DETAILED ACTION
Claims 15-17, 19-21, 25, 27, 29-36 and 38 are currently pending in the instant application.
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 with traverse of Group I, drawn to claims 15-17, 19-21, 25, 27, 35-36 and 38, and election of species
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in the reply filed on 01/15/2026 is acknowledged. The traversal is on the ground(s) that the significant structural element shared by all the Groups is the phosphatidylalkanol homologues comprising isotopically labelled glycerol moieties. This is not found persuasive because this does not constitute a structurally distinctive portion in view of Posaric et al (see WIPO Pub No. 2014/178787, pub. 11/06/2014) as discussed in the following 103 rejection.
The requirement is still deemed proper and is therefore made FINAL.
Claims 29-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/15/2026.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Applicants' elected species of
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does not appear allowable, therefore the search and examination of the claims has not been extended beyond the elected species (see the following 35 USC 103(a) rejection).
Claims 20-21 do not read on the elected embodiment and are therefore considered withdrawn claims. Since the elected embodiment is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration. It has been determined the entire scope claimed is not patentable.
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statements filed on 09/28/2023 and 09/23/2025 have been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
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 35-36 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 35-36 depend on claim 15 and recite structures such as
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or
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. However no definition for the * is provided in claims 35-36 or claim 15 and it is not clear what the * refers to.
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 15-17, 19, 25, 27, 35-36 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Posaric et al (see WIPO Pub No. 2014/178787, pub. 11/06/2014, cited in IDS filed 09/28/2023). Posaric et al teaches phosphatidyethanol-homologues of formula
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in isotopically enriched form thereof (see p. 4). Posaric et al teach specifically that the compound of formula I may be isotopically enriched with deuterium, or any other suitable heavy isotope (see p. 5, lines 19-20) and an isotopically enriched compound may, for example, advantageously be used as analytical reference by spiking samples, in which the not isotopically enriched compound is being quantified, with a known amount. The elected species in non-deuterated form is taught on p. 11
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. Posaric et al teaches isotopically enriched defined as in which one or several of the substitutable atoms carry the 2H-isotope of hydrogen instead of the more common naturally occurring 1H-isotope (see p. 16) and non-limiting examples of isotopically enriched compounds of formula I include compounds which comprise at plurality of 13C isotopes (see p. 19). Further Posaric et al teaches that NMR-signals, in particular but not limited to 1H-NMR signals, are generally more well suited for QNMR than corresponding compositions with preferable signs of phosphatidylalkanols for 1H-QNMR including but not limited to signals originating from hydrogens bound to the glycerol skeleton (herein referred to as “HA1”, “HA2”, “HB”, “HC” as well as signals originating from the hydrogens bound to the alkanol group, in particular those adjacent to the P-O-moiety (“Het”). The same reasoning is valid for other NMR detectable nuclei, including 13C - see p. 17, lines 6-27. Posaric et al exemplifies deuteration of the hydrogens bound to the alkanol group, in particular those adjacent to the P-O-moiety (see p. 29, lines 17).
Prior to the filing of the instant application, it would be obvious to one of ordinary skill in the art following the teachings of Posaric et al to deuterate other hydrogen atoms in the species
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, such as those corresponding to “HA1”, “HA2”, “HB”, “HC” since isotopically enriched compound may advantageously be used as analytical reference by spiking samples, in which the not isotopically enriched compound is being quantified, with a known amount of isotopically enriched compound. Posaric et al specifically teaches hydrogens bound to the glycerol skeleton as a modifiable group of hydrogens as NMR-signals, in particular but not limited to 1H-NMR signals, as generally more well suited for QNMR. Further, since Zheng (see Clinica Chimica Acta, 2011, Vol. 412, No. 15, p. 1428-1435, cited in IDS filed 09/28/2023) teaches markedly improved analytical accuracy in ESI-MS/MS when using deuterated PEth analogs over PProp – 18:1/18:1 as the internal standard (see p. 1434, last sentence of first full paragraph in 1st column), one of ordinary skill in the art would be motivated to modify the known compound of Posaric et al to produce further deuterated compounds for use as analytical references especially given that Zheng teaches the deuterated versions had been shown to provide greater accuracy as internal standards.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623