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 Preliminary Amendment filed on 01/05/23 is acknowledged.
Claim 17 was cancelled; and claims 3-11 and 13-16 were amended.
Claims 1-16 are pending and included in the prosecution.
Priority
This Application claims foreign priority to IN 202211000994 filed on 01/07/22. Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119 (a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 01/05/23; 06/28/23; 12/26/23; and 05/22/25 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities:
In claim 1, the commas following parts (a), (c), and (e) should be replaced with semi-colons.
In claim 13, the periods following the components a-e should be deleted. Please see MPEP 608.01(m) which states: “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations.”
Appropriate correction is required.
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 1-6, 10-12, and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-6, 10-12, and 14 are directed to a composition comprising natural products. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on December 16, 2014 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (Inter alia). See e.g. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and technological work", and are thus excluded from patentability because "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at 2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this "exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980. The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural phenomena; i.e., one may not patent every "substantial practical application" of an abstract idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". Products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
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It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.
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When a claim recites a nature-based product limitation, examiners use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A. Nature-based products, as used herein, include both eligible and ineligible products and merely refer to the types of products subject to the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this analysis to identify product of nature exceptions. If the claim includes a nature-based product that has markedly different characteristics, then the claim does not recite a product of nature exception and is eligible. If the claim includes a nature-based product that does not exhibit markedly different characteristics from its closest naturally occurring counterpart in its natural state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception.
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Nature-based Product Claim Analysis
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Where the claim is to a nature-based product by itself, the markedly different characteristics analysis should be applied to the entire product.
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Where the claim is to a nature-based product produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts. Where the claim is to a nature-based product in combination with non-nature based elements, the markedly different characteristics analysis should be applied only to the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart.
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.
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Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product.
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When there are multiple counterparts to the nature-based product, the comparison should be made to the closest naturally occurring counterpart. 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. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes. In order to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at 2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
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If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception.
Instant claims are directed to a composition comprising five herbal oils or natural products, which is not markedly different from their closest naturally-occurring counterparts because there is no indication that their combination or preparation has caused the nature-based products to have any characteristics that are markedly different from the closest naturally-occurring product and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The rationale for this determination is explained below:
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter. YES, the claims are directed to a composition of matter (i.e., five herbal oils or natural products), which is a statutory category within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception
(e.g., law of nature, natural phenomenon, or an abstract idea). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., five herbal oils or natural products) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Note: with respect to extracts of natural products such as plants, the closest naturally-occurring counterpart is always the same compounds found in the extract, present in the non-isolated form in the source plant material. Extracts that are made simply by separating the extracted components from the non-extracted components, is a partitioning process that absent any specific chemical modification, merely separates the compounds leaving their activities unchanged.
Ingredients recited in the claims are natural products that would occur naturally; thus, the claims involve the use of judicial exceptions. There is no indication in the record of any markedly different characteristics (either structural or functional) of the composition as broadly claimed. For example, there is no evidence of record of a structural difference between the extract(s) in the claimed composition and that of their nature-based counterparts. Consequently, the claimed compositions are structurally the same as their closest naturally-occurring counterparts.
Nor is there any difference in functional characteristics. To show a marked difference, the characteristic(s) must be changed as compared it closest natural-occurring counterpart. For example, and assertion of changed functionality must be accompanied with evidence of a comparison of the claimed composition with its closest naturally-occurring counterpart and should apply to the full scope of the claim. Furthermore, inherent or innate characteristics of the naturally occurring counterpart cannot show a marked difference. Likewise, differences in the characteristics that came about or were produced independently of any effort or influence by Applicant cannot show a marked difference.
The recitation of specific amounts of the ingredients (instant claims 2-4) does not affect this analysis because it is well known and routine in the art to mix specific amounts of active ingredients with additional ingredients. Therefore, the claim is not meaningfully limited and does not amount to significantly more than each product of nature by itself.
Finally, the claimed mixture is like the novel bacterial mixture of Funk Brothers, which was held ineligible because each species of bacteria in the mixture (like each component in the instantly claimed mixture) continued to have “the same effect it always had”, i.e., it lacked markedly different characteristics. Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), discussed in Myriad Genetics, 133 S. Ct. at 2117. While not discussed in the opinion, it is noted that several of the claims held ineligible in Funk Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13. Funk Brothers, 333 U.S. at 128 n.1.
Thus, there is no evidence of record to indicate that the claimed product is markedly different, structurally, chemically, functionally, than its closest naturally occurring counterpart.
PRONG TWO:
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. Simply including inactive components does not markedly change to active ingredients. Claims 1-6, 10-12, and 14 are directed to a composition, not its practical use such as a particular treatment or prophylaxis for a disease or medical condition. To be integrated into a practical application the claims must have specific and well defined features as applied to the practical application, i.e., a physical embodiment of the practical application. Thus the cited claims are directed to a judicial exception to patentable subject matter.
Step 2b:
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an invention concept to the claims. MPEP 2106.05. Mere instructions to apply an exception cannot provide an inventive concept nor a feature that is well understood, routine, or conventional in this art. No other specific limitations other than what is well-understood, routine and conventional in the field at a high level of generality have been added to the claimed nature-based product (e.g., addition of well-known adjunctive ingredients which read on water).
Thus, the claimed product is not eligible subject matter under current 35 USC 101 standards.
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 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 pre-AIA the applicant regards as the invention.
Regarding claim 2, the recitation of “e.g.” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 2 recites both a broad limitation together with narrow limitations.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad range of “1-5%,” and the claim also recites “about 2.25%,” which is the narrower statement of the range. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Potnis et al. (US 11,033,594 B2 – “Potnis”) in view of Gambhir et al. (International Journal of Green Pharmacy 10.3 (2016) – “Gambhir”) and Ananthathavam et al. (IOSR Journal of Pharmacy Volume 4, Issue 1 (January 2014), pp. 39-42 – “Ananthathavam”).
Instant claim 1 is drawn to an orally acceptable topical analgesic gel comprising the following herbal oils and extracts:
(a) clove oil and/or eugenol;
(b) a cooling agent;
(c) camphor;
(d) an antimicrobial agent; and
(e) licorice,
in an orally acceptable gel base, the gel base comprising one or more nonionic surfactants, the formulation providing a sustained release of the mixture of herbal oils and extracts following application wherein the gel base provides controlled release of the mixture of herbal oils and extracts following application to the gums or teeth.
Potnis teaches an oral gel for sensitivity and tooth pain (Title), including orally acceptable topical analgesic gels comprising a mixture of analgesic oils comprising (a) clove oil and/or eugenol, (b) a cooling agent, and (c) camphor, in an orally acceptable gel base, the gel base comprising an anionic polymer and a basic amino acid, and the analgesic gel providing controlled release of the mixture of analgesic oils following application to a tooth (Abstract and claims 1-22). The gel base comprises nonionic surfactants selected from poloxamers, polysorbates, and mixtures thereof (Col. 7, lines 1-35, and claim 15).
Potnis does not expressly teach (d) an antimicrobial agent or (e) licorice.
Gambhir teaches various herbs used in dentistry such as clove oil and turmeric (Abstract). Clove oil is disclosed as containing eugenol, having excellent analgesic and antiseptic properties, and frequently used by dentists to relieve toothache, patients having periodontitis and also in treating bleeding gums (Page 2, Col. 2, 2nd ¶). Turmeric is disclosed for its use as an antiseptic, antibacterial, anti-inflammatory, and pain killer properties (Page 3, Col. 2, 2nd full ¶).
Ananthathavam teaches treating periodontitis with the use of essential oil and herbs (Title and Abstract), including licorice or liquorice root in the management of periodontal diseases (Page 41, Section 2.5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare an orally acceptable topical analgesic gel for treating sensitivity and tooth pain comprising (a) clove oil and/or eugenol, (b) a cooling agent, and (c) camphor, in an orally acceptable gel base, the gel base comprising an anionic polymer and a basic amino acid, and the analgesic gel providing controlled release of the mixture of analgesic oils following application to a tooth, as taught by Potnis, in view of the use of clove oil and turmeric as antiseptics and analgesics in oral care, as taught by Gambhir, and the use of licorice in the management of periodontal diseases, as taught by Ananthathavam, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the components taught by the prior art are known to be used orally in the treatment of dental pain and sensitivity. Furthermore, 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 had a reasonable expectation of success in producing a functional orally acceptable topical analgesic gel by adding the turmeric taught by Gambhir and the licorice taught by Ananthathavam in the gel taught by Potnis.
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 claim 1, the limitation of an orally acceptable topical analgesic gel would have been obvious over the orally acceptable topical analgesic gels (Abstract and claims 1-22), as taught by Potnis.
Regarding instant claims 1 and 14, the limitation of (a) clove oil and/or eugenol would have been obvious over the clove oil and/or eugenol (Abstract, Tables 1-4 and 6-8, and claim 1), as taught by Potnis.
Regarding instant claims 1, 5, 6, and 14, the limitations of (b) a cooling agent and menthol would have been obvious over the cooling agent (Abstract, claim 1) which is menthol (Col. 3, lines 4-5, Tables 6-10, claims 7 and 9), as taught by Potnis.
Regarding instant claims 1 and 14, the limitations of (c) camphor would have been obvious over the camphor (Abstract, Tables 1-4 and 6-10, and claims 1 and 9), as taught by Potnis.
Regarding instant claims 1 and 14, the limitations of (d) an antimicrobial agent and turmeric would have been obvious over the clove oil and/or eugenol (Abstract, Tables 1-4 and 6-8, and claim 1), as taught by Potnis since this ingredient has antiseptic properties in addition to analgesic properties, as taught by Gambhir (Page 2, Col. 2, ¶2). Furthermore, Gambhir also teaches that turmeric is frequently used by dentists (Abstract) for its antiseptic, antibacterial, anti-inflammatory, and pain killer properties (Page 3, Col. 2, 2nd full ¶).
Regarding instant claims 1 and 14, the limitations of (e) licorice would have been obvious over the use of licorice in the management of periodontal diseases (Page 41, Section 2.5), as taught by Ananthathavam.
Regarding instant claim 1, the limitation of an orally acceptable gel base comprising one or more nonionic surfactants would have been obvious over the gel base comprising nonionic surfactants selected from poloxamers, polysorbates, and mixtures thereof (Col. 7, lines 1-35, and claim 15), as taught by Potnis.
Regarding instant claim 1, the limitation of the formulation providing a sustained release of the mixture of herbal oils and extracts following application wherein the gel base provides controlled release of the mixture of herbal oils and extracts following application to the gums or teeth would have been obvious over the sustained release of the analgesic oils upon application (Col. 1, line 65 to Col. 2, line 3, Col. 2, lines 24-32, and claim 1), as taught by Potnis.
Regarding instant claim 2, the limitation of the mixture of herbal oils and extracts comprising 1-5% by weight of the formulation would have been obvious over the mixture of analgesic oils that comprises an overlapping 1-10% by weight of the formulation (claim 6), as taught by Potnis. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claims 3 and 4, the limitations of the ratio (wt%) of (a) to (b) to (c) is 5-1: 5 - 0.5: 5-0.5 would have been obvious over the composition which contains 4% clove oil, 0.5% cooling agent menthol, and 0.5% camphor (TABLE 10), or a ratio of 4:0.5:0.5, which lies within the claimed range, as taught by Potnis. Please see MPEP 2144.05.
Regarding instant claim 7, the limitations of the anionic polymer and polycarboxylate would have been obvious over the anionic polymer polycarboxylate (Col. 3, lines 16-23), as taught by Potnis.
Regarding instant claims 8 and 9, the limitations of the nonionic surfactants would have been obvious over the nonionic surfactants including poloxamers (e.g., nonionic triblock copolymers composed of a central hydrophobic chain of polyoxypropylene (polypropylene oxide)) flanked by two hydrophilic chains of polyoxyethylene (polyethylene oxide)), for example commercially available under the trade names Pluronic® or Kolliphor®, e.g., poloxamer 407), polysorbates (polyethoxylated sorbitan esterified with fatty acids, for example commercially available as Alkest®, Canarcel® or Tween®, e.g. polysorbate 20) and mixtures thereof (Col. 7, lines 9-20), as taught by Potnis.
Regarding instant claim 10, the limitation of a warming agent would have been obvious over the warming agent, e.g., a TRPV1 thermoreceptor agonists, e.g., black pepper oil, ginger oil, vanilla extract, vanillyl butyl ether, capsicum tincture, or mixtures of any of these, e.g., ginger oil, pepper oil or mixtures thereof (Col. 3, lines 45-50, Col. 5, lines 13-19, and claim 20), as taught by Potnis.
Regarding instant claims 11 and 12, the limitations of an amino acid and arginine would have been obvious over the basic amino acid arginine (Col. 6, lines 16-30, Tables 8 and 10, and claims 10-11), as taught by Potnis.
Regarding instant claim 13, the limitations of components a. – e. would have been obvious over the gel formulation comprising the following components
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(Col. 4, lines 5-19), as taught by Potnis.
Regarding instant claims 15 and 16, the methods of alleviating dental pain would have been obvious over the gel base releasing an effective amount of the analgesic oils to the tooth after 60 seconds (claim 3), as taught by Potnis.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8-10, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11, and 14-16 of U.S. Patent No. 9,463,159 B2 (“the ‘159 Patent”) in view of Gambhir et al. (International Journal of Green Pharmacy 10.3 (2016) – “Gambhir”) and Ananthathavam et al. (IOSR Journal of Pharmacy Volume 4, Issue 1 (January 2014), pp. 39-42 – “Ananthathavam”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to an orally acceptable topical analgesic gel comprising: (a) clove oil and/or eugenol; (b) a cooling agent; and (c) camphor in an orally acceptable gel base, the formulation providing a sustained release of the mixture of herbal oils and extracts following application wherein the gel base provides controlled release of the mixture of herbal oils and extracts following application to the gums or teeth, and therefore, encompass overlapping or coextensive subject matter.
One difference is that instant claims recite (d) an antimicrobial agent; and (e) licorice, whereas claim 1 of the ‘159 Patent does not recite these limitations.
The teachings of Gambhir with respect to various herbs used in dentistry such as clove oil and turmeric and the teachings of Ananthathavam with respect to treating periodontitis with the use of essential oil and herbs, including licorice or liquorice root in the management of periodontal diseases are discussed in detail above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare an orally acceptable topical analgesic gel for treating sensitivity and tooth pain comprising (a) clove oil and/or eugenol, (b) a cooling agent, and (c) camphor, in an orally acceptable gel base, the gel base comprising an anionic polymer and a basic amino acid, and the analgesic gel providing controlled release of the mixture of analgesic oils following application to a tooth, as recited in claim 1 of the ‘159 Patent, in view of the use of clove oil and turmeric as antiseptics and analgesics in oral care, as taught by Gambhir, and the use of licorice in the management of periodontal diseases, as taught by Ananthathavam, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the components taught by the prior art are known to be used orally in the treatment of dental pain and sensitivity. Furthermore, 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 had a reasonable expectation of success in producing a functional orally acceptable topical analgesic gel by adding the turmeric taught by Gambhir and the licorice taught by Ananthathavam in the gel taught by claims of the ‘159 Patent.
Another difference is that claim 1 of the ‘159 Patent recites the ratio of (a) to (b) to (c) of 8:1:1 to 10:1:1 whereas instant claim 1 does not recite this ratio. Instant claim 3 recites a ratio of 5-1:5-0.5:5-0.5. However, one of ordinary skill in the art would have found it obvious to modify the ratio of the components based on the desired therapeutic effect and the recited ratio is an obvious variant.
Yet another difference is that claim 1 of the ‘159 Patent recites an anionic polymer whereas instant claim 1 does not recite this limitation. However, instant claim 7 recites an anionic polymer, thereby rendering this limitation obvious.
Therefore, instant claims are obvious over claims of the ‘159 Patent and they are not patentably distinct over each other.
Claims 1-6, 8-12, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 15, 20, and 22 of U.S. Patent No. 11,033,594 B2 (“the ‘594 Patent”) in view of Gambhir et al. (International Journal of Green Pharmacy 10.3 (2016) – “Gambhir”) and Ananthathavam et al. (IOSR Journal of Pharmacy Volume 4, Issue 1 (January 2014), pp. 39-42 – “Ananthathavam”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to an orally acceptable topical analgesic gel comprising: (a) clove oil and/or eugenol; (b) a cooling agent; and (c) camphor in an orally acceptable gel base, the formulation providing a sustained release of the mixture of herbal oils and extracts following application wherein the gel base provides controlled release of the mixture of herbal oils and extracts following application to the gums or teeth, and therefore, encompass overlapping or coextensive subject matter.
One difference is that instant claims recite (d) an antimicrobial agent; and (e) licorice, whereas claim 1 of the ‘594 Patent does not recite these limitations.
The teachings of Gambhir with respect to various herbs used in dentistry such as clove oil and turmeric and the teachings of Ananthathavam with respect to treating periodontitis with the use of essential oil and herbs, including licorice or liquorice root in the management of periodontal diseases are discussed in detail above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare an orally acceptable topical analgesic gel for treating sensitivity and tooth pain comprising (a) clove oil and/or eugenol, (b) a cooling agent, and (c) camphor, in an orally acceptable gel base, the analgesic gel providing controlled release of the mixture of analgesic oils following application to a tooth, as recited in claim 1 of the ‘594 Patent, in view of the use of clove oil and turmeric as antiseptics and analgesics in oral care, as taught by Gambhir, and the use of licorice in the management of periodontal diseases, as taught by Ananthathavam, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the components taught by the prior art are known to be used orally in the treatment of dental pain and sensitivity. Furthermore, 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 had a reasonable expectation of success in producing a functional orally acceptable topical analgesic gel by adding the turmeric taught by Gambhir and the licorice taught by Ananthathavam in the gel taught by claims of the ‘594 Patent.
Another difference is that claim 1 of the ‘594 Patent recites the ratio of (a) to (b) to (c) of 70-100:5-15:5-15 whereas instant claim 1 does not recite this ratio. Instant claim 3 recites a ratio of 5-1:5-0.5:5-0.5. However, one of ordinary skill in the art would have found it obvious to modify the ratio of the components based on the desired therapeutic effect and the recited ratio is an obvious variant.
Yet another difference is that claim 1 of the ‘594 Patent recites an anionic polymer and a basic amino acid whereas instant claim 1 does not recite this limitations. However, instant claim 7 recites an anionic polymer, instant claim 11 recites an amino acid, and instant claim 12 recites the basic amino acid arginine, thereby rendering these limitations obvious.
Therefore, instant claims are obvious over claims of the ‘594 Patent and they are not patentably distinct over each other.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615