DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 16-32 in the reply filed on 09/08/2026 is acknowledged.
Claims 33-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/08/2026.
Status of the Claims
Claims 1-15 have been cancelled. Claims 33-35 have been withdrawn.
Claims 16-32 are pending and currently under examination.
Information Disclosure Statement
Initialed and dated copies of Applicants’ information disclosure statements (IDS) filed on 11/12/2024 is attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119
(a)-(d). The certified copy has been received and placed in the file.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim 27 is 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 27 recites “a salt of calcium, magnesium or zinc, or a mixture thereof, wherein the salt is present in the liquid formulation in an amount of 0.01-100mM, wherein the salt is calcium chloride and is present in the liquid formulation in an amount of 0.01-100mM”. This language renders the claim indefinite because it is unclear whether salt is calcium, magnesium or zinc, or whether the salt is only calcium chloride. The examiner is interpreting the claim to read as alternative embodiments.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-17, 28-32 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Menon et al (WO2018200991A1, Published 11/01/2018; cited in the IDS filed 11/12/2024).
The Applicants claims are drawn to a liquid formulation, comprising (i) botulinum toxin,(ii) a stabilizing protein, and(iii) a chelating agent or phosphate.
Regarding claims 16-17, 28-32, Menon discloses In an embodiment, BoNT/E (i.e. botulinum toxin) is supplied in a sterile solution for injection with a 5-mL vial nominal concentration of 50 ng/mL in 0.03 M sodium phosphate (i.e., a phosphate; buffer), 0.12 M sodium chloride (i.e., tonicity agent), and 1 mg/mL HAS (i.e., human serum albumin; stabilizing protein), at pH 6.0 (paragraph [091]). Menon also discloses the powder can be reconstituted by the addition of sterile unpreserved normal saline (sodium chloride 0.9% for injection) (paragraph [090]).
Accordingly, Menon anticipated the claimed invention.
Claim Rejections - 35 USC § 103
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.
Claim(s) 16-32 are rejected under 35 U.S.C. 103 as being unpatentable Forssen et al. (US20150313973A1, Published 11/05/2015).
Applicant’s Invention
The Applicants claims are drawn to a liquid formulation, comprising (i) botulinum toxin,(ii) a stabilizing protein, and(iii) a chelating agent or phosphate.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 16-17, 19-21 and 25, Forssen teaches A pharmaceutical composition comprising a therapeutically effective amount of a clostridial derivative and at least one permeabilizing agent, wherein the at least one permeabilizing agent is present in an amount effective to substantially and reversibly increase the permeability of the bladder wall to the clostridial derivative (claim 1), wherein the clostridial derivative is a botulinum toxin (claim 2). Forssen also teaches examples of permeabilizing agents include polypeptides, chelators, or mixtures thereof (paragraph [0102]), wherein the permeabilizing agent can comprise proteins such as native or recombinant human serum albumin (paragraph [0110]), and also comprise chelators such as EDTA (i.e., aminopolycarboxylic acid), EGTA etc. (paragraph [0115]). Forssen further teaches The pharmaceutical composition can take any of a variety of forms including, without limitation, a sterile solution, suspension, emulsion (paragraph [0129]).
Regarding claim 18, Forssen teaches the permeation-effective amount of the permeabilizing agent (i.e., human serum albumin) ranges from about 0.005% to about 10% (w/v) (paragraph 0119]).
Regarding claim 22, Forssen teaches the following solutions were evaluated: saline, saline containing 50 mM EDTA (i.e., chelating agent)(paragraph [0175]).
Regarding claim 23, Forssen teaches “Botulinum toxin” means a neurotoxin produced by Clostridium botulinum, as well as a botulinum toxin (or the light chain or the heavy chain thereof) made recombinantly by a non-Clostridial species. The phrase “botulinum toxin”, as used herein, encompasses the botulinum toxin serotypes A, wherein “botulinum toxin” as used herein also encompasses the neurotoxic component of the botulinum toxin (150 kDa) that is unassociated with the complex proteins (paragraph [0045]).
Regarding claim 24, Forssen teaches the therapeutically effective amount of the botulinum toxin ranges from 10 U to 1000 U (paragraph [0099]).
Regarding claims 26-27, Forssen teaches the present pharmaceutical composition may optionally include a pharmaceutically acceptable carrier that facilitates processing of an active ingredient into pharmaceutically acceptable compositions such as magnesium carbonate (i.e., salt of magnesium) (paragraph 0130]).
Regarding claims 28-29, Forssen teaches A pharmaceutical composition disclosed herein can optionally include, without limitation, other pharmaceutically acceptable components (or pharmaceutical components), including tonicity adjusters such as sodium chloride (paragraph [0131]).
Regarding claims 30-31, Forssen teaches A pharmaceutical composition disclosed herein can optionally include, without limitation, other pharmaceutically acceptable components (or pharmaceutical components), including buffers such as phosphate buffers (paragraph [0131]).
Regarding claim 32, Forssen teaches there were no differences between BOTOX® (i.e., botulinum toxin type A) in pH 6 or 8 (paragraph [0183]). Forssen also teaches Various buffers and means for adjusting pH can be used to prepare a pharmaceutical composition disclosed herein, provided that the resulting preparation is pharmaceutically acceptable, wherein acids or bases can be used to adjust the pH of the composition as needed (paragraph [0131]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Forssen does not disclose a single embodiment or example where every limitation recited in the instant claims are taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art because
Forssen teaches all of the claimed elements. It would have been prima facie obvious at the time
of filing to have to a liquid formulation, comprising (i) botulinum toxin,(ii) a stabilizing protein, and(iii) a chelating agent or phosphate because Forssen teaches these elements as components of their invention.
With regards to claim 27, wherein the salt is present in the liquid formulation in an amount of 0.01-100mM, it would have been obvious to one of ordinary skill to optimize the amount of the salt. One would have understood in view of Forssen that the present pharmaceutical composition may optionally include a pharmaceutically acceptable carrier that facilitates processing of an active ingredient into pharmaceutically acceptable compositions such as magnesium carbonate (i.e., salt of magnesium) (paragraph 0130]). It would have been obvious to optimize the amount of the salt by routine experimentation using the teachings of Forssen that the magnesium carbonate is used as a carrier, therefore one would use the magnesium carbonate in an amount sufficient to be a proper carrier of the active ingredient for the desired results of the liquid formulation. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
With regards to claim 32, wherein the pH of the liquid formulation is in the range of 5.0-8.0, it would have been obvious to one of ordinary skill to optimize the pH of the liquid formulation. One would have understood in view of Forssen that various buffers and means for adjusting pH can be used to prepare a pharmaceutical composition disclosed herein, provided that the resulting preparation is pharmaceutically acceptable, wherein acids or bases can be used to adjust the pH of the composition as needed (paragraph [0131]), and there were no differences between BOTOX® (i.e., botulinum toxin type A) in pH 6 or 8 (paragraph [0183]). Therefore, it would have been obvious to optimize pH of the liquid formulation by routine experimentation using Forssen’s teachings for the desired results of the liquid formulation. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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