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 .
Response to Amendment
This office action is responsive to the amendment filed on 27 October 2025. As directed by the amendment: claims 1, 10, 15, 20, and 21 have been amended; no claims have been canceled or added. Thus, claims 1-8, 10-13, and 15-21 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 27 October 2025 have been fully considered but they are not persuasive. Applicant argues that Tucker would require substantial structural reconstruction to arrive at the claimed invention, specifically because Tucker only teaches the use of one scale and Creaturo discloses two sets of markings in the same viewing field of the label. However, these arguments are not persuasive because the concept of using a syringe with multiple volumetric marking graduations is not novel in view of the cited prior art. Changing the label system of a syringe is within the skill of a person of ordinary skill in the art, as evidenced by the multiple embodiments of the syringes of Tucker. In addition, the specific use and intention of the claimed invention cannot be pulled from the specification. As such, the broad limitations of the claim can be taught by the prior art for different reasons and motivations than intended by the applicant. Changing the label of a syringe is the result of the requirements of a user, and the combination of Tucker, Creaturo, and Verhoeven make the claims obvious as detailed below.
Claim Objections
Claim 15 is objected to because of the following informalities: in line 1, the claim should depend on claim 1 not claim 15. Appropriate correction is required.
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.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tucker (US 2010/0130961).
Regarding claim 20, Tucker discloses:
A botulinum toxin syringe (110; Fig. 4) comprising a barrel (120) having volumetric marking graduations consisting of marking graduations scaled at 4 units per 0.1 mL (¶0048 – “a dosage concentration of 40 units ("U")/1 mL”) disposed on a first side of the barrel (120), and a second side (side not visible in Fig. 4) of the barrel (120) is absent of markings.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8, 10-13, 15-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Tucker in view of Creaturo (US 2013/0204225) further in view of Verhoeven et al (US 2015/0094667).
Regarding claim 1, Tucker discloses:
A botulinum toxin syringe (110; Fig. 4) comprising a barrel (120) having volumetric marking graduations (Fig. 4; ¶0048) scaled at 4 units per 0.1 mL (¶0048 – “a dosage concentration of 40 units ("U")/1 mL”), the volumetric marking graduations being at a fixed locations along the barrel (120) as a plunger (32) is withdrawn from the barrel (120) to draw a solution into the barrel (¶0047).
Tucker is silent regarding “the barrel having further volumetric markings having further volumetric graduations on a different scale from a scale of the volumetric marking graduations, the volumetric marking graduations being at fixed locations along the barrel as a plunger is withdrawn from the barrel to draw a solution into the barrel” and “wherein the volumetric marking graduations and the further volumetric marking graduations are aligned along a length of the barrel; wherein the volumetric marking graduations correspond to a first scale and the further volumetric graduations correspond to a second scale, wherein the first scale is marked on a side of the barrel opposite from the second scale.”
However, Creaturo teaches a label system for a syringe (Abstract), thus being in the same field of endeavor, with a barrel (402; Fig. 4) having multiple measuring markings, with a first set (103) aligned with a differently scaled second set (107) at fixed locations along the barrel (¶0043). Verhoeven teaches that using different units during the use of botulinum toxin injections allows a clinician to simplify the calculations/conversions needed during injection, which reduces the risk of errors (Verhoeven, ¶0009). As seen in Image 1 below, these two scales are on opposite sides of the barrel. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Tucker with further volumetric markings aligned with the volumetric marking graduations, as taught by Creaturo, in order to reduce errors during botulinum toxin injection, as taught by Verhoeven.
Image 1. Annotation portion of Fig. 4 of Creaturo
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Regarding claim 2, Tucker in view of Creaturo and Verhoeven discloses:
The syringe as claimed in claim 1, wherein the volumetric marking graduations increment in twos (¶0048 – the longer lines of the graduations are in increments of two units at a time).
Regarding claim 3, Tucker in view of Creaturo and Verhoeven discloses the syringe as claimed in claim 1, wherein Creaturo further teaches volumetric marking graduations (107) that increment in twos and do not include any other graduations therebetween in order to provide a scale as required by a user. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the volumetric marking graduations of Tucker to have increments in twos without any other graduations in between as taught by Creaturo in order to provide sufficient structure for a user.
Regarding claim 4, Tucker in view of Creaturo and Verhoeven discloses the syringe as claimed in claim 1 but is silent regarding “wherein the maximum volumetric marking graduation is between 8 and 16.” However, Tucker teaches that the length of the syringe depends on the maximum capacity of the syringe (¶0048). For a syringe of maximum capacity 1.0 mL the maximum marking is 40. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Tucker to have a maximum volumetric marking graduation between 8 and 16 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Tucker would not operate differently with the claimed maximum volumetric marking graduation to result in a maximum capacity of 0.2 mL to 0.4 mL and, since the graduation is intended to help measure the desired volume of fluid by a user, the device would function appropriately having the claimed maximum graduation. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the maximum graduation “may” be one of a variety of values (instant ¶0024-0027).
Regarding claim 5, Tucker in view of Creaturo and Verhoeven discloses the syringe as claimed in claim 4, wherein a maximum volumetric marking graduation of 12 and would corresponds with 0.3 mL.
Regarding claim 6, Tucker in view of Creaturo and Verhoeven discloses the syringe as claimed in claim 1, but is silent regarding “wherein a maximum volumetric marking graduation is 20 which corresponds with 0.5 mL.” However, Tucker teaches that the length of the syringe depends on the maximum capacity of the syringe (¶0048). For a syringe of maximum capacity 1.0 mL the maximum marking is 40. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Tucker to have a maximum volumetric marking graduation of 20 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Tucker would not operate differently with the claimed maximum volumetric marking graduation to result in a maximum capacity of 0.5 mL and, since the graduation is intended to help measure the desired volume of fluid by a user, the device would function appropriately having the claimed maximum graduation. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the maximum graduation “may” be one of a variety of values (instant ¶0024-0027).
Regarding claim 7, Tucker in view of Creaturo and Verhoeven discloses:
The syringe as claimed in claim 1, wherein a maximum volumetric marking graduation is 40 (Fig. 4) which corresponds with 1 mL (¶0048).
Regarding claim 8, Tucker in view of Creaturo and Verhoeven discloses the syringe as claimed in claim 1 but is silent regarding “wherein the further volumetric markings are scaled at 10 units per 0.1 mL.” However, Verhoeven further teaches further volumetric marking graduations scaled at 10 units per 0.1 mL (¶0033 – the volume unit can be 0.01, which is equivalent to 10 units per 0.1 mL). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Tucker with further volumetric marking graduations as taught by Verhoeven in order to allow a user to use different graduation markings for different solutions, as recognized by Verhoeven.
Regarding claim 10, Tucker in view of Creaturo and Verhoeven discloses the syringe as claimed in claim 1 but is silent regarding “wherein the further volumetric markings are scaled at 20 units to 0.1 mL.” However, Verhoeven further teaches further volumetric marking graduations scaled at 20 units per 0.1 mL (¶0034 – the volume unit can be 0.025, which is equivalent to 20 units per 0.1 mL). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Tucker with further volumetric marking graduations as taught by Verhoeven in order to allow a user to use different graduation markings for different solutions, as recognized by Verhoeven.
Regarding claim 11, Tucker in view of Creaturo and Verhoeven discloses the syringe as claimed in claim 10 where the modification in view of Creaturo in the rejection of claim 1 teaches having a scale with increments of 10 (Fig. 4).
Regarding claim 12, Tucker in view of Creaturo and Verhoeven discloses the syringe as claimed in claim 11 where the modification in view of Creaturo in the rejection of claim 1 teaches having a scale with the further volumetric markings (107) have graduations from 10 to 60.
Regarding claim 13, Tucker in view of Creaturo and Verhoeven discloses the syringe as claimed in claim 12, wherein the further volumetric markings have a 60 unit graduation corresponding with a 0.3 mL as modified by Verhoeven in the rejection of claim 10.
Regarding claim 15, Tucker in view of Creaturo and Verhoeven discloses the syringe as claimed in claim 15 but is silent regarding “wherein a two unit graduation of volumetric markings aligns with a 10 unit graduation of the further volumetric markings.” However, as seen in the rejection of claim 1, Tucker teaches markings at a scale of 4 units per 0.1 mL. Verhoeven further teaches further volumetric marking graduations scaled at 20 units per 0.1 mL (¶0034 – the volume unit can be 0.025, which is equivalent to 20 units per 0.1 mL) to allow a user to use different graduation markings for different solutions. Creaturo teaches markings at different scales in a syringe are aligned for simplifying an injection procedure. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Tucker to incorporate each of these teaches for the reasons detailed in the rejections of claims 1 and 10, which would result in the two unit graduation of the scale “4 units per 0.1 mL” aligning with the ten unit graduation of the scale “20 units per 0.1 mL.”
Regarding claim 16, Tucker in view of Creaturo and Verhoeven discloses:
A method of injecting botulinum toxin using the syringe as claimed in claim 1, the method comprising injecting a number of units of botulinum toxin (¶0058) according to the graduations, the graduations scaled at 4 units to 0.1 mL (¶0048 – “a dosage concentration of 40 units ("U")/1 mL”).
Regarding claim 17, Tucker in view of Creaturo and Verhoeven discloses a method of injecting botulinum toxin or insulin using the syringe as claimed in claim 8, the method comprising selecting a scale (the volumetric markings or the further volumetric markings as taught by Creaturo in the rejection of claim 1) for use depending on whether botulinum toxin or insulin is being administered (Tucker; ¶0009-0011, 0015 – units are selected depending on the reconstituted medication, which can be either insulin or botulinum toxin).
Regarding claim 18, Tucker in view of Creaturo and Verhoeven discloses a method of injecting botulinum toxin or insulin using the syringe as claimed in claim 9, the method comprising selecting a scale (the volumetric markings or the further volumetric markings as taught by Creaturo in the rejection of claim 1) for use depending on a type of botulinum toxin being administered using the syringe (¶0050 – the volumetric markings are selected based on the concentration of botulinum toxin, which is interpreted as a type of botulinum toxin).
Regarding claim 19, Tucker in view of Creaturo and Verhoeven discloses the method as claimed in claim 18 and further teaches the graduations of the volumetric markings are scaled at 4 units to 0.1 mL (Tucker; ¶0048) but is silent regarding “the graduations of the further volumetric markings are scaled at 20 units to 0.1 mL.” However, Verhoeven further teaches further volumetric marking graduations scaled at 10 units per 0.1 mL (¶0034 – the volume unit can be 0.025, which is equivalent to 20 units per 0.1 mL). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the device of Tucker with further volumetric marking graduations as taught by Verhoeven in order to allow a user to use different graduation markings for different solutions, as recognized by Verhoeven.
Regarding claim 21, Tucker discloses:
A botulinum toxin syringe (110; Fig. 4) comprising a barrel (120) having volumetric marking graduations (Fig. 4; ¶0048) scaled at 4 units per 0.1 mL (¶0048 – “a dosage concentration of 40 units ("U")/1 mL”), the volumetric marking graduations being at a fixed locations along a first side of the barrel (120) as a plunger (32) is withdrawn from the barrel (120) to draw a solution into the barrel (¶0047), and a second side (side not visible in Fig. 4) of the barrel (120).
Tucker is silent regarding “wherein the volumetric marking graduations increment in twos and do not include any other graduations therebetween.” However, Creaturo teaches a label system for a syringe (Abstract), thus being in the same field of endeavor, with a barrel (402; Fig. 4) having volumetric marking graduations (107) that increment in twos and do not include any other graduations therebetween in order to provide a scale as required by a user. Verhoeven teaches that using different units during the use of botulinum toxin injections allows a clinician to simplify the calculations/conversions needed during injection, which reduces the risk of errors (Verhoeven, ¶0009). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the volumetric marking graduations of Tucker to have increments in twos without any other graduations in between as taught by Creaturo in order to reduce error, as taught by Verhoeven.
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 TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783