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 .
Response to Argument and Amendment
Status of Claims
Claims 1-3,5, 7, 9-11, 13-16 and 18 are pending and under examination in this office action.
Claims 22-27 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/31/25.
Claim Rejections - 35 USC § 103 (necessitated by amendment)
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) 1-3,5, 7, 9-11, 13-16 and 18 stand rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/062429) in view of Tan et al. (Nature Communications 2017) and Strickler et al. (US 2007/0232169) and Du et al. (Advance Materials 31(52) 2019)
With regards to instant claims 1, Tamayol teaches a multi-compartment hydrogel fiber (see 0038, 0067)comprising an outer and an inner layer (absent factual evidence, layers do have an inner and outer) wherein the hydrogen bond (i.e, ionic bonding as required also by instant claim 10) wherein it comprises hydrogel and hydrophilic solution (i.e., alginate mixed non-alginate within the hydrogel layer therefore are different, see 0056 ) having different compartments that are axial having a diameter less than 200 μm ie., 10 μm (see0048, 0056 as required by instant claim 2-3) wherein the gel is an alginate (as required by instant claim 4, see 0056) and from collagen based hydrogels such as gelatin (see 0040, as required by claim 7) as 3D focusing (as required by instant claim 8, see 0004-0005) photo-crosslinked (see 0084, as required by instant claim 9) and further comprises a therapeutic agent (see 0053, i.e., anti-inflammatory, as required by instant claim 14) wherein the cell is a stem cell (see 0050, as required by instant claim 15) and intrinsically in a suitable carrier i.e., a cell carrier (as required by claim16, see 0094). Tamayol teaches regards to the hydrogel fiber obtainable by 3D (see 0005 and 0025) wherein the hydrogel is from alginate (as required by claim 1).
However fails to teach per se a kit (as required by instant claim 18) and the shape as required by instant claim 1. With regards to the kit as recited in instant claim 18, although a kit per-se is not taught, it is within reason that the composition is in a form of a package/kit
The printed matter on a label or package insert of a kit or container does not lend patentable weight as a limitation of the claimed product, composition, or article of manufacture, absent a functional relationship between the label or package insert of a kit and the product, composition, or article of manufacture of a kit or container.
See In re Haller 73 USPQ 403 (CCPA 1947), where it is held that application of printed matter to old article cannot render the article patentable. In the opinion text of In re Haller, it is stated that: Whether the statement of intended use appears merely in the claim or in label on the product is immaterial so far as the question of Patentability is concerned . . . In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is intended. The difficulty is not that there can never be invention in discovering a new process involving the use of an old article, but that the statutes make no provision for patenting of an article or composition which is not, in and of itself, new.
Also see In re Venezia 189 USPQ 49 (CCPA 1976), where kits are drawn to the structural attributes of interrelated component parts and not to activities that may or may not occur. Further, In re Miller 164 USPQ 46 (CCPA 1969) and In re Gulak (CAFC) 217 USPQ 401 relate to a mathematical device and to a measuring cup respectively as well as In re Ngai, 70 USPQ2d 1862 (CAFC 2004). In each of these cases, the printed matter is considered a patentable distinction because the function of the device depends upon the printed matter itself, which is a patentable distinction because the function of the device depends upon the printed matter itself, which is a part of the substrate; without the printed indicia or numbers, the substrates lose their function. Such is not the case with the instantly claimed articles or kits. The claimed articles of the kit remain fully functional absent the labeling or printed instructions for use.
Tan teaches multi-compartment hydrogel comprising an outer and inner layer (see pg 3, rt col, 1st para) with different compositions (see pg. 2, last few lines of the paragraph) wherein the hydrogel fiber comprises a core-shell (see result) diameter less than 200 μm.
Strickler teaches a medical devices as required comprising multi-compartment fibers (see tittle) comprising a first and second hydrogel (see 0027), wherein the first and second therapeutic agents may be the same (e.g., an anti-proliferative agent) or different (e.g., an anti-thrombotic agent (see 0036) with regards to a kit. Additionally, Stricker teaches vary widely in shape wherein the shape is a ribbon (see 0062).
Du teaches multifunctional multicompartmental shell microfibre with a cross-sectional area is a double-Janus and double -layered shell fiber, wherein the hydrogel is an alginate (ionic), wherein the cross-section can be chosen from flat, grooved (see Fig. 2).
It would have been obvious to one of ordinary skill in the art to have combined the cited prior art to result in the instant claimed invention with a reasonable expectation of success that Indeed, MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art' to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). This is because “The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the time of the invention.” (MPEP 2141.03(I)) and an artisan must be presumed to know something about the art apart from what the references disclose. See /n re Jacoby, 309 F.2d 513, 516 (CCPA 1962). “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSA, 550 U.S. at 421, 82 USPQ2d at 1397. “[l]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418, 82 USPQ2d at 1396. (MPEP 2141.03 (I)). “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
One would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a).
Applicant argues that Claim 1 is directed to a multi-compartment hydrogel fibre obtainable by three-dimensional flow-focusing, wherein the fibre has an outer and an inner layer and a cross-sectional area in the shape of a core-shell, a ribbon, a tricoaxial, a double-Janus, or a double core-shell. The claimed fibre comprises a first ionic hydrogel forming the outer layer and a second component arranged in a plurality of compartments, wherein the first ionic hydrogel and the second hydrogel have different compositions. The claim further requires that the fibre comprises axially nonconcentric compartments, and/or non-circular compartment cross-sections, and/or an equivalent diameter below 200 pm and that Tamayol does not disclose or suggest the claimed fibre architecture.
In response, contrary to Applicant’s argument, Tamayol does teach a multi-compartment hydrogel fiber (see 0038, 0067)comprising an outer and an inner layer even if in arguendo Tamayol fails to teach such, Tan teaches multi-compartment hydrogel comprising an outer and inner layer (see pg 3, rt col, 1st para), and Strickler teaches a medical devices as required comprising multi-compartment fibers (see tittle) comprising a first and second hydrogel, wherein the shape is a ribbon.
Therefore it would have been obvious to one of ordinary skill in the art to have modified the Tamayol reference by incorporating the teachings of Tan, Stricker and Du to reach the instant claimed invention with a reasonable expectation of success
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 2/9/25