DETAILED ACTION
Any rejections and/or objections made in the previous Office action and not repeated below are hereby withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Mar. 25, 2026 has been entered.
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 .
Claim Rejections – 35 U.S.C. § 103
Claims 1-9, 11-13, and 20-26 are rejected under 35 U.S.C. § 103 as being unpatentable over US 2017/0281669 A1 (herein “Melrose”) in view of Chemical Engineering and Processing, 2008, 47(12), 2029-2050 (herein “Anxionnaz”), US Patent No. 3,257,363 (herein “Miller”) and WO 00/00875 A1 (herein “Anderson”).
As to claims 1, 5-6, 8-9, and 11: Melrose describes biologically active polymers (see the abstract). Melrose describes a process of making such a polymer (see Example 1 in ¶¶ [0124]-[0131]) comprising reacting polyethylene glycol (MW 200) with acrolein in an aqueous solution, and the temperature of the reactants was maintained between approximately 25 °C and 35 °C (see ¶ [0124]). The resulting polymer has a molecular weight of approximately 500 Daltons (see ¶ [0127]).
Melrose more generally discloses that the process described therein may include maintaining the reaction temperature in the range of from 10 °C to 40 °C (see ¶ [0077]), and this range of temperatures overlaps the presently recited range of no more than 10 °C.
Melrose does not specifically disclose an embodiment of a process performed at a temperature of 10 °C; Melrose does not disclose the use of a heat exchanger; and Melrose does not disclose computer control of the presently recited reaction parameters.
Anxionnaz discloses various aspects of heat exchangers (see the abstract). Anxionnaz discloses that removing heat generated by an exothermic reaction is necessary to control the reaction temperature and to avoid thermal runaway reactions or to suppress endothermic by-product reactions (see section 2.1 on p. 2030). Anxionnaz discloses various heat exchangers including a stirred batch reactor with a double jacket through which a cooling fluid is passed (see the right of Fig. 1 on p. 2031).
In light of the disclosure in Melrose that the reaction temperature is maintained in the range of from 10 °C to 40 °C, one of ordinary skill in the art would have been motivated to perform Melrose’s process at any temperature within the disclosed range, including at the temperature of 10 °C which fall within the scope of the presently recited range of no more than 10 °C.
In light of the disclosure in Melrose that the reaction temperature is maintained within the disclosed range, one of ordinary skill in the art would have been motivated to use well-known techniques and equipment to maintain the reaction temperature. In light of Anxionnaz, it is evident that one of ordinary skill in the art would have been apprised of the use of heat exchangers such as a double jacket heat exchanger to control reaction temperature. One of ordinary skill in the art would further have been motivated by ordinary creativity to control the adjustable parameters of the double jacket heat exchanger (stirring rate, coolant flow rate, and coolant temperature) in order to achieve the desired amount of heat exchange.
Miller describes polymerization reactor (see Fig. 1). Miller discloses a coolant jacket (see item 12) including the heat exchange medium water (see col. 2, l. 41).
Anderson describes a system for controlling temperature of a polymerization process (see the abstract). Anderson discloses that PID or PI controllers (see p. 6, ll. 4-7) are used to achieve more effective control the reactor temperature by controlling the temperature of coolant feeding a heat exchanger (see p. 6, ll. 26-29).
In light of Anxionnaz’ disclosure of a cooling fluid, one of ordinary skill in the art would have been motivated by ordinary creativity to use any well-known cooling fluid in the jacket. In light of Miler, it is evident that one of ordinary skill in the art would have been apprised of the use of water as a heat exchange medium in a polymerization reactor. One of ordinary skill in the art would therefore have been motivated to perform the process of Melrose using a stirred batch reactor with a double jacket as described in Anxionnaz, as set forth above, while using water as the cooling fluid in the jacket. In light of Anderson, one of ordinary skill in the art would have been motivated to control the temperature of the water in the jacket to achieve more effective control the reactor temperature.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the polymer of Melrose’s Example 1 using a stirred batch reactor with a double jacket, as described in Anxionnaz; to have used water as the cooling fluid in the jacket, as described in Miller; and to have used PID or PI controllers, as described in Anderson, to control the temperature of the water in the jacket to maintain the reaction at a temperature of 10 °C.
As to claim 2: The cited process of Melrose’s Example 1 includes an aqueous solution at pH 12 (see ¶ [0124]).
As to claim 3: The cited process of Melrose’s Example 1 includes an aqueous solution comprising about 38 wt% of water (see the amounts in ¶ [0124]).
As to claims 4, 7, 12-13, 20-23, and 25-26: The cited process of Melrose’s Example 1 includes adding aqueous acrolein (about 20 wt% concentration) to aqueous polyethylene glycol (pH 12, about 25 wt% water) in a weight ratio of polyethylene glycol to acrolein of 12:1 (see the amounts in ¶ [0124]); and then adjusting the pH to 7.5 with acid (see ¶ [0125]).
As to claim 24: As set forth above, Melrose discloses the maintenance of the reaction at a temperature within the range of 10 °C, and this range overlaps the presently recited range.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but it would be allowable if written in independent form.
Response to Arguments
Applicant’s arguments filed Mar. 25, 2026 (herein “Remarks”) and the accompanying Declaration have been fully considered and they are persuasive in part.
Applicant argues (item 22 of the Declaration) that Melrose does not provide any motivation to investigate a temperature lower than ambient to change the structure of the copolymer or to achieve beneficial biological properties.
With respect to the presence of a motivation in Melrose: Melrose provides adequate motivation to use a temperature of 10 °C by virtue of a disclosure of the temperature 10 °C in ¶ [0077].
With respect to the structure of the copolymer and its properties: The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. MPEP 2144(IV). One of ordinary skill in the art need not be motivated by Melrose et al. to achieve any particular structure or properties of the copolymers described therein to be motivated to use any of the reaction temperatures described by Melrose.
Applicant presents a discussion (items 35-43 of the Declaration) regarding effects drawn to S. aureus. This discussion is not accompanied by a comparison to a material prepared at 25-35 °C according to the procedure of the cited Example 1 of Melrose. This showing is therefore not adequately comparative to Melrose. MPEP 716.02(e).
Applicant presents a discussion (items 43-57, in particular items 47-50, of the Declaration) regarding results drawn to UV absorption properties. The discussion includes speculation (item 53) as to quantities of certain functional groups that may be present or absent in the polymer, but this is not an explanation of a practical or statistical significance of the UV results. The discussion does not establish that the UV absorption properties have practical or statistical significance sufficient to outweigh a prima facie case for obviousness. MPEP 716.02(b).
The results regarding minimum inhibitory concentrations (Table 2, item 46 of the Declaration) are not accompanied by a comparison to a material prepared at 25-35 °C according to the procedure of the cited Example 1 of Melrose. This showing is therefore not adequately comparative to Melrose. MPEP 716.02(e).
Applicant argues (items 55-57 of the Declaration) that the recited temperature range would include a lower limit due to the freezing point of the reaction medium. This argument does not establish with evidence that the results that occur at 10 °C would occur through the recited range of temperatures down to such a freezing point, and therefore it does not establish that the results that occur specifically at 10 °C are commensurate in scope with those across the recited range of no more than 10 °C.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD A. HUHN whose telephone number is (571)270-7345. The examiner can normally be reached Monday through Friday, 9 AM to 6 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arrie (Lanee) Reuther can be reached at (571) 270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD A. HUHN/Primary Examiner, Art Unit 1764
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