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 .
Priority
The instant application was filed 01 April 2026. The Applicant claims priority to provisional application 63/789,054 filed 15 April 2025. The effective filing date of the instant application is therefore 15 April 2025.
Examiner’s Note
The Applicant's amendments and arguments filed 21 September 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 21 September 2026, it is noted that claims 1, 24, and 101 have been amended, no claims have been canceled, and no claims have been newly added. Support for the amendments can be found in para. 54 of the specification. No new matter has been added.
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) 1-3, 18, 20-38, 43, 45, 50, 52, 101-103 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gumudavelli et al. (US 20210015776 A1) in view of Hoang et al. (Desiccated Thyroid Extract Compared With Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-Blind, Crossover Study, J Clin Endocrinol Metab, 2013), and Armour Thyroid (2024), as evidenced by American Thyroid Association (thyroid.org).
Regarding claim 1, Gumudavelli teaches a composition comprising active agents, such as levothyroxine (para. 25), in an amount of 10-20% (para. 31) to treat a disease or disorder related to the thyroid (paras. 5, 6), such as hypothyroidism (para. 25). The composition may be formulated for oral use (para. 34). The composition may further comprise microcrystalline cellulose and a lubricant (para. 33). The amount of microcrystalline cellulose may be 25 mg and 64.890 mg, or a total of 89.89 mg, as exemplified in Formulation 8.
Regarding claim 2, the composition may comprise 0.025-0.3 mg of levothyroxine (para. 3).
Regarding claim 3, Gumudavelli teaches amounts of liothyronine as impurities ranging from 0.026-0.408%.
Regarding claim 18, the composition may comprise mannitol (para. 30).
Regarding claim 20, the composition may comprise calcium stearate (para. 58) and magnesium stearate (para. 49).
Regarding claim 21, the composition may comprise 1-5 wt% of colloidal silicon dioxide (para. 58).
Regarding claim 22, the amount of active agent concentration may be 10-20% (para. 31).
Regarding claim 23, the amount of microcrystalline cellulose may be 25 mg and 64.890 mg, or a total of 89.89 mg, as exemplified in Formulation 8.
Regarding claim 24, Gumudavelli teaches a composition comprising active agents, such as levothyroxine (para. 25), in an amount of 10-20% (para. 31). The amount of microcrystalline cellulose may be 25 mg and 64.890 mg, or a total of 89.89 mg, as exemplified in Formulation 8. The amount of mannitol may be 25-1000 micrograms (para. 30) or “about 16%” (para. 60). The composition may comprise 1-5 wt% of colloidal silicon dioxide (para. 58).
Regarding claims 25-38, Gumudavelli teaches a total degradation of the product, which appears to show less than 1% of degradation (Table 1). The storage conditions were performed at a temperature of 40°C, a relative humidity of 75%, and various time parameters of 1 month, 3 months, and 6 months, which is interpreted as addressing the limitations regarding the temperatures and humidities of “about 23°C” or “about 55%,” for example.
Regarding the liothyronine content in claims 32-38, the amounts of liothyronine varied during storage conditions, where in some instances, the amount of liothyronine increased, which is interpreted as maintaining at least 90% of the original liothyronine content.
Regarding claims 43, 45, 50, 52, the limitation regarding “2 grams of desiccant placed in a contained sealed with a closure” is interpreted as a product-by-process limitation and is given minimal patentable weight. Gumudavelli teaches a total degradation of the product, which appears to show less than 1% of degradation (Table 1). The storage conditions were performed at a temperature of 40°C, a relative humidity of 75%, and various time parameters of 1 month, 3 months, and 6 months, which is interpreted as addressing the limitations regarding the temperatures and humidities of “about 23°C” or “about 55%,” for example.
Regarding claim 101, Gumudavelli teaches a composition comprising active agents, such as levothyroxine (para. 25), in an amount of 10-20% (para. 31), microcrystalline cellulose in an amount of 25 mg and 64.890 mg, or a total of 89.89 mg, as exemplified in Formulation 8, mannitol in an amount of 25-1000 micrograms (para. 30) or “about 16%” (para. 60), 1-5 wt% of colloidal silicon dioxide (para. 58), and calcium stearate (para. 58).
Regarding claim 102, the composition may comprise 0.025-0.3 mg of levothyroxine (para. 3).
Regarding claim 103, Gumudavelli teaches amounts of liothyronine as impurities ranging from 0.026-0.408%.
Gumudavelli does not teach an exact combination of a non-blended porcine thyroid powder, microcrystalline cellulose, and a lubricant, glidant, diluent, or disintegrant in claims 1, 24 and 101. Gumudavelli does not teach porcine thyroid powder or the recited weight percentage ranges for non-blended porcine thyroid powder and microcrystalline cellulose in claims 1 and 23. Gumudavelli does not teach the concentration range for liothyronine in claims 3 and 103. Gumudavelli does not teach non-blended porcine thyroid powder as the sole active pharmaceutical ingredient in newly amended claims 1, 24, and 101.
Hoang teaches that desiccated thyroid extract, which is understood to mean pure extract (not blended with other ingredients) derived from the thyroid glands of pigs (evidenced by American Thyroid Association, pg. 1), showed improvement in symptoms and mental health in patients with hypothyroidism compared to synthetic compounds commonly used in thyroid treatment (abs; pgs. 1982 and 1989; entire teaching).
Since Gumudavelli does not teach non-blended porcine thyroid powder as the sole active ingredient in newly amended claims 1, 24, and 101, one of ordinary skill in the art would have been motivated to use Hoang’s teaching with a reasonable expectation of success. A skilled artisan would have recognized the added benefit of using porcine thyroid powder to improve and provide relief of symptoms associated with hypothyroidism, especially since some patients preferred it to synthetic compounds commonly used to treat hypothyroidism. Since Gumudavelli teaches ameliorating symptoms caused by certain diseases or disorders related to the thyroid (para. 15), such as hypothyroidism (para. 25), a skilled artisan would have been led to combine or substitute the teachings and improve Gumudavelli’s composition, especially because both treatment options resulted in similar quality of life measurements. Generally, it is prima facie obvious to combine or substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
In regards to selecting the combination of ingredients recite in claims 1, 24, and 101, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Gumudavelli teaches a composition comprising active agents, such as levothyroxine (para. 25), in an amount of 10-20% (para. 31), microcrystalline cellulose in an amount of 25 mg and 64.890 mg, or a total of 89.89 mg (Formulation 8), and a lubricant (para. 33), whereas the claimed invention is directed towards an oral solid dosage form comprising 11-15 wt% of non-blended porcine thyroid powder, 57-70 wt% of microcrystalline cellulose, and a lubricant, glidant, diluent, or disintegrant. Since Gumudavelli teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
In regards to recited weight percentage ranges for non-blended porcine thyroid powder and microcrystalline cellulose in claims 1 and 23 and the concentration range for liothyronine in claims 3 and 103, Gumudavelli teaches active in an amount of 10-20% (para. 31), microcrystalline cellulose in an amount of 25 mg and 64.890 mg, or a total of 89.89 mg (Formulation 8), and liothyronine as impurities ranging from 0.026-0.408%. Furthermore, Amour Thyroid teaches an amount of 38 micrograms of levothyroxine and 9 micrograms of liothyronine in their formulated tablets (pg. 1). That being said and in lieu of objective evidence of unexpected results, the weight percentages and concentrations can be viewed as a variable that achieves the recognized result of successfully making the levothyroxine composition, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Gumudavelli and Amour Thyroid. The optimum or workable range of weight percentages and concentrations can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized amounts of the components as nonobvious.
Response to Arguments
Applicant's arguments filed 21 September 2026 have been fully considered but they are not persuasive.
The Applicant argues the claimed invention would not have been obvious in view of Gumudavelli, ESA Position, and Armour (Remarks, pg. 10). The Applicant further argues that there is no teaching or suggestion that would result in the claimed invention (Remarks, pg. 10).
Applicant’s argument is not found persuasive. ESA Position has been removed as prior art and the arguments against it will not be addressed.
Gumudavelli teaches a composition comprising active agents, such as levothyroxine (para. 25), in an amount of 10-20% (para. 31) to treat a disease or disorder related to the thyroid (paras. 5, 6), such as hypothyroidism (para. 25). The composition may be formulated for oral use (para. 34). The composition may further comprise microcrystalline cellulose and a lubricant (para. 33). The amount of microcrystalline cellulose may be 25 mg and 64.890 mg, or a total of 89.89 mg, as exemplified in Formulation 8.
Hoang teaches that desiccated thyroid extract, which is understood to mean pure extract (not blended with other ingredients) derived from the thyroid glands of pigs (evidenced by American Thyroid Association, pg. 1), showed improvement in symptoms and mental health in patients with hypothyroidism compared to synthetic compounds commonly used in thyroid treatment (abs; pgs. 1982 and 1989; entire teaching).
Since Gumudavelli does not teach non-blended porcine thyroid powder as the sole active ingredient in newly amended claims 1, 24, and 101, one of ordinary skill in the art would have been motivated to use Hoang’s teaching with a reasonable expectation of success. A skilled artisan would have recognized the added benefit of using porcine thyroid powder to improve and provide relief of symptoms associated with hypothyroidism, especially since some patients preferred it to synthetic compounds commonly used to treat hypothyroidism. Since Gumudavelli teaches ameliorating symptoms caused by certain diseases or disorders related to the thyroid (para. 15), such as hypothyroidism (para. 25), a skilled artisan would have been led to combine or substitute the teachings and improve Gumudavelli’s composition, especially because both treatment options resulted in similar quality of life measurements. Generally, it is prima facie obvious to combine or substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
The Applicant argues that ESA Position teaches away from using porcine thyroid powder (Remarks, pg. 11).
Applicant’s argument is not found persuasive. ESA Position has been removed as prior art and the arguments against it will not be addressed.
The Applicant argues that ESA Position teaches away from relying on porcine thyroid powder as the sole active pharmaceutical ingredient in a dosage form (Remarks, pgs. 11-12).
Applicant’s argument is not found persuasive. ESA Position has been removed as prior art and the arguments against it will not be addressed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
