DETAILED ACTION
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.
Status of the Claims
The response and amendment filed 07/13/2026 is acknowledged.
Claims 4-17 and 19-23 are pending.
Claims 19-23 are new.
Applicant’s election of Group II, claims 4-17, in the reply filed on 07/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of direct administration to the central nervous system as species of administration, in the reply filed on 07/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant indicates he elected species reads on claim 5.
Claims 6-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/13/2026.
Claims 4-5 and 19-23 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 of carrying out his invention.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 20 includes the limitation of wherein the oxygen levels in the blood plasma are measured by a standardized blood gas machine. It is not clear what “standardized blood gas machine” is used to determine the increased oxygen levels in the blood.
Clarification is required.
Claim 20 includes the limitation of further comprising increasing oxygen levels in a blood plasma. It is not clear if the blood plasma in claim 20 refers to blood plasma of the subject in claim 1, or some other blood plasma. The specification characterizes the increased oxygen levels in a blood plasma as being done ex vivo. See Example 4.
Clarification is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 4-5, and 19-23 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Ambati, US 2020020261495.
Ambati teaches methods for treating hypoxia/ischemia (Ambati, e.g., 0008 and claim7), the method comprising administering PLGA nanoparticles encapsulating liquid oxygen to a human (Ambati, e.g., Abstract, 0004, 0038-0040, claims 1-5).
The composition may be administered intravenously (Ambati, e.g., 0019, and claim 5). Direct administration to the central nervous system reads on intravenous administration. See Ambati, e.g., brain injury/stroke, claim 7.
Amount administered is effective to increase oxygen concentration in blood (Ambati, e.g., Abstract). The effects of claims 20-23 are obtained by administering PLGA nanoparticles encapsulating liquid oxygen to a human as directed by Ambati. Since Ambati teaches administering PLGA nanoparticles encapsulating liquid oxygen to a subject intravenously, the prior art method must result in providing oxygen to the blood of the human being for an extended period of time, including about 4-6 months in the same way recited in claim 19. See specification, e.g., ¶ spanning pp. 6-7.
Ambati anticipates the subject matter of instant claims 4, 5, and 19-23.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 4-5 and 19-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-15 of Boston, US 10561682 in view of Ambati, US 2020020261495. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach a method of treating hypoxia/ischemia by injecting an oxygen containing liquid into an eye of a subject. Direct administration to the central nervous system reads on administration to the eye (Specification, e.g., pg. 7:10-17).
The reference claims do not expressly teach the oxygen containing liquid is in nanoparticles comprising PLGA.
However, Ambati teaches oxygen liquid encapsulated in nanoparticles which is effective to increase oxygen concentration in patient’s blood and/or organs when administered intravenously. See Ambati teachings and citations above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify methods claimed by the reference claims by additionally administering liquid oxygen encapsulated in PGLA nanoparticles as suggested by Ambati with a reasonable expectation of success. The skilled artisan would have been motivated to include Ambati’s nanoparticles in the composition of the method in the reference claims since Ambati teaches nanoencapsulated liquid oxygen in PLGA is effective to increase the oxygen levels in a patient’s organs and blood. Thus, the skilled artisan would have seen this modification as a combination of two known administration techniques each effective to increase oxygen levels in a patient’s organs with liquid oxygen. Alternatively/Additionally, the skilled artisan would have been motivated to modify the method of the reference claims by separately administering nanoencapsulated liquid oxygen in PLGA intravenously since Ambati suggests this would be effective to increase oxygen levels in the patient’s organs and blood supplying organs. The method of the reference claims is already practiced on a subject suffering from hypoxia/ischemia and Ambati suggests intravenous administration for the same patient population for improved oxygen supply to the blood and organs. The skilled artisan would have had a reasonable expectation of success since Ambati suggests intravenous administration is effective for increasing oxygen levels in organs of the body, the eyes are vascular organs of the body requiring oxygen, and since intravenous administration is easier than direct injection into the eye.
Accordingly, the subject matter of claims 4-5 and 19-23 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
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