DETAILED ACTION
Claims 42-62, submitted 01 May 2024, are pending in the application. Claims 59-62 have been withdrawn. Claims 42-58 are under examination in the instant Office 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 .
Election/Restrictions
Applicant’s election of Group I, claims 42-58, in the reply filed on 23 June 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)).
Claims 59-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim.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 23 June 2026.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code found in paragraph 0068. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 49 is objected to because of the following informalities: Part (v) of instant claim 49, found in line 4 of the claim, recites “…reducing plasma IL-10 levels and decreasing IL-6 levels in the subject”. However, in view of the provided disclosure (i.e., paragraphs 35, 40 and 94; Figure 15A), it appears that the claim limitation is meant to read “…increasing plasma IL-10 levels and decreasing IL-6 levels in the subject”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 54 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 54 recites the limitation "wherein the injury is to lung tissue" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. There is a lack of antecedent basis on the fact that claim 54 depends from dependent claim 49 which is further dependent of independent claim 42 and “lung tissue” is not a tissue injury limitation found in either claim 49 or claim 42.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 42, 44-45, 49 and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Nishikimi et al. ("Identification of Decreased Plasma Lysophosphatidylcholine Using Phospholipidomics in Cardiac Arrest: A Novel Therapeutic Application." Circulation 142.Suppl_4 (2020): A155-A155.) as evidenced by Hendrickx et al. (Hendrickx, Hans HL, et al. "Asphyxia, cardiac arrest and resuscitation in rats. I. Short term recovery." Resuscitation 12.2 (1984): 97-116.).
Nishikimi teaches a method of treatment of a subject post cardiac arrest using a rat model of 10 and 14 minutes of asphyxia-induced cardiac arrest (pg. 1, Section “Methods and Results”, 1st paragraph). This reference teaches the administration of a pharmaceutical composition comprising lysophosphatidylcholine (18:1) (pg. 1, Section “Methods and Results”, 1st paragraph; pg. 2, Figures A-D) to a subject who has suffered from cardiac arrest, which reads on the limitations of instant claim 55.
With respect to claims 45 and 46, Nishikimi teaches a rat model of 10 and 14 minutes of asphyxia-induced cardiac arrest. It’s known in the art that successful resuscitation and treatment after asphyxia-induced cardiac arrest models happens quickly after the time of asphyxia (Abstract, 2nd paragraph), as evidenced by Hendrickx. Thus, in view of the teachings of Nishikimi and as evidenced by Hendrickx, it would have been prima facie obvious for one skilled in the art to administer the LPC composition to a subject within 1 minute to 120 minutes or, according to the limitation taught by claim 45, 30 minutes after cardiac arrest because Hendrickx teaches that resuscitation was successful in 65% of the rats within 60 seconds (Abstract, 2nd paragraph).
Claim 49 is rejected, in part, as Nishikimi teaches that LPC administration substantially increased rat survival, displayed improved brain function, provided neuroprotective properties demonstrated by improved brain histology, and also decreased IL-6 levels post-cardiac arrest (Abstract, Section “Methods and Results”, 2nd paragraph). Nishikimi does not teach wherein the LPC composition reduces injury to heart muscle tissue, kidney tissue or liver tissue. This reference also does not teach wherein the IL-10 levels of the subject are reduced. In fact, this reference teaches away from the limitation of the claim in that LPC (18:1) increased plasma IL-10 levels.
Allowable Subject Matter
Claims 43, 44, 47, 48, 50-53 and 55-58 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The claims would be allowable if rewritten in independent form for the reason that the closest prior art is Nishikimi, disclosed above, which teaches the administration of a pharmaceutical composition comprising LPC(18:1) in the treatment of a rat model in 10 and 14 minutes of asphyxia-induced cardiac arrest. Nishikimi does not teach the use of LPCs (18:2) and (22:6) in the treatment of a post-cardiac arrest model and additionally does not teach, anticipate, nor obviate the administration of a pharmaceutical composition comprising a combination of LPCs, much less the claimed combinations.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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