Prosecution Insights
Last updated: October 25, 2026
Application No. 18/260,012

LIPIDS THAT REDUCE LUNG DAMAGE, IMPROVE PULMONARY FUNCTION AND DECREASE PRO-INFLAMMATORY CYTOKINES

Final Rejection §102§103§112
Filed
Jun 29, 2023
Priority
Jan 29, 2021 — provisional 63/143,511 +2 more
Examiner
RODRIGUEZ, RAYNA B
Art Unit
1628
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Signpath Pharma Inc.
OA Round
2 (Final)
34%
Grant Probability
At Risk
3-4
OA Rounds
1m
Est. Remaining
53%
With Interview

Examiner Intelligence

Grants only 34% of cases
34%
Career Allowance Rate
197 granted / 587 resolved
-26.4% vs TC avg
Strong +19% interview lift
Without
With
+19.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
69 currently pending
Career history
666
Total Applications
across all art units

Statute-Specific Performance

§101
2.0%
-38.0% vs TC avg
§103
48.4%
+8.4% vs TC avg
§102
12.8%
-27.2% vs TC avg
§112
21.5%
-18.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 587 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION This office action is in response to applicant’s filing dated August 7, 2026. 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 . Status of Claims Claims 1, 2, 4-6, 9, 13, 15-20, 23, 27, 29-31, 33, 34, 37, 41, and 43-45 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed August 7, 2026. Acknowledgement is made of Applicant's amendment of claim 30; and cancelation of claim 46. Claims 3, 7, 8, 10-12, 14, 21, 22, 24-26, 28, 32, 35, 36, 38-40, and 42 were previously canceled. Applicants elected with traverse Group III, drawn to a method for preventing or treating a disease or pathology caused by an increase in levels of inflammatory cytokines comprising administering to the subject in need thereof a therapeutically effective amount of 1,2- dimyristoyl-sn-glycero-3-phosphocholine (DMPC), 1,2-Dimyristoyl-sn-glycero-3- phosphoglycerol (DMPG), or DMPC/DMPG, lysophosphatidylglycerol includes at least one of a lysophosphatidylcholine, lauroyl-lysophosphatidylcholine, myristoyl-lysophosphatidylcholine, palmitoyl-lysophosphatidylcholine, stearoyl-lysophosphatidylcholine, arachidoyl- lysophosphatidylcholine, oleoyl-lysophosphatidylcholine, linoleoyl-lysophosphatidylcholine, linolenoyl-lysophosphatidylcholine or erucoyl-lysophosphatidylcholine or a compound of formula (I) or stereoisomer as the elected invention and PNG media_image1.png 316 393 media_image1.png Greyscale as the elected compound of Formula (I) species and acute respiratory distress syndrome as the elected disease or pathology species in the reply filed on January 28, 2026. The requirement is still deemed proper. Claims 1, 2, 4-6, 9, 13, 15-20, 23, 27, 29, 33, 41, 43, and 45 remain withdrawn. The elected compound is a compound of formula (I) wherein R1 is a C13 unbranched hydrocarbon possessing 0 double bonds and 0 triple bonds; R2 is a C13 unbranched hydrocarbon possessing 0 double bonds and 0 triple bonds; R3 is PNG media_image2.png 198 278 media_image2.png Greyscale , wherein X is direct linkage, Y is direct linkage, R5 is C4 branched alkyl substituted with one NH2, and R6 is C4 branched alkyl substituted with one NH2; and R4 is H. Claims 30, 31, 34, 37, and 44 are presently under examination as they relate to the elected species: PNG media_image1.png 316 393 media_image1.png Greyscale and acute respiratory distress syndrome. The Examiner notes that the claim under examination is drawn for purposes of prosecution to that elected species until the generic claim is found allowable. The generic claim is not yet deemed allowable. Therefore, the generic claim is currently RESTRICTED to the elected species only (i.e., all other non-elected subject matter is WITHDRAWN). Please note that this species/restriction election practice was also affirmed by the courts. See St. Jude Medical, Inc. v. Access Closure, Inc., 729 F. 3d 1369, 1377, 1378 (CAFC 2013) (“A species election is a restriction if no generic is found allowable. When the Examiner has required the applicant to elect single chemical species for examination, the issue in prosecution and on appeal is the patentability of the single elected species, and it is appropriate to limit discussion to that single species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987). Priority The present application is a 371 of PCT/US22/13283 filed on January 21, 2022, which claims benefit of US Provisional Application No. 63/143,511 filed on January 29, 2021. Objections and/or Rejections and Response to Arguments Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application. Withdrawn Objections and/or Rejections Claim Objections The objection to claim 46 has been rendered moot in view of the cancelation of claim 46. Thus, the objection has been withdrawn. Claim Rejections - 35 USC § 112 The rejection of claims 30, 31, 34, 37, 44, and 46 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 has been rendered moot in view of the amendment of claim 30. Thus, the rejection has been withdrawn. Claim Rejections - 35 USC § 102 The rejection of claims 30, 31, and 37 under 35 U.S.C. 102(a)(1) as being anticipated by Chochrane et al (WO 2007/005672 A2) has been rendered moot in view of the amendment of claim 30. Claim Rejections - 35 USC § 103 The rejection of claims 34, 44, and 46 under 35 U.S.C. 103 as being unpatentable over Chochrane et al (WO 2007/005672 A2) as applied to claims 30, 31, and 37 above has been rendered moot in view of the amendment of claim 30. Thus, the rejection has been withdrawn. Modified Objections and/or Rejections Modifications Necessitated by Claim Amendment Drawings The drawings are objected to because Figures 2A-2E do not contain a key for the symbols. In a review of the amendment of paragraph [0020] submitted August 7, 2026, which discloses “open dot= mice treated with SPPCT-800; black dot= mice treated with LPS and vehicle; open dot= untreated mice.” The description gives 2 definitions for open dots and there is a third checkered dot that has no definition. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 112(a) Written Description The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112: 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. Claims 30, 31, 34, 37, and 44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Examiner notes, as set forth above, the claim under examination is drawn for purposes of prosecution to that elected species until the generic claim is found allowable. The generic claim is not yet deemed allowable. Therefore, the generic claim is currently RESTRICTED to the elected species only (i.e., all other non-elected subject matter is WITHDRAWN). In view of the instant election, the subject matter currently under examination is a method for treating acute respiratory distress syndrome comprising administering to a subject in need thereof a therapeutically effective amount of: PNG media_image1.png 316 393 media_image1.png Greyscale Applicant contends that support for the elected species is disclosed in claim 30 in formula (I): PNG media_image3.png 232 297 media_image3.png Greyscale wherein: R3 is PNG media_image2.png 198 278 media_image2.png Greyscale R5 is a C1-C10 branched or unbranched hydrocarbon optionally substituted with one or more groups selected ... NH2, ... ; R6 is a C1-C10 branched or unbranched hydrocarbon optionally substituted with one or more groups selected from ... NH2, ... X is a direct linkage, CH2, O or NH; Y is a direct linkage, CH2, O or NH... . It is well-established that an amendment to the claims must be supported by the description of the invention in the application as filed. See MPEP § 2163.03(I), citing In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). The introduction of claim changes that involve narrowing the claims by introducing elements or limitations that are not supported by the specification, as originally filed, is a violation of the written description requirement of 35 U.S.C. 112, first paragraph. MPEP § 2163.05(II). It is particularly relevant that the recitation of an undisclosed species may violate the written description requirement. In this case it does. In re Ruschig, 54 CCPA 1551, 154 USPQ 118 (CCPA 1967), is especially instructive with respect to the present matter. In Ruschig, the Court of Customs and Patent Appeals affirmed the holding of the Patent Office Board of Appeals that one of the claims of the patent application at issue was not supported by the application's disclosure. The claim at issue was directed to a single compound. The specification disclosed a compound with three moieties, R, R1, and R2, and subsequently listed a myriad of different chemical compounds from which to choose for each of the variables. As the court noted: "[T]he general disclosure of the application encompasses something like half a million possible compounds." Id. at 1555, 154 USPQ at 121. The court, in determining that the broad disclosure did not adequately support the narrow subgenus, stated: “Specific claims to single compounds require reasonably specific supporting disclosure and while we agree with the appellants, that naming is not essential, something more than the disclosure of a class of 1000, or 100, or even 48, compounds is required.” Id. at 1556, 154 USPQ at 122. The court required more specific guidance to direct the reader of the patent specification to the claimed compound in order to satisfy § 112. In Ruschig, the court announced the now-famous metaphor that a sufficient disclosure is one that marks a trail through the woods by supplying blaze marks on the trees. Id. at 1557, 154 USPQ at 122. In other words, in a patent application, one cannot disclose a forest but then later claim a particular tree as the invention. In the instant case, the specification discloses a genus of compounds of General Formula I: PNG media_image3.png 232 297 media_image3.png Greyscale located in claim 30 and is located on page 3, line 3 of the specification as originally filed. The original claims and specification do not explicitly recite the elected species: PNG media_image1.png 316 393 media_image1.png Greyscale None of the disclosed compounds are substituted with NH2 or contain a H at R4. There is no disclosure in applicant’s original specification or original claims that supplements General Formula I by guiding the reader toward the elected compound. In the words of Ruschig, there simply is no blaze mark that leads the reader to this compound. Consequently, the application, as originally filed, does not support the elected compound as a compound within the Markush group recited in claim 30. In sum, the present application does not reasonably convey to one skilled in the art that the inventors, at the time the application was filed, had possession of the elected compound of formula (I) in claim 30. Accordingly, on the basis of the foregoing observations and reasoning, it is appropriate to reject claims 30 and all claims depending therefrom under 35 U.S.C. 112, first paragraph. Response to Arguments Applicant argues: The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claim language. See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-564, 19 USPQ2d 1111, 1116-117 (Fed. Cir. 1991) and In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983). On the one hand, the Office requires the election of a species, and when Applicants make that election with a molecule that is clearly supported in Markush, the Office rejects the claims, arguing that the molecule is not supported by the written description. The Office cannot have it both ways. Examiner's response: The above argument has been carefully considered and has not been found persuasive. The requirements for restriction and species election are separate from the requirements for written description. Moreover, in the restriction requirement set forth on November 6, 2025, Applicant was required to elect a single disclosed compound of Formula (I). As noted above, the elected compound was not disclosed in the originally filed specification. The Examiner further notes that the elected compound was not disclosed in the earlier filed provisional application. The fact that the instantly elected compound is within the scope of the instantly claimed genus is insufficient for written description support for the elected species. As set forth above, none of the disclosed compounds are substituted with NH2 or contain a H at R4. There is no disclosure in applicant’s original specification or original claims that supplements General Formula I by guiding the reader toward the elected compound. As set forth above, the present application does not reasonably convey to one skilled in the art that the inventors, at the time the application was filed, had possession of the elected compound of formula (I) in claim 30. Claim Rejections - 35 USC § 112(a) Scope of Enablement Claims 30, 31, 34, 37, and 44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for treating acute respiratory distress syndrome comprising administering a composition comprising SPPCT-800 and a pharmaceutically acceptable carrier, does not reasonably provide enablement for a method for preventing or treating any disease or pathology caused by an increase in levels of inflammatory cytokines. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is a scope of enablement rejection. To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that: The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation". The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors: 1- the quantity of experimentation necessary, 2- the amount of direction or guidance provided, 3- the presence or absence of working examples, 4- the nature of the invention, 5- the state of the prior art, 6- the relative skill of those in the art, 7- the predictability of the art, and 8- the breadth of the claims These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons: 1. The nature of the invention Claims 30, 31, 34, 37, and 44 recite a method for preventing or treating a disease or pathology caused by an increase in levels of inflammatory cytokines comprising administering to the subject in need thereof a therapeutically effective amount of a compound of formula (I): PNG media_image3.png 232 297 media_image3.png Greyscale . 2. The relative skill of those in the art The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience. 3. The state and predictability of the art As illustrative of the state of the art regarding the treatment of disease or pathology caused by an increase in levels of inflammatory cytokines, the Examiner refers to Jarczak et al (Int. J. Mol. Sci., 2022; 23:11740 pp 1-30). Jarczak teaches the human innate and adaptive immune systems consist of effector cells producing cytokines (interleukins, interferons, chemokines, and numerous other mediators); usually, a fragile equilibrium of pro- and anti-inflammation effects is maintained by complex regulatory mechanisms; disturbances of this homeostasis can lead to intricate chain reactions resulting in a massive release of cytokines; this may result in a drastic self-reinforcement of various feedback mechanisms, which can ultimately lead to systemic damage, multi-organ failure, or death; not only pathogens can initiate such disturbances, but also congenital diseases or immunomodulatory therapies; due to the complex and diverse interactions within the innate and adaptive immune systems, the understanding of this important clinical syndrome is incomplete to date and effective therapeutic approaches remain scarce (abstract). Jarczak teaches to date, there is no valid definition for the term CS (cytokine storm); it is usually understood to mean an overwhelming immune response characterized by the release of cytokines, including interleukins, interferons, chemokines, and other mediators (page 1, last paragraph); and CS means that the dynamics and quantity of systemically released cytokines cause serious damage in the host organism; however, distinguishing between an appropriate and a pathologically dysregulated inflammatory response in critical illness is difficult or impossible (page 2, 1st paragraph). Jarczak teaches since most of the mediators involved in the CS exhibit pleiotropic downstream effects and, in addition, are often interdependent in their biological activity, an extremely complex dynamic arises; the interaction of the mediators and the signaling pathways triggered by them are neither linear nor uniform; moreover, their quantitative values may indicate the severity of the reactions, but not necessarily pathogenesis, clinical features, and prognosis; this complex interplay highlights the limitations of intervening in the acute inflammatory response based on single mediators and at undifferentiated time points (page 2, 1st paragraph). Jarczak teaches depending on the underlying causes and therapeutic measures, cases of CS differ from each other both in onset and duration (page 4, last paragraph). In regards to the elected inflammatory disease species sepsis, Jarczak teaches the complexity of the sepsis syndrome, together with the multi-level inter-organ cross talk, entails that even after more than three decades of research, there is no specific cure—and there probably never will be; even in precision or personalized medicine, where treatments are targeted at pre-specified conditions or individual patient requirements, no ground-breaking success has been achieved to date; an example of this is the approach known as theranostics, where selected biomarkers are used to choose a specific therapy and simultaneously measure the response to this treatment; however, it is likely that there is a right time for each element of the immune response to be enhanced or attenuated during the defense against severe infections; initially, when the pathogen load is high, the demands on the immune system are quite different from those at a later stage, when the pathogens are largely contained by effective anti-infective measures; in other words, applying the right therapeutic approach at the wrong time can potentially worsen clinical outcomes; furthermore, if anti-inflammatory interventions are only effective in certain subgroups of patients, demonstrating their efficacy in heterogeneous populations recruited in most clinical sepsis trials remains extremely difficult (page 5, 3rd paragraph). 4. The breadth of the claims The breadth of the claims is not commensurate in scope with the disclosure. Claim 30 encompasses compounds of formula (I). The general formula: PNG media_image3.png 232 297 media_image3.png Greyscale encompasses a diverse number of compounds. For this reason, one of ordinary skill in the art may envision hundreds of possible compounds according to the above general formula. However, the specification only discloses 30 compounds (see specification, pages 13-14). For example, R1 and R2 are always an unbranched hydrocarbon having 0 double bonds or triple bonds, C13H27, despite Applicant claiming that R1 and R2 can be any C1-C20 branched or unbranched hydrocarbon possessing 0-10 double bonds, 0-10 triple bonds, or a combination of 0-10 double and triple bonds. When R3 is PNG media_image2.png 198 278 media_image2.png Greyscale , X and Y are direct linkage, and R5 and R6 are C1-C4 branched or unbranched hydrocarbon, unsubstituted or substituted with OAc, despite Applicant claiming R5 and R6 are a C1-C10 branched or unbranched hydrocarbon optionally substituted with one or more groups selected from OH, OAc, OMe, NH2, NHAc, NHMe, N(Me)2, SH, CN, COOH, CONH2, Cl, Br and I. R4 is Na, Mg, or Ca, despite Applicant claiming R4 is H or any pharmaceutically acceptable cation, wherein incorporation of said pharmaceutically acceptable cation results in a salt. The disclosed compounds are insufficient to support enablement for the full scope of compounds encompassed by formula (I). Moreover, the scope of diseases encompassed by disease or pathology caused by an increase in levels of inflammatory cytokines is extremely broad. 5. The amount of direction or guidance provided and the presence or absence of working examples MPEP 2164.03 states: “The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work”. The specification only discloses SPPCT-800 was effective against ARDS in three studies in mouse model of ARDS [0064]. The specification further discloses that SPPCT-800 and SPP4040 reduce proinflammatory cytokines in plasma and BALF (see Tables 1 and 2). As noted in the response, SPP4040 has the structure: PNG media_image4.png 143 652 media_image4.png Greyscale Thus, SPP4040 is not encompassed by instantly claimed formula (I). Thus, SPP4040 is not a working example. A single compound for treating ARDS is insufficient to provide support for enablement for the full scope of compounds of claim 30 for treating the full scope of diseases encompassed by disease or pathology caused by an increase in levels of inflammatory cytokines. While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the treatment of any diseases or pathologies caused by an increase in levels of inflammatory cytokines, and in particular with novel untested compounds, is required for practice of the claimed invention. 6. The quantity of experimentation necessary As discussed above (see: 3. the state and predictability of the art), there is a high unpredictability in the art of treating any disease or pathology caused by an increase in levels of inflammatory cytokines. The specification provides evidence that SPPCT-800 is useful for treating ARDS. There is no biological/pharmacological data known to be associated with the claimed structures for preventing disease or pathology caused by an increase in levels of inflammatory cytokines including ARDS or for treating any disease or pathology caused by an increase in levels of inflammatory cytokines. Based on this and in the absence of experimental evidence commensurate in scope with the claims (see: 5. The amount of direction or guidance and the presence or absence of working examples above), the skilled in the art will not accept that a compound of formula I, will be effective in preventing or treating any disease or pathology caused by an increase in levels of inflammatory cytokines as inferred by the claims and contemplated by the specification because neither the prior art nor the specification disclose a single compound of formula I that correlates with the treatment of any disease or pathology caused by an increase in levels of inflammatory cytokines except for dimyrsitoyl-sn-glycero-3-phoshocholine (DMPC) or SPPCT-800 for the treatment of ARDS. So, determining which compounds of formula I, if any, will be effective in treating any disease or pathology caused by an increase in levels of inflammatory cytokines, will require first require testing new synthetic pathways for the hundreds of compounds that were not specifically disclosed in the specification, assaying these compounds in an assay that correlates with the treatment of any disease or pathology caused by an increase in levels of inflammatory cytokines, and then further determine their efficacy in a validated animal model. All this is undue experimentation given the limited guidance and direction provided by Applicants. Response to Arguments Applicant argues: Applicants have extensive experience with the claimed molecules and have shown that the effect is applicable to the molecules in the claims. In a parallel model system, Applicants have extensive data showing the effect of the molecules claimed herein. As such, the claims are enabled. Examiner's response: The above argument has been carefully considered and has not been found persuasive. In a careful review of the instant specification, the data presented in the arguments by the attorney do not appear to be disclosed in the specification as filed. In a review of the data presented in the arguments, Examiner notes that there does not appear to be cited references for the data provided. Thus, it is unclear if the data presented is the applicant’s own work or if the data was obtained from published prior art. Applicant is reminded that Attorney arguments do not replace evidence where evidence is necessary. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Moreover, applicants have the burden of explaining the data. There is no explanation of the “parallel model system” or what model is being tested with the compounds tested in the data presented in the arguments. Thus, the data presented is insufficient to support that the disclosure is enabled for the prevention and treatment of the full scope of diseases encompassed by the instant claims with the full scope of compounds of formula (I). Conclusion Claims 30, 31, 34, 37, and 44 are rejected. No claim is allowed. 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 RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm ET, Monday - Thursday. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Rayna Rodriguez/ Primary Examiner, Art Unit 1628
Read full office action

Prosecution Timeline

Jun 29, 2023
Application Filed
May 07, 2026
Non-Final Rejection mailed — §102, §103, §112
Aug 07, 2026
Response Filed
Oct 08, 2026
Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
34%
Grant Probability
53%
With Interview (+19.2%)
3y 5m (~1m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 587 resolved cases by this examiner. Grant probability derived from career allowance rate.

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