DETAILED ACTION
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 the Application
Receipt is acknowledged of Applicants’ preliminary amendment, filed on 04/12/2023, in which claims 1-17 are amended.
Claims 1-17 are pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/IB2021/052900, filed on 04/07/2021, which claims foreign priority to ITALY 102020000024118, filed on 10/13/2020.
Information Disclosure Statement
The information disclosure statement (IDS) dated 04/12/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted below. Accordingly, the information disclosure statement has been considered by the examiner.
An English abstract of NPL document 6 was not found in the file in accordance with 37 CFR 1.97. The reference has been lined through on the IDS and has not been considered.
Objections to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, at least at page 23, lines 13, 26, and 27 and at page 21 line 31. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. For example, the instant specification on page 23, line 26 recites http://www.asdera.com/sars-nutrition.html. The bolded text is that which is beyond the top-level domain name (www. asdera.com) and cannot be included. Claim Rejections - 35 USC § 112(b)
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.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 15, and 16, the phrase "such as" in line 4 of claim 1, line 5 of claim 15, and line 6 of claim 16 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For purposes of compact prosecution, under broadest reasonable interpretation, the claim will be interpreted under the broader limitation of “and/or nutraceutically acceptable derivatives”.
Regarding claim 3, the phrase "in particular" in line 3 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For purposes of compact prosecution, under broadest reasonable interpretation, the claim will be interpreted under the broader limitation of “medical device, cosmetic mouthwash, traditional medicinal product of plant origin (botanical) or food for special medical purposes”.
Claim 6 recites the limitation “wherein the two components are present in an effective amount.” MEPE 2173.05(c) states that the common phrase "an effective amount" may or may not be indefinite. The proper test is whether or not one skilled in the art could determine specific values for the amount based on the disclosure. As discussed in detail below in the rejection of claim 6 under 35 U.S.C. 112(a), one of ordinary skill in the art would not have been able to determine what amount of the components is effective for the use in the prevention of a SARS-CoV2 infection because there is no known or disclosed method that could be used to establish that a SARS-CoV-2 viral infection was prevented using the claimed composition as there is no way to predictably know that the subject would have a SARS-CoV-2 viral infection without the claimed composition. For purposes of compact prosecution, the claim will be interpreted as an amount effective to treat a SARS-CoV-2 infection.
Claims 7 and 13-14 recite the limitation “(m/m)” on lines 3 and 4 of claim 7, lines 5 and 6 of claim 13, and lines 5 and 6 of claim 14. This limitation renders the claims indefinite because it is unclear whether the parenthetical m/m is limiting or provides an optional example. For example, it is unclear whether the scope of the claims encompass compositions in which hydroxytyrosol is present in a concentration of about 3.80-11.40% calculated by vol/vol. For purposes of compact prosecution, under broadest reasonable interpretation, the claim will be interpreted as concentration calculated using any units.
Claim 12 recites the limitation "said administration on the oropharyngeal or nasal mucosa" in line 2. There is insufficient antecedent basis for the limitation of said administration on the nasal mucosa in the claim. For purposes of compact prosecution, under broadest reasonable interpretation, the claim will be interpreted as “administration on the oropharyngeal or nasal mucosa”.
Regarding claims 13-14, the phrase "preferably" in line 3 of each of claims 13-14 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For purposes of compact prosecution, under broadest reasonable interpretation, the claim will be interpreted under the broader limitation of “repeated administrations”.
Regarding claim 16, the claim is missing a conjunction after “esters;” and before (ii). Thus it is unclear whether the claimed device requires both (i) the recited composition and (ii) a spray head, or if instead only one of (i) or (ii) is required to fulfill the claim limitation. For purposes of compact prosecution, the claim will be interpreted as requiring both (i) and (ii). Regarding claim 17, the phrase "preferably" in line 3 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. For purposes of compact prosecution, under broadest reasonable interpretation, the claim will be interpreted under the broader limitation of any number of doses.
Further regarding claim 17, recites the limitation "said aqueous solution" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is not clear what solution is being limited by “an aqueous solution” and thus the metes and bounds of the claim are indefinite. For purposes of compact prosecution, under broadest reasonable interpretation, the claim will be interpreted requiring “an aqueous solution” in which the aqueous solution is one comprising water, hydroxytyrosol, and α-cyclodextrin.
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 4-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a SARS-CoV-2 viral infection, does not reasonably provide enablement for preventing a SARS-CoV-2 viral infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue,’ not 'experimentation.'" (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
The nature of the invention
The instantly claimed invention in claims 4-14 encompasses a composition with the intended use for preventing a viral infection caused by a SAR-CoV-2 comprising administration of a composition comprising α-cyclodextrin and hydroxytyrosol and/or their nutraceutically acceptable derivatives. MPEP § 2164.01(c) states that when a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation.
The breadth of the claims
The claims are broad in that they encompass the prevention of a SARS-CoV-2 viral infection. In the absence of a limiting definition for “preventing” in the instant specification, the term is interpreted per Wojtczak (Medical Teacher, 2002; PTO-892), which teaches that “prevention” reflects the goal of preserving health and includes protection of health by personal and community wide effects. Thus, in its broadest reasonable interpretation, the prevention of cancer or viral infection indicates that that the onset of the cancer or viral infection, or symptoms thereof, never occurs.
The amount or direction provided by the inventor / the existence of working examples
The examples of the instant disclosure describe administration of an aqueous solution of α-cyclodextrin and hydroxytyrosol to volunteers negative for COVID-19 (page 9, paragraph 4-6) and page 11, paragraph 3), as well as patients who had tested positive for SARS-CoV-2 (page 12, paragraph 1). The specification notes that swab positivity in a PCR-test does not always correspond to the clinical manifestation of the disease (page 12, lines 5-6). The specification also provides docking studies of hydroxytyrosol and ACE2, TMPRSS2 and Spike proteins (page 12, paragraph 2). The examples do not describe a study demonstrating the prevention of a viral infection in a subject. Additionally, the disclosure does not identify a method through which an ordinarily skilled artisan would be able to predictably determine that a subject or individual would have developed a SARS-CoV-2 viral infection in order to determine that the claimed composition resulted in prevention of a SARS-CoV-2 viral infection.
The state of the prior art / the level of predictability in the art
Shi et al. (23 March 2020) COVID-19 infection: the perspectives on immune responses Cell Death & Differentiation, 27; 1451–1454; teaches that not all people exposed to SARS-CoV-2 are infected and not all infected patients develop severe respiratory illness. As a result, there is an asymptomatic incubation period with or without detectable virus. Thus from the point of view of prevention, individuals at stage I, the stealth carriers, are the least manageable because, at least on some occasions, they spread the virus unknowingly (page 1451 paragraph 1). One of the biggest unanswered questions is why some develop severe disease, whilst others do not. Clearly, the conventional wisdom based on overall immunity of the infected patients cannot explain this broad spectrum in disease presentation (page 1451 paragraph 2). Shi goes on to teach that, alarmingly, after discharge from hospital, some patients remain/return viral positive and others even relapse. This indicates that a virus-eliminating immune response to SARS-CoV-2 may be difficult to induce at least in some patients and vaccines may not work in these individuals (page 1451 paragraph 1).
The teachings of Shi demonstrate that, although SARS-CoV-2 infections can cause disease and can be treated, it is not possible to predict whether an exposed individual will be infected and that people who appear asymptomatic or recovered may still be infected with the virus. These teachings demonstrate that there would have been no way to know whether treatment for a potential SARS-CoV-2 exposure successfully prevented an infection that would actually have occurred or re-occurred. Shu therefore suggests that there would have been no method to predictably determine that the SARS-CoV-2 infection was prevented using the claimed composition.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
As discussed in detail above, there is no disclosed or art-recognized method through which an ordinarily skilled artisan would be able to determine that a subject or an individual would have predictably developed a SARS-CoV-2 viral infection in order to apply the claimed composition as a preventative measure. Furthermore, as there is no known or disclosed method that could be used to establish that a SARS-CoV-2 viral infection was prevented using the claimed composition as there is no way to predictably know that the subject would have a SARS-CoV-2 viral infection without the claimed composition. Therefore, in order to implement the invention as claimed, one of ordinary skill in the art would have to participate in undue experimentation to find a composition that could be used to determine that a SARS-CoV-2 viral infection was prevented.
In view of the Wands factors discussed above, a person of ordinary skill in the art would have to engage in undue experimentation to practice the full scope of the claimed invention. As such, the instant claims were determined to not meet the scope of enablement requirement of 35 USC 112(a).
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.
Claims 1-5 and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Efmorfopoulou et al. (Chemistry of Natural Compounds, 2005; IDS 04/12/2023) as evidenced by PubChem in PTO-892 (Hydroxytyrosol PubChem CID 82755).
Efmorfopoulou discloses an analysis of the extraction of phenolic compounds from olive oil with cyclodextrins, including α- β- and γ-cyclodextrin (abstract). This includes 3,4-dihydroxyphenylethanol (3,4-DHPEA), which is one of the compounds that contributes most to the antioxidant activity of olive oil (page 22, paragraph 3 and Figure on page 22). Efmorfopoulou discloses the inclusion of 3,4-DHPEA into each of α- β- and γ-cyclodextrin (Figure 3). The formation of the 3,4-DHPEA-cyclodextrin complexes was accomplished by combining an aqueous solution of the cyclodextrin with olive oil and collection of the resulting precipitate by centrifugation (page 25, paragraph 7).
The instant specification defines hydroxytyrosol as the IUPAC structure 4-(2-hydroxyethyl)-l,2-dihydroxybenzene, having a CAS number 10597-60-1 (Specification, Page 3, lines 17-19). As evidenced by PubChem CID 95086 hydroxytyrosol has the CAS number 10597-60-1 and is also known as 3,4-dihydroxyphenylethanol.
It is noted that Efmorfopoulou does not provide a single embodiment of the composition used in the manner instantly claimed: for application as a food supplement or with a medical device (claim 2), for application as medical device, cosmetic mouthwash, traditional medicinal product of plant origin or food for special medical purposes (claim 3), for use in the prevention of the SARS-CoV-2 infection (claim 4), or for the contemporaneous reduction of halitosis for prolonged use of a mask (claim 5). However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Quiles et al. (Environmental Research, 2020; IDS 04/12/2023) in view of Radic et al. (Nutrients, 2020; PTO-892) and Efmorfopoulou et al. (Chemistry of Natural Compounds, 2005; IDS 04/12/2023).
Quiles discusses candidates for natural therapies against COVID-19, teaching that these molecules should show effects such as restoring mitochondrial function and cellular redox balance and (abstract). One such molecule is hydroxytyrosol, which also known as 3,4-dihydroxhyphenyl ethanol and is found in olive oil and olive leaves and has great antioxidant, anti-inflammatory and antiatherogenic capacities, as well as powerful antimicrobial activity. Quiles discloses that hydroxytyrosol has also been found to be effective in the treatment of some viral diseases, such as influenza virus and HIV. Quiles suggests that hydroxytyrosol is a natural molecule of potential interest in treating COVID-19 because it is expected to reduce the oxidative and inflammatory response, and it may be a good adjuvant therapy in combination with other treatments such as antivirals (page 5, paragraph 3).
The teachings of Quiles differ from that of the instantly claimed invention in that Quiles does not teach a composition comprising α-cyclodextrin.
Radic discusses the influence of cyclodextrin encapsulation on the bioavailability of olive pomace phenols (abstract). Radic teaches that hydroxytyrosol is one of the main compounds responsible for the pharmacological effect of olive pomace and is a powerful antioxidant with a broad spectrum of biological effects (paragraph bridging pages 1-2). Radic teaches that hydroxytyrosol has a low oral bioavailability and membrane permeability that can be significantly influenced by the presence of cyclodextrin in its formulation (abstract). Radic teaches that the capability of cyclodextrins to improve the biological, chemical, and physical properties of plant bioactive molecules is known in the art (paragraph bridging pages 12-13). Cyclodextrins have direct impact on biological membranes and thus influence permeability of biologically active compounds (paragraph bridging pages 3-4). Cyclodextrins have been successfully applied for achieving higher polyphenol yields from olive pomace and for the formulation of stable and organoleptically acceptable olive pomace extracts. Moreover, α- β- and γ-cyclodextrin are listed on the generally regarded as safe list of the U.S. FDA (page 2, paragraph 1). Radic tests encapsulation of hydroxytyrosol in β-cyclodextrin, hydroxypropyl β-cyclodextrin, and randomly methylated β-cyclodextrin (page 3, paragraph 2) and discloses an in vitro study of transepithelial transport (page 5, paragraph 1) and antioxidative activity (page 6, paragraph 2) of encapsulated hydroxytyrosol. The compositions of Radic are formed with the compounds in ultrapure water (page 3, paragraph 2). The presence of β-cyclodextrin and randomly methylated β-cyclodextrin in the reaction mixture increased the permeability of hydroxytyrosol (page 12, paragraph 2). Radic discloses the antioxidative effects of hydroxytyrosol and other compounds derived from olive pomace and teaches that the presence of cyclodextrins in formulations of hydroxytyrosol increased its permeability and that the results were cyclodextrin specific (page 13, paragraph 1).
Efmorfopoulou discloses an analysis of the extraction of phenolic compounds from olive oil with cyclodextrins, including α- β- and γ-cyclodextrin (abstract). This includes 3,4-dihydroxyphenylethanol (3,4-DHPEA), which is one of the compounds that contributes most to the antioxidant activity of olive oil (page 22, paragraph 3 and Figure on page 22). Efmorfopoulou discloses the inclusion of 3,4-DHPEA into each of α- β- and γ-cyclodextrin (Figure 3). The formation of the 3,4-DHPEA-cyclodextrin complexes was accomplished by combining an aqueous solution of the cyclodextrin with olive oil and collection of the resulting precipitate by centrifugation (page 25, paragraph 7). Efmorfopoulou discloses that the rate of release and degree of complexation of 3,4-DHPEA to a cyclodextrin was dependent on the size of the cyclodextrin (page 25, paragraphs 1-2) and that 3,4-DHPEA easily forms inclusion complexes with α- β- and γ-cyclodextrins (page 12, paragraph 3).
It would have been prima facie obvious to combine the teachings of Quiles, Radic, and Efmorfopoulou before the effective filing date of the claimed invention by formulating a composition comprising α-cyclodextrin and hydroxytyrosol in amounts effective for the treatment of COVID-19 to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to combine the hydroxytyrosol of Quiles with a cyclodextrin because Radic teaches that hydroxytyrosol has low bioavailability which can be improved by complexation to cyclodextrins and that the antioxidant activity of hydroxytyrosol can be improved by complexation to cyclodextrins. It would have been prima facie obvious for one of ordinary skill in the art to optimize the size of the cyclodextrin because Efmorfopoulou teaches that the size of the cyclodextrin is a result effective variable for the release rate and degree of complexation of hydroxytyrosol such that one of ordinary skill in the art would have been motivated to optimize the size of the cyclodextrin in order to achieve the desired release rate and degree of complexation for a composition for treating COVID-19. One of ordinary skill in the art would have a reasonable expectation of success in selecting α-cyclodextrin for complexation with hydroxytyrosol in a composition for the treatment of a COVID-19 infection because Radic teaches that α-cyclodextrin is recognized as a safe ingredient, and Efmorfopoulou teaches that hydroxytyrosol easily forms inclusion complexes with α-cyclodextrins.
It is noted that Quiles does not provide a single embodiment of the composition used in the manner instantly claimed: for application as a food supplement or with a medical device (claim 2), for application as medical device, cosmetic mouthwash, traditional medicinal product of plant origin or food for special medical purposes (claim 3), for use in the prevention of the SARS-CoV-2 infection (claim 4), or for the contemporaneous reduction of halitosis for prolonged use of a mask (claim 5). However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Claims 7 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Quiles et al. (Environmental Research, 2020; IDS 04/12/2023) in view of Radic et al. (Nutrients, 2020; PTO-892) and Efmorfopoulou et al. (Chemistry of Natural Compounds, 2005; IDS 04/12/2023) as applied to claims 1, 4, 6, 8, 10, and 12 further in view of López-García et al. (Tetrahedron, 2010; PTO-892).
The combined teachings of Quiles, Radic, and Efmorfopoulou teach the composition of claim 6 as discussed in detail above.
The combined teachings of Quiles, Radic, and Efmorfopoulou differ from that of the instantly claimed invention in that they do not teach that composition has a concentration of 3.80 - 11.40 % (m/m) hydroxytyrosol and 0.20 - 0.60 % (m/m) α-cyclodextrin.
López-García describes the complexation of hydroxytyrosol and cyclodextrin in aqueous solutions, including the photoprotection of and antioxidant activity by encapsulated hydroxytyrosol (abstract). Specifically, López-García discloses a DPPH assay which calculates the effect of encapsulation of hydroxytyrosol on its antioxidant activity (page 8009, paragraph 1). López-García compares host/guest ratios of hydroxytyrosol and β-cyclodextrin from 1:1 to 1:4 and teaches there is an enhancement of about 25% of the antiradical capacity of hydroxytyrosol with excess amounts of the cyclodextrin, demonstrated by decreases in the EC50 values were obtained (page 8009, paragraph 4 and table 2). López-García teaches solutions comprising 0.3 mM of hydroxytyrosol and either 0.30 mM or 1.50 mM cyclodextrin (Figure 6). López-García further teaches that the ratio of the hydroxytyrosol to cyclodextrin alters the degree of photoprotection, which helps to avoid the degradation of hydroxytyrosol, and that a ratio of 1:4 provides a strong protection effect (page 8006, paragraph 6-8 and table 3).
One of ordinary skill in the art would have been motivated to optimize the concentration and ratio of hydroxytyrosol and cyclodextrin in the composition suggested by combined teachings of Quiles, Radic, and Efmorfopoulou because López-García teaches that the concentration and ratio of hydroxytyrosol and cyclodextrin in solutions of encapsulated hydroxytyrosol are result effective variables which one of ordinary skill in the art would have optimized the ratio in order to achieve optimal antioxidant activity of hydroxytyrosol and avoid photodegradation of hydroxytyrosol. One of ordinary skill in the art would have had a reasonable expectation of success because López-García teaches amounts of hydroxytyrosol and cyclodextrin that are suitable for anti-oxidant activity and Quiles teaches that hydroxytyrosol is a natural molecule of potential interest in treating COVID-19 because it is an antioxidant expected to reduce the oxidative response.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Prakash et al. (US 8,962,058; PTO-892).
Prakash discloses functional sweetening compositions comprising a sweetener and at least one functional ingredient, wherein the functional ingredient is an antioxidant (abstract and claim 1). The composition comprises a sweet taste improving composition selected from, among others, carbohydrates (claim 6). Examples of carbohydrates include, among others, α-cyclodextrin (col. 16, lines 39-42). The antioxidant is selected from, among others, hydroxytyrosol (claim 17). The compositions may be formulated as gargling agents, mouth rinsing agents, and mouth sprays, among others (col 70, lines 36-40).
The teachings of Prakash differ from that of the instantly claimed invention in that they do not exemplify a mouthwash comprising α-cyclodextrin and hydroxytyrosol.
It would have been prima facie obvious to select hydroxytyrosol as the antioxidant and α-cyclodextrin as the carbohydrate in the composition of Prakash and to formulate the composition as a mouth rinsing agent to arrive at the instantly claimed invention because it is prima facie obvious to combine these prior art elements according to known methods to achieve the predictable result of a functional sweetening composition and Prakash teaches hydroxytyrosol and α-cyclodextrin as components in the functional sweetening composition, and suggests that the functional sweetening composition may be formulated as a mouth rinsing agent.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Prakash et al. (US 8,962,058; PTO-892) in view of Hersh et al. (US 5,906,811; PTO-892).
Prakash discloses functional sweetening compositions comprising a sweetener and at least one functional ingredient, wherein the functional ingredient is an antioxidant (abstract and claim 1). The compositions may provide medicinal or health benefits (col. 70, lines 47-50). The composition comprises a sweet taste improving composition selected from, among others, carbohydrates (claim 6). Examples of carbohydrates include, among others, α-cyclodextrin (col. 16, lines 39-42). The antioxidant is selected from, among others, hydroxytyrosol (claim 17). The compositions may be formulated as gargling agents, mouth rinsing agents, and mouth sprays, among others (col 70, lines 36-40).
The teachings of Prakash differ from that of the instantly claimed invention in that they do not teach administration of the recited composition using a dispensing device comprising a spray head.
Hersh discloses compositions comprising a combination of antioxidants and other active ingredients in appropriate delivery vehicles including, among others, aerosol carriers and mist and pump oral sprays (col 1, lines 5-10). Hersh teaches that intra-oral sprays are well known in the art and are prepared in vials of variable sizes and milliliter concentrations which contain a predetermined number of metered sprays. Dosages will depend on product compositions and labeled so that a predetermined number of sprays equals one daily dose (col 13, lines 48-64). Hersh teaches that aerosol systems diminish the loss of the active medication through volatilization from non-aerosol containers (col 16, lines 55-57). Hersch teaches that the compositions may additionally comprise sweeteners (col 12, lines 37-41). Mist aerosols may include aqueous mixtures (col 16, line 66 – col. 17, line 4). Hersh describes delivery techniques for spray or aerosol distribution and teaches that this can be accomplished by pump atomizers. By means of a piston pump mechanism in the spray head, an excess pressure is generated in the atomizer vessel, resulting in the active liquid complex being forced through the atomizer jet and distributed in the surrounding air (col 17, lines 5-11). The minute, finely distributed particles in the spray liquid may then reach their targets in the oral cavity. Measured doses are calculated such that a number of sprays per day would deliver a total dose of antioxidants (col 18, lines 10-15). The intra-oral sprays may be administered by the user 2 to 3 sprays 3 to 4 times per day, and an example of a suitable package could be a 0.45 fl. oz. vial containing a fixed number of metered sprays, for example, 240 sprays (col 17, lines 60-64).
It would have been prima facie obvious to select hydroxytyrosol as the antioxidant and α-cyclodextrin as the carbohydrate in the composition of Prakash and to formulate the composition as a mouth spray to arrive at the instantly claimed invention because it is prima facie obvious to combine these prior art elements according to known methods to achieve the predictable result of a functional sweetening composition and Prakash teaches hydroxytyrosol and α-cyclodextrin as components in the functional sweetening composition, and suggests that the functional sweetening composition may be formulated as a mouth spray. Furthermore, one of ordinary skill in the art would have been motivated to formulate the mouth spray of Prakash in an aerosol dispensing device comprising a spray head because Hersh teaches that aerosol systems diminish the loss of the active compounds that may otherwise occur through volatilization from non-aerosol containers, and that aerosol systems include pump atomizers which comprise a spray head. One of ordinary skill in the art would have had a reasonable expectation of success because Prakash teaches functional sweeteners comprising antioxidants that may be administered as oral sprays and Hersh teaches vehicles for administration of intra-oral sprays comprising an antioxidant which may also comprise a sweetener.
Regarding instant claim 17, the combined teaching of Prakash and Hersh do not expressly teach that the spray head is adapted to dispense doses after activation the multiple of which corresponds to about 0.5 or 1 ml of aqueous solution. However, Hersh teaches that intra-oral sprays are well known in the art and that dosages depend on product compositions and are labeled so that a predetermined number of sprays equals one daily dose. For example, an intra-oral sprays may be administered by the user 2 to 3 sprays 3 to 4 times per day, and an example of a suitable package could be a 0.45 fl. oz. vial containing a fixed number of metered sprays, for example, 240 sprays. Thus it would have been prima facie obvious to optimize the number of sprays and volume dispensed by each spray in the aerosol dispensing devise of Hersh in order to achieve a suitable dosage for the formulation of Prakash because Hersh teaches that it is known in the art that measured doses for intra-oral sprays will be calculated such that a number of sprays per day would deliver a desired total dose of antioxidants.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sarah Grace Scrivener whose telephone number is (703) 756-5341. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm (EST).
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/S.G.S./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693