DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications No. 60/733,757, 11/636,859, 12/557,753 and 13/927,454 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the independent claims of the present application. 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. Therefore, this filing date is the effective filing date for all claims of the present application.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] refers to U.S. Patent Application No. 16/863,404; since this application was issued as US Patent 11,793,944 on 10/24/2023, paragraph [0001] should be updated to indicate this. Appropriate correction is required.
Claim Objections
Claim 15 is objected to because of the following informalities: The term “the” in the phrase “the barrel portion” on lines 3-4 should be replaced with the term “a” since this is the first time this feature is being introduced. The term “the” in the phrase “the stoppage” on line 6 should be removed since this is the first time this feature is being introduced. The phrase “said module body” on line 10 should be replaced with the phrase “said body of said module” to match the language used earlier in the claim. The term “pressurized” on lines 10 and 14 should be removed from the phrase “said pressurized gaseous anesthetizing composition” in order to match the language used earlier in the claim. The period at the end of line 17 should be replaced with a semi-colon. The term “the” in the phrase “the temperature” on line 19 should be removed since this is the first time this feature is being introduced. A comma should be inserted before the term “wherein” on line 20 in order to be grammatically correct. The term “gaseous” should be inserted on line 20 before the phrase “anesthetizing composition” to match the language used earlier in the claim. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: The term “the” in the phrase “the vapor pressure” on line 3 should be replaced with the term “a” since this is the first time this feature is being introduced. The term “refrigerant” should be inserted after the term “134a” on line 3 in order for the phrase to be complete. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: The term “the” in the phrase “the amount” on line 3 should be replaced with the term “an” since this is the first time this feature is being introduced. The term “the” should be inserted before the phrase “134a refrigerant” on line 3 since this feature has already been introduced in claim 15. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: The term “the” in the phrase “the amount” on line 3 should be replaced with the term “an” since this is the first time this feature is being introduced. The term “the” should be inserted before the phrase “227a refrigerant” on line 3 since this feature has already been introduced in claim 15. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: The term “the” in the phrase “the barrel portion” on lines 3-4 should be replaced with the term “a” since this is the first time this feature is being introduced. The term “the” in the phrase “the stoppage” on line 6 should be removed since this is the first time this feature is being introduced. The phrase “said module body” on line 10 should be replaced with the phrase “said body of said module” to match the language used earlier in the claim. The term “pressurized” on lines 10 and 14 should be removed from the phrase “said pressurized gaseous anesthetizing composition” in order to match the language used earlier in the claim. The period at the end of line 17 should be replaced with a semi-colon. The term “the” in the phrase “the temperature” on line 19 should be removed since this is the first time this feature is being introduced. A comma should be inserted before the term “wherein” on line 20 in order to be grammatically correct. The term “gaseous” should be inserted on line 20 before the phrase “anesthetizing composition” to match the language used earlier in the claim. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: The term “the” in the phrase “the vapor pressure” on line 3 should be replaced with the term “a” since this is the first time this feature is being introduced. The term “refrigerant” should be inserted after the term “227a” on line 3 in order for the phrase to be complete. Appropriate correction is required.
Claims 16-20, 22 and 23 are objected to because of the following informalities: Each of claims 16-20, 22 and 23 should include a comma before the term “wherein” in order to be grammatically correct. Appropriate correction is required.
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 17, 19, 20 and 23 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.
Each of claims 17 and 23 recites “the antimicrobial”. This phrase lacks proper antecedent basis because claim 17 depends from claim 15 and claim 23 depends from claim 21, neither of which introduce an “antimicrobial”. Since claims 16 and 22 introduce an “antimicrobial”, it is unclear if claims 17 and 23 are intended to introduce “an antimicrobial” or are intended to depend on claims 16 and 22, respectively. For the sake of examination, claims 17 and 23 is interpreted as depending on claims 16 and 22, respectively, instead of claims 15 and 21. It is suggested to amend claim 17 to recite “according to Claim [[15]] 16” and to amend claim 23 to recite “according to Claim [[21]] 22”.
Claim 19 recites “the amount of 134a refrigerant can be from about 0.001% to 99.999% by weight”. This phrase is incomplete since it does not specify what the weight belongs to (i.e. “by weight of what?”). Based on the disclosure, it appears that the weight belongs to the “gaseous anesthetizing composition”; accordingly, this is the interpretation applied for the sake of examination. It is suggested to amend each of claim 19 to recite “0.001% to 99.999% by weight of the gaseous anesthetizing composition”.
Claim 20 recites “the amount of 227a refrigerant can be from about 0.001% to 94.999% by weight”. This phrase is incomplete since it does not specify what the weight belongs to (i.e. “by weight of what?”). Based on the disclosure, it appears that the weight belongs to the “gaseous anesthetizing composition”; accordingly, this is the interpretation applied for the sake of examination. It is suggested to amend each of claim 20 to recite “0.001% to 94.999% by weight of the gaseous anesthetizing composition”.
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.
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 for dispensing one or more compositions (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) 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 body (all components of the module 40+63+65+71), said body including a dispensing trigger 65, said dispensing trigger operably connected to a valve assembly 63 for controlling the 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 through a flexible hose connection 35 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 for directing 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). 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 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 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).
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 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 with the 227a 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 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 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 for dispensing one or more compositions (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) 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 body (all components of the module 40+63+65+71), said body including a dispensing trigger 65, said dispensing trigger operably connected to a valve assembly 63 for controlling the 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 through a flexible hose connection 35 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 for directing 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). 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 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).
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 gaseous anesthetizing composition further includes an antimicrobial. Wycoki, however, teaches including an antimicrobial (“povidone iodine”, Para 10) in a 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat 6,290,683 to Erez et al., PG PUB 2009/0004628 to Knutson, PG PUB 2010/0174237 to Halaka, and PG PUB 2012/0130340 to Knutson each disclose an applicator attachable to a syringe and used for anesthetizing the skin where an injection by the syringe is made.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783