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 .
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Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/26/2026 has been entered.
Receipt of amendments and arguments filed on 06/26/2026 is acknowledged. Claim 15 and 18 have been canceled. Claim 21 has been added.
Claims 1-5 have been amended to require that the orally administrable composition includes a tri-block copolymer and that the compound is encapsulated in the tri-block copolymer. Claims 17 and 19-21 require that the orally administrable composition comprises a self-emulsifying drug delivery system (SEDDS).
Claims 6-14 and 16 have been amended to a composition comprising 2-nitrocinnamaldehyde.
Thus, claims 1-14, 17 and 19-21 are the subject of this Office action.
Rejections and objections not reiterated herein have been withdrawn. The search has not been extended.
Claim interpretations
The recitation “the compound is incorporated into a formulation for oral bioavailability” does not have any specific ingredient requirements. This is interpreted to mean that the compound is in a formulation that contains one or more pharmaceutical excipients or inactive ingredients, and that is suitable for oral administration.
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.
Claims 6-14, 16-17 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Brackman et al. (BMC Microbiology 2008, 8:149) and Shafreen et al. (J. Mol. Recognit. 2014; 27: 106-116), in view of Faikoh et al. (Fish & Shellfish Immunology 38 (2014) 15-24), and Li et al. (Macromolecules 2015, 20, 6022-6032-previously cited) and further in view of Gursoy (Biomedicine & Pharmacotherapy 58 (2004) 173-182), and Nikam et al. (Advance Pharmaceutical Journal 2018; 3(2): 43-54- published online on 29 July 2018) and Singh (Journal of Controlled Release 252 (2017) 28-49), and Grossen (2017) as previously cited. All references have been previously provided.
This rejection was presented for claims 17-20 in the Final Office action of 03/26/2026 and for the other claims in the Office action of 10/07/2025.
Cinnamaldehyde and analogs, such as 2-nitrocinnamaldehyde and 4-nitrocinnamaldehyde, are known to exhibit antibacterial properties. These compounds inhibit quorum sensing (QS) and biofilm formation, thereby disrupting virulence in pathogens such as Vibrio spp. (see Brackman) and Streptococcus pyogenes (See Shafreen). Streptococcus pyogenes (Group A strep bacteria) causes highly contagious infections, such as strep throat and pneumonia, which are treated with oral antibiotics.
The art knows that cinnamaldehyde and its derivatives are hydrophobic and have poor water solubility. This problem has been addressed by Faikoh through the preparation of "liposome-encapsulated cinnamaldehyde (LEC)". See page 16, left column, last four lines. Cinnamaldehyde was encapsulated in liposomes by mixing cinnamaldehyde, lecithin and alpha-tocopherol in ethanol. See section 2.2 at page 16. Additionally, this problem was also addressed by Li. In order to increase water solubility of poorly-soluble cinnamaldehyde, they taught the preparation of nanocapsular/nanoemulsion dispersions of cinnamaldehyde by first adding and mixing Tween-80 surfactant, followed by ethanol cosurfactant, 1,2-propanediol, extra virgin olive oil and cinnamaldehyde. The antifungal activity and solubility were improved. See page 6028.
Gursoy teaches self-emulsifying drug delivery systems (SEDDS), and necessary ingredients for improved oral delivery of lipophilic drugs: “The oral delivery of hydrophobic drugs presents a major challenge because of the low aqueous solubility of such compounds. Self-emulsifying drug delivery systems (SEDDS), which are isotropic mixtures of oils, surfactants, solvents and co-solvents/surfactants, can be used for the design of formulations in order to improve the oral absorption of highly lipophilic drug compounds. SEDDS can be orally administered in soft or hard gelatin capsules and form fine relatively stable oil-in-water (o/w) emulsions upon aqueous dilution owing to the gentle agitation of the gastrointestinal fluids.”
Regarding co-solvents, at section “2.1.3. Co-solvents” Gursoy teaches that “the production of an optimum SEDDS requires relatively high concentrations of surfactants” and “organic solvents such as ethanol, propylene glycol (PG), and polyethylene glycol (PEG) are suitable for oral delivery, and they enable the dissolution of large quantities of either the hydrophilic surfactant or the drug in the lipid base.”
Nikam and Singh are evidence of commonly used nanoemulsion ingredients in drug delivery. Castor oil, olive oil or other oils are used. Surfactants, co-surfactants and enhancers used are PEG300, PEG400 and Poloxamers (triblock copolymers formed by poly-ethylene oxide and poly- propylene oxide). Particularly, see Singh: "Other common surfactants include those belonging to poloxamer family and PEG containing block copolymers". See also Table 3, nanoemulsions intended for oral use for the natural product curcumin. A nanoemulsion was prepared in castor oil, with Cremophor, Tween 80 and Pluronic F-68 to "increase oral bioavailability for improved anti-cancer activity". Grossen is evidence that PEG-PCL triblock copolymers are well-known biodegradable drug delivery systems in nanomedicine.
Ascertainment of the Difference Between the Prior Art and the Claims
(MPEP §2141.012)
Brackman and Shafreen do not teach a composition comprising a SEDDS, or comprising an oil, a surfactant, a co-surfactant, or a co-solvent all-together, or encapsulation as claimed.
Finding of prima facie obviousness--rational and motivation (MPEP §2142-2413)
The primary references are in the same field of endeavor, i.e. antibacterial, antifungal cinnamaldehyde and derivatives. One of ordinary skill in the art is a chemist practitioner with the knowledge and skill of the authors of the references cited to support the examiner's position. As discussed above, 2-nitrocinnamaldehyde and 4-nitrocinnamaldehyde were known to have antibacterial activity at least against Streptococcus pyogenes, which is responsible for a wide range of human infections, such as strep throat and pneumonia, which are commonly treated with oral antibiotics.
It would have been prima facie obvious to one of ordinary skill in the art to make self-emulsifying drug delivery systems (SEDDS) for oral administration of the lipophilic 2-nitrocinnamaldehyde or 4-nitrocinnamaldehyde, and nano-dispersions of liposome encapsulated 2-nitrocinnamaldehyde or 4-nitrocinnamaldehyde, in the interest of improving their solubility in water and thereby, improving their oral absorption and antibacterial activities (as evidenced at least by Faikoh, and Li). Claims 6, 14, 16-17 and 21 are prima facie obvious.
One of ordinary skill would have used the surfactants and co-solvents (co-surfactants) suggested by the references to be used in oral emulsion formulations. Propylene glycol (PG) and polyethylene glycol (PEG) are taught by Gursoy to be very suitable for oral delivery. Castor oil, PEG-300, and the poloxamer (tri-block copolymers) poly(ethylene oxide)-poly(propylene oxide)- poly(ethylene oxide) (PEO-PPO-PEO), and PEG-PCL, are ingredients commonly used in nano-emulsions for encapsulation of therapeutics in drug delivery (see cited references). Castor oil comprises the ingredients in claim 7. Thus, the ordinary skilled artisan would have been motivated to use these known ingredients in making the self-emulsifying drug delivery systems and in encapsulating the active cinnamaldehyde derivatives of the above references.
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There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004).
With regards to the intended use and the purpose of the product (“pharmaceutical composition for reducing a rate at which nicotine is metabolized.…”, “for reducing a rate of nicotine metabolism”, nothing precludes the use of the obvious compositions as instantly claimed (see MPEP 2112.02(II)), nor does the recitation impart any structural characteristic that would distinguish it from the prior art. “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”.
A person of ordinary skill in the art knew about the poor water solubility problem of cinnamaldehyde and derivatives, and was also aware of solutions pertinent to the problem. Making SEDDS was a solution known in the art and taught by the references.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Here at least exemplary rationales (A), (C) and (G) apply.
Applicant’s arguments have been carefully considered but have been found unpersuasive. Applicant argues that the cited references fail to teach the cinnamaldehyde compound as claimed is “encapsulated in a nanosphere formed from the tri-block copolymer”. In response, claims 6-14, 16-17 and 19-21 do not claim those features. The arguments are thus not convincing.
Regarding claim 17, Applicant argues about the goal of improving oral bioavailability for reducing a rate at which nicotine is metabolized in the context of nicotine cessation compared to the goal of improving oral bioavailability for antibacterial purposes. Further,
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These arguments are not convincing because the motivation to improve oral bioavailability for the antibacterial of the prior art would have afforded the same formulation as claimed by Applicant, even if Applicant’s ultimate goal was to achieve a specific concentration of the compound in the liver. In addition, MPEP 2144 states that rationale different from Applicant’s is permissible:
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Applicant additionally mentioned “therapeutic synergy between the SEDDS delivery vehicle and the enzyme time-dependent inhibition mechanism of the claimed compound”. However, the specification of this application does not contain results/tests of a SEDDS delivery vehicle.
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Brackman et al. (BMC Microbiology 2008, 8:149) and Shafreen et al. (J. Mol. Recognit. 2014; 27: 106-116), in view of Faikoh et al. (Fish & Shellfish Immunology 38 (2014) 15-24), and Li et al. (Macromolecules 2015, 20, 6022-6032-previously cited) and further in view of Gursoy (Biomedicine & Pharmacotherapy 58 (2004) 173-182) and Grossen (2017), and Singh (Journal of Controlled Release 252 (2017) 28-49), all as previously cited. Further, in view of evidentiary references about the state of the art, Jee (Pharm Res (2012) 29:69-82), Hoang (J. Pharm. Invest. (2017) 47:27-35), Bae (Biomacromolecules (2007), 8, 650-656) or Ali (AAPS Open (2017) 3:6, 1-17).
Cinnamaldehyde and analogs, such as 2-nitrocinnamaldehyde and 4-nitrocinnamaldehyde, are known to exhibit antibacterial properties. These compounds inhibit quorum sensing (QS) and biofilm formation, thereby disrupting virulence in pathogens such as Vibrio spp. (see Brackman) and Streptococcus pyogenes (See Shafreen). Streptococcus pyogenes (Group A strep bacteria) causes highly contagious infections, such as strep throat and pneumonia, which are treated with oral antibiotics.
The art knows that cinnamaldehyde and its derivatives are hydrophobic and have poor water solubility. This problem has been addressed by Faikoh through the preparation of “liposome-encapsulated cinnamaldehyde (LEC)”. See page 16, left column, last four lines. Cinnamaldehyde was encapsulated in liposomes by mixing cinnamaldehyde, lecithin and alpha-tocopherol in ethanol. See section 2.2 at page 16. Additionally, this problem was also addressed by Li. In order to increase water solubility of poorly-soluble cinnamaldehyde, they taught the preparation of nanocapsular/nanoemulsion dispersions of cinnamaldehyde by first adding and mixing Tween-80 surfactant, followed by ethanol cosurfactant, 1,2-propanediol, extra virgin olive oil and cinnamaldehyde. The antifungal activity and solubility were improved. See page 6028.
Gursoy, teaches that “The oral delivery of hydrophobic drugs presents a major challenge because of the low aqueous solubility of such compounds. Self-emulsifying drug delivery systems (SEDDS), which are isotropic mixtures of oils, surfactants, solvents and co-solvents/surfactants, can be used for the design of formulations in order to improve the oral absorption of highly lipophilic drug compounds.”
See whole document for the different ingredients making the formulations. The droplet (sphere) size is in the nanometers:
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. Low aqueous solubility drugs are incorporated:
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. At Conclusion:
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Singh teaches commonly used nanoemulsion ingredients in drug delivery. Castor oil, olive oil or other oils are used. Surfactants, co-surfactants and enhancers used are PEG300, PEG400 and Poloxamers (triblock copolymers formed by poly-ethylene oxide and poly- propylene oxide). Particularly, see Singh: “Other common surfactants include those belonging to poloxamer family … and PEG containing block copolymers”. See also Table 3, nanoemulsions intended for oral use for the natural product curcumin. A nanoemulsion was prepared in castor oil, with Cremophor, Tween 80 and Pluronic F-68 to “increase oral bioavailability for improved anti-cancer activity”. The droplet size is in the nanometer range. See other nanoemulsions in the Tables. The droplets are spherical, thus, nanospheres. See the Figures for drawing of spheres and encapsulation of the drug. Section 9.2 teaches encapsulation for oral drug delivery.
Grossen discussed many drug-loaded nano-sized particles based on triblock copolymers of PEG-PCL as biodegradable drug delivery systems in nanomedicine. (previously cited)
Additional references as evidence of the state of the art: Jee, Hoang, Bae, Ali
Jee is evidence that:
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For these reasons, Jee encapsulated and released Amphotericin B (poorly water soluble antifungal) from an ABC triblock fluorous copolymer, in which the sizes of encapsulated AmB ranged between 12-23nm. See Table III.
Similarly, regarding triblock copolymers for nano-sized drug delivery systems (DDS), Hoang (and references therein, such as Kabanov 2002) evidences that
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Similarly, Bae taught oil-encapsulating PEO-PPO-PEO/PEG nanocapsules for delivery of paclitaxel.
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Ali taught spherical shape particles of average size about 57.07 nm of SSNEDDS, loaded with candesartan cilexetil. These are composed of cinnamon oil, tween 80, poloxamer 407 and transcutol HP, adsorbed on a mixture of avicel 101 and aerosil 200.
Ascertainment of the Difference Between the Prior Art and the Claims
(MPEP §2141.012)
Brackman and Shafreen do not teach a composition comprising a tri-block copolymer wherein the compound is encapsulated in a nanosphere formed from the tri-block copolymer, an oil (cl. 2), a surfactant which is polysorbate 80 (cl. 4), or a co-surfactant (cl. 5).
Finding of prima facie obviousness--rational and motivation (MPEP §2142-2413)
Brackman, Shafreen, Faikoh and Li are in the same field of endeavor, i.e. antibacterial, antifungal cinnamaldehyde and derivatives. One of ordinary skill in the art is a chemist practitioner with the knowledge and skills of the authors of the references cited to support the examiner's position. 2-nitrocinnamaldehyde and 4-nitrocinnamaldehyde were known to have antibacterial activity at least against Streptococcus pyogenes, which is responsible for a wide range of human infections.
It would have been prima facie obvious to one of ordinary skill in the art to make nano-dispersions or nano-emulsions for oral administration of the antibacterials 2-nitrocinnamaldehyde and 4-nitrocinnamaldehyde in which these active agents are encapsulated (as liposomal drug delivery systems (DDS)) in tri-block copolymers, and with oil, or the surfactant Tween-80 or co-surfactant, with the purpose of improving said nitrocinnamaldehyde’s solubility in water, controlling its bioavailability, biodegradability and thereby, improving their oral absorption and antibacterial activities.
The triblock copolymers of poly(ethylene oxide)-poly(propylene oxide)- poly(ethylene oxide) (PEO-PPO-PEO), PEG-PCL, Castor oil, Tween-80 (polysorbate 80) surfactant, and co-surfactants, are ingredients commonly used in nano-emulsions for drug encapsulation in drug delivery, as taught by Singh, Grossen, Gursoy and evidentiary references. The triblock copolymers have been used to encapsulate active agents in nano-sized drug delivery systems (DDS). Thus, the ordinary skilled artisan would have known how to make the nano-emulsions containing a tri-block copolymer encapsulating the nitrocinnamaldehyde active and the additional ingredients.
With regards to the intended use and the purpose of the product (“pharmaceutical composition for reducing a rate at which nicotine is metabolized.…”, “for reducing a rate of nicotine metabolism”, “wherein the rate is reduced based on orally administrable pharmaceutical composition inhibiting an enzyme that metabolizes nitcotine in a time-dependent manner” nothing precludes the use of the obvious composition as instantly claimed (see MPEP 2112.02(II)), nor does the recitation impart any structural characteristic that would distinguish it from the prior art. “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Here at least exemplary rationales (A), (C) and (G) apply.
Applicant’s arguments have been carefully considered but have been found unpersuasive. Applicant argues that the cited references fail to teach the cinnamaldehyde compound as claimed is “encapsulated in a nanosphere formed from the tri-block copolymer”. The argument is not convincing because the rejection is based on a combination of references.
Regarding the arguments against the Singh reference, they measure droplet size in the nanometer range. The droplets are spherical, thus, nanospheres. In addition, the Figures show drawing of spheres and encapsulation of the drug and Section 9.2 teaches encapsulation for oral drug delivery.
In addition, several secondary and evidentiary references above teach the use of poloxamers to encapsulate agents by forming nanospheres or nanodroplets.
Regarding the rationale or motivation to combine and modify the references, the arguments are not convincing because the motivation to improve oral bioavailability for the antibacterial of the prior art would have afforded the same formulation as claimed by Applicant, even if Applicant’s ultimate goal was to achieve a specific concentration of the compound in the liver. In addition, MPEP 2144 states that rationale different from Applicant’s is permissible:
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Applicant additionally mentioned “therapeutic synergy between the SEDDS delivery vehicle and the enzyme time-dependent inhibition mechanism of the claimed compound”. However, the specification of this application does not contain results/tests of a SEDDS delivery vehicle.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
A person of ordinary skill in the art knew about the poor water solubility problem of cinnamaldehyde and derivatives, and was also aware of solutions pertinent to the problem. Making SEDDS and nano-encapsulating the insoluble agent with the use of triblock copolymers was a solution known in the art and taught by the references.
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.
Claim(s) 6 and 16 are rejected under 35 U.S.C. 102(a)(1) and as 102(a)(2) as being clearly anticipated by Purdy et al. (WO 2018/141051-previously cited in the Office action of 10/07/2025).
Purdy teaches a product (corrosion inhibition package) comprising a terpene which is an essential oil selected from citral, carvone, ionone, ocimene and cymene; cinnamaldehyde or a derivative thereof, such as p-nitrocinnamaldehyde and o-nitrocinnamaldehyde; at least one amphoteric surfactant and a solvent. See claims 2-3 and cinnamaldehyde derivates of lines 4-13 of page 14 of the specification. See the solvents in claim 13 and surfactants in at least claims 3-6. Water is not present in the compositions of claims 1-6 of Purdy, the compositions will be later mixed with an aqueous acidic composition. The composition of Purdy has all the claimed elements that make the composition pharmaceutically suitable for oral administration. Purdy thus teaches a pharmaceutical composition comprising the claimed compound wherein R1 is ortho-nitro, wherein the composition comprises an oil and a surfactant/co-solvent. The amphoteric surfactant disclosed in Purdy can perform as co-surfactant.
With regards to the intended use and the purpose of the product (“an orally administered pharmaceutical composition for reducing a rate at which nicotine is metabolized.…”, “for reducing a rate of nicotine metabolism”, “wherein the rate is reduced based on the pharmaceutical composition inhibiting an enzyme that metabolizes nicotine in a time-dependent manner”), nothing precludes the use of the composition of Purdy as instantly claimed (see MPEP 2112.02(II)), nor does the recitations impart any structural characteristic that would distinguish it from the prior art composition.
In addition, based on the specification, the compounds of the invention have the following properties recited in the claims:
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Conclusion
Claims 1-14, 16-17 and 19-21 are rejected.
Note to Applicant
Not every piece of prior art has been applied against the instant claims. See MPEP 904.03.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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