DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Summary
Claims 1-12 and 18-26 are pending in this office action. Claims 13-17 are cancelled. All pending claims are under examination in this application.
Priority
The current application filed on December 11, 2023 is a 371 of PCT/US2022/033095 filed June 10, 2022, which in turn claims domestic priority to provisional patent 63/209,646 filed on June 11, 2021.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on July 1, 2025 is acknowledged. The signed document is attached to this office action.
Claim Objections
Claims 9 and 24 are objected to because of the following informalities: the full name of DPPC is dipalmitoylphosphatidylcholine, these claims truncate the full name. Appropriate correction is required.
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 1-3, 8, 12, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garibyan et al. (US2017/0274078A1).
Garibyan et al. is regarded as being the prior art closest to the subject matter of the present application as it teaches compositions and methods for treatment of neurological disorders (see title). Furthermore, Garibyan et al. disclose compositions comprising, and methods for using, biocompatible cold slurries and methods of administering the same to provide reversible inhibition of peripheral nerves in a subject in need thereof (see abstract).
Regarding instant claim 1, Garibyan et al. teach a composition comprising: an amount of water; a non-water-soluble substance; and a first excipient. The necessary citations within Garibyan et al. that correspond to instant claim 1 are compiled within Table I.
Table I
Instant Claim 1
Garibyan et al. Citations
A composition comprising: an amount of water; a non-water-soluble substance; and a first excipient,
Garibyan et al. disclose a composition comprising an amount of water; a non-water-soluble substance; and a first excipient (see claims 1-10; also see claims 16-17 regarding an excipient such as a surfactant).
wherein the composition is configured to form a flowable ice slurry when exposed to freezing temperatures.
Garibyan et al. disclose wherein the composition is configured to form a flowable ice slurry when exposed to freezing temperatures (see paragraphs [0073-0076] and Table 1).
[Henceforth within the office action, all elements of instant claim 1 are taught by Garibyan et al.].
Regarding instant claim 2, Garibyan et al. teach wherein the non-water-soluble substance is a lipid (see paragraph [0085]).
Regarding instant claims 3 and 8, Garibyan et al. teach wherein the composition comprises a plurality of lipids (see paragraph [0085] and claim 15).
Regarding instant claim 12, Garibyan et al. teach wherein the first excipient is selected from the group consisting of a salt, an ion, Lactated Ringer's solution, a sugar, a biocompatible surfactant, a polyol, and a combination thereof. Garibyan et al. disclose use of an ion, Lactated Ringer's solution, a sugar, a biocompatible surfactant, and a combination thereof (see claims 2 and 12).
Regarding instant claim 18, Garibyan et al. teach wherein an average freezing point of a total volume of the composition is between about -25°C and about -5°C. Garibyan et al. disclose freezing temperatures of the binary mixture of water and glycerol from 0°C to -46.5°C (overlapping region; see Table 1).
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 non-obviousness.
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 1-10 and 19-26 are rejected under 35 U.S.C. 103 as being unpatentable over Garibyan et al. in view of Garibyan et al. ‘424 (US2019/0192424A1), Zeng et al. (US2017/0326042A1) and Kirby (WO96/17899).
[The Examiner is going to introduce each new reference and then combine them where appropriate to reject the instant claims.]
1. Garibyan et al. ‘424
Garibyan et al. ‘424 teach injectable slurries and methods of manufacturing the same (see title). Additionally, Garibyan et al. ‘424 disclose a method for treating vascular diseases is provided. The method includes fabricating a sterile ice slurry including water and ice particles, cooling the sterile ice slurry to a predetermined temperature, and injecting the sterile ice slurry into a desired tissue region. The desired tissue region includes perivascular adipose tissue (see abstract).
2. Zeng et al.
Zeng et al. teach liposomes, emulsions, and methods for cryotherapy (see title). Also, Zeng et al. disclose a method and system in accordance with a particular embodiments of the technology includes applying a substance onto skin of a human subject. The applied substance can include a freezing point depressant and a liposome, an oil-in-water emulsion, a water-in-oil emulsion, or an oil-in-oil emulsion and can be configured to protect or target tissue. The substance and a surface of the skin can be cooled using the applicator to treat acne and other skin conditions (see abstract).
3. Kirby
Kirby teaches anti-oxidant compositions (see title). In addition, Kirby discloses an anti-oxidant composition is provided comprising at least one anti-oxidant species solubilized in a hydrophobic solvent in which it would not normally be soluble. Processes for preparing such a composition are also provided (see abstract).
The teachings of Garibyan et al. are disclosed above within the 35 U.S.C. § 102 Section.
Combination of Garibyan et al., Garibyan et al. ‘424, and Zeng et al.
Regarding instant claims 4, 7, and 22, Garibyan et al., Garibyan et al. ‘424, and Zeng et al. teach wherein the composition comprises a lipid particle, and wherein the lipid particle comprises the plurality of lipids. Please see the discussion and citations within instant claim 1. Zeng et al. disclose the lipid particle, liposomes, for encapsulation purposes (see PTO-892 NPL V) (see paragraphs [0214-0217] within Zeng et al.).
Regarding instant claim 5, Garibyan et al., Garibyan et al. ‘424, and Zeng et al.
teach wherein the first excipient is configured to pass through a lipid bilayer of the lipid particle. Please see the discussion and citations within instant claim 1. An excipient such as a surfactant is designed to pass through a lipid bilayer of the lipid particle (liposome) (see PTO-892 NPL U). Garibyan et al. disclose the use of an excipient such as a surfactant (see claims 16-17 within Garibyan et al.) which can pass through the lipid bilayer because of its molecular structure.
Regarding instant claims 6 and 21, Garibyan et al., Garibyan et al. ‘424, and Zeng et al. teach wherein a first solution encapsulated within the lipid particle and a second solution outside of the lipid particle are substantially equal in composition. Zeng et al. disclose the use of the freezing point depressant, propylene glycol liposome (see claim 3 within Zeng et al.; also see PTO-892 NPL W). Furthermore, claim 1 within Zeng et al. states, “A method for treating a subject's skin, comprising applying a coupling media to the skin, wherein the coupling media includes a freezing point depressant and either a liposome…” Therefore, the freezing point depressant of propylene glycol with liposomes which encapsulate propylene glycol would afford a substantially equal composition inside and outside of the lipid particle.
Regarding instant claim 19, Garibyan et al., Garibyan et al. ‘424, and Zeng et al. teach a method of preparing a cold slurry for administration to a patient at a clinical point of care, the method comprising: preparing a composition comprising a plurality of lipid particles; adding an excipient to the composition, wherein the excipient is configured to reduce the freezing point of a volume external to the plurality of lipid particles and of a volume internal to the plurality of lipid particles; and cooling the composition to a predetermined temperature such that the cold slurry is formed, wherein the cold slurry comprises a plurality of ice particles. Please see the discussion and citations within instant claim 1-4, 8, 12, and 18. Furthermore, Garibyan et al. disclose use of agents which depress the freezing point (see paragraph [0076] within Garibyan et al.), and the process of cooling to afford a cold slurry (see abstract, paragraph [0070], and Table 1 all within Garibyan et al.). Moreover, Garibyan et al. disclose a method for administration to a subject (see claim 1 within Garibyan et al.).
Regarding instant claim 20, Garibyan et al., Garibyan et al. ‘424, and Zeng et al.
teach wherein the volume internal to the lipid particles is between about 20% and 50% of a total volume of the composition. Garibyan et al. disclose the lipid emulsion such as commercially available Intralipid used within their slurry (see paragraph [0085] within Garibyan et al.). Additionally, Garibyan et al. ‘424 also disclose the use of Intralipid used in their slurry (see paragraph [0135] within Garibyan et al.). Moreover, Zeng et al. disclose the use of the freezing point depressant, propylene glycol, in the presence of a liposome (see claim 3 within Zeng et al.). Therefore, since it is well-known that liposomes encapsulate materials, a skilled artisan could undertake routine experimentation (liposome concentration) and quantify the volume of the solvent encapsulated by the liposomes within 20% and 50% of the total composition.
Regarding instant claim 23, Garibyan et al., Garibyan et al. ‘424, and Zeng et al. teach wherein the plurality of lipid particles comprises a plurality of lipids, and wherein the plurality of lipids comprises a phospholipid. Garibyan et al. teach wherein the composition comprises a plurality of lipids including a phospholipid (see paragraph [0085] and claim 15). Combination of Garibyan et al., Garibyan et al. ‘424, and Zeng et al. would allow a skilled artisan (POSITA; person of ordinary skill in the art) to employ the liposomes of Zeng et al. and the phospholipid of Garibyan et al. under routine experimental conditions.
Regarding instant claim 26, Garibyan et al., Garibyan et al. ‘424, and Zeng et al. teach wherein the first excipient is selected from the group consisting of a salt, an ion, Lactated Ringer's solution, a sugar, a biocompatible surfactant, a polyol, and a combination thereof. Garibyan et al. disclose use of an ion, Lactated Ringer's solution, a sugar, a biocompatible surfactant, and a combination thereof (see claims 2 and 12 within Garibyan et al.).
Combination of Garibyan et al., Garibyan et al. ‘424, Zeng et al., and Kirby
Regarding instant claims 9-10 and 24-25, Garibyan et al., Garibyan et al. ‘424, Zeng et al., and Kirby teach the phospholipid, L-a-phosphatidylcholine (soy PC), at the desired concentration. Garibyan et al. disclose the use of phospholipids (see paragraph [0085] within Garibyan et al.). Kirby et al. disclose the use of the phospholipid, L-a-phosphatidylcholine (soy PC), at 100 mg/g within an aqueous solution (density of water 1 g/mL; 0.100 g/mL). Therefore, a skilled artisan (POSITA) could substitute one phospholipid for another under routine experimental procedures.
In the context of instant method claims 19-26 the desired purpose defines an effect that arises from, and is implicit in the method step(s). Thus, where the purpose is limited to stating a technical effect that inevitably occurs during the performance of the claimed method step(s), and is therefore inherent in that/those step(s), that technical effect is not limiting to the subject-matter of the claim. Thus, the present method claims, defining the application/use of the composition and defining its purpose as "use", is anticipated by any document of the state of the art describing a method of application/use although not mentioning this specific use.
Analogous Art
The combination of the Garibyan et al., Garibyan et al. ‘424, Zeng et al., and Kirby references are relevant for the rejection of instant claims 1-12 and 18-26 due to their direct application to the present invention.
Obviousness
It would have been prima face obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biocompatible cold slurry disclosed by Garibyan et al., using the teachings of Garibyan et al. ‘424, Zeng et al., and Kirby to incorporate the necessary claim limitations.
The motivation to combine the Garibyan et al., Garibyan et al. ‘424, Zeng et al., and Kirby references relies on the common theme to develop a biocompatible cold slurry formed in the presence of liposomes. Both Garibyan et al. and Garibyan et al. ‘424 support the development of a biocompatible cold slurry. Zeng et al. disclose the use of liposomes within liposomes, emulsions, and methods for cryotherapy. Finally, Kirby discloses the specific phospholipid soy PC needed for the liposomes. These four references support the development of an enhanced biocompatible cold slurry, thus making them analogous art to a skilled artisan (POSITA).
Starting with Garibyan et al., the skilled person only had to try the necessary claimed limitations disclosed by Garibyan et al. ‘424, Zeng et al., and Kirby. The combination of Garibyan et al., Garibyan et al. ‘424, Zeng et al., and Kirby would allow one to arrive at the present application without employing inventive skill. This combination of the biocompatible cold slurry taught by Garibyan et al. along with the necessary use of the claimed limitations taught by Garibyan et al. ‘424, Zeng et al., and Kirby would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the biocompatible cold slurry disclosed by Garibyan et al. with the use of the necessary claimed limitations disclosed taught by Garibyan et al. ‘424, Zeng et al., and Kirby. This combined modification would have led to an enhanced biocompatible cold slurry, and thus beneficial for patients.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The subject-matter of claim 11 is allowable due to the specific concentration of the phospholipid, soy PC, at 0.26 g/mL. This value was absent from the prior art. Motivation is lacking to add this claim limitation to the relevant prior art references of Garibyan et al. and Kirby.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615