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 .
Claim Status
Claims 1-5, 7-10 are pending. Claims 1, 7, and 10 are amended. claims 1-5, 7-10 are being examined on the merits in this office action.
Drawings - Withdrawn
The objection to the drawings is withdrawn in view of the amended drawings.
Claim Objections - Withdrawn
The objection of claim 10 is withdrawn in view of the claim amendment.
Claim Rejections - Withdrawn
The rejection of claims 1-5 under 35 U.S.C. 102(a)(1) as being anticipated by Lallemand et al. (WO2012028733A1 – hereinafter “Lallemand”) is withdrawn in view of the claim amendment.
Claim Rejections - 35 USC § 112 - New
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 1-5, 7-10 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.
Claim 1 recites the limitation "..when exposed to an aqueous medium…" in claim 1, line 2. The instant specification does not define what being exposed encompasses and therefore it is unclear what is considered being “exposed”. Thus, the metes and bounds of that limitation “exposed to an aqueous medium” is unknown. Claims 2-5, 7-10 depend on claim 1 and are also rejected.
Claim Rejections - 35 USC § 102 – Maintained and Updated
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.
Claim Interpretation
The instant claims recite that the composition forms liquid crystals in an aqueous medium. Liquid crystals are defined as follows in the instant invention: that component a) is a liquid crystal former, and component b) is a liquid crystal hardener. Thus, Examiner notes that a references that teaches a composition that comprises component a) and b) at the recited concentrations in an aqueous medium would read on a composition that forms liquid crystals.
Examiner notes that the instant claims recites the concentrations of the ingredients in terms of “parts”. Examiner is interpreting the recitation of “parts” as being one part in 100 total parts and is equivalent to percentage. Thus, cited references that disclose the amounts of active ingredients as a percentage, would read on “parts”.
Claims 1-5, and 7 are still rejected under 35 U.S.C. 102(a)(1) as being anticipated by Autuori et al. (US20030171299A1 – hereinafter “Autuori”).
Regarding claim 1, Autuori teaches a composition that comprises an aqueous phase, 30 to 98% hydrophobic phase and up to 50% of a surfactant [0022], wherein the hydrophobic phase includes vegetable oils such as soybean, peanut, sesame, cottonseed, sunflower oils [0026], and wherein the surfactant includes cholesterol and sugar alcohols such as sorbitol [0024]. Examiner notes that the taught vegetable oils comprise unsaturated fatty acid having 14 to 20 carbon atoms. Examiner is further interpreting up to 50% to be concentration of 50% and below which includes the instant range. Autuori teaches that the composition comprises a biologically active compound such as Goserelin, octreotide acetate (claim 6, 16; [0028, 0030, 0031]), and that such a biologically active agent is in the amount of 1% or 1.5% [0055, 0070]. Examiner notes that since Lallemand teaches all the components of the claimed invention, in the instant concentrations, the characteristic of forming liquid crystals would be inherently present when the composition is exposed to an aqueous medium. The reference anticipates instant claim 1.
Regarding claims 2-3, Autuori teaches the composition comprises 30 to 98% hydrophobic phase and up to 50% of a surfactant [0022], wherein the hydrophobic phase includes vegetable oils such as soybean, peanut, sesame, cottonseed, sunflower oils [0026], which reads on component a).
Regarding claims 4-5, Autuori teaches a composition comprises an aqueous phase, 30 to 98% hydrophobic phase and up to 50% of a surfactant [0022], wherein the surfactant includes cholesterol and sugar alcohols such as sorbitol [0024].
Regarding claim 7, Autuori teaches that the composition comprises a biologically active compound such as Goserelin, octreotide acetate (claim 6, 16; [0028, 0030, 0031]), and that such a biologically active agent is in the amount of 1% or 1.5% [0055, 0070].
Claim Rejections - 35 USC § 103 – Maintained and Updated
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 1-5, and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lallemand et al. (WO2012028733A1 – hereinafter “Lallemand”) in view of Autuori et al. (US20030171299A1 – hereinafter “Autuori”), Houchin et al. (US20110212138A1– hereinafter “Houchin”) and Krayukhina et al. (Journal of Pharmaceutical Sciences 109 (2020) 515-523).
Lallemand teaches a sustained release composition that comprises an oil-phase such as vegetable oil (Page 5, line 22-24; page 8, line 11-16) and the vegetable oil includes castor oil, soybean oil (Page 8, line 14-16), mannitol (Page 7, line 1) and a lipophilic surfactant such as cholesterol (Page 8, line 27). Examiner notes that castor oil comprises an unsaturated fatty acid having 14-20 carbon atoms. Lallemand teaches that the composition in an aqueous phase (Abstract). Lallemand teaches that the composition further comprises a therapeutic agent (Page 9, line 14-28). Lallemand teaches that the composition comprises mannitol which reads on sugar alcohol and that the mannitol is in the concentration of 3-5% (Page 14, line 28-29), and that the amount of oil phase in the composition is 50 to 98% (Page 8, line 17-19). Lallemand teaches that the composition comprises a lipophilic surfactant such as cholesterol (Page 8, line 27) and that the lipophilic surfactant is in the amount of 0.1 to less than 50% (Page 9, line 9-11).
Lallemand does not teach wherein the drug is nafamostat, doxycycline, liraglutide, semaglutide, lanreotide or goserelin and does not teach the addition of a stabilizer as recited in claim 8 and does not teach the injection force recited in claim 10.
Autuori teaches a composition that comprises an aqueous phase, 30 to 98% hydrophobic phase and up to 50% of a surfactant [0022], wherein the hydrophobic phase includes vegetable oils such as soybean, peanut, sesame, cottonseed, sunflower oils [0026], and wherein the surfactant includes cholesterol and sugar alcohols such as sorbitol [0024]. Examiner notes that the taught vegetable oils comprise unsaturated fatty acid having 14 to 20 carbon atoms. Autuori teaches that the composition comprises a biologically active compound such as Goserelin, octreotide acetate (claim 6, 16; [0028, 0030, 0031]), and that such a biologically active agent is in the amount of 1% or 1.5% [0055, 0070]. Examiner notes that since Lallemand teaches all the components of the claimed invention, in the instant concentrations, the characteristic of forming liquid crystals would naturally be present when the composition is exposed to an aqueous medium.
Additionally, Examiner notes that the addition of stabilizers in such sustained-release composition is known in the art as taught by Houchin et al.
Houchin teaches a sustained release composition comprising a pharmaceutical ingredient such as exenatide or liraglutide [0047], non-aqueous carrier such as an oil, and that the formulation further comprises sorbitol, maltitol, lactitol, mannitol, xylitol, that the oil includes coconut oil, corn oil, soybean oil, safflower oil etc. (Abstract; [0006-0007, 0025-0029]; claims 119-125). Houchin teaches that the composition comprises butylated hydroxy toluene and sodium metabisulfite ([0035]; and claim 132). Houchin teaches that the composition had the advantage of long shelf life for the stability and potency of the formulation and sustained release of active pharmaceutical ingredients to reduce the frequency of medication dosing and to increase patient compliance (Abstract).
With regards to the injectable force, Examiner notes that Lallemand teaches that the composition has the viscosity from 25 to 500 mPas (Page 11, line 15-20), which is the same as 25 to 500 cP. Further, Kyayukhina teaches that viscosity has an effect on injection force, and specifically that injection of highly concentrated bio pharmaceuticals can lead to exceptionally high injection forces, due to their high viscosity (Abstract), and that the injection forces were linearly proportional to the viscosities (Page 517, left col., last paragraph). Further, Kyayukhina teaches in Fig. 2 that a viscosity of about 600 cP, shows an injection force of about 10 N.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition of Lallemand and include a drug such as lanreotide since Autuori teaches a similar composition with lanreotide as the drug. It would have been obvious to include a stabilizer as taught by Houchin so as aid in the stability of the formulation. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in including a stabilizer such as butylated hydroxy toluene and sodium metabisulfite for the stability and potency of the formulation. Examiner further notes that the cited references hail in the same field of endeavor, i.e. compositions that comprise vegetable oil and cholesterol or sugar alcohol. Further, a reference that teaches the instant active ingredients, at the instant concentrations and having the same viscosity as the instant composition, would necessarily have the same injection force as the instant composition.
Regarding claim 2, Lallemand teaches a sustained release composition that comprises an oil-phase such as vegetable oil (Page 5, line 22-24; page 8, line 11-16) and the vegetable oil includes castor oil, soybean oil (Page 8, line 14-16).
Regarding claim 3, Lallemand teaches that the amount of oil phase (component a)) in the composition is 50 to 98% (Page 8, line 17-19).
Regarding claim 4, Lallemand teaches a sustained release composition that comprises an oil-phase such as vegetable oil (Page 5, line 22-24; page 8, line 11-16) and mannitol (Page 7, line 1).
Regarding claim 5, Lallemand teaches that the composition comprises a lipophilic surfactant such as cholesterol (Page 8, line 27) and that the lipophilic surfactant is in the amount of 0.1 to less than 50% (Page 9, line 9-11).
Regarding claims 6-7, Autuori teaches that the composition comprises a biologically active compound such as Goserelin, octreotide acetate (claim 6, 16; [0028, 0030, 0031]), and that such a biologically active agent is in the amount of 1% or 1.5% [0055, 0070]. It would have been obvious to modify Lallemand and include a biologically active compound such as Goserelin, octreotide acetate.
Regarding claims 8-9, Houchin teaches that the composition comprises excipients such as butylated hydroxy toluene and sodium metabisulfite ([0035]; and claim 132), and that such excipients are in the amount including 0.1 to 5% [0053]. It would have been obvious to modify the composition of Lallemand to include the stabilizers of Houchin.
Regarding claim 10, Lallemand teaches that the composition has the viscosity from 25 to 500 mPas (Page 11, line 15-20), which is the same as 25 to 500 cP. Further, Kyayukhina teaches that viscosity has an effect on injection force, and specifically that injection of highly concentrated bio pharmaceuticals can lead to exceptionally high injection forces, due to their high viscosity (Abstract), and that the injection forces were linearly proportional to the viscosities (Page 517, left col., last paragraph). Further, Kyayukhina teaches in Fig. 2 that a viscosity of about 600 cP, shows an injection force of about 10 N. It would have been obvious to arrive at the injection force given the viscosity that is taught by Lallemand.
Claims 1-5, and 7 are still rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (US20150265535A1 – hereinafter “Yu”) in view of Autuori et al. (US20030171299A1 – hereinafter “Autuori”).
Yu teaches a sustained-release lipid pre-concentrate, comprising: a) at least one liquid crystal former; b) at least one neutral phospholipid; c) at least one liquid crystal hardener; and d) at least one anionic anchoring agent, wherein the sustained-release pre-concentrate forms into a liquid crystal upon exposure to aqueous fluid (Abstract; [0014-0017], wherein the liquid crystal former has a hydrophobic moiety has a triacyl group with 15 to 40 carbon atoms and includes sorbitan unsaturated fatty acid ester which is derived from fatty acids that can be obtained from whale oils and fish oils as well as vegetable oils (e.g., coconut oil, castor oil, olive oil, peanut oil, rapeseed oil, corn oil, sesame oil, cotton seed oil, soybean oil, sunflower seed oil, safflower oil, linseed oil [0020-0022]. Yu teaches that the liquid crystal hardener includes cholesterol (claim 13-14, [0036, 0073]). Yu teaches that the composition comprises at least one cationic pharmacologically active substance such as goserelin, liraglutide [0045-0049].
Yu does not explicitly teach that the sustained-release lipid pre-concentrate comprises vegetable oil. However, such sustained-release lipid pre-concentrate are known to include vegetable oil such as peanut oil as taught by Autuori.
Autuori teaches a composition that comprises an aqueous phase, 30 to 98% hydrophobic phase and up to 50% of a surfactant [0022], wherein the hydrophobic phase includes vegetable oils such as soybean, peanut, sesame, cottonseed, sunflower oils [0026], and wherein the surfactant includes cholesterol and sugar alcohols such as sorbitol [0024]. Examiner notes that the taught vegetable oils comprise unsaturated fatty acid having 14 to 20 carbon atoms. Autuori teaches that the composition comprises a biologically active compound such as Goserelin, octreotide acetate (claim 6, 16; [0028, 0030, 0031]), and that such a biologically active agent is in the amount of 1% or 1.5% [0055, 0070]. Autuori teaches that that formulations for the therapeutical use can be injected without problems or significant side effects and are easily prepared industrially, providing a remarkable technical improvement [0001].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the formulation of Yu and use another hydrophobic phase compound such as vegetable oil as taught by Autuoli since it produces a similar sustained release formulation for use as a carrier for therapeutic active ingredients such as Geserelin [0028]. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using vegetable oil as the hydrophobic phase compound since Autuoli teaches that the formulation can be injected without problems or significant side effects and are easily prepared industrially, providing a remarkable technical improvement [0001]. The disclosures render obvious claim 1.
Regarding claims 2-3, Autuori teaches a composition comprises an aqueous phase, 30 to 98% hydrophobic phase and up to 50% of a surfactant [0022], wherein the hydrophobic phase includes vegetable oils such as soybean, peanut, sesame, cottonseed, sunflower oils [0026]. It would have been to modify the formulation of Yu and use another hydrophobic phase compound such as vegetable oil as taught by Autuoli since it produces a similar sustained release formulation for use as a carrier for therapeutic active ingredients such as Goserelin [0028].
Regarding claims 4-5, Yu teaches that the liquid crystal hardener includes cholesterol (claim 13-14, [0036, 0073]). Further, Autuori teaches a composition comprises an aqueous phase, 30 to 98% hydrophobic phase and up to 50% of a surfactant [0022], wherein the surfactant includes cholesterol and sugar alcohols such as sorbitol [0024].
Regarding claim 6-7, Yu teaches that the composition comprises at least one cationic pharmacologically active substance such as goserelin, liraglutide [0045-0049]. Similarly, Autuori teaches that the composition comprises a biologically active compound such as Goserelin, octreotide acetate (claim 6, 16; [0028, 0030, 0031]), and that such a biologically active agent is in the amount of 1% or 1.5% [0055, 0070]. It would have been obvious to include the pharmacologically active substance such as goserelin in the amounts taught by Autuori.
Response to Arguments
Applicant's arguments filed 08/10/2026 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant argues that Lallemand has nothing to do with and fails to teach lipid pre-concentrates and liquid crystals and that Lallemand fails to teach the use of mannitol to strengthen liquid crystals and fails to teach the drugs recited in claim 1 (claims 7-9 of Arguments).
Applicant argues that the composition of Autuori is formulated as a water-in-oil (w/o) microemulsion and is not a lipid pre-concentrate. Applicant argues that Autuori merely lists vegetable oils, cholesterol, and sugar alcohols each as a possible component alone, but does not provide any example using these components in combination and that none of the examples of Autuori uses a vegetable oil as the oily phase in combination with cholesterol and a sugar alcohol (Page 9-11 of Arguments).
Applicant further argues that Houchin nor Krayukhina remedy the deficiencies of Lallemand and Autuori described above and that Houchin is structurally and technically different from the present invention and is not relevant to the liquid crystalline lipid pre-concentrate of the present invention and that the references do not teach or suggest the sustained-release lipid pre-concentrate of the present invention, which forms a liquid crystalline phase in an aqueous medium (Page 11-12 of Arguments).
Applicant argues that Yu merely lists vegetable oils as one of many possible liquid crystal formers and does not disclose a component corresponding to the sugar alcohol of the present invention (Page 12-13 of Arguments).
Examiner’s Response
The arguments disclosed above have been fully considered but are unpersuasive. With regards to the argument that Lallemand does not teach lipid pre-concentrates and liquid crystals and that Lallemand fails to teach the use of mannitol, Examiner notes that the instant claims are directed to a composition comprising vegetable oil, cholesterol and sugar alcohol and a drug and specific concentrations. Lallemand teaches the same ingredients and the instant concentrations. Thus, the result of forming liquid crystals would naturally flow. Additionally, even though Lallemand teaches the addition of a drug, Lallemand does not teach the instant drug. Examiner combined the Lallemand reference with the Autuori references which similarly teaches the instant ingredients at the instant concentrations and teaches the addition of the instant drugs. One of ordinary skill in the art would be motivated to substitute the drugs of Lallemand with the drugs of Autuori and would have had a reasonable expectation of success.
Regarding the argument that Autuori merely teaches vegetable oil, cholesterol, and sugar alcohols each as a possible component alone, but does not provide any example using these components in combination, Examiner notes that Autuori does not need to provide an example to show all the ingredients in a composition since Autuori teaches that the composition may comprises 30 to 98% hydrophobic phase and up to 50% of a surfactant [0022], wherein the hydrophobic phase includes vegetable oils such as soybean, peanut, sesame, cottonseed, sunflower oils [0026], and wherein the surfactant includes cholesterol and sugar alcohols such as sorbitol [0024]. The instant ingredients are all taught by Autuori and specifically taught in concentrations recited in the instant claims and that the composition comprises the instant drugs. The Autuori reference anticipates the instant claims.
Regarding the arguments of the Houchin nor Krayukhina references, Examiner used the references to teach the addition of a stabilizer and injection force. Specifically, Houchin teaches a composition that comprises the instant excipients and drug, i.e. Houchin teaches a sustained release composition comprising a pharmaceutical ingredient such as exenatide or liraglutide [0047], non-aqueous carrier such as an oil, and that the formulation further comprises sorbitol, maltitol, lactitol, mannitol, xylitol, that the oil includes coconut oil, corn oil, soybean oil, safflower oil etc. (Abstract; [0006-0007, 0025-0029]; claims 119-125). Houchin teaches that the composition comprises the instant stabilizers butylated hydroxy toluene and sodium metabisulfite ([0035]; and claim 132). One of ordinary skill in the art would be motivated to include the stabilizers of Houchin. With regards to the injectable force, Examiner notes that Lallemand teaches that the composition has the viscosity from 25 to 500 mPas (Page 11, line 15-20), which is the same as 25 to 500 cP. Further, Kyayukhina teaches that viscosity has an effect on injection force, and specifically that injection of highly concentrated bio pharmaceuticals can lead to exceptionally high injection forces, due to their high viscosity (Abstract), and that the injection forces were linearly proportional to the viscosities (Page 517, left col., last paragraph). Further, Kyayukhina teaches in Fig. 2 that a viscosity of about 600 cP, shows an injection force of about 10 N. the arguments are unpersuasive.
The arguments regarding the Yu reference are unpersuasive since Yu teaches a composition comprising the instant drugs such as goserelin, liraglutide, cholesterol and the addition of a crystal former and a liquid crystal hardener. Examiner notes that the rejection using the Yu reference is combined with the Autuori reference which teaches the missing limitations of the Yu reference. Applicant is respectfully reminded that the examiner made the obviousness rejection based on the combined teachings of Yu and Autuori. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). All the claimed limitations are taught by the cited references and taught to be combined and included in the concentrations recited in the instant claims. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The arguments are unpersuasive.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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