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
Status of Application
1. Receipt of the Request for Continued Examination (RCE) under 37 C.F.R. 1.114, the Amendment and Applicants’ Arguments/Remarks, all filed 20 May 2026 are acknowledged.
Claims 1, 3-4, 6-12, and 14-16 are currently pending. Claims 2, 5, and 13 have been cancelled. Claims 1 and 3-4 have been amended. Claims 9-12 and 14-16 were previously withdrawn. Claims 1, 3-4, and 6-8 are examined on the merits within.
Continued Examination Under 37 C.F.R. 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 May 2026 has been entered.
Modified Rejections
Claim Rejections – 35 U.S.C. 102
3. 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.
4. Claim(s) 1 and 3 is/are again rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allen (WO88/03799).
Regarding instant claims 1 and 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. The phrase “configured to be implanted” is a future intended use of the composition. Since the combination of ingredients are the same, and Allen teaches the composition can be in the form of a suppository, i.e., inserted into the body, the composition should be capable of implantation.
Thus the instant claims are anticipated by
Claim Rejections – 35 U.S.C. 103
5. 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.
6. Claim(s) 1, 3-4 and 6-7 is/are again 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. The phrase “configured to be implanted” is a future intended use of the composition. Since the combination of ingredients are the same, and Allen teaches the composition can be in the form of a suppository, i.e., inserted into the body, the composition should be capable of implantation. In addition, it would have been obvious to formulate the composition as an implant because the composition can be safely inserted into the body as a suppository and D’Souza teach the effectiveness of using PEG in implants.
7. Claim(s) 8 is/are again 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, 3-4 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.
Response to Arguments
Applicant's arguments filed 20 May 2026 have been fully considered but they are not persuasive.
8. Applicants argued, “Allen fails to disclose or suggest a fast release implant. Instead Allen describes a composition for topical application or direct injection into tumors.”
In response to applicants’ arguments, Allen teaches the compositions can be in the form of lotions, creams and suppositories. See page 16. A suppository is “inserted” into the body. This reads on implanted. Allen teaches the same combination of ingredients and thus should function the same. Since the same combination of ingredients are directly injected into tumors, this is deemed “implanted”.
Thus this rejection is maintained.
9. Applicants argued “The mixture of PEG 400 and PEG 3350 is characterized as an ointment. An injectable or ointment are not implants that are solid at room temperature and liquid at body temperature. Ying does not remedy the deficiencies of Allen and D’Souza.”
In response to applicants’ arguments, the prior art of D’Souza was provided to make obvious the amount of each PEG with motivation to control the consistency of the composition and release rate. In addition, D’Souza teaches PEG can be used in implantable devices. See page 1270. The phrase “configured to be implanted” is a future intended use of the composition. Since the combination of ingredients are the same, and Allen teaches the composition can be in the form of a suppository, i.e., inserted into the body, the composition should be capable of implantation. In addition, it would have been obvious to formulate the composition as an implant because the composition can safely be inserted into the body as a suppository and D’Souza teach the effectiveness of using PEG in implants.
With regards to Ying, the rejection over Allen and D’Souza are maintained. Thus there are no deficiencies to cure.
Thus these rejections are maintained.
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
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