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 .
DETAILED ACTION
Claims 1-15 are pending
Claims 3-15 are withdrawn from examination as being drawn to a nonelected specie.
Claims 1-2 are under consideration in the instant office action.
Election/Restrictions
Applicant’s election with traverse of Group I (Claims 1-10) drawn to a composition for inhibiting Parkinson’s disease and the presence of cinnamic acid in the composition (specie 1b) in their response dated 1/23/2026 is acknowledged.. However Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Examination of the claims are conducted to the extent they read on the elected species. Claims 3-15 is withdrawn from examination as being drawn to a nonelected specie.
Claims 1-2 are under examination and the requirement for restriction is made final.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 1-2 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1 with dependent claims 2 are vague and indefinite because they recite the term "inhibiting Parkinson’s disease" The claim is unclear due to a lack of what condition or biomarker or physical symptom or state of the Parkinson’s disease is being inhibited. It is unclear if the composition is inhibiting the progression of the disease, or inhibiting the disease from occurring or inhibiting specific symptoms of the disease. It is unclear as to how the particle size of 30 nm and polydispersity index of 0.14-0.18 inhibits Parkinson’s disease as the disease on the whole cannot be inhibited . Inhibiting is a relative term and without a specific indication of the parameter which is being inhibited, the claim is unclear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Priority
This application claims the benefit of Taiwan Patent Application Serial
No.111128027, filed July 26, 2022 and Serial No.111147050, filed Dec. 07, 2022.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103(a) as being unpatentable over by Ouyang et al (CN 102302449, priority date 08/25/2011, English translaiton) in view of Lee (KR 20100058032A English translation )
Instant claims are drawn to a composition for inhibiting Parkinson’s disease comprising 1 part by weight of soybean oil, 5 to 14 parts by weight of emulsifier, 0.5 to 2 parts by weight of lecithin, 81 to 91 parts by weight of deionized water, and 2.345 to 17.833 parts by weight of cinnamaldehyde, wherein an average particle size of the composition for inhibiting Parkinson’s disease is 30nm, and a polydispersity index of the composition for inhibiting Parkinson’s disease is ranged between 0.14 to 0.18
Ouyang et al. discloses an oil in water cinnamic aldehyde nano emulsion medicament, where the nanao emulsion is between 10-100 nm and the medicament is prepared from the following raw materials: 18.09 to 37.19 percent of surfactant (emulsifier), 0 to 6.86 percent of cosurfactant, 0 to 8.62 percent of oil, 0.10 to 8.31 percent of cinnamic aldehyde and the balance of distilled water, wherein the mass percentage sum of the components is 100 percent (abstract page 1), They further disclose that the e optimal ratio of the oil-in-water cinnamaldehyde nanoemulsion drug of the present invention: Surfactant 20.93% ～ 34.88% Co-surfactant 2.00% ～ 6.20% Oil 1.03% ～ 7.86% Cinnamaldehyde 1.94% ～ 8.26% The balance is distilled water The sum of the mass percentages of the above components is 100%. (page 3 beginning paragraphs). The non-ionic surfactants used in their composition include polyoxyethylene (40) hydrogenated castor oil (RH40), polyoxyethylene (40) castor oil (EL40), Tween-80 (page 3, 2nd para). The oil phase comprises of selected oils and fats including vitamin E oil, isopropyl myristate (IPM), and wheat germ oil, almond oil, triacetin, ethyl acetate and olive oil (Page 3, last para). They disclose that their oil-in-water cinnamaldehyde nanoemulsions of the invention has the functions of treating fungal skin diseases, suppurative skin infections, anti-ulcers, treating stomach pain, gastrointestinal colic, regulating blood sugar and blood lipids and other diseases (page 5, 2nd para). In Example 1-15 they disclose a different formulation of nanoemulsions composition of cinnamaldehyde with Tween 80, vitamin E oil and propanediol, RH40 and wheat germ oil etc, They further discloses that Cinnamaldehyde dosage forms currently used in clinic include oil solvents and alcohol solvents. Both oil solvents and alcohol solvents have the disadvantages of being volatile, poor stability, and low bioavailability. Therefore, it is necessary to find a better new dosage form of cinnamaldehyde to replace the shortcomings of the old dosage form to meet the clinical use. (under background technique page 2) and disclose tht compared with the prior art, the oil-in-water cinnamaldehyde nanoemulsion drug of the present invention has the following advantages: 1)High thermodynamic stability, simple operation during preparation, no phase separation, no precipitation, improved storage stability; 2)Good light transmittance, any non-uniformity or the presence of precipitates are easy to be found, and the perceived quality is improved; 3)It has a good solubilizing effect and can effectively improve the solubility of poorly soluble drugs; 4)It can improve the solubility of cinnamaldehyde and delay the decay time of cinnamaldehyde, thus improving the bioavailability of cinnamaldehyde; 5)The method is simple and suitable for large-scale production (page 5).
It is noted that the composition of Ouyang et al. while they disclose vegetable oils do not teach soybean oil. However, it would have been prima facia obvious to a person of ordinary skill in the art to substitute soybean oil in the compositions of Ouyang et al. in place of said vitamin E oil, wheat germ oil, almond oil or olive oil, as they all are functional equivalents imparting the same properties to the composition. Substituting equivalents, namely specific vegetable oils , motivated by the reasonable expectation that the respective species will behave in a comparable manner or even provide comparable results in related circumstances, see In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958) is prima facie obvious. Moreover, the express suggestion to substitute one equivalent for another need not be present to render the substitution obvious, see In re Font 213 USPQ 532.
With regards to the applicants reference to the composition for inhibiting Parkinson’s disease in the claims , as disclosed in the 112 rejection above, inhibiting Parkinson’s disease as recited is very vague and unclear.
However, Lee discloses compositions comprising cinnamaldehyde as an active ingredient is useful in the prevention and treatment of Parkinson’s disease (Claim 1, claim 7, entire document) and as such it would have been obvious to a person of ordinary skill in the art to use the composition of Ouyang et al in the method of preventing or treating Parkinson’s, absence of evidence to the contrary, Further the property of inhibiting Parkinson’s disease is the intended use of the instant composition and will occur inherently in the composition of Ouyang et al. absence of evidence to the contrary. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph.
With regards to the exact composition and the concentrations instantly claimed,. Formation of nanoemulsions of cinnamaldehyde using the specific excipients which include a surfactant and an emulsifier is very well known in the and Ouyang et al. provide the basic guidelines to the amounts used. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention. With regards to the amount of each of the excipient added to the composition. it would be within the skill of an ordinary artisan to be able to optimize the concentrations of each of the excipient to maximize its effect and utility in the composition. It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). An ordinarily skilled artisan would arrive at the instantly claimed concentration while conducting routine optimization testing to achieve this goal. As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in formulating the instantly claimed composition , absence of evidence to the contrary
Claim 2 is rejected under 35 U.S.C. 103(a) as being unpatentable over Ouyang et al (CN 102302449, priority date 08/25/2011, English translation) and Lee (KR 20100058032A English translation ) as applied to claim 1 above, and further in view of Huang et al. (Industrial crops and products 162, 2021 , pages 1-9)
Ouyang et al. and Lee teach as discussed supra and are applied here in the same manner. The cited references do not teach the composition comprising cinnamic acid.
However, Huang et al. discloses that cinnamaldehyde and cinnamic acid in Cinnamon have synergistic effects as an antibacterial agent (abstract) and disclose that both cinnamaldehyde and cinnamic acid inhibited the biosynthesis of membrane glycophospholipids (GPLs ) regulating levels of phosphatidylethanolamines and phosphatidylglycerols, phosphatidic acids (PAs), and some cardiolipins (CLs).
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of the cited references above and use cinnamic acid in the composition along with cinnamaldehyde motivated by the teachings that they have similar activity which will act synergistically when administered together.
.
Double Patenting – Obviousness-Type
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 of copending Application No. 18/359,636 (‘636). Although the conflicting claims are not identical, they are not patentably distinct from each other because application ‘636, claims obvious subject matter. ‘636 claims the same composition of cinnamaldehyde instantly claimed, the main difference is the composition of ‘636 is intended to inhibit diabetes mellitus where as in the instant claims the composition is intended to inhibit Parkinson. The intended uses are inherent to the composition and as such the composition of ‘636 can be used in the method of instant claims and as such they two copending applications are obvious over each other. The concentration and the parameters between the conflicting claims are slightly different, but this is obtained with routine optimization and is therefore obvious.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Claims 1-2 are rejected. No claims are allowed
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/SAVITHA M RAO/ Primary Examiner, Art Unit 1691