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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/4/2026 has been entered. Claims 1, 3-12, 14-18, and 29-40 are pending.
Response to Arguments
Applicant’s arguments filed 1/2/2026, with respect to the claim amendments have been fully considered and are persuasive. Examiner agrees the amendments made to claims 1 and 29 overcome the previous rejections. Therefore, the rejections have been withdrawn and upon further consideration a new grounds of rejection is set forth below.
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.
Claim 38 is 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.
Claim 38 requires “the second surface of the second outer portion does not include any three dimensional attachment features.” However, amended claim 29 requires the plurality of three dimensional attachments features on the first surface are configured to engage with the second surface of the second outer portion and the specification describes this being possible via a plurality of three dimensional attachments features on the second surface. This is also apparent in claims 1 and 30. Therefore, the limitation is rendered indefinite. For examination purposes the claim is interpreted as the second surface of the second outer portion does not include any three dimensional attachment features apart from the first and second end portions on the second surface of the second outer portion.
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.
Claims 1, 3, 5, 7-10, 29-31, 33-36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Kubiak (US 2011/0288566) in view of Jacobs et al. (US 2003/0065360).
Regarding claims 1, 29, and 30, Kubiak discloses a tissue wrap device (Figs.4A, 4B, 6A), the tissue wrap device comprising a sheet (12) of biocompatible material ([0014-0015]), the sheet being rectangular (Figs. 4A-4B), and having a length (46), measured along a longitudinal axis of the tissue wrap device, that is greater than a width (48; Figs. 4A-4B), and the sheet being configured to be wrapped around a tissue ([0039]), transitioning to a rolled configuration (Fig. 6A), in which longitudinal sides of the sheet overlap with each other (Fig. 6A illustrates the longitudinal edges of the sheet move towards each other as the sheet transitions to the rolled configuration and thereby are configured to overlap each other as claimed), and the sheet further having a middle portion (middle portion along the length of the sheet), a first outer portion (along the length of the sheet) on one side of the middle portion relative to the longitudinal axis, and a second outer portion (along the length of the sheet) on another side of the middle portion relative to the longitudinal axis (Figs. 4A-4B), each of the middle portion, the first outer portion, and the second outer portion having a first surface (top surface) and an opposing second surface (bottom surface), and the first surface of the first outer portion being configured to overlap and interface with the second surface of the second outer portion when the sheet is transitioned to the rolled configuration (Fig. 6A illustrates the longitudinal edges of the sheet move towards each other as the sheet transitions to the rolled configuration and thereby are configured to overlap and interface as claimed), each of the middle portion, the first outer portion, and the second outer portion having a first end portion and a second end portion (see Figs. 4A-4B).
Kubiak fails to disclose at least a portion of the first surface of the first outer portion comprises a first plurality of three dimensional attachment features, and at least a portion of the second surface of the second outer portion comprises a second plurality of three dimensional attachment features, and wherein the first plurality of three dimensional attachment features are configured to engage with the second plurality of three dimensional attachment features on the second surface of the second outer portion to maintain the sheet in the rolled configuration.
Jacobs also discloses a tissue wrap device (Fig. 11N) comprising a sheet (1120) of biocompatible material ([0051]) having a first surface (inner surface 1130) and a second surface (opposing outer surface). Jacobs teaches at least a portion of the first surface comprises a first plurality of three dimensional attachment features (1136), and at least a portion of the second surface comprises a second plurality of three dimensional attachment features (1136; see paragraph [0069] describing any number of conventional mechanical fasteners may be used along the edges, including clasps and hooks), and wherein the first plurality of three dimensional attachment features are configured to engage with the second plurality of three dimensional attachment features to maintain the sheet in the rolled configuration (see paragraph [0069] and Fig. 11N in which the opposing fasteners engage each other in order to lock the edges together). Therefore, 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 Kubiak to include a first plurality of three dimensional attachment features on at least a portion of the first surface of the first outer portion, and a second plurality of three dimensional attachment features on at least a portion of the second surface of the second outer portion, wherein the first plurality of three dimensional attachment features are configured to engage with the second plurality of three dimensional attachment features on the second surface of the second outer portion to maintain the sheet in the rolled configuration, as taught by Jacobs, in order to prevent the sheet from unrolling and slipping off of tissue (see paragraph [0069]).
With further respect to claims 29 and 30, Kubiak as modified by Jacobs fails to disclose the first plurality of three dimensional attachment features provided only on the first end portion and the second end portion of the first outer portion such that the first plurality of three dimensional attachment features on the first end portion of the first outer portion are configured to engage with the second plurality of three dimensional attachment features on the first end portion of the second outer portion and the first plurality of three dimensional attachment features on the second end portion of the first outer portion are configured to engage with the second plurality of three dimensional attachment features on the second end portion of the second outer portion. Instead, Kubiak as modified by Jacobs discloses the plurality of three dimensional attachment features extends along the majority of, or the entire length of, the first outer portion. However, Applicant discloses in paragraph [049] of the instant specification that the attachment features may be included only at one or more end portions [of the outer portions] or extend along a majority of, or the entirety of, a length of opposite portions (the claimed outer portions) that are configured to overlap one another. Therefore, the embodiments are disclosed to be obvious variants. There is no evidence of record that establishes that providing the three dimensional attachment features only on the first end portion of the first outer portion and the second end portion of the first outer portion would result in a difference in function of Kubiak’s device as modified by Jacobs. Further, a person of ordinary skill in the art, being faced with modifying the extent of the three dimensional attachment features of Kubiak in view of Jacobs, would have a reasonable success in making such a modification and it appears the device would function as intended given the claimed extent. Lastly applicant has not disclosed that the claimed extent solves any stated problem or is used for a particular purpose, indicating that either variation is suitable (specification at paragraph [049]) and therefore there appears to be no criticality placed on the extent as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the first plurality of three dimensional attachment features only on the first end portion of the first outer portion and the second end portion of the first outer portion, instead of along the entirely of the length thereof, such that the first plurality of three dimensional attachment features on the first end portion of the first outer portion are configured to engage with the second plurality of three dimensional attachment features on the first end portion of the second outer portion and the first plurality of three dimensional attachment features on the second end portion of the first outer portion are configured to engage with the second plurality of three dimensional attachment features on the second end portion of the second outer portion to maintain the sheet in the rolled configuration, as an obvious matter of design choice within the level of skill in the art.
Regarding claims 3 and 31, Kubiak as modified discloses a plurality of barbed or un-barbed microneedles (18) located on the first surface of the middle portion (Figs. 4A, 4B, 6A).
Regarding claims 5 and 33, Kubiak as modified is silent as to the height of the barbed or un-barbed microneedles. However, there is no evidence of record that establishes that changing the height of the barbed or un-barbed microneedles would result in a difference in function of Kubiak’s device. Further, a person of ordinary skill in the art, being faced with modifying the height of the barbed or un-barbed microneedles of Kubiak, would have a reasonable success in making such a modification and it appears the device would function as intended given the claimed height. Lastly applicant has not disclosed that the claimed height solves any stated problem or is used for a particular purpose, indicating that the height “may” be within the claimed range, and offering other acceptable ranges (specification at paragraph [064]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, 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 height of the barbed or un-barbed microneedles to 150 μm or less as an obvious matter of design choice within the level of skill in the art.
Regarding claims 7 and 34, the limitation “the first plurality of three dimensional attachment features and the second plurality of three dimensional attachment features are 3D printed” is being treated as a product by process limitation. 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. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Kubiak is silent as to the process used to make the plurality of three dimensional attachment features, it appears that the plurality of three dimensional attachment features would be the same as that claimed; especially since both applicant’s plurality of three dimensional attachment features and the prior art plurality of three dimensional attachment features function to maintain the sheet in the rolled configuration.
Regarding claim 8, Kubiak teaches attachment members being made from polyurethane, polycaprolactone, etc. (see paragraph [0013]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have also made the first and second plurality of three dimensional attachment features from one or more of polyurethane, polyurethane/urea, poly(glycolic acid), poly(lactic acid), poly(lactic-co-glycolic acid), polycaprolactone, and poly(ethylene glycol) diacrylate (PEGDA), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended us as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 9, 10, 35, and 36, Kubiak as modified is silent as to the diameter and height of the first and second plurality of three dimensional attachment features. However, there is no evidence of record that establishes that changing the diameter and height of the three dimensional attachment features would result in a difference in function of Kubiak’s device. Further, a person of ordinary skill in the art, being faced with modifying the diameter and height of the three dimensional attachment features of Kubiak, would have a reasonable success in making such a modification and it appears the device would function as intended given the claimed diameter and height. Lastly applicant has not disclosed that the claimed diameter and height solves any stated problem or is used for a particular purpose, indicating that the diameter and height “may” be within the claimed range, and offering other acceptable ranges (specification at paragraph [064]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, 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 diameter of at least some of the first and second plurality of three dimensional attachment features to about 25 μm to about 75 μm and to modify the height of at least some of the first and second plurality of three dimensional attachment features to about 1000 μm or less as an obvious matter of design choice within the level of skill in the art.
Regarding claim 38, Kubiak as modified discloses the second surface of the second outer portion does not include any three dimensional attachment features apart from the first and second end portions on the second surface of the second outer portion (see Fig. 6A and rejection of claim 29 above).
Claims 4 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Kubiak and Jacobs et al. as applied to claims 3 and 31 above, and further in view of Matheny (US 2014/0148897).
Kubiak as modified discloses the claimed invention except for the barbed or un-barbed microneedles being hollow and configured to release one or more of a chemical adhesive or a drug formulation. Matheny also discloses an implant comprising a plurality of barbed microneedles (40). Matheny teaches the barbed microneedles are hollow (42) and configured to release one or more of a chemical adhesive or a drug formulation (see Fig. 9, [0140]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Kubiak’s barbed microneedles being hollow and configured to release one or more of a chemical adhesive or a drug formulation as taught by Matheny in order to treat surrounding tissue as needed and/or desired (see [0135-0137], [0140]).
Claims 6, 11, 14, 17, 18, 37, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Kubiak and Jacobs et al. as applied to claims 1 and 29 above, and further in view of Clements et al. (US 2018/0064931).
Regarding claims 6 and 40, Kubiak as modified fails to disclose the sheet is made from a material selected from one or more of: small intestine submucosa, amniotic/chorionic membrane, reconstituted denatured collagen, collagen, elastin, thrombin, fibronectin, starches, poly(amino acid), gelatin, alginate, pectin, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid, fibrin-based materials, collagen-based materials, hyaluronic acid-based materials, glycoprotein-based materials, cellulose-based materials, and silk.
Clements also discloses a tissue wrap device (one of the tissue repair sheets in Fig. 8 which may be wrapped around tissue as disclosed in paragraph [0048]). Clements teaches the sheet may be made from a material selected from one or more of: small intestine submucosa, amniotic/chorionic membrane, reconstituted denatured collagen, collagen, elastin, thrombin, fibronectin, starches, poly(amino acid), gelatin, alginate, pectin, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid, fibrin-based materials, collagen-based materials, hyaluronic acid-based materials, glycoprotein-based materials, cellulose-based materials, and silk (see [0061]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made Kubiak’s sheet from a material selected from one or more of small intestine submucosa, amniotic/chorionic membrane, reconstituted denatured collagen, collagen, elastin, thrombin, fibronectin, starches, poly(amino acid), gelatin, alginate, pectin, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid, fibrin-based materials, collagen-based materials, hyaluronic acid-based materials, glycoprotein-based materials, cellulose-based materials, and silk, as taught by Clements, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended us as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 11 and 37, Kubiak as modified fails to disclose the first plurality of three dimensional attachment features on the first surface of the first outer portion include barbed microneedles. Clements also discloses a tissue wrap device (Fig. 8) using three dimensional attachment features (mechanical fasteners 400A, 400B) to maintain the tissue wrap device in a rolled configuration (see paragraph [0048]). Clements teaches the plurality of three dimensional attachment features (400A) may include barbed microneedles (see Fig. 8). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the first plurality of three dimensional attachment features on the first surface of Kubiak’s first outer portion in the form of barbed microneedles as taught by Clements in order to provide a known mechanical fastening means for effectively maintaining the tissue wrap in the rolled configuration (see paragraph [0048]).
Regarding claim 14, Kubiak as modified discloses the first surface of the middle portion comprises a plurality of barbed or un-barbed microneedles (18; Figs. 4A, 4B, 6A).
Regarding claim 17, Kubiak as modified discloses the mechanical fasteners may include clasps and hooks. Kubiak as modified fails to disclose whether the first plurality of three dimensional attachment features specifically includes hooks and the second plurality of three dimensional attachment features specifically includes loops. Clements also discloses a tissue wrap device (Fig. 8) using three dimensional attachment features (mechanical fasteners 400A, 400B) to maintain the tissue wrap device in a rolled configuration (see paragraph [0048]). Clements teaches a first plurality of three dimensional attachment features including hooks (400A) and a second plurality of three dimensional attachment features including loops (400B) for engaging the hooks (see paragraph [0048]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Kubiak’s first plurality of three dimensional attachment features in the form of hooks and the second plurality of three dimensional attachment features in the form of loops as taught by Clements in order to provide a known mechanical fastening means for effectively maintaining the tissue wrap in the rolled configuration (see paragraph [0048]).
Regarding claim 18, Kubiak as modified discloses the first surface of the middle portion comprises a plurality of barbed or un-barbed microneedles (18; Figs. 4A, 4B, 6A).
With further respect to claim 40, Kubiak teaches attachment members being made from polyurethane, polycaprolactone, etc. (see paragraph [0013]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have also formed the plurality of three dimensional attachment features from one or more of polyurethane, polyurethane/urea, poly(glycolic acid), poly(lactic acid), poly(lactic-co-glycolic acid), polycaprolactone, and poly(ethylene glycol) diacrylate (PEGDA) since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended us as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 12 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Kubiak, Jacobs et al., and Clements et al. as applied to claims 11 and 37 above, and further in view of Matheny.
Kubiak as modified discloses the claimed invention except for the barbed microneedles being hollow and configured to release one or more of a chemical adhesive or a drug formulation. Matheny also discloses an implant comprising a plurality of barbed microneedles (40). Matheny teaches the barbed microneedles are hollow (42) and configured to release one or more of a chemical adhesive or a drug formulation (see Fig. 9, [0140]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Kubiak’s barbed microneedles being hollow and configured to release one or more of a chemical adhesive or a drug formulation as taught by Matheny in order to treat surrounding tissue as needed and/or desired (see [0135-0137], [0140]).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kubiak and Jacobs et al. as applied to claim 1 above, and further in view of Yang et al. (US 2014/0163587).
Regarding claim 15, Kubiak as modified fails to disclose the first plurality of three dimensional attachment features includes ball portions and the second plurality of three dimensional attachment features includes socket portions. Yang also discloses a tissue conduit device comprising a plurality of three dimensional attachment features (see Figs. 2-3). Yang teaches a first plurality of the three dimensional attachment features include ball portions (116, 117) and a second plurality of the three dimensional attachment features includes socket portions (126, 127) for fixing the conduit device in a closed configuration around tissue (see [0025]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Kubiak’s (in view of Jacobs) first plurality of three dimensional attachment features as ball portions and Kubiak’s (in view of Jacobs) second plurality of three dimensional attachment features as socket portions, or vice versa if desired, as taught by Yang, since doing so would have yielded predictable results, namely, provided a sufficient fastening means for maintaining the sheet in the rolled configuration as desired by Kubiak.
Regarding claim 16, Kubiak as modified discloses the middle portion comprises a plurality of barbed or un-barbed microneedles (18; Figs. 4A, 4B, 6A).
Conclusion
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/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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