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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Aug. 17, 2023. Claims 1-2, 5, 7, 9, 18, 20, 25-26, 28-29, 32-33, 36-38, 47-48, 52, 54 and 149 are pending. Claims 5, 7, 25, 28-29, 32-33, 38, 47, and 149 are withdrawn. Claims 1-2, 9, 18, 20, 26, 36-37, 48, 52, and 54 are currently examined.
Election/Restrictions
Applicant's species election in the reply filed on Aug. 17, 2023, is acknowledged.
In the species election, Applicant elected claims 20, 26, 37 and 48. Accordingly, claims 5, 7, 25, 28-29, 32-33, 38, 47, and 149 are withdrawn.
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)).
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 48 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.
Claim 48 recites a phrase “before collecting the specimen sample” that renders the claim indefinite. Based on the base claim 1, “before collecting the specimen sample” can indicate a time frame after the nasal wash and before the specimen collecting or a time frame before the nasal washing. Therefore, one of skilled in the art would not know the metes and bounds of the claimed time for performing the oral washing ““before collecting the specimen sample”.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 9, 18, 20, 26, 36-37, 52, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Kawanami Q. (JP2006167411A, published on June 29, 2006) as evidenced by Massey et al. (Int Forum Allergy Rhinol. 2020 Mar;10(3):303-313), Epub 2019 Dec 17), Nasopharyngeal Wash (https://www.childrenscolorado.org/globalassets/healthcare-professionals/nasopharyngeal-wash.pdf, Jan. 2014), Rietsema WJ. (CMAJ. 2016 Oct 18;188(15):1107) and Hamasuna et al. (Int J Urol. 2007 May;14(5):473-5.).
The base claim 1 is directed to a method comprising:
intranasally dispensing nasal wash fluid into a nasal cavity of a subject such that the nasal wash fluid washes biological material into an oropharynx of the subject from (a) the nasal cavity, (b) a nasopharynx of the subject, or (c) the nasal cavity and the nasopharynx; and
thereafter, collecting a specimen sample that passed out of an anterior opening of an oral cavity of the subject and contains at least a portion of the biological material washed into the oropharynx by the nasal wash fluid.
Kawanami Q. teaches a method for nasal rinsing/washing using nasal irrigation cup that allows nasal irrigation (a nasal cavity irrigation method in which irrigation solution is inhaled through the nose and expelled through the mouth) to be performed efficiently and easily with a small amount of irrigation solution (See Abstract), where the washing solution of nasal cavity need to pass nasopharynx, oropharynx and oral cavity to reach mouth. Here the description teaches the base claim 1 (a)-(c) for a method comprising a nasal wash fluid into a passing route from nasal cavity and nasopharynx into the oropharynx and oral cavity and then expelled through the mouth, where the mouth is an anterior opening of an oral cavity.
Although Kawanami Q. does not explicitly point out the specimen collection for biological samples, it is obvious that the nasal irrigation cup washing method can be used as a method to collect biological samples/specimen washed through nasal cavity, nasopharynx, oropharynx and oral cavity. Especially, Kawanami Q teaches that the method is used by the patient (See [0002]). Here the nasal washing fluid comprising the biological materials specimen can be evidenced by Massey’s study. Massey et al. teaches that “Methods for introducing a suction device to collect nasal secretions seem to vary widely. Flexible or rigid suction may be employed, usually connected to a mucus specimen collector such as the Lukens Trap (McKesson, San Francisco, CA). The location of directed suctioning may depend on the process being studied. For example, the nasal cavity or nasopharynx may be of interest for the study of rhinitis or nasopharyngeal microbial colonization, respectively. The middle meatus is an ideal single site for obtaining samples for microbiologic analysis” (See page 4, paragraph 2), and further teaches that Bacteria, fungal organisms, and viruses can all be easily recovered from nasal secretions. Microbial collection is most commonly performed via nasal swab or lavage (See page 3, paragraph 2), which demonstrates that the washing solution form the nasal cavity or nasopharynx contain the biological materials. Because the washing solution in the oral cavity/mouth of Kawanami Q. is from the nasal cavity and nasopharynx of the subject, it is obvious that the irrigation solution expelled through the mouth of Kawanami Q contains the biological material washed into the oropharynx by the nasal wash fluid. Accordingly, these descriptions also teach claims 2 and 9.
Thus, the invention as a whole is clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claims 18, 20 and 26, Massey teaches that nasal lavage involves instilling a volume of solution into the nasal cavities followed by its collection after a predetermined dwell time. The most widely cited protocol was presented by Naclerio et al. Nasal lavage fluid has been used to identify biomarkers used in determining the inflammatory endotype of chronic rhinosinusitus (CRS). Given the inherent dilution that occurs in this technique, it may be helpful in qualitative assessment (i.e., presence or absence of target), or when subsequent laboratory assays are highly sensitive or are able to concentrate the compound of interest (See page 4, paragraph 4). Here this description indicates a test is performed after the specimen collection to identify if a particulate is present in the specimen, where the particulate is disclosed in Massey as: “Nasal mucus contains ions and proteins in an aqueous base, and is composed of 2 distinct layers–the apical mucus layer, which traps inhaled particulate matter and pathogens” (See page 3, paragraph 1), and the nasal lavage can be used to collect mucus (See page 10, Nasal Lavage). Here Massey et al. teaches claim 18. Also, Massey et al. further teaches a technique for nasal secretion exosome concentration and isolation in a nine-steps that include centrifuging the nasal secretions with 4.5 ml PBS, filtering the suspensions of the centrifuging twice, and then the supernatant is collected and the pellet resuspended in PBS for further protein analysis (See page 13), where the exosome is part of the nasal mucus and the method for concentrating it through filtration teaches the claim 20. For claim 26, Massey et al. teaches that Nasal lavage fluid has been used to identify biomarkers used in determining the inflammatory endotype of chronic rhinosinusitus (CRS) (See page 4, paragraph 4) and exosomes may be used as a biomarker that shows great potential for noninvasive diagnostics and conducting “liquid biopsies (See page 7). Massey et al. also teaches that Bacteria, fungal organisms, and viruses can all be easily recovered from nasal secretions. Microbial collection is most commonly performed via nasal swab or lavage, the former of which has been shown to be representative of mucosal tissue sampling (See page 13, paragraph 2). Based on the teachings of Massey et al., although Kawanami Q. does not mention the words such as “cellular biomarker” and “testing”, Kawanami’s method, using a nasal irrigation cup allowing nasal cavity irrigation liquid passing from nose to mouse in patients, can be used to collect the specimen of the nasal wash fluid of Massey through the mouth, where the specimen can contain the biomarkers. It is obvious that the samples from mouth of Kawanami Q can be used to perform the testing as claimed, and the result would be predictable base on Massey’s teaching.
Regarding claim 36, Kawanami Q teaches that the nasal irrigation cup that allows nasal irrigation (a nasal cavity irrigation method in which irrigation solution is inhaled through the nose and expelled through the mouth) to be performed efficiently and easily with a small amount of irrigation solution (See Abstract). In Figure 4, showing how to use the present invention. By tilting the neck further upward, the cleaning solution in the cup can be poured into the nasal cavity, making it easier to suck up the cleaning solution, which is said to be difficult to do when rinsing your nose (See page 4, Figure 4 and
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below). This method is comparable to the intranasally dispensing multidirectionally.
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Regarding claim 37, Kawanami Q teaches a nasal washing using the nasal irrigation cup that allows nasal irrigation (a nasal cavity irrigation method in which irrigation solution is inhaled through the nose and expelled through the mouth) to be performed efficiently and easily with a small amount of irrigation solution (See Abstract), which indicates a natural route for nasal washing through the posterior direction (straight back, parallel to the floor of the nose) towards the nasopharynx. This can be evidenced by the Nasopharyngeal Wash. The Nasopharyngeal Wash teaches procedure for collecting ciliated columnar respiratory epithelial cells from posterior nasopharynx for virus testing (See page 1 and the picture and below).
As for the “superoposterior direction toward an olfactory area of the nasal cavity”, Kawanami’s nasal washing method being from nose to expelled through the mouth can pass the “superoposterior direction toward an olfactory area of the nasal cavity” if using a correct head position. This can be evidenced by Rietsema’s study. Rietsema W. teaches that little and colleagues show a modest effect of nasal irrigation in people with recurrent or chronic sinusitis. Participants used a neti pot, which delivers the irrigation fluid to the lower part of the nasal cavity. However, the openings of the sphenoid, ethmoid and frontal sinuses are located at the top of the nasal cavity. Irrigation can only reach these openings when the head is positioned upside down (See page 1107, right column, paragraphs 1-2), where the ethmoid is in the region of superoposterior the nasal cavity.
Regarding claims 52 and 54, Kawanami Q teaches a nasal washing using the nasal irrigation cup that allows nasal irrigation (a nasal cavity irrigation method in which irrigation solution is inhaled through the nose and expelled through the mouth) to be performed efficiently and easily with a small amount of irrigation solution (See Abstract), where the nasal irrigation fluid expelled from the mouth is from the nasal wash to the oropharynx and can be used as the first specimen as claimed. At the same time, Massey teaches that using nasal lavage to collect the specimen via nostril as “the fluid is usually left within the nasal cavity for 10 seconds. The subject then leans forward and expels the fluid from the nostrils by gently exhaling into a collecting funnel that drains into a container” (See page 10, Nasal lavage), where this collection can be a second specimen containing some of the nasal wash fluid from the nasal cavity. There are benefit for collecting both oral and nasal samples. These can be evidenced by Massey’s study and Hamasuna’s study. Massey et al. teaches the Nasal lavage fluid has been used to identify biomarkers used in determining the inflammatory endotype of chronic rhinosinusitus (CRS) (See page 4). Hamasuna et al. teaches that the usefulness of oral wash specimens for detecting Chlamydia trachomatis from high-risk groups in Japan and discloses that the positive rates were 6% by swabs and 10% by oral wash specimens. Thus, their findings therefore indicate that oral wash specimens more effectively detected pharyngeal CT infection than pharyngeal swabs (See Abstract).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings from Kawanami, Massey and Hamasuna to arrive at an invention as claimed. One of skill in the art would be motivated to do so to combine the nasal wash and the oral wash together at the same time in order to detect different pathogen and biomarker in the subject. There would be a reasonable expectation of success to develop such as method for collecting first specimen and second specimen as claimed.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Kawanami Q. (JP2006167411A, published on June 29, 2006) as evidenced by Massey et al. (Int Forum Allergy Rhinol. 2020 Mar;10(3):303-313), Epub 2019 Dec 17), Nasopharyngeal Wash (https://www.childrenscolorado.org/globalassets/healthcare-professionals/nasopharyngeal-wash.pdf, Jan. 2014) and Rietsema WJ. (CMAJ. 2016 Oct 18;188(15):1107) applied to claims 1-2, 9, 18, 20, 26, 36-37, 52, and 54 as applied above, and in view of CDC-2016 as evidenced by Larson-OralDNA-2018 and Mcphillips et al. (Access Microbiol. 2022 May 20;4(5): acmi000366).
Claim 48 is directed to a method according to claim 1, wherein the method further comprises, before collecting the specimen sample: orally dispensing oral wash fluid into the oral cavity via the anterior opening of the oral cavity; and gargling, by the subject, the oral wash fluid, such that the oral wash fluid forms a mixture with the nasal wash fluid, and wherein collecting comprises collecting the specimen sample that passed out of the anterior opening of the oral cavity and contains at least a portion of the mixture and the at least a portion of the biological material washed into the oropharynx with the nasal wash fluid.
Based on the description above, Kawanami Q teaches that the nasal irrigation cup that allows nasal irrigation (a nasal cavity irrigation method in which irrigation solution is inhaled through the nose and expelled through the mouth) to be performed efficiently and easily with a small amount of irrigation solution (See Abstract), which indicates that the nasal wash also comprise the fluid from the oral cavity.
Nevertheless, CDC-2016 teaches a Self-Collected Oral Rinse Instructions includes steps of poring 10 mL of saline liquid into mouth, Swish and gargle the liquid in the mouth for 30 seconds and spit all of the liquid back into the same container (See page 1). Based on the description, the self-Collected Oral Rinse can provide a non-invasive nature, ease of use, and effectiveness in sampling a large surface area of the oral cavity. In addition, it is a common knowledge in the art that the oral cavity wash is primarily for collecting saliva and secretions of the mouth, which can provide different utility for detecting different pathogen. This can be evidenced by Larson-OralDNA-2018 and Mcphillips et al. (Access Microbiol. 2022 May 20;4(5): acmi000366). Larson teaches that “Saliva is a representative diagnostic specimen for an overall view of the oral microbiota, since bacteria from various sites and surface of the oral cavity are found in saliva and mouth rinse” (See page 1). Mcphillips et al. teaches that “Saliva offers a number of advantages over the current reference standard including the less invasive nature of specimen collection creates greater patient acceptability and thus individuals are more likely to get tested and give repeated specimens” (See Introduction).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the self-Collected Oral Rinse of CDC-2016 into Kawanami’s invention. One of skill in the art would be motivated to do so to combine the oral wash with the nasal wash for collecting a specimen comprising different types of the pathogen or biomarkers. There would be a reasonable expectation of success to develop such as method for collecting both samples from oral cavity wash and nasal wash together as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am..
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/RUIXUE WANG/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/ Primary Examiner, Art Unit 1672