DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 8, 13, 18, and 42-71 are pending and represent all claims currently under consideration.
Priority
This application claims priority to PRO 63/607,987 filed 12/08/2023.
Claims 8, 13, 18, and 42-71 are considered to have an effective filing date of 12/08/2023.
Information Disclosure Statement
The information disclosure statement filed 04/23/2025 has been considered.
Claim Objections
Claims 42, 52, and 62 are objected to because of the following informalities: “stie” should read “site”. Appropriate correction is required.
Specification
The use of the term BOTOX, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Drawings
The drawings are objected to because Figures 3-9 contain the term BOTOX, which is a trade name or a mark used in commerce. As above, the term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 42, 44, 52, 54, 62, and 64 are 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.
Regarding claims 42, 52, and 62, the parenthetical recitation of “approximately 1 to 2 cm apart” renders the claims indefinite because it is unclear whether the limitations in parentheses are part of the claimed invention or describing an example or preference. See MPEP § 2173.05(d).
Regarding claims 42, 52, and 62, the recitation of “slightly anterior” is a relative term which renders the claim indefinite. The term “slightly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how far one can deviate from the “angle of the mandible”. Regarding claims 44, 54, and 64, each claim is dependent on the rejected claims 42, 52, and 62, and does not cure its deficiencies, and therefore is deficient for the same reason as above.
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.
Claims 8, 13, 18, 42-47, 49, 51-57, 59, 61-67, 69, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Brys (Rejuvenation Resource, 2020), further in view of Yi (Toxins, 2022; IDS reference, 04/23/2025).
Regarding claim 8, Brys teaches treatment of the platysma to result in a more defined jawline (Brys, page 22), and teaches injections to treat neck bands which are accentuated by having the patient grimace (i.e., at maximum contraction; Brys, page 24). Brys demonstrates the platysmal band is visible (Brys, figures 15-16), and teaches the most posterior platysmal band is typically the strongest, and the number of anteriorly located bands is variable (Brys, page 24), demonstrating a human patient with only one continuous vertical neck band (Brys, figure 18). Brys further demonstrates 4 injection points 1 cm below (i.e., inferior and parallel to) the edge of the mandible (i.e., “i”; below the jawline, administered to the upper platysma muscle as claimed), and 5 injection points distributed vertically along the platysma band (i.e., “ii”). Brys teaches a dose of about 20-25 units of onabotulinum (i.e., a botulinum toxin as defined by the instant claim 46), which should be distributed evenly between each neck band and region of the platysma (Brys, page 26), which would result in about 1-1.25 units (i.e., about 1) per platysma band injection and about 1.25-1.56 units (i.e., about 2) per mandibular injection if one band is present on each side.
Brys does not specify the distance of each of the 5 neck band injections and does not specify the onabotulinumtoxin is onabotulinumtoxinA. Yi, however, teaches a procedure for botulinum injections targeting the platysma muscle to treat platysma bands (Yi, abstract), and specifically teaches type A botulinum toxins (i.e., BoNT/A; Yi, page 3). Yi teaches BoNT is directly injected into the muscular bands in 5 points below the jawline to the clavicle (i.e., 5 injection sites along the vertical neck band) approximately 2 cm from each other along the band (i.e., approximately 1 to 2 cm apart distributed vertically; Yi, pages 3-4; figure 4).
Brys and Yi are considered to be analogous to the claimed invention, because Brys, Yi, and the instant invention are in the same field of platysmal injections of botulinum toxins. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same 5 injection points along the platysmal band, while Yi specifies a measured distance and a specific type of onabotulinumtoxin to be known in the field.
Regarding claim 13, Brys teaches treatment of the platysma to result in a more defined jawline (Brys, page 22), and teaches injections to treat neck bands which are accentuated by having the patient grimace (i.e., at maximum contraction; Brys, page 24). Brys demonstrates the platysmal band is visible (Brys, figures 15-16), and teaches the most posterior platysmal band is typically the strongest, and the number of anteriorly located bands is variable (Brys, page 24), demonstrating a human patient with two continuous vertical neck bands on each side (Brys, figure 16). Brys further demonstrates 4 injection points 1 cm below (i.e., inferior and parallel to) the edge of the mandible (i.e., “i”; below the jawline, administered to the upper platysma muscle as claimed), and 5 injection points distributed vertically along each platysma band (i.e., “ii”). Brys teaches a dose of about 15-50 units of onabotulinum (i.e., a botulinum toxin as defined by the instant claim 46), which should be distributed evenly between each neck band and region of the platysma (Brys, page 26), which would result in about 0.5-1.7 units (i.e., about 1) per platysma band injection and about 0.6-2.1 units (i.e., about 2) per mandibular injection if two bands are present on each side.
Brys does not specify the distance of each of the 5 neck band injections and does not specify the onabotulinumtoxin is onabotulinumtoxinA. Yi, however, teaches a procedure for botulinum injections targeting the platysma muscle to treat platysma bands (Yi, abstract), and specifically teaches type A botulinum toxins (i.e., BoNT/A; Yi, page 3). Yi teaches BoNT is directly injected into the muscular bands in 5 points below the jawline to the clavicle (i.e., 5 injection sites along the vertical neck band) approximately 2 cm from each other along the band (i.e., approximately 1 to 2 cm apart distributed vertically; Yi, pages 3-4; figure 4). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same 5 injection points along the platysmal band, while Yi specifies a measured distance and a specific type of onabotulinumtoxin to be known in the field.
Regarding claim 18, Brys teaches treatment of the platysma to result in a more defined jawline (Brys, page 22), and teaches injections to treat neck bands which are accentuated by having the patient grimace (i.e., at maximum contraction; Brys, page 24). Brys demonstrates the platysmal band is visible (Brys, figures 15-16), and teaches the most posterior platysmal band is typically the strongest, and the number of anteriorly located bands is variable (Brys, page 24), demonstrating a human patient with two continuous vertical neck bands on a first side and two continuous vertical neck bands on a second side (Brys, figure 15). Brys further demonstrates 4 injection points 1 cm below (i.e., inferior and parallel to) the edge of the mandible (i.e., “i”; below the jawline, administered to the upper platysma muscle as claimed), and 5 injection points distributed vertically along each platysma band (i.e., “ii”). Brys teaches a dose of about 15-50 units of onabotulinum (i.e., a botulinum toxin as defined by the instant claim 46), which should be distributed evenly between each neck band and region of the platysma (Brys, page 26), which would result in about 0.6-2 units (i.e., about 1) per platysma band injection and about 0.75-2.5 units (i.e., about 2) per mandibular injection if one band is present on a first side and two are present on a second side.
Brys does not specify the distance of each of the 5 neck band injections and does not specify the onabotulinumtoxin is onabotulinumtoxinA. Yi, however, teaches a procedure for botulinum injections targeting the platysma muscle to treat platysma bands (Yi, abstract), and specifically teaches type A botulinum toxins (i.e., BoNT/A; Yi, page 3). Yi teaches BoNT is directly injected into the muscular bands in 5 points below the jawline to the clavicle (i.e., 5 injection sites along the vertical neck band) approximately 2 cm from each other along the band (i.e., approximately 1 to 2 cm apart distributed vertically; Yi, pages 3-4; figure 4). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same 5 injection points along the platysmal band, while Yi specifies a measured distance and a specific type of onabotulinumtoxin to be known in the field.
Regarding claim 42, Brys and Yi teach all the elements of the current invention as applied to claim 8. Brys teaches 4 injections points matching those shown in the instant specification (figures 2A-B), which are defined as an anterior site in line with the oral commissure, a posterior site slightly anterior to the angle of the mandible, and two remaining injections which are equidistant between the anterior and posterior injection points (instant specification, paragraph 00329). As above, Brys does not specify the distance of each of the 4 injections. Yi, however, teaches the mandibular injections have a distance of 2 cm (Yi, page 4, “Jawline Lift”). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies a measured distance between injections.
Regarding claim 43, Brys and Yi teach all the elements of the current invention as applied to claim 8. Brys demonstrates the vertical neck band injection sites start below the jawline injection sites (Brys, figure 18, but as above does not measure a distance. As above, Yi teaches the injections are approximately 2 cm from each other (Yi, pages 3-4). Therefore, it would be reasonable to expect the distance between the most superior injection site of the 5 injection sites along the vertical neck band and the jawline injections would also be 2 cm as claimed. As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies a measured distance between injections.
Regarding claim 44, Brys and Yi teach all the elements of the current invention as applied to claim 42. Brys demonstrates the vertical neck band injection sites start below the jawline injection sites (Brys, figure 18, but as above does not measure a distance. As above, Yi teaches the injections are approximately 2 cm from each other (Yi, pages 3-4). Therefore, it would be reasonable to expect the distance between the most superior injection site of the 5 injection sites along the vertical neck band and the jawline injections would also be 2 cm as claimed. As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies a measured distance between injections.
Regarding claim 45, Brys and Yi teach all the elements of the current invention as applied to claim 8. Brys teaches treatment may result in a more defined jawline with less jowling (i.e., blunting; Brys, page 22; figures 15-16), suggesting the neck band results in blunting of the jawline as claimed.
Regarding claim 46, Brys and Yi teach all the elements of the current invention as applied to claim 8. As above, Brys teaches injections of onabotulinum (Brys, page 26), but does not specify the onabotulinumtoxin is onabotulinumtoxinA. Yi, however, specifically teaches type A botulinum toxins (i.e., BoNT/A; Yi, page 3). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same onabotulinumtoxin injections for the same purpose, while Yi teaches a specific type of onabotulinumtoxin to be known in the field.
Regarding claim 47, Brys and Yi teach all the elements of the current invention as applied to claim 8. As above, Brys teaches a dose of about 20-25 units of onabotulinum (Brys, page 26), which is substantially close to the claimed dose of 26 units. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP §2144.05(I).
Regarding claim 49, Brys and Yi teach all the elements of the current invention as applied to claim 8. As above, Brys teaches injections of onabotulinum (Brys, page 26), which suggests the composition is a liquid, but does not specify. Yi, however, specifically states that the onabotulinumtoxinA is diluted in saline (i.e., a liquid; Yi, page 3, “Platysmal Band Injection Points and Methods”). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies the injection is a solution (i.e., liquid).
Regarding claim 51, Brys and Yi teach all the elements of the current invention as applied to claim 8. Brys does not teach an additional dose of the botulinum toxin to the patient’s neck, which therefore reads on the method as claimed.
Regarding claim 52, Brys and Yi teach all the elements of the current invention as applied to claim 13. Brys teaches 4 injections points matching those shown in the instant specification (figures 2A-B), which are defined as an anterior site in line with the oral commissure, a posterior site slightly anterior to the angle of the mandible, and two remaining injections which are equidistant between the anterior and posterior injection points (instant specification, paragraph 00329). As above, Brys does not specify the distance of each of the 4 injections. Yi, however, teaches the mandibular injections have a distance of 2 cm (Yi, page 4, “Jawline Lift”). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies a measured distance between injections.
Regarding claim 53, Brys and Yi teach all the elements of the current invention as applied to claim 13. Brys demonstrates the vertical neck band injection sites start below the jawline injection sites (Brys, figure 18, but as above does not measure a distance. As above, Yi teaches the injections are approximately 2 cm from each other (Yi, pages 3-4). Therefore, it would be reasonable to expect the distance between the most superior injection site of the 5 injection sites along the vertical neck band and the jawline injections would also be 2 cm as claimed. As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies a measured distance between injections.
Regarding claim 54, Brys and Yi teach all the elements of the current invention as applied to claim 52. Brys demonstrates the vertical neck band injection sites start below the jawline injection sites (Brys, figure 18, but as above does not measure a distance. As above, Yi teaches the injections are approximately 2 cm from each other (Yi, pages 3-4). Therefore, it would be reasonable to expect the distance between the most superior injection site of the 5 injection sites along the vertical neck band and the jawline injections would also be 2 cm as claimed. As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies a measured distance between injections.
Regarding claim 55, Brys and Yi teach all the elements of the current invention as applied to claim 13. Brys teaches treatment may result in a more defined jawline with less jowling (i.e., blunting; Brys, page 22; figures 15-16), suggesting the neck band results in blunting of the jawline as claimed.
Regarding claim 56, Brys and Yi teach all the elements of the current invention as applied to claim 13. As above, Brys teaches injections of onabotulinum (Brys, page 26), but does not specify the onabotulinumtoxin is onabotulinumtoxinA. Yi, however, specifically teaches type A botulinum toxins (i.e., BoNT/A; Yi, page 3). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same onabotulinumtoxin injections for the same purpose, while Yi teaches a specific type of onabotulinumtoxin to be known in the field.
Regarding claim 57, Brys and Yi teach all the elements of the current invention as applied to claim 13. As above, Brys teaches a dose of about 15-50 units of onabotulinum (Brys, page 26), which encompasses the claimed amount of 36 units. Brys teaches the doses vary significantly from individual differences in muscle mass and strength and that it is crucial to adjust accordingly (Brys, page 26). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to optimize the amount within the general range taught by Brys.
Regarding claim 59, Brys and Yi teach all the elements of the current invention as applied to claim 13. As above, Brys teaches injections of onabotulinum (Brys, page 26), which suggests the composition is a liquid, but does not specify. Yi, however, specifically states that the onabotulinumtoxinA is diluted in saline (i.e., a liquid; Yi, page 3, “Platysmal Band Injection Points and Methods”). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies the injection is a solution (i.e., liquid).
Regarding claim 61, Brys and Yi teach all the elements of the current invention as applied to claim 13. Brys does not teach an additional dose of the botulinum toxin to the patient’s neck, which therefore reads on the method as claimed.
Regarding claim 62, Brys and Yi teach all the elements of the current invention as applied to claim 18. Brys teaches 4 injections points matching those shown in the instant specification (figures 2A-B), which are defined as an anterior site in line with the oral commissure, a posterior site slightly anterior to the angle of the mandible, and two remaining injections which are equidistant between the anterior and posterior injection points (instant specification, paragraph 00329). As above, Brys does not specify the distance of each of the 4 injections. Yi, however, teaches the mandibular injections have a distance of 2 cm (Yi, page 4, “Jawline Lift”). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies a measured distance between injections.
Regarding claim 63, Brys and Yi teach all the elements of the current invention as applied to claim 18. Brys demonstrates the vertical neck band injection sites start below the jawline injection sites (Brys, figure 18, but as above does not measure a distance. As above, Yi teaches the injections are approximately 2 cm from each other (Yi, pages 3-4). Therefore, it would be reasonable to expect the distance between the most superior injection site of the 5 injection sites along the vertical neck band and the jawline injections would also be 2 cm as claimed. As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies a measured distance between injections.
Regarding claim 64, Brys and Yi teach all the elements of the current invention as applied to claim 62. Brys demonstrates the vertical neck band injection sites start below the jawline injection sites (Brys, figure 18, but as above does not measure a distance. As above, Yi teaches the injections are approximately 2 cm from each other (Yi, pages 3-4). Therefore, it would be reasonable to expect the distance between the most superior injection site of the 5 injection sites along the vertical neck band and the jawline injections would also be 2 cm as claimed. As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies a measured distance between injections.
Regarding claim 65, Brys and Yi teach all the elements of the current invention as applied to claim 18. Brys teaches treatment may result in a more defined jawline with less jowling (i.e., blunting; Brys, page 22; figures 15-16), suggesting the neck band results in blunting of the jawline as claimed.
Regarding claim 66, Brys and Yi teach all the elements of the current invention as applied to claim 18. As above, Brys teaches injections of onabotulinum (Brys, page 26), but does not specify the onabotulinumtoxin is onabotulinumtoxinA. Yi, however, specifically teaches type A botulinum toxins (i.e., BoNT/A; Yi, page 3). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same onabotulinumtoxin injections for the same purpose, while Yi teaches a specific type of onabotulinumtoxin to be known in the field.
Regarding claim 67, Brys and Yi teach all the elements of the current invention as applied to claim 18. As above, Brys teaches a dose of about 15-50 units of onabotulinum (Brys, page 26), which encompasses the claimed amount of 31 units. Brys teaches the doses vary significantly from individual differences in muscle mass and strength and that it is crucial to adjust accordingly (Brys, page 26). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to optimize the amount within the general range taught by Brys.
Regarding claim 69, Brys and Yi teach all the elements of the current invention as applied to claim 18. As above, Brys teaches injections of onabotulinum (Brys, page 26), which suggests the composition is a liquid, but does not specify. Yi, however, specifically states that the onabotulinumtoxinA is diluted in saline (i.e., a liquid; Yi, page 3, “Platysmal Band Injection Points and Methods”). As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys to include the specific injections as taught by Yi, because Brys and Yi teach the same platysmal band and jawline injections, while Yi specifies the injection is a solution (i.e., liquid).
Regarding claim 71, Brys and Yi teach all the elements of the current invention as applied to claim 18. Brys does not teach an additional dose of the botulinum toxin to the patient’s neck, which therefore reads on the method as claimed.
Claims 48, 50, 58, 60, 68, and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Brys (Rejuvenation Resource, 2020) and Yi (Toxins, 2022; IDS reference, 04/23/2025) as applied to claims 8, 13, 18, 42-47, 49, 51-57, 59, 61-67, 69, and 71, further in view of Hunt (US 9629904 B2) and as evidenced by BOTOX® Cosmetic (onabotulinumtoxinA; IDS reference, 04/23/2025).
Regarding claim 48, Brys and Yi teach all the elements of the current invention as applied to claim 8. As above, Brys teaches injections of onabotulinum (Brys, page 26), and Yi specifically states that the onabotulinumtoxinA is diluted in saline (i.e., a liquid; Yi, page 3, “Platysmal Band Injection Points and Methods”), but neither teaches a reconstituted composition as claimed. Hunt, however, teaches that BOTOX® is a vacuum dried mixture (i.e., a powder) of a botulinium toxin type A (i.e., BoNT/A) complex, human albumin, and sodium chloride, which is reconstituted with normal saline (Hunt, column 8, lines 10-23). Hunt further teaches such botulinum toxins include 900 kDa complexes (Hunt, column 11, lines 46-50). As evidenced by BOTOX® Cosmetic, BOTOX® is onabotulinumtoxinA.
Brys, Yi, and Hunt are considered to be analogous to the claimed invention, because Brys, Yi, Hunt, and the instant invention are in the same field of injections of botulinum toxins. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys and Yi to include the brand of botulinum as taught by Hunt, because Brys and Yi teach the injection of onabotulinumtoxin, while Hunt teaches that BOTOX® is a commercially available botulinum toxin known in the field (Hunt, columns 7-8).
Regarding claim 50, Brys and Yi teach all the elements of the current invention as applied to claim 8. Brys and Yi do not teach repeating of the method. Hunt, however, teaches that botulinum toxin type A injections last about 3-6 months (Hunt, column 3, lines 15-16), which would suggest to one of ordinary skill in the art that the method of Brys and Yi, which uses botulinum toxin injections, would need to be repeated after about 12 weeks.
Regarding claim 58, Brys and Yi teach all the elements of the current invention as applied to claim 13. As above, Brys teaches injections of onabotulinum (Brys, page 26), and Yi specifically states that the onabotulinumtoxinA is diluted in saline (i.e., a liquid; Yi, page 3, “Platysmal Band Injection Points and Methods”), but neither teaches a reconstituted composition as claimed. Hunt, however, teaches that BOTOX® is a vacuum dried mixture (i.e., a powder) of a botulinium toxin type A (i.e., BoNT/A) complex, human albumin, and sodium chloride, which is reconstituted with normal saline (Hunt, column 8, lines 10-23). Hunt further teaches such botulinum toxins include 900 kDa complexes (Hunt, column 11, lines 46-50). As evidenced by Abbvie, BOTOX® is onabotulinumtoxinA. As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys and Yi to include the brand of botulinum as taught by Hunt, because Brys and Yi teach the injection of onabotulinumtoxin, while Hunt teaches that BOTOX® is a commercially available botulinum toxin known in the field (Hunt, columns 7-8).
Regarding claim 60, Brys and Yi teach all the elements of the current invention as applied to claim 13. Brys and Yi do not teach repeating of the method. Hunt, however, teaches that botulinum toxin type A injections last about 3-6 months (Hunt, column 3, lines 15-16). As above, this would suggest to one of ordinary skill in the art that the method of Brys and Yi, which uses botulinum toxin injections, would need to be repeated after about 12 weeks.
Regarding claim 68, Brys and Yi teach all the elements of the current invention as applied to claim 18. As above, Brys teaches injections of onabotulinum (Brys, page 26), and Yi specifically states that the onabotulinumtoxinA is diluted in saline (i.e., a liquid; Yi, page 3, “Platysmal Band Injection Points and Methods”), but neither teaches a reconstituted composition as claimed. Hunt, however, teaches that BOTOX® is a vacuum dried mixture (i.e., a powder) of a botulinium toxin type A (i.e., BoNT/A) complex, human albumin, and sodium chloride, which is reconstituted with normal saline (Hunt, column 8, lines 10-23). Hunt further teaches such botulinum toxins include 900 kDa complexes (Hunt, column 11, lines 46-50). As evidenced by Abbvie, BOTOX® is onabotulinumtoxinA. As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Brys and Yi to include the brand of botulinum as taught by Hunt, because Brys and Yi teach the injection of onabotulinumtoxin, while Hunt teaches that BOTOX® is a commercially available botulinum toxin known in the field (Hunt, columns 7-8).
Regarding claim 70, Brys and Yi teach all the elements of the current invention as applied to claim 18. Brys and Yi do not teach repeating of the method. Hunt, however, teaches that botulinum toxin type A injections last about 3-6 months (Hunt, column 3, lines 15-16). As above, this would suggest to one of ordinary skill in the art that the method of Brys and Yi, which uses botulinum toxin injections, would need to be repeated after about 12 weeks.
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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