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 Arguments
Applicant’s amendment filed 04/13/2026 is accepted and entered. Applicant’s amendments to the specification have overcome the previous specification objections and the previous specification objections have been withdrawn. Applicant’s amendments to the claims have overcome the previous 112 rejections and the previous 112 rejections have been withdrawn. Applicant’s amendment to Claim 16 has overcome the previous statutory double patenting rejection and the previous double patenting rejection of Claim 16 has been withdrawn.
Applicant’s arguments, see Remarks pages 11 - 18, filed 04/13/2026, with respect to the rejection(s) of claim(s) 1 and 16 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lafe/Lebovic/Bryzek, and Lafe/Lebovic/Bryzek/Fogel, as set forth below.
Election/Restrictions
Newly submitted claims 21-24 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Applicant previously elected the apparatus claims. The newly added method claims are still distinct from the claimed apparatus claims for the same reasons set forward in the restriction requirement dated 10/01/2025.
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 Accordingly, claims 21-24 are withdrawn from consideration as being directed to a non-elected invention.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.
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, 10, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lafe (US 2011/0054377) in view of Lebovic et al (US 2022/0104611) further in view of Bryzek et al (US 2019/0126023).
Regarding Claim 1, Lafe discloses a nasal swab for cleaning and sanitizing a skin of human nose nasal vestibules (¶ [0001 – 0008]), the nasal swab comprising:
a nasal swab device (Fig. 5) having a body (hinge portion, Fig. 5; ¶ [0041]) from which two spaced apart prongs (10, 12, Fig. 5) extend, and each of the prongs (10, 12, Fig. 5) having a free end to which a swab (bud 14, Fig. 5) is attached, and a columellar guard (stop 16, Fig. 5; ¶ [0030, 0039] indicates the stops can be a disc or a continuous ring around the bud, which would be capable of contacting the patient’s columella as well as the ala, depending on the patient’s anatomy) extending from at least one of the prongs (10, 12, Fig. 5), the columellar guard limiting an insertion depth of the prongs (10, 12, Fig. 5) and the swabs (14, Fig. 5) into the human nose to position the swabs (14, Fig. 5) of the skin of the nasal vestibule enabling the devices to clean and sanitize the skin (¶ [0001 – 0008]).
Lafe is silent regarding a 2-step nasal swab kit, the nasal swab kit comprising a pair of nasal swab devices, wherein the swabs of a first of the devices 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 a first packet inside which the first device is sealed and a second packet inside which the second device is sealed.
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 Lafe 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]).
Lafe/Lebovic is silent regarding a first packet inside which the first device is sealed and a second packet inside which the second device is sealed.
Bryzek teaches a nasal cleansing kit, thus being in the same field of endeavor, with a first device (first swab 112, ¶ [0024]) sealed within a first packet (first wrapper, ¶ [0024]) and a second device (second swab, ¶ [0025]) sealed within a second packet (second wrapper, ¶ [0025]). Packaging each premoistened swab in a separate wrapper ensures that the second swab does not dry out during the usage of the first swab, and ensures both swabs remain sanitary until they are ready for use.
Therefore, it would have been obvious to modify the kit of Lafe/Lebovic to include a first package inside which the first device is sealed and a second package inside which the second device is sealed, as taught by Bryzek, to ensure the swabs remain sanitary until they are ready for use and that the second swab does not dry out during the use of the first swab.
Regarding Claim 4, the combination of Lafe/Lebovic/Bryzek discloses the claimed invention substantially as claimed as set forth above for Claim 1.
The combination of Lafe/Lebovic/Bryzek further discloses the at least one cleaning ingredient is selected from lavender oil and ethyl alcohol (Lebovic ¶ [0058, 0114, 0134-0135]).
Regarding Claim 10, Lafe further discloses the swabs (14, Fig. 5) are made of an absorbent material including cotton (¶ [0014]).
Regarding Claim 11, Lafe/Lebovic/Bryzek 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 Lafe/Lebovic/Bryzek.
Claim(s) 2-3, 8-9, 16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lafe (US 2011/0054377) in view of Lebovic et al (US 2022/0104611) further in view of Bryzek et al (US 2019/0126023) further in view of Fogel (US 2014/0091006).
Regarding Claims 2 and 3, Lafe/Lebovic/Bryzek 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 Lafe/Lebovic/Bryzek 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 Claims 8 and 9, Lafe/Lebovic/Bryzek is silent whether the first packet and the second packet are constructed from a material selected from a paper, a paper product, a plastic, a metal and a synthetic product, wherein the material is biodegradable.
Fogel teaches packaging for a medical kit, where the devices are packaged in a biodegradable packaging (¶ [0054, 0060]) that can be made of paper or plastic (¶ [0015]). 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 Lafe/Lebovic/Bryzek to be a biodegradable paper or plastic, 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, Lafe discloses a nasal swab for cleaning and sanitizing a skin of human nose nasal vestibules (¶ [0001 – 0008]), the nasal swab comprising:
a nasal swab device (Fig. 5) having a body (hinge portion, Fig. 5; ¶ [0041]) from which two spaced apart prongs (10, 12, Fig. 5) extend, and each of the prongs (10, 12, Fig. 5) having a free end to which a swab (bud 14, Fig. 5) is attached, the body having a longitudinal axis (x-axis, Fig. 5) and an attachment edge (portion where hinge meets arms 10, 12, Fig. 5) extending transverse to the longitudinal axis (x-axis, Fig. 5), the two prongs (10, 12, Fig. 5) extending from the attachment edge parallel to the longitudinal axis (x-axis, Fig. 5).
Lafe is silent regarding a 2-step nasal swab kit, the nasal swab kit comprising a pair of nasal swab devices, wherein the swabs of a first of the devices are saturated with at least one cleaning ingredient and the swabs of a second of the devices are saturated with a sanitizing ingredient, and a first packet inside which the first device is sealed and a second packet inside which the second device is sealed, 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 swab 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 Lafe 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, 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]).
Lafe/Lebovic is silent regarding a first packet inside which the first device is sealed and a second packet inside which the second device is sealed.
Bryzek teaches a nasal cleansing kit, thus being in the same field of endeavor, with a first device (first swab 112, ¶ [0024]) sealed within a first packet (first wrapper, ¶ [0024]) and a second device (second swab, ¶ [0025]) sealed within a second packet (second wrapper, ¶ [0025]). Packaging each premoistened swab in a separate wrapper ensures that the second swab does not dry out during the usage of the first swab, and ensures both swabs remain sanitary until they are ready for use.
Therefore, it would have been obvious to modify the kit of Lafe/Lebovic to include a first package inside which the first device is sealed and a second package inside which the second device is sealed, as taught by Bryzek, to ensure the swabs remain sanitary until they are ready for use and that the second swab does not dry out during the use of the first swab.
Lafe/Lebovic/Bryzek 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 Lafe/Lebovic/Bryzek 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 18, the combination of Lafe/Lebovic/Bryzek/Fogel discloses the claimed invention substantially as claimed as set forth above for Claim 16.
The combination of Lafe/Lebovic/Bryzek/Fogel further discloses the at least one cleaning ingredient is selected from lavender oil and ethyl alcohol (Lebovic ¶ [0058, 0114, 0134-0135]).
Regarding Claim 20, Lafe/Lebovic/Bryzek/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 Lafe/Lebovic/Bryzek/Fogel.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lafe (US 2011/0054377) in view of Lebovic et al (US 2022/0104611) further in view of Bryzek et al (US 2019/0126023) further in view of Stracener (US 2005/0090836).
Regarding Claim 5, Lafe/Lebovic/Bryzek is silent whether the swabs of the first device are saturated with sterile water and either 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 of Lafe/Lebovic/Bryzek 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 Lafe (US 2011/0054377) in view of Lebovic et al (US 2022/0104611) further in view of Bryzek et al (US 2019/0126023) further in view of Coates et al (US 2018/0311232).
Regarding Claims 6 and 7, Lafe/Lebovic/Bryzek 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 Lafe/Lebovic/Bryzek 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 Lafe (US 2011/0054377) in view of Lebovic et al (US 2022/0104611) further in view of Bryzek et al (US 2019/0126023) 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 Lafe/Lebovic/Bryzek/Fogel discloses the claimed invention substantially as claimed as set forth above for Claim 16.
The combination of Lafe/Lebovic/Bryzek/Fogel further discloses the at least one cleaning ingredient is selected from lavender oil and ethyl alcohol (Lebovic ¶ [0058, 0114, 0134-0135]).
Lafe/Lebovic/Bryzek/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 Lafe/Lebovic/Bryzek/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
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. Although pending Claim 1 indicates the columellar guard limits the insertion depth of the prongs, which is not present in copending Claim 11, this limitation is inherent to the claimed columellar guard recited in copending Claim 11.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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