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
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 23 June 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. Applicants’ arguments/remarks filed 20 October 2025 are acknowledged. Claims 1-4, 6-12, and 14-16 are currently pending. Claims 9-12 and 14-16 were previously withdrawn. Claims 1-2 and 6-7 are amended. Claims 1-4 and 6-8 are examined on the merits within.
Withdrawn Rejections
3. Applicants’ arguments, filed 20 October 2025, with respect to the 35 U.S.C. 112(b) Rejection have been fully considered and are persuasive. The 35 U.S.C. 112(b) Rejection of claim 5 has been withdrawn. The 35 U.S.C. 102(a)(1) Rejection over Kim et al. (KR20140120409A) has been withdrawn in view of the claim amendments. The 35 U.S.C. 103 Rejection of Kim et al. (KR20140120409A) in view of D’souza et al. (Expert Opinion on Drug Delivery, 2016) and Kim et al. (KR20140120409A) in view of D’souza et al. (Expert Opinion on Drug Delivery, 2016) and further in view of Ying et al. (Current Protocols in Neuroscience, 2000) has been withdrawn in view of the claim amendments. However, upon further consideration a new rejection is made in view of Allen (WO88/03799).
New Rejections
Claim Rejections – 35 U.S.C. 102
4. 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.
5. Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allen (WO88/03799).
Regarding instant claims 1-3, Allen discloses compositions comprising platinum cis-diamine-dichloride (cisplatin) as a pharmacologically active agent. See page 10. The compositions can be in the form of lotions, creams and suppositories. See page 16. Carriers include polyethylene glycol. See page 16. Example 1 is directed to an antineoplastic preparation comprising PEG 400 and PEG 3350. 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Thus the formulation assumes a solid phase at room temperature and a liquid phase at a body temperature.
Thus the instant claims are anticipated by
Claim Rejections – 35 U.S.C. 103
6. 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.
7. Claim(s) 1-4 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen (WO88/03799) in view of D’souza et al. (Expert Opinion on Drug Delivery, 2016).
Allen teaches compositions comprising platinum cis-diamine-dichloride (cisplatin) as a pharmacologically active agent. See page 10. The compositions can be in the form of lotions, creams and suppositories. See page 16. Carriers include polyethylene glycol. See page 16. Example 1 is directed to an antineoplastic preparation comprising PEG 400 and PEG 3350. Since Allen teaches the same combination of ingredients, it should function in the same manner, i.e., the formulation assumes a solid phase at room temperature and a liquid phase at a body temperature.
Example 1 comprises a ratio of high molecular weight polymer to low molecular weight polymer of 0.17:1. Example 2 comprises ratios of high molecular weight polymer to low molecular weight polymer of 20.6:1 to 3.29:1. Example 2 comprises 25.75 mg of antineoplastic agent to 12.55 g of formulation (i.e., about 2 mg/1g).
Allen does not teach the ratio of high molecular weight PEG to low molecular weight PEG.
D’souza et al. teach mixtures of PEG 400 (60%) and PEG 3350 (40%) wherein solid PEGS are generally employed with consistency adjusted with liquid PEGs. PEG blends are selected so they can withstand warm tropical climates with improved stability. See page 1264. MW mainly governs the fate and half-life of PEG. Absorption of PEG across gastrointestinal tract and skin decreases with increase in MW, with almost 50% of absorption observed with PEG 400. See page 1260. PEG 400 can be used for liquids, creams, lotions, and ointment bases whereas PEG 3350 can be used for toothpastes, laxatives, etc. See Figure 3. Acceptable daily intake of all PEGS is up to 10 mg/kg body weight. See page 1261. PEG can be used in implantable devices. See page 1270. SonoVue is a commercially available PEG containing a contrast agent for diagnosis. See page 1621.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the ratio of PEG 400 and PEG 3350 to achieve the desired consistency and release rate as taught by D’souza et al. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the amount of cisplatin within known safe and effective amounts to achieve the desired effect. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use a contrast agent to provide an added diagnostic effect in combination with the therapeutic effect.
8. Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen (WO88/03799) in view of D’souza et al. (Expert Opinion on Drug Delivery, 2016) as applied to claims 1-4 and 6-7 above and further in view of Ying et al. (Current Protocols in Neuroscience, 2000).
Allen and D’souza et al. do not teach trypan blue.
Ying et al. teach various assays to assess neuronal cell viability including MTT assays and trypan blue. See Table 7.18.1.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one contrast agent for another dependent on the testing desired because Ying et al. teach various assays to assess neuronal cell viability including MTT and trypan blue.
Conclusion
9. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence
10. No claims are allowed at this time.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615