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 .
Applicant's amendment and reply filed June 30, 2026 have been received and entered into the case. Claim 38 is canceled; claims 1 - 2, 5 - 7, 9, 13 - 16, 18 - 29 and 32 - 37 are pending and have been considered on the merits. All arguments have been fully considered.
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 - 2, 5 - 7, 9, 13 - 16, 18 - 29 and 32 - 37 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 recites a method of treating lateral canthal lines wherein the treatment interval is “at least 6 months." This interval is not described in the specification as originally filed. The specification does not literally recite any treatment that is "at least" 6 months, but rather "up to a six month" duration (examples 2 and 6). No data, examples or disclosure is drawn to more than 6 months, which is encompassed by "at least 6 months." Instead, the specification repeatedly states intervals from about 3 months to "about 6 months" (0041, 0349) and "through 6 months" (0371, 0380). This is a new matter rejection.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15 and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15 fails to depend from a preceding claim. MPEP 608.01 (n)(III).
Claim 16 fails to further limit the claim on which it depends because the claim requires the subject to have LCL, which is already required by claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 2, 5 – 7, 9, 13 – 16, 18 – 29 and 32 – 37 remain rejected under 35 U.S.C. 102a1 as being anticipated by Pickett et al. (US 2020/0383894).
Regarding claims 1 and 15 – 16, Pickett teaches a method of treating glabellar lines (GL) and/or lateral canthal lines (LCL) in a human subject, comprising administering 30, 45, 50, 60 or 75 units (claim 23) of QM1114-DP (ready to used liquid formulation of RelabotulinumtoxinA) (0006, claim 24, figures, examples) via one or more injections (claim 26) in order to reduce the appearance of moderate to severe GL and/or LCL. Picket shows that 96.1% (45 units) and 95.1% (60 units) did not experience eyelid ptosis (Table 1). Pickett teaches treatment intervals of about 6 months (0024, 0083, claims 36 - 37) which includes 6 months and is encompassed by “at least 6 months” as claimed.
Regarding claim 2, no severe adverse events were experienced in some subjects (example 1, 0102, figure 8).
Regarding claims 5 – 6, although the reference does not teach the RelabotulinumtoxinA has the claimed activity, the RelabotulinumtoxinA used by Pickett is the same used by applicant. Therefore, the RelabotulinumtoxinA of Pickett must also inherently exhibit the claimed activity. Regarding measuring the activity, it is initially noted the limitation is optional and not required by the claim. Notwithstanding, Pickett teaches measuring the specific activity of the RelabotulinumtoxinA via a mouse LD50 assay (the standard assay for assessment of BoNT-A potency) (example 2, 0139).
Regarding claims 7, 9, 14, Pickett does not teach the RelabotulinumtoxinA has the claimed activity or wherein no human or animal excipients or proteins are included. However, since the reference uses the same RelabotulinumtoxinA (QM1114-DP) as applicant, the RelabotulinumtoxinA must also inherently exhibit the claimed characteristics, results post administration and components.
Regarding claim 13, Pickett teaches treating moderate to severe GL and/or LCL (claim 1).
Regarding claim 18, the liquid composition further comprises 1 – 5 buffering agents selected from sodium chloride, potassium chloride, sodium phosphate, potassium phosphate, di-sodium hydrogen phosphate dehydrate, and sodium dihydrogen phosphate dehydrate (claim 8).
Regarding claims 19 – 23, the first buffering agent is present at a concentration of about 100 to about 300 mM, or at a concentration of about 0.1-10 mg/mL; the second buffering agent is present at a concentration of about 1 to about 25 mM, or at a concentration of about 0.1-1.0 mg/mL; the third buffering agent is present at a concentration of about 1 to about 25 mM, or at a concentration of about 0.1-1.0 mg/mL; the fourth buffering agent is present at a concentration of about 1 to about 25 mM, or at a concentration of about 0.1-1.0 mg/mL and the fifth buffering agent, and in some embodiments, the fifth buffering agent is present at a concentration of about 1 to about 25 mM, or at a concentration of about 0.1-1.0 mg/mL (0010 – 0014).
Regarding claims 24 – 27, the composition comprises at least one stabilizer that is an amino acid selected from the group consisting of alanine, valine, leucine, isoleucine, methionine, phenylalanine, tyrosine, and tryptophan; in the D isoform or the L isoform; and is present at a concentration of about 0.1 to about 3.0 mg/mL (0016).
Regarding claims 28 – 29, the composition comprises at least one surfactant is a non-ionic surfactant at a concentration of about 0.01% (v/v) to about 5.0% (v/v), or at a concentration of about 0.1 to about 3.0 mg/mL (0017).
Regarding claim 33, the RelabotulinumtoxinA has a molecular weight of about 150 kDa (0018).
Regarding claims 32 and 34, the pH is between 6.6 and 6.9 and the osmolality of the liquid composition is between 270 mosm/kg and 310 mosm/kg (0019).
Regarding claims 35 – 37, between 1 and 100 units or between 10 and 75 units of botulinum toxin is administered to the subject (0021) via injection, for example, by subdermal, transdermal, intradermal or intramuscular injection (0022).
The reference anticipates the claimed subject matter.
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 – 2, 5 – 7, 9, 13 – 16, 18 – 29 and 32 – 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, 11, 14, 17 – 19, 23, 25 – 26, 36 – 38, 41 – 43 of copending Application No. 16/894 684 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to administering the same liquid RelabotulinumtoxinA composition, QN1114-DP, to the same treating population and for treating the same conditions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the prior art does not teach a method for treating LCL wherein the treatment interval is at least 6 months with sufficient specificity; and that no examples are disclosed wherein a single treatment has a 6 month or longer duration. Applicant argues the instant claims are distinct from the cited copending application.
However, these arguments fail to persuade. Pickett specifically teaches treatment intervals of about 6 months (0024, 0083, claims 36 - 37) which includes 6 months and is encompassed by at least 6 months as claimed.
Regarding the argument that the prior art does not provide sufficient specificity for treating intervals of at least 6 months, the reference specifically states intervals from about 6 months which includes 6 months, or "at least 6 months" as claimed. Further, the reference states "In some embodiments of the disclosed method, said method is repeated at intervals from about 1 month to about 6 months to inhibit said recurrence" (0024) which is verbatim to applicant's own specification at paragraph 0041 of the published application. Moreover, the specificity of the prior art treating at "about 6 months" is identical to that of applicant.
Regarding the argument that the prior art does not provide examples wherein a single treatment has a 6 month or longer duration, the claims do not require treatment to have a 6 month or longer duration, but only treatment intervals of at least 6 months. In this regard, the argument is not commensurate in scope with the claimed invention. Notwithstanding, examples are not required to demonstrate sufficient specificity. Rather, what constitutes a "sufficient specificity" is fact dependent (MPEP 2131.03 (II)). In this case, both Pickett and applicant disclose identical ranges of "up to 6 months," neither exemplify a single treatment having a 6 month or longer duration, but only up to 6 months, and both administer the same active composition to the same treating population, in the same number of units. As such, the cited prior art is deemed sufficiently specific with regard to both the claimed and disclosed invention.
Regarding the co-pending application, claims 36 and 37 recite administering at “about 6 months” which encompasses “at least 6 months.” As such, the claims remain rejected.
No claims are allowed.
Conclusion
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 RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
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