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 .
Specification
The disclosure is objected to because of the following informalities: The continuation data listed in Paragraph 1 of the specification for Application No. 18/502,937, filed November 6, 2023, should be updated, as Application No. 18/502,937 is now U.S. Patent No. 12,053,560. Appropriate correction is required.
The continuation data listed in Paragraph 1 of the specification for Application No. 18/322,852, filed May 24, 2023, should be updated, as Application No. 18/322,852 is now U.S. Patent No. 11,844,870. Appropriate correction is required.
The continuation data listed in Paragraph 1 of the specification for Application No. 18/001,024, filed December 7, 2022, should be updated, as Application No. 18/001,024 is now U.S. Patent No. 12,478,710. Appropriate correction is required.
Claim Objections
Claim 5 is objected to because of the following informalities: crosslinkable polymer (line 2) should be the first crosslinkable polymer; the crosslinkable polymer (line 4) should be the first crosslinkable polymer. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “polysiloxane , an” should be “polysiloxane, an”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the first filler (line 1) should be the first silica filler; the second filler (line 1) should be the second silica filler. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the first filler (line 1) should be the first silica filler; the second filler (line 1) should be the second silica filler. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: the first filler (line 1) should be the first silica filler; the second filler (line 1) should be the second silica filler. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: the first filler (line 1) should be the first silica filler; the second filler (line 1) should be the second silica filler. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: the first filler (line 1) should be the first silica filler; the second filler (line 1) should be the second silica filler. Appropriate correction is required.
Claim 24 is objected to because of the following informalities: the first filler (line 1) should be the first silica filler; the second filler (line 1) should be the second silica filler. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: crosslinkable polymer (line 2) should be the crosslinkable polymer. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: “polysiloxane , an” should be “polysiloxane, an”. Appropriate correction is required.
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.
Claims 11, 16-17, 26, and 29 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation hydroxy-terminated polymers and dendrimers, and the claim also recites hydroxy-terminated (polyalkylene oxides) and hydroxy-terminated polyvinyl alcohol which is the narrower statement of the range/limitation. In the present instance, claim 29 recites the broad recitation hydroxy-terminated polymers and dendrimers, and the claim also recites hydroxy-terminated (polyalkylene oxides) and hydroxy-terminated polyvinyl alcohol which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 16 recites the limitation "crosslinkable polymer" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination, crosslinkable polymer will be interpreted as the polysiloxane having two or more unsaturated groups.
Claim 16 recites the limitation "the crosslinker" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination, the crosslinker will be interpreted as the hydride material.
Claim 17 recites the limitation "the first crosslinkable polymer" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination, the first crosslinkable polymer will be interpreted as the polysiloxane having two or more unsaturated groups.
Claim 26 recites the limitation "the first crosslinkable polymer" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination, the first crosslinkable polymer will be interpreted as the crosslinkable polymer.
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.
Claim(s) 1-6 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de Vries et al. (EP 1 435 249).
Regarding claims 1-6: de Vries et al. (EP ‘249) discloses a kit for use in an in vivo aneurysm repair [abstract; 0080] comprising a biocompatible polymer system, mixer, and injection system (needle or catheter) [0089]. de Vries et al. (EP ‘249) discloses Example 2 [Ex. 2; 0105-0108] contains components A and B. Component A contains vinyl terminated PDMS, vinyl Q (contrast agent [0066]), silica (Aerosil R8200, hydrophobic [0066]), and hydride methyl siloxane (10 functional) (HMS-301 [0101]). Component B contains vinyl terminated PDMS, vinyl Q, silica, and platinum catalyst (platinum-divinyltetramethyldisiloxane complex [0101]) [Ex. 2; 0105-0108]. de Vries et al. (EP ‘249) discloses mixing Vinyl Q with PDMS [0106] {instant (a)}, then adding silica {instant (c)} to the mixture [0106]. de Vries et al. (EP ‘249) discloses adding the hydride methyl siloxane (10 functional) (HMS-301 [0101]) {instant (b)} to the PDMS/vinyl Q/silica mixture to afford component A [0107] {corresponding to instant claimed kit} [Ex. 2; 0105-0108]. de Vries et al. (EP ‘249) discloses mixing and curing the composition [Ex. 2; 0089, 0105-0108].
Regarding claim 8: de Vries et al. (EP ‘249) discloses the basic claimed kit [as set forth above with respect to claim 1].
The claimed effects and physical properties, i.e. the crosslinkable composition is hydrophobic, would inherently be achieved, as “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) [see MPEP 2112.01].
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over de Vries et al. (EP 1 435 249) as applied to claim 1 above.
Regarding claim 9: de Vries et al. (EP ‘249) discloses the basic claimed kit [as set forth above with respect to claim 1]; wherein de Vries et al. (EP ‘249) discloses the filler vinyl Q (contrast agent [0066]) has a particle size of 10 to 500 nm [0059].
In the case where the claimed ranges “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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) [See MPEP 2144.05].
Claim(s) 12-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over by de Vries et al. (EP 1 435 249).
Regarding claim 12-17: de Vries et al. (EP ‘249) discloses a kit for use in an in vivo aneurysm repair [abstract; 0080] comprising a biocompatible polymer system, mixer, and injection system (needle or catheter) [0089]. de Vries et al. (EP ‘249) discloses Example 2 [Ex. 2; 0105-0108] contains components A and B. Component A contains vinyl terminated PDMS, vinyl Q (contrast agent [0066]), silica (Aerosil R8200, hydrophobic [0066]), and hydride methyl siloxane (10 functional) (HMS-301 [0101]). Component B contains vinyl terminated PDMS, vinyl Q, silica, and platinum catalyst (platinum-divinyltetramethyldisiloxane complex [0101]) [Ex. 2; 0105-0108]. de Vries et al. (EP ‘249) discloses mixing Vinyl Q with PDMS [0106] {instant (a)}, then adding silica {instant (c)} to the mixture [0106]. de Vries et al. (EP ‘249) discloses adding the hydride methyl siloxane (10 functional) (HMS-301 [0101]) {instant (b)} to the PDMS/vinyl Q/silica mixture to afford component A [0107] {corresponding to instant claimed kit} [Ex. 2; 0105-0108]. de Vries et al. (EP ‘249) discloses mixing and curing the composition [Ex. 2; 0089, 0105-0108]. de Vries et al. (EP ‘249) discloses the filler vinyl Q (contrast agent [0066]) has a particle size of 10 to 500 nm [0059].
de Vries et al. (EP ‘249) does not specifically disclose vinyl Q containing 80 nm to 200 nm silica filler. However, in the case where the claimed ranges “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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) [See MPEP 2144.05].
Regarding claim 19: de Vries et al. (EP ‘249) discloses the basic claimed kit [as set forth above with respect to claim 12].
The claimed effects and physical properties, i.e. the crosslinkable composition is hydrophobic, would implicitly be achieved, as “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) [see MPEP 2112.01].
Claims 1-11 is/are rejected under 35 U.S.C. 103 as being obvious over Wiltsey et al. (US 2020/0268932), when taken with Alfa Aesar Bismuth(III) Oxide Certificate of Analysis and Bismuth(III) Oxide Product Specification.
The applied reference has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claims 1-11: Wiltsey et al. (US ‘932) discloses crosslinkable compositions for vascular embolization [abstract; 0093], wherein Example 3 [Ex. 3; 0098; Table 6, Formulation VHS68A] contains Phase A and Phase B {kit}. Phase A contains vinyl-terminated PDMS (GP-977 [0055]), 5 wt% bismuth(III) oxide (U23D045; 80-200 nm average particle size), fumed silica, and catalyst modifier. Phase B contains Hydride PDMS (GP-536 [0058]), Hydride PDMS (GP-499 [0058]), 5 wt% bismuth(III) oxide (U23D045; 80-200 nm average particle size) and fumed silica. Wiltsey et al. (US ‘932) discloses mixing Phase A and Phase B at a 1:1 volume ratio [Ex. 3; 0098; Table 6, Formulation VHS68A]. Wiltsey et al. (US ‘932) discloses delivery of the composition to vascular locations via catheter [0086-0093]. Wiltsey et al. (US ‘932) discloses treatment of intracranial aneurysms [0093].
Wiltsey et al. (US ‘932) does not disclose Ex. 3 having 3 phases corresponding to (a), (b) and (c) of the kit of instant claim 1. However, a prima facie case of obviousness exists where changes in the sequence of adding ingredients derived from the prior art process steps. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.) [See MPEP 2144.04].
Alfa Aesar Bismuth(III) Oxide Certificate of Analysis provides evidence that bismuth(III) oxide (U23D045) is a nanopowder [§ Product; Lot No.].
Bismuth(III) Oxide Product Specification provides evidence that the bismuth(III) oxide nanopowder has 80-200 nm average particle size [§ Particle Size].
Claims 12-20 is/are rejected under 35 U.S.C. 103 as being obvious over Wiltsey et al. (US 2020/0268932), when taken with Alfa Aesar Bismuth(III) Oxide Certificate of Analysis and Bismuth(III) Oxide Product Specification.
The applied reference has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claims 12-20: Wiltsey et al. (US ‘932) discloses crosslinkable compositions for vascular embolization [abstract; 0093], wherein Example 3 [Ex. 3; 0098; Table 6, Formulation VHS68A] contains Phase A and Phase B {kit}. Phase A contains vinyl-terminated PDMS (GP-977 [0055]), 5 wt% bismuth(III) oxide (U23D045; 80-200 nm average particle size), fumed silica, and catalyst modifier. Phase B contains Hydride PDMS (GP-536 [0058]), Hydride PDMS (GP-499 [0058]), 5 wt% bismuth(III) oxide (U23D045; 80-200 nm average particle size) and fumed silica. Wiltsey et al. (US ‘932) discloses mixing Phase A and Phase B at a 1:1 volume ratio [Ex. 3; 0098; Table 6, Formulation VHS68A]. Wiltsey et al. (US ‘932) discloses delivery of the composition to vascular locations via catheter [0086-0093]. Wiltsey et al. (US ‘932) discloses treatment of intracranial aneurysms [0093].
Wiltsey et al. (US ‘932) does not disclose Ex. 3 having 3 phases corresponding to (a), (b) and (c) of the kit of instant claim 12. However, a prima facie case of obviousness exists where changes in the sequence of adding ingredients derived from the prior art process steps. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.) [See MPEP 2144.04].
Alfa Aesar Bismuth(III) Oxide Certificate of Analysis provides evidence that bismuth(III) oxide (U23D045) is a nanopowder [§ Product; Lot No.].
Bismuth(III) Oxide Product Specification provides evidence that the bismuth(III) oxide nanopowder has 80-200 nm average particle size [§ Particle Size].
Claims 21-29 is/are rejected under 35 U.S.C. 103 as being obvious over Wiltsey et al. (US 2020/0268932), when taken with Alfa Aesar Bismuth(III) Oxide Certificate of Analysis and Bismuth(III) Oxide Product Specification.
The applied reference has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claims 21-29: Wiltsey et al. (US ‘932) discloses crosslinkable compositions for vascular embolization [abstract; 0093], wherein Example 3 [Ex. 3; 0098; Table 6, Formulation VHS68A] contains Phase A and Phase B {kit}. Phase A contains vinyl-terminated PDMS (GP-977 [0055]), 5 wt% bismuth(III) oxide (U23D045; 80-200 nm average particle size), fumed silica, and catalyst modifier. Phase B contains Hydride PDMS (GP-536 [0058]), Hydride PDMS (GP-499 [0058]), 5 wt% bismuth(III) oxide (U23D045; 80-200 nm average particle size) and fumed silica. Wiltsey et al. (US ‘932) discloses mixing Phase A and Phase B at a 1:1 volume ratio [Ex. 3; 0098; Table 6, Formulation VHS68A]. Wiltsey et al. (US ‘932) discloses delivery of the composition to vascular locations via catheter [0086-0093]. Wiltsey et al. (US ‘932) discloses treatment of intracranial aneurysms [0093].
Wiltsey et al. (US ‘932) does not disclose Ex. 3 having 3 phases corresponding to (a), (b) and (c) of the kit of instant claim 21. However, a prima facie case of obviousness exists where changes in the sequence of adding ingredients derived from the prior art process steps. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.) [See MPEP 2144.04].
Alfa Aesar Bismuth(III) Oxide Certificate of Analysis provides evidence that bismuth(III) oxide (U23D045) is a nanopowder [§ Product; Lot No.].
Bismuth(III) Oxide Product Specification provides evidence that the bismuth(III) oxide nanopowder has 80-200 nm average particle size [§ Particle Size].
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, 3-6 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,324,853. Although the claims at issue are not identical, they are not patentably distinct from each other because the system for controlling the movement of bodily fluid within the vasculature of a patient, comprising: an in-situ crosslinkable composition comprising a first polysiloxane having two or more unsaturated groups, a first silanol compound, fumed silica, an imaging agent comprising a radiopaque agent, a first hydride material having two or more hydride groups, and a catalyst for catalyzing a reaction between the unsaturated groups and the hydride groups, the composition being configured for injection into a vasculature of a patient such that movement of bodily fluid within the patient is controlled, wherein the weight ratio of total amount of silica to total amount of silanol in the composition is in the range of from 2:1 to 1:1 and wherein the composition has a viscosity as measured by oscillatory rheology at 0.1 Hz and 1% strain at 25° C. that is at least tenfold greater than a viscosity as measured by flow rheology at a frequency of 30 Hz at 25° C.; and a delivery device containing the composition, wherein the composition comprises two or more composition portions that when combined form the composition, wherein the two or more composition portions comprise a first composition portion and a second composition portion separated from each other within the delivery device, wherein the first composition portion comprises the first polysiloxane having two or more unsaturated groups and wherein the first polysiloxane is a vinyl-terminated polydimethylsiloxane, wherein the second composition portion comprises the first hydride material having two or more hydride groups and wherein the first hydride material is a hydride polydimethylsiloxane; wherein the composition cures into a solid within the vasculature of the patient within a time period of 1 minute to 120 minutes; wherein the first composition portion comprises the first silanol compound; wherein the second composition portion comprises a second silanol compound; wherein the catalyst is within at least one of the first and second composition portions; (a) wherein the first composition portion further comprises a first physical crosslinking agent comprising a plurality of hydrogen bonding groups and the second composition portion further comprises a second physical crosslinking agent comprising a plurality of hydrogen bonding groups, wherein the first and second physical crosslinking agents may be the same or different and/or (b) wherein the first composition portion further comprises a first imaging agent and the second composition portion further comprises a second imaging agent, wherein the first and second imaging agents may be the same or different; wherein the delivery device is for mixing the first and second components and deliver the mixed composition substantially overlap in scope with the instant claimed kit.
A prima facie case of obviousness exists where changes in the sequence of adding ingredients derived from the prior art process steps. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.) [See MPEP 2144.04].
Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,992,576. Although the claims at issue are not identical, they are not patentably distinct from each other because the kit of U.S. Patent No. 11,992,576 comprising (a) a first fluid composition comprising a first polysiloxane having two or more unsaturated groups and a first imaging agent, (b) a second fluid composition that comprises a first hydride material having two or more hydride groups and a second imaging agent which is the same or different from the first imaging agent, (c) a dry composition comprising a first silica filler and optionally a second silica filler which is the same or different from the first silica filler, and wherein the first fluid composition, second fluid composition, and dry composition are stable, and when mixed, form a crosslinkable composition having the first and second imaging agents substantially evenly dispersed in the crosslinkable composition anticipates the instant claimed kit of claims 1-8and 10-11. While U.S. Patent No. 11,992,576 does not claim the kit of claim 1 having the first and second imaging agent having a particle size of 80-200 nm, and the first and second imaging agent as bismuth trioxide, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the first and second imaging agent as bismuth trioxide having a particle size of 80-200 nm, as U.S. Patent No. 11,992,576 claims the first and second imaging agent comprise bismuth trioxide [claim 6], and the first and second imaging agent having a particle size of 10 nm -20 µm [claim 7]. In the case where the claimed ranges “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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) [See MPEP 2144.05].
Claims 1-6, 8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,521,467. Although the claims at issue are not identical, they are not patentably distinct from each other because the kit of U.S. Patent No. 12,521,467 comprising (a) a first fluid composition comprising a first polysiloxane having two or more unsaturated groups, (b) a first dry composition comprising a first silica filler or a mixture of a first silica filler and a first imaging agent, (c) a second fluid composition comprising a first hydride material having two or more hydride groups, at least one of said first and second fluid compositions comprising a catalyst for catalyzing a reaction between the unsaturated groups and the hydride groups, (d) an optional second dry composition comprising a first second imaging agent or a mixture of a second silica filler and a second imaging agent, (e) one or more components for mixing and delivery of the first fluid composition, the first dry composition, the second fluid composition and the optional second dry composition, wherein the first silica filler and the second silica filler may be the same or different, wherein the first imaging agent and the second may be the same or different, wherein when the first dry composition comprises the first silica filler, the second dry composition comprises the first second imaging agent and when the first dry composition comprises a mixture of the first silica filler and the first imaging agent, the second dry composition is optional, and wherein the first fluid composition, the first dry composition, the second fluid composition, and optionally the second dry composition, when mixed, form a crosslinkable composition anticipates the instant claimed kit.
Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12,296,065. Although the claims at issue are not identical, they are not patentably distinct from each other because the kits of U.S. Patent No. 12,296,065 anticipates the instant claimed kits.
Claims 1-5 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,478,710. Although the claims at issue are not identical, they are not patentably distinct from each other because the kits of U.S. Patent No. 12,478,710 substantially overlaps in scope with the instant claimed kit.
A prima facie case of obviousness exists where changes in the sequence of adding ingredients derived from the prior art process steps. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.) [See MPEP 2144.04].
Claims 1-6 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 19/417850 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the kit of Application No. 19/417850 substantially overlaps in scope with the instant claimed kit.
A prima facie case of obviousness exists where changes in the sequence of adding ingredients derived from the prior art process steps. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.) [See MPEP 2144.04].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 19/248,143 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the kit of Application No. 19/248,143 substantially overlaps in scope with the instant claimed kits.
A prima facie case of obviousness exists where changes in the sequence of adding ingredients derived from the prior art process steps. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.) [See MPEP 2144.04].
While Application No. 19/248,143 does not claim the kit of claim 1 having the first and second imaging agent having a particle size of 80-200 nm, and the first and second imaging agent as bismuth trioxide, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the first and second imaging agent as bismuth trioxide having a particle size of 80-200 nm, as Application No. 19/248,143 claims the first and second imaging agent comprise bismuth trioxide [claim 6], and the first and second imaging agent having a particle size of 10 nm -20 µm [claim 7]. In the case where the claimed ranges “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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) [See MPEP 2144.05].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
See attached form PTO-892.
Correspondence
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/MICHAEL F PEPITONE/Primary Examiner, Art Unit 1767
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