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 .
Status of Application
The Examiner acknowledges receipt of amendments filed 08/31/2026, wherein claims 1-3, 8, 11, 12, and 18 have been amended and claims 19-21 have been added.
Claims 1-13 and 18-21 are presented for examination on the merits. The following rejections are made.
Priority
Provisional application filed 05/20/2023 is acknowledged.
Maintained Rejections of Record following Amendments
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 and 20-21 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 natural products, without any additional elements ; 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 and 20-21 are ineligible from their dependency on claim 1.
Modified Rejections of Record following Amendments
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 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. [0009-0010]).
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 claim 5, 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 Hwang (KR 20170125481 A; see machine translation retrieved 9/28/2026).
Mitra teaches the claimed invention as above, but does not teach that the composition further comprises curcuma xanthorrhiza root powder.
Regarding claim 8, Hwang teaches a composition with curcuma xanthorrhiza, where the composition treats oral dryness or salivary secretion abnormality (i.e. xerostomia, see abstract). The composition of Hwang can be in the form of a powder or tablet (para. [0069]). Further, Hwang describes that curcuma xanthorrhiza can be in the powder form (para. [0092]).
Mitra and Hwang are considered to be analogous to the claimed invention because they are in the same field of formulations that are in the powder form and can be used to improve oral health. One of ordinary skill in the art would be motivated to add the curcuma xanthorrhiza root powder of Hwang into the composition of Mitra for the benefit of reduced oral dryness or salivary secretion abnormalities, as described in Hwang. MPEP § 2143(I)(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 § 2143(I)(b).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 20090185987 A1) in view of Schulz (DE 102017000086 A1; see machine translation retrieved 9/28/2026).
Mitra teaches the claimed invention as above, but fails to teach that the composition contains salvadora persica stem in the powdered form.
Regarding claim 11, Schulz teaches a formulation for dental care that maintains dental health (see abstract). Schulz describes that the composition can comprise Salvadora persica powder, describing that particles in the powder allow for a mechanical cleaning of all tooth surfaces (para. [0016]).
Mitra and Schulz 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 powder of Schulz into the composition taught in Mitra, for its benefit of mechanical cleaning of tooth surfaces, as taught in Schulz. MPEP § 2143(I)(a).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 20090185987 A1) as evidenced by Prakash et al. (Journal of Indian Society of Periodontology, 2014, 18(2), 132-135).
While Mitra teaches the claimed invention as above, it fails to teach that the triphala of the composition comprises a powder mixture of ground Emblica officinalis fruit, ground Terminalia belerica fruit, and ground Terminalia chebula fruit, as recited in amended claim 12.
Regarding claim 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]). Further, Prakash discloses that triphala is a well-known powdered (i.e. ground) preparation in medicine, consisting of equal parts of the Emblica officinalis, Terminalia chebula, and Terminalia belerica, and has several applications in dentistry (see abstract).
Mitra and Prakash are considered to be analogous to the claimed invention because they are in the same field of oral compositions for improving dental health. It would be obvious to one of ordinary skill in the art to substitute the triphala extract of Mitra with the powdered form of triphala taught in Prakash to yield predictable results, as Prakash describes that powdered triphala is known in the art for applications in dental formulations. MPEP § 2143(I)(b).
Claim(s) 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 20090185987 A1) in view of Pushpangadan (US 20050142074 A1), in further view of MacKinnon (US 20040175334 A1).
Regarding claims 18 and 20, Mitra teaches an oral composition that is a chewable tablet for tooth cleansing and treatment of dental disorders (para. [0037]). The composition of Mitra contains 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 § 2143(I)(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 § 2143(I)(g).
Mitra, Pushpangaden, and MacKinnon are in the same field of oral compositions for cleaning the teeth that can be in the powdered form. Mitra teaches examples where the powder mixtures are compressed into tablets (para. [0078-0079]), and states that the tablets can be chewable (para. [0070]). 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.
Claim(s) 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mitra (US 20090185987 A1) in view of Pushpangadan (US 20050142074 A1), in view of MacKinnon (US 20040175334 A1), in further view of Hwang (KR 20170125481 A) and Reynolds (US 11504305 B2).
Mitra, Pushpangadan, and MacKinnon teach the claimed invention as above, but fail to teach that the composition can comprise curcuma xanthorrhiza root powder and bentonite.
Regarding claims 19 and 21, MacKinnon teaches that the composition can comprise baking soda (i.e. sodium bicarbonate, para. [0018]) and miswak fibers (para. [0019]). As above, Hwang teaches a composition with curcuma xanthorrhiza, where the composition treats oral dryness or salivary secretion abnormality (see abstract). The composition of Hwang can be in the form of a powder or tablet (para. [0069]). Further, Hwang describes that curcuma xanthorrhiza can be in the powder form (para. [0092]). Reynolds describes a composition that is used to mineralize dental enamel (see abstract), where bentonite is used as a polishing material for the teeth (pg. 12, col. 1, line 43).
Mitra, Pushpangadan, MacKinnon, Hwang, and Reynolds are considered to be analogous to the claimed invention because they are in the same field of formulations in the powder form that improve oral health. One of ordinary skill in the art would be motivated to incorporate the sodium bicarbonate of MacKinnon into the composition of Mitra because Mackinnon describes that sodium bicarbonate in combination with miswak fibers is effective and safe for compositions to clean the teeth. MPEP § 2143(I)(a). Further, as above, it would be obvious to one of ordinary skill in the art to add the curcuma xanthorrhiza root powder of Hwang into the composition of Mitra to reduce oral dryness or salivary secretion abnormalities. MPEP § 2143(I)(a). One of ordinary skill in the art would further be motivated to add the bentonite of Reynolds to the composition of Mitra for its function as a polishing material in oral compositions. MPEP § 2143(I)(a).
Response to Applicant’s Arguments
Applicant’s amendments filed 08/31/2026 overcome the objection to claim 12 due to it being a duplicate of claim 5. As such the objection has been withdrawn. Further, the amendments over overcome the rejection of claims 1-13 under 35 U.S.C. 112(b) regarding the phrase “…effective amounts of organic ingredients including…”, and as such the rejection is withdrawn. Further, the rejection of claims 2 and 3 under 35 U.S.C. 112(b) is overcome by amendments, and the rejections are withdrawn.
Applicant asserts the following:
Amended claim 1 recites a mixture of neem, miswak, and triphala. Since this is not a naturally occurring mixture, the composition is something more than a natural phenomenon. The combination does not appear in nature without inventive mixing interaction, and the claimed invention is thus patentable subject matter under Section 101.
Mitra discloses that U.S. Patent 7,074,390 discusses a dentifrice including "miswak fibers along with choline and albumin for coating purposes". Mitra does not itself teach the use of miswak in any way. Since Mitra does not disclose a mixture of neem, miswak, and triphala, it cannot reasonably be said to provide limitations of Applicant's claimed invention.
The ingredients of Mitra, such as Azadirachta indica (neem), Terminalia chebula, Terminalia bellica, and Emblica officinalis are all extracts. Mitra does not disclose the use of powdered materials, such as explicitly recited in claims 3, 12, and 20.
Gulizio does not provide or suggest use of root powder in an oral treatment composition, as recited in amended claim 8.
Pushpangadan also does not provide or suggest the use of Azadirachta indica leaf powder in the composition, as recited in claim 10.
Razmpour discusses an extract, and does not disclose or suggest a composition including salvadora persica stem powder as recited in claim 11.
The rejection of claim 18 is transversed for the same reasons above, as the prior art does not disclose the ground or powdered forms of the components, but rather their extracts.
Mitra discloses a dental care composition of extracts, and not a powder mixture of including ground neem leaf, ground miswak stem, and ground triphala fruits. MacKinnon discloses encapsulated toothpaste including miswak fibers along with choline and albumin. Extracts and encapsulated toothpaste are not relevant to the Applicant's tablet of powdered ingredients. The combination does not reasonably provide or suggest a tablet of the powdered materials in claim 18. Therefore claim 18 is not obvious since the combination of prior art does not provide the components in the form as actually recited.
Prior art does not disclose or suggest the particular combinations of new claims 19-21.
In response to argument A, claim 1 remains rejected under 35 U.S.C. 101, for reasons as described above. Each component of claim 1, and further the combination or mixture of these components, can be found in nature. There is no evidence on the record that the mixture of the natural substances produces anything more than their combination, or transforms them into something materially 'new', rather it is just natural products 'mixed' without any transformation/difference. Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (“Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.”) MPEP § 2106.04(b)(II). Claim 1 does not have amendments that further limit the claim to something that is not natural, and the components are not transformed into something materially different than what can be found in nature, therefore the rejection of claim 1 under 35 U.S.C. 101 is maintained.
Regarding argument B, while Mitra does not teach miswak fibers in its composition specifically, it describes the benefit of miswak for a coating material in an oral formulation through referencing U.S. Patent 7,074,390 [0010]. Therefore, through the teachings of Mitra, one of ordinary skill in the art would be motivated to incorporate miswak fibers into an oral composition for their benefit and efficacy of acting as a coating material in an oral formulation.
In response to argument C, specifically in regard to claim 3, as above Mitra describes that the oral formulations can be in the form of a tooth powder (para. [0005]). The limitations of claim 3 do not specify that each of the components have to be in a powder form, but that the final composition is a tooth powder. While amendments to claim 12 and new claim 20 overcome the previous rejections made under 35 U.S.C. 103 under Mitra, new rejections under 35 U.S.C. 103, as necessitated by amendments above, teach these claims and as such the rejections are maintained.
Regarding arguments D and F, while amended claim 8 and 11 overcomes the previous rejections under 35 U.S.C. 103, the new rejections necessitated by amendments, as above, maintain this rejection.
Regarding argument E, as discussed in detail above, Pushpangadan teaches a composition containing Azadirachta indica leaf, in a powdered form (see claim 6).
In response to argument G and H, as above, Pushpangadan teaches the Azadirachta indica leaf (i.e. neem) as a powdered form (see claim 6) and MacKinnon describes that the composition comprises finely ground fibers of miswak. As described in the rejections under 35 U.S.C. 103 above, substituting one form of the triphala fruits for another known form (i.e. powder in place of extract) to arrive at the same product, which is a powdered dental composition, is within purview of the skilled artisan, and as such would yield predictable results. Further, the extracts and encapsulated toothpaste of Mitra and MacKinnon are considered relevant and analogous to the claimed invention because they are all formulations for the use in dental care. As above, Mitra describes that dental formulations can be in the form of tooth powders, toothpastes and gels, and as dental care tablets or capsules. Mitra and MacKinnon teach the benefits of the components of instant invention, demonstrating that they can be safely and effectively be used in dental compositions.
Regarding argument I, new rejections of claims 19-21 are made under 35 U.S.C. 103, as described in detail above.
Examiner thanks Applicant for the amendments and following arguments, but the rejections of claims 1-13 and 18-21 under 35 U.S.C. 103 are maintained.
Conclusion
Claim(s) 1-13 and 18-21 are rejected.
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.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
