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.
Response to Amendment
This action is in response to applicant’s amendment received 1/2/2026. Claims 19-28 have been canceled and new claims 29-38 have been added. Claims 1-18 and 29-38 are pending.
Response to Arguments
Applicant’s arguments filed 1/2/2026, with respect to the 35 U.S.C. 102(a)(1) rejections of claim 1 by Jacobs et al. and Clements et al. have been fully considered and are persuasive. Examiner agrees the amendments made to claim 1 overcome the previous rejections. Therefore, the rejections have been withdrawn and upon further consideration new grounds of rejection necessitated by applicant’s amendment received 1/2/2026 is set forth below.
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 29-38 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.
New claim 29 recites “wherein the first side of the first outer portion comprises a plurality of three dimensional attachment features provided only on the first end portion of the first outer portion and the second end portion of the first outer portion, and wherein the plurality of three dimensional attachment features are configured to engage with at least one of the first end portion of the second outer portion and the second end portion of the second outer portion.” However, at the time the application was filed, the inventors failed to disclose the plurality of three dimensional attachment features on the first end portion of the first outer portion being configured to engage with the second end portion of the second outer portion and the plurality of three dimensional attachment features on the second end portion of the first outer portion being configured to engage with the first end portion of the second outer portion, both of which the limitation as recited encompasses. Therefore, the limitation is considered new matter.
It is suggested that the limitation be amended as follows: “wherein [[the first side of]] the first outer portion comprises a plurality of three dimensional attachment features provided only on the first end portion of the first outer portion and the second end portion of the first outer portion, and wherein the plurality of three dimensional attachment features on the first end portion of the first outer portion are configured to engage with the plurality of three dimensional attachment features on the second end portion of the first outer portion are configured to engage with the second end portion of the second outer portion
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.
Claims 1-18 and 29-38 are 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 1 recites the limitation "the first side of the first outer portion" and “the second side of the second outer portion” in lines 8-10. There is insufficient antecedent basis for this limitation in the claim. Claims 2-18 are also rendered indefinite due to indefinite claim 1.
Claim 29 recites the limitation "the first side of the first outer portion" and “the second side of the second outer portion” in lines 3-5. There is insufficient antecedent basis for this limitation in the claim. Claims 30-38 are also rendered indefinite due to indefinite claim 29.
It appears the recited “first side” and “second side” in the claims are the same portions of the sheet as the recited “first outer portion” and “second outer portion”, respectively. For examination purposes the recited “first side” and “second side” are treated as the recited “first outer portion” and “second outer portion”, respectively, throughout all the claims as disclosed and illustrated in Fig. 2.
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, 5-11, 13, 14, 17, 18, 29-31, and 33-38 are rejected under 35 U.S.C. 103 as being unpatentable over Kubiak (US 2011/0288566) in view of Clements et al. (US 2018/0064931).
Regarding claims 1 and 29, 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), the first outer portion being configured to overlap and interface with 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), and the sheet having a first longitudinal end portion, which includes a first end portion of the middle portion, a first end portion of the first outer portion, and a first end portion of the second outer portion, and a second longitudinal end portion, which includes a second end portion of the middle portion, a second end portion of the first outer portion, and a second end portion of the second outer portion (see Figs. 4A-4B).
Kubiak fails to disclose at least a portion of the first outer portion comprises a plurality of three dimensional attachment features, wherein the plurality of three dimensional attachment features are configured to engage with at least a portion of the second outer portion to maintain the sheet in the rolled configuration. 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 [0048]). Clements teaches a first plurality of three dimensional attachment features (400A) along at least a portion of a first outer portion of the sheet (Fig. 8), wherein the first plurality of three dimensional attachment features (400A) are configured to engage with at least a portion of the second outer portion to maintain the sheet in a rolled configuration ([0048], [0160]). 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 included a plurality of three dimensional attachment features on at least a portion of Kubiak’s first outer portion, wherein the plurality of three dimensional attachment features are configured to engage with at least a portion of the second outer portion, as taught by Clements, in order to maintain the sheet in the rolled configuration after wrapping ([0048], [0160]).
With further respect to claim 29, Kubiak as modified by Clements fails to disclose the first outer portion comprises a plurality of three dimensional attachment features provided only on the first end portion of the first outer portion and the second end portion of the first outer portion. Instead, Kubiak as modified by Clements 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 Clements. 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 Clements, 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 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 plurality of three dimensional attachment features on the first end portion of the first outer portion engage with the first end portion of the second outer portion and the plurality of three dimensional attachment features on the second end portion of the first outer portion engage with 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 2 and 30, Kubiak as modified discloses the plurality of three dimensional attachment features (400A) is a first plurality of three dimensional attachment features (see Fig. 8). Kubiak as modified fails to disclose the second outer portion comprises a second plurality of three dimensional attachment features. Clements also teaches a second plurality of three dimensional attachment features (400B) along the length of a second outer portion of the sheet (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 Kubiak’s second outer portion with a second plurality of three dimensional attachment features (400B) as taught by Clements in order to maintain the sheet in the rolled configuration after wrapping ([0048], [0160]). With further respect to claim 30, Kubiak as modified discloses the second plurality of three dimensional attachment features provided on at least one of the first end portion of the second outer portion and the second end portion of the second outer portion because they are provided along the majority, or an entirety of, the length of the second outer portion as taught by Clements (Fig. 8).
Regarding claims 3 and 31, Kubiak as modified discloses a plurality of barbed or un-barbed microneedles (18) located on the middle portion (Figs. 4A, 4B, 6A).
Regarding claim 6, 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. However, 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 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 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 as modified discloses suitable materials for the three dimensional attachment features include polymers (see Clements [0111]). 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 the 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 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 three dimensional attachment features to about 25 μm to about 75 μm and to modify the height of at least some of the 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 claims 11 and 37, Kubiak as modified discloses the plurality of three dimensional attachment features (400A) on the first outer portion include barbed microneedles (see Fig. 8).
Regarding claims 13 and 38, Kubiak as modified discloses the second outer portion does not include any three dimensional attachment features (as modified 400A are provided on the first outer portion only).
Regarding claim 14, Kubiak as modified discloses 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 plurality of three dimensional attachment features (400A) is a first plurality of three dimensional attachment features (see Fig. 8), wherein the first plurality of three dimensional attachment features includes hooks (Fig. 8, [0048]). Kubiak as modified fails to disclose the second outer portion comprises a second plurality of three dimensional attachment features, wherein the second plurality of three dimensional attachment features includes loops. Clements also teaches a second plurality of three dimensional attachment features (400B) on a second outer portion of the sheet (Fig. 8), wherein the second plurality of three dimensional attachment features includes loops (Fig. 8, [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 second outer portion with a second plurality of three dimensional attachment features (400B) in the form of loops as taught by Clements in order to maintain the sheet in the rolled configuration after wrapping ([0048], [0160]).
Regarding claim 18, Kubiak as modified discloses the middle portion comprises a plurality of barbed or un-barbed microneedles (18; Figs. 4A, 4B, 6A).
Claims 4, 12, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Kubiak and Clements et al. as applied to claims 3, 11, 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 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kubiak et al. and Clements as applied to claim 1 above, and further in view of Yang et al. (US 2014/0163587).
Regarding claim 15, Kubiak as modified discloses the plurality of three dimensional attachment features is a first plurality of three dimensional attachment features (400A). Kubiak as modified fails to disclose the second outer portion comprises a second plurality of three dimensional attachment features. Clements also teaches a second plurality of three dimensional attachment features (400B) on a second outer portion of the sheet (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 Kubiak’s second outer portion with a second plurality of three dimensional attachment features (400B) as taught by Clements in order to maintain the sheet in the rolled configuration after wrapping ([0048], [0160]).
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 Clements) first plurality of three dimensional attachment features as ball portions and Kubiak’s (in view of Clements) 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
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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/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774