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
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/29/2026 has been entered.
Response to Amendment
Applicant’s amendment filed on 01/19/2026 wherein claim 1 is amended to recite 5% to 35% w/w is acknowledged.
Status of Claims
Claims 1-8 and 10-17 are pending in the instant application.
Claims 13-16 remain withdrawn.
Claims 1-8, 10-12 and 17 are currently under examination in this office action.
Action Summary
Applicant's Remarks filed 01/29/2026 have been fully considered. Claims 1-8, 10-12 and 17 are rejected as being unpatentable over WANG-ZHANG in view of Stogniew, Baheti and Gibson under 35 U.S.C§103. Please see response to argument in following sections.
Priority
This application 17/779,943 filed on 05/25/2022 is a 371 of PCT/EP2020/083148 filed on 11/24/2020 and claims priority of foreign Application No. EP 19211244.9 filed on 11/25/2019.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of foreign Application No. EP 19211244.9 is filed on 05/25/2022.
Information Disclosure Statement
The information disclosure statement dated 04/10/2024, 07/22/2024 fail to comply with 37 CFR 1.98(a)(3)(i) because they do not include a concise explanation of the relevance of each reference listed that is not in the English language as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information. As discussed in the interview dated 07/21/2025 and explained in last office action, the third party analysis of the non-English document is only opinion of foreign office and is NOT a substitute for a translation or partial translation of non-English Russian references required by 3 (ii) of 37 CFR 1.98. In the absence of full office action/ context and English translated reference , the relevance of Russian reference to the instant application is not illustrated/understood by the examiner, thus cannot be considered.
The information disclosure statement dated 01/29/2026 includes machine translated English copy of Russian non-patent literature. Accordingly, the reference listed in IDS are being considered by the Examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 non-obviousness.
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 1-8, 10-12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over WANG-ZHANG et al. (EP 3330251 A1, family member of WO2018100008A1 and US11021442B2), in view of Stogniew et al. ( US6407278B2) and Baheti et al. (J. Excipients and Food Chem.2010, 1(1); pp. 41-54, Applicant’s IDS dated 10/09/2025, Excipients used in lyphilization of small molecules) and Gibson et al. (EP0386960 A2).
Regarding freeze-dried powder comprising 2-[(3-aminopropyl)amino]ethanethiol for preparing a thermo-gel, WANG-ZHANG teaches a thermosensitive gel formulated from lyophilisate, freeze-dried 2-[(3-aminopropyl)amino]ethanethiol and preparation process thereof (See abstract, [0001], [0006]-[0009], Examples B/C , claims 1-15). WANG-ZHANG teaches amifostine is a phosphorylated prodrug that is converted into free active 2-[(3-aminopropyl)amino]ethanethiol (aminothiol) and preparation of aminothiol from amifostine (See [0001]-[0002], Example A). WANG-ZHANG further teaches addition of pharmaceutical excipients (e.g. poloxamer, carbohydrate, etc.) in the preparation of freeze-dried aminothiol that can be further reconstituted into stable thermogel (See [0040]-[0051], Examples B2-B5, Example C, F ).
Regarding limitation of poloxamer recited in claims 1-6, WANG-ZHANG discloses one or more poloxamers (commercial names: Pluronics®, Lutrol®, Kolliphor®) were added into the composition of 2-[(3-aminopropyl)amino]ethanethiol, wherein poloxamer 407, poloxamer 188, and mixtures thereof, are preferred (See [0038]-[0041]).
Regarding further limitation of poloxamer recited in claim 6, WANG-ZHANG explicitly teaches a mixture of poloxamer 407 and poloxamer 188 is widely used in pharmaceutical application for the thermosensitive property. The combination of the two grades of poloxamers-407 and 188 allows targeting several sol-gel temperatures transition (See [0043]). WANG-ZHANG teaches variety of embodiments comprising a mixture of poloxamer 407 and poloxamer 188 at various percentage and ratio thereof, e.g. Poloxamers P407/P188 21/4 w/w with a final gel comprising 50mg/ml of aminothiol (See Example B2 to B5, [0072]-[0086], Example F).
Regarding the carbohydrate compound and percentage thereof, WANG-ZHANG teaches embodiments comprising various amount of Kleptose HPB, e.g. 3.4%, 10%, etc. (See Gel Formulation F). Please note Kleptose HPB is modified beta-cyclodextrin, cyclic oligosaccharides composed of glucose units linked together, thus considered as a carbohydrate.
Regarding the amount/percentage limitation of 2-[(3-aminopropyl)amino]ethanethiol and poloxamers recited in claims 1-4, WANG-ZHANG teaches 80 mg/mL amifostine is equivalent to 50 mg/mL aminothiol using molecular ratio and embodiments (See Example B and F), wherein amifostine 80 mg/ml converted in aminothiol (50mg/mL) in combination with Kleptose HPB 3.4%, HCI 1M 19.5%, Kolliphor P407 11.6%, Kolliphor P188 20.8% that can be reconstituted with 44.7% water into aminothiol gel (See Example F1, [0120]). The weight percentage of 50mg/mL of aminothiol in the freeze-dried powder before reconstitution would be about 5%.
WANG-ZHANG teaches embodiments comprising various amount of aminothiol (i.e.2-[(8- aminopropyl)amino]ethanethiol) and salt thereof converted from 80- 500mg/mL of amifostine, diluted/ mixed with poloxamer(s) and/or water to 50mg/ml of aminothiol (See [0021], Example B1-7 etc.). For example, 5g of aminothiol (i.e.10ml of aminothiol at 500mg/ml ) diluted with 90g of poloxamers (approximately 90ml, the density of Poloxamer 407 is approximately 1.018 g/mL at 25 °C, the density of Poloxamer 188 is approximately 1.06 g/cm³ at 70°C ) in Example B2/B3 would provide 100ml of aminothiol at 50mg/mL, wherein the weight percentage of aminothiol would be about 5.2%(=5/95) and the weight percentage of poloxamers P407/P188 would be about 95% (=90/95) in absence of other ingredients. WANG-ZHANG also teaches the aminothiol solution might comprise other ingredients(e.g. pH adjusting agent, flavoring agent, Kleptose HPB, etc.)(See [0027], [0031]). 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. MPEP 2144.05.
Regarding flavoring agent and sweetener limitation of instant claim 12, WANG-ZHANG teaches the freeze-dried aminothiol contains a mint flavor, a bitter masker and water, preferably in the following respective amounts: 4%, 0.05% and 95.95% w/w/w (See [0052],[0096]).
Regarding the overall framework of production process of the freeze-dried aminothiol, WANG-ZHANG teaches variety of freeze- drying process (See Example B1- B7) and thermogel formulation/ reconstitution process(See Example C, F). For example, a solution of amifostine at 500mg/ml is firstly converted totally into aminothiol in hydrochloric acid 4M during 1 hour at 60°C (based on Example A-2). After conversion, the solution is diluted into Poloxamers P407/P188 21/4 w/w to obtain a final gel at 50mg/ml expressed in aminothiol. Then 2ml are distributed in glass vial for lyophilization (See Example B-2, [0072]). WANG-ZHANG also teaches 0.2% of polysorbate 80 as cryoprotectant in the 50mg/mL of aminothiol before lyophilization(See Example B-5).
WANG-ZHANG collectively teaches freeze-dried 2-[(3-aminopropyl)amino]ethanethiol comprising poloxamer (e.g. Kolliphor P407 and Kolliphor P188), carbohydrate (Kleptose HPB), flavoring agent and sweetener at various amount/percentage that can be further reconstituted into stable thermogel. WANG-ZHANG teaches the stability of free-dried powder at 25°C/60%RH after 1 month wherein less than 2% of impurities have been detected in all tested aminothiol formulations and this value remained stable (See [0099]- [0101])
The major difference between WANG-ZHANG and instant application is the carbohydrate: Kleptose HPB versus sugar (e.g. sorbitol, mannitol, etc.).
Stogniew teaches a thermo-stable lyophilized dosage form of amifostine comprising carbohydrates (e.g. mannitol, sorbitol, dextrose, sucrose, inositol, etc.), method of preparation thereof and use thereof. Stogniew teaches dosage form of amifostine may comprise suitable stabilizer/excipient, e.g. carbohydrates( mannitol, sorbitol, dextrose, sucrose, inositol, etc.) that maybe added before, during or after lyophilization of bulk amifostine (See Col. 5, lines 3-5; Col. 12, lines 25-31; claim 11). Stogniew explicitly teaches stabilized amorphous form embodiments comprising mannitol lyophilized from about 5 ml of a solution of 100 mg/ml amifostine and 100 mg/ml mannitol, that are stable for parental administration (See Col. 2, lines 52-67).
Baheti reviews excipients used in lyophilization of small molecules (See whole article). Baheti explicitly teaches carbohydrate excipients (e.g. sorbitol, mannitol, dextrose, sucrose, etc.) as bulking agent in variety of active drugs (See Table 1 and 2). Baheti lists Ethylol@ lyophilized formulation in Table 1. Baheti and its incorporated reference teaches mannitol is one of the most commonly used bulking agents, followed by glucose, sucrose, lactose, trehalose and dextran, and moisture containing cake showed better stability with mannitol, than with lactose as bulking agent (See page 45, left column).
Gibson teaches use of a hydroxy- or polyhydroxy-compound (e.g. mannitol, sorbitol, etc.) in gel composition enhances the gel strength, lowers the sol-gel transition temperature, and increases the physical stability of gel composition comprising poloxamers (e.g. Pluronic F127) as gelling agent in high quantities (1-30% w/w) for drug delivery of active agents (See page 9, lines 14-20; page 12, lines 1-3; page 14, lines 39-41). Gibson teaches the preferred stabilizing agent sorbitol in amounts of from 0.5% to 20%, more preferably from 1 % to 10% by weight of the composition in combination with poloxamer (e.g. Pluronic F127) (See page 9, lines 14-20; Examples 1-10, claims 21, 35). Gibson teaches compositions comprising sorbitol, poloxamer and unstable agents as freeze-dried powder which is reconstituted as gel before use for the delivery of unstable agents (See Example 4).
It would have been prima facie obvious for one of ordinary skilled in the art before the effective filing date of instant claimed invention to modify the freeze-dried 2-[(3-aminopropyl)amino]ethanethiol (aminothiol) comprising poloxamers and carbohydrate taught by WANG-ZHANG by incorporating/substituting carbohydrate excipient Kleptose HPB with sugar (e.g. sorbitol, mannitol) taught by Stogniew, Baheti and Gibson, and further explore the optimal range of ingredients and process steps based on the general knowledge of lyophilized formulation. At the time when instantly claimed invention was filed, it was already known a freeze-dried 2-[(3-aminopropyl)amino]ethanethiol (aminothiol) formulation comprising poloxamers and carbohydrate can be prepared and further formulated into thermogel as taught by WANG-ZHANG. It was also known that sugar (e.g. mannitol, sorbitol) can be used in the freeze-dried dosage form of amifostine as taught by Stogniew. Baheti and its incorporated reference teaches mannitol is one of the most commonly used bulking agents and can stabilize active ingredient. Gibson explicitly teaches sorbitol and mannitol in combination with poloxamers (e.g. Pluronic F127) enhances the gel strength, lowers the sol-gel transition temperature, and increases the physical stability of gel composition for drug delivery of active agents.
The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to explore/optimize a disclosed set of components and percentage ranges thereof to achieve the optimum combination of components and percentages thereof. As stated in MPEP 2144.05 II : " Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [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). The combined teachings of prior art, together with experimentation /optimization based on the general knowledge of lyophilized formulation would provide a stable freeze-dried 2-[(3-aminopropyl)amino]ethanethiol (aminothiol) comprising poloxamers and sugar (e.g. sorbitol, mannitol) with better thermo-stability that overcome the stability problem of 2-[(3-aminopropyl)amino]ethanethiol (aminothiol).
As stated in MPEP 2144.05, " It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with experimentation/ optimization based on general knowledge of lyophilized powder formulation for thermos-gel. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues the present invention is intended to be an improvement over Wang-Zhang, presence of the carbohydrate compound and its effect on the stability as shown in Tables 4, 5 and 6, addition of carbohydrate compound, in particular mannitol (see LP2) in freeze-dried composition is beneficial to reconstitution(Remarks, page 5-6).
RESPONSE: The examiner noted instant application is a modification/optimization of Wang-Zhang.
Wang-Zhang is the closest prior art that discloses freeze-dried 2-[(3-aminopropyl)amino]ethanethiol comprising poloxamer (e.g. Kolliphor P407 and Kolliphor P188), carbohydrate (Kleptose HPB), flavoring agent and sweetener at various amount/percentage that can be further reconstituted into stable thermogel. Wang-Zhang already teaches Kleptose HPB as carbohydrate and teaches the stability of free-dried powder at 25°C/60%RH after 1 month wherein less than 2% of impurities have been detected in all tested aminothiol formulations and this value remained stable (See [0099]- [0101]). To show improvement of instant application over Wang-Zhang, instant LP1 and LP2 should be compared with freeze-dried powder comprising carbohydrate Kleptose HPB as taught by Wang-Zhang. It’s noted the reference freeze-dried powder used in instant application does not contain carbohydrate compound. Thus, Applicant’s argument is not persuasive.
More importantly, as stated in MPEP 716.02(d): “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”. Please note the stability of instant LP1 and LP2 embodiment are the result of specific combination of active ingredient, and inactive ingredients, Kolliphor P407, Kolliphor P188, mannitol or sorbitol at specific concentration. Instant claim are directed to freeze-dried powder genus comprising 2-[(3-aminopropyl)amino]ethanethiol comprising and 0.1%-20% carbohydrate/sugar genus. As such, the alleged unexpected/improved result based on LP1/ LP2 comprising specific amount of mannitol or sorbitol do not commensurate with the scope of instant claims.
Further, the major difference between WANG-ZHANG and instant application is the carbohydrate: Kleptose HPB versus sugar (e.g. sorbitol, mannitol, etc.). As stated in MPEP 2144.05, " It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In instant case, mannitol (or sorbitol) is considered as substitution of carbohydrate Kleptose HPB taught by Wang-Zhang. It would have been prima facie obvious for a POSA to modify the freeze-dried 2-[(3-aminopropyl)amino]ethanethiol (aminothiol) powder comprising poloxamers and carbohydrate by substituting/modifying carbohydrate Kleptose HPB with mannitol (or sorbitol) because mannitol is commonly used bulking agent for freeze-dried powder which can stabilize active ingredient as taught by Baheti and Stogniew.
Applicant argues extensively about the calculation of active and inactive ingredients, and the percentage of amifostine thiol should be 4.86% or below 5% (Remarks, page 6-9).
RESPONSE: Wang-Zhang explicitly teaches the final composition comprising amifostine thiol 50mg/ ml which is about 5%. The calculation of amount/percentage active and inactive ingredients is rounded up to further illustrated teachings of Wang-Zhang is closely related with instant application whether amifostine thiol is 5% or 4.86% as Applicant argues . As stated in MPEP 2144.05 II : " Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [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).
Applicant argues again about Stogniew: “Stogniew relates to a composition comprising amifostine, not amifostine-thiol as in the present invention. One of the purposes of Stogniew is to provide composition avoiding "degradation" of amifostine into "amifostine-thiol"…although Stogniew discloses as excipients, they are particularly tailored for use with amifostine. Furthermore, Stogniew relates to a composition adapted for IV injection, not for topical application. Nor does Stogniew disclose or suggest possible use of a thermogel (Remarks, page 9).
RESPONSE: As explained in last office action mailed on 10/29/2025 , amifostine taught by Stogniew is a prodrug that can be converted into 2-[(3-aminopropyl)amino]ethanethiol (aminothiol). Stogniew teaches lyophilized dosage form of amifostine comprising carbohydrate excipients (e.g. dextrose, sucrose, sorbitol, etc.). Stogniew explicitly teaches stabilized amorphous form embodiments comprising mannitol lyophilized from solution. A skilled artisan would refer to Stogniew for excipients that could be used in the freeze-dried powder of aminothiol. Please also note instant claims are product claims wherein the intended use of the product for preparing topical thermo-gel or IV injection does not necessarily contribute to the structural limitation of product. Once the freeze-dried powder is formed, a skilled artisan would know to further reconstitute the freeze-dried powder into solution or gel for desired purpose.
Applicant repeatedly argues “Compositions disclosed in Gibson are thermo-gel compositions and are in liquid form… Gibson does not teach that mannitol or sorbitol may be used to stabilize freeze-dried powder when combined with a poloxamer, but only that this may be used to stabilize a gel forming solution (Remarks, page 10).
RESPONSE: Instant freeze-dried powder are recited for thermos-gel preparation. For unstable active ingredients, Gibson teaches embodiments supplied as a freeze-dried powder for reconstitution before topical administration (See Example 4). A skilled artisan would know the combination of mannitol or sorbitol and a poloxamer could be formulated into freeze powder then reconstituted into thermo-gel. The function of excipient is the property of excipient no matter it’s in powder or gel. Gibsons is a reference teaching use of carbohydrate excipient as a delivery vehicle for active agents. Gibon is NOT a 102 reference that requires teaching all the elements of instant composition.
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 1-8, 10-12 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No.11,021,442 B2, in view of WANG-ZHANG et al. (EP 3330251 A1) and Gibson et al. (EP0386960 A2 ).
Reference claims are directed to a process of preparing freeze-dried 2-[(3-aminopropyl)amino]ethanethiol wherein reference claim 10 recites addition of an aqueous solution comprising at least one poloxamer into the solution of 2-[(3-aminopropyl)amino]ethanethiol in the freeze-drying process. Reference claim 11 explicitly recites the lyophilisate of 2-[(3-aminopropyl)amino]ethanethiol obtained according to the process of reference claim 1.
Reference claims are silent about carbohydrate compounds. The collective teachings of WANG-ZHANG and Gibson are elaborated in preceding 103 rejection and applied as before. WANG-ZHANG collectively teaches freeze-dried 2-[(3-aminopropyl)amino]ethanethiol (aminothiol) comprising poloxamer (e.g. Kolliphor P407 and Kolliphor P188), carbohydrate (Kleptose HPB), flavoring agent and sweetener at various amount/percentage that can be further reconstituted into stable thermos-gel. Gibson teaches sorbitol and mannitol in combination with poloxamers enhances the gel strength, lowers the sol-gel transition temperature, and increases the physical stability of gel composition for drug delivery of active agents.
It would have been prima facie obvious for one of ordinary skilled in the art to modify the freeze-dried 2-[(3-aminopropyl)amino]ethanethiol (aminothiol) comprising poloxamers taught by reference claims by incorporating carbohydrate compound taught by WANG-ZHANG and Gibson, together with further experimentation/ optimization based on general knowledge of lyophilized powder formulation for thermos-gel. A skilled artisan would be motivated to combine reference claims with WANG-ZHANG and Gibson, because the combined teachings of reference claims and prior art, together with experimentation /optimization based on the general knowledge of lyophilized formulation and thermos-gel formulation would provide a stable freeze-dried 2-[(3-aminopropyl)amino]ethanethiol (aminothiol) comprising poloxamers and sugar (e.g. sorbitol, mannitol) with better stability for preparing thermogel with enhanced gel strength.
The instant application shares one common inventor/applicant with the reference patent. Based on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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, Amy L Clark can be reached on (571)272-1310. 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.
/LIYUAN MOU/ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
Prosecution Insights