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 10-17 are pending
Claims 15-17 are withdrawn from examination as being drawn to a nonelected invention.
Claims 10-14 are under consideration in the instant office action.
Election/Restrictions
Applicant’s election without traverse of the Group 1 (claims 10-14), in their response dated 8/3/2026 is acknowledged.
Examinations of the claims are conducted to the extent they read on the elected invention. Claims 15-17 are withdrawn from examination as being drawn to a nonelected species.
Claims 10-14 are under examination and the requirement for restriction is made final.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/24/2024 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application is a U.S. National phase application under 35 U.S.C 371 of PCT application PCT/SE2022/050722, filed 7/18/2022, which claims benefit under Title 35 U.S.C 119 to Sweden patent application no. SE2130219-5 filed on 8/8/2021. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
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.
Claims 10-14 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Pokroy et al. (US 2018/0117177) and Lee et al. (US 8728536) (both references cited in IDS dated 01/24/2024)
Instant claims are drawn to a pharmaceutical composition comprising: an inorganic salt; and hydroxyurea, or a pharmaceutically acceptable salt thereof, wherein the inorganic salt is selected from the group consisting of calcium carbonate, magnesium carbonate, calcium phosphate, and any combination thereof, and the pharmaceutical composition is in the form of doped crystals so that the hydroxyurea, or the pharmaceutically acceptable salt thereof, is included in the crystal lattice of the inorganic salt.
Pokroy et al. discloses a pharmaceutical composition comprising an inorganic salt in the form of calcium carbonate (Calcite) and the anticancer drug Doxorubicin ( [0134], claims 1 and 21). And wherein the composition is in the form of doped crystals so that the doxorubicin is included in the crystal lattice of the calcite ( [0138-0140], [0142]). Pokroy et al. discloses that their composition is characterized by an X-Ray Powder Diffraction which is devoid of peaks at positions that correspond to said organic agent (claim 14).
Pokroy et al. fails to disclose hydroxyurea as the anticancer drug.
Lee et al. discloses (i) a calcium phosphate comprising an amorphous calcium phosphate (ACP) or a poorly crystalline apatite (PCA) calcium phosphate; (ii) an anticancer agent; and (iii) a physiologically acceptable fluid, wherein said composition is formulated as a formable or injectable paste that hardens in an endothermic reaction (claim 1), they disclose hydroxyurea as one of the anticancer agents (claim 3). They fail to discloses that the composition is in the form of doped crystals.
Doxorubicin and Hydroxyurea are both anti-cancer agents which are know in the art as noted above to be formulated for controlled drug release and targeted treatment of cancer. A person of ordinary skill in the art is well aware of methods of formulating anticancer agent such as doxorubicin ina formulation comprising inorganic salts for better delivery of the drug to the subject as taught by Pokroy et al. Lee et al. provides motivation to also formulate the anticancer agent hydroxy urea for extended drug release. It therefore would have been prima facia obvious to a person of ordinary skill in the art to arrive at the instant claims motivated and guided by the combined teachings of Pokroy et al. and Lee et al. An ordinarily skilled artisan would be motivated from Pokroy et al. to formulate a composition of calcium carbonate and an anticancer agent in a doped crystal lattice composition and Lee et al. discloses hydroxyurea as an anticancer agent formulated for extended drug release with an inorganic ion. The hydroxyurea taught by Lee et al in addition to other anti-cancer agents is functional equivalent of the Doxorubicin used by Pokroy et al. in their study. Substituting equivalents, namely anticancer agents, 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. Due to the fact that Pokroy et al. teach and provide the skilled artisan with the necessary motivation to use a anticancer agents in the doped crystal lattice formulation with an inorganic salt such as calcium carbonate and it is further known from Pokroy et al. that other therapeutic agents can be included in the crystal lattice of calcite [0152-0154]. and the fact that Lee et al. discloses hydroxyurea, which is also an anticancer agent, formulated for controlled drug release, one having ordinary skill in the art is clearly provided with direction and ample motivation to use any anti-cancer agents including those taught by Lee et al for in the composition of the doped crystal formulation.
With regards to claim 14. It would have been obvious to one of ordinary skill in the art to optimize the dosage of hydroxyurea which is a well-known anti-cancer agent used in the treatment of cancer, in the composition based on the amount of calcite, with guidance provided by Pokroy et al. 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).
Formulating anti-cancer agents for better delivery as doped crystals using inorganic salts is well known in the art as taught by Pokroy et al who provides ample motivation to a person of ordinary skill in the art formulate other anti-cancer agents such as hydroxyurea in a similar manner, absence of evidence to the contrary. As such a person of ordinary skill in art would be imbued with a reasonable expectation of success in developing the instantly claimed pharmaceutical composition.
Conclusion
Claims 10-14 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691
