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 .
Election/Restrictions
Applicant’s election with of Invention I (claims 1-13 and 18) in the reply filed on 05/19/2026 is acknowledged. Regarding the species requirement, the applicant’s election of the mouth chewable tablet of Claim 2, with traverse, is acknowledged. Upon further search and consideration, art was located that teaches the both the tablet and powder form of the composition, and as such the species requirement is withdrawn and both claims 2 and 3 are examined herein.
Priority
Provisional application filed 05/20/2023 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 09/19/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the references included have been considered by the examiner.
Claim Objections
Applicant is advised that should claim 5 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 12 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 5. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1-13 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.
Regarding claim 1, the phrase "effective amounts of organic ingredients including" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "organic ingredients"), thereby rendering the scope of the claim(s) unascertainable. Further effective amounts of organic ingredients cannot be determined and is thereby indefinite as one person’s idea of an effective amount of an organic compound would perhaps not be the same as another person’s and applicants have not clearly laid out what exactly it is effective to do nor which organics the claim is limited to. Claims 2-13 are rejected by virtue of their dependency on rejected claim 1. See MPEP § 2173.05(d).
Claim 2 is 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.
Regarding claim 2, the phrase “embodied” limitation is indefinite as it is not clear if the formulation of a tablet is required or not or if it is merely an abstract idea.
Claim 3 is 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.
Regarding claim 3, the meaning of “a tooth powder” is unclear, does applicant mean that the composition of claim 1 is a powdered formulation or that ‘additionally’ a powder of unknown origin is added to the composition of claim 1. Therefore it is unclear what the tooth powder contains, and how this powder further limits instant claim 1 therefore for prior art purposes any powder in a composition can read on this limitation.
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.
Claim(s) 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon or product of nature) without significantly more.
The claimed invention is directed to a composition of natural products without significantly more. The claim(s) recite(s) a composition of organic ingredients which reads on natural products the claim states it may include neem, miswak, and triphala which are naturally occurring but does not limit the claim to anything that is not natural (claim 1). This judicial exception is not integrated into a practical application because the claims only recite ; thus the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. A detailed analysis follows.
Each of the compounds recited in the composition of claim 1 are known to be found in nature. Mitra et al. (2009) teaches an oral composition comprising an extract of herbs from bark of Azadirachta indica (i.e. neem, para. [0018]), and fruits of Terminalia chebula, Terminalia bellerica, Emblica officinalis (i.e. fruits that make up triphala, para. [0018]). Further, Razmpour et al. (2021) teaches an oral cleanser composition comprising the stem or root of the native salvadora persica tree (i.e. miswak, pg. 2, para. [0005]).
Under the 101 analysis for patent eligibility:
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
The claims are drawn to a composition of matter.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claim 1 is drawn to natural products (natural phenomenon). Each of the elements cited in the claims are themselves natural products. As discussed above, Mitra (of record) teaches that neem comes from the from bark of Azadirachta indica, and triphala comprises three fruits that are naturally occurring (para. [0018]). Razmpour (of record) further teaches that msiwak in an oral composition is sourced from the stem or root of the native salvadora persica tree. (“the ‘manifestations of laws of nature’ are ‘part of the storehouse of knowledge,’ ‘free to all men and reserved exclusively to none.’ Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948)). See MPEP § 2016.04(b)(I).
Step 2A, Prong 2: Does the claim recite additional elements that integrated the Judicial Exception into a practical application?
Each of the components recited in claim 1 are natural products, as described above. Claim 1 does not recite any additional elements that integrate the judicial exception into a practical application, as the oral composition (claim 1) may be formed from the instantly recited components themselves without additional elements. Thus, the claim does not recite additional elements that integrate the Judicial Exception into a practical application.
When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. See MPEP § 2016.04(c)(II)(a).
Step 2B: Does the claim recite additional elements that amount to significantly more than the Judicial Exception?
Each of the components recited in claim 1 is merely a natural product and does not add significantly more to the Judicial Exception.
Accordingly, the claimed composition recites a natural product that is not markedly different in structure from naturally occurring elements and hence reads on patent ineligible subject matter under above guidelines.
To transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature. Essentially, appending conventional steps specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible. The Court provides long standing exceptions (laws of nature, natural phenomena, and abstract ideas) to categories of patent eligibility defined in 35 U.S.C.§ 101. A claim that recites a law of nature or natural correlation, with additional steps that involve well- understood, routine, conventional activity previously engaged in by researchers in the field is not patent-eligible, regardless of whether the steps result in a transformation for the reasons cited above.
Thus, claim 1 is ineligible, and claims 2-13 are ineligible from their dependency on claim 1.
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) 1-7, 9, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 20090185987 A1).
Regarding claims 1 and 2, Mitra teaches an oral composition that is a chewable tablet for tooth cleansing and treatment of dental disorders (para. [0037]). The composition comprises Azadirachta indica (i.e. neem) and terminalia bellerica (i.e. triphala, see example 18 para. [0071]). Further, Mitra references the use of miswak in a capsule for the mouth (para. [0009]).
Regarding claim 3, Mitra teaches that the use of various herbal powders for dental diseases is well known in the prior art (para. [0002]), and that there are many dentifrices in the form of powders available for cleansing the teeth (para. [0003]).
Regarding claims 5 and 12, Mitra teaches that the composition contains fruits of Terminalia bellerica (i.e bibhitaki fruit), Emblica officinalis (i.e. amalaki), and Terminalia chebula (i.e. haritaki, para. [0018]).
Regarding claims 6 and 7, Mitra discloses that the composition contains xylitol as a sweetener (para. [0030]), and clove (para. [0036]).
Regarding claim 9, Mitra teaches that the composition can contain calcium carbonate (para. [0031]).
Regarding claim 4 and 13, in response to applicant’s argument that the composition can be used to treat xerostomia, a recitation of the intended use of the 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.
Mitra does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Mitra with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the method of the instant claims with predictable results.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 20090185987 A1) in view of Gulizio (US 20200009033 A1).
Mitra teaches the claimed invention as above, but does not teach that the composition further comprises curcuma xanthorrhiza root.
Regarding claim 8, Gulizio teaches an oral care composition that can be in the form of a tooth powder. Gulizio describes that curcumin compounds have antioxidant properties and may be used in oral care compositions to prevent gingivitis or periodontitis (para. [0012]). The curcumin compound in the composition described in Gulizio is selected from a group containing curcuma xanthorrhiza (para. [0016]).
Mitra and Gulizio are considered to be analogous to the claimed invention because they are in the same field of oral compositions that can be in the form of a tooth powder. While Mitra does not teach that curcuma xanthorrhiza is present in the invention, Gulizio teaches a composition containing this curcumin compound. As discussed above, Gulizio teaches the many benefits of curcuma xanthorrhiza, such as its use in preventing gingivitis or periodontitis. It would have been obvious to one of ordinary skill in the art before the effective filing date of instant invention to incorporate curcuma xanthorrhiza into the composition taught in Mitra for its use in oral compositions and its known benefits of preventing oral ailments. MPEP (I) § 2143 (a).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 20090185987 A1) in view of Pushpangadan (US 20050142074 A1).
While Mitra teaches the claimed invention as above, and that the composition contains Azadirachta indica extract, it does not teach the use of Azadirachta indica leaves specifically.
Regarding claim 10, Pushpangaden teaches an oral care composition that is used as a tooth powder. The composition contains Azadirachta indica leaf, in a powdered form (see claim 6).
Mitra and Pushpangaden are considered to be analogous to the claimed invention because they are in the same field of oral care compositions that can be in the form of a tooth powder. It would be obvious to the skilled artisan before the effective filing date of the claimed invention to substitute the extract of the Azadirachta indica taught in Mitra with the ground Azadirachta indica leaves taught in Pushpangaden, while maintaining the activity of the Azadirachta indica in the oral composition and to yield predictable results. MPEP (I) § 2143 (b).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 20090185987 A1) in view of Razmpour (WO 2021234429 A1).
Mitra teaches the claimed invention as above, but fails to teach that the composition contains salvadora persica.
Regarding claim 11, Razmpour teaches an oral composition that comprises salvadora persica (see abstract). Razmpour further teaches that since ancient times people have been using salvadora persica for tooth decay and whitening (pg. 1, para. [0004]).
Mitra and Razmpour are considered to be analogous to the claimed invention because they are in the same field of compositions for cleaning the teeth. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of instant invention to incorporate the salvadora persica into the composition taught in Mitra, for the benefit of optimizing oral health, and for the benefits of salvadora persica that are taught in Razmpour. MPEP (I) § 2143 (a).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 20090185987 A1) in view of MacKinnon (US 20040175334 A1).
Regarding claim 18, Mitra teaches that the composition contained a powdered herbal blend containing fruits of Terminalia chebula, Terminalia bellerica, and Emblica officinalis (para. [0069]). While Mitra teaches the claimed invention as above, and teaches the ground triphala fruits, it fails to teach that the organic powder comprises ground neem leaf and ground miswak stem.
Pushpangadan teaches an oral care composition that comprises Azadirachta indica (i.e. neem) that is in the powdered form (i.e. ground) and is obtained from the leaves (see claim 6). As discussed in detail above, it would be obvious to the skilled artisan before the effective filing date of the claimed invention to substitute the extract of the Azadirachta indica taught in Mitra with the ground Azadirachta indica leaf taught in Pushpangaden, while maintaining the function of the Azadirachta indica in the composition, to yield predictable results. MPEP (I) § 2143 (b)
Further, MacKinnon teaches an oral composition in the form of a capsule. MacKinnon describes that the composition contains ground fibers of miswak, which when circulated throughout the mouth will help to brush the teeth (para. [0010]). The skilled artisan would have found it obvious at the time of filing to incorporate the ground miswak fibers taught in MacKinnon into the composition taught in Mitra for the known benefit of them functioning to clean the teeth. MPEP (I) § 2143 (g).
Mitra, Pushpangaden, and MacKinnon are in the same field of oral compositions for cleaning the teeth that can be in the powdered form. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute the source of neem extract in the composition taught in Mitra with the powdered neem leaf taught in Pushpangadan. Further, it would have been obvious to incorporate the ground fibers of miswak, as taught in MacKinnon, into the composition taught in Mitra for their benefit of being able to clean the teeth.
Conclusion
Claims 1-13 and 18 are rejected.
Claims 14-17 are withdrawn from consideration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Makenna Miller whose telephone number is (571)272-9852. The examiner can normally be reached Mon-Fri 7:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
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