DETAILED ACTION
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 .
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 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,907,880 (hereafter ‘880) in view of Constant et al. (WO 2012/145431).
Regarding claims 1 and 6, ‘880 claims an embolic composition containing polymeric particles including at least one macromer and at least one monomer. (claim 1).
‘880 does not claim the amount of derivatized macromer.
Constant et al. discloses an embolic device which is made of radiopaque hydrogel filaments (i.e. polymer particles) comprises an ethylenically unsaturated shapeable macromer, an ethylenically unsaturated monomer and a radiopaque element. (Abstract). The monomers may include those other than n-isopropyl acrylamide. (par. [0035]). The macromer is derivatized and included in amounts in the range of 5-50% w/w from a mechanical standpoint. (par. [0030] and [0033]).
It would have been obvious to one of ordinary skill in the art to include the macromer content for ‘880 in the amount disclosed in Constant et al. for adjusting the mechanical properties to compositions including the claimed macromer to yield an improved product.
Regarding claims 2-3, ‘880 claims a polyethylene glycol diacrylamide, diacrylate, dimethacrylate or dimethacrylamide. (claim 1).
Regarding claim 4, ‘880 does not claim PEG-diacrylamide 10,000.
Constant et al. discloses that the preferred macromer is poly(ethylene) glycol diacrylamide 10,000. (par. [0034]).
It would have been obvious to one of ordinary skill in the art to use PEG-diacrylamide 10,000 as the macromer in view of the disclosure that PEG-diacrylamide 10,000. is a preferred macromer for an embolic device composition, which would imply a material having improved properties.
Regarding claim 5, ‘880 claims a particle size of 50-1500 micrometers, overlapping with the presently claimed range. (claim 1).
Regarding claim 7, ‘880 claims a polyethylene glycol diacrylamide, diacrylate, dimethacrylate or dimethacrylamide. (claim 1).
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,907,880 (hereafter ‘880) in view of Constant et al. (WO 2012/145431), further in view of Um et al. (U.S. App. Pub. No. 2003/0124371).
‘880 in view of Constant et al. is relied upon as described in the rejection of claim 1, above.
‘880 in view Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8.
Um et al. teaches a water-swellable hydrophobic hydrogel and analytical devices containing the hydrogel. (Abstract). Um et al. teaches that the hydrogel can include hydrophobic and hydrophilic moieties for adjusting the water swellability of the hydrogel and the content of the hydrophilic monomers should be 50-100% of the polymer and includes monomers such as glycerol methacrylate. (par. [0068]).
It would have been obvious to one of ordinary skill in the art to include glycerol methacrylate as a hydrophilic monomer in the macromer composition in ‘880.
One of ordinary skill in the art would have found it obvious to include glycerol methacrylate in the macromer of ‘880 in order to adjust the water swelling properties of the macromer material of ‘880.
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).
Claims 8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,907,880 (hereafter ‘880) in view of Constant et al. (WO 2012/145431), further in view of Scognamillo et al. (Thermoresponsive Super Water Absorbent Hydrogels Prepared by Frontal Polymerization of N-Isopropyl Acrylamide and 3-Sulfopropyl Acrylate Potassiun Salt, Journal of Polymer Science Part A: Polymer Chemistry, Vol. 49, 1228-1234 (2011).
‘880 in view Constant et al. is relied upon as described in the rejection of claim 1, above.
‘880 in view of Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8.
Scognamillo et al. teaches a water absorbent polymer hydrogel composition made by copolymerizing N-isoproply acrylamide and 3-sulfopropylacrylate potassium salt (SAPK) and N,N’-methylene-bis-acrylamide as a crosslinker. (Abstract). The compositon is used as polymer composition for drug release system. (page 1229, left col.) Scognamillo et al. teaches that the monomer ratio of SPAK to other components affects the swelling ratio of the hydrogel and generally ranges from 100 mol% or less relative to NIPAAm (page 1229, Table 1).
It would have been obvious to one of ordinary skill in the art to use 3-sulfopropylacrylate a monomer in the macromer hydrogel taught in‘880.
One of ordinary skill in the art would have found it obvious to use 3-sulfopropylacrylate as it known in the art to dramatically influence the swelling ratio of the polymer hydrogel. (page 1230, left col). Furthermore, based on the explicit teaching in Scognamillo et al. that the content thereof in the polymer is a result effective variable for adjusting the swelling ratio, 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 amount of 3-sulforpopyl acrylate as a weight basis in ‘880 (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 8 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,907,880 (hereafter ‘880) in view of Constant et al. (WO 2012/145431), further in view of Chudzik et al. (U.S. Pat. No. 6,007,833).
‘880 in view Constant et al. is relied upon as described in the rejection of claim 1, above.
‘880 in view of Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8.
Constant et al. does disclose that the monomers may include pH sensitive monomers in an amount of 1-12.5% and include aminomethacrylamide and derivatives thereof. (par. [0035]).
Chudzik et al. teaches a crosslinkable macromer including polymer pendant polymerizable and initiator groups. (Abstract). Chudzik et al. teaches that the reactive polymerizable groups can be introduced into the macromer using monomers including aminopropylmethacrylamide (APMA). (col. 5, lines 54-67).
It would have been obvious to one of ordinary skill in the art to use aminopropylmethacrylamide as the pH sensitive monomer in ‘880 in view of Constant et al.in the same amount as disclosed in Constant et al., thereby overlapping with the presently claimed range. 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).
One of ordinary skill in the art would have found it obvious to use aminopropylmethacrylamide in view of the teachings in Constant et al. that amino methacrylate derivatives may be selected and Chudzik et al. advantageously teaching the use of a polymer hydrogel having aminopropylmethacrylamide derived reactive groups for providing reactive groups to alter the physical and chemical properties of a macromer composition.
Claims 8 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,907,880 (hereafter ‘880) in view of Constant et al. (WO 2012/145431), further in view of Song et al. (U.S. App. Pub. No. 20100297155).
‘880 in view of Constant et al. is relied upon as described in the rejection of claim 1, above.
‘880 in view of Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8. Constant et al. does disclose that the monomers may include pH sensitive monomers in an amount of 1-12.5% and include amino methacrylate and derivatives thereof. (par. [0035]).
Song et al. teaches a phosphazene based polymer hydrogel material (Abstract) which further contains aminoethylmethacrylate groups which are useful for the purpose of forming crosslinks in the hydrogel. (par. [0494]). Song et al. further teaches that the content of the aminoethylmethacrylate group can be adjusted to increase the pore size in the hydrogel material for use as a drug delivery carrier. (par. [0495]).
It would have been obvious to one of ordinary skill in the art to use aminoethylmethacrylate as the pH sensitive monomer in ‘880 in view of Constant et al.in the same amount as disclosed in Constant et al., thereby overlapping with the presently claimed range. 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).
One of ordinary skill in the art would have found it obvious to use aminoethylmethacrylate in view of the teachings in Constant et al. that amino methacrylate derivatives may be selected and Song et al. advantageously teaching the use of a polymer hydrogel having aminoethylmethacrylate groups for crosslinking sites and to control the pore size of the hydrogel material.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,201,632 (hereafter ‘632) in view of Constant et al. (WO 2012/145431).
Regarding claims 1 and 6, ‘632 claims a polymer particle including a monomer having a functional group and crosslinker. (claim 1).
‘632 does not claim a derivatized macromer in an amount of 15-50% w/w.
Constant et al. discloses an embolic device which is made of radiopaque hydrogel filaments (i.e. polymer particles) comprises an ethylenically unsaturated shapeable macromer, an ethylenically unsaturated monomer and a radiopaque element. (Abstract). The monomers may include those other than n-isopropyl acrylamide. (par. [0035]). The macromer is derivatized and included in amounts in the range of 5-50% w/w from a mechanical standpoint. (par. [0030] and [0033]).
It would have been obvious to one of ordinary skill in the art to include the macromer content for ‘632 in the amount disclosed in Constant et al. for adjusting the mechanical properties to compositions including the claimed macromer to yield an improved product.
Regarding claims 2-4, Constant et al. discloses that the macromer is a poly(ethylene glycol), poly(propylene glycol) or poly(tetramethylene oxide). (par. [0030]). Constant et al. discloses that the preferred macromer is poly(ethylene) glycol diacrylamide 10,000. (par. [0034]).
It would have been obvious to one of ordinary skill in the art to use PEG-diacrylamide 10,000 as the macromer in view of the disclosure that PEG-diacrylamide 10,000. is a preferred macromer for an embolic device composition, which would imply a material having improved properties.
Regarding claim 5, ‘632 claims the polymer particle has a diameter of 40-1200 micrometers. (claim 2).
Regarding claim 7,’632 claims that the monomer includes an acrylamide. (claim 13).
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,201,632 (hereafter ‘632) in view of Constant et al. (WO 2012/145431), further in view of Um et al. (U.S. App. Pub. No. 2003/0124371).
‘632 in view of Constant et al. is relied upon as described in the rejection of claim 1, above.
‘632 in view Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8.
Um et al. teaches a water-swellable hydrophobic hydrogel and analytical devices containing the hydrogel. (Abstract). Um et al. teaches that the hydrogel can include hydrophobic and hydrophilic moieties for adjusting the water swellability of the hydrogel and the content of the hydrophilic monomers should be 50-100% of the polymer and includes monomers such as glycerol methacrylate. (par. [0068]).
It would have been obvious to one of ordinary skill in the art to include glycerol methacrylate as a hydrophilic monomer in the macromer composition in ‘632.
One of ordinary skill in the art would have found it obvious to include glycerol methacrylate in the macromer of ‘632 in order to adjust the water swelling properties of the macromer material of ‘632.
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).
Claims 8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,201,632 (hereafter ‘632) in view of Constant et al. (WO 2012/145431), further in view of Scognamillo et al. (Thermoresponsive Super Water Absorbent Hydrogels Prepared by Frontal Polymerization of N-Isopropyl Acrylamide and 3-Sulfopropyl Acrylate Potassiun Salt, Journal of Polymer Science Part A: Polymer Chemistry, Vol. 49, 1228-1234 (2011).
‘632 in view Constant et al. is relied upon as described in the rejection of claim 1, above.
‘632 in view of Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8.
Scognamillo et al. teaches a water absorbent polymer hydrogel composition made by copolymerizing N-isoproply acrylamide and 3-sulfopropylacrylate potassium salt (SAPK) and N,N’-methylene-bis-acrylamide as a crosslinker. (Abstract). The compositon is used as polymer composition for drug release system. (page 1229, left col.) Scognamillo et al. teaches that the monomer ratio of SPAK to other components affects the swelling ratio of the hydrogel and generally ranges from 100 mol% or less relative to NIPAAm (page 1229, Table 1).
It would have been obvious to one of ordinary skill in the art to use 3-sulfopropylacrylate a monomer in the macromer hydrogel taught in ‘632.
One of ordinary skill in the art would have found it obvious to use 3-sulfopropylacrylate as it known in the art to dramatically influence the swelling ratio of the polymer hydrogel. (page 1230, left col). Furthermore, based on the explicit teaching in Scognamillo et al. that the content thereof in the polymer is a result effective variable for adjusting the swelling ratio, 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 amount of 3-sulforpopyl acrylate as a weight basis in ‘880 (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 8 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,201,632 (hereafter ‘632) in view of Constant et al. (WO 2012/145431), further in view of Chudzik et al. (U.S. Pat. No. 6,007,833).
‘632 in view Constant et al. is relied upon as described in the rejection of claim 1, above.
‘632 in view of Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8.
Constant et al. does disclose that the monomers may include pH sensitive monomers in an amount of 1-12.5% and include aminomethacrylamide and derivatives thereof. (par. [0035]).
Chudzik et al. teaches a crosslinkable macromer including polymer pendant polymerizable and initiator groups. (Abstract). Chudzik et al. teaches that the reactive polymerizable groups can be introduced into the macromer using monomers including aminopropylmethacrylamide (APMA). (col. 5, lines 54-67).
It would have been obvious to one of ordinary skill in the art to use aminopropylmethacrylamide as the pH sensitive monomer in ‘880 in view of Constant et al.in the same amount as disclosed in Constant et al., thereby overlapping with the presently claimed range. 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).
One of ordinary skill in the art would have found it obvious to use aminopropylmethacrylamide in view of the teachings in Constant et al. that amino methacrylate derivatives may be selected and Chudzik et al. advantageously teaching the use of a polymer hydrogel having aminopropylmethacrylamide derived reactive groups for providing reactive groups to alter the physical and chemical properties of a macromer composition.
Claims 8 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,201,632 (hereafter ‘632) in view of Constant et al. (WO 2012/145431), further in view of Song et al. (U.S. App. Pub. No. 20100297155).
‘632 in view of Constant et al. is relied upon as described in the rejection of claim 1, above.
‘632 in view of Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8. Constant et al. does disclose that the monomers may include pH sensitive monomers in an amount of 1-12.5% and include amino methacrylate and derivatives thereof. (par. [0035]).
Song et al. teaches a phosphazene based polymer hydrogel material (Abstract) which further contains aminoethylmethacrylate groups which are useful for the purpose of forming crosslinks in the hydrogel. (par. [0494]). Song et al. further teaches that the content of the aminoethylmethacrylate group can be adjusted to increase the pore size in the hydrogel material for use as a drug delivery carrier. (par. [0495]).
It would have been obvious to one of ordinary skill in the art to use aminoethylmethacrylate as the pH sensitive monomer in ‘632 in view of Constant et al.in the same amount as disclosed in Constant et al., thereby overlapping with the presently claimed range. 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).
One of ordinary skill in the art would have found it obvious to use aminoethylmethacrylate in view of the teachings in Constant et al. that amino methacrylate derivatives may be selected and Song et al. advantageously teaching the use of a polymer hydrogel having aminoethylmethacrylate groups for crosslinking sites and to control the pore size of the hydrogel material.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,546,236 (hereafter ‘236) in view of Constant et al. (WO 2012/145431).
Regarding claims 1 and 6, ‘236 claims a polymer particle including a monomer having a functional group and a crosslinker. (claim 1).
‘236 does not claim a derivatized macromer in an amount of 15-50% w/w.
Constant et al. discloses an embolic device which is made of radiopaque hydrogel filaments (i.e. polymer particles) comprises an ethylenically unsaturated shapeable macromer, an ethylenically unsaturated monomer and a radiopaque element. (Abstract). The monomers may include those other than n-isopropyl acrylamide. (par. [0035]). The macromer is derivatized and included in amounts in the range of 5-50% w/w from a mechanical standpoint. (par. [0030] and [0033]).
It would have been obvious to one of ordinary skill in the art to include the macromer content for ‘236 in the amount disclosed in Constant et al. for adjusting the mechanical properties to compositions including the claimed macromer to yield an improved product.
Regarding claims 2-4, Constant et al. discloses that the macromer is a poly(ethylene glycol), poly(propylene glycol) or poly(tetramethylene oxide). (par. [0030]). Constant et al. discloses that the preferred macromer is poly(ethylene) glycol diacrylamide 10,000. (par. [0034]).
It would have been obvious to one of ordinary skill in the art to use PEG-diacrylamide 10,000 as the macromer in view of the disclosure that PEG-diacrylamide 10,000. is a preferred macromer for an embolic device composition, which would imply a material having improved properties.
Regarding claim 5, ‘236 claims a particle diameter in the range of 40 to 1,200 micrometers. (claim 1).
Regarding claim 7, ‘236 claims that the monomer functional group is acrylate, acrylamide, methacrylate or methacrylamide. (claim 3).
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,546,236 (hereafter ‘236) in view of Constant et al. (WO 2012/145431), further in view of Um et al. (U.S. App. Pub. No. 2003/0124371).
‘236 in view of Constant et al. is relied upon as described in the rejection of claim 1, above.
‘236 in view Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8.
Um et al. teaches a water-swellable hydrophobic hydrogel and analytical devices containing the hydrogel. (Abstract). Um et al. teaches that the hydrogel can include hydrophobic and hydrophilic moieties for adjusting the water swellability of the hydrogel and the content of the hydrophilic monomers should be 50-100% of the polymer and includes monomers such as glycerol methacrylate. (par. [0068]).
It would have been obvious to one of ordinary skill in the art to include glycerol methacrylate as a hydrophilic monomer in the macromer composition in ‘236.
One of ordinary skill in the art would have found it obvious to include glycerol methacrylate in the macromer of ‘236 in order to adjust the water swelling properties of the macromer material of ‘236.
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).
Claims 8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,546,236 (hereafter ‘236) in view of Constant et al. (WO 2012/145431), further in view of Scognamillo et al. (Thermoresponsive Super Water Absorbent Hydrogels Prepared by Frontal Polymerization of N-Isopropyl Acrylamide and 3-Sulfopropyl Acrylate Potassiun Salt, Journal of Polymer Science Part A: Polymer Chemistry, Vol. 49, 1228-1234 (2011).
‘236 in view Constant et al. is relied upon as described in the rejection of claim 1, above.
‘236 in view of Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8.
Scognamillo et al. teaches a water absorbent polymer hydrogel composition made by copolymerizing N-isoproply acrylamide and 3-sulfopropylacrylate potassium salt (SAPK) and N,N’-methylene-bis-acrylamide as a crosslinker. (Abstract). The compositon is used as polymer composition for drug release system. (page 1229, left col.) Scognamillo et al. teaches that the monomer ratio of SPAK to other components affects the swelling ratio of the hydrogel and generally ranges from 100 mol% or less relative to NIPAAm (page 1229, Table 1).
It would have been obvious to one of ordinary skill in the art to use 3-sulfopropylacrylate a monomer in the macromer hydrogel taught in ‘236
One of ordinary skill in the art would have found it obvious to use 3-sulfopropylacrylate as it known in the art to dramatically influence the swelling ratio of the polymer hydrogel. (page 1230, left col). Furthermore, based on the explicit teaching in Scognamillo et al. that the content thereof in the polymer is a result effective variable for adjusting the swelling ratio, 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 amount of 3-sulforpopyl acrylate as a weight basis in ‘880 (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 8 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,201,632 (hereafter ‘632) in view of Constant et al. (WO 2012/145431), further in view of Chudzik et al. (U.S. Pat. No. 6,007,833).
‘236 in view Constant et al. is relied upon as described in the rejection of claim 1, above.
‘236 in view of Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8.
Constant et al. does disclose that the monomers may include pH sensitive monomers in an amount of 1-12.5% and include aminomethacrylamide and derivatives thereof. (par. [0035]).
Chudzik et al. teaches a crosslinkable macromer including polymer pendant polymerizable and initiator groups. (Abstract). Chudzik et al. teaches that the reactive polymerizable groups can be introduced into the macromer using monomers including aminopropylmethacrylamide (APMA). (col. 5, lines 54-67).
It would have been obvious to one of ordinary skill in the art to use aminopropylmethacrylamide as the pH sensitive monomer in ‘880 in view of Constant et al.in the same amount as disclosed in Constant et al., thereby overlapping with the presently claimed range. 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).
One of ordinary skill in the art would have found it obvious to use aminopropylmethacrylamide in view of the teachings in Constant et al. that amino methacrylate derivatives may be selected and Chudzik et al. advantageously teaching the use of a polymer hydrogel having aminopropylmethacrylamide derived reactive groups for providing reactive groups to alter the physical and chemical properties of a macromer composition.
Claims 8 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,546,236 (hereafter ‘236) in view of Constant et al. (WO 2012/145431), further in view of Song et al. (U.S. App. Pub. No. 20100297155).
‘236 in view of Constant et al. is relied upon as described in the rejection of claim 1, above.
‘236 in view of Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8. Constant et al. does disclose that the monomers may include pH sensitive monomers in an amount of 1-12.5% and include amino methacrylate and derivatives thereof. (par. [0035]).
Song et al. teaches a phosphazene based polymer hydrogel material (Abstract) which further contains aminoethylmethacrylate groups which are useful for the purpose of forming crosslinks in the hydrogel. (par. [0494]). Song et al. further teaches that the content of the aminoethylmethacrylate group can be adjusted to increase the pore size in the hydrogel material for use as a drug delivery carrier. (par. [0495]).
It would have been obvious to one of ordinary skill in the art to use aminoethylmethacrylate as the pH sensitive monomer in ‘236 in view of Constant et al.in the same amount as disclosed in Constant et al., thereby overlapping with the presently claimed range. 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).
One of ordinary skill in the art would have found it obvious to use aminoethylmethacrylate in view of the teachings in Constant et al. that amino methacrylate derivatives may be selected and Song et al. advantageously teaching the use of a polymer hydrogel having aminoethylmethacrylate groups for crosslinking sites and to control the pore size of the hydrogel material.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 contains the limitation “at least one monomer”. The limitation “at least one monomer that is not n-isopropyl acrylamide” is a narrower form of the same limitation and therefore claim 6 does not further limit claim 1 since “at least one monomer” is broader by not excluding n-isopropyl acrylamide.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
It is not clear if the limitation “at least one monomer” refers to the same or a different/additional at least monomer than the “at least one monomer that is not n-isopropyl acrylamide” referred to claim 1.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1-7 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Constant et al. (WO 2012/145431).
Regarding claim 1, Constant et al. discloses an embolic device which is made of radiopaque hydrogel filaments (i.e. polymer particles) comprises an ethylenically unsaturated shapeable macromer, an ethylenically unsaturated monomer and a radiopaque element. (Abstract). The monomers may include those other than n-isopropyl acrylamide. (par. [0035]). The macromer is derivatized and included in amounts in the range of 5-50% w/w. (par. [0030] and [0033]). In specific examples, the macromer is included in an amount of 25% w/w and 29% w/w. (par. [0067] and [0069]). The range disclosed in Constant et al. teaches the presently claimed range with sufficient specificity as to anticipate the claim due to fully encompassing the presently claimed range and teaching a specific value inside a claimed range in an inventive example. MPEP 2131.03.
Regarding claim 2, Constant et al. discloses that the macromer is a poly(ethylene glycol), poly(propylene glycol) or poly(tetramethylene oxide). (par. [0030]).
Regarding claims 3-4, Constant et al. discloses that the preferred macromer is poly(ethylene) glycol diacrylamide 10,000. (par. [0034]).
Regarding claim 5, Constant et al. discloses a microfilament diameter of 0.0167 inches (i.e. 424 microns) in a specific example which lies within the presently claimed range. (see par. [0070, System A). Therefore, the diameter disclosed in Constant et al. anticipates the presently claimed range. MPEP 2131.03.
Regarding claim 6, Constant et al. discloses the inclusion of at least one monomer. (par. [0035]).
Regarding claim 7, Constant et al. discloses that the monomers include acrylamide and methacrylate functional groups. (par. [0038]).
Regarding claims 13-14, Constant et al. discloses an embolic apparatus, system and composition which would meet the limitation of a kit and of an injectable composition. (Abstract).
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 (i.e., changing from AIA to pre-AIA ) 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 nonobviousness.
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 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Constant et al. (WO 2012/145431) in view of Um et al. (U.S. App. Pub. No. 2003/0124371).
Constant et al. is relied upon as described in the rejection of claim 1, above.
Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8.
Um et al. teaches a water-swellable hydrophobic hydrogel and analytical devices containing the hydrogel. (Abstract). Um et al. teaches that the hydrogel can include hydrophobic and hydrophilic moieties for adjusting the water swellability of the hydrogel and the content of the hydrophilic monomers should be 50-100% of the polymer and includes monomers such as glycerol methacrylate. (par. [0068]).
It would have been obvious to one of ordinary skill in the art to include glycerol methacrylate as a hydrophilic monomer in the macromer composition in Constant et al.
One of ordinary skill in the art would have found it obvious to include glycerol methacrylate in the macromer of Constant et al. in order to adjust the water swelling properties of the macromer material of Constant 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).
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Constant et al. (WO 2012/145431) in view of Scognamillo et al. (Thermoresponsive Super Water Absorbent Hydrogels Prepared by Frontal Polymerization of N-Isopropyl Acrylamide and 3-Sulfopropyl Acrylate Potassiun Salt, Journal of Polymer Science Part A: Polymer Chemistry, Vol. 49, 1228-1234 (2011).
Constant et al. is relied upon as described in the rejection of claim 1, above.
Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8.
Scognamillo et al. teaches a water absorbent polymer hydrogel composition made by copolymerizing N-isoproply acrylamide and 3-sulfopropylacrylate potassium salt (SAPK) and N,N’-methylene-bis-acrylamide as a crosslinker. (Abstract). The compositon is used as a polymer composition for drug release system. (page 1229, left col.) Scognamillo et al. teaches that the monomer ratio of SPAK to other components affects the swelling ratio of the hydrogel and generally ranges from 100 mol% or less relative to NIPAAm (page 1229, Table 1).
It would have been obvious to one of ordinary skill in the art to use 3-sulfopropylacrylate a monomer in the macromer hydrogel taught in Constant et al.
One of ordinary skill in the art would have found it obvious to use 3-sulfopropylacrylate as it known in the art to dramatically influence the swelling ratio of the polymer hydrogel. (page 1230, left col). Furthermore, based on the explicit teaching in Scognamillo et al. that the content thereof in the polymer is a result effective variable for adjusting the swelling ratio, 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 amount of 3-sulforpopyl acrylate as a weight basis in Constant et al. (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 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Constant et al. (WO 2012/145431) in view of Chudzik et al. (U.S. Pat. No. 6,007,833).
Constant et al. is relied upon as described in the rejection of claim 1, above.
Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8. Constant et al. does disclose that the monomers may include pH sensitive monomers in an amount of 1-12.5% and include aminomethacrylamide and derivatives thereof. (par. [0035]).
Chudzik et al. teaches a crosslinkable macromer including polymer pendant polymerizable and initiator groups. (Abstract). Chudzik et al. teaches that the reactive polymerizable groups can be introduced into the macromer using monomers including aminopropylmethacrylamide (APMA). (col. 5, lines 54-67).
It would have been obvious to one of ordinary skill in the art to use aminopropylmethacrylamide as the pH sensitive monomer in Constant et al.in the same amount as disclosed in Constant et al., thereby overlapping with the presently claimed range. 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).
One of ordinary skill in the art would have found it obvious to use aminopropylmethacrylamide in view of the teachings in Constant et al. that amino methacrylate derivatives may be selected and Chudzik et al. advantageously teaching the use of a polymer hydrogel having aminopropylmethacrylamide derived reactive groups for providing reactive groups to alter the physical and chemical properties of a macromer composition.
Claims 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Constant et al. (WO 2012/145431) in view of Song et al. (U.S. App. Pub. No. 2010/0297155).
Constant et al. is relied upon as described in the rejection of claim 1, above.
Constant et al. does not disclose that the monomers are selected from the materials as claimed in claim 8. Constant et al. does disclose that the monomers may include pH sensitive monomers in an amount of 1-12.5% and include amino methacrylate and derivatives thereof. (par. [0035]).
Song et al. teaches a phosphazene based polymer hydrogel material (Abstract) which further contains aminoethylmethacrylate groups which are useful for the purpose of forming crosslinks in the hydrogel. (par. [0494]). Song et al. further teaches that the content of the aminoethylmethacrylate group can be adjusted to increase the pore size in the hydrogel material for use as a drug delivery carrier. (par. [0495]).
It would have been obvious to one of ordinary skill in the art to use aminoethylmethacrylate as the pH sensitive monomer in Constant et al.in the same amount as disclosed in Constant et al., thereby overlapping with the presently claimed range. 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).
One of ordinary skill in the art would have found it obvious to use aminoethylmethacrylate in view of the teachings in Constant et al. that amino methacrylate derivatives may be selected and Song et al. advantageously teaching the use of a polymer hydrogel having aminoethylmethacrylate groups for crosslinking sites and to control the pore size of the hydrogel material.
Conclusion
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/ALEXANDRE F FERRE/Primary Examiner, Art Unit 1788 07/10/2026
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