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 .
Specification
The disclosure is objected to because of the following informalities: On page 5, lines 16-27 of the specification, the test strip is referred to with reference numeral “20”. However, Figure 1 uses the reference numeral “10” to designate the test strip. Therefore, Applicant is requested to amend anywhere in the specification that recites “test strip 20” to –test strip 10--.
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 1-20 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.
On line 2 of claim 1, the phrase “a chemically treated test strip biomarker” is indefinite since a biomarker usually refers to some type of chemical substance or analyte in a sample, not a physical structure such as a test strip. Therefore, it is suggested to change this phrase to –a chemically treated test strip--. On line 2 of claim 1, the phrase “the saliva” should be changed to –saliva—since a sample of saliva has not been previously recited.
In claim 2, the full meaning for the abbreviation “VOCs” should be recited. Claim 2 is indefinite since it is not clear whether the recited VOCs are produced from the bacteria recited in claim 1.
Claim 3 is indefinite since it is not clear whether the recited unbound hormones are produced from the bacteria recited in claim 1.
Claim 4 is indefinite since it is not clear whether the recited lipidomic biomarkers are produced from the bacteria recited in claim 1.
Claim 5 is indefinite since it is not clear whether the recited key lipids are produced from the bacteria recited in claim 1.
On line 3 of claim 9, the phrase “low pH” is indefinite since it is not clear what constitutes being “low” in this phrase.
Claim 10 is indefinite since it recites a “breathalyzer”. However, claim 10 recites that the sensor of the breathalyzer collects a saliva sample from a user, not a breath sample. Therefore, it is not clear how the device recited in claim 10 can be a breathalyzer when it analyzes a saliva sample, not a breath sample. Claim 10 should be amended to recite a device for analyzing a saliva sample. It is noted that for examination purposes, claim 10 and its dependent claims 11-20 are being interpreted as a device for detecting bacteria in the mouth of a user, not as a “breathalyzer” since a breath sample is not analyzed by the device. The “analyzer” recited in claim 10 is indefinite since it is not clear where in the device the analyzer is located. Is the analyzer located inside the housing, or is the analyzer located external to the housing?
Claim 12 is indefinite since it is not clear how the test strip can be a “chemically treated cloth biomarker”. A biomarker usually refers to some type of chemical substance or analyte in a sample, not a physical structure such as a test strip. Therefore, it is suggested to change the phrase “wherein the test strip is a chemically treated cloth biomarker” to -- wherein the test strip is a chemically treated cloth--.
On line 1 of claim 14, the phrase “the level” lacks antecedent basis.
On line 1 of claim 15, the phrase “the level” lacks antecedent basis.
In claim 19, the phrase “each test strip” is indefinite since this phrase implies that there are more than one test strip in the breathalyzer recited in claim 12, from which claim 19 depends. However, claim 12 only positively recites a single test strip as the sensor in the breathalyzer.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burns et al (US 2010/0304397).
With regards to claims 1-3, Burns et al teach of a saliva sensing device for detecting oral health and overall health conditions, such as diseases and disorders in a subject. The device comprises one or more chemically treated test strips or analytic sponges 16 which are targeted to detect multiple different biomarkers in a saliva sample. See Figure 1 in Burns et al which depicts a test strip comprising a transparent sheet 13 having multiple analytic sponges 16 attached thereto, wherein the analytic sponges 16 contain different chemical reagents for reacting with different biomarkers in a saliva sample to produce a chromogenic/color response. Burns et al teach that the biomarkers detected in a saliva sample using the saliva sensing device comprise bacteria (claim 1, see paragraph 0034 and claim 12 in Burns et al), alcohols (claim 2, see paragraph 0067 and claim 12 in Burns et al), and unbound hormones (claim 3, see claim 12 in Burns et al). See Figure 1, paragraphs 0033-0053 and 0063-0068, and claims 1-18 in Burns et al.
Claim(s) 10-12 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Southern (US 8,771,962).
With regards to claim 10, Southern teaches of a health test device for detecting different disorders related to altered levels of stress response pathway biomarkers. The device comprises a housing (see the holder and reader depicted Figure 6 in Southern which together form a “housing”), a sensor coupled to the housing and extending outwardly from the housing for placing in the mouth of a user and for collecting a saliva sample (see the cartridge attached to the reader in Figure 6 of Southern), and an analyzer for testing saliva that contacts the sensor (see the reader in Figure 6 of Southern which constitutes an “analyzer”). Also, see lines 4-12 in column 18 of Southern where it states “In one embodiment of the analyzer device, there is provided a pen-size digital device consisting of a disposable test strip, a reusable electronic reader and a clip-on holster. The user briefly puts the end of the test strip in the mouth to collect saliva and then inserts the test strip into the reader. In less than 3 minutes, the reader shows a digital stress measurement. A color guide shows whether the results indicate normal health (green), a mild health problem (yellow), or serious health deterioration (red).” Also, see Figure 6, lines 55-67 in column 1, lines 1-20 in column 2, lines 6-13 in column 5, lines 57-67 in column 17 and lines 4-12 in column 18 of Southern. With regards to the limitation “for detecting bacteria in the mouth of a user” recited in the preamble of claim 10, it is noted that this limitation has not been given patentable weight since it relates to an intended use of the device, and it has been held that a recitation of the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Yabnush, 168 USPQ 530 (CCPA 1971), In re Casey, 152 USPQ 235 (CCPA 1967), and In re Otto, 136 USPQ 458 (CCPA 1963).
With regards to claims 11-12, Southern teaches that the sensor in the device includes a test strip that is chemically treated with reagents which react with stress response biomarkers in a saliva sample to produce a color response. See lines 1-16 in column 2, lines 57-67 in column 17 and lines 4-12 in column 18 of Southern.
With regards to claims 19-20, Southern teaches that the test strip (see the cartridge in Figure 6 of Southern) is targeted to detect different stress response biomarkers in a saliva sample, and that these stress response biomarkers are indicative of different disease states such as different types of cancer, Alzheimer’s Disease, and heart disease/heart attack. See lines 47-62 in column 15, lines 45-67 in column 18, and lines 45-67 in column 19 of Southern.
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.
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) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burns et al (US 2010/0304397). For a teaching of Burns et al, see previous paragraphs in this Office action.
With regards to claims 7-9, Burns et al fail to specifically teach that the saliva testing device can be used to detect gram negative bacteria, gram positive bacteria, or one of the types of bacteria recited in claim 9. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the saliva testing device taught by Burns et al for detecting one of gram negative bacteria, gram positive bacteria, or one of the types of bacteria recited in claim 9 because Burns et al teach that the biomarkers detected in a saliva sample using the saliva sensing device can comprise bacteria (claim 1, see paragraph 0034 and claim 12 in Burns et al), and thus, one of ordinary skill in the art would expect that any type of bacteria in a saliva sample could be detected with the sensing device, including gram negative bacteria, gram positive bacteria, or one of the types of bacteria recited in claim 9 since saliva is known to contain all of these different types of bacteria under certain circumstances (i.e. when a specific disease is present).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burns et al (US 2010/0304397) in view of Meikle et al (US 2013/0023054). For a teaching of Burns et al, see previous paragraphs in this Office action.
With regards to claims 4-5, Burns et al fail to specifically teach that the saliva testing device can be used to detect lipidomic biomarkers or different key lipids in a saliva sample, wherein the lipidomic biomarkers or key lipids are associated with specific diseases used for diagnosing the diseases.
Meikle et al teach of lipidomic biomarkers and specific key lipids found in biological samples that are associated with the presence of specific diseases in a subject, such as different forms of heart disease and cardiovascular disease. The lipidomic biomarkers and key lipids comprise those listed in Table 1 of Meikle and are used to diagnose and classify different diseases in a subject, such as different types of heart disease. Meikle et al teach that the biomarkers can be measured in different types of biological samples obtained from a subject, including saliva. See the abstract, Table 1, and paragraphs 0010-0018, 0085-0086, 0149 and 0162 in Meikle et al.
Based upon a combination of Burns et al and Meikle et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the saliva testing device taught by Burns et al for detecting lipidomic biomarkers and specific key lipids in a saliva sample known to be associated with diseases such as different types of heart disease because Burns et al teach that the saliva testing device serves to detect multiple different biomarkers in a saliva sample that are indicative of the overall health condition of a subject, such as the presence of diseases and disorders in the subject, and Meikle et al teach that lipidomic biomarkers and specific key lipids present in saliva samples are known to be associated with the presence of specific diseases in a subject, such as different forms of heart disease and cardiovascular disease.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burns et al (US 2010/0304397) in view of Braun et al (US 9,002,654). For a teaching of Burns et al, see previous paragraphs in this Office action.
With regards to claim 6, Burns et al fail to specifically teach that the saliva testing device can be used to detect one or more of S. mutans, S. sanguis, P. gingivalis, and F. nucleatum.
Braun et al teach of a method for measuring different biomarkers in a saliva sample that are indicative of periodontal disease in a subject. The biomarkers measured in the method include F. nucleatum and P. gingivalis. These biomarkers measured in a saliva sample obtained from a subject are correlated to the presence of an oral disease state in the subject, such as periodontal disease. See the abstract, lines 60-67 in column 2, lines 103 and 53-64 in column 3, and claims 1, 9 and 12-13 in Braun et al.
Based upon a combination of Burns et al and Braun et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the saliva testing device taught by Burns et al for detecting one or more of S. mutans, S. Sanguis, P. gingivalis, and F. nucleatum in a saliva sample because Burns et al teach that the saliva testing device serves to detect multiple different biomarkers including bacteria in a saliva sample that are indicative of the overall health condition of a subject, and Braun et al teach that F. nucleatum and P. gingivalis are known types of bacteria found in saliva samples that can be correlated to the presence of a disease in the subject, such as periodontal disease.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Southern (US 8,771,962) in view of Burns et al (US 2010/0304397). For a teaching of Southern and Burns et al, see previous paragraphs in this Office action.
With regards to claims 13-16, Southern fails to teach that the test strip in the health test device for detecting different disorders is configured to detect bacteria in a saliva sample indicated by a color change and a color intensity produced in the test strip. However, based upon a combination of Southern and Burns et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in the test strip of the device taught by Southern reagents for detecting bacteria in a saliva sample by producing a color change and color intensity in the test strip because Southern teaches that the device is targeted to detect different stress response biomarkers in a saliva sample that are indicative of different disease states, and Burns et al teach that the presence of bacteria in a saliva sample is also indicative of different diseases in a subject.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Southern (US 98,771,962) in view of Meikle et al (US 2013/0023054). For a teaching of Southern and Meikle et al, see previous paragraphs in this Office action.
With regards to claims 17-18, Southern fails to teach that the test strip in the health test device for detecting different disorders is configured to detect lipidomic biomarkers and key lipids in a saliva sample. However, based upon a combination of Southern and Meikle et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in the test strip of the device taught by Southern reagents for detecting lipidomic biomarkers and key lipids in a saliva sample because Southern teaches that the device is targeted to detect different stress response biomarkers in a saliva sample that are indicative of different disease states, and Meikle et teach that lipidomic biomarkers and specific key lipids present in saliva samples are known to be associated with the presence of specific diseases in a subject, such as different forms of heart disease and cardiovascular disease.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Burgess-Cassler et al (US 2009/0311142) who teach of a device for the rapid determination of disease-associated thiol compounds in a saliva sample; Green (US 2017/0304164) who tech of an apparatus for detecting metabolites in a saliva sample; Reddy (US 2020/0337594) who teach of a device for detecting biomarkers in a breath sample of a subject; Fleming et al (US 6,998,273) and Bogema (US 6,248,598) who teach of devices for collecting and testing oral fluids; and Thieme et al (US 5,714,341) who teach of a saliva assay test device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 March 26, 2025