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 .
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Claims
Claims 1-6, 8-17 and 21-25 are pending. Claims 1, 5 and 9-13 are the subject of this NON-FINAL Office Action. This is the first office action on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-6 and 9-13), and the species of oral wash composition comprising a salivating agent, an antimicrobial agent, and a dye; citric acid monohydrate as the salivating agent; sodium benzoate as the antimicrobial agent; caffeine-1³C₃ as the internal tracer; trisodium citrate dihydrate as the aqueous buffer solution of the oral wash composition; and trisodium citrate dihydrate as the aqueous buffer solution of the post collection stabilization solution in the reply filed on 03/25/2026 is acknowledged. However, the election of an internal tracer is not required because Applicants elected an oral wash solution without a tracer. Claims 2-4, 6, 8, 14-17 and 21-25 are withdrawn.
Claim Objection
Claim 1 is objected to because it contains two periods.
Claim Interpretations
Claim 1 is too broad for its britches.
As to “salivating agent,” this is anything that can even remotely induce salivation. The specification fails to define this phrase, opting instead for very broad sweeping language. “The oral wash can also include agents to induce salivation”; “Examples include but are not limited to inorganic and/or organic edible acids and/or salts or mixtures thereof . . .” (Spec., pg. 10). In fact, the specification proceeds to state that an incredibly diverse range of compositions meet this limitation: omega-3 fatty acids; silica; glycerol; plant pulp. Even more, the “inorganic and/or organic edible acids and/or salts or mixtures thereof” include vitamin C, citric acid, lactic acid and other natural, ubiquitous compositions.
As to “antimicrobial agent,” this is anything that can even remotely affect microbes. Once again, the specification fails to define this phrase, opting instead for very broad sweeping language. The specification is ambiguous about what constitutes an “antimicrobial agent,” but mentions some examples:
The compositions include one or more active agents to maintain oral wash integrity at room temperature, preferably, agents, which prevent bacterial/fungal growth, and/or agents, which stabilize the collected oral fluid. Examples include, but are not limited to, food-grade conservatives such as potassium benzoate, trisodium citrate dihydrate, citric Acid monohydrate, disodium EDTA, sodium Benzoate and Potassium sorbate: [sic]
(Spec, pgs. 10-11). The Specification also seems to hint that protease inhibitors count: “Saliva contains several bacterial proteases, which can degrade salivary proteins affecting some techniques,” so “[t]o avoid this pre-analytical issue, it is useful to include protease inhibitors and stabilizing substances (such as aprotinin, leupeptin, antipain, pepstatin A, phenyl methyl sulfonyl fluoride, EDT A, thimerosal)” (pg. 11). This all leads a skilled artisan to understand (to the extent they can from this vague description) “antimicrobial agent” to encompass all compositions, chemicals, etc. that have any effect on microbes, which is a huge number of things.
Finally, the “dye” can be anything that stains to causes color. Once again, the specification fails to define this phrase, opting instead for very broad sweeping language. Pages 12-13 list examples of dyes that encompass natural to artificial coloring from plants and other sources.
Example of dyes that can be used in the oral wash composition/ post collection stabilization solution include, but are not limited to, riboflavin, riboflavin-5'-phosphate, chlorophylls and chlorophyllines, copper-containing complexes of chlorophyll and Chlorophyllines, caramel dye, simple sugar-based dye, sulphite lye-caramel die, ammonia-caramel dye, ammonium sulphite-caramel die, vegetable carbons, paprika extract, capsanthin, capsorubin, beetroot, betanine, anthocyans, iron oxides and hydroxides, azorubin, carmoisin, Ponceau 4R, 25 cochineal red A,, patent blue V, indigotin, indigo carmine, brilliant blue FCF, green S, fast green, brilliant black BN, black PN, brown HT, lycopene, beta-apo-8'-carotinal (C30), beta-apo-8'-carotinic acid (C30)-ethyl ester, lutein, substances of Maillard compounds, tartrazine, curcumin, saffron, quinoline yellow, sunset yellow FC/ yellow orange S, orange B, citrus red, cochineal, carminic acid, carmine, and carotene
(pg. 13). In light of this very broad swath of dyes, the claims encompass the use of anything natural or artificial that causes a color.
Claim Rejection - 35 USC § 112- Indefiniteness
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.
Claims 1, 5 and 9-13 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
In claim 1, “the post collection stabilization composition” lacks antecedent basis because claim 1 only recites “post collection stabilization solution.”
Claim 5 is an improper list of alternatives. Alternatives must have common structure and function. A yellow dye has no structural or functional relation with a pH, flavor enhancing agents, and sweetening agents. Furthermore, the use of “(a)” and “(b)” to demarcate the yellow dye options “and/or” pH options versus “further comprising a, flavor enhancing agents, and sweetening agents” is confusing. This implies that (a) and (b) are alternatives, but they are not. Applicants should split claim 5 into 3 separate claims.
In claims 10 and 13, the listed compositions are not alternative of each other. For example, sodium benzoate is listed as an exemplary antimicrobial agent in the specification; whereas trisodium citrate dihydrate is listed as a buffering agent. Furthermore, the transitional phrase “one or more agents selected from the group consisting of” lacks antecedent basis because there are three specific agents in claim 1 (“salivating agent,” “antimicrobial agent” for wash solution and “antimicrobial agent” for post collection stabilization solution). It is unclear which is referenced. Moreover, a generic “agent” is broader than the specific agents species in claim 1, which potentially renders claims 10 and 13 broader than claim 1. Applicants should split claims 10 and 13 into separate claims that list alternative specific agents (e.g. “salivating agent selected from the group consisting of . . . “). This would also provide more clarity as to which compositions fall under which specific agents.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5 and 9-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claims are directed to natural compositions combined into kits. See Subject Matter Eligibility Examples: Life Sciences, available at http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf, 05/05/2016 (Examples); Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant's Response to a Subject Matter Eligibility Rejection, available at http://www.uspto.gov/sites/default/files/documents/ieg-may-2016-memo.pdf, 05/05/2016 (Memo); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131, 68 S.Ct. 440 (1948) (“[H]owever ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants.”); Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107, 2117 (2013) (Supreme Court “considered a composition patent that claimed a mixture of naturally occurring strains of bacteria” and held that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way.”); Id. at 2117-18 (purification “is not an act of invention.”). Specifically, at Alice step 2A prong one, the claims amount to combinations of naturally-occurring compositions. As explained above, the “salivating agent” is anything natural or artificial that can even remotely induce salivation; the “antimicrobial agent,” this is anything natural or artificial that can even remotely affect microbes; and the “dye” can be anything natural or artificial that stains to cause color. No matter what Applicants label the components of the kit (here, “oral wash composition” and “post collection stabilization composition”), their broad claims encompass compositions with nothing more than natural components.
As Step 2A, prong two, and Step 2B, Applicants simply fail to recite any additional elements. At best, claim 5 recites natural buffer pH; and “flavor enhancing agents” or “sweetening agents” that encompass natural components such as sugar, fruit, etc. Claims 10 and 13 simply list more natural compositions.
Merely combining such natural compositions into kits fails to add significantly more than the natural components themselves. See Funk Bros., 333 U.S. at 131 (1948) (“[H]owever ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants.”); Association for Molecular Pathology, 133 S.Ct. at 2117 (2013) (Supreme Court “considered a composition patent that claimed a mixture of naturally occurring strains of bacteria” and held that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way.”); Id. at 2117-18 (purification “is not an act of invention.”). Thus, the claims are not patent eligible subject matter.
As an example of what the claims encompass, the “dye” can be “chlorophylls,” carotene and carotenoids (pg. 13); the “salivating agent” can be ascorbic acid or citric acid (pg. 10); and the “antimicrobial agent” can be citric acid (pg. 11). This encompasses ripened (carotenoid-heavy, e.g. carotene) and less-ripened (chlorophyll-heavy) fruits (which contain vitamin C/ascorbic acid and citric acid, and juices therefrom.
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.
Claim(s) 1, 5 and 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over BRANDT (US20210371773), in view of MOORE (US 20080069876).
The prior art as a whole demonstrates that it would have been obvious to a skilled artisan at the time of filing to combine familiar shampoo and body wash products into kits for convenience with a reasonable expectation of success.
BRANDT teaches shampoos, body washes, mouth washes, micellular water, etc. with citric acid monohydrate 2-9 g/L (Example formulations 1-2, 4 & 27); sodium benzoate 100-1,000 mg/L (id.); and trisodium/sodium citrate dihydrate 3-10 g/L (id.). The pH can be 3.5-9 (e.g. para. 0031). Flavor enhancing such as sucralose can be used (Example 149, 184).
BRANDT does not teach kits.
However, combining these various personal products into kits is an obvious option for convenience. For example, MOORE teaches “forming a kit of separately packaged particulate personal hygiene products comprising two or more different particulate personal hygiene products (e.g., a toothpaste, a shaving cream, a skin lotion, etc.)” (para. 0062). A skilled artisan would recognize this as a basic acknowledgement of the well-known fact that kits are routinely made for end-user convenience. Thus, it is the epitome of obviousness to combine the personal care components of the prior art into kits.
Prior Art
The following prior art is also pertinent: US20230348888; US 20110159483; US 20070154414; US20140316302; US20220003741; US 6291178; US 20040087874; JP 2005201768; US 20220016234.
Allowable Subject matter
1. A kit comprising an oral wash composition and a post collection stabilization composition, the oral wash composition configured to collect saliva from a human, the post collection stabilization composition configured to stabilize the oral wash composition after saliva collection, wherein: (a) the oral wash composition, comprises one or more salivating agents comprising citric acid, one or more antimicrobial agents comprising sodium benzoate, a buffer comprising trisodium citrate dihydrate, one or more dyes and optionally, an internal tracer suitable for detection by mass spectrometry and (b) the post collection stabilization composition comprises one or more antimicrobial agents and one or more dyes.[[.]]
Conclusion
No claims are allowed.
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/AARON A PRIEST/Primary Examiner, Art Unit 1681
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