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 .
Claim Status
The claims are not amended.
Response to Arguments
Applicant's arguments filed 4/20/26 have been fully considered but they are not persuasive in-part and persuasive in-part.
Pages 6-7 of the remarks argue the following:
Tsai teaches a radioactive microsphere and a method for preparing the same. Tsai states that the method includes "melting a mixture comprising glass powder represented by a chemical formula Ca₃Si₂O7 and yttrium oxide powder to form glass," "grinding the glass to obtain glass fine grains," and "flame spraying the glass fine grains to form a radioactive microsphere." (Tsai, claim 12). Tsai further states that the radioactive microsphere may include "a coating layer formed on a surface of the glass," and that the coating layer may include poly-vinyl-pyrrolidone and other listed coating materials. (Tsai, " [0026], [0030]). Thus, Tsai teaches a glass microsphere having an outer coating layer.
The Office argues that Tsai teaches a radioactive microsphere composition comprising a radioactive compound mixed with glass powder and further argues that "[t]o the glass material, there is a coating layer (para. 26), which can include a polymer coating layer (para. 30)." (Office Action, pp. 3-4). However, even accepting that mapping of elements for purposes of argument, Tsai still teaches, at most, a single coated microsphere. That is, Tsai teaches one glass microsphere with one outer coating layer on its surface. Tsai does not teach or suggest "fragments encapsulated within a non-porous substrate material," as recited in claim 1, or "encapsulating fragments within at least one non-porous substrate material," as recited in claim 15. In particular, the claim term "fragments" is plural, while Tsai, at most, can be considered to teach a single microsphere that is coated. Accordingly, Tsai's single coated microsphere is inconsistent with the claim term "fragments" in claims 1 and 15.
The remarks are respectfully not persuasive. Tsai teaches that the waste includes multiple radioactive microspheres (see para. 26 of Tsai and Figures 1 and 2).
Next, the remarks argue on pages 7-8, the following:
Consistent with this, Tsai's teachings are directed to forming individual coated microspheres, not to forming multiple fragments and then encapsulating those multiple fragments within a common polymer substrate body. Tsai states that the glass fine grains are flame sprayed "to form a radioactive microsphere," and that the coating layer is formed "on a surface of the glass." (Tsai, T [0026]; claim 12). In other words, Tsai teaches coating the exterior of an individual microsphere. There is no teaching or suggestion in Tsai of multiple "fragments encapsulated within a non-porous substrate material," nor any teaching or suggestion of encapsulating multiple fragments within such a substrate material, as set forth in claims 1 and 15, and illustrated in FIGS. 2A and 2B, which depict multiple isotope fragments 206 encapsulated in the substrate material 204:
The Office's position that Tsai's coating layer can be considered the claimed substrate does not address the additional quoted elements of claims 1 and 15. Even if Tsai's glass microsphere could be considered a fragment, Tsai still teaches only a single coated microsphere, not multiple microspheres encapsulated within a coating. Nor does the Office identify where Tsai teaches or suggests a non-porous substrate material that encapsulates multiple fragments, as opposed to simply coating the exterior of one microsphere.
The remarks are respectfully not persuasive for the following reasons. As mentioned, Tsai teaches multiple fragments and encapsulating those multiple fragments (see above and the rejection under Tsai). Returning to the claims, Claim 1 requires that there are “fragments encapsulated within a non-porous substrate material comprising at least one polymer” and that the fragments comprise particles disposed within at least one glass matrix”. The remarks argue that individual microspheres do not conform to the claims, but this not consistent with the language of Claim 1. Furthermore, Tsai also discloses the claimed features, but the argument that Tsai teaches individually coated microspheres would not prevent this reference from reading on the claims even if it had been limited in this way.
Next, the remarks argue the following:
Nor does AHL cure these deficiencies. As applied in the Office Action, AHL is cited only for half-life information. (Office Action, p. 3). Those teachings do not provide, and are not relied upon to provide, any teaching or suggestion of multiple fragments encapsulated within a non-porous polymer substrate.
Since none of the cited references, when combined, teach or suggest all the elements of independent claims 1 and 15, claims 1 and 15 are not obvious considering the cited references.
The remarks are not persuasive. AHL is an evidence reference, which was used to for the limited teaching of half-life duration.
Next, page 8 argues the following:
The Office argues that "Tsai teaches that the polymer coating can include polyvinyl pyrrolidone." (Office Action, p. 5). However, polyvinyl pyrrolidone is not an aromatic polyamide. An aromatic polyamide is a polymer having aromatic groups in the polymer
backbone linked by amide linkages. Polyvinyl pyrrolidone, by contrast, is a vinyl polymer
having a carbon-carbon backbone and does not have aromatic groups linked by amide linkages in the polymer backbone. Thus, even accepting the Office's identification of polyvinyl pyrrolidone in Tsai, Tsai still does not teach or suggest "wherein the at least one polymer of the non-porous substrate material comprises an aromatic polyamide," as recited in claim 9.
AHL does not cure that deficiency. AHL is cited for half-life information, not polymer composition. Accordingly, Tsai and AHL do not teach or suggest all the elements of claim 9, and claim 9 is independently allowable over Tsai in view of AHL.
These remarks are persuasive and the rejection to adjusted below.
Next, the remarks argue on page 10, the following:
Furthermore, claim 10 is independently allowable because Tsai, AHL, and Day do not teach or suggest "wherein the structure is substantially rectangular with a substantially planar upper surface," as recited in claim 10. The Office acknowledges that Tsai "does not describe the shape of the microsphere to be substantially rectangular." (Office Action, pp. 5-6). The Office relies on Day only for the proposition that glass compounds can be shaped into rectangles "prior to forming spheres," and reasons that it would have been obvious to shape the radioactive-glass material into rectangles as an intermediate form before sphere formation. (Office Action, pp. 5- 6). However, this rationale does not teach or suggest the final structure recited in claim 10. At most, Day teaches a temporary intermediate form that is subsequently converted into spheres. In other words, Day does not provide any teaching or suggestion, or any articulated reason, to modify Tsai so as to retain a substantially rectangular form with a substantially planar upper surface in the final article. To the contrary, the Office's own characterization of Day confirms that the rectangular form is merely a precursor on the way to a sphere. Thus, claim 10 is not obvious considering Tsai in view of AHL and Day.
Accordingly, Applicant requests withdrawal of the 35 U.S.C. § 103 rejection of claim 10.
This rejection is persuasive and adjusted below.
Next, pages 11-12 argues the following:
Claim 13 depends from and includes all the elements of claim 1. As discussed above,
claim 1 is not obvious considering Tsai in view of AHL at least because the cited references do not teach or suggest all the elements recited in claim 1. Moharrer and Moon do not cure the deficiencies of the cited references.
The Office argues that "Moharrer describes a method of processing medical wastes. This waste is then further encapsulated in a polymer material to form pellets and solidified. Moharrer does not specifically state that the medical waste fragment is distributed across the pellet in the form of a gradient. Moon describes an absorbing radioactive material that employs fibers used in a density gradient. Moon explains that the difference in density gradient between the fibers and the adsorbent improves the waste retention." (Office Action, p. 7).
However, neither Moharrer nor Moon teaches or suggests multiple fragments encapsulated within a non-porous substrate material. Furthermore, there are no teachings or suggestions in Tsai, AHL, Moharrer, and Moon that would motivate a person of ordinary skill in the art to modify the teachings of any of the cited references in any way that would result in the elements recited above.
Furthermore, claim 13 is independently allowable because Tsai, AHL, Moharrer, and Moon do not teach or suggest "wherein the fragments are distributed across the structure to provide a gradient of radioactivity across the structure," as recited in claim 13. The Office acknowledges that Moharrer "does not specifically state that the medical waste fragment is distributed across the pellet in the form of a gradient." (Office Action, p. 7). The Office relies on Moon only for the proposition that a "difference in density gradient between the fibers and the adsorbent improves the waste retention," and reasons that "the different density gradients used to stabilize the waste produces a different waste gradient in the stabilizing structure." (Office Action, p. 7). However, that rationale does not teach or suggest the element recited in claim 13.
Moon is directed to a multilayer radioactive material adsorption material in which a first fiber layer and a second fiber layer are used to improve retention of an adsorbent. Moon states that the radioactive material adsorption material includes a first fiber layer and a second fiber layer laminated on the first fiber layer, and that the retention of the adsorbent is improved through the difference in density gradient between the fiber layers and the adsorbent. (Moon, IT [0023], [0063]-[0069]). In other words, Moon's density gradient concerns the relative densities of fiber layers and adsorbent in a multilayer filter-like material to improve adsorbent retention.
Moon does not teach or suggest distributing radioactive fragments across a structure so as to provide a gradient of radioactivity across the structure.
Accordingly, even if Moon were combined with Moharrer, Tsai, and AHL, the cited references still would not teach or suggest the element recited in claim 13. At most, Moon teaches using a density gradient in a multilayer adsorption material to improve retention of an adsorbent. That is not a teaching or suggestion of a gradient of radioactivity across a solid structure. Nor does the Office identify any articulated reason why a person of ordinary skill in the art would have modified Moharrer's stabilized waste form based on Moon's adsorbent-retention technique so as to arrive at the claimed distribution of fragments across the structure.
Since the cited references, when combined, do not teach or suggest all the elements of claim 1, claim 1 is not obvious considering the cited references.
The remarks are persuasive and adjusted accordingly.
The remarks then argues on pages 14-15, the following:
As discussed above, Tsai and AHL do not teach or suggest "fragments encapsulated
within a non-porous substrate material comprising at least one polymer, the fragments comprising particles disposed within at least one glass matrix material." Moharrer does not cure these deficiencies.
Moharrer teaches "a method comprising melt mixing an encapsulation composition
comprising a nonbiodegradable thermoplastic polymer and a wax with the radioactive and/or hazardous waste, thereby encapsulating the waste in the encapsulation composition." (Moharrer, T [0060]). Moharrer further explains that the melt mixing feature "advantageously enables a uniform distribution of waste products within the polymer and wax blend" and that "[u]pon cooling, the melt-mixed composition produced according to this method forms a solid, unitary mass of the polymer and wax blend in which the radioactive and/or hazardous waste is safely encapsulated.' (Id., 1 [0061]) (emphasis added). Moharrer also characterizes the polymer and wax blend as providing an "encapsulating matrix." (Id., I [0061]). Thus, Moharrer's melt-mixing process is directed to producing a single monolithic/unitary waste form from a melt-mixed polymer/wax matrix containing waste.
The Office further argues that Moharrer teaches that containers "may be stored in a space or a facility," and that storing multiple structures would have been obvious based on duplication of parts. (Office Action, pp. 9-10). However, Moharrer's teachings regarding storage of stabilized waste in a storage site or facility do not teach or suggest "selectively placing, in a facility, multiple removable structures," as recited in claim 17. Storing a waste container for subsequent storage is not the same as selectively placing multiple removable structures in a facility as part of a method of simulating a radioactive contamination environment.
The remarks are respectfully not persuasive. The features of stabilizing the waste in Moharrer were not relied on for the rejection, because the storage features are already disclosed in by the Tsai reference. Moharrer is relied upon to disclose the storage features.
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.
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) 1, 2, 3, 5, 6, 7, 11, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai (US Pub.:2020/0155715) and evidenced by the University of Alabama “Accepted Half-Lives of Commonly Used Radioisotpes” (AHL).
As to Claims 1, 5, 11 and 15, Tsai describes a radioactive microsphere composition (para. 8) comprising uniformly mixing a radioactive compound with a glass powder (para. 47) that is melted (para. 47). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that there are no pores. Some of the radioactive compounds have a half-life between one year to thirty years (see para. 21, see cobalt-60).
To the glass material, there is a coating layer (para. 26), which can include a polymer coating layer (para. 30). The radioactive isotope used are many (para. 21), but can include cobalt 60, which has a half life of about 5 years (see the “Accepted Half-Lives of Commonly Used Radioisotpes” attached).
Since glass is not porous, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the same composition used the same way would substantially have no pores.
As to Claims 2 and 3, Tsai teaches that the glass material is a microsphere (para. 42, 43), which can be considered “encapsulated within” and the outside of the microsphere can be considered a shell.
As to Claim 6, Tsai teaches that the polymer material coats the glass and radioactive mixture (see above). Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the radioactive material can be considered embedded within the substrate.
As to Claim 7, Tsai teaches that the radioactive material is mixed with the glass material (see above). To the glass material, there is a coating layer (para. 26), which can include a polymer coating layer (para. 30). The coating material contains the radioactive material inside. Therefore, the one side of the coating can be considered a first region and the other side of the coating can be considered a second region.
Claim(s) 4, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai and evidenced by AHL as applied to claims 2 or 15 above, and further in view of Gray (US Pub.: 2019/0175768).
Gray teaches that alumina and silica in the glass components can be activated to undesirable radionuclides when placed in a neutron beam (para. 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the glass of Tsai and evidenced by AHL includes silica, as taught by Gray, which facilitates containment of the waste.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai and evidenced by AHL as applied to claim 11 above, and further in view of Boyd (EP 3223867).
Tsai describes use of radioactive microsphere to use in tumor treatment (para. 1), but does not describe use of one of the compounds in Claim 12.
Boyd describes radioactive polymeric and glass particles used for treatment of biological issues, particularly tumors (para. 2). The radioactive compound can include Europium-152 (table 78). Further, the particles used for treatment is a glass microsphere (para. 67), which can include a glass particle that can include both irregular particles and beads (para. 70).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ Europium-152, as taught by Boyd for use with the glass beads of Tsai and evidenced by AHL because this radiological compound is known to be used to treat tumors.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai and evidenced by AHL as applied to claim 1 above, and further in view of Moharrer (CN 108292537), EPO translation, and further in view of Ota (JP 2015/028473).
Tsai and evidenced by AHL describes a radioactive composition but does not describe stabilizing the compound after use in the form of medical waste.
Moharer describes a method of processing medical wastes (para. 50). This waste is then further encapsulated (para. 51) in a polymer material to form pellets and solidified (para. 130).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to stabilize used radioactive composition into encapsulated pellets, as taught by Moharer for use with used radioactive composition of Tsai and evidenced by AHL because these compounds require safe disposal after use.
Moharer does not specifically state that the medical waste fragment is made to have a dimension of at least about 0.1cm.
Ota describes an absorbent for radioactive substrates (title). The material includes a base material used to encapsulate the waste (“see page 4, last para). Ota explains that the shape of the adsorbed materials can be in the form of pellets, balls, granules (page 7, para. 1). The size can range from 10nm to 5,000µm (page 7, para. 4). The adsorbent material can be a polymeric composition (page 5, last para.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to shape the pellets of Moharer used to stabilize medical radioactive waste into a size of 10nm to 5,000µm, as taught by Ota for use with Tsai and evidenced by AHL because this size range is effective for encapsulating radioactive waste using adsorbent materials.
Claim(s) 4, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai and evidenced by AHL as applied to claims 2 or 15 above, and further in view of Gray (US Pub.: 2019/0175768).
Gray teaches that alumina and silica in the glass components can be activated to undesirable radionuclides when placed in a neutron beam (para. 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the glass of Tsai and evidenced by AHL includes silica, as taught by Gray, which facilitates containment of the waste.
Claim(s) 17, 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai (US Pub.: 2020/0155715) and evidenced by the University of Alabama “Accepted Half-Lives of Commonly Used Radioisotpes” (AHL) and in view of Moharrer (CN 108292537), EPO translation.
Tsai describes a radioactive microsphere composition (para. 8) comprising uniformly mixing a radioactive compound with a glass powder (para. 47) that is melted (para. 47).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that there are no pores. Some of the radioactive compounds have a half-life between one year to thirty years (see para. 21, see cobalt-60).
To the glass material, there is a coating layer (para. 26), which can include a polymer coating layer (para. 30). The radioactive isotope used are many (para. 21), but can include cobalt 60, which has a half-life of about 5 years (see the “Accepted Half-Lives of Commonly Used Radioisotopes” attached).
The reference does not describe storing this radioactive contaminant.
Moharer describes a method of processing medical wastes (para. 50). This waste is then further encapsulated (para. 51) in a polymer material to form pellets and solidified (para. 130). AS to the storage feature, Moharrer teaches that the containers may be stored in a space or a facility (para. 211, 207, storage site). As to storing multiple, this is not taught.
As to storing multiple structures, Moharrer teaches storing one container, but does not specifically state storing multiple. However, it has been held that duplicating a feature of a claim is obvious in the art. See MPEP section 2144.04: Duplication of Parts: In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a “web” which lies in the joint, and a plurality of “ribs” projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to stabilize and store medical waste in the method described by Moharrer, for use with the medically-used radioactive compound of Tsai and AHL, after the radioactive material is used and becomes waste as a safe means to secure the composition.
As to Claim 18, Tsai, AHL and Moharrer do not describe spraying of any liquid solutions.
As to the features of Claim 19, Moharrer teaches storing the waste in a storage facility (see above). The reference states that in some cases, the waste can be stored in water or underground (para. 12) or in a facility (para. 13) or in a near-surface landfill facility (para. 104). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that although the reference does not mention storing the waste on the floor in the facility that this is one viable option when storing containers in a facility unless otherwise stated.
Claim(s) 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai, AHL and Moharrer as applied to claim 17 above, and further in view of Moir (JP 2019/045148).
The references do not describe the features of Claims 19 and 20.
As to Claim 19, Mori teaches storing contains 13 (abstract), but does not describe storing multiple contains. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the storage. See MPEP section 2144.04: duplication of parts, citing In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). As to storing in an indoor facility, Mori teaches storing the contains, but does not specifically state that they are stored in an indoor facility. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that Mori means storing in an indoor facility when they describe storing the devices.
Nonetheless, Mori states that use of a radioactive material removal device (title) used to remove radioactive iodine (page 2, last para). The device is removable and the filters used within the casing are removable (title and Figure 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the adsorbed-radioactive material in a structure that is removable, as taught by Mori for use with the structure and composition of Tsai, AHL and Moharrer because use of a removal device is known to effectively optimize the storage of radioactive material sorbed using adsorbents.
As to Claim 20, Moir describes storing the device (page 5, para. 2) and that the stored device can be moved (para. 5, para. 2).
REASONS FOR ALLOWANCE
Claims 9, 10 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
As to Claim 9, Tsai teaches that the polymer coating can include polyvinyl pyrrolidone (para. 30), but does not describe use of an aromatic polyamide.
As to Claim 10, Day teaches making microspheres of radioactive energy but does not teach forming rectangles as a final structure.
As to Claim 13, Tsai does not teach formation of a gradient of fragments across the structure.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHENG HAN DAVIS whose telephone number is (571)270-5823. The examiner can normally be reached 9-5:30.nnExaminer 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.nnIf attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fung Coris can be reached at 571-270-5713. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHENG H DAVIS/Primary Examiner, Art Unit 1732 May 19, 2026
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