DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-3, 5, 8, 10, 12-17, 19, and 32-38 are pending.
Claims 1, 3, 5, 8, and 10 are examined herein.
Claims 2, 12-17, 19, and 32-38 are withdrawn (see restriction/election below).
Priority
This application is filed 03/01/2024, and claims the benefit of domestic priority as below:
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Information Disclosure Statements
One IDS(s) received on 07/18/2024 have been considered unless marked with a strikethrough, and reference(s) without English translation(s) is/are also not considered.
Election/Restrictions
Applicant elects Group I, claims 1, 3, 5, 8, and 10, is drawn to a method for the treatment of a disease associated with myocardial depression using compositions of Formula II or a pharmaceutically acceptable salt, hydrate, prodrug or stereoisomer thereof, without traverse in the reply field on 05/19/2026 is acknowledged. Claims 2, and 32-38 (Group II), and claims 12-17 (Group III) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of use, there being no allowable generic or linking claim.
However, claim 19 was incorrectly omitted and should have been placed in the composition claim group (e.g., Group III). This error is corrected herein as follows:
Group I: Claims 1, 3, 5, 8, 10, drawn to methods of using compositions of formula II for the treatment of a disease associated with myocardial depression.
Group II: Claims 2, and 32-38, drawn to methods of using compositions of formula II for increasing adrenergic signaling responsiveness.
Group III: Claims 12-17, and 19, drawn to compositions of formula II.
In view of this correction, the restriction requirement is not made final in this Office Action to allow Applicants an opportunity to respond to the revised grouping.
Accordingly, claims 2 and 32-38 (Group II), and claims 12-17 and 19 (Group III) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of using compositions of formula II for increasing adrenergic signaling responsiveness /compositions of formula II, there being no allowable generic or linking claim.
Applicant elects the “cholesterol” in claim 3 as the species in the reply field on 05/19/2026 is acknowledged.
The claims 1, 3, 5, 8, and 10 are readable on the elected species in elected Group I, as Applicant asserts.
If the elected species is not identified in the prior arts, the elected species would be allowable if
an independent claim were drafted with that species alone. (see MPEP 802.03)
The elected species was identified in the prior art. Accordingly, claims 1, 3, 5, 8, and 10 read on the elected species, and will be examined on their merits.
With respect to the elected species, the art is rejected under 35 USC 102 and 35 USC 103 below.
Claim Objections
Claims 1, 3, and 5 are objected to because of the following informalities:
Regarding to claims 1, and 5, the phrase “may be” is unclear in form. The phrase should be replaced with “optionally” or other language that clarifies the intended bonding arrangement.
Regarding to claim 3, The phrases “one or more compounds … is cholesterol” and “one or more phytosterols are selected” contain a grammatical inconsistency. The phrases are revised to ensure consistent verb usage. Moreover, the colon is unnecessary.
Claim Rejections - 35 USC § 112
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 1, 3, 5, 8, and 10 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by applicants. (see MPEP 2163.02)
An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. (Emphasis added)
Further, the MPEP states that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. (see MPEP 2161.01)
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.") (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that "only similar language in the specification or original claims is necessary to satisfy the written description requirement").
As set forth in the en banc decision in Ariad Pharmaceuticals Inc. v. Eli Lilly and Company, 94 USPQ2d 1161 (Fed. Cir. 2010) at 1171, the court stated as follows:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. At 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. At 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 [25 USPQ2d 1601] (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
With respect to claims 1, 3, 5, 8, and 10, the claim 1 recites “one or more compounds of Formula (II) or a pharmaceutically acceptable salt, hydrate, prodrug or stereoisomer thereof”. Claim 3 further recites that the compound of Formula (II) may be cholesterol and/or one or more phytosterols, and claim 5 limits the compound of Formula (II) to be a compound of Formula (I). Claims 8 and 10 depend from claim 1, and have the same deficiencies as claim 1. Accordingly, the claims encompass the specifically recited cholesterol and phytosterol embodiments, and pharmaceutically acceptable prodrug thereof.
In the instant case, the claims of the present invention embrace compounds of Formula (II), including “prodrug” thereof. The specification provides a general description of “prodrug” in page 23. However, these generic categories do not, by themselves, reasonably convey possession of the full scope of the broadly claimed embodiments.
In the instant case, the claims of the present invention encompass compounds of Formula (II), including “prodrug” thereof. The specification states that “the term prodrug of a compound of the disclosure refers to any compound or pharmaceutically acceptable salt thereof which, after administration to the human body, may be metabolized in vivo to a compound of the disclosure. Typical prodrugs include acyl, ester and carbamyl derivatives of the compound of formula (II), for example acyl, ester and carbamyl derivatives of the compound of formula (I), wherein the acyl, ester or carbamyl moiety is directly bonded to a heteroatom in moiety X.” in page 23. However, this disclosure does not necessarily demonstrate possession of such prodrug embodiments. In particular, the specification fails to 1) provide representative structural examples of prodrug of the claimed compounds of Formula (II), including prodrug of cholesterol or phytosterol embodiments, 2) provide synthetic examples or working examples or experimental data demonstrating the preparation, conversion or biological activity of O-acyl, O-ester, or O-carbamyl prodrugs; 3) identify the specific prodrug species that are part of the claimed therapeutic invention, 4) disclose common structural features sufficient to define the full prodrug genus encompassed by the claims, and 5) establish a structure function correlation showing that the full scope of the prodrug would retain the relevant therapeutic or biological properties of the claimed invention. As a result, the disclosure is more consistent with a general conceptual description of possible prodrug forms than with evidence that the inventors are in possession of the claimed prodrug genus at the time of filing.
The art teaches that prodrug may have their own pharmacological activity. Zhang et al. (Drug metabolism in drug discovery and development, Acta Pharmaceutica Sinica B, 8(5), 72-732, pub’d 04/12/2018) teaches that prodrug of a drug can distinctly drug candidates from the parent drug, therefore emphasizing the importance of designing prodrug in a manner that requires the causes that necessitate the use of the prodrug approach be defined and clearly understood (prodrug or active metabolites as new drug candidates section). Without definitive boundaries the Examiner can only assume that the term “prodrug” may encompass a broad range of structural modifications, including modifications involving large promoieties or macromolecular moieties. Specifically, in view of the teachings of Zhang, if small structural changes to compounds within the field of the invention cause an effect pharmacological behavior, a person skilled in the art could not predict what would be expected of large structural changes. Thus, one of ordinary skill would not expect these compounds to necessarily have similar properties and a person skilled in the art would not be able to determine whether the structure or function of the claimed invention would be maintained.
The specification, although, the specification may support cholesterol and certain specifically disclosed sterol or phytosterol embodiments with a general description of “prodrug”, lacks representative structural examples of actual prodrug compounds within the claimed cholesterol/phytosterol/Formula (II) embodiments. Thus, it does not reasonably convey possession of the full scope of claimed compounds of Formula (II), including the broadly recited prodrug thereof.
As set forth in the en banc decision in Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010), to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. Specifically, the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art in a way that shows that the inventor actually invented the claimed invention at the time of filing. Id.; Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172. (see MPEP 2161.01).
Accordingly, in view of the breadth of the claimed genus, the lack of representative examples of prodrug, and lack of disclosed common structural features or structure function correlation for the full scope of the claimed prodrug thereof, as discussed above, the specification does not reasonably convey to those skilled in the art that the inventors are in possession of the full scope of claimed combination therapies at the time of filing.
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.
The rejections under this section are made when the scope of the claimed subject matter is not clear. (See MPEP 2173)
Claims 1, 3, 5, 8, and 10 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.
Regarding claim 1, the phrase "a disease associated with myocardial depression" renders the
claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. The specification does not explicitly define “associated with” or provide sufficient guidance as to the type or degree of association required. For example, it is unclear whether the association must be structural, functional, causal , or merely correlative. It is also unclear how direct the relationship must be between the inhibition and the treatment, or whether treatment of a symptom associated with myocardial depression would fall within the scope of the claim.
Claims 3, 5, 8 and 10 depend from claim 1, and do not further define or resolve the unclarity in the phrase "a disease associated with myocardial depression". Accordingly, claims 3, 5, 8 and 10 are indefinite for the same reason set forth with claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 5, 8, and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The Examiner has followed the guidance set forth in MPEP 2106 and has concluded that the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter.
Eligibility Step 1: The Four Categories of Statutory Subject Matter
Step 1 asks if the claim is to a process, machine, manufacture or composition of matter. The claims 1 and 3 are drown to methods of using compositions of formula II for the treatment of a disease associated with myocardial depression. Therefore, the answer to the question of Step 1 for claims 1 and 3 is Yes, because the claims are considered directed to a process of using a composition of matter, which is eligible subject matter.
Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception
Prong One asks if the claim recites a natural phenomenon. In the instant case, Formula (II) in claims 1 and 3 is corresponded to cholesterol. Cholesterol is a naturally occurring, waxy, fat-like substance found in all cells in the body. The specification also describes that cholesterol as present within the body and as an integral component of cell membranes (lines 22-26 page 1, and lines 4-6 page 2), and that “when formulated as a blend together with of one or more compounds of formula (II), for example formula (I), the cholesterol may be any cholesterol that is suitable for combining with of one or more compounds of formula (II), for example formula (I). For example, the cholesterol may be bound to a lipoprotein, for example very-low density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL), or natural or recombinant apolipoproteins and apolipoprotein mimetics” (line 22-27, page 25). VLDL, LDL, and HDL are also naturally occurring substances. The specification further describes that “administered intravenously, it will replace 'natural' eukaryotic cholesterol in cell membranes.” (lines 15-20, in page 43) Accordingly, in view of the specification, cholesterol is described as playing pleiotropic roles within the body and as an integral component of cell membranes, and it is formulated as natural or recombinant apolipoproteins and apolipoprotein mimetics. The claimed cholesterol is not recited as having markedly different characteristics from naturally occurring cholesterol. Therefore, the answer to the question of Step 2A in Prong One is Yes, claims 1 and 3 are directed to using a natural product that is present in all humans (i.e., a law of nature/a natural phenomenon) – which would include the instantly claimed patient population.
Prong Two asks if the claim recites additional elements that integrate the judicial exception into a practical application. In the instant case, the judicial exception is not integrated into a practical application because the claim encompass the natural in the body, including cholesterol present in a patient population having a disease associated with myocardial depression. The claim recites the its constituents without reciting any additional steps or elements that rely on or use the compound for any practical purpose. Therefore, the answer to the question of Step 2A in Prong Two is No, claims 1 and 3 are not integrated into a practical application.
Eligibility Step 2B: Whether a Claim Amounts to Significantly More
Step 2B asks if claims recite additional elements that amount to significantly more than the judicial exception. In the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because there are no “additional elements” required by the present claim since they are directed only to the naturally occurring substance itself (i.e., cholesterol), including naturally occurring or background cholesterol present in the body.
Therefore, the claimed composition is not deemed to be different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterpart(s) (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303 (1980)). Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 66, 70, 106 USPQ2d 1972, 1979 (2013)).
Applying the BRI, Formula II could also be at least an additional molecule of cholesterol. In addition, based on the specification at least at page 2, the instant process does not rule out endogenous chlolesterol providing a background treatment of the disease such that this protecting “treatment” take place as a natural phenomenon in the body: “…[d]rop in cholesterol levels, the magnitude of which prognosticates for a poor outcome.” Thus, based on the specification there is an interpretation that baseline levels of endogenous cholesterol are ‘treating’ the disease and as background levels reduce less diseases is treated.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, 8, and 10 is/are rejected under 35 U.S.C. 102(a)(1), and 102(a)(2) as being anticipated by Azeredo da Silverira Lajaunias et al. (WO 2019/202101 A1, pub’d 10/24/2019, cited in IDS, hereinafter Azeredo).
With respect to claim 1, Azeredo teaches administering a cholesterol containing empty liposome composition for the treatment of sepsis (claim 1). Cholesterol is readable on the recited compound of Formula (II), the treatment of sepsis is readable on a method for the treatment of a disease associated with myocardial depression, as the specification identifies infectious diseases as diseases associated with myocardial depression and specifically identifies sepsis, including pneumococcal sepsis, as an example (lines 17-21 page 48, and claim 8). Moreover, Azeredo further teaches “a therapeutically effective amount of the inventive compositions are typically and preferably used for the disclosed treatments” (lines 15-16, page 12). Accordingly, Azeredo satisfy the limitations of claim 1.
With respect to claim 3, Azeredo teaches a first empty liposome comprising cholesterol (claim 1). Thus, Azeredo discloses the limitation that the one or more compounds of Formula (II) is/are cholesterol.
With respect to claim 5, Azeredo teaches a first empty liposome comprising cholesterol, and cholesterol is readable on the recited compound of Formula (I). Accordingly, Azeredo satisfy the limitation of claim 5.
With respect to claim 8, Azeredo teaches treatment of sepsis (claim 1), which is an infection associated disease and fall within the instant specification (lines 14-21 page 48) and the broadly interpreted scope of a disease associated with myocardial depression, as discussed with respect to claim 1). Accordingly, Azeredo discloses the limitation of claim 8.
With respect to claim 10, Azeredo teaches the empty liposomes constitute a pharmaceutically acceptable carrier, because Azeredo discloses the cholesterol containing composition in the form of empty liposomes for therapeutic administration to an animal, preferably a human (claim 1). Azeredo further teaches the inventive empty liposomes, typically and preferably, means encapsulated/ encapsulating into the cavity of the liposome (lines 5-9, page 5). Accordingly, Azeredo discloses the limitation of claim 10.
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.
Although the claims 1, 3, 5, 8, and 10 are rejected under 35 USC 102, this rejection under 35 USC 103 rejection is made in the alternative to extent that the claimed subject matter is considered adequately supported by the specification and not anticipated by the prior art.
Claim(s) 1, 3, 5, 8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Azeredo da Silverira Lajaunias et al. (WO 2019/202101 A1, pub’d 10/24/2019, cited in IDS, hereinafter "Azeredo"), in view of Habimana et al. (Sepsis-induced cardiac dysfunction: a review of pathophysiology, Acute Crit. Care, 35(2), 57-66, pub'd 05/27/2020).
With respect to independent claim 1, the claim recites that a method for the treatment of a disease associated with myocardial depression comprising administering to a subject in need thereof a therapeutically effective amount of a composition comprising one or more compounds of formula (II) or a pharmaceutically acceptable salt, hydrate, prodrug or stereoisomer thereof.
Azeredo teaches 1) a composition comprising a mixture of empty liposomes, wherein a first empty liposome comprises cholesterol, and a second empty liposome comprises sphingomyelin, for use in the treatment of sepsis, sever sepsis, septic shock, or prolonged and severe hypotension, including persistent hypotension, and 2) preferred composition produced improved hemodynamic parameters, prevention of hemodynamic deterioration, and faster resolution of septic shock (claim 1 and 4, and lines 22-29, page 2). Thus, Azeredo teaches administering a cholesterol containing liposomal composition to a subject suffering from sepsis or septic shock in order to improve clinically relevant cardiovascular/ hemodynamic dysfunction.
Although, Azeredo teaches sepsis, as discussed in 35 USC 102 rejection above, Azeredo fails to explicitly state ‘a disease associated with myocardial depression’.
Habimana teaches that sepsis induced cardiac dysfunction is associated with significantly increased mortality and that the pathophysiology of sepsis induced cardiac dysfunction involves impaired myocardial circulation, direct myocardial depression, and mitochondrial dysfunction (abstract and introduction). Habimana further teaches that the mechanisms behind direct myocardial depression include downregulation of β-adrenoceptors and myocardial suppressants such as cytokines and nitric oxide (abstract). Accordingly, Habimana provides that sepsis and septic shock, the same disease state treat in Azeredo, are diseases associated with myocardial depression.
It would have been obvious to a PHOSITA at the time of the invention to administer the cholesterol containing liposomal composition of Azeredo to a subject suffering from sepsis associated myocardial depression, as taught by Habimana, with a reasonable expectation of improving cardiovascular dysfunction in sepsis. The motivation to combination is the advantage taught by Azeredo of improving hemodynamic parameters, preventing hemodynamic deterioration, and accelerating resolution of septic shock,. Habimana provides the additional teaching that sepsis induced cardiac dysfunction includes direct myocardial depression. Therefore, a person of ordinary skill in the art would have understood that the sepsis and septic shock treated by Azeredo include disease states associated with myocardial depression.
The references is directed to the same field of endeavor and address related to the application. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Alternatively, applying KSR example rationale (A) in the independent claim 1, it would have been prima facie obvious that combination of the known cholesterol containing liposomal composition and its use for treating sepsis and septic shock taught by Azeredo, and sepsis induced cardiac dysfunction includes myocardial depression taught by Habimana would have predictably resulted in administering a cholesterol containing liposomal composition to treat sepsis associated myocardial depression.
With respect to claim 3, the claim recites that the one or more compounds of formula (II) is cholesterol and/or one or more phytosterols, optionally wherein said one or more phytosterols are selected from the group consisting of sitosterol, campesterol, stigmasterol, campestanol, brassicasterol, ergosterol, lupeol, cycloartenol, and sitostanol.
Azeredo teaches a composition comprising a mixture of empty liposomes, wherein a first empty liposome comprises cholesterol.
With respect to claim 5, the claim recites that the one or more compounds of formula (II) are one or more compounds of formula (I).
Azeredo teaches cholesterol, and cholesterol falls within Formula (I).
With respect to claim 8, the claim recites the subject is suffering from a disease caused by an infection, optionally wherein the infection is a bacterial infection, a viral infection or a parasitic infection, further optionally wherein the disease is sepsis.
Azeredo teaches treatment of sepsis, severe sepsis, and septic shock. Azeredo further identifies sepsis as life threatening organ dysfunction caused by a dysregulated host response to infection. Thus, Azeredo teaches administering the cholesterol containing composition to a subject suffering from a disease caused by infection, including sepsis.
With respect to claim 10, the claim recites the composition further comprises a pharmaceutically acceptable carrier, optionally wherein the carrier is a liposome, micelle, nanoparticle, nanoworm or nanorod.
Azeredo teaches that the cholesterol containing composition comprises liposomes that are pharmaceutically acceptable carries.
Conclusion
Claims 1, 3, 5, 8, and 10 are rejected.
Claims 1, 3, and 5 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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