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 .
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 1 of U.S. Patent No. 12,352,725 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of claim 1 of U.S. Patent No. 12,352,725 B2 implicitly uses the kit of claim 1 of the instant application. To wit,
Claim 1 of the instant application
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Claim 1 of U.S. Patent No. 12,352,725 B2
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Claim 1 of the instant application
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Claim 1 of U.S. Patent No. 12,352,725 B2
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Claim 1 of the instant application
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Claim 1 of U.S. Patent No. 12,352,725 B2
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Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,352,725 B2. As a first matter, claim 1, from which claim 2 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 2 of the instant application.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12,352,725 B2. As a first matter, claim 1, from which claim 3 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 3 of the instant application.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,352,725 B2. As a first matter, claim 1, from which claim 4 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 4 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 4 of the instant application.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12,352,725 B2. As a first matter, claim 1, from which claim 5 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 5 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 5 of the instant application.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12,352,725 B2. As a first matter, claim 1, from which claim 6 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 6 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 6 of the instant application.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,352,725 B2. As a first matter, claim 1, from which claim 7 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 7 of the instant application.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,352,725 B2. As a first matter, claim 1, from which claim 10 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because
claim 10 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 8 of the instant application.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,352,725 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of claim 8 of U.S. Patent No. 12,352,725 B21 implicitly uses the kit of claim 9 of the instant application. To wit,
Claim 9 of the instant application
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Claim 8 of U.S. Patent No. 12,352,725 B2
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Claim 9 of the instant application
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Claim 8 of U.S. Patent No. 12,352,725 B2
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Claim 9 of the instant application
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Claim 8 of U.S. Patent No. 12,352,725 B2
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Claim 1 of the instant application
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Claim 8 of U.S. Patent No. 12,352,725 B2
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Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 12,352,725 B2. As a first matter, claim 9, from which claim 10 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because
claim 9 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 10 of the instant application.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 5 together of U.S. Patent No. 12,352,725 B2. As a first matter, claim 9, from which claim 11 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 5 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 11 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 4 together of U.S. Patent No. 12,352,725 B2. As a first matter, claim 9, from which claim 12 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 4 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 12 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 2 together of U.S. Patent No. 12,352,725 B2. As a first matter, claim 9, from which claim 13 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 2 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 13 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 3 together of U.S. Patent No. 12,352,725 B2. As a first matter, claim 9, from which claim 14 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 3 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 14 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12,352,725 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of claim 3 of U.S. Patent No. 12,352,725 B22 implicitly uses the kit of claim 15 of the instant application. To wit,
Claim 15 of the instant application
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Claim 3 of U.S. Patent No. 12,352,725 B2
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Claim 15 of the instant application
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Claim 3 of U.S. Patent No. 12,352,725 B2
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Claim 15 of the instant application
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Claim 3 of U.S. Patent No. 12,352,725 B2 (via claim 1)
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Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 3 together of U.S. Patent No. 12,352,725 B2. As a first matter, claim 15, from which claim 16 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 5 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 16 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 3 together of U.S. Patent No. 12,352,725 B2. As a first matter, claim 15, from which claim 17 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 6 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 17 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 3 together of U.S. Patent No. 12,352,725 B2. As a first matter, claim 15, from which claim 18 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 18 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 3 together of U.S. Patent No. 12,352,725 B2. As a first matter, claim 16, from which claim 19 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 8 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 19 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention.
20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 3 together of U.S. Patent No. 12,352,725 B2. As a first matter, claim 15, from which claim 20 depends, has been addressed above. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 10 of U.S. Patent No. 12,352,725 B2 meets the additional limitation of claim 20 of the instant application. Note that it would have been obvious to one of ordinary skill in the art to consider combining together features from dependent claims in a patent, especially when they depend from the same independent claim as they then clearly modify the same base invention. Also note that to one of ordinary skill in the art adjust the calcium:magnesium molar concentration range of claim 10 of U.S. Patent No. 12,352,725 B2 to be consistent with that set forth in claim 3.
Other Relevant Prior art
Zhang et al. US 2011/0139638 A1 together with Rayana et al., “Guidelines for sampling, measuring and reporting ionized magnesium in undiluted serum, plasma, or blood” Clin Chem Lab Med 2005; 43(5);564-569, Zhang et al., “Point of Care testing of Ionized Magnesium in Blood with potentiometric Sensors – Opportunities and Challenges,” American Journal of Biomedical Sciences 2011, 3(4) 301-312, and U. E. Spichiger “History of the Development of Magnesium – Selective Ionophores and Magnesium – Selective Electrodes,” Electroanalysis, 5(1993) 739-745, Spectrum® Mfg. Corp. catalog product listing for Brij 700, as applied in the rejections under 35 U.S.C 103 in parent application 17/2264213 is the closest prior art to the claims in the instant application (19/236612)4. However, these references do not disclose or suggest, as required by independent claims 1, 9, and 15 of the instant application,”
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. . . .“
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER STEPHAN NOGUEROLA whose telephone number is (571)272-1343. The examiner can normally be reached on Monday - Friday 9:00AM-5:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached on 571 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
1 Note that claim 8 of U.S. Patent No. 12,352,725 B2 depends from claim 7, which in turn depends from claim 1, So claim 8 includes all of the limitations of claim 7 and claim 1.
2 Note that claim 3 of U.S. Patent No. 12,352,725 B2 depends from claim 1. So claim 3 includes all of the limitations of claim 1.
3 See, for example, the non-final Office action in parent application 17/226421 mailed November 30, 2023, pages 11-26.
4 All of these documents are cited in the Information Disclosure Statement in parent applications 17/226421 and 18/738534.
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