DETAILED ACTION
This office action is in response to applicant’s filing dated January 28, 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 43-46 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed January 28, 2026. Claims 3, 7, 8, 10-12, 14, 21, 22, 24-26, 28, 32, 35, 36, 38-40, and 42 were previously canceled.
Election/Restrictions
Applicant’s election without traverse of 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 in the reply filed on January 28, 2026 is acknowledged.
Claims 1, 2, 4-6, 9, 13, 15-20, 23, 27, and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 28, 2026.
Applicant's election with traverse of:
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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 is acknowledged. The traversal is on the grounds that there would not be an undue burden for the Office to examine additional non-elected species, namely, the Markush of the above compound, as these would be part of a standard patentability search. This is not found persuasive because:
Firstly, Applicant is reminded that the instant requirement is a Lack of Unity. There are no provisions for serious burden under 37 C.F.R. 1.475 and MPEP 1800. Further, the requirement for restriction between inventions or groups of inventions and/or species fail to relate to a single general inventive concept because they lack the same or corresponding technical feature. See PCT Rules 13.1 and 13.2. These reasons have already been provided to Applicant (see the Office Action dated November 6, 2025), and will not be repeated herein so as not to burden the record, but are herein incorporated by reference. Since Applicant has failed to demonstrate that the species do, in fact, relate to a single general inventive concept, the Examiner defers to the reasons previously set forth as to why the restriction is proper.
The requirement is still deemed proper and is therefore made FINAL.
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
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, 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 33, 41, 43, and 45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 28, 2026.
Claims 30, 31, 34, 37, 44, and 46 are presently under examination as they relate to the elected species:
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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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on August 9, 2023; October 29, 2024; and January 6, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner, except where marked with a strikethrough.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because Figures 2A-2E do not contain a key for the symbols. In a review of the brief description of the drawings, the specification discloses “Red dot=mice treated with SPPCT-800; black dot=mice treated with LPS and vehicle; open dot=untreated.” The drawings are not in color. No symbols can be a red dot. The examiner suggests amending the drawings to include a key and deleting the phrase in the description or amending the description to accurately reflect the colors of the symbols in the figures.
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.
Specification
The disclosure is objected to because of the following informalities:
The specification discloses SPP4040 (Fig 3A and 3H; [0021], Table 1, [0068-0073], and Table 2. In a review of the specification, disclosure of the structure of SPP4040 was not identified.
Appropriate correction is required.
Claim Objections
Applicant is advised that should claim 44 be found allowable, claim 46 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 30, 31, 34, 37, 44, and 46 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 30 recites the broad recitation lysophosphatidylglycerol, and the claim also recites 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 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 31, 34, 37, 44, and 46, which depend from claim 30, do not clarify the ambiguity of claim 30. Thus, the rejection also applies to claims 31, 34, 37, 44, and 46.
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, 44, and 46 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:
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Applicant contends that support for the elected species is disclosed in claim 30 in formula (I):
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wherein:
R3 is
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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:
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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:
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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.
Claim Rejections - 35 USC § 112(a)
Scope of Enablement
Claims 30, 31, 34, 37, 44, and 46 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 dimyrsitoyl-sn-glycero-3-phoshocholine (DMPC) or 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, 44, and 46 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 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):
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.
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).
A search of the prior art revealed that dimyrsitoyl-sn-glycero-3-phoshocholine (DMPC) is known to be useful for treating acute respiratory distress syndrome. However, there is no teachings that dimyrsitoyl-sn-glycero-3-phoshocholine (DMPC) is useful for preventing acute respiratory distress syndrome or that the listed compounds or compounds of formula (I) of claim 30 are useful for preventing or treating any of the various pathogen related disorders, congenital diseases or immunomodulatory therapies encompassed by disease or pathology caused by an increase in levels of inflammatory cytokines.
4. The breadth of the claims
The breadth of the claims is not commensurate in scope with the disclosure. Claim 30 encompasses 13 explicitly named compounds and those encompassed by general formula (I). The general formula:
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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, pages13-14). 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
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, 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). In a review of the specification, disclosure of the structure of SPP4040 was not identified. Thus, the Examiner is unable to ascertain if SPP4040 is a compound of formula (I). Thus, SPP4040 is not construed as 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; dimyrsitoyl-sn-glycero-3-phoshocholine (DMPC) is known in the art for use in treating ARDS and 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 listed in claim 30 or compounds 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.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 30, 31, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chochrane et al (WO 2007/005672 A2).
Regarding claims 30 and 31, Chochrane teaches a method of treating a respiratory disease or condition in a mammal comprising administering to the mammal a therapeutically effective dosage of a composition (claim 45); wherein the respiratory disease is acute respiratory disease syndrome (claim 46); a composition comprising a pharmaceutically acceptable carrier, and a therapeutically effective amount of a neutral lipid; a phospholipid; and a lung-surfactant polypeptide (claim 1); wherein the phospholipid comprises dimyristoyl phosphatidylcholine (claim 15). Dimyristoyl phosphatidylcholine reads on dimyrsitoyl-sn-glycero-3-phoshocholine (DMPC) as evidenced by STN (CAS Registry 18194-24-6, dated November 16, 1984), which teaches dimyristoyl phosphatidylcholine as alternative names dimyrsitoyl-sn-glycero-3-phoshocholine (DMPC).
Regarding claim 37, Chochrane teaches the active ingredients including phospholipids can be mixed with excipients that are pharmaceutically acceptable and compatible with the active ingredients and suitable excipients include buffered solutions (page 46, 2nd paragraph). Moreover, Chochrane teaches the composition is formulated for administration by inhalation (claim 33).
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.
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.
Claims 34, 44, and 46 are rejected 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.
As set forth above, Chochrane teaches a method of treating acute respiratory disease syndrome comprising administering a composition comprising a pharmaceutically acceptable carrier and dimyrsitoyl-sn-glycero-3-phoshocholine (DMPC).
Regarding claim 34, Chochrane teaches suitable dose of the compositions for administration to a mammal (e.g. a human) is in the range of from about 0.1 to about 300 mg phospholipid per kilogram (page 45, 2nd paragraph) and the desired dose may conveniently be presented in a single dose or as divided doses administered at appropriate intervals, for example, as two, three, four or more sub-doses per day (page 45, 3rd paragraph). MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Taken together, all this would result in the method of claim 34 with a reasonable expectation of success.
Regarding claims 44 and 46, the cited art does not explicitly teach the method further comprises identifying a subject in need of treatment for pulmonary distress. However, Cochrane does teach acute respiratory distress syndrome (ARDS) is an inflammatory disease of the lung, occurring in all ages, involving approximately 50,000-100,000 people in the United States per year; as the disease progresses pulmonary function fails, requiring mechanical ventilation, and approximately 40-50% of patients die with the disease; many initiating factors lead to the development of ARDS, including aspiration of injurious substances such as gastric contents, inhalation of noxious fumes, including smoke or NO2, pneumonia, pulmonary contusion, trauma, multiple transfusions, bums, sepsis, pancreatitis, and the like; the early disease is marked by an edematous response in the lung, with accumulation of neutrophils, leading to the development of chronicity within a week, with fibrin deposits and collagen production; injury to epithelial cells is observed in the early phase together with interstitial edema (page 2, 2nd paragraph). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to identify the subject having acute respiratory distress syndrome is in need of treatment for pulmonary distress with a reasonable expectation of success since the art teaches as the disease progresses pulmonary function fails, requiring mechanical ventilation, and approximately 40-50% of patients die with the disease and early disease is marked by an edematous response in the lung, with accumulation of neutrophils, leading to the development of chronicity within a week, with fibrin deposits and collagen production; injury to epithelial cells is observed in the early phase together with interstitial edema. One of ordinary skill in the art would have been motivated to identify a subject suffering from acute respiratory distress syndrome (ARDS) identified as having pulmonary distress to avoid disease progression to pulmonary function failure.
Taken together, all this would result in the practice of the method of claims 44 and 46 with a reasonable expectation of success.
Conclusion
Claims 30, 31, 34, 37, 44, and 46 are rejected.
No claim is allowed.
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, Monday - Thursday.
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/Rayna Rodriguez/Primary Examiner, Art Unit 1628
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