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 .
Status of Claims
Claims 1-12 are pending in the instant application.
Priority
This application claims priority to provisional Application No. 63/614,964, filed December 27th, 2023.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 12/11/2024 and 06/23/2025 were considered by the Examiner.
Claim Objections
Claims 1-12 are objected to because of the following informalities: the term “novel” in claim 1-12 is improper. Novelty is a legal determination made by the Examiner, not stating that it’s patentable. Appropriate correction is required, it is recommended that Applicant delete the term.
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 1-12 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. This is a written description rejection.
Claim 1 recites a composition merely containing finasteride at a dosage range of 10 mg to 40 mg. However, from the instant disclosure, it appears that the claimed composition can only exhibit the claimed effects if it is formulated as a sustained release microparticles containing the finasteride.
On pages 23-24 of the instant specification, Applicant provides the only example of the preparation of the composition. Instant specification paragraphs [00115]-[00132], detail that the composition is a “sustained-release microparticles (main drug)”.
As instant claim 1 encompasses a large range of compositions outside of the examples disclosed, the disclosure does not enable one of ordinary skill in the art to practice the invention without knowing what type of composition is required to produce the claimed effects.
Applicant has failed to show that he was in possession of all the diverse compositions encompassed by instant claim 1. Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to have a composition with the claimed effects.
As claims 2-12 do not align the composition with the instant disclosure, the claims are also rejected as failing to comply with the written description requirement.
In order to bring the claims in compliance with what is disclosed, it is suggested application provides more specific and narrower composition, in scope with the instant disclosure.
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 1-12 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.
The term “long-acting” in claims 1-12 is a relative term which renders the claim indefinite. The term “long-acting” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
As drafted, "long-acting" within claims 1-12 renders the metes and bounds of claims 1-12 undefined (hence rendering claims 1-12 indefinite) since the artisan has no idea what standard constitutes "long-acting".
Claim Rejections - 35 USC § 102
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 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 1-2 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kang et al (International Journal of Pharmaceutics 631 (2023) 122510, published January 25th, 2023, as cited on the IDS dated 06/23/2025).
Regarding claim 1, Kang teaches a long-acting injectable formulation of finasteride (title). Kang teaches that the dose is 16.80 mg of the long-acting injectable formula, as finasteride (abstract). With regard to the phrase “for preventing or treating androgenetic alopecia”, this phrase is intended use and the claim limitations are presumed met by the composition. Also, the claim contain limitations drawn to properties of the claimed compound: inhibits androgen-mediated hair follicle miniaturization for one month or more. MPEP 2112.01.II states: "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Since Kang teaches a long-acting injectable formula of finasteride in a dose of 10 mg to 40 mg, it would be expected that the compound would have the same physical properties as the compounds in the instant application, namely that the compound exhibits the ability to inhibit androgen-mediated hair follicle miniaturization for one month or more. In interest of compact prosecution, Examiner notes that the formulation of Kang is a 1-month sustained-release formulation.
Regarding claim 2, Kang teaches that the injectable is a subcutaneous formulation (page 5, left column).
Regarding claim 7, Kang teaches that the clearance of finasteride from central compartment is 12.64 ± 1.17 L/hr (Table 2).
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.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al (International Journal of Pharmaceutics 631 (2023) 122510, published January 25th, 2023, as cited on the IDS dated 06/23/2025).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Regarding claim 1, Kang teaches a long-acting injectable formulation of finasteride (title). Kang teaches that the dose is 16.80 mg of the long-acting injectable formula, as finasteride (abstract). With regard to the phrase “for preventing or treating androgenetic alopecia”, this phrase is intended use and the claim limitations are presumed met by the composition. Also, the claim contain limitations drawn to properties of the claimed compound: inhibits androgen-mediated hair follicle miniaturization for one month or more. MPEP 2112.01.II states: "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Since Kang teaches a long-acting injectable formula of finasteride in a dose of 10 mg to 40 mg, it would be expected that the compound would have the same physical properties as the compounds in the instant application, namely that the compound exhibits the ability to inhibit androgen-mediated hair follicle miniaturization for one month or more. In interest of compact prosecution, Examiner notes that the formulation of Kang is a 1-month sustained-release formulation.
Regarding claim 2, Kang teaches that the injectable is a subcutaneous formulation (page 5, left column).
Regarding claim 7, Kang teaches that the clearance of finasteride from central compartment is 12.64 ± 1.17 L/hr (Table 2).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art is deemed to anticipate instant claims 1-2 and 7 where anticipation is the epitome of obviousness. In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974)). Kang does not explicitly teach the numerical ranges and properties of instant claims 3-6 and 8-12.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding claim 3, Kang teaches that the elimination half-life of finasteride in the human body was estimated to be 11.99 hours and an equilibrium state is reached within 3-4 days in a simulation of multiple administrations (page 5, right column).
Regarding claim 4, Kang teaches that the first-order absorption rate contestant of finasteride is 1.30 ± 0.55 (Table 2).
Regarding claim 5, Kang teaches that the volume of distribution of finasteride in central compartment is 69.34 ± 10.35 L (Table 2).
Regarding claim 6, Kang teaches that the volume of distribution of finasteride in peripheral compartment is 76.62 ± 25.93 L (Table 2).
Regarding claim 8, Kang teaches that the clearance of finasteride between central compartment and peripheral compartment is 7.87 ± 8.10 L/hr (Table 2).
Regarding claim 9, Kang teaches that the Cmax is 13.69 μg/L (page 7, left column).
Regarding claim 10-12, Kang teaches the average plasma concertation in the equilibrium state in the repeated administration simulation is calculated by dividing AUC0-ɟ by the administration interval (page 4, left column). Further, Kang teaches that the AUC0-1month was 1425.44 (page 7, left column).
While the numerical ranges of Kang are not exactly the ranges as instantly claimed, the ranges as instantly claimed can be easily derived by a person of ordinary skill in the art, looking to optimize the teachings of the prior art. Further, with regard to each of the absorption rate constant, distribution and elimination parameters are estimated on the basis of the extracted pharmacokinetic profile and are used as initial estimation values, similar to the values of claims 9-12. Thus, the conditions of claims 4-8 and 9-12 are considered to be result-effective variables. See MPEP 2144.05: The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because “obvious to try” is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that “obvious to try” was a valid rationale for an obviousness finding, for example, when there is a “design need” or “market demand” and there are a “finite number” of solutions. 550 U.S. at 421, 82 USPQ2d at 1397 (“The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.”). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
Thus, one of ordinary skill in the art would look to these variables to optimize the results. See, again, MPEP 2144.05: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In reKulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was “unexpectedly good”); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
Conclusion
No claim is allowed.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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