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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/JP2022/023486 filed 06/10/2022, which claims the benefit of the priority of Japan Patent Application No. 2021-098061 filed 06/11/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1 and 9 are amended. Claims 1-10 are being examined on the merits in this office action.
Claim Objections
The objection of claim 9 is withdrawn in view of the claim amendment.
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 “a physiological substance” in claim 10. The instant specification defines “a physiological substance” includes compounds such as “levodopa, cyclosporine A, docetaxel, paclitaxel, capecitabine, oxaliplatin, geftinat, doxorubicin, irinotecan, gemcitabine, pemetrexed, temozolomide, imatinib, vinorelbine, letrozole, teniposide etc.” (See specification [0026]. Examiner notes that compositions that comprise any of the substances listed in [0026] of the instant specification, would thus read on “a physiological substance”.
Additionally, the instant claims recite “..a light transmittance of a water phase at 660 nm…”. Examiner notes that the limitation recites an intended or expected result of the claimed preparation. A reference that teaches the claimed preparation in the recited concentrations would display the recited light transmittance.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (US20170189532A1 – hereinafter “Chen”).
Regarding claim 1, Chen teaches a gel composition that comprises about 20% to about 60% by weight of a phospholipid, 1% to 50% by weight of an oil, wherein the phospholipid is a member selected from the group consisting of a lecithin, phosphatidylcholine or a mixture thereof (claim 1), wherein the content of the phospholipid may be 20 to 80% [0025], and that the term oil includes fatty acid [0066], and specifically, that the oil used in the present invention is oleic acid and that the concentration is 1 to 50%, preferably 2 to 20% and more preferably 5 to 10% of the PG weight, such as 5%, 6%, 7%, 8%, 9% or 10% [0105]. Examiner notes that from the concentration disclosed in the above teachings, the total mass of components a and b (phospholipids and fatty acid) is 60 to 100% and that the mass ratio of falls between 0.5 to 3.0 (for instance if fatty acid is 50% and phospholipid is 60% results in a ratio of 0.8). Chen teaches that the concentration of other lipids such as cholesterol in the amount of 0.6% (See Example 1 and 2 on [0208 and 0221]). Examiner notes that the concentration reads on the instant recitation of 30% or less. Additionally, Chen teaches the amount of water is at least 70-80% [0182]. Chen teaches that the composition is a gel composition, that the phospholipid is mixed with an excessive amount of water [0028-0029, 0033-0034]. With the regards to the limitation of “a light transmittance of a water phase at 660 nm…” Examiner notes that this limitation recites an expected result of the claimed composition. Examiner notes that Chen teaches all the components of the claimed preparation in the claimed concentrations. Chen teaches that the composition is a gel composition, that the phospholipid is mixed with an excessive amount of water [0028-0029, 0033-0034]. Thus, the limitation of “a light transmittance of a water phase at 660 nm…” is a property that would naturally flow. Further, MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the composition of claim 1 and is given little patentable weight. Examiner notes that even though Chen teaches that the composition is a gel, Chen teaches that the composition is a liquid [0188-0189, 0193-0195] and that it is after the excess water removal that the composition is a gel [0165]. The teachings of Chen anticipate claim 1.
Regarding claims 2-3, Chen teaches a composition that comprises about 20% to about 60% by weight of a phospholipid, 1% to 50% by weight of an oil, wherein the phospholipid is a member selected from the group consisting of a lecithin, phosphatidylcholine or a mixture thereof (claim 1), and that the term oil includes fatty acid [0066], and specifically, that the oil used in the present invention is oleic acid [0105]. Examiner notes that it is known in the art that oleic acid comprises 18 carbon atoms.
Regarding claim 4, Chen teaches a composition that comprises about 20% to about 60% by weight of a phospholipid, 1% to 50% by weight of an oil, wherein the phospholipid is a member selected from the group consisting of a lecithin, phosphatidylcholine or a mixture thereof (claim 1).
Regarding claim 5, Chen teaches that the composition comprises 20 to 80% phospholipids such as phosphocholines [0076-0079].
Regarding claim 6, Chen teaches a composition that comprises about 20% to about 60% by weight of a phospholipid, 1% to 50% by weight of an oil, wherein the phospholipid is a member selected from the group consisting of a lecithin, phosphatidylcholine or a mixture thereof (claim 1), wherein the content of the phospholipid may be 20 to 80% [0025], and that the term oil includes fatty acid [0066], and specifically, that the oil used in the present invention is oleic acid and that the concentration is 1 to 50%, preferably 2 to 20% and more preferably 5 to 10% of the PG weight, such as 5%, 6%, 7%, 8%, 9% or 10% [0105]. Examiner notes that from the concentration disclosed in the above teachings, the total mass of components a and b (phospholipids and fatty acid) is 60 to 100% and that the mass ratio of falls between 0.5 to 3.0 (for instance if fatty acid is 50% and phospholipid is 60% results in a ratio of 0.8).
Regarding claim 7, Chen teaches that the concentration of other lipids such as cholesterol in the amount of 0.6% (See Example 1 and 2 on [0208 and 0221]) which reads on less than 20%.
Regarding claim 8, Chen teaches that the composition comprises a solvent, that the preferred solvent is ethanol and the preferred concentration is preferably 1 to 15% and more preferably 2 to 10% such as 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9% or 10% [0108].
Regarding claim 9, Examiner notes that this limitation recites an expected result of the claimed composition. Examiner notes that this limitation recites an expected result of the claimed composition. Examiner notes that Chen teaches all the components of the claimed preparation in the claimed concentrations. Chen teaches that the composition is a gel composition, that the phospholipid is mixed with an excessive amount of water [0028-0029, 0033-0034]. Thus, the limitation of “a light transmittance of a water phase at 660 nm…” is a property that would naturally flow. Further, MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the composition of claim 1 and is given little patentable weight.
Regarding claim 10, Chen teaches that the composition comprises a biological drug and that the biological drugs include, but are not limited to, insulin, interferon, growth hormone, calcitonin, parathiroid hormone, exernatide, pramlintide, heparin, granulocyte colony-stimulating factor (G-CSF), epoetin, adalimumab, trastuzumab [0125-0128].
Response to Arguments
Applicant's arguments filed 08/17/2026 have been fully considered but they are not persuasive.
Applicant argues that the Chen teaches that the composition is gel and that the instant composition is a powder or liquid.
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that even though Chen teaches that the composition is a gel, Chen teaches that the composition is a gel when excess water is removed. Chen further teaches that the composition is also a liquid [0188-0189, 0193-0195] and that it is after the excess water removal that the composition is a gel [0165].
Double Patenting – Maintained and Updated
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. US11571385B2 in view of Amano (EP3626271 A1 – hereinafter “Amano”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite a composition comprising a monoacyl phospholipid, a diacyl phospholipid, oils and fats, a polyhydric alcohol, wherein: the content ratio between the monoacyl phospholipid and the diacyl phospholipid is in the range of monoacyl phospholipid:diacyl phospholipid=1:9 to 9:1 as a mass ratio, when the total content of the monoacyl phospholipid and the diacyl phospholipid is designated as x % by mass, the content of the oils and fats is designated as y % by mass, and the content of the polyhydric alcohol is designated as z % by mass, with respect to 100% by mass of the total content of the monoacyl phospholipid, the diacyl phospholipid, the oils and fats, and the polyhydric alcohol, x, y, and z are within a region surrounded by a triangle having the following points A, B, and C in a triangular diagram (x, y, z) as apexes: A: (x, y, z)=(0.1, 0.1, 99.8), B: (x, y, z)=(65.0, 0.1, 34.9), C: (x, y, z)=(45.0, 40.0, 15.0) (claim 1, 8-9), wherein the total content of the monoacyl phospholipid and the diacyl phospholipid is from 0.1% by mass to 70% by mass (claim 4), wherein the oils and fats include medium-chain fatty acids (claim 5), wherein the content of the oils and fats satisfies the requirement of being from 0.1% by mass to 35% by mass based on the total amount of the composition, or being from 0.1 part by mass to 70 parts by mass with respect to 100 parts by mass of the total content of the monoacyl phospholipid and the diacyl phospholipid (claim 6). The claims of the patent recite that the composition is mixed with water (claim 3) thus forming a liquid.
The instant claims recite a preparation comprising:(a) a fatty acid, and (b) a phospholipid, wherein a mass ratio [(a)/(b)] of a content of the component (a) to a content of the component (b) is 0.5 to 3.0, a total content of the components (a) and (b) is 60 to 100 mass% based on a total amount of the preparation, a content of lipids other than the components (a) and (b) is 30 mass% or less based on a total mass of the preparation, a content of an organic solvent is 30 mass% or less based on the total mass of the preparation, a light transmittance of a water phase at 660 nm when the preparation has been mixed with water 100 times larger than the preparation in volume is 80% or more, and contact with moisture makes it possible to form an oil gel (claim 1).
The difference between the claims of the patent and instant claims is that the claims of the patent do not recite the content of the organic solvent.
However, such compositions are known to include organic solvents such as ethanol as taught by Amano. Amano teaches a composition that comprises a monoacyl phospholipid, a diacyl phospholipid, oils and fats, and a polyhydric alcohol, wherein the total content of the monoacyl phospholipid and the diacyl phospholipid is from 0.1% by mass to 70% by mass, wherein the oils and fats include medium-chain fatty acids, wherein the content of ethanol is 15% by mass or less [0009, 0038].
It would have been obvious to one of ordinary skill in the art to modify the claims of the patent and use the organic solvent such as ethanol in order to completely dissolve the phospholipid. One of ordinary skill in the art would have had a reasonable expectation of success in using an organic solvent such as ethanol so as to be able to dissolve the phospholipid. With the regards to the limitation of “a light transmittance of a water phase at 660 nm…” Examiner notes that this limitation recites an expected result of the claimed composition. Examiner notes that the claims of the patent in view of Amano render obvious the instant claims. Thus, the limitation of “a light transmittance of a water phase at 660 nm…” would naturally flow. Further, MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitation expresses the intended result of the composition of claim 1 and is given little patentable weight. The claims of the patent render obvious the instant claims.
Regarding claims 2-3, the Amano teaches using monocapric acid in the composition, which is known to have ten carbon atoms (See Table 4 in [0070]). It would have been obvious to modify
Regarding claim 4, the claims of the patent recite that the composition comprising a monoacyl phospholipid, a diacyl phospholipid (claim 1). The claims of the patent do not recite examples of the recited phospholipid. However, Amano teaches that examples of the monoacyl phospholipid include lysophosphatidic acid, lysophosphatidylcholine [0021]. It would have been obvious to modify the claims of the patent and specifically include lysophosphatidylcholine as the monoacyl phospholipid.
Regarding claim 5, the claims of the patent recite a composition comprising a monoacyl phospholipid, a diacyl phospholipid, oils and fats, a polyhydric alcohol, wherein: the content ratio between the monoacyl phospholipid and the diacyl phospholipid is in the range of monoacyl phospholipid:diacyl phospholipid=1:9 to 9:1 as a mass ratio (claim 1). Examiner notes that phosphatidylcholine is an example of a monoacyl phospholipid. Further, Examiner is interpreting the ratio to be 10 and 90% or parts, which would read on 80 parts or more.
Regarding claim 6, the claims of the patent recite wherein the total content of the monoacyl phospholipid and the diacyl phospholipid is from 0.1% by mass to 70% by mass (claim 4), wherein the oils and fats include medium-chain fatty acids (claim 5), wherein the content of the oils and fats satisfies the requirement of being from 0.1% by mass to 35% by mass (claim 1). Examiner notes that taking 35% fatty acid divided by 35% phospholipid gives a ratio of 1.
Regarding claim 8, Amano teaches a composition that comprises a monoacyl phospholipid, a diacyl phospholipid, oils and fats, and a polyhydric alcohol, wherein the total content of the monoacyl phospholipid and the diacyl phospholipid is from 0.1% by mass to 70% by mass, wherein the oils and fats include medium-chain fatty acids, wherein the content of ethanol is 15% by mass or less [0009, 0038]. It would have been obvious to one of ordinary skill in the art to modify the claims of the patent and use the organic solvent such as ethanol in order to completely dissolve the phospholipid.
Regarding claim 10, the claims of the patent recite that the composition comprises a sparingly soluble substance (claim 1).
Response to Arguments
Applicant's arguments filed 08/17/2026 have been fully considered but they are not persuasive.
Applicant argues that the amount of polyhydric alcohol corresponding to the organic solvent is at minimum 44.4% organic solvent and that the claim has been amended to recite total content of organic solvent is 20% or less. Applicant argues that composition disclosed in Amano is a self-emulsifying composition.
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that the claims of the patent recite that the polyhydric alcohol which applicant claims is the organic solvent, can also be in the amount of 15% (see claim 1), which falls within the recitation of 30% or less. Additionally, the composition of mano includes mixing with water which suggests that the composition is a liquid. The arguments are unpersuasive, and the rejection is maintained.
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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