DETAILED ACTION
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 .
Claim Status
Claims 1-15 were pending in the present application. By virtue of a Preliminary Amendment, filed by Applicant on 27 June 2024, claims 3-5 and 7-15 were amended and claims 16-20 were added. Therefore, claims 1-20 are currently under examination.
Information Disclosure Statement (IDS)
The IDSs (2) filed on 27 June 2024 and 20 May 2025 have been considered by the examiner. Signed copies are enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the
person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach
individual associated with the filing and prosecution of a patent application has a duty of candor
and good faith in dealing with the Office, which includes a duty to disclose to the Office all
information known to that individual to be material to patentability as defined in this section.”
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-9, 12, 14-15, and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
The specification, while being enabled for an oral care composition comprising eugenol and an orally acceptable vehicle used to treat or inhibit conditions of the oral cavity, does not reasonably provide enablement for preventing such oral diseases as broadly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
It is noted that MPEP § 2164.03 teaches that “the amount of guidance or direction needed
to enable the invention is inversely related to the amount of knowledge in the state of the art as
well as the predictability of the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA
1970). The amount of guidance or direction refers to that information in the application, as
originally filed, that teaches exactly how to make or use the invention. The more that is known in
the prior art about the nature of the invention, how to make, and how to use the invention, and
the more predictable the art is, the less information needs to be explicitly stated in the
specification. In contrast, if little is known in the prior art about the nature of the invention and
the art is unpredictable, the specification would need more detail as how to make and use the
invention in order to be enabling.”
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). The factors
considered when determining if the disclosure satisfies the enablement requirement and whether
any necessary experimentation is undue include, but are not limited to (In re Wands, 858 F.2d
731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)):
1) nature of the invention;
2) the breadth of the claims;
3) the state of the prior art;
4) the level of one of ordinary skill;
5) the level of predictability in the art;
6) the amount of direction or guidance provided by the inventor;
7) the existence of working examples; and
8) the quantity of experimentation needed to make or use the invention based on the
content of the disclosure.
The following is an analysis of these factors in relationship to this application:
1) Nature of the Invention; 2) The Breadth of the Claims
Instant claims 7-9, 12, 14-15, and 18-20 are drawn to a composition and method whereby an oral care composition comprising an orally acceptable vehicle and a phenolic compound configured to provide or improve antioxidant efficacy of the oral care composition is used in an effective amount to treat, prevent, or inhibit one or more conditions of the oral cavity caused by or resulting from oxidative damage. Specifically:
Instant claim 7 is drawn to the oral care composition of claim 1, where the phenolic compound(s) are present in the oral care composition in an amount effective to treat, prevent, or inhibit one or more conditions of the oral cavity caused by or resulting from oxidative damage. The specification details oxidative damage of the oral cavity and soft tissue thereof “may often result in inflammation, periodontal disease, and other health related conditions, such as cardiovascular disease or increased susceptibility to cancer” ([0002]). In addition, the specification indicates oxidative damage originates from various sources or have many causes, for example, the oxidative damage may often result from exposure to chemicals such as tobacco products or alcohol or may result from natural processes of the body ([0002]). The specification further provides a non-limiting, illustrative list of oral cavity conditions which include aging, gum disease, or periodontal disease ([0054]).
Instant claim 12 is drawn to a method for treating, preventing, or inhibiting one or more conditions of an oral cavity resulting from oxidative damage, the method comprising contacting the oral care composition of claim 1 with the oral cavity.
Therefore, hundreds, if not thousands, of conditions are encompassed in a composition and method for preventing one or more conditions of the oral cavity. The breadth of these claims exacerbates the complex nature of the subject matter to which the present claims are
directed. The encompassed conditions are highly heterogeneous at both the molecular and clinical level.
Applicant has only generally contemplated the mechanism behind treatment, prevention, or inhibition: the oral care product is applied to an oral cavity or surface “to therapeutically or non-therapeutically treat a condition (e.g., reduce free radical or prevent oxidative damage)…” ([0029]).
4) The Level of One of Ordinary Skill; 3) The State of the Prior Art; and 5) The Level of Predictability in the Art
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a cosmetic hair treatment research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from cosmetics, medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Use of antioxidants to treat, prevent, or inhibit cancer has produced largely contradictory results within the science community. For example, a 2014 study showed that mice fed a diet of Vitamin E, which is a chemically phenolic compound, substantially increased the number, size, and stage of preexisting lung tumors (p. 1).1 Furthermore, a 2014 study showed that male smokers who received Vitamin E had a higher incidence of lung cancer that those patients who received a placebo (p. 2).2 Another, more recent study, showed that in mouse models of melanoma, levels of oxidative stress actually interfered with the formation of metastatic tumors (p. 2).3 Therefore, treating mice with antioxidants decreased oxidative stress in the circulating cancer cells and increased their ability to metastasize, thereby allowing more cancer cells to survive (p. 2).4
Basu details a review of dietary polyphenols and periodontitis (title).5 Dietary polyphenols from commonly consumed foods and beverages, as well as herbs and botanicals, are well known for their anti-microbial, antioxidant, and anti-inflammatory properties (p. 2).6 Several in vivo cell and rodent studies showed promising results using dietary polyphenols to alleviate features of periodontis (p. 3).7 However, it is cautioned that these studies might have limited application because of the large polyphenol doses used in cell and animal studies in view of the rapid metabolism and excretion of polyphenols in humans (p. 4).8
It is assumed applicant has relied upon the antioxidative properties of eugenol to extrapolate the claimed effects of all phenolic compounds in the treatment, prevention, and inhibition of diseases and conditions ranging from periodontal disease to cancer. However, the National Cancer Institute (NCI) reviewed 9 randomized controlled clinical trials and concluded there was no evidence that dietary antioxidant supplements are beneficial in primary cancer prevention (NCI, p. 6).9 Furthermore, NCI advises that until more is known about the effects of antioxidant supplements in cancer patients, these supplements should be used with caution (NCI, p. 7).10 Therefore, it is unclear how the currently claimed compositions can be used to prevent conditions such as cancer when authoritative organizations such as the NCI, frequently cited for current standards of care in oncology, are suggesting otherwise.
Despite progress being made in understanding the effectiveness of phenol compounds in prevention of certain diseases, prior art details contradictory and even cautionary use of these compounds in certain disease states. Given the extremely broad nature of the claimed conditions, which have variable etiology and pathology, and the teachings of NCI and Basu, one of ordinary skill would not be able to predict the effectiveness of the claimed phenolic compounds in preventing the broadly claimed diseases.
6) The Amount of Direction or Guidance Provided by the Inventor; 7) The Existence of Working Examples; and 8) The Quantity of Experimentation Needed to Make or Use the Invention Based on the Content of the Disclosure
Applicant has only provided one working example, where 7 different oral compositions – only 5 of which contained eugenol – were evaluated for antioxidant efficacy using an ABTS assay. Applicant has failed to provide a single working example where any formulation was administered and shown to be effective in preventing conditions and diseases as broad as cancer, aging, or periodontal disease. Given the extremely limited nature of the disclosure, the skilled artisan would be required to: first, identify which of the thousand phenolic compounds and derivatives would be suitable for pharmaceutical use in an oral composition; second, identify at which dose or doses the phenolic compound is safe and therapeutically effective (note: Basu emphasized the importance of dosing in polyphenols and periodontitis); and finally experimentally identify which one or more of the thousands of possible conditions could be prevented with the composition selected. This amounts to undue experimentation.
In conclusion, the claimed invention does not provide enablement for the entire scope of
encompassed compositions and methods for prevention of all the claimed conditions. Thus, and for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation required is undue because of the broad scope of the claims, the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claims and the specification is not fully enabled for the instant claims. In view of the above, one of ordinary skill would be forced into undue experimentation to practice the invention as claimed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 10-11, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rege (cited in Applicant’s 27 June 2024 IDS as: US PGPub No. 2018/0280263; published 04 October 2018).
Of note: Rege shares the same applicant as the current application. However, Rege was published more than 1 year prior to the effective filing date of the current application.
Rege discloses an oral care composition comprising zinc phosphate and at least one anti-microbial agent chosen from eugenol, isoeugenol, eugenol acetate, and isoeugenol acetate (abstract).
Regarding instant claims 1, 2, 3, 5, 7, 8, 10, 11, 18, and 19 –
Rege provides a working example of producing a dentifrice formulation by mixing a thickener at 1.1 wt% and acetyl isoeugenol at 0.6 wt% among other ingredients such as humectants ([0059], Table 1).
Though Rege is silent regarding the antioxidative properties of acetyl isoeugenol as recited in instant claims 1 and 7, this is an inherent property as the claimed composition is identical to the formulation disclosed by Rege, including Rege’s disclosed amount of acetyl isoeugenol falling within the claimed range of therapeutically effective amount (claims 7, 8, 18, and 19). See MPEP 2112(I): "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding instant claims 4 and 6 –
Rege claims an oral care composition comprising zinc phosphate and at least one microbial agent chosen from eugenol, isoeugenol, eugenol acetate, and isoeugenol acetate (claim 1, p. 6). Rege further claims the composition of claim 1 further comprises humectants and surfactants (claim 6, p. 7).
For the reasons stated above, Rege anticipates that which is currently claimed in instant claims 1-8, 10-11, and 18-19.
Claims 1-4, 7-11, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu (cited in Applicant’s 27 June 2024 IDS as: WO 2019/108215; published 06 June 2019).
Of note: Xu shares the same applicant/inventor as the current application. However, Xu was published more than 1 year prior to the effective filing date of the current application.
Xu discloses an oral care composition and a method of making/using said composition (abstract).
Regarding instant claims 1-4, 7-11, and 18-19 –
Xu provides a working example of producing an oral care composition by mixing sorbitol at 31.0 wt% and eugenol at 0.05 wt% among other ingredients ([0073], Table 1).
Though Xu is silent regarding the antioxidative properties of eugenol as recited in instant claims 1 and 7, this is an inherent property as the claimed composition is identical to the formulation disclosed by Xu, including Xu’s disclosed amount of eugenol falling within the claimed range of therapeutically effective amount (claims 7-9 and 18-19). In addition, Xu recognizes the antioxidative properties of eugenol ([0032]). See MPEP 2112(I): "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
For the reasons stated above, Xu anticipates that which is currently claimed in instant claims 1-4, 7-11, and 18-19.
Claims 1-3, 5, 7-11 and 18-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Scott (cited in Applicant’s 27 June 2024 IDS as: US PGPub No: 2012/0014883; published: 19 January 2012).
Scott discloses compositions containing one or more derivatives of essential oil compounds for use in personal care compositions such as oral compositions (abstract).
Regarding instant claims 1-3, 5, 7-11, and 18-20 –
Scott provides several working examples of producing dentifrice ([0121]) and mouthrinse ([0122]) compositions:
Dentifrice composition IIa contains 0.67 wt% eugenyl acetate and 0.2 wt% xanthan gum ([0121], Example II);
Dentifrice composition IIb contains: 0.5 wt% eugenol and 0.2 wt% xanthan gum ([0121], Example II);
Mouthrinse composition IIId contains 0.02 wt% methyl isoeugenol and 0.05 wt% Na Saccharin ([0122], Example III).
Though Scott is silent regarding the antioxidative properties of eugenol and derivatives as recited in instant claims 1 and 7, this is an inherent property as the claimed composition is identical to the formulation disclosed by Scott, including Scott’s disclosed amount of eugenol and derivatives falling within the claimed range of therapeutically effective amount (claims 7-9 and 18-20). See MPEP 2112(I): "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
For the reasons stated above, Scott anticipates that which is currently claimed in instant claims 1-3, 5, 7-11 and 18-20.
Claims 1-4, 7-11, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Colgate (cited in Applicant’s 27 June 2024 IDS as: WO 2020/242499; published 03 December 2020).
Of note: Colgate shares the same applicant/inventor as the current application. However, Colgate was published more than 1 year prior to the effective filing date of the current application.
Colgate discloses an oral care composition comprising a mixture of oleanic acid and eugenol (abstract).
Regarding instant claims 1-4, 7-11, and 18-19 –
Colgate provides a working example of producing an oral care composition by mixing humectants, surfactants, and eugenol at 0.05 wt% among other ingredients ([0070], Table 1).
Though Colgate is silent regarding the antioxidative properties of eugenol as recited in instant claims 1 and 7, this is an inherent property as the claimed composition is identical to the formulation disclosed by Colgate, including Colgate’s disclosed amount of eugenol falling within the claimed range of therapeutically effective amount (claims 7-9 and 18-19). In addition, Colgate recognizes the antioxidative properties of polyphenols ([0052]). See MPEP 2112(I): "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
For the reasons stated above, Colgate anticipates that which is currently claimed in instant claims 1-4 and 7-20.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-4 and 7-20 are rejected under 35 U.S.C. 103 as being unpatentable over Colgate (cited above) as evidenced by Belous (cited in Applicant’s 27 June 2024 IDS as: WO 2021/020994; published 04 February 2021; international filing date: 17 July 2020; enclosed machine translation relied upon).
As discussed above, Colgate anticipates the currently claimed invention in instant claims 1-4, 7-11, and 18-19. Specifically, Colgate provides a working example of producing an oral care composition by mixing humectants, surfactants, and eugenol at 0.05 wt% among other ingredients ([0070], Table 1). While Colgate does not explicitly disclose that which is claimed in instant claims 12-17 and 20, these claims are made obvious over Colgate as evidenced by Belous, which teaches a eugenol composition and method of use. Specifically, Belous discloses the antioxidative properties of eugenol and mechanisms behind such properties that evidence the obviousness of instant claims 12-17 and 20 over Colgate.
Belous discloses a novel complex of active ingredients used in dental and oral care
products, the preventive use of which reduces oxidative stress in the oral cavity (p. 3, ¶ 1).
Belous further discloses that oxidative stress is a factor in gingivitis and the imbalance of free
radical processes in periodontal diseases affects the oxygen stage of oxidative stress to a greater
extent and for a longer period of time (p. 6, ¶ 2-5). Thus, Belous calls for use of antioxidants to
alleviate gum inflammation and improve the course of periodontal disease (p. 6, ¶ 5). For
prevention and treatment of periodontal inflammation, Belous discloses the use of medicinal
plants and their extracts due to their less severe agitation of gum tissue, higher efficiency of
biological substances, and low frequency of side effects after use (p. 6, ¶ 6).
Belous discloses a toothpaste or mouthwash composition comprised of clove essential oil (Eugenia caryophyllus) between 0.001 to 0.1 wt% (toothpaste) and 0.001 to 0.01 wt% (mouthwash) (p. 13). Eugenol, Belous teaches, is the main biologically active ingredient of clove essential oil and has antibacterial, anti-inflammatory, antifungal, and immunomodulatory properties (p. 10, ¶ 4). In additional, Belous discloses clove essential oil has been shown to have antioxidant effects by neutralizing free radicals under oxidative stress and altering the expression of enzymes that suppress oxidative stress in cells (p. 10, ¶ 5). Finally, Belous discloses use of these compositions containing eugenol to prevent oxidative stress of the oral cavity; reduce periodontal inflammation in a subject experiencing such inflammation; and reduce bleeding gums in a subject experiencing bleeding gums (p. 26, claims 17-19).
Therefore, Belous shows one of ordinary skill could use the eugenol-containing oral care composition disclosed by Colgate in a method of treating conditions of an oral cavity resulting from oxidative damage as follows:
Belous discloses an oral care composition comprising eugenol and a humectant whereby eugenol is able to retain its antioxidative properties in an amount between 0.0001 to 0.01.
Belous discloses eugenol is an antioxidant and calls for the use of antioxidants to alleviate gum inflammation and improve the course of periodontal disease. Belous discloses clove essential oil has been shown to have antioxidant effects by neutralizing free radicals under oxidative stress and altering the expression of enzymes that suppress oxidative stress in cells. Finally, Belous discloses use of compositions containing eugenol to prevent oxidative stress of the oral cavity; reduce periodontal inflammation in a subject experiencing such inflammation; and reduce bleeding gums in a subject experiencing bleeding gums (instant claims 12 and 13). Because Belous discloses treatment with the oral care composition and reduction in periodontal disease inflammation, this implies an active step of diagnosing the presence of periodontal disease before and after treatment (instant claims 15 and 17) and measuring the decrease of free radicals post-treatment (instant claims 14 and 16).
While Colgate contemplates a method of treatment using an oral care composition containing eugenol, Colgate does so while only recognizing the antibacterial properties of eugenol. Belous provides evidence that an identical composition can be used to decrease free radicals in the oral cavity and treat conditions of an oral cavity resulting from oxidative damage because Belous teaches eugenol is an effective antioxidant in an amount as little as 0.001 wt %.
Therefore, Colgate anticipates that which is claimed in instant claims 1-4, 7-11, and 18-19. The difference between the applied reference and the claimed invention in instant claims
12-17 and 20 is that the applied reference may not teach the instantly claimed
composition and method with particularity so as to amount to anticipation. See MPEP “[t]he identical invention must be shown in as complete detail as is contained in the ... claim.” Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990). However, as evidenced by the teachings of Belous, what is currently claimed in instant claims 12-17 and 20 is made obvious over Colgate.
Since Colgate teaches administration of an oral care composition containing eugenol, instant claims 12-17 and 20 would require nothing more than recognition of eugenol’s antioxidative properties, with which Belous provides evidence of. Recognition of these properties is not so out of the grasp of a skilled artisan because Belous discloses the purpose of the components (e.g., reduce free radicals and decrease oxidative stress) and their anticipated outcome (e.g., prevents oxidative stress of the oral cavity, reduces periodontal inflammation in a subject having such inflammation, and reducing bleeding gums in a subject experiencing bleeding gums).
The applied reference Colgate, as evidenced by Belous, discloses the components of the claimed composition and a method to use with sufficient guidance, particularity, and with a reasonable expectation of success for the skilled artisan, that the invention would be prima facie obvious to one of ordinary skill in the art. Therefore, the instantly claimed invention in claims 1-4 and 7-20 are obvious over Colgate as evidenced by Belous.
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.
Co-pending application no. 18/973,959
Claims 1-4, 7-10, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. 18/973,959 (‘959 reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because each application is drawn to an oral care composition comprising eugenol and another component that is an orally acceptable vehicle. Furthermore, the currently claimed application is a genus of ‘959 and therefore, the claims of ‘959 anticipate that which is currently claimed in instant claims 1-4, 7-10, and 18-20 as outlined below:
Instant claim
Anticipatory ‘959 claim
Claims 1-4 and 10: an oral care composition comprising eugenol and an orally acceptable vehicle
Claim 1: an oral care composition comprising eugenol and oleanolic acid (known antioxidant, preservative, and antimicrobial agent)
Claims 7-9 and 18-20: various claimed ranges of eugenol present in the composition
Claim 2: eugenol is present in an amount from about 0.01 to about 1.5 wt%.
Therefore, claims 1 and 2 of ‘959 anticipate that which is currently claimed in instant claims 1-4, 7-10, and 18-20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-10, and 18-20 of copending Application No. 18/973,959 (‘959 reference application) and further in view of Xu (cited previously in this Office Action).
Although the claims at issue are not identical, they are not patentably distinct from each other because each application is drawn to an oral care composition comprising eugenol and another component that is an orally acceptable vehicle. While ‘959 claims this composition, ‘959 does not explicitly claim a method for preparing the composition as required by instant claim 11.
Regarding instant claim 11, Xu discloses an oral care composition made by mixing eugenol with oleanolic acid ([0070], Table 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the composition in ‘959 in a method to make as disclosed by Xu. One would have been motivated to do so because Xu teaches a composition comprised of oleanolic acid and eugenol, which is identical to the composition claimed in ‘959, can be formulated by mixing the components. Doing so would have yielded predictable results. Therefore, ‘959 in view of Xu makes obvious instant claim 11.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
US Patent 10,959,936
Claims 1-4 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of US Patent 10,959,936 (hereinafter ‘936).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the currently claimed invention and ‘936 are drawn to an oral care composition comprising eugenol and another component that is an orally acceptable vehicle. As shown below, claims 1-3 of ‘936 anticipate that which is currently claimed in instant claims 1-4 and 10:
Instant claim
Anticipatory ‘936 claim
Claims 1-4 and 10: an oral care composition comprising eugenol and an orally acceptable vehicle
Claim 1-3: an oral care composition comprising eugenol and an orally acceptable carrier comprising a block copolymer of ethylene oxide and propylene oxide (known thickener)
Therefore, claims 1-3 of ‘936 anticipate that which is currently claimed in instant claims 1-4 and 10.
US Patent 10,518,113
Claims 1 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of US Patent 10,518,113 (hereinafter ‘113).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the currently claimed invention and ‘113 are drawn to an oral care composition comprising a phenolic compound and another component that is an orally acceptable vehicle. As shown below, claims 1, 2, and 5 of ‘113 anticipate that which is currently claimed in instant claims 1 and 10:
Instant claim
Anticipatory ‘936 claim
Claims 1 and 10: an oral care composition comprising a phenolic compound and an orally acceptable vehicle
Claim 1, 2, and 5: dentifrice composition comprising a phenolic compound and an orally acceptable carrier
Therefore, claims 1, 2, and 5 of ‘113 anticipate that which is currently claimed in instant claims 1 and 10.
Conclusion
Claims 1-20 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30a-5:30p (MST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571)272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JULIA A ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
1 National Cancer Institute. “Antioxidants Accelerate the Growth and Invasiveness of Tumors in Mice.” 12 November 2015. Found here: https://www.cancer.gov/news-events/cancer-currents-blog/2015/antioxidants-metastasis.
2 Id.
3 Id.
4 National Cancer Institute. “Antioxidants Accelerate the Growth and Invasiveness of Tumors in Mice.” 12 November 2015. Found here: https://www.cancer.gov/news-events/cancer-currents-blog/2015/antioxidants-metastasis.
5 Basu et al. doi: 10.3390/molecules23071786.
6 Id.
7 Basu et al. doi: 10.3390/molecules23071786.
8 Id.
9 National Cancer Institute. “Antioxidants and Cancer Prevention.” 06 February 2017. Found here: https://www.cancer.gov/about-cancer/causes-prevention/risk/diet/antioxidants-fact-sheet#:~:text=In%20some%20preclinical%20studies%2C%20antioxidants,metastasize%20(29%E2%80%9331).
10 Id.