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 . Claims included in prosecution are claims 1-14.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on 12/28/2023. It is noted, however, that applicant has not filed a certified copy of the IN 202321089566 application as required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
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.
1. Claim(s) 1-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ma et al. (US 2019/0314281, Oct. 17, 2019) (hereinafter Ma).
Ma discloses a novel local anesthetic analgesic sustained-release drug delivery system (Abstract). Suitable drug solvents include inorganic acids, containing N or P, preferably, nitric acid and phosphoric acid (¶ [0009]). Embodiment 2 describes a multivesicular liposome comprising DEPC, cholesterol, DPPG, bupivacaine, nitric acid, and sodium chloride (¶ [0050-0051]). The final product was a suspension (¶ [0061]). The multivesicular liposome is administered via local injection administration (Ref. Claim 16).
Regarding embodiment 2 not comprising phosphoric acid, a reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). See MPEP 2131.02(III). As discussed above, nitric acid and phosphoric acid are specifically taught by Ma to be equivalents used for the same purpose (i.e., preferable drug solvents). As such, one of ordinary skill in the art would ‘at once envisage’ the embodiment of Ma to comprise phosphoric acid instead of nitric acid since they are taught to be equivalents.
Regarding the process steps recited in instant claims 1-6 and 8-13, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.". See MPEP § 2113. Therefore, the process of preparing the multivesicular liposome of the instant claims does not distinguish the compositions from that of the prior art.
Regarding the bupivacaine release rates recited in instant claims 7 and 14, a rejection can be made when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic. See MPEP 2112(II) and (III). Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I). Further, if the composition if physically the same, it must have the same properties. See MPEP 2112.01(II). As discussed above, the product of Ma comprises a substantially identical structure where it is in the form of a multivesicular liposome and a substantially identical composition where it comprises DEPC, cholesterol, DPPG, bupivacaine, phosphoric acid, and sodium chloride as instantly claimed. As such, the composition of Ma would inherently have the same active release rates as the instantly claimed composition.
The prior art anticipates the indicated claims because it discloses an injectable multivesicular liposome comprising DEPC, cholesterol, DPPG, bupivacaine, phosphoric acid, and sodium chloride as instantly claimed.
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.
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.
1. Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (US 2019/0314281, Oct. 17, 2019) (hereinafter Ma).
Ma discloses a novel local anesthetic analgesic sustained-release drug delivery system (Abstract). Suitable drug solvents include inorganic acids, containing N or P, preferably, nitric acid and phosphoric acid (¶ [0009]). Embodiment 2 describes a multivesicular liposome comprising DEPC, cholesterol, DPPG, bupivacaine, nitric acid, and sodium chloride (¶ [0050-0051]). The final product was a suspension (¶ [0061]). The multivesicular liposome is administered via local injection administration (Ref. Claim 16).
It is believed that Ma anticipates the instant claims. However, purely arguendo, and for the purposes of this rejection, Ma differs from the instant claims insofar as not explicitly an embodiment also comprising phosphoric acid.
Regarding embodiment 2 not comprising phosphoric acid, as required by claims 1-7, it is obvious to replace one component for another equivalent component if it is recognized in the art that the two components are equivalent and is not based on the Applicant disclosure. See MPEP 2144.06. Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the embodiment of Ma to comprise phosphoric acid instead of nitric acid since they are taught to be equivalents by Ma.
Regarding the process steps recited in instant claims 1-6, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.". "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. See MPEP § 2113. Therefore, the process of preparing the multivesicular liposome of the instant claims does not distinguish the compositions from that of the prior art.
Regarding the bupivacaine release rates recited in instant claims 7, a rejection can be made when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic. See MPEP 2112(II) and (III). Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I). Further, if the composition if physically the same, it must have the same properties. See MPEP 2112.01(II). As discussed above, the product of Ma comprises a substantially identical structure where it is in the form of a multivesicular liposome and a substantially identical composition where it comprises DEPC, cholesterol, DPPG, bupivacaine, phosphoric acid, and sodium chloride as instantly claimed. As such, it would be reasonable for one of ordinary skill in the art to conclude that the composition of Ma would have the same active release rates as the instantly claimed composition.
Therefore, the teachings of Ma render obvious claims 1-7.
2. Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (US 11,033,495, Jun. 15, 2021) (hereinafter Hall).
Hall discloses bupivacaine multivesicular liposomes (MVLs) (Abstract). In some embodiments, the composition of bupivacaine MVLs comprises DEPC, DPPG, cholesterol and tricaprylin (col 14, line 64-66). Phosphoric acid resides inside the internal aqueous chambers of the MVL particles (col 16, line 23-24). Effective injectable bupivacaine MVLs compositions is in a liquid suspension form. Such injectable suspension compositions require a liquid suspending medium such as sodium chloride (col 19, line 56-61).
Hall differs from the instant claims insofar as not disclosing all the specific process steps disclosed.
However, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.". "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product. See MPEP § 2113. Therefore, the process of preparing the multivesicular liposome of the instant claims does not distinguish the compositions from that of the prior art.
Regarding the bupivacaine release rates recited in instant claims 7 and 14, a rejection can be made when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic. See MPEP 2112(II) and (III). Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I). Further, if the composition if physically the same, it must have the same properties. See MPEP 2112.01(II). As discussed above, the product of Hall comprises a substantially identical structure where it is in the form of a multivesicular liposome and a substantially identical composition where it comprises DEPC, cholesterol, DPPG, bupivacaine, phosphoric acid, and sodium chloride as instantly claimed. As such, it would be reasonable for one of ordinary skill in the art to conclude that the composition of Hall would have the same active release rates as the instantly claimed composition.
Therefore, the teachings of Hall render obvious claims 1-14.
Conclusion
Claims 1-14 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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