DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-3 and 5-12 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 07/28/2025 has been entered.
Claim 4 was canceled. Claims 1 and 5-7 were amended.
Applicant’s amendments have overcome the previous rejection of claim 7 under 35 U.S.C. 112(b), and the objections to the specification and drawings.
The rejection of claim 4 is moot.
The rejection of claims 1-3 and 5-12 under 35 U.S.C. 103 has been modified and maintained to address the amendment.
The amended claims 1 and 5-7 are newly rejected under 35 U.S.C. 112(a).
New 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 and 5-12 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 new limitation of “a saturated phospholipid” in claims 1 and 5-7 is not supported in the disclosure and is considered to be new matter. Claims 2-3 and 8-12 are also rejected in view of their dependency on claim 1.
Response to Arguments
Applicant's arguments filed 07/28/2025 have been fully considered but they are not persuasive.
Applicant argues that Liu does not unambiguously disclose or suggest the use of saturated phospholipids as stated in the amended claim 1 (Remarks, page 9, 4th paragraph). This argument is not persuasive, because Liu teaches the phospholipid can be saturated (Liu, page 8, lines 17-18) and specifically cites DSPC as an example phospholipid (Liu, page 8, line 21), which is a saturated, synthetic phospholipid as defined by the amended claim 7.
Applicant argues that the claimed subject matter does not only focus on the creation of a liposome containing the reducing agent, but also to the complex comprising said liposome that is immersed in the solution containing this reducing agent, and states the produced mouthwash leads to a much quicker and efficient whitening (Remarks, page 9, 5th paragraph). This argument is not persuasive, because Liu teaches a step of hydrating with a phosphate buffered saline solution (i.e., adding an aqueous solution as claimed; Liu, page 26, line 19) to obtain a liposome solution (i.e., a composition comprising liposomes, “step 3b”; Liu, page 27, line 6). Liu teaches the composition comprises at least one pharmaceutically acceptable carrier (Liu, claim 19), which can be sodium metabisulfite (i.e., a reducing agent; Liu, page 18, line 31), and further teaches carriers are preferably aqueous solutions such as saline (Liu, page 19, line 7), suggesting the metabisulfite reducing agent would be present at the hydrating step.
Applicant argues that even if the combination of Liu and Carlsson produces liposomes of small size, the liposomes are clearly distinguishable from the composition of the instant claims because the claimed liposomes are submerged in the same encapsulated reducing agent solution (Remarks, page 10, 1st paragraph). This argument is not persuasive, for the same reason as above. The Examiner also notes that there is no limitation stated the liposomes are “submerged” in the solution, as emphasized in the Remarks.
Applicant argues that Liu and Faler fail to disclose or suggest a product with the presence of small liposomes submerged in the same encapsulated reducing agent solution (Remarks, page 10, 3rd paragraph). This argument is not persuasive, for the same reason as above. The Examiner also notes that there is no limitation stated the liposomes are “submerged” in the solution, as emphasized in the Remarks.
Maintained/Modified Claim Rejections - 35 USC § 103
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.
Claims 1-2, 5-9, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO 2011097563 A1) as evidenced by Supreme Pharmatech. References were previously cited by the Examiner.
Regarding claim 1, Liu teaches the preparation of liposomes (Liu, page 26, line 6) comprising dissolving (i.e., mixing) phosphatidylcholine (i.e., a membrane-forming lipid; Liu, page 26, line 8) in dichloromethane/methanol (i.e., an organic solvent, “step 1”; Liu, page 26, line 15) to form a lipid solution (i.e., a mixture; Liu, page 26, line 15), then drying by evaporation (i.e., removing the organic solvent; Liu, page 26, line 16) to form a thin lipid film (i.e., a layer of the membrane-forming lipid) on the wall of the flask (i.e., inner surface of the vessel, “step 2b”; Liu, page 26, line 19), then hydrating with a phosphate buffered saline solution (i.e., adding an aqueous solution; Liu, page 26, line 19) to obtain a liposome solution (i.e., a composition comprising liposomes, “step 3b”; Liu, page 27, line 6). Liu teaches the phospholipid can be saturated (Liu, page 8, lines 17-18), and further teaches the composition can be used as a tooth whitening agent (Liu, page 16, line 23). Liu teaches the composition comprises at least one pharmaceutically acceptable carrier (Liu, claim 19), the carrier can be sodium metabisulfite (i.e., a reducing agent; Liu, page 18, line 31), and carriers are preferably aqueous solutions such as saline (Liu, page 19, line 7). Liu is considered to be analogous to the claimed invention, because both are in the same field of methods for preparing liposome compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Liu to have included sodium metabisulfite as a carrier along with the phosphate buffered saline, thereby arriving at the claimed method.
Regarding claim 2, Liu teaches all the elements of the current invention as applied to claim 1. As above, Liu teaches an organic solvent which is a mixture of dichloromethane and methanol (Liu, page 26, line 15).
Regarding claim 5, Liu teaches all the elements of the current invention as applied to claim 4. As above, Liu teaches egg phosphatidylcholine (i.e., a natural phospholipid; Liu, page 26, line 8; claim 11).
Regarding claim 6, Liu teaches all the elements of the current invention as applied to claim 5. As above, Liu teaches phosphatidylcholine (Liu, page 26, line 8; claim 11).
Regarding claim 7, Liu teaches all the elements of the current invention as applied to claim 5. Liu teaches the liposome can comprise a phospholipid which is DSPC (i.e., a synthetic, saturated phospholipid from the claimed list; Liu, page 8, line 21).
Regarding claim 8, Liu teaches all the elements of the current invention as applied to claim 1. Liu teaches 50 mg of phosphatidylcholine (i.e., a membrane-forming lipid; Liu, page 26, line 8) in 4 mL of dichloromethane/methanol (i.e., an organic solvent, “step 1”; Liu, page 26, line 15). Phosphatidylcholine has a molecular weight of 786.1 g/mol, as evidenced by Supreme Pharmatech, which results in a concentration of 16 mM, falling within the claimed range of 1-100 mM.
Regarding claim 9, Liu teaches all the elements of the current invention as applied to claim 1. Liu teaches the composition comprises at least one pharmaceutically acceptable carrier (Liu, claim 19) and that the carrier can be sodium metabisulfite (i.e., a reducing agent, an alkaline metal salt of metabisulfite; Liu, page 18, line 31).
Regarding claim 11, Liu teaches all the elements of the current invention as applied to claim 1. Liu teaches the phosphate buffered saline solution (i.e., the aqueous solution) has a pH of 7.4 (Liu, page 26, line 19), which lies within the claimed range of 2-8.
Regarding claim 12, Liu teaches all the elements of the current invention as applied to claim 1. As above, Liu teaches the composition comprises at least one pharmaceutically acceptable carrier (Liu, claim 19), the carrier can be sodium metabisulfite (i.e., a reducing agent; Liu, page 18, line 31), and carriers are preferably aqueous solutions (Liu, page 19, line 7). Liu also teaches phosphate buffered saline solution (i.e., the aqueous solution is a buffer system; Liu, page 26, line 19).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO 2011097563 A1) as applied to claims 1-2, 5-9, and 11-12, further in view of Carlsson (WO 2005107711 A3). References were previously cited by the Examiner.
Regarding claim 3, Liu teaches all the elements of the current invention as applied to claim 1. Liu teaches preparation of liposomes to comprise sonication (i.e., a mechanical treatment; Liu, page 26, line 5), but does not specify that the size of the liposomes is reduced via this process. Carlsson teaches a pharmaceutically acceptable liposome composition (Carlsson, claim 1) and a method for preparation (Carlsson, page 17, line 15) comprising ultrasonication to reduce particle size (Carlsson, page 18, line 8). Liu and Carlsson are considered to be analogous to the claimed invention, because all are in the same field of methods for preparing liposome compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method taught by Liu to include ultrasonication as the specific method of sonication in order to reduce particle size as taught by Carlsson (Carlsson, page 18, line 8), because Carlsson teaches smaller liposomes are more physically stable (Carlsson, page 14, line 29).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO 2011097563 A1) as applied to claims 1-2, 5-9, and 11-12, further in view of Faler (US 20080112909 A1) and as evidenced by PubChem. References were previously cited by the Examiner.
Regarding claim 10, Liu teaches all the elements of the current invention as applied to claim 1. Liu teaches the carrier can be sodium metabisulfite (i.e., a reducing agent; Liu, page 18, line 31) and carriers are preferably aqueous solutions (Liu, page 19, line 7), but does not specify a concentration of the reducing agent. Faler teaches a liposome comprising an aqueous solution with a total of 2713.2 g of deionized water and 8.18 g of sodium metabisulfite (Faler, example 3, paragraph 0162). Sodium metabisulfite has a molecular weight of 190.1 g/mol, as evidenced by PubChem, which results in a concentration of 0.016 M, falling within the claimed range of 0.01-0.5 M. Liu and Faler are considered to be analogous to the claimed invention, because all are in the same field of methods for preparing liposome compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method taught by Liu to include specific amount of sodium metabisulfite taught by Faler (Faler, example 3, paragraph 0162), because while Liu does not teach a specific amount, Liu teaches pharmaceutically acceptable amounts should be used (Liu, page 18, line 24) and Faler teaches sodium metabisulfite can act as a preservative (Faler, page 13, paragraph 0132) in cosmetic or pharmaceutical compositions (Faler, page 2, paragraph 0017), suggesting the stated amount is pharmaceutically acceptable.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613