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 1-12 are under examination on the merits.
Claims 13-15 are canceled.
Claim Objections
Claims 1 and 12 are objected to for the following informalities:
Claim 1 should be amended to replace “comprising” in line 5 with “comprises”.
Claim 12 should also be amended to replace “comprising” in line 4 with “comprises”. In addition, claim 12 should be amended to replace “the botulinum toxin” in line 2 with “a botulinum toxin”.
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 10-11 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In claims 10-11, applicant compares the values of compound muscle action potential of muscles adjacent to muscle of instant formulation administration site with the corresponding values of a control formulation comprising an animal protein-containing administration site and claims higher or lower values.
It is unclear which specific target and/or target-adjacent muscles are referred to. As applicant is aware, instant invention is utilizing a topical composition and skin covers many muscles in the body such as leg muscles, neck muscles, hand muscles, stomach muscles etc. It is unclear what specific muscles are targeted in claims 10-11 respectively. It is further vague as to whether the higher or lower numbers are the result of physiological properties of targeted muscles or whether said higher or lower values are the result of specific Botox composition dosages administered. If the compound muscle action potential is a function of dosages utilized, then said dosages need to be recited in claims 10-11. Appropriate clarification is required.
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 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Ruegg (CN 102666396, 5/2015) or, in the alternative, under 35 U.S.C. 103 as obvious over Ruegg, see its English machine translation, attached).
Ruegg (see abstract) teaches about methods of purifying botulinum toxin (Botox) in high purity, to be used as an active ingredient in pharmaceutical preparations.
In [0004}, Ruegg teaches about the application of Botox for treatment of wrinkles and eyelid spasms.
In [0060], said patent teaches that its Botox many be non-complex.
In [0023], said patent discloses that its method results in a Botox basically, substantially or completely free of animal products. Storage stable basically, substantially or completely free of ability of toxin product of animal product further reduces potential risk associated with animal source product. Ruegg further indicates that a botulinum toxin form particularly suitable for pharmaceutical application in terms of safety, for example, can be prepared and stored substantially, or completely free of animal products of pharmaceutical composition.
In [0076], according to Ruegg, in some embodiments, its invention provides a purified botulinum toxin molecule is administered to a patient. The invention provides a pharmaceutical composition "applied" points to a subject or patient. pharmaceutical composition can be produced by any method known in the art, including, for example, in muscle, intradermal, intranasal or subcutaneous administration, intrathecal administration, intracranial, intraperitoneal in ( topical (transdermal) administration and slow-release device for implantation (e.g. embedded) pathway. In some preferred embodiments, the composite of purified botulinum toxin in the composition is topically or administered by injection, such as U.S. patent application No. 09/910, 432, 10/793, 138, ;11/072, 026, ;11/073, 307, 11/824, 393 and 12/154, 982.
In [0075], said Chinese patent recites that the "pharmaceutical composition" refers to the active ingredient may be a preparation of botulinum toxin. preparation containing at least one kind of additional component and adapted to subject (such as a human patient), diagnostic, therapeutic and/or cosmetic administration. a pharmaceutical composition can be liquid or solid, and may be a single component or multi-component system, such as diluent (such as saline) reconstruction of the lyophilized composition, anticipating claims 1-4, 6, 8 and 12, or in the least renders them obvious.
Regarding claim 9, the slow-release device or the implant of Ruegg inherently reduces diffusion effect or extends its duration upon two or many more topical or other administration attempts, rendering said claim obvious.
Similarly, regarding claims 10-11, many of the above-mentioned topical preparations of Ruegg inherently modulate (i.e. enhance or reduce) the muscle action potential of the muscles adjacent to the muscle at the administration site of the patient relative to muscle action potential of the muscles adjacent to the muscle at the administration site of untreated patient, again rendering said claims obvious.
Claim(s) 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ruegg (cited above) further in view of Fraunhofer et al., “Fraunhofer” (US patent No. 8,883,146, 11/2014, see also its corresponding patent publication US 2013/0156760, 6/2013, which will be used to cite relevant text).
As stated above, Ruegg teaches methods of improving wrinkles and methods of treating spasms, utilizing compositions comprising Botox together with other pharmaceutically acceptable excipients, for topical administration, injection etc., wherein said compositions may optionally be lyophilized, prior to this invention.
Said patent does not mention which specific excipients were present in its composition comprising Botox.
Fraunhofer (see abstract) discloses an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductivity resulting from the low levels of ionic excipients.
In [0024], according to said publication, the formulation may further comprise a non-ionizable excipient. Examples of non-ionizable excipients include, but are not limited to, a sugar alcohol or polyol (e.g., mannitol or sorbitol), a non-ionic surfactant (e.g., polysorbate 80, polysorbate 20, polysorbate 40, polysorbate 60), and/or a sugar (e.g., sucrose), see also claim 14.
In [0120], it is recited that the therapeutic protein in the formulation may be Botox (type A or type B).
In [0076], Frauhofer recites that its formulations may comprise antioxidants such as methionine to prevent deterioration of its preparations due to oxidative stress.
Before the effective filing of this application, it would have been obvious to one of ordinary skill in the art to start with the method of Ruegg and prepare its liquid composition comprising Botox together with methionine and polysorbate and /or sugars and sugar alcohols as taught by Fraunhofer.
One of ordinary skill in the art is motivated in preparing the Botox liquid compositions of Ruegg with methionine, polysorbate and/or sugars and alcohol sugars of Fraunhofer as excipients. This is because as mentioned above, methionine helps preserve the integrity of Botox against oxidation and polysorbate is a cryoprotectant which will be useful and protective against protein denaturation due to lyophilization of its aqueous formulations, rendering tis invention obvious.
Finally, one of ordinary skill in the art has a reasonable expectation of success in starting with the method of preparing non-complex Botox compositions free of animal proteins of Ruegg and add the methionine and polysorbate and sugars of Fraunhofer thereto because such procedures were fully established in the prior art, 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.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35-38 of copending Application No.18/006,201.
The methods of said copending application are directed to a method of use of a composition that has a narrower scope than this invention as the composition used has an additional antibody. Since instant invention uses comprising language in instant claim 1, and does not exclude the presence of additional components than Botox and excipients, the scope of instant claims overlaps with the scope of claims in said copending application.
This is a provisional nonstatutory double patenting rejection.
No claim is allowed.
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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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651