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 .
Receipt is acknowledged of Amendments made to claims on 04/17/26. Claims 1 and 4-5 have been amended, claims 15-16, 18, 20, 22-28 have been cancelled and no new claims have been added.
Election/Restrictions
Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traversal in the reply filed on 04/17/26.
Claims 1-2, 4-10 have been elected and are under examination on the merits.
Claim Rejections - 35 USC § 112
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 1-2, 4-10 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.
Claims 1-2 and 4-10 are indefinite for reciting concentrations in percentages without indicating what the basis for such percentages is. That is, it is not clear if the said percentages are based on the total weight of the suspension, part of it such as a carrier portion or else. Additionally, the suspension of claim 5 comprises 100% of the glycerin, propylene glycol, ethanol and sodium chloride in water. Thus, it is not clear if the particles of cisplatin are part of this suspension or separate.
Claim 10 is indefinite for renting the suspension comprises at least 2.5 mg/ml cisplatin particles. This limitation encompasses a concentration of 100 mg/ml, 1000 mg/ml or infinity, which are neither possible nor envisioned/ disclosed by the Specification.
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.
Claims 1-2, 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Baltezor et al (US 20190022081) in view of Pramanick et al (Excipient selection in parenteral formulation development) as evidenced by Salama (WO 2020002056).
Baltezor et al teach methods for treating solid tumors by direct injection into the tumors of chemotherapeutic particles, and compositions that include chemotherapeutic particles, small, amounts of a polysorbate, and a carrier (See abstract).
Regarding claims 1-2 and 4-5, in part, Baltezor et al teach that the said composition is a suspension (See at least [0005]-[0006], [0016], [0214] and claim 9), the said chemotherapeutic agent is cisplatin (See [0018], [0092], [0164] and claim 11), wherein the particles comprise at least 96%, 97%, 98%, 99%, or 100% of the compound (See [0079]), and wherein the said particles have a specific surface area (SSA) of at least 10 m2/g, or at least 12 m2/g, 14 m2/g, 16 m2/g, 18 m2/g, or a SSA of between 16 m2/g and 29 m2/g (See [0038], [0097] and [0167]) and wherein the aqueous liquid carrier is saline, such as normal saline (0.9%) (See [0015], [0091], [0139] and [0213]).
Further regarding claims 1-2 and 4-5, in part, Baltezor et al teach a suspension comprising one or more tonicity adjusting agents, including sodium chloride, glycerin, propylene glycol, and mixtures thereof (See [0217] and [0219]). The said composition may further comprise ethanol as a solvent (See [0236] and [0273]).
Regarding claims 1 and 6, in part, Baltezor et al teach that the said particles have a mean particle size of between about 0.4 μm and about 1.2 μm, or between about about 0.4 μm and about 5 μm (See [0076] and [0154]-[0155]).
Regarding claims 1 and 7, in part, Baltezor et al teach that the said particles of the chemotherapeutic agent may have a mean bulk density between about 0.050 g/cm3 and about 0.15 g/cm3, (See [0125]and/or
Regarding claims 1 and 8, in part, Baltezor et al teach that chemotherapeutic agent is cisplatin (See [0018], [0092], [0164] and claim 11) and wherein the particles comprise at least 98%, 99%, or 100% of the compound (See [0079] and [0153]).
Regarding claims 1 and 9, in part, Baltezor et al teach that the said particles are uncoated and the composition excludes polymers, proteins, polyethoxylated castor oil, and/or polyethylene glycol glycerides composed of mono-, di- and triglycerides and mono- and diesters of polyethylene glycol (See [0077] and [0213]).
Regarding claims 1 and 10, in part, Baltezor et al teach that the said chemotherapeutic is present in the suspension at a concentration between about 1 mg/ml and about 20 mg/ml, or from about 2 mg/ml and about 10 mg/ml (See [0096], [0211] and claim 48).
Baltezor et al differs from the instant claims in that the concentration of each component of the suspension is not disclosed. However, this would have been obvious to one of ordinary skill in the art and as taught by Pramanick et al and as evidenced by Salama.
Pramanick et al teach that excipients are the integral part of pharmaceutical products development to achieve desired product profile (stability and efficacy). This review deals with understanding of the physicochemical properties of excipients used in parenteral formulation development for solution, suspension and lyophilized drug products (See abstract).
Regarding claims 1-2 and 4-5, in part, Pramanick et al teach that cisplatin may effectively be combined with sodium chloride in a parenteral formulation (See page 64). Parenteral formulations should be isotonic with human plasma so as to avoid damage to the tissues. However, not all drugs at their recommended dosage are isotonic with blood, thus requiring the addition of a tonicity adjusting agent to the formulation. The most commonly used tonicity agents include dextrose, glycerol and sodium chloride (See page 69, 1st col.). Co-solvents include propylene glycol and ethanol. The suggested concentration ranges include ethanol at from 0.6 to 100% v/v, glycerin at from 1.6 to 70% w/v, propylene glycol at from 0.0025 to 80% (See page 70, 2nd col.).
Pramanick et al further teach that sodium chloride can be added as a tonicity adjusting agent and an electrolyte (See page 72, 1st col).
As evidenced by Salam,
Salama teach a pharmaceutical composition comprising cis-oxoplatin, or a salt and/or derivative thereof, including cisplatin, for use as a medicament in the treatment and/or prevention of stomach cancer (See abstract and page 4, line 38).
Salama teach that pharmaceutical forms suitable for injectable use include sterile aqueous solutions or dispersions and sterile powders for the extemporaneous preparation of sterile injectable solutions or dispersions, must be stable under the conditions of manufacture and storage and must be preserved against the contaminating action of microorganisms, such as bacteria and fungi. The carrier can be a solvent or dispersion medium containing, for example, water, ethanol, polyol (e.g., glycerol, propylene glycol, and liquid polyethylene glycol, and the like), suitable mixtures thereof, and/or vegetable oils. it will be preferable to include isotonic agents, for example sodium chloride (See page 19, last para).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Pramanick et al with that of Baltezor et al as evidenced by Salama to arrive at the instant invention with a reasonable expectation of success. It would have been obvious to do so because the references all teach a suspension formulation comprising a chemotherapeutic agent including cisplatin for parenteral administration wherein the suspension comprises suitable excipients including glycerin, propylene glycol, ethanol and sodium chloride 0.9% (normal saline). While Baltezor et al do not disclose the concentration ranges of such components and Pramanick et al discloses a broad concentration range, one of ordinary skill in the art would have been motivated to have determined the suitable concentration ranges from the disclosed ranges by routine experimentation. That is, the references above would serve as starting point to figure out optimal amounts. Since there is a teaching in the prior art of the ranges, it would have been obvious to find the best ranges. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. In addition, “[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); 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.”). This is what researchers do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B). There would have been a reasonable expectation of success due to the high level of skill in the art and the teachings of the references in the absence of evidence to the contrary, such as unexpected results.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/556,705 (US 20240216424) (reference application) in view of Pramanick et al (Excipient selection in parenteral formulation development) as evidenced by Salama (WO 2020002056). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the reference claims in view of Pramanick et al as evidenced by Salama.
The examined claims and the references are both directed to a composition, such as suspension comprising particles of cisplatin in a carrier formulation. In both sets of claims the said particles have a specific surface area (SSA) of from 3.5 m2/g. The difference is that the examined claims recite the ingredients making up the carrier while the reference claims do not. However, this would have been obvious in view of Pramanick et al as evidenced by Salama. Pramanick et al teaches suitable excipients for parenteral formulations including suspensions and dispersions and there is a broad disclosure of the percentage ranges of each of the said excipient ingredients. Additionally, as evidenced by Salama in a suspension for parenteral formulation comprising cisplatin, suitable excipients include 0.9% saline (sodium chloride), ethanol, propylene glycol and glycerin. Both Pramanick et al and Salama disclose the uses of each excipient ingredient. As such one of ordinary skill in the art is more than motivated to incorporate the teachings of Pramanick et al as evidenced by Salama into the formulations of the reference claims to arrive at the examined claims with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-9, 11 and 20-21 of copending Application No. 19/293,697 (US 20250360166) (reference application) in view of Pramanick et al (Excipient selection in parenteral formulation development) as evidenced by Salama (WO 2020002056). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the reference claims in view of Pramanick et al as evidenced by Salama.
The examined claims and the references are both directed to a composition, such as suspension comprising particles of cisplatin in a carrier formulation. In both sets of claims the said particles have a specific surface area (SSA) of from 3.5 m2/g. The difference is that the examined claims recite the ingredients making up the carrier while the reference claims do not. However, this would have been obvious in view of Pramanick et al as evidenced by Salama. Pramanick et al teaches suitable excipients for parenteral formulations including suspensions and dispersions and there is a broad disclosure of the percentage ranges of each of the said excipient ingredients. Additionally, as evidenced by Salama in a suspension for parenteral formulation comprising cisplatin, suitable excipients include 0.9% saline (sodium chloride), ethanol, propylene glycol and glycerin. Both Pramanick et al and Salama disclose the uses of each excipient ingredient. As such one of ordinary skill in the art is more than motivated to incorporate the teachings of Pramanick et al as evidenced by Salama into the formulations of the reference claims to arrive at the examined claims with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-10 are rejected. Claim 11 is withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
Prosecution Insights