and 2:16-20 further discloses that the object of the invention Is to provide a material useful in vascular prosthesis and other implantable devices) in a subject,
wherein the vascular graft comprises (a) a de-gassed (applicants disclosure defines “de-gassing” of the polymeric substrate in [0009; 0010, 0039] as “,..washing the polymeric substrate in acetone and ethanol, washing the polymeric substrate in an organic solvent, or applying a vacuum...”. McAuslan et al. discloses “...that portions of NAFION are washed in acetone followed by absolute ethanol...Unfilled virgin TEFLON samples were washed extensively in ethanol...”’).
a polymeric substrate (in this instance the term polymeric substrate is very broad. See claims 5-6 of McAuslan et al. which recite a porous polymer such a ptfe or eptfe. McAuslian et al. discloses in 2:31-35 that “...The various types of substrate that may be used include polymers...” thus McAuslan et al. meets the limitation of this claim) at least partially coated by an endothelial cell attachment agent and (6) human arterial endothelial cells adhered to said coated polymeric substrate (see 3:63-65 which states “_..shows the difference in morphology of human umbilical arterial endothelial cells cultured on tissue culture plastic...” Here it is inherent that that the limitation is met because of the use of human umbilical arterial endothelial cells and it is further inherent that plastic is a synthetic polymer).
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) 27-28, 32, 37 are rejected under 35 U.S.C. 103 as being unpatentable over McAuslan et al. 5,077,215 in view of Pathak 2016/0081 788.
McAuslan et al. has been disclosed (however does not specifically state that the damaged blood vessel is a result of “trauma”. Pathak teaches that vascular grafts are commonly utilized to replace or repair damaged or diseased blood vessels [0003] and that grafts can treat traumatized tissue [0037]. It is obvious (if not inherent) that the graft of McAuslan et al. would be utilized in this capacity as claimed because McAuslan et al. does not limit and states various diseases, including vascular disease, and conditions.
Claim(s) 29, 34, 38 are rejected under 35 U.S.C. 103 as being unpatentable over McAuslan et al. 5,077,215 in view Khosravi et al. 2015/0164642.
McAuslan et al. has been disclosed supra however does not specify that the graft is implanted via anastomosis. Khosravi et al. teaches that grafts may be implanted via anastomosis [0018]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of McAuslan et al. and implant the graft via anastomosis because a section of vein may have been needed to be removed and or bypassed.
Claim(s) 41 is rejected under 35 U.S.C. 103 as being unpatentable over Sims et al. 5,705,732 in view of Zamora 7820172.
Sims discloses the use of cell's natural genome is changed so that functional proteins encoded by either the class II or both the class I and the class II major (MHC) histocompatibility complex genes do not appear on the cell's surface. Sims further discloses that implant such as grafts made of polymer material (Dacron) may be coated with genetically engineered endothelial cells and then implanted in a patient. However Sims does not specify the use of an endothelial cell attachment agent.
Zamora al. teaches “…The central role of laminins in cell attachment has, in part, lead to studies using laminin to improve cell attachment to implants, including vascular grafts, neural implants, and dental implants. (See for example J. W. Dean, 3.sup.rd et al. Fibronectin and laminin enhance gingival cell attachment to dental implant surfaces in vitro”. It would have been obvious to one having ordinary skill in the art to modify the invention of Sims et al. and provide an endothelial cell attachment agent because Sims et al. envisions the use of an endothelial cells coating and with further enhance attachment of the cells to the implant.
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.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 October 24, 2025