DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 06/10/2026.
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 .
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) 1-5, 7-10, 23, 25-27, and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0148827 A1 to Odermatt et al. (hereinafter “Odermatt”) (previously of record).
Regarding claim 1, Odermatt discloses (see abstract; Figs. 1-18; and [0039]-[0244]) an expandable (see [0126]) plug (120) for closing a defect in an organ or tissue without the need for sutures (see at least [0203]-[0208]), wherein the material forming the plug has shape memory (see [0152]-[0158]), wherein the material forming the plug comprises native collagen (see [0136]/[0139], wherein native collagen is collagen that has not been denatured by an alkaline treatment (see [0136]/[0139]), wherein the plug has homogenous density and content throughout the plug (see [0136], amongst a variety of options for material(s) to form the plug, Odermatt discloses collagen as a sole option which would result in the plug having homogenous density and content throughout the plug since it would be entirely formed from the collagen), wherein the material forming the plug is able to increase in size at least 2.5-fold (see [0126], the material is capable to swell upon contact with body liquids – the ability of collagen to swell upon contact with body liquid is an inherent material property of collagen – as evidenced by US 5,456,693 to Conston at Col. 3, lines 5-9; it is known that a collagen plug when disposed in the body is capable of swelling to several times its compressed size– accordingly, it would be expected that Odermatt’s collagen plug when in contact with bodily fluid would be fully able to increase in size at least 2.5-fold which is at once envisaged as a factor falling within the parameter of “several times”).
Odermatt further discloses (claim 2) wherein the material forming the plug is biodegradable (see [0129]-[0130]); (claim 3) wherein the material forming the plug comprises or consists of native type I collagen (see [0136]/[0139]); (claim 4) wherein the material forming the plug is crosslinked (see [0141]); (claim 5) wherein the crosslinking is via the formation of covalent bonds between functional groups present in the material forming the plug (see [0141]); (claims 7-9 and 26) wherein the defect is in a membrane, such as a fetal membrane, wherein the defect is an endoscopic entry point, wherein the defect is an endoscopic entry point that was created during fetal surgery (see [0203]/[0205], the device is fully capable of being used to close a defect in a membrane such as a fetal membrane, wherein the defect is an endoscopic entry point, wherein the defect is an endoscopic entry point that was created during fetal surgery if one desired to do so - note that the limitations of these claims are merely functional limitations and do not affect the structure of the claimed invention - 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 also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art); (claim 10) wherein the expandable plug has a length of at most about 10 cm along its longest axis, and/or wherein the expandable plug has a length of at most about 1 cm along its shortest axis (see [0154]/[0240]-[0244]); (claim 27) wherein the expandable plug has one longest axis and two substantially identical shorter axes (see [0154]/[0240]-[0244]); and (claim 25) wherein the plug is comprised in an endoscopic device (see [0203]).
Regarding claim 23, Odermatt discloses a method for closing a defect in an organ or tissue without the need for sutures (see at least [0203]-[0208]), the method comprising introducing the expandable plug according to claim 1 (see rejection above) into the defect (see [0203]-[0208]).
Regarding claim 31, Odermatt discloses (see abstract; Figs. 1-18; and [0039]-[0244]) an expandable (see [0126]) plug (120) for closing a defect in an organ or tissue without the need for sutures (see at least [0203]-[0208]), wherein the material forming the plug has shape memory (see [0152]-[0158]), wherein the material forming the plug comprises native collagen (see [0136]/[0139], wherein native collagen is collagen that has not been denatured by an alkaline treatment (see [0136]/[0139]), wherein the plug has homogenous density and content throughout the plug (see [0136], amongst a variety of options for material(s) to form the plug, Odermatt discloses collagen as a sole option which would result in the plug having homogenous density and content throughout the plug since it would be entirely formed from the collagen), wherein the material forming the plug is able to increase in size at least 2-fold (see [0126], the material is capable to swell upon contact with body liquids – the ability of collagen to swell upon contact with body liquid is an inherent material property of collagen – as evidenced by US 5,456,693 to Conston at Col. 3, lines 5-9; it is known that a collagen plug when disposed in the body is capable of swelling to several times its compressed size– accordingly, it would be expected that Odermatt’s collagen plug when in contact with bodily fluid would be fully able to increase in size at least 2-fold which is at once envisaged as a factor falling within the parameter of “several times”), wherein shape memory is the repeatable ability to recover to an original shape from a deformed shape, wherein the recovery can be repeated at least 3 times (Odermatt teaches a collagen plug made of native collagen that is capable of swelling to increase in size – in other words, Odermatt teaches the same expandable plug as set forth in the claim – for an apparatus claim, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent – see MPEP 2112.01 – therefore Odermatt anticipates the claim because Odermatt teaches the same structure and the ability to recover to an original shape from a deformed shape (at least 3 times) is an inherent material property/characteristic of the material in both the claimed plug and Odermatt’s plug and thus the claimed properties are presumed to be inherent in Odermatt.)
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.
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) 19, 21 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Odermatt in view of US 2010/0272782 A1 to Owens et al. (hereinafter “Owens”).
Regarding claim 19, Odermatt discloses (see abstract; Figs. 1-18; and [0039]-[0244]) a method for producing a native collagen plug according to claim 1 (see rejection of claim 1 above), wherein native collagen is collagen that has not been denatured by an alkaline treatment (see [0136]/[0139]), wherein the method comprises the steps of: a) Providing a collagen source (see [0136]/[0140]); b) Purifying collagen from the source to obtain native collagen without exposing the collagen to an alkaline denaturation treatment (see [0136]-[0141]); d) Casting the collagen in a mould to obtain cast collagen and lyophilizing the cast collagen to form an expandable plug (see [0124]); e) Optionally crosslinking the expandable plug (see [0141]); f) lyophilizing the crosslinked expandable plug (see [0124]/[0141]); (g) inserting the crosslinked expandable plug in an endoscopic device (see [0203]).
Odermatt fails to specifically disclose, with respect to claim 19, the step of swelling the native collagen in a suitable liquid for at most 72 hours to obtain swollen collagen without exposing the collagen to an alkaline denaturation treatment, with respect to claim 21, wherein the collagen source is animal tendons, and with respect to claim 28, wherein the suitable liquid is acetic acid.
Owens discloses, in the same field of endeavor of collagen materials, the known step of preparing native collagen (see [0005]-[0013]) by obtaining the collagen from animal tendons (see [0006]) and by swelling the native collagen in acetic acid for at most 72 hours (see [0008]/[0012]] to obtain swollen collagen without exposing the collagen to an alkaline denaturation treatment (see [0005]/[0013]) for the purpose of not causing substantial irreversible denaturation of the collagen fibers (see [0005]/[0012]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Odermatt's method of collagen preparation using the steps taught by Owens in order to lead to collagen that remains native collagen as suggested by Odermatt by swelling the collagen without causing substantial irreversible denaturation of the collagen fibers.
Claim(s) 24 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Odermatt in view of US 2011/0027250 A1 to Messersmith et al. (hereinafter “Messersmith”) (previously of record).
Regarding claims 24 and 29, Odermatt fails to specifically disclose that the collagen plug is used for closing a defect that is caused by an endoscopic entry point that was created during fetal surgery. Messersmith discloses, in the same field of endeavor of collagen plugs, the known use of collagen plugs to close defects caused by endoscopic entry points during fetal surgery (see [0012]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention - as a matter of applying a known technique to a known device ready for improvement to yield predictable results - see KSR International Co. v. Teleflex Inc., 550 U.S. 398,82 USPQ2d 1385,1395- 97(2007)), to obtain the predictable result of using a known collagen plug to close defects caused by endoscopic entry points during fetal surgery since Messersmith discloses that collagen plugs are used to close such defects and Odermatt's collagen plug would likewise predictably be suitable for use in such a technique.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Odermatt.
Regarding claim 30, Odermatt fails to specifically disclose wherein the expandable plug has a length of at most about 10 cm along its longest axis, AND wherein the expandable plug has a length of at most about 1 cm along its shortest axis. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the plug to have suitable dimensions based on its intended use as a plug to occlude an aperture in tissue since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
Applicant alleges Kensey does not provide evidentiary support for a 2.5 times expansion, as the claim is now amended to recite. In response, Conston is now cited as an evidentiary reference to stand for the proposition that it is known that a collagen plug when disposed in the body is capable of swelling to several times its compressed size, including 2.5 times, and that this would be true of Odermatt’s plug. With respect to claim 31, as set forth above, Odermatt teaches a collagen plug made of native collagen that is capable of swelling to increase in size – in other words, Odermatt teaches the same expandable plug as set forth in the claim – for an apparatus claim, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent – see MPEP 2112.01 – therefore Odermatt anticipates the claim because Odermatt teaches the same structure and the ability to recover to an original shape from a deformed shape (at least 3 times) is an inherent material property/characteristic of the material in both the claimed plug and Odermatt’s plug and thus the claimed properties are presumed to be inherent in Odermatt. Applicant alleges that Odermatt does not teach lyophilizing a crosslinked plug or inserting the plug into an endoscopic device, however, as set forth above, Odermatt discloses these steps at [0124]/[0141] and [0203]. Note that a catheter delivery instrument is an “endoscopic device” in that it is capable of being used with an endoscope (such as being inserted through an accessory channel/lumen of an endoscope), and noting that the claim doesn’t specify an “endoscope” per se. Accordingly, Applicant’s arguments are not persuasive.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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