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 .
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.
DETAILED ACTION
Status of claims
The amendment filed on 04/22/2026 is acknowledged. Claims 16-20 have been withdrawn. Claims 1-15 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 04/22/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Rejections maintained
The following rejections of the claims are remained for reasons of record and the following. The rejections are modified based on the amendments.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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.
Claims 1-10 and 12-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Gann et al. (US 2017/0136140 A1) in view of Fayyaz et al. (Dextran-Based Oxygen Nanobubbles for Treating Inner Retinal Hypoxia, ACS Applied Nano Materials, Vol. 4, issue 7, page 6583-6593).
Gann et al. teach a matrix comprising gaseous oxygen contained in closed cells of the matrix (claim 1); wherein the matrix includes cross-linked water-swellable biocompatible polymer network (paragraph 42) formed from a biocompatible polymer including polyacrylate (the claimed hydrogel) (paragraph 44).
As to claims 1 and 12, the transitional phrase hydrogel composition “consisting essentially of”, as to claim 1, the transitional phrase oxygen nanobubbles “consisting essentially of”, as to claims 1, 3, 5, 6, 8, 9, 15, the transitional phrase the shells “consisting essentially of”, as to claims 12 and 15, the transitional phrase the electrolyte “consisting essentially of”, limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention (MPEP 2111.03.III). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” As far as the examiner can tell (there is no clear indication in view the claimed shell consisting essentially of five different components in claim 1 and each in different dependent claims 3-10, the composition consisting essential of ≥1 wt% of crosslinked polyacrylic acid gel (as the only component of the total composition) in claim 11, the composition consisting essential of about 2x10-4 wt% to about 20x10-4 wt% of mineral salt (as the only component of the total composition) in claim 12), the basic characteristic of hydrogel composition comprising crosslinked polyacrylic acid gel, oxygen nanobubbles encapsulated in shells, and electrolyte for effective delivering oxygen to a wound (and for the same reason thus claims 3-12 are rejected under 112(b) as being in contradiction with claim 1). In this regard the presence of antimicrobial silver materials taught by Gann et al. does not materially affect the “basic and novel characteristics of the invention”. Please refer to MPEP 2111.03.III:
If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of the claimed invention.
Gann et al. do not specify the gaseous oxygen being oxygen nanobubble encapsulated by a shell (the instant claim 2) comprising dextran, trehalose, lecithin, palmitic acid, and tocopherol in the instant claims 1, 4, 7, and 10, with electrolyte KCl in the instant claims 1 and 13, and their weight percentages in the instant claims 3, 5, 6, 8, 9, 12, and 15; and average outer diameter of the shells in the instant claims 1 and 14, and the zeta potential of the nanobubble in the instant claim 14.
This deficiency is cured by Fayyaz et al. who teaches a dextran-based oxygen nanobubble (DONB) with 119.6 ± 44.9 nm (164.5 nm, within the claimed about 165-450 nm, given ± 25% deviation according to the instant specification, the instant claims 1 and 14) and a zeta -potential of −35.54 ± 10.54 mV (-46.08, within the claimed about -65 to - 50 mV, given ± 25% deviation in the instant claim 14) (abstract);
wherein DONB is prepared from 50 mL H2O, 5 mL 0.9% w/v dextran having a MW of 200 kDa (the instant claim 4), 3 mL 0.23% w/v Epikuron 170 (soya-based lecithin, the instant claim 7), 1.5 mL 0.19% w/v palmitic acid, 2 mL 0.028% w/v tocopherol poly(ethylene glycol) 1000 succinate (TPGS, the instant claims 1 and 10), 1 mL 0.06% w/v KCl (the electrolyte in the instant claims 1 and 13), 2 mL 0.40% w/ v) of trehalose (the paragraph under “Synthesis of Nanobubbles” on page 6590) with stability and good oxygen-loading capacity (the paragraph under “Conclusions” on page 6590).
The total preparation volume is 64.5 mL (50 + 5 + 3 + 1.5 + 2 + 1 + 2 = 64.5 mL) and the concentrations of (in w/v %→ wt% given the majority of the composition being water and thus the density is about 1 g/mL): dextran 0.07 % (5/64.5 x 0.9%) (the instant claims 3 and 15), trehalose 0.012% (2/64.5 x 0.40%) (the instant claims 5 and 15), Epikuron 170 0.011% (3/64.5 x 0.23%) (the instant claims 6 and 15), palmitic acid 0.0044% (1.5/64.5 x 0.19%) (the instant claims 8 and 15), TPGS 0.00087% (2/64.5 x 0.028%) (the instant claims 9 and 15), KCl 0.00093% (1/64.5 x 0.06%) (the instant claims 12 and 15).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Gann et al. and Fayyaz et al. to specify gaseous oxygen in the matrix taught by Gann et al. being DONB. DONB stability and good oxygen-loading capacity was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose of delivery oxygen to tissue.
Fayyaz et al. do not the same weight percentages of lecithin (0.011% vs the claimed 0.017%, 0.0128% based on -25% deviation, in the instant claim 15) and KCl (0.00093% vs the claimed 0.00067%, 0.00084% based on +25% deviation, in the instant claim 15).
A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties.
The claimed range of lecithin is 0.017% by weight, 0.0128% by weight based on -25% deviation, and the range of lecithin taught in the prior art is 0.011% by weight and therefor is very close. Furthermore, about 0.002-0.05% is claimed in the instant claim 6, thus, the criticality of 0.017% (also 0.0128%) by weight over 0.011%taught by Fayyaz et al. is not established.
The claimed range of KCl is 0.00067% by weight, 0.00084% by weight based on +25% deviation, and the range of KCl taught in the prior art is 0.00093% by weight and therefor is very close. Furthermore, about 0.0002-0.002% is claimed in the instant claim 12, thus, the criticality of 0.00067% (also 0.00084%) by weight over 0.00093%taught by Fayyaz et al. is not established.
Response to Applicants’ arguments:
Applicant’s arguments based on the amendments are addressed in the modified rejection above (newly underlined).
Applicants argue that distribution of oxygen nanobubbles throughout the hydrogel is required for even delivery of oxygen to wound and it is known that silver can influence the colloidal stability by promoting aggregation and thus inclusion of silver materials could cause the dextran-based oxygen nanobubbles taught by Gann et al. to coagulate.
However, this argument is not deemed persuasive. First of all, the distribution of oxygen nanobubbles being throughout the hydrogel is not defined as at what scale, i.e., such as the number of oxygen nanobubbles in every nm3, µm3, mm3, or cm3 of hydrogel, thus the distribution of oxygen nanobubbles being throughout the hydrogel does not exclude coagulated oxygen nanobubbles.
Secondly, Gann et al. do not teach inclusion of silver in the hydrogel comprising the dextran-based oxygen nanobubbles causing the dextran-based oxygen nanobubbles coagulate while applicant merely argues that the product is different and nothing has been shown to substantiate this. From MPEP 716.01(c) II: The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Claims 1-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Gann et al. (US 2017/0136140 A1) in view of Fayyaz et al. (Dextran-Based Oxygen Nanobubbles for Treating Inner Retinal Hypoxia, ACS Applied Nano Materials, Vol. 4, issue 7, page 6583-6593) and Bergman et al. (US 2012/0259018 A).
The teachings of Gann et al. are discussed above and applied in the same manner.
The transitional phrases in claims 1, 3, 5, 6, 8, 9, 11, 12, and 15 will be construed as equivalent to “comprising.” As discussed above.
Gann et al. do not specify the concentration of polyacrylic acid in the instant claim 11.
This deficiency is cured by Bergman et al. who teaches hydrogel comprising 2.5% by weight of Carbopol (paragraph 64).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Gann et al. and Bergman et al. to specify the concentration of polyacrylic acid in the composition taught by Gann et al. being 2.5% by weight. Polyacrylic acid being incorporated at 2.5% by weight for forming a hydrogel was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Argument regarding the 103 rejection is basically the same as the above rejection, thus the response discussed above applies here as well and is not persuasive for reason discussed above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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/HONG YU/
Primary Examiner, Art Unit 1614
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