DETAILED ACTION
Claims 1, 5, 8, and 28-30 are amended.
Claims 2, 6, 9, 11, 13-20, and 26-27 are cancelled.
Claims 1, 3-5, 7-8, 10, 12, 21-25, and 28-30 are pending.
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 .
Priority
This application is a 371 of PCT/US2021/054818 filed 10/13/2021 which claims benefit of 63/091,293 filed 10/13/2020.
Claim Objections
(previous objection, withdrawn) Claim 1 is objected to because of the following informalities: there appears to be a typo in the word “muculoskeletal” as recited in claim 1, which the examiner presumes is intended to read “musculoskeletal”. Additionally, claim 1 recites “having covalently attached to each end a positively charged efficiency groups…”. This appears to contain a grammatical error because it refers to a plurality of “groups” while using singular language. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
(previous rejection, withdrawn) Claims 1, 3-5, 7-8, 10, 12, 15-17, 21-25, and 28-30 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing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. Applicants have amended claims 1 and 5 to overcome this previous rejection. In view of applicants’ amendments, the previous 112(a) rejection is withdrawn.
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.
(previous rejection, maintained; withdrawn regarding cancelled claims) Claims 1, 3-5, 7-8, 10, 12, 21-25, and 28-30 are rejected under 35 U.S.C. 103 as being obvious over Ruegg, US 20200179498 A1 (see form PTO-892), in view of Walker1 (see form PTO-892).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claim 1, Ruegg teaches a method comprising:
Administering by injection treatment a treatment dose of a sterile injectable composition into one or more of the muscles causing the cervical dystonia in the individual in need of treatment to achieve the therapeutic effect (Ruegg, claim 1);
Wherein the composition comprises a pharmaceutically acceptable diluent suitable for injection and a botulinum toxin of serotype A having a molecular weight of 150 kDa (Ruegg, claim 1; claim 8);
Wherein the total treatment dose of botulinum toxin component administered to the individual is 100 U to 450 U (Ruegg, claim 1);
Wherein the composition comprises a positively charged carrier having a positively charged backbone of polylysine having covalently attached to each end a positively charged efficiency groups having an amino acid sequence of (gly)p -RGRDDRRQRRR-(gly)q (SEQ ID NO: 1), (gly)p-YGRKKRRQRRR-(gly)q (SEQ ID NO: 2) or (gly)p -RKKRRQRRR-(gly)q (SEQ ID NO: 3), wherein the subscripts p and q are each independently an integer from 0 to 20 (Ruegg, claim 1);
Wherein the one or more muscles comprise at least one of sternocleidomastoid, levator scapulae, and scalenus complex and (Ruegg, table 1);
Wherein the therapeutic effect is associated with a risk of adverse events, risk of dysphagia, risk of musculoskeletal pain, and/or risk of muscular weakness that is below 15% (Ruegg, Fig. 3).
Regarding claim 3, Ruegg teaches injection into the one or more muscles causing the cervical dystonia, such as the sternocleidomastoid, levator scapulae, and scalenus complex and (Ruegg, claim 1; table 1). This is interpreted to include injection into all of the above muscles.
Regarding claim 4, Ruegg discloses a table (shown below, Ruegg, table 1) which sets forth the dose range for the sternocleidomastoid, levator scapulae, and scalenus complex.
PNG
media_image1.png
379
814
media_image1.png
Greyscale
Regarding claim 5, Ruegg teaches a method comprising:
Administering by injection treatment a treatment dose of a sterile injectable composition into one or more of the muscles causing the cervical dystonia in the individual in need of treatment to achieve the therapeutic effect (Ruegg, claim 1);
Wherein the composition comprises a pharmaceutically acceptable diluent suitable for injection and a botulinum toxin of serotype A having a molecular weight of 150 kDa (Ruegg, claim 1; claim 8);
Wherein the total treatment dose of botulinum toxin component administered to the individual is 100 U to 450 U (Ruegg, claim 1);
Wherein the composition comprises a positively charged carrier having a positively charged backbone of polylysine having covalently attached to each end a positively charged efficiency groups having an amino acid sequence of (gly)p -RGRDDRRQRRR-(gly)q (SEQ ID NO: 1), (gly)p-YGRKKRRQRRR-(gly)q (SEQ ID NO: 2) or (gly)p -RKKRRQRRR-(gly)q (SEQ ID NO: 3), wherein the subscripts p and q are each independently an integer from 0 to 20 (Ruegg, claim 1);
Wherein the one or more muscles comprise at least one of sternocleidomastoid, levator scapulae, and scalenus complex and (Ruegg, table 1);
Wherein the therapeutic effect is associated with a risk of adverse events, risk of dysphagia, risk of musculoskeletal pain, and/or risk of muscular weakness that is below 15% (Ruegg, Fig. 3).
Walker also teaches the dosage range for each of the one or more muscles in the table shown above (Walker, table 1)
Regarding claim 8, MPEP 2111.04(I) states that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Claim 8 recites “The method according to claim 1 wherein the risk of adverse events is less than 12%, 10%, 8%, 7%, 5%, or 3%”. The wherein clause recited in claim 8 merely recites an intended result of the method, the result being the occurrence of adverse events. Additionally, claim 8 does not recite additional process steps to the method of claim 1, from which claim 8 depends. Therefore, in view of the instant claim language, the results of the above wherein clause are considered to flow from the process steps as recited in claim 1.
Regarding claim 10, Ruegg teaches that the subscripts p and q (shown above regarding claim 1) are each independently an integer from 0 to 8; or are each independently an integer from 2 to 5 (Ruegg, claim 11).
Regarding claim 12, Ruegg teaches that the positively charged carrier has the amino acid sequence RKKRRQRRRG-(K)15-GRKKRRQRRR (Ruegg, claim 13).
Regarding claims 21-25, Ruegg teaches that the duration of treatment effect comprises at least 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, or lasts at least 6 months through 10 months (Ruegg, claims 18-25).
Regarding claim 28, MPEP 2111.04(I) states that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Claim 28 recites “The method according to claim 1 wherein the risk of dysphagia from the treatment is less than 12%, 10%, 8%, 7%, 5%, or 3%”. The wherein clause recited in claim 8 is merely recites an intended result of the method, the result being the occurrence of dysphagia. Additionally, claim 28 does not recite additional process steps to the method of claim 1, from which claim 28 depends. Therefore, in view of the instant claim language, the results of the above wherein clause are considered to flow from the process steps as recited in claim 1
Regarding claim 29, MPEP 2111.04(I) states that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Claim 29 recites “The method according to claim 1 wherein the risk of musculoskeletal pain from the treatment is less than 12%, 10%, 8%, 7%, 5%, or 3%”. The wherein clause recited in claim 29 merely recites an intended result of the method, the result being the occurrence of musculoskeletal pain. Additionally, claim 29 does not recite additional process steps to the method of claim 1, from which claim 29 depends. Therefore, in view of the instant claim language, the results of the above wherein clause are considered to flow from the process steps as recited in claim 1
Regarding claim 30, MPEP 2111.04(I) states that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Claim 30 recites “The method according to claim 1 wherein the risk of muscular weakness from the treatment is less than 12%, 10%, 8%, 7%, 5%, or 3%”. The wherein clause recited in claim 30 merely recites an intended result of the method, the result being the occurrence of muscular weakness. Additionally, claim 30 does not recite additional process steps to the method of claim 1, from which claim 30 depends. Therefore, in view of the instant claim language, the results of the above wherein clause are considered to flow from the process steps as recited in claim 1.
The deficiencies of Ruegg are shown below:
Regarding claims 1 and 7, Ruegg does not specifically teach that sternocleidomastoid, levator scapulae, and scalenus complex are only unilaterally injected.
Regarding claim 3, Ruegg does not teach that the one or more muscles injected comprise sternocleidomastoid, levator scapulae, and scalenus complex are all injected.
Regarding claims 1 and 7, Walker teaches a method treating cervical dystonia by administering botulinum toxin serotype A via unilateral injection to the sternocleidomastoid, levator scapulae, and scalenus complex (the scalenus complex includes the anterior scalene, middle scalene, and posterior scalene) (Walker, pg. 761, table 1).
Regarding claim 3, Walker teaches that in some cases four or five large muscles may be injected (Walker, pg. 759, [2]).
It would have been obvious to one of ordinary skill in the art to apply the teachings of Walker (i.e., unilateral injection into the sternocleidomastoid, levator scapulae, and scalenus complex), with the method of treating cervical dystonia as taught by Ruegg above. The unilateral injection of botulinum toxin, as taught by Walker, is part of a method to treat cervical dystonia in individuals. The method taught Ruegg is also a method of treating cervical dystonia. Ruegg teaches injecting the sterile injectable composition into one or more of the muscles causing the cervical dystonia (Ruegg, claim 1). Ruegg further teaches that the injectable muscles include sternocleidomastoid, levator scapulae, and scalene complex (Ruegg, table 1). It is known to those of ordinary skill in the art that the scalene complex is the same muscle group referred to in the instant application as “scalenus complex”. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success. Walker teaches that quick successive injections of different muscles are generally well tolerated in patients (Walker, pg. 759, [2]). Both Walker and Ruegg teach the use of botulinum toxin serotype A for the method of treating cervical dystonia (Walker, pg. 761, table 1) (Ruegg, claim 8). Additionally, both Walker and Ruegg teach injection into the same muscles/muscle groups, such as the sternocleidomastoid, levator scapulae, and scalenus complex (Walker, pg. 761, table 1) (Ruegg, table 1). Therefore, it would have obvious to one of ordinary skill in the art to apply the teachings of Walker to the method of treating cervical dystonia as taught by Ruegg. Accordingly, claims 1, 3-5, 7-8, 10, 12, 21-25, 28-30 are rejected.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
(previous rejection, maintained; withdrawn regarding cancelled claims) Claims 1, 3-5, 7-8, 10, 12, 21-25, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Waugh, US 20180311333 A1 (see form PTO-892) in view of Walker (cited above, see form PTO-892).
Waugh teaches a method of administering botulinum toxin to achieve an extended duration therapeutic in an individual, the method comprising:
administering by injection a sterile injectable composition into an area of the individual in need of treatment to achieve the therapeutic following a first treatment with the composition; wherein the composition comprises a pharmaceutically acceptable diluent suitable for injection; and 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 having an amino acid sequence of (gly)p -RGRDDRRQRRR-(gly)q , (gly)p-YGRKKRRQRRR-(gly)q or (gly)p -RKKRRQRRR-(gly)q, wherein the subscripts p and q are each independently an integer of from 0 to 20; (Waugh, claim 1). Waugh further teaches that the botulinum toxin is of serotype A having a molecular weight of 150 kDa (Waugh, claim 7). Waugh teaches that in some embodiments the treatment dose may be 1 U to 400 U (Waugh, [66]). Waugh also teaches that the therapeutic effect of the method is a reduction in symptoms associated with dystonia (Waugh, claim 50). Further, MPEP 2111.04(I) states that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Instant claims 1 and 5 recite “wherein the therapeutic effect is associated with a risk of adverse events, risk of dysphagia, risk of musculoskeletal pain, and/or risk of muscular weakness that is below 15%”. The wherein clause recited in claims 1 and 5 merely recites an intended result of the method, the result being the occurrence of adverse events. Therefore, in view of the instant claim language, the results of the above wherein clause are considered to flow from the process steps as recited in claims 1 and 5.
Regarding claim 8, MPEP 2111.04(I) states that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Claim 8 recites “The method according to claim 1 wherein the risk of adverse events is less than 12%, 10%, 8%, 7%, 5%, or 3%”. The wherein clause recited in claim 8 merely recites an intended result of the method, the result being the occurrence of adverse events. Additionally, claim 8 does not recite additional process steps to the method of claim 1, from which claim 8 depends. Therefore, in view of the instant claim language, the results of the above wherein clause are considered to flow from the process steps as recited in claim 1.
Regarding claim 10, Waugh teaches that the subscripts p and q are each independently an integer from 0 to 8; or are each independently an integer from 2 to 5 (Waugh, claim 11).
Regarding claim 12, Waugh teaches that the positively charged carrier has the amino acid sequence RKKRRQRRRG-(K)15-GRKKRRQRRR (Waugh, claim 29).
Regarding claims 21-25, Waugh further teaches that the duration of treatment effect is greater than 3 months, greater than 4 months, greater than 5 months, greater than 6 months, greater than 7 months, greater than 8 months, greater than 9 months, or is at least 6 months through 10 months (Waugh, claims 20-27).
Regarding claims 28-30, these claims recite wherein clauses that merely state an intended result of the method of claim 1.
Claim 28 recites, “The method according to claim 1, wherein the risk of dysphagia from the treatment is less than 12%, 10%, 8%, 7%, 5%, or 3%”.
Claim 29 recites, “The method according to claim 1, wherein the risk of musculoskeletal pain from the treatment is less than 12%,10%, 8%, 7%, 5%, or 3%”.
Claim 30 recites, “The method according to claim 1, wherein the risk of muscular weakness from the treatment is less than 12%, 10%, 8%, 7%, 5%, or 3%”.
MPEP 2111.04(I) states that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Claims 28-30 do not add additional process steps or limitations to the method of claim 1, and merely recite an intended result of the method of claim 1. Therefore, in view of the instant claim language, the results of the above wherein clauses of claims 28-30 are considered to flow from the process steps as recited in claim 1.
The deficiencies of Waugh are shown below:
Regarding claim 1, Waugh does not teach unilateral injection into the sternocleidomastoid, levator scapulae, or scalenus complex.
Regarding claim 3, Waugh does not teach that unilateral injection into the sternocleidomastoid, levator scapulae, and scalenus complex.
Regarding claim 4, Waugh does not teach the dose range for the sternocleidomastoid, levator scapulae, and scalenus complex set forth in Table 1 or Table 6 of the instant application.
Regarding claim 5, Waugh does not teach the dose range for the splenius capitis, splenius cervices, trapezius, longissimus, sternocleidomastoid, levator scapulae, and scalenus complex set forth in Table 1 or Table 6 of the instant application.
Regarding claim 7, Waugh does not teach that the sternocleidomastoid, levator scapulae, and scalenus complex are only unilaterally injected.
Regarding claims 1 and 7, Walker teaches a method treating cervical dystonia by administering botulinum toxin serotype A via unilateral injection to the sternocleidomastoid, levator scapulae, and scalenus complex (the scalenus complex includes the anterior scalene, middle scalene, and posterior scalene) (Walker, pg. 761, table 1).
Regarding claim 3, Walker teaches that in some cases four or five large muscles may be injected (Walker, pg. 759, [2]).
Regarding claim 5, Walker teaches both injection of botulinum toxin into the splenius capitis, splenius cervices, and trapezius. Additionally, Walker teaches the following dosage per muscle (Walker, pg. 761, table 1):
PNG
media_image2.png
815
579
media_image2.png
Greyscale
The above table from Walker discloses the dose range set forth in instant Table 1 or Table 6 of the trapezius, sternocleidomastoid, splenius capitis, splenius cervices, and levator scapulae.
It would have been obvious to one of ordinary skill in the art to combine the teachings of Waugh and Walker for the treatment of cervical dystonia. A person of ordinary skill would have been motivated to combine the above teachings because Waugh teaches that the therapeutic effect of the method is a reduction in symptoms associated with dystonia (Waugh, claim 50). Waugh further teaches that the injection of botulinum toxin has been used to treat cervical dystonia (Waugh, [8]). The methods taught by Walker are for the treatment of cervical dystonia and comprise the administration of botulinum toxin serotype A (Walker table 1). Furthermore, Waugh teaches the injection of botulinum toxin into the area of the individual in need of treatment (Waugh, claim 1). Because Waugh provides limited detail on the specific dosage and target areas of treatment, one of ordinary skill in the art would need to gather this information from another source. Walker teaches the specific dosage range and injection method in the case of cervical dystonia, and discloses specific muscles to target (Walker, table 1). Additionally, a person having ordinary skill in the art would have a reasonable expectation of success in combining the teachings of Waugh and Walker. Walker states “The beneficial effects of botulinum toxin in cervical dystonia are indisputable” (Walker, pg. 764, [5]). Additionally, Walker teaches that quick successive injections of different muscles are generally well tolerated in patients (Walker, pg. 759, [2]). Therefore, it would have been obvious to one of ordinary skill in the art to combine the above teachings of Waugh and Walker. Accordingly, claims 1, 3-5, 7-8, 10, 12, 21-25, 28-30 are rejected.
Response to Arguments
Applicant's arguments filed 08/27/2025 have been fully considered but they are not persuasive.
Applicants traverse the rejection under U.S.C 103 in view of Ruegg and Walker on the grounds that claims 1 and 5 have been amended to specify that the dose for treating cervical dystonia is either 125 U or 250 U. Applicants argue that Ruegg does not teach any subject having received either of these doses. However, these arguments are not persuasive because the difference between the instant invention and the teachings of the prior art cited above are differences in dose. A differing numerical value or range for the dosage of botulinum toxin is a change in proportion or degree.
See MPEP 2144.05(II)(A) Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
As shown above, the combination of teachings of Ruegg and Walker teach the same method steps as the claimed invention, and differ only in the degree of dosage administered to the subject. As shown above (See MPEP 2144.05(II)(A)), a mere change in proportion or degree cannot sustain the patentability of the claimed method in view of Ruegg and Walker teaching a substantially similar method. Ergo, the previous prior art rejection under U.S.C 103 is maintained. Furthermore, applicants have not traversed the rejection of claims 1, 3-5, 7-8, 10, 12, 21-25, 28-30 under U.S.C. 103 in view of Waugh and Walker, and a similar rational is applied regarding differences in dosage (proportion or degree) and the lack of a patentable distinction. Ergo, both prior art rejections are maintained.
Conclusion
No claims are allowed.
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 BENJAMIN HALL EASTON whose telephone number is (703)756-5851. The examiner can normally be reached 10:30AM - 6:30PM EST.
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, Robert Mondesi can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BENJAMIN HALL EASTON/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
1 Walker, Francis O; Botulinum toxin therapy for cervical dystonia, Physical Medicine and Rehabilitation Clinics of North America, 2003, https://doi.org/10.1016/S1047-9651(03)00045-7