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 .
Claim status
In this non-final prosecution, examiner is pursuing the claims dated 05 May 2023, Applicant has claimed claims 1-21. Therefore, claims 1-21 are herein pending.
Accordingly, claims 1-21 are under current examination.
Priority
This application was filed 05/05/2023 and, which claims benefit to Provisional Application 63339335, filed on 05/06/2022. Thus, the earliest possible priority for the instant application is 05/06/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/05/2023, 06/30/2023 and 09/15/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ramcharan et al., (US20190144818A1; published on May 16, 2019; cited in IDS filed 09/15/2023; hereinafter “Ramcharan”), in view of Seidlits et al., (Acta Biomaterialia 7 (2011) 2401–2409; cited in IDS filed 09/15/2023; hereinafter “Seidlits”).
Regarding claims 1 and 15, Ramcharan discloses a cellular support system comprising: a three-dimensional (3D) scaffold structure [0082] comprising at least one void [0086]; and a fibrillar network comprising a plurality of suspended protein bridges spanning across the at least one void in the 3D scaffold structure, wherein the suspended protein bridges comprise extracellular matrix proteins [0103], [0121] and the suspended protein bridges are capable of supporting cells and promote 3D cellular growth (see claims 1-4; and paragraphs [0087], [0123], [0148], [0149]; Fig. 5A-F). Furthermore, Ramcharan discloses that the suspended fibril comprises hydrogel [0108], [0115], [0148].
However, Ramcharan does not discloses that hydrogel is glycan (claim 1) or hyaluronic acid (claim 15). However, such was known in the prior art.
Regarding claims 1, 5-7, 15 and 18, Seidlits discloses a fibronectin-hyaluronic acid composite hydrogels for 3D endothelial cell culture, wherein the hydrogels as biomaterial scaffolds are capable of enhancing the endothelial cell adhesion and angiogenesis (abstract of Seidlits). Seidlits further discloses that hyaluronic acid has a molecular weight of 1500 kDa (p. 2402, right column 1st ¶ of Seidlits, which necessarily renders obvious claims 7 and 18).
MPEP 2143 (A) states that combining prior art elements according to known methods to yield predictable results. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395. Accordingly, it would have been obvious to practice the cellular support system of Ramcharan discloses and include the hyaluronic acid as taught by Seidlits with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so as taught by Seidlits because the photo-crosslinkable fibronectin conjugate into 3D HA hydrogel networks to enhance cellular (i.e., endothelial cell) adhesion and angiogenesis (abstract of Seidlits). The POSITA would have had a reasonable expectation of success in combining the teachings of Ramcharan and Seidlits because each of these teachings both successfully generated Fibronectin–hyaluronic acid composite hydrogels for 3D scaffold structure for the cellular support system. Therefore, the products and method as taught by Ramcharan et al. in view of Seidlits et al. would have been prima facie obvious over the products and method of the instant application. In regard to the reasonable expectation of success in doing so, include the hyaluronic acid of Seidlits had a reasonable expectation of success since the steps thereof required no more than pipetting the appropriate concentration of hyaluronic acid and cell culture technology.
Regarding claims 2 and 16, Ramcharan teaches that the void has a major dimension of greater than or equal to about 0.1 micrometers to less than or equal to about 5 centimeters ([0008], [0022] of Ramcharan).
Regarding claim 3, Ramcharan teaches that the extracellular matrix protein comprises fibronectin ([0103] of Ramcharan).
Regarding claims 4 and 17, Ramcharan teaches that suspended protein bridges comprise one or more proteins selected from the group consisting of: collagens, laminins, fibronectins, tenascins, elastin, vitronectin, periostin and combinations thereof (see paragraph ([0011], [0182] of Ramcharan).
The additional features of claims 8, 9, 12, 14 and 19-21 can be easily selected or optimized by a person skilled in the art, without the exercise of inventive skill, through repeated experimentation, because Ramcharan teaches that each of the aforementioned incubation parameters ([0145-0146] ¶) may be tuned to produce the desired suspended protein bridge characteristics. The list of parameters includes: (i) number of different proteins to be suspended ( one or more); (ii) types of protein(s) to be suspended; (iii) if multiple proteins are desired 1) a ratio of proteins relative to the others; and/or 2) scaffold incubation in one solution that is a mixture of multiple proteins, or consecutive incubation periods in solutions of one protein at a time; (iv) concentration of protein solution(s); (v) time in which scaffold structure will be in contact with protein solution; and (vi) temperature(s) at which scaffold structure will be incubated with protein solution. POSITA would recognize that determining the fibronectin to the hyaluronic acid and fibril diameter would be matter of routine optimization. Generally, differences in concentration by adjusting solution will not support the patentability of the subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation" In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) -MPEP § 2144.05.
Regarding claim 10, Ramcharan teaches that the 3D scaffold structure is formed from a material selected from the group consisting of: a metal material, a polymeric material, a composite material, a ceramic material, a biologically-derived material and combinations thereof ([0012], [0027], [0094], claim 6 of Ramcharan).
Regarding claim 11, Ramcharan teaches that the 3D scaffold structure comprises a polymer and is formed from a polymeric precursor or is a polymer selected from the group consisting of: poly lactic acid, polyglycolide, polycaprolactone, poly(lactide-co-glycolide ), poly(lactide-cocaprolactone), polyethylene glycol, starches, polydimethylsiloxane, polyurethanes, polyolefins, polyamides, celluloses, lignins, biodegradable polyesters, polystyrene and combinations thereof (see paragraph [0013], [0028], [0040] of Ramcharan).
Regarding claim 13, Ramcharan teaches that the at least one void comprises a plurality of distinct suspended protein bridges spanning across the at least one void in the 3D scaffold structure to describe a network of protein that adsorbs onto surfaces of inner walls of the voids ([0016], [0148] of Ramcharan).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 3-7, 10-11, 15, and 17-18 are rejected on the grounds of nonstatutory double patenting over claim 1, 3-7, 10-12, and 18-22 of US patent no: US11479753B2, in view of Seidlits et al., (Acta Biomaterialia 7 (2011) 2401–2409; cited in IDS filed 09/15/2023; hereinafter “Seidlits”).
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: A cellular support system comprising: a three-dimensional scaffold structure comprising at least one void; and a suspended fibril spanning across the at least one void in the three-dimensional scaffold structure, wherein the suspended fibril comprises at least one extracellular matrix protein and at least one glycan and the suspended fibril is capable of supporting cells and promoting three-dimensional cellular growth of instant application. It is clear that elements of the cited patent claims are to be found in instant claims.
The difference between the cited patent claims and the instant claims 15 lies in the fact that instant Application claims are more specific for glycan proteins hyaluronic acid which also requires in instant claim 15.
Regarding claims 1, 5-7, 15 and 18, Seidlits discloses a fibronectin-hyaluronic acid composite hydrogels for 3D endothelial cell culture, wherein the hydrogels as biomaterial scaffolds are capable of enhancing the endothelial cell adhesion and angiogenesis (abstract of Seidlits). Seidlits further discloses that hyaluronic acid has a molecular weight of 1500 kDa (p. 2402, right column 1st ¶ of Seidlits, which necessarily renders obvious claims 7 and 18).
Accordingly, it would have been obvious to practice the cellular support system of Ramcharan discloses and include the hyaluronic acid as taught by Seidlits with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so as taught by Seidlits because the photo-crosslinkable fibronectin conjugate into 3D HA hydrogel networks to enhance cellular (i.e., endothelial cell) adhesion and angiogenesis (abstract of Seidlits).
Since the instant application claims are obvious over cited patent claims, in view of Seidlits, said claims are not patentably distinct.
Pertinent References
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is the following:
Raimondi et al. (US20200046881A1; Pub. Date: Feb. 13, 2020), provides 3D cell culture structure, herein referred to as super-matrix, composed of matrices of synthetic niches with a determined configuration that presents the advantages of a stronger and more stable structure, in particular, a structure in which no deformations or defects are present and in which at the same time the 3D structure of the engineered niches is maintained (see, for example, FIG. 4D and FIG. 5 A-B) [0069]. In the context of the present invention, the term synthetic niche means a synthetic 3D structure suited to reproducing the geometric constraints to which stem cells are subjected in their native micro-environment (the stem cell niche) [0103]. The complete reproducibility structures identical one to another are obtained: 3D matrices in collagen, chitosan, hyaluronic acid or synthetic polymers instead present marked structural variations even under equivalent conditions of production [0100].
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684