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/Restrictions
Applicant’s election without traverse of Group I (claims 1-11 and 20) in the reply filed on 08/18/2026 is acknowledged.
Claims 1-20 are currently pending.
Claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/18/2026.
Claims 1-11 and 20 have been examined on their merits.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 6-8, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beachley et al (J Biomed Mater Res Part A, 2018).
Regarding claims 1-2 and 20, Beachley disclose a decellularized ECM-based composite hydrogel formulated by using modified GAGs (glycosaminoglycans) that covalently bind tissue particles and functions as a fibrous scaffold and as an implantable article (abstract, pages 147-148, page 150, page 158).
Regarding claim 6, Beachley disclose wherein the decellularized ECM was obtained from cartilaginous tissue (page 148, column 1).
Regarding claim 7, Beachley disclose wherein the ECM protein comprises collagen (page 150, column 2, page 154 column 2-page 155 column 1).
Regarding claim 8, Beachley disclose wherein the scaffolds were made from modified GAGs such as hyaluronic acid and chondroitin sulfate (page 148 column 1, page 149 column 1, page 158, column 2).
Therefore, the teaching of Beachley anticipates Applicant’s invention as claimed.
Claim(s) 1-2, 7-10, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spearman et al (J Biomed Mater Res A, 2020).
Regarding claims 1-2, 7-10, and 20, Spearman disclose multicomponent hydrogels containing collagen I, laminin (ECM proteins) and methacrylated hyaluronic acid (modified glycosaminoglycan) (page 5 last paragraph). These hydrogels are disclosed as useful as scaffolds for tissue engineering and biomedical applications (implants) (Title and abstract) and collagen is well known to be a fibrous protein and thus provides a fibrous scaffold.
Therefore, the teaching of Spearman anticipates Applicant’s invention as claimed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Beachley et al (J Biomed Mater Res Part A, 2018) in view of Voytik-Harbin et al (WO 2021/202533).
Regarding claims 3-4, Beachley disclose a decellularized ECM-based composite hydrogel formulated by using modified GAGs (glycosaminoglycans) that covalently bind tissue particles and functions as a fibrous scaffold and as an implantable article (abstract, pages 147-148, page 150, page 158). Beachley disclose an embodiment wherein these hydrogels were formed with different types of tissue ECM in an ordered pattern, such as concentric patterns wherein a core contained one type of tissue particle and an outer shell contained a second type of tissue particle (a core region and an outer shell region) (page 149 column 1). Crosslinking of these composite hydrogels and how crosslinking relates to the stiffening of the hydrogels was also disclosed (page 151 column 1-2, page 153 column 2-page 154 column 1).
Beachley do not specifically disclose wherein the different regions have different elastic moduli.
Voytik-Harbin disclose engineered collagen scaffolds (dehydrated or hydrated) for implantation for reestablishment of a tissue presence in an area of a patient that previously had been characterized by a tissue void or defect and to the regrowth tissue in this area (abstract, page 13). Material stiffness is disclosed as elastic modulus (page 2 line 25). A suitable elastic modulus can be from 18 MPa to 200 MPa or from 20 MPa to 180 MPa (page 14 lines 9-11).
One of ordinary skill in the art would have been motivated to include regions with each region having a different elastic modulus in the decellularized ECM-based composite scaffold of Beachley because Voytik-Harbin teach and select that the stiffness of the material is equated to elastic modulus and Beachley teach that their scaffold composites include embodiments with different regions from different ECM tissue sources which would provide for regions with a different stiffness (elastic modulus) dependent upon the ECM tissue source. One of ordinary skill in the art would have been motivated to select a region with an elastic modulus of 20 MPa and another region with an elastic modulus of 50 MPa in the scaffold of Beachley through routine optimization and experimentation as Voytik-Harbin teach and suggest that MPa values between 18 MPa and 180 MPa are suitable for a collagen containing scaffold intended for use as an implant. One of ordinary skill in the art would have had a reasonable expectation of success because both Beachley and Voytik-Harbin are directed to collagen containing scaffolds with collagen containing ECM particles intended for implantation to repair damaged tissue.
Therefore, the combined teachings of Beachley and Voytik-Harbin render obvious Applicant’s invention as claimed.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Beachley et al (J Biomed Mater Res Part A, 2018) in view of Murray et al (WO 2013/116744).
Regarding claim 5, Beachley disclose a decellularized ECM-based composite hydrogel formulated by using modified GAGs (glycosaminoglycans) that covalently bind tissue particles and functions as a fibrous scaffold and as an implantable article (abstract, pages 147-148, page 150, page 158). Beachley disclose an embodiment wherein these hydrogels were formed with different types of tissue ECM in an ordered pattern, such as concentric patterns wherein a core contained one type of tissue particle and an outer shell contained a second type of tissue particle (a core region and an outer shell region) (page 149 column 1). Crosslinking of these composite hydrogels and how crosslinking relates to the stiffening of the hydrogels was also disclosed (page 151 column 1-2, page 153 column 2-page 154 column 1).
Beachley do not specifically disclose wherein the different regions have different degrees of crosslinking.
Murray disclose biomaterial for articular cartilage maintenance and treatment of arthritis (Title, abstract). Murray disclose wherein type 1 collagen is the predominant component of the extracellular matrix, occurs predominantly in fibrous form, and allows for design of materials with very different mechanical properties by altering the degree of crosslinking of the collagen. The biologic properties of cell infiltration rate and scaffold degradation may also be altered by varying the degree of crosslinking and the use of additional proteins, such as glycosaminoglycans (pages 19-20 para 83).
One of ordinary skill in the art would have been motivated to include different degrees of crosslinking in the in the decellularized ECM-based composite scaffold of Beachley because Murray teach and suggest that the advantage of adjusting the biologic properties of cell infiltration rate and scaffold degradation may by varying the degree of crosslinking and the use of additional proteins, such as glycosaminoglycans (pages 19-20 para 83). One of ordinary skill in the art would have had a reasonable expectation of success because Beachley and Murray are both drawn to collagen containing scaffolds with additional proteins, such as glycosaminoglycans, and Beachley teach that their scaffolds contain regions with ECM from different tissue sources that are exposed to crosslinking conditions.
Therefore, the combined teachings of Beachley and Murray render obvious Applicant’s invention as claimed.
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Beachley et al (J Biomed Mater Res Part A, 2018) in view of Spearman et al (J Biomed Mater Res A, 2020).
Regarding claims 9-11, Beachley disclose a decellularized ECM-based composite hydrogel formulated by using modified GAGs (glycosaminoglycans) that covalently bind tissue particles and functions as a fibrous scaffold and as an implantable article (abstract, pages 147-148, page 150, page 158). Beachley disclose an embodiment wherein these hydrogels were formed with different types of tissue ECM in an ordered pattern, such as concentric patterns wherein a core contained one type of tissue particle and an outer shell contained a second type of tissue particle (a core region and an outer shell region) (page 149 column 1). Crosslinking of these composite hydrogels and how crosslinking relates to the stiffening of the hydrogels was also disclosed (page 151 column 1-2, page 153 column 2-page 154 column 1).
Beachley do not specifically disclose wherein the modified glycosaminoglycan is modified by methacrylation.
Spearman disclose tunable methacrylated hyaluronic acid-based hydrogels as scaffolds for soft tissue engineering applications (Title). Spearman teach that a wide range of mechanical properties of methylated hyaluronic acid (HA) is possible covering a wide range of soft tissues and can be easily modulated by the addition of other ECM components. An embodiment that includes native ECM, collagen I and laminin, in addition to the modified HA is also disclosed (page 15, Conclusion). Hyaluronic acid that is methacrylated in a continuous range of about 86% or 50% are disclosed (page 9 last paragraph).Mechanical properties play a critical role in the regenerative capacity of tissue-engineered scaffolds (page 3).
One of ordinary skill in the art would have been motivated to include wherein the modified glycosaminoglycan in Beachley was a methacrylated hyaluronic acid because Spearman suggest that this type of modified glycosaminoglycan is suitable and beneficial for inclusion in a hydrogel scaffold containing other ECM proteins. One of ordinary skill in the art would have been motivated to include wherein the hyaluronic acid is methacrylated in a continuous range of about 50% or 86% because Spearman teach and suggest that these are suitable values for methacrylation for hyaluronic acid when used in a hydrogel scaffold intended for applications in biomedical engineering. One of ordinary skill in the art would have had a reasonable expectation of success because Beachley is also used a modified glycosaminoglycan, such as a modified hyaluronic acid, in a hydrogel combined with ECM proteins.
Therefore, the combined teachings of Beachley and Spearman render obvious Applicant’s invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brigham et al., “Mechanically Robust and Bioadhesive Collagen and Photocrosslinkable Hyaluronic Acid Semi-Interpenetrating Networks”, TISSUE ENGINEERING: Part A, 2009, Volume 15, Number 7, pp. 1645-1653.
(Brigham disclose fibrous collagen methacrylated hyaluronic acid scaffold -see page 1647, FIG 1).
Velasco-Rodriguez et al., “Hybrid Methacrylated Gelatin and Hyaluronic Acid Hydrogel Scaffolds. Preparation and Systematic Characterization for Prospective Tissue Engineering Applications”, Int. J. Mol. Sci. 2021, Vol. 22, 6758, pp. 1-26.
(Velasco-Rodrigues disclose scaffolds containing hyaluronic acid and gelatin and methacrylation modifications.)
Bahcecioglu et al., “Hydrogels of agarose, and methacrylated gelatin and hyaluronic acid are more supportive for in vitro meniscus regeneration than three dimensional printed polycaprolactone scaffolds”, International Journal of Biological Macromolecules, 2019, Vol. 122, pp. 1152-1162.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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