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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 15-30, drawn to a tissue scaffold, classified in A61L 27/56.
II. Claims 31-35, drawn to a method of manufacturing a tissue scaffold, classified in A61L 2400/08.
The inventions are independent or distinct, each from the other because:
Inventions II. and I. are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the claimed tissue scaffold could be manufactured using a materially different method of manufacture such as 3D printing.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the species or groupings of patentably indistinct species have acquired a separate status in the art in view of their different classification;
--the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter; and/or
--the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
-For a serious examination burden explain the reason, such as non-prior art issues under 35 U.S.C. 101, pre-AIA 35 U.S.C. 112, first paragraph, and/or 35 U.S.C. 112(a) are relevant to one species or grouping of patentably indistinct species that are not relevant to the other species or grouping(s) of patentably indistinct species.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Mark Kilgore on 04/30/2026 a provisional election was made without traverse to prosecute the invention of group I., claims 15-30. Affirmation of this election must be made by applicant in replying to this Office action. Claims 31-35 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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.
Claims 27-28 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 27 recites the limitation “the constituent of the at least one cell type”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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) 15-16, 18, 20, 22-23, and 25-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MILBOCKER et al. WO 2019079622 A1, herein Milbocker.
Regarding claim 15, Milbocker discloses a tissue scaffold (Fig 3, implant 200; [0112]) comprising: a substrate ([0031], “biodegradable polymer”), the substrate further comprising a base layer (Fig 3, 210),
the base layer comprising a first pattern of microstructures (Fig 3, 300);
the first pattern of microstructures further comprising at least one first capping layer (Fig, 3 Microstructure 360) disposed on the first pattern of microstructures (Fig 3);
the at least one first capping layer comprising a smooth microstructure layer and/or a second pattern of microstructures ([0075] and [0091] teaches hydration to form separate microstructures. Therefore, partial hydration of surface 380 would have separate microstructures, see Fig 3, 380 and [0051]: “The inner surfaces 380 are partially hydrated”);
and wherein the first pattern of microstructures and the at least one first capping layer are configured to form a tissue growth surface ([0061]).
Regarding claim 16, Milbocker discloses wherein the smooth microstructure layer and the second pattern of microstructures each have a width of 0.1 um to 1000 um ([0007] While Milbocker does not teach the specific range, the claimed ranges are within the ranges taught by Milbocker).
Regarding claim 18, Milbocker discloses wherein the at least one first capping layer and the first pattern of microstructures are disposed hierarchically on the base layer (Fig 3), wherein the at least one first capping layer and the base layer have different surface energy ([0060] hierarchical structures of a substrates as shown will impart surface energy “texture” or pattern as claimed).
Regarding claim 20, Milbocker discloses further comprising a second pattern of microstructures (Fig 3, 240), wherein the second pattern of microstructures further comprise at least one second capping layer disposed on the second pattern of microstructures (Fig 3, 240 top portion)
Regarding claim 22, Milbocker discloses further comprising a plurality of cells deposited on the tissue growth surface ([0117)).
Regarding claim 23, Milbocker discloses wherein the plurality of cells are selected from cell types comprising endothelial cells, smooth muscle cells, fibroblasts, tendon cells, mesenchymal stem cells, skeletal muscle cells, chondrocytes, and epithelial cells ([00120] and [00117] anticipates all listed cell types).
Regarding claim 25, Milbocker discloses wherein an avoidance layer (the instant application define avoidant as microbe-avoidant; Milbocker [0015] teaches deposits of antimicrobials) is deposited on all or a portion of the at least one first capping layer (Milbocker [00105]).
Regarding claim 26, Milbocker discloses a tissue scaffold (Fig 3, implant 200; [0112]) comprising: a substrate ([0031], “biodegradable polymer”),
the substrate further comprising a base layer (Fig 3, 210),
the base layer comprising an at least two hierarchical (Milbocker is silent regarding single-scale construction of microstructures (non-hierarchal in nature). By definition, microstructures can only be (single-scale) non-hierarchal or hierarchal. Therefore, one of ordinary skill in the art would know the structures presented are hierarchal) microstructure patterns (Fig 3, 300 and 240);
the at least two hierarchical microstructure patterns comprising at least one first pattern of microstructures ([0051] 240; teaches discrete microstructures, which would have different patterns) and an at least one second pattern of microstructures ([0051]; 300);
the at least one first pattern of microstructures further comprising at least one first capping layer (Fig, 3 Microstructure 360);
the at least one second pattern of microstructures further comprising at least one second capping layer (Fig 3, top portion of 240);
the at least one first capping layer being hierarchically disposed on the at least one first pattern of microstructures (Fig 3);
the at least one second capping layer being hierarchically disposed on the at least one second pattern of microstructures (Fig 3);
wherein the at least two hierarchical microstructure patterns are disposed of in a geometric pattern on the substrate (Varying levels of hydration as taught by Milbocker impart separate geometric patterns, see [0051], [0075] and [0091]),
wherein the geometric pattern comprises a surface energy pattern ([0060] hierarchical structures of a substrates as shown will impart surface energy “texture” or pattern as claimed);
and the surface energy pattern directs at least one cell type ([0060]) in contact with at least one of the at least two hierarchical microstructure patterns to form at least one tissue structure ([0061]).
Regarding claim 27, Milbocker discloses wherein the at least one tissue structure is of a size at least ten times the size of the constituent of the at least one cell type (Scaffold would be 10 times larger than the largest cell type)
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.
Claim(s) 19, 21, and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milbocker in view of Milbocker et al. US 20190133222 A1, herein Milbocker US.
Regarding claim 19, Milbocker discloses the invention substantially as claimed and as discussed above with respect to claim 18, but does not disclose comprising the at least one first capping layer and the first pattern of microstructures, wherein the first microstructure layer, comprises a water sessile drop contact angle being 100 degrees or less
But Milbocker US teaches wherein the first microstructure layer, comprising the at least one first capping layer and the first pattern of microstructures, comprises a water sessile drop contact angle being 100 degrees or less (Milbocker US [0140]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Milbocker to incorporate wherein the first microstructure layer, comprising the at least one first capping layer and the first pattern of microstructures, comprises a water sessile drop contact angle being 100 degrees or less, as taught and suggested by Milbocker US in order to control hydrophobicity in each layer of the tissue scaffold (Mibocker US [0140-0141]).
Regarding claim 21, Milbocker/Milbocker US discloses the invention substantially as claimed and as discussed above with respect to claim 18 teaches wherein the second microstructure layer (Fig 3, 240), comprising the at least one second capping layer and the second pattern of microstructures (top of 240), comprises a water sessile drop contact angle greater than 100 degrees (Milbocker US [0140]).
Regarding claim 29, Milbocker/Milbocker US discloses the invention substantially as claimed and as discussed above with respect to claim 21 teaches wherein the at least two hierarchical microstructure patterns further comprise ridges and/or grooves (Milbocker US [0094]).
Regarding claim 30, Milbocker/Milbocker US discloses the invention substantially as claimed and as discussed above with respect to claim 29 teaches wherein the ridges and the grooves have a same geometry or a variety of geometries (Milbocker US [0094]), the same geometry and variety of geometries comprising convex, concave, or substantially planar surfaces (Milbocker US [0088]).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Milbocker in view of Bluecher et al. US 20210338405 A1, herein Bluecher.
Regarding claim 17, Milbocker discloses the invention substantially as claimed and as discussed above with respect to claim 15, but does not disclose wherein the first pattern of microstructures and the at least one first capping layer comprise pillars with a circular, square, triangular, or hexagonal cross-section.
But Bluecher teaches wherein the first pattern of microstructures and the at least one first capping layer comprise pillars with a circular, square, triangular cross-section (Bluecher [0122]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Milbocker to incorporate wherein the first pattern of microstructures and the at least one first capping layer comprise pillars with a circular, square, triangular, or hexagonal cross-section, as taught and suggested by Bleucher in order to change target penetration (Bluecher [0122]).
Claim(s) 24 and 28 is rejected under 35 U.S.C. 103 as being unpatentable over Milbocker in view of Schmuck et al. US 20160354447, herein referred to as Schmuck.
Regarding claim 24, Milbocker discloses the invention substantially as claimed and as discussed above with respect to claim 23, and additionally teaches wherein the endothelial cells are vascular endothelial cells (Milbocker [00121]), the smooth muscle cells are vascular smooth muscle cells (Milbocker [00121]); but does not explicitly disclose the mesenchymal stem cells are bone marrow-derived human mesenchymal stem cells.
But Schmuck teaches wherein the mesenchymal stem cells are bone marrow-derived human mesenchymal stem cells (Schumck [0015]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Milbocker to incorporate wherein the mesenchymal stem cells are bone marrow-derived human mesenchymal stem cells, as taught and suggested by Schmuck in order to provide broad biocompatibility with potential interacting cell types and allow the scaffold to be used for various types of injuries (Schmuck [0032]).
Regarding claim 28, Milbocker/Schmuck discloses the invention substantially as claimed and as discussed above with respect to claim 23 teaches wherein the at least one cell type forms a confluent monolayer ([0104] Schmuck) across an extracellular matrix while maintaining the surface energy pattern (Directed at method of use, scaffold of Milbocker is fully capable because the biocompatible materials recited [0078] match those shown in of the instant application, see [0201-0202]), the surface energy pattern further comprising alternating at least one high surface energy microstructure and at least one low surface energy microstructure (Directed at method of use, scaffold of Milbocker is fully capable because the biocompatible materials recited [0078] match those shown in of the instant application, see [0201-0202]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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