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 .
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 24-26 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 is considered indefinite because it is unclear how to interpret a limitation found in the preamble. See MPEP 2111.02. It is unclear how to interpret “which is free of animal protein excipients.” This limitation is indefinite because it is unclear if the limitation is meant to inform the relevant audience that there are no non-animal protein excipients, or if the method is designed to prevent the inclusion of animal excipients by a particular method step. Since the invention is drawn to a method of making, the quoted limitation would suggest to the relevant audience that this limitation should be interpreted as a necessary step in the method of the invention; however, since there are no specific steps present that would prevent the inclusion of animal protein excipients, it is unclear how this methodological step must be claimed and performed. If the limitation should merely be read as do not add animal protein excipients, this should be more clearly claimed. For the sake of examining the claim on its merit, if the prior art provides for situations in which there are no animal protein excipients present in a method of making, the limitation will have been met.
Claims 25 and 26 are rejected insofar as they claim dependence on claim 24 but do not cure the above indefiniteness.
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 (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 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.
Claims 24-29 and 32-37 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN103705913A [IDS Reference-Abstract provided by the Applicant, the machine translation is attached) and Hunt (CN101175478A). Please note, all references to foreign references will be with respect to the page and paragraph number of the machine translation provided. All three references provide for compositions comprising botulinum toxin as the active ingredient, and further suggest the inclusion of non-protein excipients. Chen provides a listing of various excipients that can be included in a botulinum toxin composition, wherein a composition that includes a solubilizing agent (that can comprise poloxamer), and an antioxidant that can comprise methionine; this composition can be lyophilized and is compounded for injection. See Chen, claims 1, 3 and 8; page 1, first paragraph after “Description;” page 2, paragraphs 7-9, and 12-14 after “Summary of the invention.” Chen provides for methionine that is slightly less than 1% of the composition. See page 3, Embodiment 1. Although there is no evidence to suggest that there are any animal protein excipients added, this is never explicitly stated.
Hunt teaches a lyophilized botulinum toxin composition than can comprise a poloxamer and an amino acid, wherein the amino acid can include methionine. See page 11, Embodiment 2, paragraphs 1 and 3; page 14, paragraph before Embodiment 3. Hunt explicitly states that the composition is free of animal proteins. See page 4, paragraph before “Botulinum toxin.” Hunt notes that botulinum compositions are FDA-Approved for intramuscular and subcutaneous injection. See page 4, second-to-last paragraph. Hunt does not appear to explicitly teach the claimed range of methionine.
With respect to claims 24 and 27, both Chen and Hunt describe all of the compositional limitations claimed, where Chen explicitly teaches the concentration of methionine and Hunt explicitly teaches animal protein-free excipients. Since methionine is a well-known excipient, as is clear from both Chen and Hunt, it would be obvious for the ordinary artisan to optimize the methionine concentration to a level that ranged around Chen, since this excipient is exceptionally well-known and predictable. It would further be obvious to ensure that Chen’s composition is animal protein-free because Chen explicitly provides rationale to exclude animal protein-based excipients. See pages 3 and 4, “The protein excipient” section. Based upon an assessment of the cited prior art, and the compositions provided in the cited prior art, the claimed method of making would be obvious to the ordinary artisan.
With respect to claims 25, 26, 28 and 29, Chen teaches serotype A. See claim 1. Hunt teaches serotypes A and E. See claim 3.
With respect to claims 32 and 35, Chen teaches a composition that comprises 1 g botulinum toxin, 1% methionine, sodium chloride. See page 3, Embodiment 1. Although Chen does not explicitly state a pH, Chen provides for a “pH regulator,” which is interpreted as a buffer. See claim 3. In other embodiments, Chen provides 50-150 U of botulinum toxin described in Embodiment 1, and provides the buffering agent sodium bicarbonate. See page 3, Embodiment 2. Although Chen does not explicitly state a pH, it would be obvious to the ordinary artisan to make the composition achieve a physiological pH, prior to administration. Hunt teaches a lyophilized botulinum toxin composition than can comprise a poloxamer and an amino acid, wherein the amino acid can include methionine. Hunt indicates that the composition can include trehalose, or mannitol See page 11, Embodiment 2, paragraphs 1- 3; page 14, paragraph before Embodiment 3. Hunt also notes that clostridial toxin compositions routinely include buffering agents. See page 3, “Background technology.” When taking all of this together, and considering lyophilized protein-based pharmaceutical compositions, like botulinum toxin-based pharmaceutical compositions, appear to be routine in the art, the addition and proportion of these compounds would be obvious to the ordinary artisan.
With respect to claims 33, 34, 36, and 37, Chen teaches serotype A. See claim 1. Hunt teaches serotypes A and E. See claim 3.
Claims 30 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN103705913A [IDS Reference-Abstract provided by the Applicant, the machine translation is attached) Hunt (CN101175478A) and Finzi, et al (American Society for Dermatological Surgery, 32, 645-650, 2006). Neither reference teaches, nor suggests, treating depression with a composition comprising botulinum toxin. Finzi provides a case study that shows a link between the treatment of depression and the subcutaneous injection of botulinum toxin A. See page 645, “Abstract” section. Although there is no explicit motivation for the ordinary artisan to utilize the composition described by Chen and Hunt, it is clear to the ordinary artisan that botulinum toxin is capable of treating depression. As such, it would be obvious to the ordinary artisan that all botulinum toxin compositions, that are designed for subcutaneous injection, should be equally capable of providing the treatment taught in Finzi. This would be obvious because it is the botulinum toxin that this doing the treating and not the cited excipients.
Claims 31 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN103705913A [IDS Reference-Abstract provided by the Applicant, the machine translation is attached) Hunt (CN101175478A) and Pokushalov, et al (Circulation: Arrhythmia and Electrophysiology, 8, 1334-1341, 2015). Neither reference teaches, nor suggests, treating cardiac arrhythmia with a composition comprising a botulinum toxin. Pokushalov teaches methods of treating a type of arrhythmia: atrial fibrillation, with a botulinum toxin-based pharmaceutical composition. See page 1334, “Abstract” section. Although there is no explicit motivation for the ordinary artisan to utilize the composition described by Chen and Hunt, it is clear to the ordinary artisan that botulinum toxin is capable of treating cardiac arrhythmia. As such, it would be obvious to the ordinary artisan that all botulinum toxin compositions, that are designed for subcutaneous injection, should be equally capable of providing the treatment taught in Pokushalov. This would be obvious because it is the botulinum toxin that this doing the treating and not the cited excipients.
Double Patenting
Claims 24-39 of this application is patentably indistinct from claims 20-35 of Application No. 18/629,715. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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 24-29 and 32-37 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 10,369,190. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent provides for a composition comprising a lyophilized pharmaceutical composition that includes a clostridial toxin, trehalose, poloxamer and methionine, wherein the toxin is claimed as botulinum toxin. Although significantly narrower than the claimed invention, all of the limitations of the patent read upon the claimed invention, and as such, anticipate the claimed invention. As such, the claims are considered Non-Statutory Double Patenting, with respect to the cited patent.
Claims 24-29 and 32-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,973,890. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent provides for a liquid composition comprising a botulinum toxin, an aqueous carrier, a poloxamer, and methionine, wherein the composition can further include trehalose. As discussed in the rejections above, the application claims all of these elements, with the primary difference being that the instant claims provide for a lyophilized composition/method, whereas the patent provides for a liquid composition. However, it should be noted that the claims of the instant application explicitly describe steps for providing an aqueous carrier, prior to administration. As such, the claimed invention provides for an obvious variant of the composition provided in the cited patent.
Claims 24-29 and 32-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,144,847. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited patent provides for a solid composition comprising botulinum toxin, poloxamer, methionine, and other dependent limitations drawn to buffering agents and tonicity agents. The patent also described lyophilized compositions. The cited patent provides for all of the claimed elements in the instant application, and as such, provides for anticipating claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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