RESPONSE TO AMENDMENT
WITHDRAWN REJECTIONS
The 35 U.S.C. §112 rejection of the claim 61 made of record in the office action mailed on 01/22/2026 have been withdrawn due to Applicant’s amendment in the response filed 04/01/2026.
The 35 U.S.C. §102 and 103 rejections of the claims made of record in the office action mailed on 01/22/2026 have been withdrawn due to Applicant’s amendment in the response filed 04/01/2026.
REJECTIONS
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
Claims 46-50, 53-60 and 62-65 are rejected under 35 U.S.C. 103 as obvious over Berkland et al. (U.S. App. Pub. No. 2017/0209483) in view of Hebimi et al. (JP 2004-097927).
Citations to Hebimi et al., below, refer to the machine translation document provided with this office action.
Regarding claim 46, Berkland et al. discloses a polymeric metal sequestrant based on a polyamine polymer covalently coupled to a chelator. (Abstract). The polymeric material is therefore a “chelator” as presently claimed and the chelator is coupled to the polyamine via the primary and/or secondary amines in the polyamine backbone chain as shown Fig. 1, wherein the DHBA portion is bonded to the NH moiety. Furthermore, the polyamine polymer backbone is disclosed to be crosslinked (Fig. 1 and claim 1).
Berkland et al. teaches an inventive example wherein the polymeric material is shaped in the form of particles having diameters of 100 micrometers. (par. [0081]). Berkland et al. does not teach that 90% of the particles have diameters of 100 micrometers or less as measured by laser diffraction, as claimed.
Hebimi et al. teaches a powdered heavy metal immobilization agent including a porous carrier and an organic chelating agent carried by the carrier. (Abstract and par. [0030]). Examples of chelating agents include polyamine compounds (par. [0040]) and the powdered immobilization agent is disclosed to have a diameter in the range of 1-200 micrometers by laser diffraction from the standpoint of effectively trapping heavy metals and preventing release thereof. (par. [0043]).
It would have been obvious to one of ordinary skill in the art to shape the particles of Berkland et al. into a size in the range of 1-200 micrometers as measured by laser diffraction, as taught by Hebimi et al., overlapping with the presently claimed range of 100 micrometers or less.
One of ordinary skill in the art would have found it obvious to have the particle size lie in the range disclosed Hebimi et al. in view of the teachings regarding improved heavy metal trapping and release prevention which would be reasonable expected in the polymeric heavy metal chelating materials taught in Berkland et al. As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, 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).
Regarding claims 47-50, the claims are rejected for substantially the same reasons as claim 46 regarding the anticipation or obviousness of the claimed range.
Regarding claims 53-55, the polyamine polymer includes backbone monomer units of PAI (Fig. 1) which meet the first structure where L1 is C1 and R is H. Other polymers include polyethylenimine which meets the 2nd structure and poly-L-lysine which meets the 3rd structure. (see Fig. 25).
Regarding claims 56-59, the crosslinking agent used includes N,N’-methyelenbisacrylamide (par. [0018], [0056], [0079]) resulting in the structure as shown in claim 58. (Fig. 1)
Regarding claim 60, Berkland et al. discloses a crosslinking density of 5%. (par. [0091]).
Regarding claims 62-65, Berkland et al. discloses using dihydroxybenzoic acid as the chelator which includes a vicinal diol and would have the structure as claimed in claim 65. (see Fig. 1)
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Berkland et al. (U.S. App. Pub. No. 2017/0209483) in view of Klipper et al. (U.S. App. Pub. No. 2004/0082744).
Berkland in view of Hebimi et al. is relied upon as described in the rejection of claim 46, above.
Berkland et al. does not disclose a particle diameter in the range claimed in claim 51.
Klipper et al. teaches a processed for making monodisperse ion exchangers having chelating functional groups for binding heavy and noble metals. (Abstract). Klipper et al. teaches that the ion exchanging material may have particle diameters in the range of 10-1000 micrometers. (par. [0037]).
It would have been obvious to one of ordinary skill in the art to make polymeric particle diameters in Berkland et al. in the range of 10-100 micrometers as disclosed in Klipper et al., overlapping with the presently claimed range.
One of ordinary skill in the art would have found it obvious to make the polymeric chelating agent particles of Berkland et al. in the range of 10-1000 micrometers in view of the teachings in Klipper et al. that the range disclosed in suitable for use in a monodisperse ion exchanging material. One of ordinary skill in the art would therefore have a reasonable expectation of success of selecting particle diameters in the range of 10-1000 micrometers would result in the ability to use the polymer particles of Berkland et al. as ion exchanging material for binding heavy and noble metals. The selection of a known material based on its suitability for its intended purpose is prima facie obvious. MPEP 2144.07.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Berkland et al. (U.S. App. Pub. No. 2017/0209483) in view of Holbein et al. (U.S. Pat. No. 10,709,784).
Berkland in view of Hebimi et al. is relied upon as described in the rejection of claim 46, above.
Berkland et al. does not disclose an average molecular weight of 1-50 kDa for the polyamine polymer.
Holbein et al. teaches metal chelating compositions which are soluble in aqueous media. (Abstract). Holbein et al. teaches that the metal chelating composition includes a polymeric material having a molecular weight below 1500 Daltons (i.e. 1.5 kDa) for the purpose of being sufficiently small that they can be internalized within yeast cells and for adjusting the water solubility thereof (col. 45, lines 49-67). Molecular weights in the range of 1kDa or more is useful from a standpoint of being anti-microbial and inhibitory for yeast cells. (col.47, lines 51-67).
It would therefore have been obvious to one of ordinary skill in the art to select a polymer molecular weight in the range of 1 kDa or more for the metal chelating polymer material disclosed Berkland et al.
One of ordinary skill in the art would have found it obvious to optimize the molecular weight of the polymer disclosed in Berkland et al. for the purpose of controlling the water solubility aspects thereof as well as being able to be absorbed within cell membranes of microbes for inhibiting the growth thereof.
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Berkland et al. (U.S. App. Pub. No. 2017/0209483) in view of Hoare et al. (Hydrogels in drug delivery: Progress and Challenges, Polymer 19 (2008), 1993-2007).
Berkland in view of Hebimi et al. is relied upon as described in the rejection of claims 46 and 60, above.
Berkland et al. does not disclose a crosslinking density of less than or equal to 1% as claimed.
Hoare et al. teaches hydrogels used as water soluble drug delivery mechanisms. (Abstract). Hydrogels are known three-dimensional cross-linked networks (page 1993, left col.) and the control of the crosslinking density affects the porous structure (page 2002, left col), degree of swelling and elastic properties thereof. (page 2002, left col.).
Since the instant specification is silent to unexpected results, the specific crosslinking density of polymer composition is not considered to confer patentability to the claims. In view of the disclosure of Hoare et al. regarding the well-known effects that crosslinking density has on the structure and mechanical properties of a hydrogel, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the crosslinking density of the polymer material disclosed in Berkland et al. to obtain the desired porosity, swelling degree and elastic properties thereof (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Claims 66-67 are rejected under 35 U.S.C. 103 as obvious over Berkland et al. (U.S. App. Pub. No. 2017/0209483) in view of Hebimi et al. (JP 2004-097927), further in view of Ma et al. (U.S. App. Pub. No. 2017/225969).
Berkland in view of Hebimi et al. is relied upon as described in the rejection of claim 46, above.
Berkland does not disclose the specific surface area of the polymeric metal sequestrant.
Ma et al. teaches porous organic polymer compositions for binding heavy metals via a chelating agent moiety. (Abstract). Ma et al. teaches that the compositions should have a surface area of greater than 20 m2/g (i.e. 2000 m2/g). (Abstract and par. [0021], [0054]).
It would have been obvious to one of ordinary skill in the art to adjust the surface area of the polymeric metal sequestrant in Berkland et al. such that it would have a surface area in the range taught by Ma et al.
One of ordinary skill in the art would have found it obvious to adjust the surface area of the particles to lie in the range of 20 m2/g, overlapping with the presently claimed rage, in order to improve the amount of surface area with a solution or liquid containing the heavy metal material intended to be bound by the polymeric metal sequestrant of Berkland et al., thereby resulting in a more effective chelating agent.
ANSWERS TO APPLICANT’S ARGUMENTS
Applicant’s arguments in the response filed 04/01/2026 regarding the rejections made of record in the previous office action have been considered but are moot due to the new grounds of rejection.
Conclusion
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.
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/ALEXANDRE F FERRE/Primary Examiner, Art Unit 1788 05/28/2026
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