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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/30/26 has been entered.
The response filed on 7/30/26 presents remarks and arguments to the office action mailed on 4/30/26. Applicant’s request for reconsideration of the rejection of claims in the last office action has been considered.
Applicants’ arguments have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 9-11 and 15-17 are pending and under examination in this office action.
Modified Claim Rejections - 35 USC § 103 necessitated by amendment
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.
Claim(s) 9-20 is/are rejected under 35 U.S.C. 103 as being unpatentable Day et al. (US 5011677) in view of Zhang et al. (CN 112499976) and Peng et al. (US 2011/0206603) and further in view of Liu et al. (CN 110227170).
Day teaches with regards to instant claim 9 and 15 a method of preparing radioactive glass microsphere (see col.3, lines 22+), with a foam-like foam like structure bodies (see col. 5, lines 30+) by mixing and the glass and melting to form glass (see col. 7, lines 39+) and cooled (see col. 8, lines15+) wherein the glass microspheres comprise AL2O3 (see col. 5, lines 10+, as required by instant claim 10 and 16) and the nuclide oxide Y2O3 (as required by instant claims 10-11 and 17, see col. 5, lines 10+) wherein the glass microsphere comprises 0-40% Al2O3, 20-80% SiO3 10-30%Y2O3 (a nuclide oxide) 0% B2O3), as required by instant claim 9, see same) heating at 1,500-1,600 as required by instant claim 15-16s 10 and) with a particle size of 20-30 micrometers (see col. 7, lines 10+, as required by instant claims 14 and 20 and a density of 2.0 g/cm3 (see Table 3, col 12) and cooled.
However, Day fails to teach that the preparation method is for embolization and also fails to teach the preparation also comprises a polyethylene glycol and /or polyvinyl alcohol (as required by instant claim 15 and fails to teach that the foaming comprises Na2SO4 etc. as recited in claim 9. With regards to instant claim 15, Day did not teach an inclusion of a foaming agent, therefore the preparation of claim 15(a) will be void od adding a forming agent as required as one of ordinary skill in the art would have not added a foaming agent at that point. Adding the foaming agent in b would be obvious as taught by Zhang below.
Zhang teaches a method of preparing radioactive glass microsphere (see abstract, as required by instant claim 9) comprising melting by heating (see under Embodiment 1), cooled and remelted, wherein the glass microsphere comprises a nuclide oxide Y2O3 (as required by instant claim 11) and comprise strontium carbonate (SrCo3 a foaming agent), as required by instant claim 9), wherein the heating step is performed at a temperature 1350 degrees centigrade -1600 degrees centigrade (as required by instant claims 9, 15).
Peng) teaches the use of radioactive glass microspheres (see 0006) for embolization (see 0009). Therefore, it would have been obvious to one of the ordinary skill in the art to have used the teachings above for embolization with a reasonable expectation of success.
Liu et al. (CN 110227170) teaches radioactive microsphere (see title) for embolization (see 2nd para under background) comprising Y2O3-Al2O3-SiO2 glass, polyethylene glycol.
It would have been obvious to one of ordinary skill in the art to have combined the cited art to result in the instant claimed invention with a reasonable expectation of success because the preparation as recited above can be used for embolization because both Peng and Liu teach that the art recognizes the use of radioactive microspheres for embolization. Therefore, one of the ordinary skill in the art would have incorporated the teachings of both Peng and Liu into Day to result in the method of preparing a radioactive glass microsphere comprising Al2O3, a nuclide oxide wherein the combination would result in the density, particle size recited by the instant claims.
Applicant argues that Day's core objective is to manufacture substantially void-free solid radioactive glass microspheres for radiotherapy, with foam-like structures disclosed only as a minor, non- preferred alternative embodiment (col.4, lines 10-20). Day never teaches or suggests intentionally pre-blending inorganic foaming agents into glass raw materials before primary melting to generate internal sealed cavities, nor does Day disclose microspheres with density as low as 1.4-2.3 g/cm3. All none of the cited references employed a foaming agent to create a low density, cavity-containing microsphere for embolism.
In response, Applicant should note that this rejection is a rejection under 35 USC 103, Although the Dave’s teaching does not specify that the preparation of the glass microspheres is for embolization. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggests the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (see MPEP 2144).
Applicant argues that Zhang discloses yttrium-containing glass microspheres with SrCO3 as a static glass matrix component, not a thermally decomposable foaming agent for cavity generation.
In response this is found unpersuasive as they can be their own lexicology and note that if the same agent is used without the term does not strip away its property as stated in the MPEP 2112.01 “Products of identical chemical composition cannot 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), “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.
In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." Therefore taking the teaching of Zhang that the glass microsphere comprises a nuclide oxide Y2O3 (as required by instant claim 11) and comprise strontium carbonate (SrCo3), as required by instant claim 9), wherein the heating step is performed at a temperature 1350 degrees centigrade -1600 degrees centigrade (as required by instant claim 13) with the teaching of Dave wherein the particle size of 20-30 micrometers (see col. 7, lines 10+, as required by instant claims 14 and 20 and a density of 2.0 g/cm3 (see Table 3, col 12).
Applicant acknowledges that Peng teaches that radioactive microspheres are suitable for embolization as a general field use case. The reference contains zero disclosure of glass melting formulas, foaming additives, cavity-forming manufacturing processes, or density control mechanisms. Again, as stated supra-Applicant should note that this is a rejection under 35 USC 103 and the cited references should be considered in totality.
Lastly the argument that Day discourages internal voids and provides no incentive to add dedicated foaming chemicals to reduce density.
2. Zhang's SrCO3 cannot function as a foaming agent and produces high-density microspheres incompatible with embolization fluid distribution requirements.
3. Liu's PEG/PVA is only for post-forming surface coating, not high-temperature foaming.
4. Peng merely states the field of use without any process improvement teaching.
As stated above and reiterated here, The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggests the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (see MPEP 2144).
Careful consideration has been given to the argument and found unpersuasive.
No claims allowed.
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHIRLEY V GEMBEH/ Primary Examiner, Art Unit 1615 10/28/2026
