DETAILED ACTION
Status of Claims:
Claims 1, 6-11, 15-18, and 22-25 are pending.
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 .
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 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 12,429,611. Although the claims at issue are not identical, they are not patentably distinct from each other because: The claims of the patent disclose Sutterlin teaches the separation method used for separating the substances in a mixture via a separation column, wherein the separation method comprises the steps of: charging radioactive substance in the column a column inlet with an acid of certain molarity, the radioactive substance accumulating in the top portion of the body of the column, more specifically at a column inlet end, more specifically at a charging section, directing the acid used for charging to the drain (waste effluent) via a column outlet, changing the molarity of the acid introduced to the column inlet, and thus, enabling the charged radioactive materials desired to be subjected to separation to move inside the column, more specifically inside a separation section, and after the start of said movement, a radioactivity detector detecting the activity of the mixture within the separation section (scanning process) (see claim 15).
Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. 18/706,676 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 19 of the copending application includes all the limitations of instant claim 24 and the additions limitations (such as a column assist inlet) are not excluded from the instant claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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, 6-11, 15-18 and 22-25 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.
Regarding Claim 1:
The claim states “in other words a charging section…in other words a separation section”. The phrase “in other words” renders the claim indefinite because it is not clear if the limitations that follow are intended to add patentable weight to the claim or not.
The claim states “the column comprises at least two section…which has a larger cross-sectional area compared to the other section”. There is insufficient antecedent basis for “the other section”. It is not clear “the other section” is referring to all other sections of the “at least two”, at least one of the “at least two”, or something else.
Regarding Claim 6:
The claim refers to “the inlet section” and “the outlet section”. There is insufficient antecedent basis for these limitations within the claims. It is not clear if the inlet and outlet sections are being required in addition to the first section and second section or if the correspond to the first and second sections.
Regarding Claim 7:
The claim refers to “the inlet section” and “the outlet section”. There is insufficient antecedent basis for these limitations within the claims. It is not clear if the inlet and outlet sections are being required in addition to the first section and second section or if the correspond to the first and second sections.
Regarding Claim 10:
The claim refers to “the inlet section” and “the outlet section”. There is insufficient antecedent basis for these limitations within the claims. It is not clear if the inlet and outlet sections are being required in addition to the first section and second section or if the correspond to the first and second sections.
Regarding Claim 22:
The claim refers to “the acid”. There is insufficient antecedent basis for this limitation within the claims.
Regarding Claim 24:
The claim uses the phrase “more specifically”. This phrase renders the claim indefinite because it is not clear if the limitations that follow are intended to add patentable weight to the claim or not.
The claim refers to “the drain”. There is insufficient antecedent basis for this limitation within the claim.
The claim refers to “the separation system”. There is insufficient antecedent basis for this limitation within the claims.
The remaining claims are indefinite because they depend from indefinite claims.
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, 6-8, 15-18, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guan et al (CN 1361180, English machine translation provided).
Regarding Claim 1:
Guan teaches the separation column used for separating the substances in a mixture wherein the column comprises at least two sections having different cross-sectional areas, wherein the column is a column comprising a first section, in other words a charging section (near the inlet), which has a larger cross-sectional area compared to the other section (2R about 10 mm), and a second section (near the outlet), in other words a separation section, which has a smaller cross-sectional area (2R about 3mm) compared to the first section, in other words the charging section (see Abstract).
Regarding Claim 6:
Guan teaches the separation column according to claim 1, wherein the cross-sectional area of the inlet section of the column is larger than the cross-sectional aeras of the outlet section (see Abstract, fig. 1).
Regarding Claim 7:
Guan teaches the separation column according to claim 1, wherein the column is a column, the cross-sectional area of which linearly (uniformly) decreases from the inlet section towards the outlet section (see Abstract, fig. 1).
Regarding Claim 8:
Guan teaches the separation column according to Claim 7, wherein is a column, in which the cross-sectional area is at a maximum in the inlet section, the cross-sectional area linearly decreases towards the outlet section and the cross-sectional area is at a minimum in the outlet section (see Abstract, fig. 1).
Regarding Claims 15-18:
Guan teaches the separation column according to claim 1. Guan is silent towards the use of the column for the separation of rare earth metals, radioactive substances, lutetium and ytterbium, and ytterbium 176 isotope and lutetium 177 isotope. However the materials separated by the column is the intended use of the column and only adds patentable weight to the claims to the extent that the prior art device must be cable of the same use. In the instant case as Guan teaches the separation column according to claim 1 and would therefore be capable of the intended use. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that it is well settled that the recitation of a new intended use, for an old product, does not make a claim to that old product patentable. See In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429,
1431 (Fed. Cir. 1997) (see MPEP § 2114). The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an
apparatus does not differentiate an apparatus claim from the prior art, if the prior art
apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2
USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be
structurally distinguishable from the prior art in terms of structure, not function. See In re
Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and
Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and
2173.05(g)).
Regarding Claim 23:
Guan teaches the chromatography device used for the separation of more than one radioactive substance (intended use does not add patentable weight as the prior art teaches the same structure), wherein the chromatography device comprises the column according to claim 1, having sections with variable cross-sectional areas (see Abstract).
Claim(s) 1, 9-11, 15-18, 22, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shalon et al (USPN 4,719,011).
Regarding Claim 1:
Shalon teaches the separation column (HPLC) (see col. 1 lines 16-222 used for separating the substances in a mixture wherein the column comprises at least two sections having different cross-sectional areas, wherein the column is a column comprising a first section (wider column section A), in other words a charging section, which has a larger cross-sectional area compared to the other section, and a second section, in other words a separation section (narrower column section B), which has a smaller cross-sectional area compared to the first section, in other words the charging section (see col. 8 lines 24-29).
Regarding Claim 9:
Shalon teaches the separation column according to claim 1, wherein the column is a column having a stepped structure (see figs. 16 and 27).
Regarding Claim 10:
Shalon teaches the separation column according to Claim 9, wherein the column is a column, in which the cross-sectional area is at a maximum in the inlet section and continues with its maximum along a predetermined length, and then, the cross-sectional area decreases to a comparatively smaller cross-sectional area and continues with this cross-sectional area along also a predetermined length (see col. 8 lines 24-29, fig. 16).
Regarding Claim 11:
Shalon teaches the separation column according to Claim 9, wherein the column (K) is a column, the cross-sectional area of which increases or decreases in a stepwise manner (see col. 8 lines 24-29, fig. 16).
Regarding Claims 15-18:
Shalon teaches the separation column according to claim 1. Shalon is silent towards the use of the column for the separation of rare earth metals, radioactive substances, lutetium and ytterbium, and ytterbium 176 isotope and lutetium 177 isotope. However the materials separated by the column is the intended use of the column and only adds patentable weight to the claims to the extent that the prior art device must be cable of the same use. In the instant case as Shalon teaches the separation column according to claim 1 and would therefore be capable of the intended use. The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that it is well settled that the recitation of a new intended use, for an old product, does not make a claim to that old product patentable. See In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429,
1431 (Fed. Cir. 1997) (see MPEP § 2114). The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an
apparatus does not differentiate an apparatus claim from the prior art, if the prior art
apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2
USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be
structurally distinguishable from the prior art in terms of structure, not function. See In re
Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and
Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and
2173.05(g)).
Regarding Claim 22:
Shalon teaches the separation column according to claim 1, wherein the column is a column resistant to pressure created by the acid, which is passed through said column at a pressure of 3-25 bar (150 psi) depending on the size of said column (see Col. 3 lines 4-6).
Regarding Claim 23:
Shalon teaches the chromatography device used for the separation of more than one radioactive substance (intended use does not add patentable weight as the prior art teaches the same structure), wherein the chromatography device comprises the column according to claim 1, having sections with variable cross-sectional areas (see col. 8 lines 24-29, fig. 16).
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) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutterlin (US 2021/0172042) in view of Polasek (US 2020/0282331).
Regarding Claim 24:
Sutterlin teaches the separation method used for separating the substances in a mixture via a separation column, wherein the separation method comprises the steps of: charging radioactive substance (lutetium) (see para. 0024) in the column a column inlet with an acid of certain molarity (mixing starting material in an acid) (see para. 0010), the radioactive substance accumulating in the top portion of the body of the column, more specifically at a column inlet end, more specifically at a charging section (retained in the anion exchange resin) (see para, 0011), directing the acid used for charging to the drain via a column outlet (passing an eluting solution having a low acid concentration) (see para. 0014), changing the molarity of the acid introduced to the column inlet, and thus, enabling the charged radioactive materials desired to be subjected to separation to move inside the column, more specifically inside a separation section (passing low to high gradient acid eluting solutions…collecting the eluted REEs) (see para. 0014, 0020).
Sutterlin does not teach after the start of said movement, a radioactivity detector detecting the activity of the mixture within the separation section.
Polasek teaches a separation method comprising a radioactivity detector detecting (gamma detection) (see para. 0072) the activity of the mixture within separation section (see para. 0572).
Sutterlin and Polasek are analogous inventions in the art of rare earth separations. It would have been obvious to one skilled in the art, before the effective filing date of the invention to add the radioactivity detector detecting the activity of the mixture of Polasek within the separation section of Sutterlin after the start of movement because it allows the separation to be quantitatively assessed (see Polasek para, 0572) and because it is the simple addition of a known sensor to a known method, obviously resulting in assessment of the separation, with an expectation of success. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutterlin (US 2021/0172042) in view of Polasek (US 2020/0282331) as applied to claim 24 above, and further in view of Shalon et al (USPN 4,719,011).
Regarding Claim 25:
Sutterlin, as modified, teaches the separation method according to Claim 24.
The combination is silent as to the pressure created inside the column.
Shalon teaches a separation method in which acid is passed through the column in a way to create a pressure in the range of 3-25 bar (150 psi) inside said column depending on the size of said column (see col. 3 lines 4-6).
Sutterlin, as modified, and Shalon are analogous inventions in the art of chromatographic separation. It would have been obvious to one skilled in the art to use the acid pressures of Shalon or 3-25 bar (100psi) because one skilled in the art would have found it obvious to operate a column at pressures known in the art to be effective for separation. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAIRE A NORRIS whose telephone number is (571)272-5133. The examiner can normally be reached M-Th 7:30-5 F: 8-12.
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/CLAIRE A NORRIS/Primary Examiner, Art Unit 1779 6/1/2026
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