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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 2, 2026 has been entered.
Claims 3 – 4, 8, 10 – 12, 17, 30 – 31 are canceled; claims 1 – 2, 5 – 7, 9, 13 – 16, 18 – 29 and 32 – 38 are pending and have been considered on the merits. All arguments have been fully considered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 2, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
Previous rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn due to the amendment canceling relative phrases, trade names, claims 3, 4,12, 17, and undefined terms.
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 – 38 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).
Although Pickett does not teach the QM1114-DP has the relative potency normalized or determined as claimed, Pickett administers the exact same product as applicant, QM1114-DP. Thus, the compositions must intrinsically exhibit the same relative potency, regardless of the method by which it is determined. Further, the method by which the relative potency is determined is interpreted as a product by process type limitation of the administered product. The patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), then the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113)
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 – 38, 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) at intervals from about 1 month to about 6 months to inhibit recurrence (0024).
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 – 38 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 Pickett does not inherently teach the claimed method because some patients experience some amount of eyelid ptosis as shown by applicant’s disclosure and the cited reference; and that since the claimed method requires that the “subject does not experience eyelid ptosis”, this limitation does not “necessarily flow” from Pickett.
However, Pickett administers the same RealbotulinumtoxinA in the same amount to the same location wherein 96.1 and 95.1% of patients do not exhibit eyelid ptosis, indicating that subjects do not experience eyelid ptosis as claimed. In this regard, even though some patients might experience eyelid ptosis, the reference clearly teaches 95.1% or more do not. As such, the limitation does, in fact, “necessarily flow” from the teachings of Pickett.
Applicant argues that it is surprising that the claimed higher potency botulinum toxin exhibits no eyelid ptosis compared to a lower potency botulinum toxin such as BOTOX COSMETIC™, XEOMIN™ and JEUVEAU™.
However, this argument fails to persuade. Initially, evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based (MPEP 2131.04). Notwithstanding, applicant argues a surprising or unexpected result yet fails to provide objective evidence of the argued result. Arguments presented by the applicant cannot take the place of evidence in the record (MPEP 716.01(c)(II)). Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results (MPEP 716.01(c)(I).
Applicant argues that Pickett does not teach the method administering the claimed dose and potency.
However, Pickett teaches administering 30, 45, 50, 60 or 75 units of the claimed RelabotulinumtoxinA (claims 20 - 23) which fall expressly in the claimed dose of 40 – 70. It is maintained that Pickett teaches the claimed potency since the same composition is administered. It is iterated that Pickett teaches administering QM1114-DP, a ready to be administered liquid composition (e.g., ready to use) (0006, claim 24), which is the same composition and dose administered by applicant (examples).
Applicant argues the nonstatutory double patenting rejection in that the reference application does not claim ready to use liquid composition, the claimed dose or the RelabotulinumtoxinA having the claimed potency evaluated by the claimed assay.
However, the reference application administers the claimed QM1114-DP formulation (ready to administer liquid) (figures, 0006, claim 1) in the claimed amount (claim 23). In this regard, the compositions must also exhibit the same potency, regardless of how the potency is measured. The method by which the relative potency is determined is interpreted as a product by process type limitation of the administered product. The patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), then the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113)
No claims are allowed.
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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