DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 29 August 2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Non-Compliant Amendment
The claims filed on 29 August 2025 are non-compliant with respect to 37 CFR 1.121. Claims 170-171 are indicated as “Previously Presented” in the amendment, however, they are new claims, and thus the status identifier is incorrect. Further, it appears they are copy-paste errors, as they duplicate the previous last two claims in the claim set (claims 168-169). In the interest of compact prosecution, the amendment filed 29 August 2025 is being considered. Applicant is urged to verify that any future amendment is fully compliant with 37 CFR 1.121 in order to avoid any unnecessary delays in prosecution on the merits.
Applicant is also advised that should claims 168-169 be found allowable, claims 170-171 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 152-157 and 160-175 are rejected under 35 U.S.C. 103 as being unpatentable over Ruegg et al. (PCT Patent Application Publication WO 2017/075468).
Ruegg et al. discloses a method of reducing wrinkles, lines, or furrows in an individual in need thereof, the method comprising administering to the individual as a single dose injection a composition comprising a pharmaceutically acceptable diluent for injection, a botulinum toxin component selected from the group consisting of a botulinum toxin, a botulinum toxin complex, or a reduced botulinum toxin complex; and a positively charged carrier component comprising a positively charged polylysine backbone having covalently attached thereto one or more positively charged efficiency groups (claims 2-3), the carrier having a sequence that matches that of instantly recited SEQ. ID4 (claim 13).
The botulinum toxin is administered to the individual in an amount of 20 U to 60 U (claims 2-3). The positively charged carrier is non-covalently associated with the botulinum component (claims 2-3). And the single dose injection of the composition provides a single treatment having at least about a six month to about a 10 month duration of effect in reducing the wrinkles, lines, or furrows in the individual, thereby extending treatment interval duration for the individual (claim 2-3). The toxin has a molecular weight that reads upon that instantly recited (example 5).
Ruegg et al. does not recite in the above method that the positively charged carrier is present in the composition in an amount of 11-15 µg per 50 U. Ruegg et al. does state that the amount of the carrier relative to the botulinum toxin is from 0.1 ng/U to 10,000 ng/U (paragraph [52]), a range which does not read upon the instantly recited amount. However, it does overlap (the disclosed range is from 0.005 µg per 50 U – 500 µg per 50 U). And in cases involving overlapping ranges, where the instantly claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05. Thus, instant claims 152-153, 162, 164, and 172 are rendered prima facie obvious.
Instant claims 154 and 155 further limit the botulinum toxin, and the toxin used in examples 5 reads upon these limitations.
Instant claim 156 states that the composition does not locally diffuse, which is disclosed by Ruegg et al. (claim 46).
The amount administered is recited by instant claim 157, and this is also taught by Ruegg et al. (claim 48).
Instant claims 160-161 and 173-175 recite the inclusion of additional excipients. And Ruegg et al. teaches all of these – trehalose (paragraph [58]), polysorbate (paragraph [59]), and buffer (paragraph [60]).
Instant claims 163, 165, and 169 (and duplicate instant claim 171) further limit the effect of the method. And Ruegg et al. teaches such effects for the method (claims 37 and 50).
Instant claims 166 and 167 further limit where the composition is injected, and Ruegg et al. teaches these locations and ways to administer (paragraphs [102-105]).
Instant claim 168 (and duplicate instant claim 170) recites a limitation to the subject’s age, and such limitations are taught by Ruegg et al. (paragraph [73]).
Response to Arguments
The Applicant argues that the rejection is not proper. The Applicant states that the range for the ratio of peptide carrier to toxin cited in the rejection is extremely broad. And the narrowest range disclosed by Ruegg et al. does not overlap the instantly recited range.
The Applicant also argues that the claimed range is better than the preferred range described in Ruegg et al. The Applicant states that evidence is presented in the instant specification which shows that increasing the amount of the peptide results in an increase of the botulinum toxin getting into cells. The Applicant states that these effects are surprising and exceeded expectations.
The Examiner acknowledges the arguments, but does not consider them persuasive. While the narrowest range disclosed by Ruegg et al. may not overlap the instantly recited range, the rejection is based on the broader teaching, and this range does overlap. And the reference is not limited to the narrower range disclosed. References are relevant for all contained therein. See MPEP 2123.
With respect to the arguments relating to the unexpected and surprising results, these are acknowledged, but are not found persuasive. It is noted that Ruegg et al. discloses that the inventive formulations possess enhanced potency (paragraph [15]) and the non-native molecules in the inventive formulation act of penetration enhancers to improve the toxins’ ability to reach the target (paragraph [16]). So a link between the peptide of the invention disclosed by Ruegg et al. and the ability of the active (the botulinum toxin) to penetrate and get to the desired target appears known.
As for how much of an increase is expected, it is noted that there is no evidence to support what would have been expected. The Applicant states the effect shown is surprising and exceeds expectations. However, the instant specification does not state these conclusions. And arguments of counsel cannot take the place of factually supported evidence. See MPEP 2145.
Conclusion
THIS ACTION IS MADE FINAL. 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 Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brian Gulledge/Primary Examiner, Art Unit 1699