DETAILED 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 .
Priority
The instant application claims benefit to domestic provisional application No. 63/472,975 filed on June 14, 2023.
Status of Claims
Acknowledgement is made of original (2-5, 12-15, 17-20), amended (1, 11, 16), and cancelled (6-10) claims filed on September 14, 2026. Claims 1-5, 11-20 are pending in instant application.
Response to Arguments
Applicant's arguments filed September 14, 2026 have been fully considered but they are not persuasive.
Applicant argues that Naik teaches ex vivo administration, while the newly amended claims recite in vivo administration (see 9/14/26 Remarks at pp. 5-6). However, it would be obvious to an artisan to administer a composition in vivo to treat the condition in a subject studied under ex vivo conditions.
Applicant argues that it is irrelevant Naik discusses fetal weight (see 9/14/26 Remarks at p. 8). The Examiner argues an artisan would appreciate that discussion of fetal weight is discussion of fetal growth, since weight is a measure of growth.
Applicant argues that Levin does not discuss fetal growth (see 9/14/26 Remarks at p. 9 ¶4) and Steane is irrelevant (see 9/14/26 Remarks at p. 9 ¶5). The relevance to fetal growth is taught by Naik, Levin supports phosphatidylcholine is a means for supplying choline to a pregnant subject, known to combat prenatal ethanol exposure. Steane teaches choline supplementation in pregnant subjects exposed to ethanol increased placental efficiency and fetal growth. While choline is not a lipid, the teachings of Steane in light of Levin support that the lipid phosphatidyl choline is an acceptable means to expose a pregnant subject to choline, both of which are known to have beneficial effects on pregnant subjects exposed to ethanol.
In light of Applicant’s amendments filed September 14, 2026 the following have been withdrawn:
The 35 U.S.C. 101 rejection of claims 6-9.
The 35 U.S.C. 102(a)(1) rejection of claims 6-9 over Thalacy1.
The 35 U.S.C. 103 rejection of claim(s) 10 over Thalacy as applied to claims 6-9 and in view of Sakane et. al.2
The remaining rejections have been modified.
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.
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.
Claim(s) 1-4, 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Naik et. al.3
Regarding claims 16-19 and a method of inhibiting and/or reversing blood vessel constriction in a pregnant subject exposed to ethanol during pregnancy, Naik teaches alcohol-induced impairment of uterine artery vasodilation during pregnancy can have damaging effects on the developing fetus (see Naik at p. 6 "5. Discussion”). Naik teaches that chronic binge alcohol exposure significantly reduced endothelial-dependent vasodilation of the maternal uterine artery compared to pair-fed control rats (see Naik at p. 6 "5.1 Ex vivo PA supplementation ameliorates alcohol-induced uterine artery dysfunction"), reading on the instant limitation of blood vessel constriction in a pregnant subject and an effect of ethanol exposure in a pregnant subject.
Regarding claims 1-4, 16-19 and administering a lipid, Naik teaches supplementation of 10−5 M phosphatidic acid reversed alcohol-induced vasodilatory deficit (see Naik at Abstract), which is understood to read on the instant limitation of administering phosphatidic acid.
Regarding claims 1-4 and a method of ameliorating effects of ethanol exposure in a pregnant, fetal, or post-natal subject, Naik teaches alcohol has been demonstrated to impair maternal uterine arterial adaptations in Fetal Alcohol Spectrum Disorder (FASD) animal models (see Naik at Abstract). The method of supplementing a pregnant subject with phosphatidic acid to reduce endothelial-dependent vasodilation of the maternal uterine artery taught by Naik is thus understood to read on a method of ameliorating the effects of ethanol exposure in a pregnant subject.
The prior art differs from the instant claims as follows: While Naik studies the effect ex vivo, the instant claims are drawn to administering to a pregnant subject in vivo.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of a known material based on its suitability for its intended use. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would have been obvious to an artisan to select a substance known to reduce the effect of ethanol exposure in a subject studied ex vivo (e.g. phosphatidic acid as taught by Naik) to administer in vivo to a subject exposed to ethanol with a reasonable expectation of success because it would be fulfilling its discovered function of reducing an effect of ethanol exposure.
Furthermore, it is well-within the ordinary skill in art to select a known substance for the same purpose in vivo as known for ex vivo as taught by the prior art.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim(s) 5, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Naik et. al.4 as applied to claims 1-4, 16-19 above and in further view of Avanti5.
Regarding claims 5, 20 and a phosphatidic acid with R1 and R2 are C16-22, Avanti teaches the phosphatidic acid used by Naik (see Naik at p. 4 ¶2 "PA (#840857C, Avanti Polar Lipids)”) at has the following structure:
Avanti Catalog No. 840857. 16:0 - 18:1 PA. CAS# 169437-35-8.
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Instant Claim 20 Phosphatidic Acid
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The phosphatidic acid administered by Naik corresponds with instant claim 20 wherein R1 is unsaturated C17 chain and R2 is saturated C15 chain.
The prior art differs from the instant claims as follow: While Naik’s phosphatidic acid contains an R2 C15 chain, instant claims 5, 20 limit R2 to C16-C22 alkyl chain length.
However,
This is not a patentably distinct difference because phosphatidic acid variants are adjacent homologs differing by repeating -(CH2)- fragments (C15 vs. the claimed C16 for R2).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Per MPEP § 2144.09(I)-(II), “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities” because “[c]ompounds which are…homologs…are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties” (see, e.g., MPEP § 2144.09(I)-(II)), and the Court has stated that “[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR, 127 S.Ct. at 1740. In addition, per MPEP § 2144.08(II)(A)(4)(c), the closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. Here, the prior art teaches a highly similar structural homolog of the instantly claimed invention, wherein said homolog has the same, exact utility as the instantly claimed phosphatidic acids; accordingly, an artisan would readily appreciate that such compounds could be utilized in the treatment of inhibiting or reversing blood vessel constriction in a pregnant subject exposed to ethanol during pregnancy, exactly as taught and suggested in view of the prior art.
Furthermore, it is well-within the ordinary skill in art to incorporate a homolog of phosphatidic acid in lieu of another.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claim(s) 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Naik et. al.6 in view of Avanti7 as applied to claims 1-5, 16-20 above and in further view of Steane et. al.8 and Levin et. al.9
Regarding a method of inhibiting or reversing growth restriction of a fetus exposed to ethanol in utero, Naik teaches growth deficiency of the fetus is associated with Fetal Alcohol Spectrum Disorder (FASD) (see Naik at p. 2 ¶3). Naik teaches that fetal weight differed in the alcohol administered group subjects (see Naik at p. 5 "4.1 Growth Assessment"). Naik proposes a future study to examine the effects of administered phosphatidic acid supplementation in pregnant rats exposed to alcohol to determine the effects on growth (see Naik at p. 7 “5.3 Perspectives”).
Regarding “a therapeutically effective amount”, the instant specification states “dosage may be adjusted depending on whether treatment is to be acute or continuing. One of skill in the art can determine a pharmaceutically effective amount in view of these and other considerations typical in medical practice” (see instant spec at p. 17 ¶[00113]). The instant limitation of “a therapeutically effective amount” is understood to be a tailorable, subject-dependent, result-effective variable, not limited to a specific dosage. An artisan would readily appreciate that in testing Naik’s proposed method, a therapeutically effective amount of phosphatidic acid would need to be determined. Moreover, Naik has already identified a therapeutically effective amount of phosphatidic acid for the method of ameliorating an effect of ethanol exposure in a subject, 10−5 M phosphatidic acid (see Naik at Abstract), which would serve as a dosage starting point for an artisan seeking to optimize a method of inhibiting or reversing growth restriction of a fetus.
The prior art differs from the instant claims as follows: While Naik proposes administering phosphatidic acid to pregnant subjects to determine if it can reduce growth restriction of an alcohol-exposed fetal subject, Naik does not specify it has been put into practice with success.
However,
Levin teaches choline (in the form of phosphatidylcholine) as a supplement for pregnant women to combat effects of prenatal ethanol exposure (see Levin at Title and at p. 2 ¶6). Steane teaches choline supplementation in a rat model of periconceptional ethanol exposure resulted in increased placental efficiency and fetal growth in late gestation (see Steane at p. 11 left col.).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
The prior art proposes the instantly claimed method of reversing growth restriction of a fetus subject exposed to ethanol in utero by administering phosphatidic acid (as taught by Naik), and an artisan would have a reasonable expectation of success when implementing because the prior art teaches another known lipid (phosphatidyl choline) known to combat effects of FASD in subjects increased fetal growth in subjects exposed to alcohol in utero (as taught by Levin and Steane).
Furthermore, it is well-within the ordinary skill in art to incorporate one known lipid in lieu of another in a known method taught by the prior art.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Conclusion
Claims 1-5, 11-20 are rejected.
THIS ACTION IS MADE FINAL. 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 SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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/S.R./ Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Thalacy Wayback Machine Web Archive December 5, 2022. https://web.archive.org/web/20221205232955/https://www.thalacyofficial.com/
2 Sakane et. al. "New Era of Diacylglycerol Kinase, Phosphatidic Acid and Phosphatidic Acid-Binding Protein" Int. J. Mol. Sci. 2020, 21, 18, 6794, 1-36. DOI: 10.3390/ijms21186794
3 Cite No. 1 in the IDS filed 12/4/24. Naik et. al. "Interaction of Alcohol & Phosphatidic Acid in Maternal Rat Uterine Artery Function" Reprod Toxicol. 2022, 111, 178–183. doi: 10.1016/j.reprotox.2022.05.017 Published online June 6, 2022. Hereinafter Naik.
4 Cite No. 1 in the IDS filed 12/4/24. Naik et. al. "Interaction of Alcohol & Phosphatidic Acid in Maternal Rat Uterine Artery Function" Reprod Toxicol. 2022, 111, 178–183. doi: 10.1016/j.reprotox.2022.05.017 Published online June 6, 2022. Hereinafter Naik.
5 Avanti Research. Catalog No. 840857. 16:0 - 18:1 PA. CAS# 169437-35-8. Cited by Naik (see Naik at p. 4 ¶2 "PA (#840857C, Avanti Polar Lipids)", compare with literature in Avanti citing Catalog No. 840857, see Avanti p.3 Cite No. 3 "Interaction of Alcohol & Phosphatidic Acid in Maternal Rat Uterine Artery Function"). Hereinafter Avanti.
6 Cite No. 1 in the IDS filed 12/4/24. Naik et. al. "Interaction of Alcohol & Phosphatidic Acid in Maternal Rat Uterine Artery Function" Reprod Toxicol. 2022, 111, 178–183. doi: 10.1016/j.reprotox.2022.05.017 Published online June 6, 2022. Hereinafter Naik.
7 Avanti Research. Catalog No. 840857. 16:0 - 18:1 PA. CAS# 169437-35-8. Cited by Naik (see Naik at p. 4 ¶2 "PA (#840857C, Avanti Polar Lipids)", compare with literature in Avanti citing Catalog No. 840857, see Avanti p.3 Cite No. 3 "Interaction of Alcohol & Phosphatidic Acid in Maternal Rat Uterine Artery Function"). Hereinafter Avanti.
8 Steane et. al. "Maternal choline supplementation in a rat model of periconceptional alcohol exposure: Impacts on the fetus and placenta" Alcohol Clin Exp Res 2021, 45, 2130–2146. DOI: 10.1111/acer.14685. Hereinafter Steane.
9 Levin et. al. "Strategy Emerges to Combat Effects of Prenatal Alcohol Exposure" Psychiatric News 2018, 53, 3, 1-3. Published Online January 31, 2018. DOI: 10.1176/appi.pn.2018.2a18. Hereinafter Levin.
