DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 7/31/2026 have been received and entered into the case. Claims 2, 8 and 16 have been canceled, Claims 21-23 have been added. Claims 1, 3-7, 9-15, and 17-23 are pending, Claims 6, 10-15 and 17-20 have been withdrawn, and Claims 1, 3-5, 7, 9, and 21-23 have been considered on the merits, insofar as they read on the elected species of 500 to 1000 units, and a dynamic viscosity of from 1.5 to 4 Pa*s when determined at 25℃ using an oscillation frequency of 1 Hz. All arguments have been fully considered.
Withdrawn Rejections
Rejections of Claims 1-2, 4 and 7 under 35 U.S.C. 103 as being unpatentable over Tezel et al (US 2009/0155314 A1; 6/18/2009. Cited on IDS) are withdrawn in view of applicant’s amendments.
Rejections of Claim 3 under 35 U.S.C. 103 as being unpatentable over Tezel et al (US 2009/0155314 A1; 6/18/2009. Cited on IDS) in view of Callegaro et al (US 6,020,484; 2/1/2000.) are withdrawn in view of applicant’s amendments.
Rejections of Claim 5 under 35 U.S.C. 103 as being unpatentable over Tezel et al (US 2009/0155314 A1; 6/18/2009. Cited on IDS) in view of Williams et al (International Journal of Biomaterials. 2013;2013:1-8.) are withdrawn in view of applicant’s amendments.
Rejections of Claim 9 under 35 U.S.C. 103 as being unpatentable over Tezel et al (US 2009/0155314 A1; 6/18/2009. Cited on IDS) in view of Petrella (US 2010/0172940 A1; 7/8/2010. Cited on IDS) are withdrawn in view of applicant’s amendments.
Rejections under nonstatutory double patenting are withdrawn in view of applicant’s amendments.
Claim Rejections - 35 USC § 112
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 7 and 23 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 pre-AIA the applicant regards as the invention.
Claim 7, line 1-2, the recitation of “the amount of botulinum neurotoxin” is indefinite as it is unclear whether the term “botulinum neurotoxin” refers to the botulinum neurotoxin type A complex or the neurotoxin component?
Claim 23, line 1, the recitation of “the botulinum neurotoxin type A” is indefinite as it is unclear whether the term refers to the botulinum neurotoxin type A complex or the neurotoxin component?
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-5, 7, 9, and 21-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is directed to a composition comprising purified or recombinant botulinum neurotoxin type A complex consisting of a neurotoxin component having a molecular weight of approximately 150 kDa and which can be split into a light chain and a heavy chain, and non-crosslinked hyaluronic acid, wherein the composition is a sterilized composition, and total hyaluronic acid in the composition has an average molecular weight of 2.5 MDa to 4.5 MDa. The claimed botulinum neurotoxin type A complex consisting of a neurotoxin component having a molecular weight of approximately 150 kDa and which can be split into a light chain and a heavy chain is naturally occurring (see para 0016 of Tezel. US 2009/0155314 A1; 6/18/2009. Cited on IDS), and the claimed non-crosslinked hyaluronic acid is naturally occurring. There is no indication in the instant specification that the claimed botulinum neurotoxin type A complex and the claimed non-crosslinked hyaluronic acid have any characteristics that are different from the naturally occurring botulinum neurotoxin type A complex and hyaluronic acid. Claim 1 also recite the composition is a sterilized composition. However, the optimized sterilization condition does not affect the material properties of botulinum neurotoxin type A complex and hyaluronic acid. Thus, the claimed botulinum neurotoxin type A complex and the claimed non-crosslinked hyaluronic acid do not have markedly different characteristics from their natural counterpart in their natural state, and are “product of nature” exception. Accordingly, claim 1 is directed to an exception. Therefore, claim 1 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claims 3, 5, 7, and 9 recite limitations regarding polydispersity index of the hyaluronic acid, dynamic viscosity of the composition, an amount of the botulinum neurotoxin, and an amount of the hyaluronic acid, respectively. These limitations do not result in botulinum neurotoxin and hyaluronic acid that are different from the naturally occurring botulinum neurotoxin and hyaluronic acid, and do not add significantly more to the exception. Therefore, claims 3, 5, 7, and 9 do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 4 recites an additional component, wherein the component can be a salt. A salt is naturally occurring. There is no indication in the instant specification that the claimed salt has any characteristics that are different from the naturally occurring salt. Thus, the claimed salt does not have markedly different characteristics from its natural counterpart in its natural state. Accordingly, claim 4 is directed to an exception. Therefore, claim 4 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 21 recites molecular weight of the botulinum neurotoxin type A complex. A botulinum neurotoxin type A complex produced by Clostridial bacterium has the claimed molecular weight (see para 0016 of Tezel. US 2009/0155314 A1; 6/18/2009. Cited on IDS). There is no indication in the instant specification that a botulinum neurotoxin type A complex having the claimed molecular weight has any characteristics that are different from the naturally occurring botulinum neurotoxin type A complex. Thus, the botulinum neurotoxin type A complex having the claimed molecular weight does not have markedly different characteristics from its natural counterpart in its natural state. Accordingly, claim 21 is directed to an exception. Therefore, claim 21 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 22 recites the composition comprises one or more haemagglutinin proteins. A botulinum neurotoxin type A complex consisting of botulinum neurotoxin type A and haemagglutinins is the native form of the toxin secreted by Clostridial bacterium (see p.2718 col left – para 2 of Zhou et al. FEBS Journal. 2005;272:2717-2726.). There is no indication in the instant specification that the one or more haemagglutinin proteins has any characteristics that are different from the naturally occurring haemagglutinin proteins. Thus, the one or more haemagglutinin proteins does not have markedly different characteristics from its natural counterpart in its natural state. Accordingly, claim 22 is directed to an exception. Therefore, claim 22 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim 23 recites the source and preparation steps of obtaining the botulinum neurotoxin type A. There is no indication in the instant specification that the botulinum neurotoxin type A obtained as claimed has any characteristics that are different from the naturally occurring botulinum neurotoxin type A. Thus, the botulinum neurotoxin type A obtained as claimed does not have markedly different characteristics from its natural counterpart in its natural state. Accordingly, claim 23 is directed to an exception. Therefore, claim 23 does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
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 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 of this title, 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.
Claims 1, 4, 7, 9, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (WO 2015/020982 A2; 2/12/2015.) in view of Tezel et al (US 2009/0155314 A1; 6/18/2009. Cited on IDS) and Zhou et al (FEBS Journal. 2005;272:2717-2726.).
The instant claims recite a composition comprising: a) purified or recombinant botulinum neurotoxin type A complex consisting of: i) a neurotoxin component having a molecular weight of approximately 150 kDa and which can be split into a light chain and a heavy chain; and optionally ii) one or more coat proteins, wherein the purified or recombinant botulinum neurotoxin type A complex has a molecular weight less than 900 kDa; and b) hyaluronic acid, wherein the hyaluronic acid in the composition consists of non- crosslinked hyaluronic acid and the composition does not contain crosslinked hyaluronic acid, wherein said composition is a sterilized composition, and wherein total hyaluronic acid in the composition has an average molecular weight of 2.5 MDa to 4.5 MDa.
Chang teaches a composition comprising a neurotoxin, hyaluronic acid, or a combination thereof, wherein the neurotoxin is botulinum toxin type A and the hyaluronic acid is cross-linked hyaluronic acid, non-cross-linked hyaluronic acid or a combination thereof (para 0061, 00112). The composition is sterilized (para 00214). Hyaluronic acid may be included in the composition in an amount of from about 2.4 mg/ml to about 12 mg/ml (para 00197), and botulinum toxin may be included in the composition in any amount as considered necessary to achieve the aesthetic goals set by the patient and doctor (para 00198). The composition can be prepared by dissolving these components in an aqueous buffer (para 00201).
Chang does not teach the botulinum neurotoxin type A complex consist of a neurotoxin component having a molecular weight of approximately 150 kDa and which can be split into a light chain and a heavy chain, and optionally one or more coat proteins, wherein the botulinum neurotoxin type A complex has a molecular weight less than 900 kDa (claims 1 and 21), wherein the one or more coat proteins are one or more haemagglutinin proteins (claim 22), and the botulinum neurotoxin type A is obtained from cultures of Clostridium botulinum (claim 23). However, before the effective filing date of the claimed invention, it was well-known in the art that a botulinum neurotoxin type A complex has the claimed properties, as evidenced by Tezel and Zhou. In support, Tezel teaches a composition which has a longer duration wrinkle alleviating effect (para 0021), comprising botulinum toxin (para 0044), wherein the botulinum toxin is botulinum neurotoxin type A as either pure toxin, about 150 kDa molecular weight neurotoxic component, or as a botulinum toxin complex, about 300 to about 900 kDa molecular weight, e.g., 500 kDa and 300 kDa, produced by Clostridium botulinum (para 0016, 0025). In addition, Zhou teaches botulinum neurotoxin A is a single polypeptide chain of about 150 kDa, which is cleaved endogenously or exogenously resulting in a 100 kDa heavy chain and a 50 kDa light chain (p.2717 col left – para 2), wherein botulinum neurotoxin A complex consist of botulinum neurotoxin A and hemagglutinins (coat proteins), is the native form of the toxin secreted by Clostridium botulinum (p.2718 col left – para 2-3).
Chang does not teach the composition wherein total hyaluronic acid in the composition has an average molecular weight of 2.5 MDa to 4.5 MDa (claim 1), and the amount of botulinum neurotoxin in the composition is 500 to 1000 units (claim 7).
However, Chang does teach the composition comprises botulinum toxin type A and hyaluronic acid, wherein the composition alleviates fine lines and wrinkles, and improves skin quality, clarity, elasticity, firmness, tone, vitality, and overall skin health (para 0007, 00183). Tezel teaches a composition which has a longer duration wrinkle alleviating effect (para 0021), comprising botulinum toxin (para 0044) and hyaluronic acid, such as a non-cross linked hyaluronic acid or a cross linked hyaluronic acid, or a mixture thereof, wherein the molecular weight of the hyaluronic acid is between about 10,000 Daltons and about 20 million Daltons (about 0.01 MDa – about 20 MDa) (para 0036), or about 2 million Daltons (about 2 MDa) (para 0065). Table 1 demonstrates a composition comprises 1000 units of botulinum toxin type A, 2.5% w/v of sodium hyaluronate, and sodium chloride (a salt). Tezel teaches increasing the molecular weight of the hyaluronic acid used in the composition results in a longer tissue residence time of the composition and reduces diffusion of the botulinum neurotoxin from the composition to adjacent muscle groups and importantly also reduces systemic complications from the botulinum neurotoxin (para 0047-0048).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate hyaluronic acid with a desired molecular weight, since Chang and Tezel both disclose a composition comprises botulinum neurotoxin and hyaluronic acid, and Tezel discloses that increasing the molecular weight of hyaluronic acid used in the composition results in a longer tissue residence time of the composition and reduces systemic complications from the botulinum neurotoxin. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate hyaluronic acid with a desired molecular weight, with a reasonable expectation for successfully obtaining a composition.
References cited above do not teach the composition wherein the amount of non-crosslinked hyaluronic acid is at least 0.25 mg (claim 9).
However, Chang does teach the composition wherein the hyaluronic acid may be included in the composition in an amount of from about 2.4 mg/ml to about 12 mg/ml.
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the amount of non-crosslinked hyaluronic acid, since Chang discloses a composition comprises an amount of hyaluronic acid. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references and routine practice to optimize the amount of hyaluronic acid, with a reasonable expectation for successfully obtaining a composition.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (WO 2015/020982 A2; 2/12/2015.) in view of Tezel et al (US 2009/0155314 A1; 6/18/2009. Cited on IDS) and Zhou et al (FEBS Journal. 2005;272:2717-2726.) as applied to claims 1, 4, 7, 9, and 21-23 above, further in view of Callegaro et al (US 6,020,484; 2/1/2000.).
References cited above do not teach the composition wherein the polydispersity index of the non-crosslinked hyaluronic acid is 1.1 to 4.0 (claim 3).
However, Chang and Tezel do teach the composition comprises a non-cross linked hyaluronic acid, and Tezel does teach the molecular weight of the hyaluronic acid is between about 10,000 Daltons and about 20 million Daltons (about 0.01 MDa – about 20 MDa) (para 0036). Callegaro teaches a hyaluronic acid fraction having an average molecular weight comprised between 5,000 and 300,000 and a polydispersion index lower than 1.7 (Abstract).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate hyaluronic acid with a polydispersity index of 1.1 to 4.0, since Chang and Tezel both disclose a composition comprises a non-cross linked hyaluronic acid, Tezel discloses the non-cross linked hyaluronic acid having a molecular weight between about 10,000 Daltons and about 20 million Daltons, and Callegaro discloses that hyaluronic acid plays a vital role in many biological processes (col.1 line 26-28), and that hyaluronic acid with a polydispersion index lower than 1.7 can be obtained. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references to incorporate hyaluronic acid with a polydispersity index of 1.1 to 4.0, with a reasonable expectation for successfully obtaining a composition.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chang et al (WO 2015/020982 A2; 2/12/2015.) in view of Tezel et al (US 2009/0155314 A1; 6/18/2009. Cited on IDS) and Zhou et al (FEBS Journal. 2005;272:2717-2726.) as applied to claims 1, 4, 7, 9, and 21-23 above, further in view of Williams et al (International Journal of Biomaterials. 2013;2013:1-8.).
References cited above do not teach the composition has a dynamic viscosity from 1.5 to 4 Pa*s when determined at 25℃ using an oscillation frequency of 1 Hz (claim 5).
However, Chang and Tezel do teach the composition comprises botulinum neurotoxin and hyaluronic acid, and Tezel does teach the viscosity of the composition can be between about 100 cps and about 300,000 cps (about 0.1 Pa*s – about 300 Pa*s, which encompasses the claimed range) at 25℃ at a shear rate of 0.1/second (dynamic viscosity) (para 0039), or at least about 1000 cps (at least about 1 Pa*s) (para 0059). Before the effective filing date of the claimed invention, it was well-known in the art that viscosity is determined using an oscillation frequency of 1 Hz, as evidenced by Williams (p.2 col right – para 3).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to obtain a composition with a desired dynamic viscosity when determined at 25℃ using an oscillation frequency of 1 Hz, since Chang and Tezel both disclose a composition comprises botulinum neurotoxin and hyaluronic acid, Tezel discloses that the hyaluronic acid is present in an amount effective in providing the desired viscosity to the improved composition (para 0061), and Williams discloses that viscosity is routinely determined at 25℃ using an oscillation frequency of 1 Hz. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references and routine practice to obtain a composition with a desired dynamic viscosity when determined at 25℃ using an oscillation frequency of 1 Hz with a reasonable expectation of success.
Double Patenting
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-5, 7, 9, and 21-23 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 6 and 10 of U.S. Patent No 11,969,461 B2 (referred to as the ‘461 patent) as evidenced by Tezel et al (US 2009/0155314 A1; 6/18/2009. Cited on IDS) and Zhou et al (FEBS Journal. 2005;272:2717-2726.).
Claims 1-4, 6 and 10 of the ‘461 patent recite a composition comprising: a) purified or recombinant botulinum neurotoxin; b) sterilized saline; and c) non-crosslinked hyaluronic acid having an average molecular weight of 2.5 MDa to 4.5 MDa, wherein said composition is a sterilized composition having a dynamic viscosity from 1.5 to 4 Pa*s when determined at 25°C using an oscillation frequency of 1 Hz. The botulinum neurotoxin is botulinum neurotoxin type A. The polydispersity index of the non-crosslinked hyaluronic acid is 1.1 to 4.0. The composition further comprises a salt. The amount of botulinum neurotoxin is 500 to 1000 units. The amount of non-crosslinked hyaluronic acid is at least 0.25 mg. Before the effective filing date of the claimed invention, it was well-known in the art that a botulinum neurotoxin type A complex has the claimed properties, as evidenced by Tezel and Zhou. In support, Tezel teaches a composition which has a longer duration wrinkle alleviating effect (para 0021), comprising botulinum toxin (para 0044), wherein the botulinum toxin is botulinum neurotoxin type A as either pure toxin, about 150 kDa molecular weight neurotoxic component, or as a botulinum toxin complex, about 300 to about 900 kDa molecular weight, e.g., 500 kDa and 300 kDa, produced by Clostridium botulinum (para 0016, 0025). In addition, Zhou teaches botulinum neurotoxin A is a single polypeptide chain of about 150 kDa, which is cleaved endogenously or exogenously resulting in a 100 kDa heavy chain and a 50 kDa light chain (p.2717 col left – para 2), wherein botulinum neurotoxin A complex consist of botulinum neurotoxin A and hemagglutinins (coat proteins), is the native form of the toxin secreted by Clostridium botulinum (p.2718 col left – para 2-3).
Response to Arguments
Applicant argues that the presently amended claims exclude at least a portion of additional associated proteins that are present in the naturally occurring botulinum neurotoxin.
These arguments are not found persuasive because it is unclear that the presently amended claims exclude at least a portion of additional associated proteins that are present in the naturally occurring botulinum neurotoxin, since the claimed botulinum neurotoxin A can include associated proteins. Applicant may amend claim 1 to recite a botulinum neurotoxin A or a fragment of botulinum neurotoxin A that results in different characteristics from natural counterpart in their natural state. In addition, it is unclear that the combination of botulinum neurotoxin A and non-crosslinked hyaluronic acid changes characteristics of natural botulinum neurotoxin A and non-crosslinked hyaluronic acid individually.
Applicant argues that Tezel does not describe a botulinum neurotoxin composition that uses only non-crosslinked hyaluronic acid. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Applicant argues that the claims of the '461 patent do not teach or recite a composition comprising: a) a botulinum neurotoxin type A complex consisting of: i) a neurotoxin component having a molecular weight of approximately 150 kDa and which can be split into a light chain and a heavy chain; and optionally ii) one or more coat proteins. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Conclusion
No claims are allowed.
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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
