DETAILED CORRESPONDENCE
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 of invention and/or species, and corresponding claims is acknowledged. The election has been made without traverse. Non-elected claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Allowable Subject Matter
Claim 7-8, 10-17, 38 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Objections
In claim 37, “by wash” should be –by washing--.
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 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.
Claim(s) 1-2, 6, 9, and 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choong (WO 2018053565 A1 – of record by applicant).
In reference to claim 1, Choong discloses a method for obtaining one or more individual free-form fibers of biocompatible hydrogels with a predefined diameter, the method comprising the following steps:
providing a printable biocompatible hydrogel in a first nozzle of a printing
system, the first nozzle having an interior; (See figure 6. “one nozzle opening is positioned within another opening in a co-axial arrangement” [Claim 4] and
“coaxial arrangement may advantageously allow for deposition of an outer 'shell' structure that can better confine cells encapsulated in an inner 'core' structure.” [P0039]. The specification indicates that the bioink would be the hydrogel and contain cells; it would be the core.)
providing a printable composition comprising a … shell … in a second co-axial nozzle of the printing system, the second co- axial nozzle surrounding the first nozzle; and (“one nozzle opening is positioned within another opening in a co-axial arrangement” [Claim 4] and “coaxial arrangement may advantageously allow for deposition of an outer 'shell' structure that can better confine cells encapsulated in an inner 'core' structure.” [P0039]))
extruding the biocompatible hydrogel of step a) and the composition of step b) simultaneously through the first and second nozzles, wherein the composition of step b) in a gel state coats the extruded biocompatible hydrogel. (“coaxial arrangement may advantageously allow for deposition of an outer 'shell' structure that can better confine cells encapsulated in an inner 'core' structure.” [P0039]; and
“The device 10 used for this example had a co-axial nozzle configuration (as illustrated in Figure 6). The inner opening 6b was supplied with a GelMa/HAMa hydrogel seeded with mesenchymal stem cells obtained from sheep infrapatellar fat pad, at a concentration of 2.5 χ 106 cells/ml. The outer opening 6a was supplied with a GelMa/HAMa hydrogel and 0.5 wt% photoinitiator VA-086.” [P0083]
“hydrogel comprising gelatin- methacrylamide (GelMa) and hyaluronic acid-methacrylate (HAMa)” [P0023])
Choong’s shell comprises gelatin (see paragraph 0083, quoted above). Gelatin is a thermoreversible gelling polymer. Thus, Choong alone meets the claim.
In reference to claim 2 the cited prior art discloses the invention as in claim 1.
See figure 11.
In reference to claim 6 the cited prior art discloses the invention as in claim 1.
Choong discloses the composition is a hydrogel comprising gelatin- methacrylamide (GelMa) and hyaluronic acid-methacrylate (HAMa) (P0023).
In reference to claim 9 the cited prior art discloses the invention as in claim 1.
Choong discloses the hydrogel is a hydrogel comprising gelatin- methacrylamide (GelMa) and hyaluronic acid-methacrylate (HAMa) (P0023). The core and mantle can both be hydrogels.
In reference to claim 37 the cited prior art discloses the invention as in claim 1.
Choong discloses the composition is a hydrogel comprising gelatin- methacrylamide (GelMa) and hyaluronic acid-methacrylate (HAMa) (P0023). The cited prior art does not specifically disclose that the structure has the property of being removable by washing at 0C. However, the cited prior art teaches an identical or substantially identical structure as claimed. Therefore, the property is presumed to be inherent to the cited prior art. Apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function; and, the structure must be clearly and positively specified.
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 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.
Claim 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choong (WO 2018053565 A1)
In reference to claim 3 the cited prior art discloses the invention as in claim 1.
See figures 1-4 of Choong, which show the nozzle has a conical shape. When the coaxial arrangement is used, it would be obvious to use a similarly shaped nozzle because that is the only nozzle shape disclosed by Choong.
In reference to claim 4 the cited prior art discloses the invention as in claim 1.
It would be obvious to make the fibers consistently as desired in order to form materials having predictable properties.
Conclusion
Any prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Beyer (US 20160136895 A1) teaches core shell hydrobiogels.
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/NICHOLAS KRASNOW/Examiner, Art Unit 1744