DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of prior U.S. Patent No. 10,220,113.
This is a statutory double patenting rejection.
Claims 18-20 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 17-19 of prior U.S. Patent No. 10,806,821.
This is a statutory double patenting rejection.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-8 of U.S. Patent No. 9,333,160.
Although the claims at issue are not identical, they are not patentably distinct from each other because the method of the ‘160 claims includes the instantly claimed composition and the lidocaine of the ‘160 claims is an anesthetic agent, and the concentration of lidocaine in the ‘160 claims overlaps the concentrations of lidocaine in the instant claims, and the concentration of ascorbyl-2-glucoside in the ‘160 claims overlaps the concentrations of ascorbyl-2-glucoside in the instant claims, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I), and regarding the claimed concentrations of crosslinked HA, although the ‘160 claims do not recite such concentrations, it would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to optimize the filling effectiveness of the dermal filler by varying the concentration of crosslinked HA therein, through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"). Regarding instant claim 17, such is a recitation of a limitation of the stability property, and given that the composition of the instant claims is substantially the same as the composition of the ‘160 claims, they presumably have the same properties, including the claimed stability property.
Claims 1 and 3-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-8 of U.S. Patent No. 9,655,991.
Although the claims at issue are not identical, they are not patentably distinct from each other because the composition of the ‘991 claims merely includes additional constituents and the concentration ranges overlap, and a prima facie case of obviousness exists where claimed ranges overlap ranges disclosed by the prior art per MPEP 2144.05(I). Regarding the claimed concentrations of crosslinked HA and ascorbyl-2-glucoside, although the ‘991 claims do not recite such concentrations, it would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to optimize the filling effectiveness of the dermal filler by varying the concentration of crosslinked HA and ascorbyl-2-glucoside therein, through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"). Regarding instant claim 17, such is a recitation of a limitation of the stability property, and given that the composition of the instant claims is substantially the same as the composition of the ‘991 claims, they presumably have the same properties, including the claimed stability property.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-10 of U.S. Patent No. 9,855,367.
Although the claims at issue are not identical, they are not patentably distinct from each other because the method of the ‘367 claims includes the instantly claimed composition and the concentration ranges overlap, and a prima facie case of obviousness exists where claimed ranges overlap ranges disclosed by the prior art per MPEP 2144.05(I). Regarding the claimed concentrations of crosslinked HA, although the ‘367 claims do not recite such concentrations, it would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to optimize the filling effectiveness of the dermal filler by varying the concentration of crosslinked HA therein, through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"). Regarding instant claim 17, such is a recitation of a limitation of the stability property, and given that the composition of the instant claims is substantially the same as the composition of the ‘367 claims, they presumably have the same properties, including the claimed stability property.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,449,268.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘268 claims merely recite additional elements and the concentration ranges overlap and a prima facie case of obviousness exists where claimed ranges overlap ranges disclosed by the prior art per MPEP 2144.05(I). Regarding the claimed concentrations of ascorbyl-2-glucoside, although the ‘268 claims do not recite such concentrations, it would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to optimize the filling effectiveness of the dermal filler by varying the concentration of ascorbyl-2-glucoside therein, through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization").
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,806,821.
Although the claims at issue are not identical, they are not patentably distinct from each other because the composition of the ‘821 claims merely includes additional constituents and the concentration ranges overlap, and a prima facie case of obviousness exists where claimed ranges overlap ranges disclosed by the prior art per MPEP 2144.05(I).
Claims 1 and 3-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-13 of U.S. Patent No. 10,994,049 in view of Bergman et al. (US 2007/0059276 A1; published 15 March 2007).
Although the composition recited in the ‘049 claims does not disclose steam sterilization of the dermal filler, Bergman et al. discloses hyaluronate (title) dermal fillers (paragraph [0018]) which are sterilized by steam sterilization (paragraph [0061]). It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to combine the teachings of the ‘049 claims and Bergman et al. by steam sterilizing per Bergman et al. the dermal filler of the ‘049 claims, with a reasonable expectation of success. A person of ordinary skill in the art at the time the invention was made would have been motivated to do so to sterilize the dermal filler as suggested by Bergman et al., thereby reducing chance of infection.
Regarding the claimed concentrations of lidocaine, crosslinked HA, and ascorbyl-2-glucoside, although the ‘049 claims do not recite such concentrations, it would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to optimize the anesthetizing property of the dermal filler by varying the concentration of lidocaine therein, and to optimize the filling effectiveness of the dermal filler by varying the concentrations of crosslinked HA and ascorbyl-2-glucoside therein, through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"). Regarding instant claim 17, such is a recitation of a limitation of the stability property, and given that the composition of the instant claims is substantially the same as the composition of the ‘160 claims in view of Bergman et al. as discussed above, they presumably have the same properties, including the claimed stability property.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hunter et al. (US 2006/0040894 A1; published 23 February 2006) discloses a method for augmenting soft tissue defects such as facial wrinkles with hyaluronidase inhibitor-loaded hyaluronic acid implants (Example 17). Implants comprise hyaluronic acid and a compound that inhibits degradation of hyaluronic acid and thereby enhances the duration, activity, and longevity of implanted hyaluronic acid materials such as cosmetic implants (abstract; paragraphs [0003], [0010], [0177]). Such implants are used in a variety of medical procedures including dermal injections to reduce wrinkles, scars, and contour defects (paragraph [0009]). The hyaluronidase inhibitor or HI which inhibits the degradation of hyaluronic acid may be vitamin C (paragraphs [0011], [0032], [0053], [0112], [0149], [0162], [0175], [0191], [0201], [0208], [0226], [0237], [0243]), and ascorbic acid (i.e., vitamin C) may also be added to the composition as an antioxidant additive (paragraph [0141]). Continuous exposure of target tissue to the HI via controlled release may be preferred, and the compositions can release one or more HIs over a period of several days to months and should preferably be stable for several months (paragraphs [0053], [0119]). The HI may be present in the composition at a concentration of less than about 5% or less than about 2% or less than about 1% (paragraph [0137]). The hyaluronic acid may be cross-linked (paragraph [0031]). The hyaluronic acid may have a concentration of 20 mg/ml (paragraph [0297]). An example of a suitable hyaluronic acid is JUVEDERM (i.e., a. monophasic BODE cross-linked hyaluronic acid gel) (paragraphs [0178], [0314]). The composition may be in gel form (paragraph [0132]). Sterilization of the composition may be by autoclaving (i.e., steam sterilization), such that the HA or HI does not break down (i.e., the formula is stable after sterilization) (paragraph [0142]). Example 17 discloses sterilization of the composition and administration of the composition to a patient by injecting the composition into the skin in a sufficient quantity to treat facial wrinkles without overcorrection.
However, although Hunter et al. discloses vitamin C (ascorbic acid) as a HI, Hunter et al. does not specifically disclose ascorbyl-2-glucoside as a HI, and addition of such ascorbyl-2-glucoside to a dermal filler formulation as instantly claimed produces unexpected results in that it is unexpectedly stable after steam sterilization as compared to formulations containing ascorbic acid and other derivatives thereof as discussed in the instant specification at, for example, Examples 2-6.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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