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.
Specification
The abstract of the disclosure is objected to because in lines 4-5, “a first a first surface”, is assumed to be a typo. The repeated words should be removed. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: In paragraph [0016], the feature numbers are a first resilient spring surface 19, a second substrate surface 20, the third collagen surface 21, and the collagen fibers 22. But in paragraph [0016] the first spring surface is stated to be 20, the substrate surface 21, and the collagen surface 22. Appropriate correction is required.
The disclosure is objected to because of the following informalities: In paragraph [0016], “Poliglecaprolactone (PLCL)” contradict each other and it is assumed to be a typo. PLCL is Poly(L-lactide-co-(epsilon)-caprolactone) and the examiner suggests amending as such. Appropriate correction is required.
The disclosure is objected to because of the following informalities: In paragraph [0016], “polydioxinone” is assumed to be a typo. The examiner suggests amending this to be “polydioxanone”. Appropriate correction is required.
The disclosure is objected to because of the following informalities: Paragraph [0016] recites “ATPE” without defining what ATPE is. Appropriate correction is required.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities: In claim 1, line 7 and 8, and in claim 11, line 2, “collage surface” is assumed to be a typo. The examiner suggests amending this to be “collagen surface” and has been examined as such. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: In line 2, “the spring surface” is assumed to be a typo. The examiner suggests amending this to be “the first surface” as recited in claim 1 and has been examined as such. In line 4, “poliglecaprolactone” is assumed to be a typo as it is further defined as PLCL (Paragraph [0017]) which is Poly(L-lactide-co-(epsilon)-caprolactone). The examiner suggests amending this to be “Poly(L-lactide-co-(epsilon)-caprolactone)”, and has been examined as such. In line 4, “polydioxinone” is assumed to be a typo. The examiner suggests amending this to be “polydioxanone” and has been examined as such. Appropriate correction is required.
Claims 7-9 and 12 are objected to because of the following informalities: “the substrate surface” is assumed to be a typo. The examiner suggests amending this to be “the second surface” as recited in claim 1 and has been examined as such. Appropriate correction is required.
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 6 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.
Line 5 includes “ATPE” material and it is unclear as to what this material is as there is no definition for ATPE within the specification. Therefore, the limitation is rendered indefinite. For examination purposes, the group is interpreted as consisting of “Polyglycolic Acid, Poly-Lactic Acid, Poly-L-Lactic Acid, Polyglygolic Acid, Poliglecaprolactone, Polycaprolactone Polydioxinone, and Polyglyconate.”
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 1-4, 6-8, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over D ‘Lima et al. (US PG Pub No. 2025/0025601 A1) in view of Kucklick (Wipo Pub No. WO 2021/061984 A2) and Plouhar et al. (US PG Pub No. 2003/0033022 A1).
Regarding claim 1, D ’Lima discloses a biological construct (Paragraphs [0009, 0022, 0110], Figs. 1D and 9A-9C) for treatment of a labral tear on a labrum comprising (Paragraphs [0009 and 0031]): a second surface (Paragraphs [0022 and 0110], Fig. 9B, aligned PLA mat fibers) comprising a substrate made of a biocompatible material (aligned PLA mat fibers) and secured to a first surface (Paragraph [0009], “combining the plurality of polymer scaffold compositions to form a multilayer construct”); and a third collagen surface (Paragraphs [0022 and 0110], Fig. 9C, aligned pneumatospun collagen mat) comprising a plurality of collagen fibers (aligned pneumatospun collagen mat) formed in an aligned orientation (aligned pneumatospun collagen mat), the third collagen surface secured to the second surface (Paragraphs [0022 and 0110], Fig. 9A).
D ‘Lima fails to disclose the first surface comprising a spring frame. Kucklick also discloses a biological construct (Paragraph [0044], Figs. 14-18, self-deploying sheets 49, 50, 51, and 52). Kucklick teaches a first surface comprising a spring frame (Paragraph [0044], Figs. 14-18, spring material components 49A, 50A, 51A, 52A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified D ‘Lima’s first surface to comprise a spring frame, as taught by Kucklick, in order to engage tissue anchors (Paragraph [0044]).
D ‘Lima as modified by Kucklick fails to disclose wherein the first, second and third surfaces are triangular or tent shaped and have an apex sized and dimensioned to conform to the shape and size of the labral tear. Plouhar also discloses a biological construct (Fig. 5, illustrated device 30). Plouhar teaches wherein the first, second and third surfaces are triangular or tent shaped (Fig. 5, illustrated device 30) and have an apex (Fig. 5, illustrated device 30, apex portion 38) sized and dimensioned to conform to the shape and size of the labral tear (Paragraph [0017], “cartilage repair”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified D ‘Lima’s in view of Kucklick biological construct wherein the first, second and third surfaces (Paragraphs [0041 and 0042], “plurality of layers”) are triangular or tent shaped and have an apex sized and dimensioned to conform to the shape and size of the labral tear, as taught by Plouhar, in order to be the correct shape for the cartilage repair of the labrum (Paragraph [0041], “trimmed to the desired wedge shape”)
Regarding claim 2, D ‘Lima in view of Kucklick and Plouhar discloses at least one grommet or fastener loop (Kucklick’s Paragraph [0044], Figs. 14-18, grommet points 49x, 51x, 52x) on the first surface (49A, 50A, 51A, 52A ) for attachment to the labrum.
Regarding claim 3, D ‘Lima in view of Kucklick and Plouhar discloses further including a construct opening between 1mm to 4mm (Paragraph [0009], Fig. 1D).
Regarding claim 4, D ‘Lima in view of Kucklick as modified by Plouhar fails to disclose the apex is 45 degrees or less. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the angle of the apex, 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. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984.) See the MPEP 2144.04. In the instant case, the modified device of D ‘Lima would not operate differently with the claimed apex angle since the device is intended to fit over the meniscus or labrum, thus would function appropriately having the claimed apex angle. Further, it appears that applicant places no criticality on the apex angle range claimed, indicating the apex angle range “is shaped to conform to the shape of either a labrum or meniscus” (Specification [0016]) therefore the apex angle can be any angle that conforms to the labrum or meniscus.
Regarding claim 6, D ‘Lima in view of Kucklick and Plouhar discloses wherein: the spring surface is selected from the group consisting of Polyglycolic Acid, Poly-Lactic Acid (Paragraph [0044]), Poly-L-Lactic Acid, Polyglycolic Acid, Poly(L-lactide-co-(epsilon)-caprolactone), Polycaprolactone Polydioxanone, and Polyglyconate (Poly-Lactic Acid, Kucklick’s Paragraph [0044]).
Regarding claim 7, D ‘Lima in view of Kucklick and Plouhar fails to disclose wherein: the substrate surface is selected from the group consisting of polycaprolactone, Poly(l-lactide-co-ε-caprolactone), copolymers or polydioxanone. Kucklick further teaches a substrate surface is selected from the group consisting of polycaprolactone, Poly(l-lactide-co-ε-caprolactone), copolymers or polydioxanone (Paragraph [0044]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified D ‘Lima’s in view of Kucklick and Plouhar biological construct wherein: the substrate surface is selected from the group consisting of polycaprolactone, Poly(l-lactide-co-ε-caprolactone), copolymers or polydioxanone, as further taught by Kucklick, in order for the second, substrate surface to be a bio-absorbable or biocompatible material (Paragraph [0044]).
Regarding claim 8, D ‘Lima in view of Kucklick and Plouhar discloses wherein: the substrate surface is between 0.1 to 5mm thick (Paragraphs [0009 and 0061]).
Regarding claim 10, D ‘Lima in view of Kucklick and Plouhar discloses wherein: the collagen surface is made of a collagen selected from the group consisting of bovine (Paragraph [0009], “type I collagen, type III collagen”), porcine (Paragraph [0009], “type I collagen, type III collagen”) or synthetic recombinant collagen (Paragraph [0009], “other types of collagen”).
Regarding claim 12, D ‘Lima in view of Kucklick and Plouhar discloses wherein: the substrate surface (Fig. 9B) is formed by electrospinning (Paragraph [0110]).
Regarding claim 13, D ‘Lima in view of Kucklick and Plouhar discloses a biological construct (Paragraphs [0009, 0022, 0110], Figs. 9A-9C) to treat a labral tear (Paragraphs [0009 and 0031]) within a patient’s body, said construct comprising: a second surface comprising a substrate (Paragraphs [0022 and 0110], Fig. 9B, aligned PLA mat fibers) made of a biocompatible material (aligned PLA mat fibers) and secured to a first surface (Paragraph [0009], “combining the plurality of polymer scaffold compositions to form a multilayer construct”); and a third surface comprising a plurality of aligned collagen layers (Paragraphs [0022 and 0110], Fig. 9C, aligned pneumatospun collagen mat) formed in an aligned orientation (aligned pneumatospun collagen mat) and secured to the second surface (Paragraphs [0022 and 0110], Fig. 9A).
D ‘Lima fails to disclose a method of inserting the biological construct through a cannula comprising the steps of: providing a triangular biological construct in a first collapsed configuration, wherein the first, second and third surfaces are triangular or tent shaped and have an apex sized and dimensioned to conform to the shape and size of the labral tear; advancing the biological construct via a drive device through the cannula to the torn labrum; opening the construct into a second, open configuration and positioning the biological construct over the torn labrum and aligning the biological construct so that the apex of the construct is positioned over the labral tear; securing the biological construct over the labral tear to prevent displacement of the biological construct; and removing the delivery device.
Kucklick also discloses a biological construct (Paragraph [0044], Figs. 14-18, self-deploying sheets 49, 50, 51, and 52). Kucklick teaches a method of inserting (Paragraph [0049]) a biological construct (49, 50, 51, and 52) through a cannula (Paragraph [0049]) to treat a labral tear within a patient’s body comprising the steps of: providing a triangular biological construct (49, 50, 51, and 52) in a first collapsed configuration (Figs. 12-13, Paragraphs [0043-0044]), advancing the biological construct via a drive device (Figs. 12-13, delivery device 46, Paragraphs [0043-0044 and 0049]) through the cannula (Paragraph [0049]) to the torn labrum; opening the construct into a second, open configuration (Paragraph [0043]) and positioning the biological construct over the torn labrum (Paragraphs [0049 and 0050]) securing the biological construct over the labral tear to prevent displacement (Paragraph [0050]) of the biological construct; and removing the delivery device (Paragraph [0050]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified D ‘Lima’s biological construct for use with a method of inserting a biological construct to treat a labral tear (D ‘Lima: Paragraphs [0009 and 0031]) within a patient’s body through a cannula comprising the steps of: providing a triangular biological construct in a first collapsed configuration, advancing the biological construct via a drive device through the cannula to the torn labrum; opening the construct into a second, open configuration and positioning the biological construct over the torn labrum securing the biological construct over the labral tear to prevent displacement of the biological construct; and removing the delivery device, as taught by Kucklick, in order to deliver the biological construct to the body (Paragraphs [0043-0044]).
D ‘Lima as modified by Kucklick fails to disclose wherein the first, second and third surfaces are triangular or tent shaped and have an apex sized and dimensioned to conform to the shape and size of the labral tear and aligning the biological construct so that the apex of the construct is positioned over the labral tear. Plouhar also discloses a biological construct (Fig. 5, illustrated device 30). Plouhar teaches wherein the first, second and third surfaces are triangular or tent shaped (Fig. 5, illustrated device 30) and have an apex (Fig. 5, illustrated device 30, apex portion 38) sized and dimensioned to conform to the shape and size of the labral tear (Paragraph [0017], “cartilage repair”, Paragraph [0020], “other articular cartilage”); and aligning the biological construct (30) so that the apex (38) of the construct is positioned over (Figs. 1-3 and 5) the labral tear (Paragraph [0017], “cartilage repair”, Paragraph [0020], “other articular cartilage”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified D ‘Lima’s biological construct as modified by Kucklick’s method wherein the first, second and third surfaces are triangular or tent shaped and have an apex sized and dimensioned to conform to the shape and size of the labral tear and aligning the biological construct so that the apex of the construct is positioned over the labral tear as taught by Plouhar, in order to be the correct shape for the cartilage repair of the labrum (Paragraph [0041], “trimmed to the desired wedge shape”).
Claims 5, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over D ‘Lima et al. (US PG Pub No. 2025/0025601 A1) in view of Kucklick (Wipo Pub No. WO 2021/061984 A2) and Plouhar et al. (US PG Pub No. 2003/0033022 A1), as applied to claim 1 above, and further in view of D ‘Lima et al. (US PG Pub No. 2017/0007741), herein referred to as D ‘Lima 2017.
Regarding claim 5, D ‘Lima in view of Kucklick and Plouhar fails to disclose wherein: the aligned collagen fibers are formed in a parallel orientation where each collagen fiber is parallel to each other. D ‘Lima 2017 also discloses a biological construct (Paragraphs [0003, 0116-0117, and 0241-0242], Figs. 20D and 21A). D ‘Lima 2017 teaches wherein: the aligned collagen fibers (Figs. 20D and 21A) are formed in a parallel orientation where each collagen fiber is parallel to each other (Paragraphs [0003 and 0241-0242], Figs. 20D and 21A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified D ‘Lima’s in view of Kucklick and Plouhar biological construct wherein: the aligned collagen fibers are formed in a parallel orientation where each collagen fiber is parallel to each other, as taught by D ‘Lima 2017, in order to increase the strength of the scaffold (Paragraphs [0003 and 0241-0242]).
Regarding claim 9, D ‘Lima in view of Kucklick and Plouhar fails to disclose wherein: the substrate surface has a porosity between 50 microns and 500 microns. D ‘Lima 2017 also discloses a biological construct (Paragraphs [0003, 0116-0117, and 0241-0242], Figs. 20D and 21A). D ‘Lima 2017 teaches wherein: the substrate surface has a porosity between 50 microns and 500 microns (Paragraph [0118]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify D ‘Lima’s, in view of Kucklick and Plouhar, porosity to be between 50 microns and 500 microns, as taught by D ‘Lima 2017, in order to support desired tissue ingrowth (Paragraph [0114]).
Regarding claim 11, D ‘Lima in view of Kucklick and Plouhar fails to disclose wherein: the collagen surface has a has a porosity between 50 microns and 500 microns. D ‘Lima 2017 also discloses a biological construct (Paragraphs [0003, 0116-0117, and 0241-0242], Figs. 20D and 21A). D ‘Lima 2017 teaches wherein: the collagen surface (Paragraph [0117]) has a has a porosity between 50 microns and 500 microns (Paragraph [0118]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify D ‘Lima’s, in view of Kucklick and Plouhar, porosity to be between 50 microns and 500 microns, as taught by D ‘Lima 2017, in order to support desired tissue ingrowth (Paragraph [0114]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.L.C./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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