DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 17, 2025 has been entered.
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 is a 371 National Stage Entry of PCT/EP2020/067263 filed on June 21, 2020 which claims benefit to the provisional application 62/864,073 filed on June 20, 2019.
Status of Claims
Acknowledgement is made of the previously presented (10, 17-20) amended (26), cancelled (1-9, 11-16, 21-25) claims filed on September 17, 2025. Claims 10, 17-20, and 26 are pending in instant application.
Response to Arguments
Applicant’s arguments, filed September 17, 2025, have been fully considered.
Applicant's arguments are not persuasive. Applicant cites
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references (See 9/17/25 Remarks at p. 7), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Halstead teaches a patient population seeking to avoid a TBI by explaining severe adverse effects of a single or multiple concussions (see Halstead at p. 606 “Postconcussion Syndrome” and 4/21/25 Office Action at p. 6 ¶3 lines 5-7). In addition, a pre-concussed patient being treated with LCP-EPA/LPC-DHA also falls within the patient population of a subject desiring to avoid a TBI (see also 4/21/25 Office Action at p. 5).
In response to Applicant’s argument that there is no indication that Halstead teaches any agent, including the claimed compounds, can be used for treatment of TBI could also be used for the prophylaxis (see 9/17/25 Remarks at p. 8), the Examiner points to the teachings of US’924 regarding the instantly claimed compounds for treating TBI (see 4/21/25 Office Action at p. 4) and has modified the 35 USC 103 Rejection in further view of new reference Mills et. al.1 which teaches prophylactic treatment of TBI with DHA is known in the art (see Mills at p.474 Conclusion).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable by US 2018/0325924 A12 in view of Polette et. al.3, Nguyen et. al.4, Halstead et. al.5, and Mills et. al.6
Regarding claim 10 and a administering a compound of Formula 1 or 3 when R1 or R2 is OH, US’924 claims methods of treating traumatic brain injury in patients by administering to a subject the same compounds (compare instant Formulas 1 and 3 with US’924 at claim 15-20), wherein R1 is DHA or EPA or OH, R2 is OH or EPA, and R3 is identical (choline) (see, e.g., US’924 at claim 15 showing Formula I). US‘924 discloses the positional isomers of LPC-DHA (compare instant claim 10 Formula 3 with US’924 sn-1 DHA LPC sn-2 DHA LPC [0069]), wherein R1 is DHA or OH and R2 is DHA or OH (see US’924 at Figures 11A-D).
Regarding claim 10 and a administering a compound of Formula 1 or 3 when R1 or R2 is O-CO-(CH2)n-CH, Polette teaches CAS# 262423-49-4 and CAS# 262423-48-3 (Formula 1 or 3 respectively, when R1 or R2 is O-CO-CH3) (see Polette at p. 1335 Scheme 1) as a stable forms of LPC-DHA to prevent isomerization of DHA as it accumulates in the brain (see Polette at p. 1333 right col. par. 1).
Regarding intravenous administration, US’924 claims methods requiring “administering” (see id.), wherein “administering” is defined to explicitly include intravenous administration as an option (see, e.g., US’924 at [0056]). In addition, Nguyen teaches intravenous administration of LPC-14CDHA to male mice (see at p. 505 Figure 4) which was imported into the brain across the blood-brain barrier by Mfsd2a transporter (see Nguyen at Abstract).
The prior art differs from instant claims as follows: While US’924 and Nguyen teach intravenous administration of LPC-DHA, Polette teaches stable acetyl LPC-DHA, and US’924 teaches treatment of traumatic brain injuries, the prior art does not disclose prophylaxis of traumatic brain injury.
However,
Halstead teaches athletes with 3 or more concussions are more likely to have had loss of consciousness, postevent amnesia, confusion, and 3 to 4 abnormal on-field markers of concussion (see Halstead at p. 606 "Long-term Effects"). Halstead also teaches second-impact syndrome results in cerebral vascular congestion, which often can progress to diffuse cerebral swelling and death (see Halstead at p. 606 "Second-Impact Syndrome"). Furthermore, Halstead teaches adverse symptoms of post-concussion syndrome include: headache; dizziness; fatigue; irritability; difficulty with concentrating and performing mental tasks; impairment of memory; insomnia; and reduced tolerance to stress, emotional excitement, or alcohol (see Halstead at p. 606 "Postconcussion Syndrome").
Mills teaches dietary supplementation with DHA in rats increases serum levels and, if given prior to traumatic brain injury, reduces the injury response, as measured by axonal injury counts, markers for cellular injury and apoptosis, and memory assessment by water maze testing (see Mills at p.474 Conclusion). Mills states potential for DHA to provide prophylactic
benefit to the brain against traumatic injury (see id).
LPC-DHA
DHA
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285
615
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131
594
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US’924 teaches LPC-DHA is a form of DHA for improving DHA levels in the brain (see US’924 at p. 6 ¶[0087]- ¶[0088] and at Figures 3-5).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention or otherwise at the time the invention was made, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
Regarding acetyl LPC-DHA, Per MPEP § 2143(I)(B), a prima facie case of obviousness exists for simple substitution of one known element for another to obtain predictable results. In addition, or in the alternative, per MPEP § 2143(I)(D), a prima facie case of obviousness exists for applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. Polette teaches acetyl LPC-DHA as a stable form of DHA to prevent isomerization. It would have been obvious to one skilled in the art to substitute the LPC-DHA in the methods of US’924 for Polette’s acetyl LPC-DHA because Polette teaches a structurally similar, more stable form of LPC-DHA that would not isomerize during tissue delivery (see Polette at Abstract).
Furthermore, it is well-within the ordinary skill in art to substitute one form of LPC-DHA known in the art (as taught by US’924) for another (as taught by Polette) according to known methods (as taught by US’924).
Regarding intravenous administration, per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. US’924 teaches administering LPC-DHA and positional isomers to treat traumatic brain injury and suggests intravenous administration while Nguyen reduces to practice embodiments of LPC-DHA intravenous administration to male mice. Halstead teaches a motivation for preventing traumatic brain injury in previously-concussed patients and any patient population due to the adverse side effects of a concussion.
Regarding prophylaxis, the prior art teaches administering LPC-DHA for treating TBI (as taught by US’924), and prophylactically administering structurally similar DHA prior to TBI (as taught by Mills). In addition, the prior art teaches a patient population of subjects suffering from TBI, wanting to avoid a second TBI (e.g. second impact syndrome) (as taught by Halstead). It would have been obvious to one skilled in the art to prophylactically treat with LPC-DHA a subject wishing to avoid TBI, or a subject who has already suffered a TBI wishing to avoid a second because i) LPC-DHA is known to treat TBI (as taught by US’924) and ii) DHA is known to prophylactically treat TBI (as taught by Mills), and LPC-DHA is an art-recognized suitable alternative to DHA (as taught by (US’924) (see MPEP § 2144.07, 2143(I)(B)). Furthermore it is well-within the ordinary skill in the art to administer LPC-DHA in lieu of DHA.
In addition, even though US’924is silent regarding “prophylaxis”, by practicing the method taught by the prior art “treating traumatic brain injury” one will also be “prophylaxis” of a second traumatic brain injury (a patient population identified by Halstead) even though the prior art was not aware of it.
In addition, per MPEP § 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. In instant case, the prior art teaches structurally similar DHA prophylactically administered to benefit the brain against TBI (as taught by Mills). LPC-DHA is known to be an improved form of DHA for increasing DHA levels in the brain (as taught by US’924). It would have been obvious to one skilled in the art to administer LPC-DHA prior to a TBI because DHA was known for TBI prophylaxis, and LPC-DHA is a known improved form of DHA (see also MPEP § 2143(I)(D)).
Furthermore, it is well-within the ordinary skill in art to prophylactically administer LPC-DHA for a TBI since the prior art teaches administering LPC-DHA for treating TBI. Furthermore, it is well-within the ordinary skill in art to select a known embodiment of intravenous administration when selecting an administration route.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Accordingly, claim 10 is rejected as obvious.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0325924 A1 in view of Polette, Nguyen, Halstead, and Mills as applied to claim 10 above.
The prior art differs from the claims as follows: While US’924, Polette, Nguyen, and Halstead teach intravenous administration of LPC-DHA forms for prophylaxis of TBI, they do not explicitly reduce to practice or claim embodiments wherein the LPC-DHA of Formula I constitutes from 10-99%, 20-99%, 50-99%, or 70-99% by weight of the administered pharmaceutical composition.
However,
US’924 identifies that the dosage utilized may vary from “about 0.1 µg/kg to up to about 100 mg/kg or more” (see, e.g., US’924 at [0059], [0167]-[0169]), teaches intravenous administration (see, e.g., US’924 at [0056], [0104]), and reasonably informs artisans of how to prepare formulations for intravenous administration (see, e.g., US’924 at [0104]-[0119]). US’924 expressly identifies that pharmaceutical formulations may vary by content of carriers and solvents (id. at [0108]-[0109]), optionally contain surfactants (id. at [0110]), optionally contain preservatives (id. at [0111], [0118]), optionally contain pH buffers (id. at [0112], [0116]), optionally contain water-soluble polymers (id. at [0113]), and optionally contain tonicity agents (id. at [0116]). Accordingly, an artisan would readily appreciate that the exact weight of a dosage as taught by US’924 would vary depending upon “effective concentration” required for a particular patient, the volume of the injection, and the design choices to include or exclude optional components as set forth above. Furthermore, the exact % amount of LPC-DHA administered would vary depending upon the presence or absence of additional compounds, such as those additional compounds taught and disclosed by US’924 to achieve the same effect (see, e.g., US’924 at claims 15-20).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
Per MPEP § 2144.05(II)(A), “[g]enerally, differences in concentration . . . will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration . . . is critical.” Here, US’924 provides the effective concentration ranges, identifies the application of intravenous dosages, and identifies how such intravenous formulations may be varied; therefore, an artisan would readily appreciate that the percent by weight of active agent would vary depending upon the amount of surfactants, carriers, solvents, preservatives, water-soluble polymers, buffers, and additional active agents were present, and additionally the effective concentration of compound required for a patient and the volume of the injection needed. Accordingly, it would amount to routine optimization to identify the optimal weight percentage of the pharmaceutical compound required to treat traumatic brain injury via intravenous administration as taught, claimed, and suggested in view of US’924. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Accordingly, since Applicant has not disclosed that the specific limitations recited in instant claims 17-20 are for any particular purpose or solve any stated problem and the prior art teaches that intravenous formulations often vary according optional components, and various parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the traumatic brain injury art.
Furthermore, it is well-within the ordinary skill in the art to formulate a known compound for use in a known methods of treating a known condition via a known route of administration and a known effective concentration range.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Accordingly, claims 17-20 are rejected as obvious.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0325924 A1 in view of Polette, Nguyen, Halstead, and Mills as applied to claims 10, 17-20 above.
The prior art differs from the claims as follows: While US’924, Polette, Nguyen, and Halstead teach intravenous administration of LPC-DHA forms for prophylaxis of TBI, they do not explicitly reduce to practice or claim embodiments wherein Formula 1 and Formula 3 are in a molar ratio of 1:1 to 1:5.
However, US’924 teaches and claims methods of treating traumatic brain injury by administering either LPC-DHA or LPC-EPA (see, e.g., US’924 at claims 15-20, wherein R1 may be -OH, EPA, or DHA, and wherein R2 may be -OH or EPA; compare id. at claim 15 with instant claims 10, 17-20, and 26, noting that US’924 teaches at least instantly recited Formula 1). Critically, in view of such claims, an artisan would readily appreciate that both of these compounds are identified as functional equivalents for the treatment of traumatic brain injury by US’924 (see, e.g., US’924 at claims 15-20), wherein such compounds are administered at “about 0.1 µg/kg to up to about 100 mg/kg or more” (see, e.g., US’924 at [0059], [0167]-[0169]) via intravenous administration (see, e.g., US’924 at [0056], [0104]). Accordingly, the prior art fairly informs artisans that such compounds treat the same condition at the same (or overlapping) concentration range via the same route of administration.
Additionally, US’924 discloses formulation of DHA or EPA LPC micelles “for parenteral delivery, such as injection or infusion, in the form of a solution or suspension” (see US’924 at [106]). While US’924 does not disclose specific ratios for EPA/DHA micelles, micelles do require specific ratio ranges of components for the designated micelle size in order to hold their structure and their carrier load. This would require routine optimization for one skilled in the art to arrive at successful ratios for micelle formation at desired micelle sizes with reasonable expectation of success (see MPEP § 2144.05(II)) which may encompass the claimed ratio ranges.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): The ratios at claim 26 are obvious because US’924 reasonably informs artisans that the recited compounds are functional equivalents for the purpose of treating traumatic brain injuries, and therefore it is obvious to combine such functional equivalents, and likewise to simply substitute one for the other to achieve the same purpose as taught by the prior art (see, e.g., MPEP §§ 2144.06(I)-(II)). Accordingly, an artisan would readily appreciate that an effective amount of a blend of one, two, or more prior art substances taught by US’924 could be predictably and desirably utilized to treat traumatic brain injuries, wherein the total combined amounts would fall within the range of effective concentration (i.e., “about 0.1 µg/kg to up to about 100 mg/kg or more”) as taught by the prior art. Therefore, the prior art renders obvious the entire range of ratios and blends of such functional equivalents (see, e.g., MPEP § 2144.05(I)). No unexpected results have been placed on record to date.
Furthermore, it is well-within the ordinary skill in the art to formulate a known compound for use in a known methods of treating a known condition via a known route of administration and a known effective concentration range.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Accordingly, claim 26 is rejected.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 10, 17-20, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-18 of copending Application No. 17/874,677 (US 2023/0047556 reference application, hereafter App’677) in view of Halstead7. Although the claims at issue are not identical, they are not patentably distinct from each other because as explained below.
The applicable analysis for Nonstatutory Double Patenting is set forth in MPEP § 804(II), and specifically MPEP § 804(II)(B). MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis. The instant analysis is an obviousness analysis.
Regarding instant claim 10 and Formulas 1 and 3, instant Formulas 1 and 3 and App’677 general compound structure are analogous in both sets. The table below depicts the instant and reference chemical structures, which read on one another when reference R3 is choline, and reference R1 and R2 may be DHA or OH (App’677 claim 2, instant claim 10).
Copending Reference App’677
Claim 2 Phospholipid Generic Structure
Instant Application
Formulas 1 and 3 of Claim 10
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153
147
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302
636
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129
244
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wherein R1 and R2 are a fatty acid residue (DHA or EPA) or -OH, and R3 may be choline
wherein R1 and R2 is OH
Accordingly, the copending claim sets are directed to methods of treating patient populations using the same compounds.
The copending claim scope of App’677 differs from the instant claims follows: First, the claim sets ostensibly recite different patient populations. Second, the instant claims require intravenous administration but the claims of App’677 do not specify a type of administration. Third, the instant claims do not recite or require a 15-60% w/w lysophospholipid content. Fourth, App’677 does not specify the ratios as set forth at instant claim 26.
However, these differences do not render the copending claim sets patentably distinct as explained below.
Regarding instant claims 10, 17-19, and the patient population of prophylaxis of traumatic brain injury, App’677 claims a method for “improving cognitive performance” including treating “memory loss”, “forgetfulness”, “short-term memory loss”, “aphasia”, “disorientation”, “disinhibition”, and “age-associated memory impairment or decline” (see App’677 at claims 2 and 5-18). This is pertinent because such issues are understood to be symptoms associated with cognitive diseases/conditions such as concussions.
Halstead teaches athletes with 3 or more concussions are more likely to have had loss of consciousness, postevent amnesia, confusion, and 3 to 4 abnormal on-field markers of concussion (see Halstead at p. 606 "Long-term Effects"). Halstead also teaches second-impact syndrome results in cerebral vascular congestion, which often can progress to diffuse cerebral swelling and death (see Halstead at p. 606 "Second-Impact Syndrome"). Furthermore, Halstead teaches adverse symptoms of post-concussion syndrome include: headache; dizziness; fatigue; irritability; difficulty with concentrating and performing mental tasks; impairment of memory; insomnia; and reduced tolerance to stress, emotional excitement, or alcohol (see Halstead at p. 606 "Postconcussion Syndrome").
Accordingly, the patient populations addressed in both claim sets are understood to substantially overlap in scope (e.g., patients wishing to avoid traumatic brain injuries), and therefore the different phrasing is insufficient to patentably distinguish the copending claim sets with respect to this issue.
Regarding instant claims 10, 17-20, and intravenous administration, App’677 at claims 2-3 and 5-18 broadly recite “administering” (see App’677 at claims 2 and 12), which broadly encompasses all forms of administration, including intravenous administration. Accordingly, this difference does not differentiate the copending claim scope since the claims of App’677 would be readily understood to broadly encompass all forms of administration including intravenous administration. Accordingly, the administration route does not patently distinguish the copending claim scopes.
Regarding instant claims 17-20 and the weight % of LPC-DHA, App’677 claims a substantially overlapping range. Specifically, App’677 claims the range of 15-60 wt%, whereas instant claims 17-20 recite 10-99, 20-99, 50-99, and 70-99 wt% (compare instant claims 17-20 with App’677 at claim 2). Regarding instant claims 17-19, MPEP §§ 2144.05(I) states a prima facie case of obviousness exists when claimed ranges “overlap or lie inside ranges disclosed by prior art”. Regarding instant claim 20, although claim 20 recites a slightly higher range of “from 70 to 99%”, the MPEP states that a prima facie case of obviousness also exists “where the claimed ranges do not overlap with the prior art but are merely close” (see MPEP §§ 2144.05(I)). The range at claim 20 would vary not by changing the active ingredient, but merely including other routine components (e.g., surfactants, preservatives, etc.). An artisan would readily appreciate that the exact weight of a dosage as taught by App’677 would vary depending upon “effective concentration” required for a particular patient, the volume of the injection, and the design choices to include or exclude optional components as set forth above (see MPEP §§ 21440.05(II)(A)). Furthermore, the exact % amount of LPC-DHA administered would vary depending upon the presence or absence of additional compounds, such as those additional compounds taught and disclosed by App’677 to achieve the same effect (see, e.g., App’677 at [0044]).
Regarding instant claim 26 and the ratio of LPC-EPA:LPC-DHA, App’677 does not claim specific ratios of LPC-EPA:LPC-DHA, only a “mixture of phospholipid molecules” comprising at least 1% LPC-EPA or LPC-DHA (see App’677 claim 2). However, this amounts to a routine optimization of active ingredients. Accordingly, such difference does not render the claims patentably distinct because the it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claim 26 are for any particular purpose or solve any stated problem and the prior art teaches that functionally equivalent active ingredients often vary and such parameters are expected to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the pharmaceutical arts (see MPEP §§ 2144.05(II)).
Therefore, under an obviousness rationale, the pending claims are not patentably distinct from one another because administering the same compounds to overlapping patient populations via the same or overlapping administration routes, at the same or overlapping dosages, using the same or overlapping concentrations (see MPEP §§ 2144.05(II)(A)), would be expected to have and exhibit the same properties (see MPEP §§ 2144.06(II)). Accordingly, the copending claim sets are patentably indistinct.
Accordingly, claims 10, 11, 17-20, and 26 are provisionally rejected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11, 17-20, 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-8, 10 of copending Application No. 18/226,3858 (US 2023/0364157 A1 reference application, hereafter App’385) in view of Halstead9. Although the claims at issue are not identical, they are not patentably distinct from each other because as explained below.
The applicable analysis for Nonstatutory Double Patenting is set forth in MPEP § 804(II), and specifically MPEP § 804(II)(B). MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis. The instant analysis is an obviousness analysis.
Regarding instant claims 11, 17-20, 26 and LPC-DHA Formulas 1 and 3, instant Formulas 1 and 3 and App’385 Formulas 1 and 3 are analogous in both sets (see App’385 claims 1, 2, 4). The table below depicts the instant and reference chemical structures, which read on one another when reference R1 and R2 may be OH (App’385 claim 2 and 5, instant claim 10) or -OC(O)(CH2)nCH3 and n is 0, 1, or 2 (instant claim 10).
Copending Reference App’385
Claim 1 Phospholipids
Instant Application
Formulas 1 and 3 of Claim 10
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89
191
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Greyscale
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92
199
media_image7.png
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302
636
media_image4.png
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129
244
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wherein R1 and R2 are -OH or
-OC(O)(CH2)nCH3 and n is 0, 1, or 2
wherein R1 and R2 is OH or
-OC(O)(CH2)nCH3 and n is 0, 1, or 2
Regarding claim 26 and a molar ratio range of LPC-EPA:LPC-DHA 1:1 to 5:1, App’385 recites the range LPC:EPA:LPC-DHA of 1:3 to 5:1, which lies inside the instantly claimed range.
Regarding claim 26 and the number of moles of LPC-DHA or -EPA is the number of moles of 1-substituted + the number of moles of 2-substituted, App’385 recites the proviso that and the total number of moles of LPC-DHA or -EPA is the number of moles of 1-substituted + the number of moles of 2-substituted (App’385 claim 1, 5).
Regarding claim 26 and intravenous administration, App’385 specifies intravascular administration (App’385 claims 8, 10)
Regarding instant claims 17-20 and LPC-DHA 10-99% by weight of the composition, App’385 recites wherein the total LPC composition comprises 10 to 100% by weight of the LPC composition (App’385 claim 11).
The copending claim scope of App’385 differs from the instant claims follows: First, the claim sets ostensibly recite different patient populations (App’385 claims 1, 6, 8 reciting methods for treating liver disease vs instant prophylaxis TBI). Second, the instant claims require intravenous administration but the claims of App’385 specify intravascular administration. Third, the molar ratio ranges overlap.
However, these differences do not render the copending claim sets patentably distinct as explained below.
Regarding instant claim 26 and the patient population of prophylaxis of traumatic brain injury, Halstead teaches adverse symptoms of post-concussion syndrome include: headache; dizziness; fatigue; irritability; difficulty with concentrating and performing mental tasks; impairment of memory; insomnia; and reduced tolerance to stress, emotional excitement, or alcohol (see Halstead at p. 606 "Postconcussion Syndrome").
Accordingly, the patient populations addressed in both claim sets are understood to substantially overlap in scope (e.g., patients wishing to avoid traumatic brain injuries, including patients with liver diseases), and therefore the different phrasing is insufficient to patentably distinguish the copending claim sets with respect to this issue.
Regarding intravenous administration, App’385 teaches intravascular administration which encompasses the instantly claimed intravenous. Per MPEP § 2143(I)(E), a prima facie case of obviousness exists for choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. It would have been obvious to select “intravenous” from the limited number of known “intravascular” administration routes.
Regarding overlapping ranges, per MPEP § 2144.05(I), a prima facie case of obviousness exists when claimed ranges “overlap or lie inside ranges disclosed by prior art”. The ranges of instant claim 17 (10 to 99%), 18 (20 to 99%), 19 (50 to 99%) and 20 (70 to 99%) all lie within App’385 claim 11 “10 to 100%”. Furthermore instant claim 26 molar ratio range of LPC-EPA:LPC-DHA 1:1 to 5:1 overlaps with App’385 claim 1 LPC-EPA:LPC-DHA 1:3 to 5:1.
Therefore, under an obviousness rationale, the pending claims are not patentably distinct from one another because administering the same compounds to overlapping patient populations via the same or overlapping administration routes, at the same or overlapping dosages, using the same or overlapping concentrations (see MPEP §§ 2144.05(II)(A)), would be expected to have and exhibit the same properties (see MPEP §§ 2144.06(II)). Accordingly, the copending claim sets are patentably indistinct.
Accordingly, claims 11, 17-20, 26 are provisionally rejected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 10, 17-20, 26 are rejected.
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/S.R./ Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Mills et. al. "Dietary Supplementation With the Omega-3 Fatty Acid Docosahexaenoic Acid in Traumatic Brain Injury" Neurosurgery, 2011, 68, 2, 474-481. DOI: 10.1227/NEU.0b013e3181ff692b.
2 Filed May 10, 2018 and published Nov. 15, 2018; cited in IDS filed 1/19/2024 as Cite 8. Hereinafter US ‘924. Referenced in 12/18/24 Office Action.
3 Polette et. al. "Synthesis of acetyl, docosahexaenoyl-glycerophosphocholine and its characterization using nuclear magnetic resonance" Lipids, 1999, 34, 12, 1243-1349. DOI: 10.1007/s11745-999-0486-1. Hereinafter Polette.
4 Nguyen et. al. "Mfsd2a is a transporter for the essential omega-3 fatty acid docosahexaenoic acid" Nature, 2014, 509, 503-506. DOI: 10.1038/nature13241. Hereinafter Nguyen.
5 Halstead et. al. "Clinical Report—Sport-Related Concussion in Children and Adolescents" Pediatrics, 2010, 126, 3, 597-615. DOI: 10.1542/peds.2010-2005. Hereinafter Halstead.
6 Mills et. al. "Dietary Supplementation With the Omega-3 Fatty Acid Docosahexaenoic Acid in Traumatic Brain Injury" Neurosurgery, 2011, 68, 2, 474-481. DOI: 10.1227/NEU.0b013e3181ff692b. Hereinafter Mills.
7 Halstead et. al. "Clinical Report—Sport-Related Concussion in Children and Adolescents" Pediatrics, 2010, 126, 3, 597-615. DOI: 10.1542/peds.2010-2005. Hereinafter Halstead.
8 Filed July 26, 2023
9 Halstead et. al. "Clinical Report—Sport-Related Concussion in Children and Adolescents" Pediatrics, 2010, 126, 3, 597-615. DOI: 10.1542/peds.2010-2005. Hereinafter Halstead.