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, filed 08/07/2025, is a national stage entry of PCT/US2022/026143, filed 04/25/2022, and a continuation of 18/559,705, which claims domestic priority to U.S. provisional application no. 63/179, 885, filed 04/26/2021.
Amendments and Claim Status
The amendment filed on 01/22/2026 is acknowledged and entered.
Claims 1, 2, 11, 12, 14, 17, and 18 are amended;
Claims 3, 4, and 10 are cancelled;
Claims 19-21 are added.
Claims 1, 2, 5-9, and 11-21 are pending and are under prosecution.
Information Disclosure Statement
The Information Disclosure Statement filed on 08/07/2025 is acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statement is considered.
Restriction/Election
Applicant’s election without traverse of Group I in the reply filed on 01/22/2026 is acknowledged. Further, applicant’s election with traverse of the specific surface area of 3.5 m2/g and preferably the range of 3.5 m2/g and about of 30 m2/g is acknowledged.
The traversal is on the grounds that the different species of specific surface area (SSA) do not require different field of search. This is found not persuasive because the distinct SSA values and ranges constitute patentably distinct species because each represents a materially different physical property directly affects particle morphology, dissolution behavior, aerodynamic performance, and pharmaceutical delivery characteristics. Different SSA species would require separate prior art analyses and potentially distinct search strategies directed to different particle engineering parameters and performance characteristics. Accordingly, the elected species of specific surface area of 3.5 m2/g and preferably the range of 3.5 m2/g and about of 30 m2/g remains the subject of examination.
The requirement for restriction is still deemed proper and is therefore is made FINAL.
In accordance with the MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species does not make a contribution over the prior art of record.
Status of Claims
Claims 1, 2, 5-9, and 11-21 are pending in the instant application. Claims 13-18 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention. Therefore, claims 1, 2, 5-9, 11, 12 and 19-21 read on an elected invention and species and are therefore under consideration in the instant application.
Drawings
The drawings filed on 08/07/2025 are objected to under 37 CFR § 1.83(a) for the following reason:
The different data types are indistinguishable in Figures 15A and 15B. The original figures rely on color-coding of the data, a feature not available in the black and white drawings. The figures must be remade with shapes or line-types used to describe the different data points.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR § 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR § 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of pre-AIA 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.
Claims 1, 2, 5-9, 11, and 19-21 are rejected under 35 U.S.C. § 103 as being unpatentable over Baltezor et al. (US 20190022081 A1, published January 27, 2019, cited in applicant IDS filed 08/07/2025), hereinafter Baltezor.
The instant claims are drawn to a pharmaceutical composition comprising cisplatin particles that have a specific surface area (SSA) elected to be 3.5 m2/g and preferably the range of 3.5 m2/g and about of 30 m2/g.
Baltezor teaches a pharmaceutical composition (paragraph [0212]) used in a method for solid tumor treatment. The composition comprises chemotherapeutic particles (claim 1) which include cisplatin (claim 11, see instant claim 1). The chemotherapeutic particles comprise at least 95% chemotherapeutic have a specific surface area (SSA) of between about 10 m2/g and about 50 m2/g (claim 21, see instant claims 1 and 2). The prior art further discloses that the chemotherapeutic particles are between 0.1 μm and 5 μm in diameter (paragraph [0153], see instant claims 5 and 19). Baltezor further teaches wherein the particles comprise at least 96%, 97%, 98%, 99%, or 100% of the chemotherapeutic compound (paragraph [0079], see instant claim 6) that are between 0.1 μm and 5 μm in diameter (paragraph [0153], see instant claims 19 and 21). The prior art discloses wherein the particles are uncoated and the suspension or kit excludes polymers, proteins, polyethoxylated castor oil, and/or polyethylene glycol glycerides composed of mono-, di- and triglycerides and mono- and diesters of polyethylene glycol (paragraph [0138], see instant claim 8). The prior art further teaches a suspension further comprising a pharmaceutically acceptable liquid carrier (paragraph [0139], see instant claim 9). Finally, the prior art discloses wherein the composition may be in the form of a powder, and teaches wherein lower powder bulk densities yield faster dissolution rate (paragraph [0166]), and teaches a specific embodiment wherein a chemotherapeutic particle is in the form of a powder for suspension ([0373, [0376]).
Regarding claim 1, Baltezor expressly identifies cisplatin as one of the chemotherapeutic agents within the disclosed group of chemotherapeutic agents (claim 11). As such, a prima facie case of obviousness is established because picking one of a finite number of known solutions to a known problem is prima facie obvious. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). That is, cisplatin is explicitly contemplated as part of the claimed subject matter, and therefore selection of cisplatin from the expressly disclosed group constitutes more than the predictable selection of a disclosed species from a finite number of identified options, which is considered prima facie obvious.
Further regarding claims 1, 2, 5, 6, 9, 20, and 21, the instantly claimed ranges overlap with those taught by the prior art. Regarding claims 1 and 2, and the specific recitation of a specific surface area range between 3.5 m2/g and about of 30 m2/g (claim 1) and between 7 m2/g and about of 30 m2/g (claim 2), the prior art teaches wherein the SSA of the chemotherapeutic particles disclosed is 10 m2/g and about 50 m2/g (claim 21, see instant claims 1 and 2). Regarding claims 5, 19, and 21, which recite a specific mean particle size by volume distribution, the prior art further discloses that the chemotherapeutic particles are between 0.1 μm and 5 μm in diameter (paragraph [0153], see instant claims 5 and 19). Baltezor further teaches wherein the particles comprise at least 96%, 97%, 98%, 99%, or 100% of the chemotherapeutic compound (paragraph [0079], see instant claim 6) that are between 0.1 μm and 5 μm in diameter (paragraph [0153], see instant claims 19 and 21). Regarding claims 6 and 20, which recite a specific mean bulk density of 0.02 g/cm3 to about 0.8 g/cm3, the prior art teaches wherein the chemotherapeutic particles have a mean bulk density between about 0.050 g/cm3 and about 0.15 g/cm3, and/or a specific surface area (SSA) of at least 18 m2/g (paragraph [0166]). Thus, the ranges taught by the prior art overlap with those of the instant claims. With regard to overlapping ranges, it is noted that the courts have stated,
where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that,
“where 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 MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant of the values of the cited prior art.
Regarding, claim 11, wherein the suspension is aerosolized with a median aerodynamic diameter of aerosol droplets at about 0.5 mm to 6 mm, this is merely a recitation of intended use of the composition already taught by the prior art. The prior art teaches a suspension having the same characteristics as that of the instant claims. As such, the prior art suspension is necessarily capable of the claimed intended use. According to MPEP § 2112.01 (I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. The courts have stated
In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See In re Spada "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. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
Therefore, because the prior art teaches a suspension having the same characteristics and claimed compositional features, it is capable of the intended use—being aerosolized to produce droplets within the recited media and aerodynamic diameter range. Accordingly, the prior art satisfies the limitations of the claim although not explicitly recited in the prior art.
Claim 12 is rejected under 35 U.S.C. § 103 as being unpatentable over Baltezor (as applied to claims 1, 2, 5-9, 11, and 19-21 above) in view of Kosmidis et al. (Int J Mol Sci, Volume 20, Issue 8, published April 24, 2019), hereinafter Kosmidis.
Baltezor is as set forth above.
Baltezor does not specifically exemplify cisplatin as a dry powder composition capable of being aerosolized with a specific mass median aerodynamic diameter (MMAD).
However, as detailed above Baltezor specifically teaches that the formulation, wherein the active chemotherapeutic agent may be selected as cisplatin, is prepared as a dry powder formulation [0166]. Thus the dry powder formulation of Baltezor which comprises cisplatin as the chemotherapeutic particles is necessarily capable of being aerosolized as claimed in claim 12.
In addition, Kosmidis, teaches inhaled cisplatin administration for lung cancer (Abstract, Table 1). Kosmidis teaches wherein the cisplatin particles may be in the form of dry powder that may be aerosolized (Table 1, see instant claim 12). Kosmidis teaches wherein the optimal mass media and aerodynamic diameter (MMAD) for deep lung penetration is between 3-5 µm (page 5, see instant claim 12).
One of ordinary skill in the art prior to the effective filing date of the instant claims would have been motivated to select cisplatin from Baltezor’s disclosed chemotherapeutic genus in order to optimize the particle aerodynamic properties consistent with inhalation parameters expressly taught by Kosmidis to achieve effective systemic distribution. The combination of chemotherapeutic particle engineering teachings to the known inhalation cisplatin delivery parameters disclosed by Kosmidis would yield a predictable expectation of success in the use of said particles as a cancer therapeutic, as taught by both Baltezor and Kosmidis.
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, 5-9, 11, 12, and 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-9, 15, 16, 18, 20, 22- 26 of copending Application No. 18/492,232, (US 20240156861 A1) in view of Kosmidis (as applied to instant claims 11 and 12, above). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims teach the composition as instantly claimed.
The co-pending application fails to teach specific MMDA values of cisplatin particles.
The deficiencies of the co-pending application are remedied by Kosmidis teaches wherein the cisplatin particles may be in the form of dry powder that may be aerosolized (Table 1, see instant claim 11). Kosmidis teaches wherein the optimal mass media and aerodynamic diameter (MMAD) for deep lung penetration is between 3-5 µm (page 5, see instant claims 11 and 12).
Regarding instant claim 1, co-pending claims 1, 2, 4, 5, 15, 16, 18, and 22 teach a suspension and/or dry powder composition comprising cisplatin particles were in the particles include at least 95% by weight cisplatin with a specific surface area that falls within the instantly claimed SSA.
Regarding instant claim 2, co-pending claims 5 and 20 teach wherein the particles may have a specific surface area within the instantly claimed range.
Regarding instant claims 5, 19, and 21, co-pending claim 6 teaches wherein the mean particle size by volume distribution is within the instantly claimed ranges.
Regarding instant claims 6 and 20, the co-pending claims 7 and 24 teach wherein the particles have a mean bulk density within the instantly claimed range.
Regarding instant claim 7, co-pending claims 8 and 25 teach wherein the particles comprise at least 98% by weight cisplatin.
Regarding instant claim 8, co-pending claims and 9 and 26 teach wherein the particles are uncoated and exclude the same components as instantly claimed.
Regarding instant claim 9, co-pending claims 1, 2, 4, 5, 15, 16, 18, and 22 teach a suspension further comprising a pharmaceutically acceptable carrier.
Regarding instant claims 11 and 12, Kosmidis teaches wherein the optimal mass media and aerodynamic diameter (MMAD) for deep lung penetration of cisplatin dry powder particles is between 3-5 µm (page 5, see instant claims 11 and 12).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. If a notice of allowance is issued in the co-pending application 18/492,232 upon issue of the patent, the provisionary NSDP rejection over the co-pending application will convert to a NSDP rejection over the published patent.
Claims 1, 2, 5-9, 11, 12, and 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9, 11, and 12 of copending Application No. 18/556,705, (US 20240216424 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims teach the composition as instantly claimed.
Regarding instant claims 1 and 2, co-pending claims 1-4 teach a suspension and/or dry powder composition comprising cisplatin particles were in the particles include at least 95% by weight cisplatin with a specific surface area that falls within the instantly claimed SSA.
Regarding instant claims 5, 19, and 21, co-pending claim 5 teaches wherein the mean particle size by volume distribution is within the instantly claimed ranges.
Regarding instant claims 6 and 20, the co-pending claim 6 teaches wherein the particles have a mean bulk density within the instantly claimed range.
Regarding instant claim 7, co-pending claim 7 teaches wherein the particles comprise at least 98% by weight cisplatin.
Regarding instant claim 8, co-pending claim 8 teaches wherein the particles are uncoated and exclude the same components as instantly claimed.
Regarding instant claim 9, co-pending claim 9 teaches a suspension further comprising a pharmaceutically acceptable carrier.
Regarding instant claim 11, co-pending claim 11 teaches the aerosolized composition with overlapping MMAD values.
Regarding instant claim 12, co-pending claim 12 teaches the dry powder composition with overlapping MMAD values.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. If a notice of allowance is issued in the co-pending application 18/556,705, upon issue of the patent, the provisionary NSDP rejection over the co-pending application will convert to a NSDP rejection over the published patent.
Correspondence
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623