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 .
Drawings
The drawings are objected to because the drawing numbering is incorrect (it appears figure 10 should be ‘figure 9’ and there is inconsistencies in figures 13, 14A-D, 15A-C, and 15A-B). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gay (WO 2020/227107 cited by applicant with citation made to corresponding US Pub 2022168452) in view of Higham (EP 1407729 cited by applicant with citations made to corresponding US Pub 2004054413).
Re claim 1: Gay discloses a method of visualizing a tissue, space, or location of a radiographic subject, comprising disposing an imaging contrast composition, said composition comprising: a viscoelastic medium; and a first visual additive, wherein said first visual additive is a metal [0118, 0149, abstract; see the injecting of the viscoelastic material with hyaluronic acid particles and with visualization additive].
Gay discloses the metal having a particle diameter of at least 20 microns [0149] but not necessarily greater than about 80 micrometers. However, Higham teaches of a hydrogel implanted comprising a metal such as gold or tungsten as radiopaque material for x-ray visualization wherein the metal powder has a diameter between 10-100 microns [0073]. It would have been obvious to the skilled artisan to modify Gay, to have the additive with diameter greater than 80 microns as taught by Higham, as such is well known and would permit x-ray visualization.
Re claim 2: Gay discloses steps comprising:(a) disposing the composition within a first tissue site, and (b) imaging said composition within said first tissue site [0118, 0149, abstract; see the injecting of the composition and imaging].
Re claim 3: Gay/Higham teach that the metal diameter is between 10-100 microns but not greater than 100 micrometers. It would have been obvious to the skilled artisan to modify Gay/Higham, to make the diameter greater than 100 microns as such would permit x-ray visualization be achieved with routine experimentation to obtain predictable results.
Re claim 4: Gay discloses a concentration of said first visual additive in said viscoelastic medium results in a contrast to noise ratio of about 0.1 to about 40 when imaged [0149; see the concentration that results in the contrast to noise ratio].
Re claims 5, 6: Gay discloses the metal is a precious metal chosen from the group consisting of gold (Au), iodine (I), gadolinium (Gd), iron (Fe), barium (Ba), calcium (Ca), magnesium (Mg),and combinations thereof [0149; see the Gadolinium].
Re claims 7, 9: Gay discloses the first visual additive further comprises one or more microbubbles [0150; see the microbubbles in the additives].
Re claim 8: Gay discloses the composition comprises a second visual additive different than said first visual additive [0149; see the “combination” of additives that can be selected].
Re claims 10, 11: Gay discloses a concentration of said first visual additive in said viscoelastic medium is less than 90 mg/ml and is between 15 mg/ml and 30 mg/ml [0149; see the 0.1-15% concentration which is about 0.5-6 mg/ml].
Re claim 12: Gay discloses the composition is configured to not substantially migrate prior to or during imaging, wherein the imaging occurs about 3 months to about 9 months after the composition is disposed [0121; the composition remains for 2 weeks to 2 years].
Re claim 13: Gay discloses the composition is configured to be disposed through injection [0118; see the injection of the composition].
Re claim 14: Gay discloses the viscoelastic medium comprises hyaluronic acid, polyethylene glycol, or dextranomers [0118; see the hyaluronic acid].
Re claim 15: Gay discloses a concentration of said hyaluronic acid, polyethylene glycol, or dextranomers in said viscoelastic medium is between about 5 mg/ml to about 100 mg/ml [0135; see the 5-100 mg/ml concentration].
Re claim 16: Gay discloses the viscoelastic medium comprises gel particles, wherein said gel particles comprise said metal particles [0122; see the gel with metal additive].
Re claim 17: Gay discloses the viscoelastic medium comprises non-animal stabilized hyaluronic acid ("NASHA") [0122; see the NASHA].
Re claim 18: Gay discloses the viscoelastic medium is injected one time every six months over a period of at least 12 months [0100, 0140; see the subsequent injections].
Re claim 19: Gay discloses the viscoelastic medium is completely resorbed within 20 months [0121; see the reabsorption of the medium].
Re claim 20: Gay discloses the composition is configured to be detectable on an imaging modality for at least 9 months [0121; see the imaging detections for at least 9 months].
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7, 8, 10-14, and 16-18 of copending Application No. 17/522,674 in view of Higham (EP 1407729 cited by applicant with citations made to corresponding US Pub 2004054413). ‘674 recites a method of injecting an imaging contrast composition, said composition comprising: a viscoelastic medium; and a first visual additive, wherein said first visual additive is a metal. ‘674 recites other features including gel particles, hyaluronic acid, and imaging the tissue site, but does not recite the metal having a particle diameter greater than about 80 micrometers. However, Higham teaches of a hydrogel implanted comprising a metal such as gold or tungsten as radiopaque material for x-ray visualization wherein the metal powder has a diameter between 10-100 microns [0073]. It would have been obvious to the skilled artisan to modify ‘674, to have the additive with diameter greater than 80 microns as taught by Higham, as such is well known and would permit x-ray visualization.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797
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