Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 Mar 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Amendments to the claims filed 23 Jul 2026 are acknowledged. Claims 11-12 and 21 are amended. Claims 13-20 are canceled. Claims 24-28 are newly presented. Claims 26-28 are withdrawn.
Claims 1-10 were previously canceled and claims 21-23 were previously withdrawn.
Claims 11-12 and 21-28 are pending. Claims 11-12 and 24-25 are considered on the merits.
Claim Objections
Objection to claim 1 is moot due to cancellation of the claim.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Rejection of claims 11-20 under 35 U.S.C. § 112(b) is moot due to cancellation of claims 13-20 or withdrawn due to amendment to claims 11-12.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Rejection of claims 11-20 under 35 U.S.C. § 112(a) is moot due to cancellation of claims 13-20 or withdrawn due to amendment to claims 11-12.
Claim Rejections - 35 USC § 101
The following is a quotation of 35 U.S.C. § 101:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Rejection of claim 11 under 35 U.S.C. § 101 is withdrawn due to amendment to claim 11.
Claim Rejections - 35 USC § 102
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.
Rejections of claims 13-20 under 35 U.S.C. § 102(a)(1) are moot due to cancellation of the claims.
Rejection of claim 11 under 35 U.S.C. 102(a)(1) as being anticipated by Moqrich (US 9884088 B2, 2018) is withdrawn due to amendment to the claim.
Claims 11-12 remain rejected and claims 24-25 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gu (CN 106668840 B, Feb 2020) and as evidenced by Guyton (A.C. Guyton and J.E. Hall, Textbook of Medical Physiology, 2006). The rejection is amended as necessitated by amendments to the claims.
Gu discloses a hypotonic solution with osmolality 72 mOsm/kg comprising 5 mM sodium chloride (NaCl), 20 mM glucose, and 15 mM sodium dihydrogen phosphate (NaH2PO4) (par. 18) (claims 11-12 and 24-25).
The density of a dilute aqueous solution is about 1 kg/L (Guyton p. 297); therefore, the osmolarity of the hypotonic solution taught by Gu is about 72 mOsm/L, which is within the claimed ranges of 42.8 to 220 mOsm/L (claims 11 and 24) and 42.8 to 113 mOsm/L (claims 12 and 25).
Regarding claims 24-25, the disclosed concentration of NaCl is 0.29 g/L, concentration of glucose is 3.60 g/L, and concentration of NaH2PO4 is equal to 1.80 g/L. Therefore, the weight ratio of NaCl to glucose is 0.08, which is within the claimed range of 1:0.06 to 1:2560. The weight ratio of NaCl to NaH2PO4 is 0.16, which is within the claimed range of 1:0.015 to 1:133. The weight ratio of glucose to NaH2PO4 is 2.00, which is within the claimed range of 1:0.0007 to 1:22.
The transitional phrase "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. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). 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". See MPEP § 2111.03(III). In the present instance, in absence of evidence to the contrary, the inclusion of additional components in the solution disclosed by Gu does not alter the properties of the solution as the osmolarity and ratios of components fall within the claimed ranges and thus the additional components do not distinguish the solution disclosed by Gu from the composition of the claimed solution.
§ 102 – Response to Arguments
Applicant argues that because the amended claims now recite that the solution is "consisting essentially of" the recited solutes (claims 11-12) or combination of solutes (claims 24-25) and because the solution disclosed by Gu comprises additional components, the amended claims are free of the prior art (Remarks filed 23 Jul 2026 p. 6 6th-7th par.). Applicant further argues that the additional components in the solution disclosed by Gu, including 15 mM NaHCO3, 2 mM ATP, and 3 mM glutathione, act as functional components related to its use in Gu to sustain erythrocyte viability and enable insulin encapsulation that would materially affect the basic and novel characteristics of the solution and therefore distinguish the solution from the claimed solution (Remarks p. 7 1st par.). Applicant further notes that in addition to being structurally distinct from the solution disclosed by Gu, the claimed solution achieves the unexpected result of simultaneous high extraction efficiency and high retention of mitochondrial function under hypotonic conditions (Remarks p. 7 4th par.).
In response, arguments have been fully considered and are not persuasive.
Regarding use of the solution disclosed by Gu, product claims are directed to the product itself and not how it used or made. The use of the hypotonic buffer disclosed by Gu for sustaining erythrocyte viability and enable insulin encapsulation does not relate to the basic and novel characteristics of the present claims, which merely require a particular range of osmolarity and in the case of claims 24-25, a ratio of the components. The solution disclosed by Gu meets both criteria as discussed in the rejection of claims 11-12 and 24-25 under 35 U.S.C. § 102 above. As noted above, in absence of clear indication from the claims or from the specification of what the basic and novel characteristics of the claimed invention actually are, the phrase, "consisting essentially of" is construed in the present case to be equivalent to "comprising". The term "comprising" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See MPEP § 2111.03(I). Therefore, in the present case, the inclusion of additional components does not distinguish the solution disclosed by Gu from the claimed solution.
Regarding functional distinction between the claimed solution and the solution disclosed by Gu, evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. § 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). The prior art need not disclose limitations not present in the claims. High extraction efficiency and protection of mitochondrial function in isolation of mitochondria are not required elements of the claims and therefore, the solution disclosed by Gu need not have those properties to anticipate the claimed solution.
Conclusion
No claim is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Eric B Wright whose telephone number is (571) 272-2607. The examiner can normally be reached Mo - Fr, 09:00 a.m. - 05:00 p.m. Eastern. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant may use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Eric B Wright, PhD
Examiner
Art Unit 1632
/Eric B Wright/Examiner, Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
