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 .
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
Claims 1-20 are pending in this application. This application claims priority to provisional application 63/344,030, filed on 05/19/2022.
Election/Restrictions
Applicants’ election without traverse of group I, claims 1-15, filed on 09/22/2025 is acknowledged. Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim. Claims 1-15 will presently be examined to the extent they read on the elected subject matter of record.
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).
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.
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.
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.
Correspondence
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HONG YU/
Primary Examiner, Art Unit 1614