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 Amendments, Remarks, and Request for Continued Examination filed on 02/04/26 are acknowledged.
Claim 2 was amended.
Claims 1-8 are pending and included in the prosecution.
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/04/26 has been entered.
Response to Amendments
Rejection of claims under 35 USC § 112(b)
In light of the amendment of claim 2 to recite the source of the specific plants the rejection of claim 2 under 35 USC § 112(b) as being indefinite is withdrawn.
Claim Objections
Claims 1-4 and 8 are objected to because of the following informalities:
In claim 1, line 7, a comma should be inserted after the term “curcuma spp.”
In claim 1, line 9, the term “natrumn” should be corrected to recite “Natrum.”
In claims 1, 2, 3, and 8, the first letter of each of the terms “curcuma,” “litsea,” and “lepidium” should be capitalized as “Curcuma,” “Litsea,” and “Lepidium,” respectively.
In claims 1, 4, and 8, the first letter of the first element in the chemical names of group II components should be capitalized. For example, “kali sulphuricum” should be corrected to recite “Kali sulphuricum.”
Appropriate correction is required.
Maintained Rejections
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 1-7 are again 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.
Claims 1-7 are drawn to a non-steroidal topical formulation comprising the following natural products: a plant extract obtained from Curcuma spp, Litsea spp., Lepidium spp., as well as the natural salts Potassium sulfate (Kali sulphuricum), Potassium Phosphate (Kali phosphoricum), Sodium sulfate (Natrum sulphuricum), Sodium chloride (Natrum muriaticum), Potassium Chloride (Kali muriaticum), and Sodium Phosphate (Natrum phosphoricum). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons.
With regard to natural products, the MPEP states: “product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 11A F.3d at 760, 113 USPQ2d at 1244 (“Contrary to Myriads 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."). Thus, a synthetic, artificial or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g. In re Roslin Institute (Edinburgh). 750 F.3d 1333, 1337. 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.” (MPEP 2106.04(b)(II)).
The rationale for this determination is explained below:
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Yes, the instant claims are directed to a statutory patent-eligible subject matter category, a composition of matter.
Step 2a Prong 1: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea?
The claims are directed to a natural phenomenon, specifically nature-based products which are plant extracts obtained from Curcuma spp, Litsea spp., Lepidium spp., as well as the natural salts Potassium sulfate (Kali sulphuricum), Potassium Phosphate (Kali phosphoricum), Sodium sulfate (Natrum sulphuricum), Sodium chloride (Natrum muriaticum), Potassium Chloride (Kali muriaticum), and Sodium Phosphate (Natrum phosphoricum).
The instant specification discloses that the plant extracts may be selected from powdered plant parts of Curcuma spp, Litsea spp, and Lepidium spp. ([0019]), “plant extracts from Curcuma spp., which may include, but are not limited to, C. aromatica, C. amada, C. longa, or C. domestica. The plant from Curcuma spp is commonly known as Haldi” ([0020]), and “Lepidium sativum Linn., commonly known as "garden cress," or "halo meda" belongs to Cruciferae family. Litsea glutinosa commonly known as "meda lakari" is a rainforest tree in the laurel family, Lauraceae” ([0021]). The natural salts Potassium sulfate (Kali sulphuricum ), Potassium Phosphate (Kali phosphoricum), Sodium sulfate (Natrum sulphuricum), Sodium chloride (Natrum muriaticum). Potassium Chloride (Kali muriaticum), and Sodium Phosphate (Natrum phosphoricum) are disclosed ([0022]). All these products exist in nature and there is no evidence in the record that the claimed products impart new properties.
Step 2a Prong 2: Does the Claim recite additional elements that integrate the judicial exception into a Practical Application?
Yes, claim 1 recites a non-steroidal topical formulation and claim 6 recites that the formulation is in the form of an ointment, cream, lotion, gel and spray.
Step 2b: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. With regards to claims 1-7, the recitation of a non-steroidal topical formulation (claim 1) and the form of the formulation (claim 6) does not distinguish these claims from the judicial exception.
The non-steroidal topical formulation could be a natural product by itself which does not amount to significantly more than the judicial exception.
The claims, as a whole, do not recite any additional elements that amount to significantly more than the judicial exception. Specifically, the claims do not include any elements in addition to the natural product. As such, claims 1-7 are drawn to a judicial exception.
Response to Arguments
Applicant’s arguments (Pages 5-7, filed 08/28/25) with respect to the rejection of claims 1-7 under 35 U.S.C. 101 have been fully considered but are not persuasive.
Applicant argues that: “The claim is not directed to a naturally occurring product, but instead to a human-made composition of matter that requires selection of multiple plant species, extraction from specific plant parts, combination with defined inorganic components, and formulation with pharmaceutically acceptable excipients. Such a formulation does not occur in nature and cannot be obtained without human intervention.”
This is not persuasive because even though instant claims are drawn to a combination of natural plant extracts and natural salts, none of the component plant extracts and salts are markedly different from products of nature. The claims are similar to those in the Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) case, where the court ruled that combining various natural products, even in certain ratios or amounts, is not eligible.
Applicant argues that: “As recognized by the Supreme Court in Diamond v. Chakrabarty, compositions resulting from human ingenuity and having characteristics not found in nature constitute patent-eligible subject matter. Although individual components may be naturally derived, the claimed combination as a whole represents a structurally and functionally distinct composition. Accordingly, the claims are not "directed to" a judicial exception, and the §101 analysis should conclude at Step 2A, Prong One.”
This is not persuasive because all the claimed natural plant extracts and natural salts exist in nature and there is no evidence in the record that the claimed products impart new properties.
Applicant argues that: “Even assuming arguendo that the claims involve nature-based products, the claims clearly integrate those products into a practical application. The claims recite a pharmaceutical formulation having defined active and inactive ingredient percentages and specific topical dosage forms such as ointments, creams, lotions, gels, and sprays. These limitations apply the ingredients in a specific, concrete, and meaningful therapeutic context for alleviating pain and inflammation, thereby imposing meaningful limits on any alleged natural principle. Under MPEP §2106.04(d), claims that apply natural products in a manner that improves a particular technological or medical field qualify as patent eligible. Therefore, the claims satisfy Step 2A, Prong Two.”
This is not persuasive because the pharmaceutical formulation having active and inactive ingredient percentages and specific topical dosage forms could be a natural product by itself which does not satisfy Step 2A, Prong Two.
Applicant argues that: “… the claims recite additional elements that, when considered individually and as an ordered combination, amount to significantly more than any alleged judicial exception. These additional elements include defined weight percentages of active and inactive ingredients, the presence of pharmaceutically acceptable excipients forming a topical dosage form, and a specific multi-component combination that produces enhanced analgesic and anti-inflammatory effects relative to the individual components. These features do not merely instruct one to observe or apply a natural phenomenon, but instead define a manufactured pharmaceutical composition with specific structural and functional characteristics. Accordingly, the claims recite an inventive concept sufficient to satisfy Step 2B.”
This is not persuasive because the defined weight percentages of active and inactive ingredients are not relevant based on Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) case, where the court ruled that combining various natural products, even in certain ratios or amounts, is not eligible.
Applicant’s argument regarding the presence of pharmaceutically acceptable excipients forming a topical dosage form is not persuasive because these also include natural products. For example, the inactive ingredients listed in claim 5 contain natural products, i.e., emollient which includes natural shea butter, jojoba oil, cocoa butter etc. A chelating agent includes natural citric acid which is present in citrus fruits. A pH adjuster also includes natural citric acid. An antioxidant includes natural vitamin C or ascorbic acid which is present in citrus fruits. An emulsifying wax includes wax from palm or corn. A cooling agent includes natural menthol, eucalyptol, or peppermint. A natural solvent includes water. None of these excipients are different from those found in nature.
Applicant’s argument about a specific multi-component combination that produces enhanced analgesic and anti-inflammatory effects relative to the individual components is not persuasive because these are future intended effects which are not given patentable weight in composition or product claims. Instant claims do not recite a method of treating pain or inflammation. Rather, instant claims 1-7 are drawn to a formulation. Nonetheless, the enhanced analgesic and anti-inflammatory effects would have been obvious over the prior art composition, i.e., the composition used in the method of treatment of musculoskeletal pain (Abstract, claims 1-18) and inflammation (claims 14-18), which includes degenerative joint disease, degenerative disc disease, osteoarthritis, etc. ([0013]-[0017], [0047]-[0050], [0091], and claims 14-18), as taught by Parris. Therefore, the enhanced analgesic and anti-inflammatory effects are associated with the natural components, as evidenced by the art.
The recited components are still natural products and the amounts or percentages associated with these components are not relevant based on Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) case, where the court ruled that combining various natural products, even in certain ratios or amounts, is not eligible.
Applicant argues that: “The Examiner's reliance on Funk Bros. Seed Co. v. Kala Inoculant Co. is misplaced. In Funk Bros., the claimed invention merely combined naturally occurring bacteria without altering their characteristics or creating a new functional composition. In contrast, Applicant's claims require a formulated pharmaceutical composition with defined concentrations, excipients, and dosage forms that together produce enhanced therapeutic performance. The claimed invention therefore goes beyond a simple aggregation of natural products and constitutes a patent-eligible composition of matter.”
This is not persuasive because Applicant is also merely combining natural plant extracts and natural salts without altering their characteristics or creating a new functional composition. The claimed combination does not involve or require any modification of the natural plant extracts or natural salts.
Applicant argues that: “… the formulation claimed in independent claim 1 is capable of efficiently eliminating or reducing age-related osteoarthritic joint pain, inflammation and musculoskeletal diseases and provides long-term relief to the aged patients.”
This is not persuasive because instant claims 1-6 are drawn to a formulation and not to a method of treating, such as eliminating or reducing age-related osteoarthritic joint pain, etc. Even though instant claim 7 recites that the formulation is effective in reducing age-related osteoarthritic joint pain and musculoskeletal diseases, this is a future intended use of the formulation that is not given patentable weight. Nonetheless, this limitation would have been obvious over the prior art composition, i.e., the composition used in the method of treatment of musculoskeletal pain (Abstract, claims 1-18) and inflammation (claims 14-18), which includes degenerative joint disease, degenerative disc disease, osteoarthritis, etc. ([0013]-[0017], [0047]-[0050], [0091], and claims 14-18), as taught by Parris. Therefore, the eliminating or reducing of age-related osteoarthritic joint pain, inflammation and musculoskeletal diseases is associated with the natural components, as evidenced by the art.
Therefore, the rejection of 05/30/25 is maintained.
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
Maintained Rejections
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1 and 3-8 are again rejected under 35 U.S.C. 103 as being unpatentable over Parris (US 2017/0056464 A1) in view of Peltier et al. (US 2020/0359670 A1 – “Peltier”), and Luria et al. (US 2008/0279902 A1 – “Luria”).
The claimed invention is a non-steroidal topical formulation comprising: 10 wt% to 20 wt% of an active ingredient consisting of a combination of group I and group II component; and 80 wt% to 90 wt% of inactive ingredient comprising one or more pharmaceutically acceptable excipient; wherein group I component is a plant extract obtained from Curcuma spp, Litsea spp., and Lepidium spp. and group II component is selected from a group comprising Potassium sulfate (Kali sulphuricum), Potassium Phosphate (Kali phosphoricum), Sodium sulfate (Natrum sulphuricum), Sodium chloride (Natrum muriaticum), Potassium Chloride (Kali muriaticum), and Sodium Phosphate (Natrum phosphoricum).
Parris teaches compositions and method of treatment for musculoskeletal pain (Abstract, claims 1-18). The musculoskeletal pain includes degenerative joint disease, degenerative disc disease, osteoarthritis, etc. ([0013]-[0017], [0047]-[0050], [0091], and claims 14-18). The composition is suitable for topical application ([0012]-[0015], [0017], Tables 1-10, claims 11, 14-18). The composition contains turmeric and litsea ([0010], [0034], and claim 4).
Parris does not expressly teach Lepidium spp. or the group II components recited in instant claim 1.
Peltier teaches a composition comprising a mixture of plant extracts for the prevention and/or treatment of chronic abdominal pain from chronic inflammatory bowel disease (Abstract, [0127], and claims 1-16). The composition may be in the form of a gel, emulsion, or liquid ([0122] and claim 16). The composition contains curcumin ([0120] and claim 15) and Lepidium spp. such as Lepidium meyenii Walp. and Lepidium sativum ([0121]).
Luria teaches a delivery system and method to deliver topically homeopathic amounts of a homeopathic complex (Abstract, claims 1-51). Skin conditions suitable for treatment with homeopathic remedies include pain and pain management ([0006], Tables 2, 5, and 8). The homeopathic complex also comprises Curcuma longa ([0014]-[0016], Table 1, [0058], [0093], and claims 12, 24, 43) and Litsea cubeba ([0083]). Homeopathic Complex 1 includes Potassium sulfate (Kali sulphuricum), Potassium Phosphate (Kali phosphoricum), Sodium sulfate (Natrum sulphuricum), Sodium chloride (Natrum muriaticum), Potassium Chloride (Kali muriaticum), and Sodium Phosphate (Natrum phosphoricum) (Table 4). The formulation is in the form of a face cream, an eye cream, a lotion, a facial serum, a facial scrub ([0014], [0016], [0056], [0067], Example 12, Table 20, claims 9 and 41), an ointment, or a gel ([0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a composition used for treating musculoskeletal pain wherein the composition is suitable for topical application and includes turmeric and litsea, as taught by Parris, in view of the composition in the form of a gel, emulsion, or liquid which is used for the treatment of pain and contains curcumin and Lepidium spp. such as Lepidium meyenii Walp. and Lepidium sativum, as taught by Peltier, and the delivery system for the treatment of pain which contains a homeopathic complex including Curcuma longa, Litsea cubeba and the salts potassium sulfate (Kali sulphuricum), potassium phosphate (Kali phosphoricum), sodium sulfate (Natrum sulphuricum), sodium chloride (Natrum muriaticum), potassium chloride (Kali muriaticum), and sodium phosphate (Natrum phosphoricum), as taught by Luria, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the references are drawn to compositions used in the treatment of pain, and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have found it obvious to include the constituents of the compositions taught by Peltier and Luria in the composition of Parris because all the constituents would be expected to effectively treat pain.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 1 and 8, the limitations of a non-steroidal topical formulation (instant claim 1) and a method of preparing a topical formulation (instant claim 8) would have been obvious over the preparation of a composition suitable for topical application ([0012]-[0015], [0017], Tables 1-10, claims 11, 14-18), as taught by Parris, the composition in the form of a gel, emulsion, or liquid ([0122] and claim 16), as taught by Peltier, and by the topical delivery of a homeopathic complex in the form of a face cream, an eye cream, a lotion, a facial serum, a facial scrub ([0014], [0016], [0056], [0067], Examples 11-12, Tables 19-20, claims 9 and 41), an ointment, or a gel ([0063]), as taught by Luria.
Regarding instant claim 1, the limitation of 10 wt% to 20 wt% of an active ingredient from group I and group II components, and 80 wt% to 90 wt% of pharmaceutically acceptable excipients would have been obvious over Example 11 which describes eye creams having an inactive base of oils and butters at a calculated concentration of 85.67% (butter and oil at the lower limit of the recited ranges of 22.4% by weight (b.w.) + 32.3% b.w. = 54.7% b.w.; butter and oil based on total weight of the formulation: 54.7% b.w. ÷ 63.85% b.w. = 85.67% b.w.) (Table 19), as taught by Luria. Luria also teaches a night lotion formulation in Example 12 which contains a calculated concentration of inactive base of butter and oil of 86.27% (butter and oil at the lower limit of the recited ranges of 23.0% by weight (b.w.) + 34.5% b.w. = 57.5% b.w.; butter and oil based on total weight of the formulation: 57.5% b.w. ÷ 66.65% b.w. = 86.27% b.w.) (Table 20). Since the inactive base of butter and oil is 85.67% b.w. or 86.27% b.w., one of ordinary skill in the art would have found it obvious to calculate the remainder of the formulation, i.e., as 100% - 85.67% = 14.33%; and 100% - 86.27% = 13.75%, as being the active portion of the formulation, which lies within the recited range of 10 wt% to 20 wt%, thereby rendering this limitation obvious.
Regarding instant claims 1 and 8, the limitations of group I components would have been obvious over the turmeric and litsea ([0010], [0034], and claim 4), as taught by Parris, the curcumin ([0120] and claim 15) and Lepidium spp. such as Lepidium meyenii Walp. and Lepidium sativum ([0121]), as taught by Peltier, and the Curcuma longa ([0014]-[0016], Table 1, [0058], [0093], and claims 12, 24, 43) and Litsea cubeba ([0083]), as taught by Luria.
Regarding instant claims 1 and 8, the limitations of group II components would have been obvious over Homeopathic Complex 1 which includes Potassium sulfate (Kali sulphuricum), Potassium Phosphate (Kali phosphoricum), Sodium sulfate (Natrum sulphuricum), Sodium chloride (Natrum muriaticum), Potassium Chloride (Kali muriaticum), and Sodium Phosphate (Natrum phosphoricum) (Table 4), as taught by Luria.
Regarding instant claims 3 and 8, the limitations of the concentration of the group I components would have been obvious over the turmeric and litsea ([0010], [0034], and claim 4), as taught by Parris, the curcumin ([0120] and claim 15) and Lepidium spp. such as Lepidium meyenii Walp. and Lepidium sativum ([0121]), as taught by Peltier, and the Curcuma longa ([0014]-[0016], Table 1, [0058], [0093], and claims 12, 24, 43) and Litsea cubeba ([0083]), as taught by Luria. One of ordinary skill in the art would have found it obvious to use equal parts of the three components, i.e., in thirds, in the composition. The recited ranges would have been obvious variants over the prior art unless there is evidence of criticality or unexpected results.
Regarding instant claims 4 and 8, the limitations of group II components would have been obvious over the Homeopathic Complex 1 which includes Potassium sulfate (Kali sulphuricum), Potassium Phosphate (Kali phosphoricum), Sodium sulfate (Natrum sulphuricum), Sodium chloride (Natrum muriaticum), Potassium Chloride (Kali muriaticum), and Sodium Phosphate (Natrum phosphoricum) (Table 4), as taught by Luria. One of ordinary skill in the art would have found it obvious to use different concentrations of the salts in the compositions which contain 0.05-20.0 percent by weight of homeopathic complex (Tables 19 and 20) based on the desired therapeutic efficacy. The recited ranges would have been obvious variants over the prior art unless there is evidence of criticality or unexpected results.
Regarding instant claims 5 and 8, the limitation of an emollient as an inactive ingredient would have been obvious over the emollients which include butters and oils ([0065]), as taught by Luria.
Regarding instant claim 6, the limitation of an ointment, cream, lotion, gel and spray would have been obvious over the composition suitable for topical application ([0012]-[0015], [0017], Tables 1-10, claims 11, 14-18), as taught by Parris, the composition in the form of a gel ([0122] and claim 16), as taught by Peltier, and by the topical delivery of a homeopathic complex in the form of a face cream, an eye cream, a lotion, a facial serum ([0014], [0016], [0056], [0067], Examples 11-12, Tables 19-20, claims 9 and 41), an ointment, or a gel ([0063]), as taught by Luria.
Regarding instant claim 7, the limitation of the formulation being effective in reducing age-related osteoarthritic joint pain and musculoskeletal diseases is a future intended use of the formulation that is not given patentable weight. Nonetheless, this limitation would have been obvious over the composition used in the method of treatment of musculoskeletal pain (Abstract, claims 1-18), which includes degenerative joint disease, degenerative disc disease, osteoarthritis, etc. ([0013]-[0017], [0047]-[0050], [0091], and claims 14-18), as taught by Parris.
Claim 2 is again rejected under 35 U.S.C. 103 as being unpatentable over Parris (US 2017/0056464 A1) in view of Peltier et al. (US 2020/0359670 A1 – “Peltier”), and Luria et al. (US 2008/0279902 A1 – “Luria”), as applied to claims 1 and 3-8 above, in view of Lantz et al. (Phytomedicine 12 (2005) 445-452 – “Lantz”).
Instant claim 2 is drawn to the formulation as claimed in claim 1, wherein the plant extract is obtained from rhizome, wood and seeds of a plant.
The teachings of Parris, Peltier, and Luria are discussed above.
Parris, Peltier, and Luria do not expressly teach that the plant extract is obtained from the rhizome, wood and seeds of a plant.
Lantz teaches that turmeric is isolated from the powdered rhizomes of Curcuma longa L. (Abstract, Page 445, Col. 2, lines 7-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a composition used for treating musculoskeletal pain wherein the composition is suitable for topical application and includes turmeric and litsea, as taught by Parris, in view of the composition in the form of a gel, emulsion, or liquid which is used for the treatment of pain and contains curcumin and Lepidium spp. such as Lepidium meyenii Walp. and Lepidium sativum, as taught by Peltier, the delivery system for the treatment of pain which contains a homeopathic complex including Curcuma longa, Litsea cubeba and the salts potassium sulfate (Kali sulphuricum), potassium phosphate (Kali phosphoricum), sodium sulfate (Natrum sulphuricum), sodium chloride (Natrum muriaticum), potassium chloride (Kali muriaticum), and sodium phosphate (Natrum phosphoricum), as taught by Luria, use turmeric from the powdered rhizomes of Curcuma longa L., as taught by Lantz, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the turmeric is known to be extracted from the powdered rhizomes of Curcuma longa L. and used as a supplement having anti-inflammatory properties, as evidenced by Lantz (paragraph bridging Pages 445-446).
Regarding instant claim 2, the limitation of the plant extract obtained from the rhizome of a plant would have been obvious over the turmeric isolated from the powdered rhizomes of Curcuma longa L. (Abstract, Page 445, Col. 2, lines 7-10), as taught by Lantz. One of ordinary skill in the art would have found it obvious to use extracts from various parts of the plants, including, rhizomes, as taught by Lantz, and leaves, stems, seeds etc. absent evidence of criticality or unexpected results.
Response to Arguments
Applicant’s arguments (Pages 9-14, filed 02/04/26) with respect to the following rejections have been fully considered.
Rejection of claims 1 and 3-8 under 35 U.S.C. 103 as being unpatentable over Parris in view of Peltier, and Luria
Rejection of claim 2 under 35 U.S.C. 103 as being unpatentable over Parris in view of Peltier, Luria, and Lantz
Applicant argues that: “… the formulation of the present application is effective in eliminating or reducing age-related osteoarthritic joint pain, inflammation and musculoskeletal diseases in older patients. The formulation provides extensive relief in osteoarthritis of the knee joint. It provides long-term relief i.e. for 6 to 8 hours which later extends from 12 to 24 hours, without the administration of any oral medication and side effects. The formulation may be added to any conventional formula to provide novelty and invention.”
This is not persuasive because, as discussed above, instant claims 1-6 are drawn to a formulation and not to a method of treating, such as eliminating or reducing age-related osteoarthritic joint pain, etc. Even though instant claim 7 recites that the formulation is effective in reducing age-related osteoarthritic joint pain and musculoskeletal diseases, this is a future intended use of the formulation that is not given patentable weight. Nonetheless, this limitation would have been obvious over the prior art composition, i.e., the composition used in the method of treatment of musculoskeletal pain (Abstract, claims 1-18) and inflammation (claims 14-18), which includes degenerative joint disease, degenerative disc disease, osteoarthritis, etc. ([0013]-[0017], [0047]-[0050], [0091], and claims 14-18), as taught by Parris.
Applicant’s arguments regarding the long-term relief, i.e., for 6 to 8 hours which later extends from 12 to 24 hours, and the formulation added to any conventional formula to provide novelty and invention, are neither recited nor relevant to the instant product claims. All the limitations of the form of the formulation, the components of the formulation, the corresponding weight percentage ranges of the components, and the arrangement of the components are taught by the prior art. 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.
Also, it is noted that the features upon which applicant relies (i.e., long-term relief, i.e., for 6 to 8 hours) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that: “… the cited references, whether alone or in combination, fail to teach or suggest a non-steroidal topical pharmaceutical formulation comprising a defined combination of Curcuma spp. extract, Litsea spp. extract, and Lepidium spp. extract together with the recited inorganic salts and in the claimed weight percentages.”
This is not persuasive because the limitations of a non-steroidal topical formulation (instant claim 1) and a method of preparing a topical formulation (instant claim 8) would have been obvious over the preparation of a composition suitable for topical application ([0012]-[0015], [0017], Tables 1-10, claims 11, 14-18), as taught by Parris, the composition in the form of a gel, emulsion, or liquid ([0122] and claim 16), as taught by Peltier, and by the topical delivery of a homeopathic complex in the form of a face cream, an eye cream, a lotion, a facial serum, a facial scrub ([0014], [0016], [0056], [0067], Examples 11-12, Tables 19-20, claims 9 and 41), an ointment, or a gel ([0063]), as taught by Luria.
The limitation of 10 wt% to 20 wt% of an active ingredient from group I and group II components, and 80 wt% to 90 wt% of pharmaceutically acceptable excipients would have been obvious over Example 11 which describes eye creams having an inactive base of oils and butters at a calculated concentration of 85.67% (butter and oil at the lower limit of the recited ranges of 22.4% by weight (b.w.) + 32.3% b.w. = 54.7% b.w.; butter and oil based on total weight of the formulation: 54.7% b.w. ÷ 63.85% b.w. = 85.67% b.w.) (Table 19), as taught by Luria. Luria also teaches a night lotion formulation in Example 12 which contains a calculated concentration of inactive base of butter and oil of 86.27% (butter and oil at the lower limit of the recited ranges of 23.0% by weight (b.w.) + 34.5% b.w. = 57.5% b.w.; butter and oil based on total weight of the formulation: 57.5% b.w. ÷ 66.65% b.w. = 86.27% b.w.) (Table 20). Since the inactive base of butter and oil is 85.67% b.w. or 86.27% b.w., one of ordinary skill in the art would have found it obvious to calculate the remainder of the formulation, i.e., as 100% - 85.67% = 14.33%; and 100% - 86.27% = 13.75%, as being the active portion of the formulation, which lies within the recited range of 10 wt% to 20 wt%, thereby rendering this limitation obvious.
The limitations of group I components would have been obvious over the turmeric and litsea ([0010], [0034], and claim 4), as taught by Parris, the curcumin ([0120] and claim 15) and Lepidium spp. such as Lepidium meyenii Walp. and Lepidium sativum ([0121]), as taught by Peltier, and the Curcuma longa ([0014]-[0016], Table 1, [0058], [0093], and claims 12, 24, 43) and Litsea cubeba ([0083]), as taught by Luria.
The limitations of group II components would have been obvious over Homeopathic Complex 1 which includes Potassium sulfate (Kali sulphuricum), Potassium Phosphate (Kali phosphoricum), Sodium sulfate (Natrum sulphuricum), Sodium chloride (Natrum muriaticum), Potassium Chloride (Kali muriaticum), and Sodium Phosphate (Natrum phosphoricum) (Table 4), as taught by Luria.
Applicant argues that: “Although Parris includes a long list of optional essential oils, it does not disclose or exemplify Curcuma spp. extract, Litsea spp. extract, or Lepidium spp. extract, nor does it describe combining these three botanical extracts together in a topical pharmaceutical formulation. Instead, Parris defines its compositions as unique combinations of essential oils and optional pharmaceutical active agents such as capsaicin, diclofenac, magnesium salicylate, or acetylsalicylic acid. Thus, Parris fails to teach Applicant's core three-extract system.”
This is not persuasive because turmeric and litsea ([0010], [0034], and claim 4), are taught by Parris. The specific Curcuma spp. is rendered obvious by the turmeric of Parris in view of the curcumin ([0120] and claim 15), as taught by Peltier, and the Curcuma longa ([0014]-[0016], Table 1, [0058], [0093], and claims 12, 24, 43), as taught by Luria.
Similarly, the limitations of litsea would have been obvious over the litsea ([0010], [0034], and claim 4), as taught by Parris. The specific litsea spp. would have been obvious over the Litsea cubeba ([0083]), as taught by Luria.
Also, the limitations of lepidium would have been obvious over the Lepidium spp. such as Lepidium meyenii Walp. and Lepidium sativum ([0121]), as taught by Peltier.
The teachings of Parris, Peltier, and Luria are properly combined because all the references are drawn to compositions used in the treatment of pain, and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have found it obvious to include the constituents of the compositions taught by Peltier and Luria in the composition of Parris because all the constituents would be expected to effectively treat pain.
Applicant’s argument regarding Parris failing to teach Applicant’s core three-extract system is not persuasive because the rejection does not rely solely on Parris. As explained above, the deficiencies regarding the specific Curcuma spp, litsea spp. and lepidium spp. are cured by the supporting references Peltier and Luria. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, the obviousness rejection relies on a combination of references. Peltier is combined with Parris and Luria. Luria teaches the combination of the homeopathic complex containing the salts with Curcuma longa, Litsea cubeba. The rationale for combining these references is based on the common utility of all the cited prior art compositions, i.e., all the references are drawn to compositions used in the treatment of pain. it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have found it obvious to combine components which are known for treating musculoskeletal pain, such as the turmeric and litsea taught by Parris, the curcumin and Lepidium spp. taught by Peltier, and the curcuma longa, Litsea cubeba and the salts taught by Luria.
Applicant argues that: “Peltier does not disclose Curcuma spp., Litsea spp., or Lepidium spp., does not address topical administration, and does not concern musculoskeletal or joint pain. Accordingly, Peltier cannot supply the missing botanical components or topical analgesic context required by the claims.”
Applicant argues that “… Luria does not teach or suggest a topical pharmaceutical formulation comprising the specific combination of Curcuma spp. extract, Litsea spp. extract, and Lepidium spp. extract as active agents for analgesic or anti-inflammatory treatment. Nor does Luria disclose the particular extract sources and coordinated use of these three botanicals as a functional system. Consequently, Luria likewise fails to remedy the deficiencies of Parris and Peltier.”
Applicant’s arguments regarding Peltier and Luria are not persuasive because one of ordinary skill in the art would have found it obvious to combine components which are used for the same purpose, i.e., are known for treating pain, such as the turmeric and litsea taught by Parris, the curcumin and Lepidium spp. taught by Peltier, and the Curcuma longa, Litsea cubeba and the salts taught by Luria. Luria clearly teaches that Curcuma longa is turmeric ([0016]). The primary reference, Parris, teaches turmeric ([0010], [0034] and claim 4). One of ordinary skill in the art would have found it obvious to use the turmeric of Parris and combine it with the curcumin of Peltier, and the Curcuma longa of Luria, and have a reasonable expectation of success in treating pain.
MPEP 2144.06 states: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine said plant extracts and salts (as taught by Parris, Peltier, and Luria) with a reasonable expectation of success because each component is taught to be useful for the same purpose (treating pain) and it is prima facie obvious to combine said components to form a third composition to be used for the very same purpose.
Applicant argues that: “The Examiner's proposed combination would require selecting unrelated disclosures from references directed to essential-oil musculoskeletal rubs (Parris), oral/nutritional gastrointestinal therapies (Peltier), and homeopathic/cosmetic complexes (Luria), and then reconstructing them into Applicant's claimed formulation. None of the references contains a teaching, suggestion, or motivation to combine Curcuma spp. extract, Litsea spp. extract, and Lepidium spp. extract into a single topical pharmaceutical composition for pain relief. Such a reconstruction can only be achieved with impermissible hindsight.”
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the present case, one of ordinary skill in the art would have been motivated to combine the teachings of Parris, Peltier, and Luria because each of these references are drawn to compositions used in the treatment of pain, and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A).
Parris teaches compositions and method of treatment for musculoskeletal pain (Abstract, claims 1-18). The musculoskeletal pain includes degenerative joint disease, degenerative disc disease, osteoarthritis, etc. ([0013]-[0017], [0047]-[0050], [0091], and claims 14-18). Peltier teaches a composition comprising a mixture of plant extracts for the prevention and/or treatment of chronic abdominal pain from chronic inflammatory bowel disease (Abstract, [0127], and claims 1-16). Luria teaches a delivery system and method to deliver topically homeopathic amounts of a homeopathic complex (Abstract, claims 1-51). Skin conditions suitable for treatment with homeopathic remedies include pain and pain management ([0006], Tables 2, 5, and 8).
In addition to all three references being drawn to compositions used for the same purpose of treating pain, all three references also teach the same form of the composition, i.e., topical compositions. Parris teaches the composition suitable for topical application ([0012]-[0015], [0017], Tables 1-10, claims 11, 14-18); Peltier teaches the composition in the form of a gel ([0122] and claim 16), and Luria teaches the topical delivery of a homeopathic complex in the form of a face cream, an eye cream, a lotion, a facial serum ([0014], [0016], [0056], [0067], Examples 11-12, Tables 19-20, claims 9 and 41), an ointment, or a gel ([0063]).
Therefore, based on the same form of the composition and the same purpose for the composition, one of ordinary skill in the art would have found it obvious to include the constituents of the compositions taught by Peltier and Luria in the composition of Parris because all the constituents would be expected to effectively treat pain and are in the same form of topical compositions.
Also, MPEP 2144.06(I) states: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine said plant extracts and salts (as taught by Parris, Peltier, and Luria) with a reasonable expectation of success because each component is taught to be useful for the same purpose (treating pain) and it is prima facie obvious to combine said components to form a third composition to be used for the very same purpose.
Applicant argues that: “… Applicant's claims recite defined weight percentages of active ingredients (10-20 wt%) and pharmaceutically acceptable excipients (80-90 wt%). Parris teaches carrier-oil-dominant formulations where essential oils are minor constituents, and Peltier's compositions are directed to oral or nutritional formulations without comparable topical active/excipient ratios. None of the cited references teaches or suggests Applicant's claimed quantitative framework for a three-extract topical pharmaceutical composition.”
This is not persuasive because the limitation of 10 wt% to 20 wt% of an active ingredient from group I and group II components, and 80 wt% to 90 wt% of pharmaceutically acceptable excipients would have been obvious over Example 11 which describes eye creams having an inactive base of oils and butters at a calculated concentration of 85.67% (butter and oil at the lower limit of the recited ranges of 22.4% by weight (b.w.) + 32.3% b.w. = 54.7% b.w.; butter and oil based on total weight of the formulation: 54.7% b.w. ÷ 63.85% b.w. = 85.67% b.w.) (Table 19), as taught by Luria. Luria also teaches a night lotion formulation in Example 12 which contains a calculated concentration of inactive base of butter and oil of 86.27% (butter and oil at the lower limit of the recited ranges of 23.0% by weight (b.w.) + 34.5% b.w. = 57.5% b.w.; butter and oil based on total weight of the formulation: 57.5% b.w. ÷ 66.65% b.w. = 86.27% b.w.) (Table 20). Since the inactive base of butter and oil is 85.67% b.w. or 86.27% b.w., one of ordinary skill in the art would have found it obvious to calculate the remainder of the formulation, i.e., as 100% - 85.67% = 14.33%; and 100% - 86.27% = 13.75%, as being the active portion of the formulation, which lies within the recited range of 10 wt% to 20 wt%, thereby rendering this limitation obvious.
Applicant’s argument regarding Parris teaching carrier-oil-dominant formulations where essential oils are minor constituents is not persuasive because Parris teaches a composition suitable for topical application ([0012]-[0015], [0017], Tables 1-10, claims 11, 14-18). The teaching of Parris is not limited to carrier-oil-dominant formulations. One of ordinary skill in the art would have found it obvious to read the entire disclosure of Parris and glean that compositions suitable for topical application are embraced. Moreover, according to MPEP § 2123, “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” and “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure of preferred embodiments.”
Applicant’s argument regarding Peltier’s compositions directed to oral or nutritional formulations without comparable topical active/excipient ratios is not persuasive because Peltier teaches that the composition is in the form of a gel, emulsion, or liquid ([0122] and claim 16). Peltier teaches that their compositions are intended to be administered to humans or animals by any administration means ([0122]). One of ordinary skill in the art would have found it obvious to topically apply the gel, emulsion or liquid taught by Peltier since any administration means are disclosed.
Since each of the claimed components (group I and group II components and excipients), their corresponding weight percentage ranges, and the arrangement of the components in the same form of the composition (a non-steroidal topical formulation) are disclosed by the prior art references (Parris, Peltier, Luria), one of ordinary skill in the art would have found the claimed invention obvious.
Rejection of Claim 2
Applicant argues (Page 14, filed 02/04/26) that “… even considering Lantz, which merely describes isolation of turmeric from Curcuma rhizomes, there remains no teaching or suggestion to combine Curcuma extract with Litsea extract obtained from wood and Lepidium extract obtained from seeds, nor to incorporate such extracts into Applicant's claimed topical formulation.”
This is not persuasive because Lantz is relied upon for curing the deficiency of the plant extract obtained from the rhizomes of Curcuma. One of ordinary skill in the art would have found it obvious to combine the teachings of Lantz with those of Parris, Peltier, and Luria because all the references teach components which are used for the same purpose, i.e., are known for treating pain, such as the turmeric and litsea taught by Parris, the curcumin and Lepidium spp. taught by Peltier, and the Curcuma longa, Litsea cubeba and the salts taught by Luria. Please see MPEP 2144.06(I).
Applicant argues that: “… Applicant has discovered that the specific combination of Curcuma spp., Litsea spp., and Lepidium spp. extracts produces enhanced analgesic and anti-inflammatory effects compared to the individual components. Such unexpected synergistic results further rebut any prima facie case of obviousness.”
This is not persuasive because neither the instant claims nor the instant specification mention synergy or a comparison with the closest prior art. According to MPEP 716.01(a)(I), greater than expected results are evidence of nonobviousness. However, this section also states that: “Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive sweetness resulting from the claimed mixture of saccharin and L-aspartyl-L-phenylalanine was not sufficient to outweigh the evidence of obviousness because the teachings of the prior art lead to a general expectation of greater than additive sweetening effects when using mixtures of synthetic sweeteners.).”
In the instant case, Applicant has not presented any evidence showing synergy, unexpected results, or a comparison with the closest prior art. MPEP 2145 states: “If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case ... However, arguments presented by applicant cannot take the place of factually supported objective evidence. See, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).”
In the absence of such evidence, the obviousness rejection based on the supporting reference Lantz of 05/30/25 is maintained.
Conclusion
13. No claims are allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615