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 .
Claim Objections
Claims 10 and 12-21 are objected to because of the following informalities: On line 5 of claim 10, the phrase “for placing in the mouth of user” should be changed to –for placing in the mouth of a user—so as to make proper sense. On lines 1-2 of claim 14, the phrase “wherein the test strip detects the presence of bacteria in the saliva sample and the amount and/or” should be changed to -- wherein the test strip detects a presence of bacteria in the saliva sample and an amount and/or--. On lines 1-2 of claim 15, the phrase “wherein the test strip detects the presence of bacteria in the saliva sample and the amount and/or” should be changed to -- wherein the test strip detects a presence of bacteria in the saliva sample and an amount and/or--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 and 12-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Amended independent claim 1 now recites a saliva sensing device comprising a chemically treated test strip having a base layer along with an integral chemical layer attached to the base layer. Amended independent claim 10 now recites a testing device comprising a sensor in the form of a multi-layer test strip having a chemical layer integral and attached to the multi-layer test strip. The specification, as originally filed, does not describe the saliva sensing device or sensor as comprising multiple layers (i.e. a multi-layer test strip) comprising a base layer along with an integral chemical layer attached to the base layer. Rather, the specification only describes the saliva sensing device as a test strip made of paper, plastic, cloth or a combination thereof that is coated with testing materials for reacting with different biomarkers in a saliva sample. See lines 5-12 on page 6 of the instant specification. The specification does not contain any description of the saliva sensing device as being a multi-layer test strip comprising a base layer and one or more chemical layers attached to the base layer. Therefore, these limitations recited in the amended claims represent new matter not supported by the specification as originally filed.
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 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8-16 of copending Application No. 19/176,113 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a saliva sensing device comprising a chemically treated test strip targeted to identify biomarkers comprising bacteria, VOCs, unbound hormones, lipidomic biomarkers, and key lipids useful in diagnosing diseases, wherein the test strip comprises paper, plastic, cloth or a combination thereof containing chemicals for reacting with and detecting the different biomarkers.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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, 10 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berry (US 3,507,269, submitted in the IDS filed on April 15, 2022).
With regards to claims 1, 10 and 21, Berry teaches of a saliva sensing device for determining causes of halitosis that arise from the presence of abnormal conditions in a subject such as metabolic disorders, cancer, allergies, infections or traumatic conditions (see lines 13-38 in column 1 of Berry). As depicted in Figures 1-3 of Berry, the saliva sensing device 1 comprises a multi-layer chemically treated test strip targeted to detect different biomarkers in a saliva sample. The test strip comprises a base layer 3 made of a rigid material such as plastic and a plurality of integral chemical layers 7 attached to the base layer 3. The chemical layers 7 are preferably made of filter paper impregnated with different chemical reagents for detecting different biomarkers in a saliva sample. In use, the saliva sensing device is placed into the mouth of a subject and exposed to saliva which wets the different chemical layers 7 of the test strip. Any biomarkers in the saliva sample react with the chemicals on the layers 7 and produce a visible color change when the targeted biomarkers are present. The color changes are compared to an analyzer in the form of a suitable color chart (claims 10 and 21, see lines 59-68 in column 3 of Berry) in order to determine a presence and an amount of the different biomarkers in the tested saliva sample. The comparison to the color chart serves to determine a disease state in the subject associated with the developed color changes on the test strip. See Figures 1-3, columns 1-2, lines 1-68 in column 3, and the claims of Berry.
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 3,507,269, submitted in the IDS filed on April 15, 2022) in view of Trevejo et al (US 2009/0230300). For a teaching of Berry, see previous paragraphs in this Office action.
With regards to claim 2, Berry fails to teach that the test strip is targeted to detect a presence of bacteria in saliva based upon a detection of one or more volatile organic compounds.
Trevejo et al teach that a presence of bacteria in a saliva sample can be detected by measuring different volatile organic compounds (VOCs) in the saliva. Trevejo et al teach that various different VOCs such as ketones are associated with bacterial metabolism in saliva samples. See the abstract and paragraphs 0014-0016, 0023, 0057, 0061 and 0064 in Trevejo et al.
Based upon a combination of Berry and Trevejo 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 one of the chemical layers 7 on the saliva sensing device taught by Berry for detecting a presence of bacteria in saliva based upon a detection of one or more volatile organic compounds because Berry teaches that the chemical layers 7 in the saliva sensing device are for detecting biomarkers indicative of different disease states, and Trevejo et al teach that saliva samples often contain bacteria that undergo metabolism to produce VOCs which are indicative of a disease state comprising a bacterial infection.
Claim(s) 3 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 3,507,269, submitted in the IDS filed on April 15, 2022) in view of Burns et al (US 2010/0304397, cited in the last Office action). For a teaching of Berry, see previous paragraphs in this Office action.
With regards to claims 3 and 7-9, Berry fails to teach that the test strip is targeted to detect a presence of unbound hormones and both gram negative and gram positive bacteria in a saliva sample.
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.
Based upon a combination of Berry 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 use one of the chemical layers 7 on the saliva sensing device taught by Berry for detecting a presence of unbound hormones and both gram negative and gram positive bacteria in a saliva sample because Berry teaches that the chemical layers 7 in the saliva sensing device are for detecting different biomarkers in a saliva sample that are indicative of different disease states, and Burns et al teach that a saliva sensing device can be used to detect both unbound hormones and different types of bacteria in a saliva sample as an indication of a health status of a subject (see paragraph 0034 and claim 12 in Burns et al), 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 Berry (US 3,507,269, submitted in the IDS filed on April 15, 2022) in view of Meikle et al (US 2013/00230054, cited in the last Office action). For a teaching of Berry, see previous paragraphs in this Office action.
With regards to claims 4-5, Berry fails to teach that the test strip is targeted to detect a presence of lipidomic biomarkers and key lipids useful to diagnose different 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 Berry 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 one of the chemical layers 7 on the saliva sensing device taught by Berry for detecting a presence of lipidomic biomarkers and key lipids useful to diagnose different diseases because Berry teaches that the chemical layers 7 in the saliva sensing device are for detecting different biomarkers in a saliva sample that are indicative of different disease states, 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 Berry (US 3,507,269, submitted in the IDS filed on April 15, 2022) in view of Braun et al (US 9,002,654, submitted in the last Office action). For a teaching of Berry, see previous paragraphs in this Office action.
With regards to claim 6, Berry fails to teach that the test strip is targeted to detect a presence of 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 Berry 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 one of the chemical layers 7 on the saliva sensing device taught by Berry for detecting a presence of one or more of S. mutans, S. sanguis, P. gingivalis, and F. nucleatum because Berry teaches that the chemical layers 7 in the saliva sensing device are for detecting different biomarkers in a saliva sample that are indicative of different disease states such as periodontal diseases (see lines 1-6 in column 3 of Berry), 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) 12 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 3,507,269, submitted in the IDS filed on April 15, 2022) in view of Blankenstein et al (US 2005/0145046). For a teaching of Berry, see previous paragraphs in this Office action.
With regards to claim 12, Berry fails to teach that the chemical layers 7 of the test strip are chemically treated cloth materials.
Blankenstein et al teach of a sampling and testing device that can be used to collect and test a saliva sample. The device comprises a sampling means 1 for collecting a saliva sample and a testing means 3 for testing the saliva sample for a presence of an analyte. The testing means 3 is comprised of an analysis means 12 which can be a reagent test strip containing reagents therein for reacting with different analytes in a saliva sample. The reagent test strip comprises a reagent carrier that is made from one of nitrocellulose, paper or cloth. See Figure 2 and paragraphs 0002-0005, 0023-0024, 0033, 0041 and 0043-0047 in Blankenstein et al.
Based upon a combination of Berry and Blankenstein 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 a cloth material as the chemical layers 7 of the test strip taught by Berry because Berry teaches that the chemical layers 7 are impregnated with chemicals that react with different biomarker analytes in a saliva sample, and Blankenstein et al teach that cloth is a useful material for reagent carriers in a saliva testing device.
With regards to claims 19-20, Berry teaches that the test strip comprises a base layer 3 made of a rigid material such as plastic and a plurality of integral chemical layers 7 attached to the base layer 3. The chemical layers 7 are impregnated with different chemical reagents for detecting different biomarkers in a saliva sample, wherein the different biomarkers are indicative of different disease states in a subject such as cancer. See Figures 1-3, columns 1-2, lines 1-68 in column 3, and the claims of Berry.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 3,507,269, submitted in the IDS filed on April 15, 2022) in view of Blankenstein et al (US 2005/0145046) as applied to claims 12 and 19-20 above, and further in view of Burns et al (US 2010/0304397, cited in the last Office action). For a teaching of Berry, Blankenstein et al and Burns et al, see previous paragraphs in this Office action.
With regards to claims 13-16, the combination of Berry and Blankenstein et al fails to teach that the test strip is targeted to detect a presence of different types of bacteria in a saliva sample based upon color changes and color change intensities in the chemical layers 7 of the test strip. However, based upon a combination of Berry, Blankenstein et al 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 use one or more of the chemical layers 7 on the saliva sensing device taught by the combination of Berry and Blankenstein et al for detecting a presence of different types of bacteria in a saliva sample because Berry teaches that the chemical layers 7 in the saliva sensing device are for detecting different biomarkers in a saliva sample that are indicative of different disease states, and Burns et al teach that a saliva sensing device can be used to detect different types of bacteria in a saliva sample as an indication of a health status of a subject (see paragraph 0034 and claim 12 in Burns et al) since saliva is known to contain different types of bacteria under certain circumstances (i.e. when a specific disease is present).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berry (US 3,507,269, submitted in the IDS filed on April 15, 2022) in view of Blankenstein et al (US 2005/0145046) as applied to claims 12 and 19-20 above, and further in view of Meikle et al (US 2013/00230054, cited in the last Office action). For a teaching of Berry, Blankenstein et al and Meikle et al, see previous paragraphs in this Office action.
With regards to claims 17-18, the combination of Berry and Blankenstein et al fails to teach that the test strip is targeted to detect a presence of lipidomic biomarkers and key lipids useful to diagnose different diseases. However, based upon a combination of Berry, Blankenstein 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 one or more of the chemical layers 7 on the saliva sensing device taught by the combination of Berry and Blankenstein et al for detecting a presence of lipidomic biomarkers and key lipids useful to diagnose different diseases because Berry teaches that the chemical layers 7 in the saliva sensing device are for detecting different biomarkers in a saliva sample that are indicative of different disease states, 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10 and 12-21 have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The previous objection to the specification made in the last Office action mailed on March 31, 2025 has been withdrawn in view of the amendments made to the drawings which now include the same reference numerals as described in the specification. The previous rejections of the claims under 35 USC 112(b) made in the last Office action have been withdrawn in view of the amendments made to the claims. All of the previous rejections of the claims under 35 USC 102(a)(1) and 35 USC 103 made in the last Office action have been withdrawn in view of the amendments made to the claims. The amended claims are newly rejected under each of 35 USC 112(a), provisional obviousness-type double patenting, 35 USC 102(a)(1) and 35 USC 103 for the reasons set forth above. The new rejections of the claims made in this Office action are all necessitated by the amendments made to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 December 19, 2025
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