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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 10/08/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/08/2025.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 9 indicates the packet material is biodegradable which is not included in the specification.
Claim 10 indicates the swab is made of absorbent material including any of cotton or other natural product which is not included in the specification.
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.
Claim 5 is 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 Claim 5, the limitation “wherein the swabs of the first device are saturated with sterile water and ethyl alcohol 62% or isopropyl alcohol 70%.” It is unclear if this limitation is to be read as the swabs are saturated with either 1) sterile water and ethyl alcohol 62% or 2) isopropyl alcohol 70% or if the limitation is to be read as the swabs are saturated with either 3) sterile water and ethyl alcohol 62% or 4) sterile water and isopropyl alcohol 70%. For the purpose of compact prosecution, the limitation is interpreted as the swabs are saturated with either sterile water and ethyl alcohol 62% or sterile water and isopropyl alcohol 70%.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1, 4, 8, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kern et al (US 4457756) in view of Lebovic et al (US 2022/0104611).
Regarding Claim 1, Kern discloses a nasal swab device (10, Figs. 1-4), the device (10, Figs. 1-4) having a body (legs 12 and 14, Figs. 1-4) from which two spaced apart prongs (end portions 30 and 32, Figs. 1-4) extend, and each of the prongs (30 and 32, Figs. 1-4) having a free end (head 35, Figs. 1-4) to which a swab (absorbent pads 18 and 20, Figs. 1-4) is attached, wherein the swabs (18 and 20, Figs. 1-4) are saturated with a medical liquid (Col. 6 lines 40-46);
a columellar guard (stop elements 22 and 24, Figs. 1-4; Col. 6 lines 10-13 indicates the stop elements can also be formed by enlargement of the shoulders 34 and 36) formed as an edge of the body (12 and 14, Figs. 1-4); and
a packet inside which the device (10, Figs. 1-4) is sealed (Col. 5 lines 50-57).
Kern is silent regarding a 2-step nasal swab kit comprising a pair of nasal swab devices, wherein the swabs of a first device are saturated with at least one cleaning ingredient and the swabs of a second of the devices are saturated with a sanitizing ingredient or antibiotic, and wherein each nasal swab device is sealed inside an individual packet.
Lebovic teaches a 2-step nasal swab kit, thus being in the same field of endeavor, where the kit comprises a pair of nasal swabs (¶ [0002, 0123, 0127]), where the swab of the first device is saturated with at least one cleaning ingredient and the swab of a second of the devices are saturated with a sanitizing ingredient or antibiotic (¶ [0107, 0123, 0127-0128, 0134, 0143]; the system can comprise one or more swabs and one or more substances, and one substance can be ethyl alcohol and another substance can be an antiseptic). This allows one swab to focus on debridement of the nasal cavity and the other swab to deliver a substance to the nasal cavity (¶ [0009-0010]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kern to come in a kit form with two devices, where the swabs of the first device are saturated with at least one cleaning ingredient and the swabs of the second device are saturated with a sanitizing ingredient or antibiotic, as taught by Lebovic, so that the first swab can focus on debridement and cleaning of the nasal cavity and the second swab can deliver a substance to treat the nasal cavity (as motivated by Lebovic ¶ [0009-0010]). This would be beneficial in the case of a nosebleed, as the first swab could remove any debris and dried blood from the nose, and the second swab would be able to more efficiently deliver medication to the nose once the debris and dried blood has been removed. The combination of Kern/Lebovic would have the first device sealed inside a first packet and the second device sealed inside a second packet, as Kern indicates that the devices should be kept in a sealed package to ensure the medication does not evaporate (Kern Col. 5 lines 50-57); one would understand that devices would be individually packaged.
Regarding Claim 4, the combination of Kern/Lebovic discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Kern/Lebovic further discloses the at least one cleaning ingredient is selected from lavender oil and ethyl alcohol (Lebovic ¶ [0058, 0114, 0134-0135]).
Regarding Claim 8, the combination of Kern/Lebovic discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Kern/Lebovic further discloses the first packet and the second packet are constructed from a metal (Kern Col. 5 lines 50-53).
Regarding Claim 10, Kern further discloses the swabs (18 and 20, Figs. 1-4) are made of an absorbent material including cotton (Col. 3 lines 28-32).
Regarding Claim 11, Kern/Lebovic is silent whether the first packet is identified by a “step 1 clean” label on an outside surface thereof and the second packet is identified by a “step 2 sanitize” label on an outside surface thereof.
However, it has been held that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). A functional relationship can be found where the printed matter performs some function with respect to the product to which it is associated. See Lowry, 32 F.3d at 1584, 32 USPQ2d at 1035. Where a product merely serves as a support for printed matter, no functional relationship exists. There is no functional relationship between the claimed packaging and the printed matter. The printed matter (the “step 1 clean” and “step 2 sanitize” label) does not perform any function with respect to the packaging, and the packaging merely serves as a support for the label. Therefore, the content of the label on the packaging does not distinguish the claimed product from the prior art of Kern/Lebovic.
Claim(s) 2, 3, 9, 16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kern et al (US 4457756) in view of Lebovic et al (US 2022/0104611) further in view of Fogel (US 2014/0091006).
Regarding Claims 2 and 3, Kern/Lebovic is silent whether the first packet and the second packet each have a notch formed in an edge thereof providing starting points for tearing open the packets, and wherein the first packet and the second packet are conjoined at a perforated seam.
Fogel teaches a medical treatment kit, thus being in the same field of endeavor, with a dual compartment container where the first packet (402, Fig. 6) and the second packet (404, Fig. 6) are conjoined at a perforated seam (406, Fig. 6; ¶ [0070]), and the first packet (402, Fig. 6) and the second packet (404, Fig. 6) each have a notch (notches that form tabs 410 and 408, Fig. 6) formed in an edge thereof providing starting points for tearing open the packets (402, 404, Fig. 6; ¶ [0070]). This construction allows both packets to be easily opened and also the packets to be easily separated if desired (¶ [0070]).
Therefore, it would have been obvious to modify the first and second packet of Kern/Lebovic to each have a notch formed in an edge thereof providing starting points for tearing open the packets, and wherein the first packet and the second packet are conjoined at a perforated seam, as taught by Fogel, as this allows for the formation of a multi-compartment container with each container holding a different item, where each packet of the container can be easily torn open and the packets can be separated from one another if desired (as motivated by Fogel ¶ [0070]).
Regarding Claim 9, Kern/Lebovic is silent whether the packet material is biodegradable.
Fogel teaches packaging for a medical kit, where the devices are packaged in a biodegradable packaging (¶ [0054, 0060]). Biodegradable packaging allows the packaging to degrade which is more friendly to the environment.
Therefore, it would have been obvious to modify the packet material of Kern/Lebovic to be biodegradable, as taught by Fogel, to allow the packet to degrade and therefore be more friendly to the environment (as motivated by Fogel ¶ [0054, 0060]).
Regarding Claim 16, Kern discloses a nasal swab device (10, Figs. 1-4), the device (10, Figs. 1-4) having a body (legs 12 and 14, Figs. 1-4) from which two spaced apart prongs (end portions 30 and 32, Figs. 1-4) extend, and each of the prongs (30 and 32, Figs. 1-4) having a free end (head 35, Figs. 1-4) to which a swab (absorbent pads 18 and 20, Figs. 1-4) is attached, wherein the swabs (18 and 20, Figs. 1-4) are saturated with a medical liquid (Col. 6 lines 40-46);
a packet inside which the device (10, Figs. 1-4) sealed (Col. 5 lines 50-57).
Kern is silent regarding a 2-step nasal swab kit comprising a pair of nasal swab devices, wherein the swabs of a first device are saturated with at least one cleaning ingredient and the swabs of a second of the devices are saturated with a sanitizing ingredient, and wherein each nasal swab device is sealed inside an individual packet, and whether the first packet and the second packet each have a notch formed in an edge thereof providing starting points for tearing open the packets, and wherein the first packet and the second packet are conjoined at a perforated seam.
Lebovic teaches a 2-step nasal swab kit, thus being in the same field of endeavor, where the kit comprises a pair of nasal swabs (¶ [0002, 0123, 0127]), where the swab of the first device is saturated with at least one cleaning ingredient and the swabs of a second of the devices are saturated with a sanitizing ingredient (¶ [0107, 0123, 0127-0128, 0134, 0143]; the system can comprise one or more swabs and one or more substances, and one substance can be ethyl alcohol and another substance can be an antiseptic). This allows one swab to focus on debridement of the nasal cavity and the other swab to deliver a substance to the nasal cavity (¶ [0009-0010]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kern to come in a kit form with two devices, where the swabs of the first device are saturated with at least one cleaning ingredient and the swabs of the second device are saturated with a sanitizing ingredient or antibiotic, as taught by Lebovic, so that the first swab can focus on debridement and cleaning of the nasal cavity and the second swab can deliver a substance to treat the nasal cavity (as motivated by Lebovic ¶ [0009-0010]). This would be beneficial in the case of a nosebleed, as the first swab could remove any debris and dried blood from the nose, and the second swab would be able to more efficiently deliver medication to the nose once the debris and dried blood has been removed. The combination of Kern/Lebovic would have the first device sealed inside a first packet and the second device sealed inside a second packet, as Kern indicates that the devices should be kept in a sealed package to ensure the medication does not evaporate (Kern Col. 5 lines 50-57); one would understand that devices would be individually packaged.
Kern/Lebovic is silent whether the first packet and the second packet each have a notch formed in an edge thereof providing starting points for tearing open the packets, and wherein the first packet and the second packet are conjoined at a perforated seam.
Fogel teaches a medical treatment kit, thus being in the same field of endeavor, with a dual compartment container where the first packet (402, Fig. 6) and the second packet (404, Fig. 6) are conjoined at a perforated seam (406, Fig. 6; ¶ [0070]), and the first packet (402, Fig. 6) and the second packet (404, Fig. 6) each have a notch (notches that form tabs 410 and 408, Fig. 6) formed in an edge thereof providing starting points for tearing open the packets (402, 404, Fig. 6; ¶ [0070]). This construction allows both packets to be easily opened and also the packets to be easily separated if desired (¶ [0070]).
Regarding Claim 18, the combination of Kern/Lebovic/Fogel discloses the claimed invention substantially as claimed as set forth above for Claim 16.
The combination of Kern/Lebovic/Fogel further discloses the swabs of the first device are saturated with at least one of lavender oil and ethyl alcohol (Lebovic ¶ [0058, 0114, 0134-0135]).
Regarding Claim 20, Kern/Lebovic/Fogel is silent whether the first packet is identified by a “step 1 clean” label on an outside surface thereof and the second packet is identified by a “step 2 sanitize” label on an outside surface thereof.
However, it has been held that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). A functional relationship can be found where the printed matter performs some function with respect to the product to which it is associated. See Lowry, 32 F.3d at 1584, 32 USPQ2d at 1035. Where a product merely serves as a support for printed matter, no functional relationship exists. There is no functional relationship between the claimed packaging and the printed matter. The printed matter (the “step 1 clean” and “step 2 sanitize” label) does not perform any function with respect to the packaging, and the packaging merely serves as a support for the label. Therefore, the content of the label on the packaging does not distinguish the claimed product from the prior art of Kern/Lebovic/Fogel.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kern et al (US 4457756) in view of Lebovic et al (US 2022/0104611) further in view of Stracener (US 2005/0090836).
Regarding Claim 5, Kern/Lebovic is silent whether the swabs of the first device are saturated with sterile water and ethyl alcohol 62% or isopropyl alcohol 70%.
Stracener teaches a medical swab system, thus being in the same field of endeavor, with a swab saturated in 70% isopropyl alcohol as a disinfectant (¶ [0036]). 70% isopropyl alcohol is a mixture of 70% isopropyl alcohol and 30% water. Stracener discusses that the device is sterile (¶ [0038]), and therefore one of ordinary skill in the art would have recognized that the water within the solution would also be sterile water to ensure the disinfecting swab is not carrying contaminants.
Therefore, it would have been obvious to modify the swab of the first device to be saturated with sterile water and isopropyl alcohol 70%, as taught by Stracener, to act as a disinfectant (as motivated by Stracener ¶ [0036, 0038]).
Claim(s) 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kern et al (US 4457756) in view of Lebovic et al (US 2022/0104611) further in view of Coates et al (US 2018/0311232).
Regarding Claims 6 and 7, Kern/Lebovic is silent whether the sanitizing ingredient is mupirocin, a PEG carrier agent, and sterile water or chlorhexidine, an associated carrying agent, and sterile water, and where the swabs of the second device are saturated with mupirocin in a range of 1-10%, a PEG carrier agent, and sterile water or chlorhexidine, an associated carrying agent, and sterile water.
Coates teaches a sanitizing agent suitable for nasal use (¶ [0001, 0062, 0067-0068]) where the sanitizing ingredient is 2% mupirocin, a PEG carrier agent, and sterile water (see Table 2, pg. 10; ¶ [0078-0079] indicates that topical compositions for pharmaceutical use that are solutions utilize sterile water) to provide improved antimicrobial activity and therefore improved sanitization (¶ [0023]).
Therefore, it would have been obvious to modify the sanitizing ingredient saturating the swabs of the second device of Kern/Lebovic to be 2% mupirocin, a PEG carrier agent, and sterile water, as taught by Coates, to provide improved antimicrobial activity and therefore improved sanitization (as motivated by Coates ¶ [0023]).
Claim(s) 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kern et al (US 4457756) in view of Lebovic et al (US 2022/0104611) further in view of Fogel (US 2014/0091006) further in view of Coates et al (US 2018/0311232).
Regarding Claims 17 and 19, the combination of Kern/Lebovic/Fogel discloses the claimed invention substantially as claimed as set forth above for Claim 16.
The combination of Kern/Lebovic/Fogel further discloses the at least one cleaning ingredient is selected from lavender oil and ethyl alcohol (Lebovic ¶ [0058, 0114, 0134-0135]).
Kern/Lebovic/Fogel is silent whether the sanitizing ingredient is mupirocin, a PEG carrier agent, and sterile water or chlorhexidine, an associated carrying agent, and sterile water, and where the swabs of the second device are saturated with mupirocin in a range of 1-10%, a PEG carrier agent, and sterile water or chlorhexidine, an associated carrying agent, and sterile water.
Coates teaches a sanitizing agent suitable for nasal use (¶ [0001, 0062, 0067-0068]) where the sanitizing ingredient is 2% mupirocin, a PEG carrier agent, and sterile water (see Table 2, pg. 10; ¶ [0078-0079] indicates that topical compositions for pharmaceutical use that are solutions utilize sterile water) to provide improved antimicrobial activity and therefore improved sanitization (¶ [0023]).
Therefore, it would have been obvious to modify the sanitizing ingredient saturating the swabs of the second device of Kern/Lebovic/Fogel to be 2% mupirocin, a PEG carrier agent, and sterile water, as taught by Coates, to provide improved antimicrobial activity and therefore improved sanitization (as motivated by Coates ¶ [0023]).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 16 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 17 of copending Application No. 18/605,418 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Although the claims are not exactly identical, the only difference between the claims is one word in the preamble. The preamble of currently pending Claim 16 recites “A 2-step nasal swab kit for cleaning and sanitizing human nose nasal vestibules, the nasal swab kit comprising:” whereas the copending application’s Claim 17 recites “A nasal swab kit for cleaning and sanitizing human nose nasal vestibules, the nasal swab kit comprising:”. Other than the lack of “2-step,” copending Claim 17 otherwise recites the exact invention as Claim 16 and is therefore considered to claim the same invention.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of copending Application No. 18/605,418 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending Claim 11 recites all of the limitations of pending Claim 1. Copending Claim 11 is merely narrower in scope as the nasal columellar guard is defined in more detail than present in pending Claim 1. As such, copending Claim 11 reads on pending Claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bryzek et al (US 2019/0126023)
Freeman (US 4955896)
Husain (US 2016/0030253)
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781