DETAILED ACTION
Claims 1-8 are pending, of which claims 4-8 have been withdrawn.
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 with traverse of Group I in the reply filed on 8/20/25 is acknowledged. The traversal is on the ground(s) that Groups I and V possess unity of invention.
Applicant argues that JP 2016035032 (“Otsuka”) cited in the restriction requirement lacks a conception overlap with the present invention. Applicant argues that the present invention is directed to synthesis of lutetium borate and the preparation of colloidal solutions thereof. Applicant argues that Otsuka lacks a teaching or enabling disclosure regarding either the synthesis of the lutetium borate or the preparation of their colloidal forms.
This argument is not persuasive. Group I recites a method of synthesis of lutetium borate. Group V recites a method of using lutetium borate. The claims of Group I do not require that the synthesized lutetium borate be used in forming a colloidal material, and the claims of Group V do not require any specific synthesis of the starting lutetium borate. The only technical features the two groups share is that both require lutetium borate. However, as lutetium borate is known in the art as shown in the restriction requirement, this technical feature cannot be considered a special technical feature for the purposes of unity of invention. As indicated in the restriction requirement, Groups I and V do not share any special technical features.
The requirement is still deemed proper and is therefore made FINAL.
Claims 4-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/20/25.
Drawings
The drawings are objected to because each of FIG.’s 1-5 contain text and numbers that is far too small or blurry to be read. 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 § 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 1-3 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.
The term “plenty of water” in claim 1 is a relative term which renders the claim indefinite. The term “plenty of water” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, it is unclear how much water is required to be used.
Claim 1 recites the limitation "the reaction flask" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the solid part" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 also recites the limitation "the precipitated solid part" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the centrifuge" in line 18. There is insufficient antecedent basis for this limitation in the claim.
In step a, claim 1 recites dissolving lutetium nitrate in water. However, in step b, claim 1 recites adding sodium hydroxide or sodium carbonate and boric acid or borate solid into “the water in a separate container.” It is unclear how the same water can be used in each step while being in different containers. Examiner believes that claim 1 is referring to a separate amount of water in step b. However, appropriate clarification is required.
In step c, claim 1 requires that the solution from step a and a surfactant solution are added together. However, in step d, claim 1 recites that either the solution from step a or the solution from step c can be used. It is unclear how the solution from step a can be used in step d when step c uses the solution from step a to form a separate solution. For the purposes of examination, step d of claim 1 is interpreted as only allowing the use of the solution from step c.
Claims 2-3 depend from claim 1 and therefore inherit the same indefiniteness as claim 1.
Claim Rejections - 35 USC § 103
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 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 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over WO2020091699 (“Sahin”).
The applied reference has a common 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 claim 1, Sahin teaches a method of synthesizing a lanthanide borate (see e.g. page 7, lines 4-5 and claim 1). Examiner notes that the term “nanostructured” recited in claim 1 is not defined or even discussed in the Specification. As such, the broadest reasonable interpretation of “nanostructure” is any nano-sized particle. Sahin teaches that the particles are nano-sized and therefore meets the limitation of “nanostructured” (see e.g. page 7, line 4).
The method of Sahin includes the steps of preparing a lanthanide nitrate solution by dissolving the lanthanide nitrate compound in water (see e.g. page 7, lines 12-14). Sahin further teaches adding sodium hydroxide and boric acid into water in a separate container and mixing (see e.g. page 7, lines 8-11). Although Sahin does not specifically teach that the solution is mixed until transparent, one of ordinary skill in the art would understand that Sahin allows full mixing of the solution, and that this would result in a transparent solution. Sahin teaches adding a solution of a surfactant, namely polyethylene glycol, which is biocompatible and water soluble (see e.g. page 7, lines 28-30). Sahin does not specifically teach that the solution is formed at the saturation limit. However, given that Sahin teaches that the product is obtained by precipitation, one of ordinary skill in the art would use saturated or nearly saturated solutions in the synthesis to more effectively precipitate the products. Sahin teaches that the ratio of metal-nitrate to surfactant is 1:1.5 (see e.g. page 8, lines 9-11). Although 1:1.5 is not one of the specific ratios claimed, given that the prior art ratio is directly in between two of the recited ratios, either or both of the recited 1:1 or 1:2 ratios is considered obvious.
Sahin teaches that the lutetium nitrate – YAM solution is added to the borate solution under a mechanical mixer and stirred for a half hour at constant speed (see e.g. page 7, lines 15-18). Sahin teaches that the borate buffer solution is initially at a pH of between 8 and 9.5, but does not teach the ending pH (see e.g. page 7, lines 21-24). However, given that Sahin uses the same sodium hydroxide to boric acid ratio as described in the instant application and the same or similar ratio of lanthanide nitrate, one of ordinary skill in the art would understand that the pH at the end of the reaction in Sahin will be the same as the pH at the end of the method recited in claim 1.
Sahin teaches washing the solid obtained with distilled water (see e.g. page 7, lines 18-19). Given that Sahin teaches that the washing removes the impurities, Sahin is considered to teach using “plenty of water.” Sahin then teaches drying the obtained solids for 24 hours at 60 °C (Id.). Although this temperature is slightly lower than the claimed temperature of 70 °C, given how close the values are the temperature of Sahin is considered to render the claimed temperature of 70 °C obvious, particularly as the instant application does not provide any data showing that the drying temperature is important.
Although Sahin teaches that the method is to make lanthanide borates, the specific examples provided by Sahin are directed to dysprosium or erbium borate (see e.g. page 7, lines 4-5). However, given that Sahin clearly teaches and even claims the use of lanthanide borates without requiring the lanthanide to be limited to erbium or dysprosium (see e.g. claim 1), prior to the effective filing date it would have been obvious to a person of ordinary skill in the art to use lutetium as the lanthanide in the method of Sahin to expand the types of lanthanide borates that can be made.
Regarding claim 3, Sahin teaches that the surfactant in step (c) is polyethene glycol (see e.g. page 7, lines 28-30).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sahin as applied to claim 1 above, and further in view of CN 102229838 (“Huang”, machine translation used for citations).
Regarding claim 2, Sahin teaches the limitations of claim 1 as described above. Sahin fails to teach that the borate used in step (b) is Na2B4O7.10H2O, closed formula. Examiner notes that the recited formula is commonly known as borax.
Huang teaches a method for making cerium borate, which is a lanthanide borate similar to that made by the method of Sahin (see e.g. paragraph [0001]). Similar to Sahin, Huang teaches reacting a borate compound with the lanthanide nitrate, in this case, cerium (see e.g. paragraphs [0010]-[0011]). Although Sahin teaches that the borate solution is formed by mixing sodium hydroxide and boric acid in water, Huang teaches that the borate solution is formed by dissolving borax in water (see e.g. paragraph [0010]). However, both methods would be understood to result in the same sodium borate solution being added to the lanthanide nitrate. Per MPEP § 2143(I)(B), a simple substitution of one known element for another to yield predictable results is prima facie obvious. Here, the method of Sahin differs from the claimed method in the use of solid borax rather than a boric acid and sodium hydroxide solution. Per Huang, it was known in the art that solid borax can be used for the same type of reaction. Accordingly, prior to the effective filing date of the invention, it would have been obvious to a person of ordinary skill in the art to use borax as taught by Huang in the method of Sahin to obtain predictable results.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12,139,415. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 11 of the reference patent depends from claim 1 and therefore contains all the limitations of claim 1. As such, claim 11 of the reference patent recites a method of making lanthanide borate, which would include lutetium borate (see e.g. claim 1), comprising the steps of: preparing the lanthanide nitrate solution by dissolving the lanthanide nitrate in water (claim 1, lines 6-7), preparing a borate solution by mixing sodium hydroxide and boric acid in water (claim 1, lines 3-5), mixing a surfactant and the nitrate solution (claim 11, note that the PEG used in the reference patent is a biocompatible and water soluble surfactant), mixing the borate and nitrate solutions (claim 1, lines 8-9), and washing and drying the product (claim 1, line 10).
Conclusion
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/E.S.S./Examiner, Art Unit 1736
/ANTHONY J ZIMMER/Supervisory Patent Examiner, Art Unit 1736