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 12-15 have been canceled. Claim 1-11 are still at issue and are present for examination.
Applicants' arguments filed on 6/4/26, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
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 1-11 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. Claim 1 (and its dependent claims 2-11) are directed to a generic method of treating a condition in a patient comprising topically administering a composition comprising a genus of botulinum toxin (Botox) compositions, wherein said generic method and said generic Botox composition are inadequately described in the disclosure.
The court of Appeals for the Federal Circuit has recently held that such a general definition does not meet the requirements of 35 U.S.C. 112, first paragraph. “A written description of an invention involving chemical genus, like a description of a chemical species, requires a precise definition, such as be structure, formula {or} chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). The court held that “in claims involving chemical materials, generic formulae usually indicate with specificity what generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. accordingly, such a formula is normally an adequate description of the claimed genus. In claims to genetic material, however, a generic statement such as “vertebrate insulin cDNA” or “mammalian insulin cDNA,’ without more, is not an adequate written description of the genus because it does not distinguish it from others. One skilled in the art therefore cannot, as one can do with a fully described genus visualize the identity of the members of the genus”. Here, applicant is claiming a method of use of a genus of Botox compositions by what supposedly said product does rather than what it structurally is. More specifically, in claim 1, applicant has provided no specific structural features (such as specific ingredients, the types of Botox used etc.) for the genus of Botox composition(s) utilized. In fact, even the functional language may lack disclosure support because the data which support instant invention were obtained by injection of Botox composition rather than topical administration.
Even if, for arguments’ sake, one assumes that topical administration diffusion pattern of claimed animal free Botox composition utilized is directly correlating to its diffusion pattern by injection, looking at the genus of Botox molecules in pages 4-5 of the disclosure, applicant mentions that Botox of this invention is produced recombinantly and reads on all serotypes, variants or fusion proteins thereof and the Botox composition of this invention (see page 5) may be complex or non-complex.
Given the breadth of said definition, the disclosure fails to provide any specific structural features for those Botox variants, or Botox molecules that are complexed, non-complexed or fused to other molecules, which upon topical administration at a target site display reduced diffusion as compared to a Botox composition that has animal protein. All applicant provides are two species of Botox (namely Coretox an Neuronox), which is totally inadequate to fully describe the genus of Botox compositions utilized.
In claims 2 and 5 some more structural information about the Botox composition utilized are provided but again said compositions do not specify which type of Botox is/are utilized.
Further, in claim 1, regarding the genus of administration sites of the Botox composition, applicant once again has merely provided a single species ( Gastrocnemius site), wherein said site only shows results due to injection, and given the fact that the “administration site” may be in many places such as back, arms, scalp etc. displaying many diseases or symptoms, Some more information regarding correlation between diffusion patterns of instant Botox composition (comprising both animal and non-animal protein containing) at the various “administration sites” by injection versus topical application deems necessary that is currently lacking in the disclosure.
Therefore, based on the information provided, one of skill in the art cannot reasonably conclude that applicant had full possession of the invention (namely claim 1-11) before the effective filing of this application.
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 10-11 remain 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 according to previous office action.
In traversal of this rejection applicant refers to [0051] of the disclosure and argues that (1) “muscle adjacent the muscle at the administration site” refers to a muscle that is separated by a pre-determined distance from “the muscle at the administration site” and the term “predetermined distance” may be interpreted as any distance separated from the muscle at the administration site sufficient to permit CMAP measurement.
Applicant then goes on to refer to some facial muscles to explain the target administration injection site and the site adjacent thereto.
(2) according to applicant, when administered locally, Botox will act on the muscle at “the administration site”, so even without a specific administration site, muscle adjacent to the administration site of the composition” can be clearly understood. Therefore, the “A” muscle which is the muscle at the administration site encompasses any muscle that undergoes neurotramission regardless of which muscle or what muscle is included.
He/she then concludes that based on the explanation summarized above, this rejection should be withdrawn.
These arguments were fully considered but were found totally unpersuasive.
With regards to applicant’s first argument above, explanation of “predetermined distance”, paragraph [0051] of the disclosure recites ““muscle adjacent to the administration site” may be a site that is preferably not affected (pharmacological action) by the composition of an embodiment.”. This definition is ambiguous because of the term “preferably” and does not exclude the pharmacological effects of the Botox composition at the “muscle adjacent to the administration site”. Further, said paragraph does not refer to the “predetermined distance” at any site from the injection site, which allows CMAP measurements “. Said last phrase is merely applicant’s interpretation. Furthermore, said definition contradicts applicant’s data, which shows that the injection at the administration site affects the neural transmission in the “adjacent muscles (see for example, Figure 1).
Finally, with respect to facial examples mentioned above, said examples merely focus on facial muscles, but instant invention does not mention any facial muscles at all and is generic.
Regarding applicant’s second argument, firstly, the term “adjacent” in the Merriam Webster dictionary, is defined as “very near, next to, or sharing a border or common point without anything in between”. However, looking at [0067] of the disclosure, the injection administration site was “gastrocnemius muscle” in mice leg and the “adjacent site” was in the opposite leg of said mice. Obviously, said two muscles are not “very near, next to each other, or sharing a border or common point without anything in between”. Therefore, the examiner maintains that in the context of this invention the term “administration site’ and the “site adjacent thereto”, remain confusing.
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.
Claim(s) 1-4, 6, 8-12 remain rejected under 35 U.S.C. 103 as being unpatentable over Ruegg (CN102666396, 2015, cited previously, see also its corresponding world patent WO2011/050072) according to previous office action.
In traversal of this rejection, applicant argues that Ruegg discloses a method of administration of an animal free composition of a non-complexed Botox, wherein said administration is done through skin implantation such as through slow-release device. The term “release” refers to liberation of drug from the device at the administration site whereas diffusion refers to the movement of the drug from the administration site into the surrounding tissues. Slow release does not necessarily reduce diffusion away from the administration site and hence, Ruegg’s invention is different than instant invention.
Further, instant claim 1 is directed to a method for treating a disease or improving a condition in a patient in need thereof, wherein the method comprises topically administering a therapeutically effective amount of botulinum toxin composition to a subject in need of treatment or improvement, wherein the botulinum toxin composition comprises a botulinum toxin as an active ingredient and is free of animal protein, and at an administration site, diffusion is reduced compared to a botulinum toxin composition comprising animal protein.
Thus, Ruegg does not disclose the feature “at an administration site, diffusion (of an animal free Botox is reduced compared to a Botox composition having animal products”.
In view of applicant, in Examples 1-2, the administration site muscle shows efficacy with no significant differences compared to control whereas the contralateral muscle demonstrates significant difference and this indicates that the selective reduction in functional effect is non target muscles results not simply due to toxin potency or variation in dose but rather from a specific property of the composition. Ruegg does not provide motivation f or composition design directed to reducing functional effect in non-target muscles while maintaining efficacy in the muscle at the administration site.
Therefore, Ruegg does not render this invention obvious and the rejection should be withdrawn.
These arguments were fully considered but were found unpersuasive. This is because firstly, Ruegg’s patent does not merely disclose a method of topical administration of its Botox composition by slow release. In fact, as mentioned previously, Ruegg in [0076] refers to patent applications such as 09/910432, where Botox composition is applied topically without any mention of slow-release implants.
Secondly, even if Ruegg’s administration system was merely restricted to operation of “slow release” devices or implants, the examiner maintains that the Botox composition applied to the diseased skin of the patient will display the same diffusion pattern as instant invention for two reasons: (1) as mentioned above, applicant has failed to show any comparative topical Botox composition diffusion results between animal and non-animal Botox compositions. The date shown in the specification are obtained through injection. (2) Applicant is reminded that in claim 1, he/she has not specified any specific structural features about the Botox composition utilized topically (which reads on creams, ointments or rubbing formulations) and thus, there is no reason that the applied composition of Ruegg will not function in the same or identical way as compared to that of instantly claimed Botox composition.
Regarding applicant’s reference made to Examples 1-2, once again, as mentioned above, applicant is relying on the diffusion properties of its Botox composition and diffusion pattern thereof upon injection at the “injection site” (see 112 second rejection above). However, according to Wikipedia, “Topical administration refers to the method of delivering a medication directly onto the body’s surface — most often the skin or mucous membranes — so that it acts locally at the site of application”. Here, as mentioned previously, applicant has not shown any correlation between diffusion patterns of instantly claimed “Botox composition” by topical administration (using for example any creams, or ointments etc.) at the administration site versus injection therein and no correlation between the diffusion patterns of animal and non-animal compositions by topical administration.
Therefore, due to reasons explained above, in addition to those elaborated previously, this rejection is also maintained.
Claim(s) 5 and 7 remain rejected under 35 U.S.C. 103 as being unpatentable over Ruegg (cited above) in view of Fraunhofer (cited previously) according to previous office action.
In traversal of this rejection, applicant argues that Ruegg and deficiencies thereof are discussed above and Fraunhofer discloses an aqueous composition comprising protein and non-ionic excipients wherein the non-ionic excipients include sugar alcohols and non-ionic surfactants and the protein is Botox and the composition may comprise antioxidants such as methionine. However, said art combination does not teach or suggest a method of use of a Botox composition with specific combinations of excipients recited in claims 5 and 7.
This argument was considered but again was found unpersuasive. Firstly, applicant is reminded that instant rejection is a 103 and not a 102 rejection. Therefore, the art combination cited does not need to teach the limitations of claims 5 and 7 explicitly.
Secondly, given the knowledge of common excipients used in Botox formulations since 2006 (when Botox was discovered) till now, to one of ordinary skill, it was merely routine to prepare formulations such as those recited in claims 5 and 7 for topical applications with reasonable expectation off success, before the effective filing of this application.
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 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.
Claim 1-11 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-35 of copending Application No. 18/006,201. Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons previously explained.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In response to this rejection applicant mentions that once allowable subject matter is identified, applicant will consider the required terminal disclaimer.
Currently nothing is found allowable, therefore this rejection is maintained.
No claim is 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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651
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