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 Amendment
Claims 1-20 are pending in the application. Claims 1-3, 6-8, 10-12, and 14 have been amended. Claims 15-20 are newly added. Claims 1-20 are rejected.
Drawings
The drawings were received on January 27, 2026. These drawings are unacceptable.
The drawings do not show how the extendable element comprises a release mechanism which is “clasps, gripping claws, or an engagement surface” as recited in the claims.
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 “extendable element comprising a release mechanism configured to temporarily hold the amnion tissue against the patient tissue” as recited in claims 8 and 9 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 14, Claim 1 has been amended to recite “…the amnion-based tissue graft…free of the extendable element and any mechanical supports.” Claim 14 has been amended to recite “…to leave the amnion-based tissue graft within the patient free of any support structures.” The specification fails to provide support for the graft being deployed “free of any supports”. The specification does not define “support structures” or “mechanical supports”. Additionally, paragraph [0023] of the specification as published states “a mechanical barb may be used to secure the amnion graft inside the body”. Since the specification does not define “mechanical supports” or “support structures”, the disclosed barbs fall within the reasonable definition of “mechanical supports” thus there is not support in the specification for the graft to be completely free of mechanical supports or support structures. Applicant is encouraged to amend the claims with terminology consistent with the disclosure. Appropriate action is required.
Claim Rejections - 35 USC § 102
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 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) 1-4, 6, 8, 9, 11-15, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agnew et al (US PG Pub 2010/0114307).
Regarding claim 1, Agnew teaches an amnion tissue delivery system (See Figs. 25-26; paragraphs [0014]; [0098]-[0101]) comprising:
a catheter (234) designed for placement into a location within a patient (See paragraph [0098]),
an extendable element (balloon 235 & 236) mounted on the catheter (See Figs. 25-26; paragraphs [0098]-[0101]), and
a section of amnion-based (see paragraph [0056]) tissue graft (33/231) mounted over the extendable element in a configuration such that extension of the extendable element deploys the amnion-based tissue graft separately at a position selected within the patient free of the extendable element and any mechanical supports. (See paragraphs [0098]-[0101]).
Regarding claim 2, Agnew teaches the tissue delivery system as required by claim 1 and further teaches the location1 within the patient is a tube, vessel, or lumen (See paragraphs [0013], [0015], [0049])
Regarding claim 3, Agnew teaches the tissue delivery system as required by claim 1 and further teaches the extendable element comprises plastic2 and wherein the section of-amnion-based tissue graft is associated for delivery with a biologic or a polymer.(See paragraphs [0056], [0062]-[0064]).
Regarding claim 4, Agnew teaches the tissue delivery system as required by claim 1 and further teaches the extendable element comprises a balloon (See paragraphs [0012], [0014], and [0098]).
Regarding claim 6, Agnew teaches the tissue delivery system as required by claim 1 and further teaches the amnion-based tissue graft has a biological glue on its outer surface to adhere the amnion-based tissue graft to the patient upon deployment. (See paragraphs [0009], [0054], and [0065]).
Regarding claim 8, Agnew teaches the tissue delivery system as required by claim 1 and further teaches the extendable element comprises3 a release mechanism that is configured to temporarily hold the amnion-based tissue graft against the patient tissue prior to or simultaneously with release of the amnion-based tissue graft from the extendable element. (See paragraphs [0009], [0054], and [0065])
Regarding claim 9, Agnew teaches the tissue delivery system as required by claim 8 and further teaches the release mechanism comprises clasps, gripping claws (barbs) or an engagement surface (balloon surface which engages the tissue implant). (See paragraphs [0009], [0054], and [0065])
Regarding claim 11, Agnew teaches the tissue delivery system as required by claim 1 and further teaches the amnion-based tissue graft comprises a patch or barrier that is temporarily mounted on the expandable delivery mechanism. (See paragraphs [0098]-[0101]).
Regarding claim 12, Agnew teaches the tissue delivery system as required by claim 1 and further teaches the amnion-based tissue graft forms a tubular shaped element. (See Figs. 1, 25, 26; paragraphs [0009] and [0055]).
Regarding claim 13, Agnew teaches the tissue delivery system as required by claim 12 and further teaches the tubular shaped element is rolled amnion patch. (See Fig. 9, paragraph [0055])
Regarding claim 14, Agnew teaches a method for delivery of amnion tissue within a patient using the amnion tissue delivery system of claim 1 (See paragraph [0101]), the method comprising: placing the catheter within the patient using a minimally invasive, endoluminal, or endoscopic procedure (See paragraphs [0015], [0102]) to position the amnion-based tissue graft at a desired location; and deploying the extendable element (balloons 235 & 236) to deliver the amnion-based tissue graft at the selected location in the patient (See paragraphs [0098]-[0101]; and removing the extendable element from the patient (See paragraph [0100]) to leave the amnion-based tissue graft within the patient free of any support structures (See paragraphs [0098]-[0101]).
Regarding claim 15, Agnew teaches the method of tissue delivery as required by claim 14 and further teaches the extendable element comprises a balloon (235 & 236) (See Figs. 25-26; paragraphs [0098]-[0101]).
Regarding claim 18, Agnew teaches the method of tissue delivery as required by claim 14 and further teaches the amnion-based tissue graft forms a tubular shaped element. (See Figs. 1, 25, 26; paragraphs [0009] and [0055]).
Regarding claim 20, Agnew teaches the method of tissue delivery as required by claim 14 and further teaches has a biological glue on its outer surface to adhere the amnion-based tissue graft to the patient upon deployment. (See paragraphs [0009], [0054], and [0065]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Agnew et al (US PG Pub 2010/0114307) as applied to claims 1 and 14 above and further in view of DiCarlo (US PG Pub 2004/0054402).
Regarding claim 5, Agnew teaches the tissue delivery system as required by claim 4 as set forth above but does not explicitly teach the extendable element comprises a self-extending mechanical element comprising a shape memory metal configured to transition to the extended configuration. Agnew teaches deploying the graft with an extendable element that is a balloon.
DiCarlo teaches an analogous tissue graft delivery system featuring a catheter (210), a frameless graft (100) and a temporary stent (220) made of shape memory material (See paragraph [0029]) configured to transition to the extended configuration. DiCarlo teaches using the stent to deploy a graft is an advantageous means by which to reliably deploy a graft and minimize the risk of endoleaks or migration.
It would have been obvious to one of ordinary skill in the art before the effective filing date to use a temporary self-expanding shape memory stent as taught by DiCarlo to deploy a frameless amnion graft since using a temporary self-expanding retractable stent is a known means for reliably deploying a graft to a desired location within the body. Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183)
Regarding claims 16, and 17, Agnew teaches the method of delivering amnion-based tissue graft according to 14 as set forth above but does not explicitly teach extendable element is a self-expanding stent frame.
DiCarlo teaches an analogous graft and deployment method which employs a temporary self-expanding stent (220) to deploy a stentless graft (100) to a site within a patient. (See paragraphs [0028]-[0029]). DiCarlo teaches this arrangement reduces the risks of endoleaks, migration and graft thrombosis. (See paragraphs [0006]-[0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use a temporary self-expanding stent as taught by DiCarlo to deploy a frameless amnion graft since using a temporary self-expanding retractable stent is a known means for reliably deploying a graft to a desired location within the body. Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183)
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Agnew et al (US PG Pub 2010/0114307), as applied to claim 1 above, and further in view of DiCarlo (US PG Pub 2004/0054402) and previously cited Razavi (US Pat No. 5,676,685).
Regarding claim 7, Agnew teaches the amnion-based tissue delivery system as required by claim 1 as set forth above but does not explicitly teach the amnion-based tissue graft is associated with a removable stent structure that releases with a thermal bond release mechanism.
DiCarlo teaches an analogous graft and deployment method which employs a temporary self-expanding stent (220) to deploy a stentless graft (100) to a site within a patient. (See paragraphs [0028]-[0029]). DiCarlo teaches this arrangement reduces the risks of endoleaks, migration and graft thrombosis. (See paragraphs [0006]-[0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use a removable stent structure as taught by DiCarlo to deploy a frameless amnion graft since using a removable stent structure is a known means for reliably deploying a graft to a desired location within the body. Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183)
Agnew in view of DiCarlo does not explicitly teach the removable stent releases with a thermal bond release mechanism. DiCarlo teaches the graft is held to the removable stent via a suture, a pocket, or bead of adhesive. (See paragraph [0028])
Razavi teaches an analogous removable temporary stent (10) with a coating (14) where the removable stent structure (wire 12) is released with a thermal bond release mechanism (See Col. 2, lines 25-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the removable stent as taught by Agnew in view of DiCarlo to be released with a thermal bond release mechanism, as taught by Razavi, since thermal release is a known reliable way to remove a stent structure while leaving a biological coating material in place in the body.
Furthermore, using thermal bond release is merely applying a known technique (thermal release of a removable stent) to a known device (biologically coated stent graft) which would yield a predictable result of easily removing the removable stent while keeping the coating in place. (See MPEP §2143(I)(D)) Additionally, neither the claim, nor the originally filed specification give any reason for or criticality to the parameter of a removable stent structure that releases with a thermal bond release mechanism.
Claim(s) 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Agnew et al (US PG Pub 2010/0114307), as applied to claims 1 and 14 respectively above, and further in view of Ryzhuk et al (US PG Pub 2018/0100139).
Regarding claims 10 and 19, Agnew teaches the amnion-based tissue graft system and method according to claims 1 and 14 as set forth above but does not explicitly teach the amnion-based tissue graft is amnion tissue processed to be decellularized.
Agnew teaches a graft made of remodelable material which can be amniotic ECM. Agnew also states the ECM material may be manipulated before being assembled and “treated with one or more property modifiers” including crosslinking. Agnew further states the material can be treated with a variety of compositions and other property modifiers. Agnew also states the ECM material used is “preferably highly purified” (See paragraphs [0056]-[0066]).
Ryzhuk teaches an analogous amnion based tissue material for implantation which is processed to be decellularized. Ryzhuk teaches decellularization eliminates immune response in the patient thus making the implant safer for the patient to receive (See paragraphs [0101]-[0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the amnion based tissue as taught by Agnew to be processed to be decellularized as taught by Ryzhuk since it is known that decellularizing tissue eliminates an immune response in the resulting ECM making it safer for the patient.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 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. Neither the Petrucci nor the Schorgl references are being applied.
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
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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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
1 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). Agnew discloses deploying the implant in a vein which is a ”tube vessel or lumen”.
2 Agnew teaches the expandable element is a balloon (See paragraphs [0012], [0014]) which may be made of “latex silicone or other suitable material” (See paragraph [0098]). Silicone is a synthetic elastomer and can be considered a “plastic” under the broadest reasonable interpretation standard. Additionally, it is widely known in the medical arts that plastic is a suitable balloon material. See, for example, Fischell et al (US Pat. No. 5,792,172).
3 It is noted the adhesive and barbs disclosed by Agnew operate in the same manner as that which is disclosed in applicant’s specification. Further, since the barbs and glue work in concert to hold the graft in the desired location during deployment they can be considered part of the extendable element.
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