DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
As set forth in the last Office Action, the earliest prior-filed application that provides support for the subject matter of independent claims 15 and 21 is Application No. 14/453,475 which has a filing date of 8/6/2014 and, accordingly, this filing date is the effective filing date for all claims of the present application.
Election/Restrictions
Newly submitted claims 24-34 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The invention of claims 15-23 and the invention of claims 24-34 are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because it does not require the valve assembly to be a component of the canister as in the subcombination. The subcombination does not include the canister as a part of the claimed invention nor does it require the structural ability to be attachable to a syringe; therefore, the subcombination has a separate utility from the combination because it can be used as a solo applicator (absent connection with another type of applicator, i.e. a syringe) and it can be used to deliver a non-anesthetizing and/or non-gaseous composition from a vial or other non-canister container.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 24-34 have been withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Specification
The amendment to Paragraph [0001] is acceptable and overcomes the objection set forth in the last Office Action.
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 15, 16, 18, 21 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,793,944 in view of Vehring et al. (PG PUB 2011/0135737). The subject matter of independent claim 15 of the present application is fully disclosed in patented claim 1 except requiring the gaseous anesthetizing composition to include 134a refrigerant; similarly, the subject matter of independent claim 21 is also fully disclosed in patented claim 1 except requiring the gaseous anesthetizing composition to include 227a refrigerant. Vehring, however, teaches using 134a refrigerant and 227a refrigerant in a propellant since it is safe, toxicologically innocuous, and more environmentally-friendly than traditional propellants (Para 5,84,85). Therefore, the subject matter of independent claims 15 and 19 is unpatentable on the ground of nonstatutory double patenting. In view of this combination, the subject matter of present claim 16 is fully disclosed in patented claim 2 and the subject matter of present claims 18 and 22 is also fully disclosed in patented claim 1. Although the patent and Vehring do not explicitly disclose that the refrigerants are “capable of blanching the user’s skin to provide a visible target for insertion of said needle” as newly added to claims 15 and 21, this limitation does not overcome the double patenting rejection because this is an inherent characteristic of the 134a and 227a refrigerants.1
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 15, 18, 19, 20 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Salzman (PG PUB 2010/0022965) in view of Vehring et al. (PG PUB 2011/0135737).
Re claim 15, Salzman discloses an applicator 20+31 (Fig 1,2; it is noted that all reference characters cited below refer to Fig 1,2 unless otherwise noted) attachable to a syringe (it is noted that the italicized text constitutes functional language and, therefore, “a syringe” is not a part of the claimed invention; this limitation is met in view of Fig 1,2), the applicator configured to dispense one or more compositions (Para 53) comprising: a module 40+63+65+71 configured to be removably attached to the barrel portion of a syringe (the italicized text constitutes functional language; as set forth above, the “syringe” is not a part of the claimed invention and, therefore, the “barrel portion” is also not a part of the claimed invention; this limitation is met via clip 21, Para 49), said module including a module body (all components of the module 40+63+65+71), said module body including a dispensing trigger 65, said dispensing trigger operably connected to a valve assembly 63, said dispensing trigger configured to control stoppage and flow of a pressurized gas (Para 54,57); a canister 31 containing an anesthetizing composition (comprising “ethyl chloride”, Para 64), said canister fluidly connected to said module body so that said anesthetizing composition is in fluid communication with a first side (the proximal side of valve assembly 63 in Fig 2) of said valve assembly (Para 52); an elongated outlet nozzle 51 extending from an outlet side (the distal side of valve assembly 63 in Fig 2) of said valve assembly, said elongated outlet nozzle configured to direct said anesthetizing composition therefrom to intersect with a delivery axis of a needle connected to said syringe when said syringe is attached to said module (it is noted that the italicized text constitutes functional language and, therefore, “a needle” – like the “syringe” – is not a part of the claimed invention; this limitation is met in view of Fig 1 that shows a needle having any distal shape can be attached to tip 11); wherein said anesthetizing composition decreases a temperature of a user's skin to cause numbness prior to an injection (“ethyl chloride”, Para 64, is a topical vapocoolant that numbs skin by freezing the area), and wherein said anesthetizing composition is capable of blanching the user’s skin to prove a visible target for insertion of said needle (the ability to blanche skin is a known characteristic attribute of ethyl chloride2). Since Para 15 discloses that the composition is a spray and Para 57 discloses that the composition automatically sprays from the canister upon the removal of compressor 63, one of ordinary skill in the art would be led to believe that the composition must be a pressurized gaseous aerosol propellant, but this is not explicitly disclosed. Additionally, Salzman does not explicitly disclose that the composition includes 134a refrigerant.
Vehring, however, teaches applying a composition that is a pressurized gaseous aerosol propellant for topical administration (Para 84, “topical use”), wherein the propellant includes 134a refrigerant (Para 85); Vehring teaches that 134a refrigerant provides the pressure necessary to carry the composition to the target site (Para 5) and is safe and toxicology innocuous (Para 84) and more environmentally-friendly than traditional propellants (Para 5). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Salzman to include the composition as a gaseous aerosol propellant that includes 134a refrigerant, as also taught by Vehring, for the purpose of ensuring that the composition has the propulsive force necessary to reach the target site (Para 5) and ensuring that the composition is safe and toxicology innocuous (Para 84) and more environmentally-friendly than traditional propellants (Para 5). It is also noted that the ability to blanch a user’s skin is a characteristic attribute of 134a refrigerant3.
Re claim 18, Salzman as modified by Vehring in the rejection of claim 15 above discloses all the claimed features with Vehring teaching that the pressurized gaseous anesthetizing composition further includes 227a refrigerant (Para 82, “one or more non-CFC propellants”; Para 85).
Re claim 19, Salzman as modified by Vehring in the rejection of claim 18 above discloses all the claimed features except the % by weight of the two refrigerants in the composition; therefore, Salzman/Vehring do not explicitly disclose that the amount of 134a refrigerant can be from about 0.001% to 99.999% by weight of the pressurized gaseous anesthetizing composition with the 227a refrigerant comprising the remainder of the pressurized gaseous anesthetizing composition. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the amount of 134a refrigerant in the composition to be from about 0.001% to 99.999% by weight and to include the 227a refrigerant as comprising the remainder of the composition since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Re claim 20, Salzman as modified by Vehring in the rejection of claim 18 above discloses all the claimed features except the % by weight of the two refrigerants in the composition; therefore, Salzman/Vehring do not explicitly disclose that the amount of 227a refrigerant can be from about 0.001% to 94.999% by weight of the pressurized gaseous anesthetizing composition with the 134a refrigerant comprising the remainder of the gaseous anesthetizing composition. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the amount of 227a refrigerant in the composition to be from about 0.001% to 94.999% by weight and to include the 134a refrigerant as comprising the remainder of the composition since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Re claim 21, Salzman discloses an applicator 20+31 (Fig 1,2; it is noted that all reference characters cited below refer to Fig 1,2 unless otherwise noted) attachable to a syringe (it is noted that the italicized text constitutes functional language and, therefore, “a syringe” is not a part of the claimed invention; this limitation is met in view of Fig 1,2), the applicator configured to dispense one or more compositions (Para 53), the applicator comprising: a module 40+63+65+71 configured to be removably attached to a barrel portion of a syringe (the italicized text constitutes functional language; as set forth above, the “syringe” is not a part of the claimed invention and, therefore, the “barrel portion” is also not a part of the claimed invention; this limitation is met via clip 21, Para 49), said module including a module body (all components of the module 40+63+65+71), said module body including a dispensing trigger 65, said dispensing trigger operably connected to a valve assembly 63, said dispensing trigger configured to control stoppage and flow of a pressurized gas (Para 54,57); a canister 31 containing an anesthetizing composition (comprising “ethyl chloride”, Para 64), said canister fluidly connected to said module body (Para 52) so that said anesthetizing composition is in fluid communication with a first side (the proximal side of valve assembly 63 in Fig 2) of said valve assembly; an elongated outlet nozzle 51 extending from an outlet side (the distal side of valve assembly 63 in Fig 2) of said valve assembly, said elongated outlet nozzle configured to direct said anesthetizing composition therefrom to intersect with a delivery axis of a needle connected to said syringe when said syringe is attached to said module (it is noted that the italicized text constitutes functional language and, therefore, “a needle” – like the “syringe” – is not a part of the claimed invention; this limitation is met in view of Fig 1 that shows a needle having any distal shape can be attached to tip 11); wherein the anesthetizing composition decreases the temperature of a user's skin to cause numbness prior to an injection (“ethyl chloride”, Para 64, is a topical vapocoolant that numbs skin by freezing the area), and wherein the anesthetizing composition is capable of blanching the user’s skin to provide a visible target for insertion of said needle (the ability to blanche skin is a known characteristic attribute of ethyl chloride4). Since Para 15 discloses that the composition is a spray and Para 57 discloses that the composition automatically sprays from the canister upon the removal of compressor 63, one of ordinary skill in the art would be led to believe that the composition must be a pressurized gaseous aerosol propellant, but this is not explicitly disclosed. Additionally, Salzman does not explicitly disclose that the composition includes 227a refrigerant.
Vehring, however, teaches applying a composition that is a gaseous aerosol propellant for topical administration (Para 84, “topical use”), wherein the propellant includes 227a refrigerant (Para 85); Vehring teaches that 227a refrigerant provides the pressure necessary to carry the composition to the target site (Para 5) and is safe and toxicology innocuous (Para 84) and more environmentally-friendly than traditional propellants (Para 5). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Salzman to include the composition as a gaseous aerosol propellant that includes 227a refrigerant, as also taught by Vehring, for the purpose of ensuring that the composition has the propulsive force necessary to reach the target site (Para 5) and ensuring that the composition is safe and toxicology innocuous (Para 84) and more environmentally-friendly than traditional propellants (Para 5). It is also noted that the ability to blanch a user’s skin is a characteristic attribute of 227a refrigerant5.
Claims 16, 17, 22 and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Salzman (PG PUB 2010/0022965)/Vehring et al. (PG PUB 2011/0135737) in view of Wycoki (PG PUB 2011/0098634).
Re claims 16 and 22, Salzman/Vehring disclose all the claimed features except that the pressurized gaseous anesthetizing composition further includes an antimicrobial. Wycoki, however, teaches including an antimicrobial (“povidone iodine”, Para 10) in a pressurized gaseous anesthetizing composition (“pressurized combination of ethyl chloride and povidone iodine”, Para 10) for the purpose of providing an antiseptic effect along with the anesthetic effect (Para 28). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Salzman/Vehring to include the composition with an antimicrobial, as taught by Wycoki, for the purpose of providing an antiseptic effect along with the anesthetic effect (Para 28).
Re claim 17, Salzman/Vehring as modified by Wycoki in the rejection of claim 16 above disclose that the antimicrobial alters the vapor pressure of the 134a propellant (Raoult’s Law establishes that changes in the proportion of a propellant in a composition alter the vapor pressure; therefore, based on Raoult’s Law, the inclusion of an antimicrobial in a composition (which decreases the proportion of propellant in the composition) would alter the vapor pressure).
Re claim 23, Salzman/Vehring as modified by Wycoki in the rejection of claim 16 above disclose that the antimicrobial alters the vapor pressure of the 227a propellant (Raoult’s Law establishes that changes in the proportion of a propellant in a composition alter the vapor pressure; therefore, based on Raoult’s Law, the inclusion of an antimicrobial in a composition (which decreases the proportion of propellant in the composition) would alter the vapor pressure).
Response to Arguments
Applicant's arguments filed 8/5/2026 have been fully considered but they are not persuasive.
Applicant argues that the amendments to claims 15 and 21 overcome the double patenting rejections set forth in the last Office Action. This is not persuasive because, although the patent and Vehring do not explicitly disclose that the refrigerants are “capable of blanching the user’s skin to provide a visible target for insertion of said needle” as newly added to claims 15 and 21, this is a characteristic attribute of the claimed 134a and 227a refrigerants (see NPL cited above).
Applicant argues that the amendments made to claims 15 and 21 – requiring their respective compositions to be “capable of blanching the user’s skin to provide a visible target for insertion of said needle” – overcome the references cited in the last Office Action. This is not persuasive because this function is a characteristic attribute of ethyl chloride, disclosed by Salzman, and 134a and 227a refrigerants, taught by Vehring (see NPL cited above). The claims are not method claims and, therefore, do not require the step of the skin actually being blanched.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571)272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1R-134a Safety Data Sheet. National Refrigerants, Inc. <https://refrigerants.com/wp-content/uploads/2019/12/SDS-R134a.pdf>.
See “Potential Health Hazards” on page 1.
HFC227ea Safety Data Sheet. A-GAS. <https://www.agas.com/uk/products-and-services/fire-suppressants-and-halons/r227ea>.
See “Section 4 First aid measures” on page 3.
2 “Ethyl Chloride”. RX List. <https://www.rxlist.com/ethyl-chloride-drug.htm>.
See “What Are Side Effects of Ethyl Chloride?” on Page 1.
3 R-134a Safety Data Sheet. National Refrigerants, Inc. <https://refrigerants.com/wp-content/uploads/2019/12/SDS-R134a.pdf>.
See “Potential Health Hazards” on page 1.
4 “Ethyl Chloride”. RX List. <https://www.rxlist.com/ethyl-chloride-drug.htm>
5 HFC227ea Safety Data Sheet. A-GAS. <https://www.agas.com/uk/products-and-services/fire-suppressants-and-halons/r227ea>.
See “Section 4 First aid measures” on page 3.
