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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 24 Oct 2025 has been entered.
Claims 1-8 remain pending in the application.
Claims 1-6 are amended.
Claims 1-8 are pending and under consideration.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections of claims 1-8 pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 27 Jun 2025 are hereby withdrawn in light of applicants amendment of the claims.
Rejections Maintained
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.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2014/0371186, published 18 Dec 2014)
Wang teaches testosterone booster injection solutions comprising testosterone cypionate in combination with anastrozole (abstract). Wang teaches the use of cottonseed oil ([0017]) and the solvents benzyl alcohol and benzyl benzoate ([0016]) as suitable for the compositions. Wang teaches an example formulation comprising 5-20% w/v testosterone cypionate, 0.005-0.5% w/v anastrozole, up to 46% w/v benzyl benzoate, up to 10% w/v benzyl alcohol, and q.s. to 100% w/v (see [0054] Table 1). For ease of comparison with the claims, the amounts taught by Wang are shown in the table below along with unit conversions.
Component
% w/v (taught by Wang)
mg/mL
%v/v
Testosterone cypionate
5-20
50-200
NA
Anastrozole
0.005-0.5
0.05-5
NA
Benzyl Benzoate
Up to 46
Up to 460
Up to 41
Benzyl Alcohol
Up to 10
Up to 100
Up to 9.6
Cottonseed Oil
q.s to 100 (i.e. 23.5-94.995)
~235-940
NA
Wang does not expressly teach selecting the amounts of testosterone cypionate, benzyl benzoate, benzyl alcohol or cottonseed oil as part of the injection solution with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed an injectable composition with 5-20% w/v (50-200 mg/mL) testosterone cypionate, 0.005-0.5% w/v (0.05-5 mg/mL) anastrozole, up to 46% w/v (41% v/v) benzyl benzoate, up to 10% w/v (up to 100 mg) benzyl alcohol, and 23.5-94.995% w/v (~235-940 mg/mL) cottonseed oil. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success as injectable testosterone solutions are taught by Wang as suitable and each of these components and their amounts are taught in an example by Wang. The amounts taught by Wang for the components overlap with and render obvious the amounts of the instant claims. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Wang.
Response to Arguments
Applicant's arguments filed 24 Oct 2025 have been fully considered but they are not persuasive. Applicant states that the instant application and the teaching of Wang are trying to solve different problems as Wang’s is directed to testosterone booster formulations combining testosterone and anastrozole whereas the instant application aims at solving crystal formation in commercial testosterone formulations (page 3 of remarks). The examiner is not persuaded by this argument as the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention). In KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court cautioned that, "[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103." Id. at 419. In this case, the teachings of Wang render obvious testosterone formulations with the same components as the instant claims and in amounts that overlap with the amounts of the instant claims, thereby rendering obvious the claims.
The applicant argues that Wang does not teach any specific amounts of formulation components within the ranges disclosed and their effect on solubility (page 3 of remarks). Again, it is not necessary for the art to disclose the concept of solubility in order to render the claims as obvious, even if the solubility served as the motivation for the applicant in constructing the composition. Regarding the lack of specific amounts noted by the applicant, the examiner notes that the rejection with Wang was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. While Wang may not provide a specific embodiment of the instantly claimed invention, the examiner maintains that the invention as claimed is nonetheless made obvious over Wang as the same components with overlapping ranges are taught.
The applicant argues that wAng does not disclose formulation without anastrozole. The examiner does not find this persuasive as the formulation of claims 1-4 are limited with the transitional phrase “comprising” and the formulation of claims 5-8 are limited with the phrase “consisting essentially of.” The examiner notes that the use of “comprising” language is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03(I)). The phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). "A ‘consisting essentially of’ claim occupies a middle ground between closed claims that are written in a ‘consisting of’ format and fully open claims that are drafted in a ‘comprising’ format." PPG Industries v. Guardian Industries, 156 F.3d 1351, 1354, 48 USPQ2d 1351, 1353-54 (Fed. Cir. 1998). See also Atlas Powder v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 224 USPQ 409 (Fed. Cir. 1984); In re Janakirama-Rao, 317 F.2d 951, 137 USPQ 893 (CCPA 1963); Water Technologies Corp. vs. Calco, Ltd., 850 F.2d 660, 7 USPQ2d 1097 (Fed. Cir. 1988). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. Thus, the inclusion of anastrozole is not excluded from the claims and its inclusion as in the composition of Wang still renders the instant claims as obvious.
The applicant argues that the formulation of the instant claims has improved solubility as seen in Table 1 of the application (page 4 of remarks). This is not persuasive as Wang teaches formulations with components in amounts that overlap with and render obvious the instant formulations. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). To the extent that applicant is attempting to establish criticality for the range of values for the components, the examiner notes that applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See also Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 271 (1916).
Claims 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2014/0371186, published 18 Dec 2014) as applied to claims 1-3 above and further in view of Nickell (US 2016/0120712, published 05 May 2016, as listed on the IDS filed 26 Apr 2023) as evidenced by the instant specification.
The teachings of Wang are described supra.
Wang does not teach a formulation volume of 1 mL (claim 4), a vial (claim 7) or a kit (claim 8). These deficiencies are made up for in the teachings of Nickell.
Nickell teaches a kit with all the necessary components for a medical practitioner to inject testosterone to a patient (abstract). Nickell teaches that a convenience kit aids a medical practitioner in areas such as locating the necessary and correct medications, correct strength/percentage, current dating, and insuring the liquid is not contaminated or crystallized ([0002]-[0003]). Nickell teaches that the kit has a 1 mL container of testosterone cypionate 200 mg/mL ([0005]). Nickell teaches the container of testosterone cypionate as a vial ([0016]). An example kit taught by Nickell includes 1 mL of testosterone cypionate, benzyl benzoate, benzyl alcohol, and cottonseed oil ([0024]). Nickell does not teach an instruction sheet for warming and shaking the vial.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have formed the composition of Wang as 1 mL vials in a kit. Similar formulations comprising testosterone cypionate, benzyl benzoate, benzyl alcohol and cottonseed oil and 1mL vials are taught by Nickell as suitable for a kit and it would be obvious to have the composition of Wang in such a kit to aid a medical practitioner during treatment. Regarding claim 5, the specific amounts recited are obvious from the amounts taught by Wang when used in a 1mL formulation. Regarding the limitation that the formulation is “free of visible crystals when stored at 20 °C,” this is understood as a functional limitation that is necessarily present in the compositions rendered obvious over Wang. As evidenced by the instant specification, a formulation of 200 mg testosterone cypionate, 0.3 mL benzyl benzoate, 470 mg cottonseed oil and 9.45 mg benzyl alcohol was stable (page 5 example 3). Such as composition is obvious from the teachings of a Wang and 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.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
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/E.C.M./Examiner, Art Unit 1619 /ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600