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 . Claims 1-20 filed September 18, 2025 are currently pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 09/18/2025 has been entered.
Status of Claims
As indicated in the Office Action of 02/07/2023, claims 11-20 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/03/2023.
Response to Amendment
Applicant’s amendments, filed 09/18/2025 are acknowledged. Claim 1 is amended as follows: A method for treating a medical condition and a combination of side effects of a drug that treats the medical condition comprising administering a unit dose of the drug individual suffering from the medical condition in accordance with a prescription by a healthcare provider to treat the medical condition or a symptom of the medical condition; administering a separate unit dose of a supplement including a fixed combination of ingredients to the individual in connection with administering the unit dose of the drug, the fixed combination of ingredients including cassia bark, calcium, magnesium, vitamin B6 and vitamin D, each ingredient of the fixed combination of ingredients included in the separate unit does of the supplement in a predetermined, fixed amount, the fixed combination of ingredients and the predetermined, fixed amount of each ingredient of the separate unit dose of the supplement tailored to address the combination of side effects caused by the drug.
Applicant's arguments, filed 09/18/2025 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and objections presently being applied to the instant application.
Claim Rejections - 35 USC § 112-Paragraph 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 1-9 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984). (Holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.') Mere indistinct terms (such as "a drug” found within instant claim 1), however, may not suffice to meet the written description requirement. This is particularly true when a compound is claimed in purely functional terms. See Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886 (CAFC 2004) at 1892, stating: "[T]he appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. As recited in MPEP 2163, describing a composition by its function alone typically will not suffice to sufficiently describe the composition. See Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406 (Holding that description of a gene’s function will not enable claims to the gene "because it is only an indication of what the gene does, rather than what it is."); see also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). Conversely, a description of a chemical genus will usually comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. See Univ. of Calf. V. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under 35 U.S.C. 112, first paragraph, by showing the enablement of a representative number of species within the genus.
A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus. See MPEP 2163.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. MPEP 2163.
Here, the specification does not provide a reasonably representative disclosure of useful "drugs”. Paragraphs [0002]-[0010] of the specification describes the genus of “drugs” by listing 12 distinct species with different pharmacological activities and chemical structures including: 1) prednisone (anti-inflammatory), 2) metformin (diabetes), 3) carvedilol (beta-blocker), 4) propranolol (beta-blocker), 5) risperidone (atypical antipsychotic), 6) aripiprazole (atypical antipsychotic), 7) quetiapine (atypical antipsychotic), 8) olanzapine (atypical antipsychotic), 9) phenytoin (anti-epileptic), 10) divalproex (anti-epileptic), 11) carbamazepine (anti-epileptic), 12) phenobarbital (anti-epileptic).
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The specification does not provide blaze-marks to defining structural limitations and physical properties encompassing a "drug" or how far a chemical structure of a compound may vary to be encompassed in the genus either a “drug”, and which compounds lie inside or alternatively, outside the purported genus.
The lack of examples is not viewed as being reasonably representative of the genus in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of “a drug” in the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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.
Claim(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Yang (CN105832746 published 08/10/2016; machine translation provided), Johns Hopkins University Hospital (published 2011), Zhang (Molecules Vol. 24 e3473 published online 09/24/2019) and Yalcin (Clin Sci. Nutr. Vol. 1 pages 113-122. Published online 12/26/2019).
Claim 1 is directed to a method for treating a medical condition and a combination of side effects of a drug that treats the medical condition comprising administering a unit dose of the drug individual suffering from the medical condition in accordance with a prescription by a healthcare provider to treat the medical condition or a symptom of the medical condition; administering a separate unit dose of a supplement including a fixed combination of ingredients to the individual in connection with administering the unit dose of the drug, the fixed combination of ingredients including cassia bark, calcium, magnesium, vitamin B6 and vitamin D, each ingredient of the fixed combination of ingredients included in the separate unit does of the supplement in a predetermined, fixed amount, the fixed combination of ingredients and the predetermined, fixed amount of each ingredient of the separate unit dose of the supplement tailored to address the combination of side effects caused by the drug.
Yang (CN105832746 published 08/10/2016; machine translation provided) teaches the treatment of rheumatoid arthritis in a subject in need comprising administering a therapeutically effective amount of prednisone acetate. Yang teaches administering cinnamaldehyde to the rheumatoid arthritis patient receiving prednisone acetate as cinnamaldehyde also comprises desirable anti-inflammatory and antipyretic effects on the rheumatic patient. The combination of cinnamaldehyde to the prednisone acetate regimen helps eliminate pain and reduces the toxic side effects of prednisone, improves treatment compliance and reduces complications and recurrence rates (bullet point 2, page 3 of translation).
Johns Hopkins University Hospital (published 2011) teaches that prednisone has a long list of side effects making it dangerous to use at significant doses for a long term treatment. Insomnia and bone thinning due to nutrient loss (calcium and vitamin D) are two of the common side effects associated with prednisone treatments.
Zhang (Molecules Vol. 24 e3473 published online 09/24/2019) teaches Cinnamomum cassia (C. Cassia) and its pharmacological properties, including the treatment of rheumatoid arthritis as well as insomnia, nausea and diarrhea (Table 1; page 17-18). As shown in Table 2, Zhang teaches that cinnamaldehyde of Yang is the main component of Cassia bark (pages 4-5, pages 9-10).
The difference between the presently claimed methodology and that of Yang, Johns Hopkins and Zhang is that the combination of Yang, Johns Hopkins and Zhang does not specifically teach administering a supplement including a fixed combination including cassia bark, calcium, magnesium, vitamin B6 and Vitamin D in a separate unit dose form to the rheumatoid arthritis patient receiving prednisone.
Yalcin (Clin Sci. Nutr. Vol. 1 pages 113-122. Published online 12/26/2019) teaches drug-induced nutritional disorders. Yalcin teaches that patients using the steroid prednisone experience deficiencies in calcium, magnesium, zinc, vitamin B6, vitamin C, vitamin D and folic acid (page 119, right col.).
Therefore, one of ordinary skill in the art, knowing that the administration of the steroid prednisone is efficacious at treating rheumatoid arthritis in a subject in need but also comprises toxic side effects, and that it is suitable to administer cinnamaldehyde in combination with the prednisone regimen in order to eliminate pain and reduce the toxic side effects of the glucocorticoid as taught by Yang, coupled with the knowledge that the cinnamaldehyde is the main component of the claimed cassia bark as taught by Zhang, said skilled artisan would have found it prima facie obvious to administer to the rheumatoid arthritis patient receiving prednisone a composition comprising cassia bark, calcium, magnesium, vitamin B6 and vitamin D to the prednisone-treated patient in view of Zhang and Yalcin.
MPEP 2143 provides rationale for a conclusion of obviousness including (A) Combining prior art elements according to known methods to obtain predictable results;
In the present case, Johns Hopkins teaches that insomnia and bone thinning due to nutrient loss (calcium and vitamin D) are two of the common side effects associated with prednisone treatments while Yalcin teaches that patients receiving prednisone also experience the side-effect of nutrient deficiency, wherein patients using the steroid prednisone experience deficiencies in calcium, magnesium, zinc, vitamin B6, vitamin C, vitamin D and folic acid (page 119, right col.). Considering cassia bark is efficacious at treating insomnia as taught by Zhang as well as its major component cinnamaldehyde is art-recognized at treating toxicity associated with prednisone, said skilled artisan would have found it prima facie obvious to administer the rheumatoid arthritis patient receiving prednisone a composition comprising cinnamaldehyde from cassia bark, in order to treat the side effects of toxicity of prednisone and insomnia as taught by Yang and Johns Hopkins. Said skilled artisan would have also found prima facie obvious to include calcium, magnesium, vitamin B6 and vitamin D with the cinnamaldehyde from cassia bark regimen in order to improve the nutrient deficiency in said prednisone-receiving patient as calcium, magnesium vitamin B6 and vitamin D are art-recognized as being depleted due to the chronic administration of prednisone to the afflicted subject.
Regarding the limitation wherein the cinnamaldehyde sourced from cassia bark, calcium, magnesium, zinc, vitamin B6, vitamin C, vitamin D are administered separately from the prednisone to the rheumatoid arthritis patient receiving prednisone, said skilled artisan would have found it prima facie obvious to administer the supplement separately in order to offset the toxicity and nutrient depletion afforded by prednisone. Applicant is also reminded of MPEP 2144.05 wherein selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results) In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946).
Regarding the limitation of wherein each ingredient of the fixed combination of ingredients are in a predetermined fixed amount, it is considered well within the capabilities of one of ordinary skill in the art to optimize the amount of cinnamaldehyde from cassia bark, calcium, magnesium, vitamin B6 and vitamin D in the supplement formulation. The amount of amount of cinnamaldehyde from cassia bark, calcium, magnesium, vitamin B6 and vitamin D in the supplement formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of cinnamaldehyde from cassia bark, calcium, magnesium, vitamin B6 and vitamin D in the supplement formulation, is clearly a results effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amounts of cinnamaldehyde from cassia bark, calcium, magnesium, vitamin B6 and vitamin D in the supplement formulation to best achieve the desired result of inhibiting toxicity of prednisone and supplement the nutrient loss afforded by the glucocorticoid to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the supplement composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding the limitation of claim 2, wherein the administered unit dose of the supplement containing cinnamaldehyde from cassia bark, calcium, magnesium, vitamin B6 and vitamin D addresses all treatable common side effects and treatable very common side effects of the administered prednisone in the anti-arthritic methodology,
one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to incorporate a supplement tailored to address all treatable common side effects associated with the corticosteroid therapy. Said artisan would have been motivated to incorporate a supplement that addresses all treatable common side effects in order to inhibit the development of the side effects associated with the corticosteroid therapeutic regimen.
Regarding the limitation wherein the supplement does not interfere with beneficial activity of the drug (prednisone) (claims 4-5), as shown in paragraphs [0020]-[0023] and Table 1 of instant specification, calcium, magnesium, vitamin B6 and Vitamin D do not interfere with prednisone's therapeutic ability.
It is further noted that the combination of Yang, Zhang, Yalcin is silent on administering the supplement composition comprising a fixed dose of cinnamaldehyde in the form of cassia bark, vitamin B6, vitamin D, calcium and magnesium at a plurality of different times during the day (claims 6-7) or at a time wherein the effectiveness of the drug is expected to end (claims 8-9). However, the optimum dosing cycle and frequency of administration of the supplemental composition comprising a fixed dose of cinnamaldehyde in the form of cassia bark, vitamin B6, vitamin D, calcium and magnesium vitamin D to the rheumatoid arthritis patient receiving prednisone would have been a matter well within the insight of one of ordinary skill in the art. Such a determination would have been made in accordance with a variety of factors, such as pharmacological considerations, such as activity, efficacy, pharmacokinetics and toxicology profiles of the combined regimen, as well as the age, weight, sex, diet and severity of the medical condition of the prednisone treated patient.
Thus, the dosing cycle and frequency of administration that would have been employed would have varied widely and, in the absence of evidence to the contrary, the current claimed specific administration regimen is not seen to be inconsistent with one that would have been determined by the skilled artisan. Furthermore, absent and evidence demonstrating a patentable difference between the compositions administered and the criticality of the claimed frequency and dosing cycles, the determination of the optimum or workable frequency of administration given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)("[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the workable ranges by routine experimentation.").
Conclusion
In view of the rejections set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621