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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-21, in the reply filed on Apr. 27, 2026 is acknowledged.
Claims 22-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Apr. 27, 2026.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Seven double patenting rejections are set forth below.
Double patenting rejection no. 1:
Claims 1-2 and 4-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 9,546,236 B2.
As to claims 1-2 and 4-8: US ‘236 claims a method of making a polymer particle comprising reacting a prepolymer solution including a monomer and crosslinker in which the crosslinker includes at least two functional groups (see claim 23 of US ‘236); wherein the crosslinker susceptible to degradation through hydrolysis or enzymatic action, and wherein the polymer particle has a diameter between about 40 µm and about 1,200 µm (see claim 17 of US ‘236). The recitation of a diameter implies that the particles are spherical.
Claim 23 of US ‘236 thus reads on present claims 1-2 and 4-8 in an anticipatory manner.
The further limitations of present claims 9-15 are adequately set forth in claims 4-6, 12, 15-16, and 20-21 of US ‘236.
Double patenting rejection no. 2:
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,803,043 B2.
As to claims 1-8: US ‘043 claims a polymer particle comprising at least one monomer including at least one functional group; and at least one crosslinker with two functional groups (see claim 8 of US ‘043) which is susceptible to degradation through hydrolysis or enzymatic action, the degradation providing less than about 10% of the polymer particle intact after about 5 days (see claim 1 of US ‘043); wherein the polymer particle has a spherical diameter between about 40 µm and about 1,200 µm (id.).
Present independent claim 1 recites a reaction product of a prepolymer solution. The claim thus refers to the polymer particles as a product-by-process. Case law has established that the patentability of a product-by-process is determined by the patentability of the product itself, i.e. that the patentability of a product does not depend upon its method of production (MPEP 2113). The process limitations are only given consideration regarding patentability if there is criticality to the structure implied by the steps of the process. No such criticality has been demonstrated to the use of a prepolymer solution to the preparation of the claimed polymer particles; and therefore claim 8 of US ‘043 thus reads on present claims 1-8 in an anticipatory manner notwithstanding any difference in the method by which the polymer particles claimed by US ‘043 are made.
The further limitations of claims 9-15 are adequately set forth in claims 4-5, 10-12, and 16 of US ‘043.
Double patenting rejection no. 3:
Claims 1-12 and 14-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,938,367 B2.
As to claims 1, 4, 6-8, 10, 16: US ‘367 claims an embolic system including polymer particles comprising at least one monomer including a functional group; and a crosslinker with two functional groups (see claim 6 of US ‘367); wherein the polymer particle has a spherical diameter between about 40 µm and about 1,200 µm (see claim 1 of US ‘367).
Present independent claim 1 recites a reaction product of a prepolymer solution. The claim thus refers to the polymer particles as a product-by-process. Case law has established that the patentability of a product-by-process is determined by the patentability of the product itself, i.e. that the patentability of a product does not depend upon its method of production (MPEP 2113). The process limitations are only given consideration regarding patentability if there is criticality to the structure implied by the steps of the process. No such criticality has been demonstrated to the use of a prepolymer solution to the preparation of the claimed polymer particles; and therefore claim 6 of US ‘367 thus reads on present claims 1, 4, 6-8, 10, and 16 in an anticipatory manner notwithstanding any difference in the method by which the polymer particles claimed by US ‘367 are made.
The further limitations of claims 2-3, 5, 9, 11-12, 14-15, and 17-19 are adequately set forth in claims 2-3, 8-9, 13-17, 20 of US ‘043.
As to claims 20-21: US ‘367 does not claim a method of administration of the embolic systems. In light of the recitation in US ‘367 of an embolic system, one of ordinary skill in the art would have merely exercised ordinary creativity by using the embolic systems of US ‘367 to perform embolization by administering the embolic system claimed by US ‘367 to a vessel in need thereof. It would have been obvious to one of ordinary skill in the art to have administered the embolic system claimed by US ‘367 to a vessel.
Double patenting rejection no. 4:
Claims 1-2 and 4-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,144,793 B2.
As to claims 1-2 and 4-7: US ‘793 claims a polymer particle comprising a reaction product of a prepolymer solution including at least one monomer including at least one functional group and at least one crosslinker including at least two functional groups and wherein the polymer particle is susceptible to degradation through hydrolysis or enzymatic action (see claim 1 of US ‘793); wherein the polymer particle has a diameter between about 40 µm and about 1,200 µm (see claim 6 of US ‘793). The recitation of a diameter implies that the particles are spherical.
Claim 6 of US ‘793 thus reads on present claims 1-2 and 4-7 in an anticipatory manner.
The further limitations of present claims 8-15 are adequately set forth in claims 8-10, 13-14, and 16 of US ‘793.
Double patenting rejection no. 5:
Claims 1-2, 4-8, 10-12, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,400,051 B2.
As to claims 1 and 4: US ‘051 claims a method of treating a vessel with polymer particles comprising at least one monomer; and at least one crosslinker (see claim 1 of US ‘051) wherein the particles having a diameter of about 75 µm and about 1,200 µm (see claim 5 of US ‘051). The recitation of a diameter implies that the particles are spherical.
US ‘051 further claims monomers having functional groups (see claims 6-8 of US ‘051) and crosslinkers having at least two functional groups (see claim 10 of US ‘051).
US ‘051 does not specifically claim the presently recited combination of particle sizes, monomer functional groups, and crosslinker linkages.
In light of the recitation in US ‘051 of particles that have specified particle sizes, of monomer functional groups, and of crosslinker linkages, one of ordinary skill in the art would have merely exercised ordinary creativity by performing the method claimed by US ‘051 using particles that have such particle sizes, monomer functional groups, and crosslinker linkages. It would have been obvious to one of ordinary skill in the art to have performed the method claimed by US ‘051 using particles that have the particle sizes, monomer functional groups, and crosslinker linkages recited therein.
Present independent claim 1 recites a reaction product of a prepolymer solution. The claim thus refers to the polymer particles as a product-by-process. Case law has established that the patentability of a product-by-process is determined by the patentability of the product itself, i.e. that the patentability of a product does not depend upon its method of production (MPEP 2113). The process limitations are only given consideration regarding patentability if there is criticality to the structure implied by the steps of the process. No such criticality has been demonstrated to the use of a prepolymer solution to the preparation of the claimed polymer particles; and therefore claims 5-8 and 10 of US ‘051 suggest the subject matter of present claims 1 and 4, notwithstanding any difference in the method by which the polymer particles claimed by US ‘051 are made.
The further limitations of present claims 2, 5-8, 10-12, 15 are adequately set forth in claims 6-10 and 13 of US ‘051.
Double patenting rejection no. 6:
Claims 1-8, 10-12, and 15-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,135,167 B2.
As to claims 1, 4, 6-8, 11, and 16: US ‘167 claims an embolic solution comprising polymer particle comprising at least one monomer including at least one functional group; and at least one crosslinker including at least two functional groups (see claims 6-8 of US ‘167), wherein the polymer particle has a spherical diameter between about 40 µm and about 1,200 µm (see claim 1 of US ‘167).
Present independent claim 1 recites a reaction product of a prepolymer solution. The claim thus refers to the polymer particles as a product-by-process. Case law has established that the patentability of a product-by-process is determined by the patentability of the product itself, i.e. that the patentability of a product does not depend upon its method of production (MPEP 2113). The process limitations are only given consideration regarding patentability if there is criticality to the structure implied by the steps of the process. No such criticality has been demonstrated to the use of a prepolymer solution to the preparation of the claimed polymer particles; and therefore claims 6-8 of US ‘167 thus reads on present claims 1, 4, 6-8, 11, and 16 in an anticipatory manner notwithstanding any difference in the method by which the polymer particles claimed by US ‘167 are made.
The further limitations of present claims 2-3, 5, 10-12, 15, 17-19 are adequately set forth in claims 2, 5, 12, and 16-20 of US ‘167.
As to claims 20-21: US ‘167 does not claim a method of administration of the embolic systems. In light of the recitation in US ‘167 of an embolic system, one of ordinary skill in the art would have merely exercised ordinary creativity by using the embolic systems of US ‘167 to perform embolization by administering the embolic system claimed by US ‘167 to a vessel in need thereof. It would have been obvious to one of ordinary skill in the art to have administered the embolic system claimed by US ‘167 to a vessel.
Double patenting rejection no. 7:
Claims 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,786,630 B2.
As to claims 1-2, 4, and 15-21: US ‘630 claims an embolic solution comprising polymer particle comprising at least one monomer including at least one functional group; and at least one crosslinker including at least two functional groups (see claims 14-17 of US ‘630), wherein the polymer particle has a spherical diameter between about 40 µm and about 1,200 µm and a circularity greater than about 0.9 (see claim 1 of US ‘630); and US ‘630 claims methods of administering the embolic solution to a vessel (see claims 18-19 of US ‘630).
Present independent claim 1 recites a reaction product of a prepolymer solution. The claim thus refers to the polymer particles as a product-by-process. Case law has established that the patentability of a product-by-process is determined by the patentability of the product itself, i.e. that the patentability of a product does not depend upon its method of production (MPEP 2113). The process limitations are only given consideration regarding patentability if there is criticality to the structure implied by the steps of the process. No such criticality has been demonstrated to the use of a prepolymer solution to the preparation of the claimed polymer particles; and therefore claims 14-19 of US ‘630 thus reads on present claims 1-2, 4, and 15-21 in an anticipatory manner notwithstanding any difference in the method by which the polymer particles claimed by US ‘167 are made.
The further limitations of present claims 3 and 5-14 are adequately set forth in claims 2, 4-6, 8-13 of US ‘630.
Claim Rejections – 35 U.S.C. § 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 7, and 10-12 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by European Patent Application Publication No. 2 295 480 A1 (herein “Moine”).
As to claims 1 and 4: Moine describes spherical polymer particles (see ¶ [0010]). The particles include units of a monomer including a functional group (see ¶ [0012]) and units of a crosslinker (see component (ii) of ¶ [0012]). Preferably the crosslinker is according to formulas that include two ethylenically unsaturated functional groups (see ¶ [0028]). The particles have a size of more preferably 100 to 600 microns (see ¶ [0048]).
Present independent claim 1 recites a reaction product of a prepolymer solution. The claim thus refers to the polymer particles as a product-by-process. Case law has established that the patentability of a product-by-process is determined by the patentability of the product itself, i.e. that the patentability of a product does not depend upon its method of production (MPEP 2113). The process limitations are only given consideration regarding patentability if there is criticality to the structure implied by the steps of the process. No such criticality has been demonstrated to the use of a prepolymer solution to the preparation of the claimed polymer particles; and therefore Moine reads on present claims 1 and 4 in an anticipatory manner notwithstanding any difference in the method by which the polymer particles described by Moine are made.
As to claims 2 and 5: Moine discloses that the crosslinker is susceptible to hydrolysis (see ¶ [0022]) and that the crosslinker is bio-resorbable and degrades in a living organism, corresponding to the presently recited biodegradation.
As to claim 7: Moine further discloses crosslinkers including PGA and PLA units (see ¶ [0024]-[0025] and [0028]).
As to claims 10-12: Moine further discloses monomers including (meth)acylate functional groups (see ¶ [0033]) and ionizable, acidic groups (e.g. see acrylic acid in ¶ [0035]).
Claims 1, 4, and 10-12 are rejected under 35 U.S.C. §§ 102(a)(1) and 102(a)(2) as being anticipated by US 2014/0030350 A1 (herein “Ashrafi”).
As to claims 1, 4, and 10-12: Ashrafi describes microparticles that are preferably microspheres (see the abstract and ¶ [0032]) having a diameter most preferably of 40-300 μm (see ¶ [0034]). One particularly preferred type of monomer is an (alk)acrylamido alkane-sulfonic acid, such as 2-acrylamido-2-methyl-1-propane-sulfonic acid (AMPS) (see ¶ [0042]), and the particles include units of a crosslinker having two ethylenically unsaturated functional groups (see ¶¶ [0049] and [0098]).
Present independent claim 1 recites a reaction product of a prepolymer solution. The claim thus refers to the polymer particles as a product-by-process. Case law has established that the patentability of a product-by-process is determined by the patentability of the product itself, i.e. that the patentability of a product does not depend upon its method of production (MPEP 2113). The process limitations are only given consideration regarding patentability if there is criticality to the structure implied by the steps of the process. No such criticality has been demonstrated to the use of a prepolymer solution to the preparation of the claimed polymer particles; and therefore Ashrafi reads on present claims 1, 4, and 10-12 in an anticipatory manner notwithstanding any difference in the method by which the polymer particles described by Ashrafi are made.
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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