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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/28/2026 has been entered.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 and 20-22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being clearly anticipated by Thomas et al., Blood (2020) 136 {Supplement 1}: 27 (hereinafter “Thomas”).
Thomas discloses a method for using plasmapheresis (plasma exchange) to reduce a concentration of substance e.g., different inflammatory agents in individuals in need thereof, such as individuals diagnosed with COVID-19 which is associated with hyperinflammatory, pro-thrombotic state. Thomas studied plasmapheresis to determine its effects on thrombo-inflammatory markers (p. 1: Introduction- 1st full ¶). The method comprises: (a) measuring, before administering the plasmapheresis (plasma exchange), a pretreatment concentration of the inflammatory agents (thrombo-inflammatory markers) which are LDH, D dimer, vWF, and Factor VIII. All inflammatory agents were measured in blood sample of the individuals as elevated and/or doubling from baseline (LDH>800 IU/L, D dimer>1000 ug/L) (p. 1: Methods- 2nd full ¶ to p. 2; Figure 1). The method further comprises administering the plasmapheresis to the individuals comprising (steps (b)-(d) is known steps in plasmapheresis):
(b) withdrawing a volume of whole blood from the individual;
(c) separating the volume of whole blood into:
(i) a cellular fraction; and
(ii) a plasma fraction comprising the substance;
(d) returning the cellular fraction and an exchange fluid to a circulatory system of the individual; and
(e) performing steps (b) through (d) until:
(i) at least one plasma volume has been exchanged in the individual; and
(ii) the level of the substance e.g., inflammatory agents in the individual reaches a target level, and
the method further comprising measuring, after performing step (d), a posttreatment level of the substance in a further whole blood sample of the individual wherein repeating the plasmapheresis of step (b)-(d) daily for five days or until the posttreatment concentration of the inflammatory agents in the individuals are lower than the pretreatment concentrations (p. 2, 1st ¶; Figure 1. Figure 1 shows the inflammatory agents decreased by 60% to 70% following administration of the plasmapheresis. The thrombo-inflammatory agents D dimer, vWF, and Factor VIII are non-cellular agents (Figure 1).
Thomas teaches that the plasmapheresis exchanges at least one unit (single volume unit) of 3 liter plasma volume (p. 2, 1st ¶). Thomas further teaches performing step a) within 24 hours of administering the plasmapheresis to the individual in steps (b)-(d). The plasmapheresis is administered over a single treatment or over a plurality of treatment sessions (5 times) (p. 2, 1st ¶)). Accordingly, Thomas appears to read on Applicant’s claimed invention.
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.
Claims 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas as applied to claim 1 above and further in view of US 2018/0318348 A1 to Corash et al. (hereinafter “Corash”).
Thomas discloses the method of claim 1 for reducing a level of a substance in an individual in need thereof.
Thomas differs from the claimed invention in failing to teach administering intravenous immunoglobulin to the individual.
Corash discloses a method for using plasmapheresis (therapeutic plasma exchange: TPE) to reduce a pretreatment concentration of an inflammatory agent (proinflammatory cytokines) in an individual in need thereof such as individuals diagnosed with chronic inflammatory demyelinating polyneuropathy (CIPD) or Guillain-Barré Syndrome (GBS). CIPD and GBS are inherently mediated or exacerbated by proinflammatory cytokines including TNF-α, IFN-γ, IL-6, IL17 (i.e. inflammatory agent). Corash teaches administering plasmapheresis to the individuals having CIPD and GBS; and then measuring a posttreatment concentration of the inflammatory agents in the blood sample of the individuals. Corash teaches repeating the step of administering plasmapheresis to the individuals (i.e. 2-5 times or more) until the posttreatment concentration of the inflammatory agents in the individuals are lowered or reduced (see paragraphs [0029, 0030, 0147, 0153, 0159, 0216]; Example 7). Corash specifically teaches repeating the step of administering plasmapheresis to the individuals (i.e. 2-5 times or more) until specific lowered posttreatment concentrations of the inflammatory agents are achieved with improved inflammation conditions (see paragraphs [0159, 0214-0219]; Example 6; Example 7).
Corash specifically teaches administering an intravenous immunoglobulin (IVIg) to the individual, within 24 hours, following plasmapheresis in steps (b)-(d), or during the same plasmapheresis treatment (see paragraphs [0006, 0030, 0147, 0153, 0156, 0214]). Corash teaches performing step a) within 24 hours of administering the plasmapheresis to the individuals in step (b)-(d). The plasmapheresis is administered over a single treatment or over a plurality of treatment sessions (2-5 times or more) (see paragraphs [0029, 0030, 0147, 0159, 0214-0219]; Example 6; Example 7). Corash shows performing steps (a)-(d) on the individual at least two times per month (within a period of two weeks) for at least three months, wherein two of the at least two times per month are within the same week of the month resulting to overall reduced inflammation (see paragraphs [0029, 0147, 0156, 0159, 0214-0219]; Example 6; Example 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to further treat subjects diagnosed with inflammation condition with IVIg as taught by Corash into the plasma exchange method of treatment taught by Thomas because Corash taught that IVIg can be combined with plasmapheresis in treating inflammatory conditions. One or ordinary skill in the art would have had reasonable expectation of success in combining the teachings of Corash with Thomas because both Thomas and Corash teach analogous art in the field of using plasmapheresis to treat inflammatory diseases.
Thomas and Corash do not teach that the IVIg is administered in an amount of 2 grams per kg body weight of the individual.
With respect to the recitation of “the IVIg is administered in an amount of about 2 grams per kilogram of body weight of the individual” in claim 16; generally, differences in concentrations or percentages of a component relative to other testing parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). Since Applicant has not disclosed that the specific limitation recited in claim 16 is for any particular purpose or solve any stated problem and the prior art teaches that parameters often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well; absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures.
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.
Claims 1-5, 7, 9, 10-13, 16-17 and 19-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11-13, and 16-18 of U.S. Patent No. 12,318,525. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claim comparison table discusses claims and relevant differences below.
The corresponding claims of U.S. Patent No. 12,318,525 anticipates the instant claims of Application No. 19/365,163.
Claims of
Application No. 19/365,163
Claims of
U.S. Patent No. 12,318,525
Comparison
1
1
Narrow claim 1 anticipates broad instant claim 1 and contains all the limitation of claim 1.
2
1
Narrow claim 1 anticipates broad instant claim 2 and contains all the limitation of claim 2.
3
1
Narrow claim 1 anticipates broad instant claim 3 and contains all the limitation of claim 3.
4
1
Narrow claim 1 anticipates broad instant claim 4 and contains all the limitation of claim 4.
5
1
Narrow claim 1 anticipates broad instant claim 5 and contains all the limitation of claim 5.
7
1
Narrow claim 1 anticipates broad instant claim 7 and contains all the limitation of claim 7.
9
17/1
Narrow claim 17/1 anticipates broad instant claim 9 and contains all the limitation of claim 9.
10
8/1
Narrow claim 8/1 anticipates broad instant claim 10 and contains all the limitation of claim 10.
11
13/1
Narrow claim 13/1 anticipates broad instant claim 11 and contains all the limitation of claim 11.
12
15/1
Narrow claim 15/1 anticipates broad instant claim 12 and contains all the limitation of claim 12.
13
11/10/9/8/1
Narrow claim 11/10/9/8/1 anticipates broad instant claim 13 and contains all the limitation of claim 13.
16
12/11/10/9/8/1
Narrow claim 12/11/10/9/8/1 anticipates broad instant claim 16 and contains all the limitation of claim 16.
17
11/10/9/8
Narrow claim 11/10/9/8 anticipates broad instant claim 17 and contains all the limitation of claim 17.
19
18/1
Narrow claim 18/1 anticipates broad instant claim 19 and contains all the limitation of claim 19.
20
1
Narrow claim 1 anticipates broad instant claim 20 and contains all the limitation of claim 20.
21
16/1
Narrow claim 16/1 anticipates broad instant claim 21 and contains all the limitation of claim 21.
22
1
Narrow claim 1 anticipates broad instant claim 22 and contains all the limitation of claim 22.
Claims 1-4, 7, 9, 10-12 and 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-11, 13 and 17-18 of U.S. Patent No. 12,109,345. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claim comparison table discusses claims and relevant differences below.
The corresponding claims of U.S. Patent No. 12,109,345 anticipates the instant claims of Application No. 19/365,163.
Claims of
Application No. 19/365,163
Claims of
U.S. Patent No. 12,109,345
Comparison
1
17/1
Narrow claim 17/1 anticipates broad instant claim 1 and contains all the limitation of claim 1.
2
17/1
Narrow claim 17/1 anticipates broad instant claim 2 and contains all the limitation of claim 2.
3
17/1
Narrow claim 17/1 anticipates broad instant claim 3 and contains all the limitation of claim 3.
4
18/1
Narrow claim 18/1 anticipates broad instant claim 4 and contains all the limitation of claim 4.
7
17/1
Narrow claim 17/1 anticipates broad instant claim 7 and contains all the limitation of claim 7.
9
9/1
Narrow claim 9/1 anticipates broad instant claim 9 and contains all the limitation of claim 9.
10
10/1
Narrow claim 10/1 anticipates broad instant claim 10 and contains all the limitation of claim 10.
11
11/1
Narrow claim 11/1 anticipates broad instant claim 11 and contains all the limitation of claim 11.
12
13/1
Narrow claim 13/1 anticipates broad instant claim 12 and contains all the limitation of claim 12.
20
13/1
Narrow claim 13/1 anticipates broad instant claim 20 and contains all the limitation of claim 20.
21
11/1
Narrow claim 11/1 anticipates broad instant claim 21 and contains all the limitation of claim 21.
22
17/1
Narrow claim 17/1 anticipates broad instant claim 22 and contains all the limitation of claim 22.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-8 and 14-20 of copending Application No. 19/193,964. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claim comparison table discusses claims and relevant differences below.
The corresponding claims of copending Application No. 19/193,964 anticipates the instant claims of Application No. 19/365,163.
Claims of
Application No. 19/365,163
Claims of copending
Application No. 19/193,964
Comparison
1
1
Narrow claim 1 anticipates broad instant claim 1 and contains all the limitation of claim 1.
2
3/1
Narrow claim 3/1 anticipates broad instant claim 2 and contains all the limitation of claim 2.
3
1
Narrow claim 1 anticipates broad instant claim 3 and contains all the limitation of claim 3.
4
1
Narrow claim 1 anticipates broad instant claim 4 and contains all the limitation of claim 4.
5
1
Narrow claim 1 anticipates broad instant claim 5 and contains all the limitation of claim 5.
6
1
Narrow claim 1 anticipates broad instant claim 6 and contains all the limitation of claim 6.
7
1
Narrow claim 1 anticipates broad instant claim 7 and contains all the limitation of claim 7.
8
4/1
Narrow claim 4/1 anticipates broad instant claim 8 and contains all the limitation of claim 8.
9
5/1
Narrow claim 5/1 anticipates broad instant claim 9 and contains all the limitation of claim 9.
10
6/1
Narrow claim 6/1 anticipates broad instant claim 10 and contains all the limitation of claim 10.
11
7/1
Narrow claim 7/1 anticipates broad instant claim 11 and contains all the limitation of claim 11.
12
8/1
Narrow claim 8/1 anticipates broad instant claim 12 and contains all the limitation of claim 12.
13
14/1
Narrow claim 14/1 anticipates broad instant claim 13 and contains all the limitation of claim 13.
14
15/1
Narrow claim 15/1 anticipates broad instant claim 14 and contains all the limitation of claim 14.
15
16/15/1
Narrow claim 16/15/1 anticipates broad instant claim 15 and contains all the limitation of claim 15.
16
17/15/1
Narrow claim 17/15/1 anticipates broad instant claim 16 and contains all the limitation of claim 16.
17
18/1
Narrow claim 18/1 anticipates broad instant claim 17 and contains all the limitation of claim 17.
18
19/1
Narrow claim 19/1 anticipates broad instant claim 18 and contains all the limitation of claim 18.
19
20/19/1
Narrow claim 20/19/1 anticipates broad instant claim 19 and contains all the limitation of claim 19.
20
8/1
Narrow claim 8/1 anticipates broad instant claim 20 and contains all the limitation of claim 20.
21
7/1
Narrow claim 7/1 anticipates broad instant claim 21 and contains all the limitation of claim 21.
22
1
Narrow claim 1 anticipates broad instant claim 22 and contains all the limitation of claim 22.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 13-19 of copending Application No. 19/193,961. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claim comparison table discusses claims and relevant differences below.
The corresponding claims of copending Application No. 19/193,961 anticipates the instant claims of Application No. 19/365,163.
Claims of
Application No. 19/365,163
Claims of copending
Application No. 19/193,961
Comparison
1
1
Narrow claim 1 anticipates broad instant claim 1 and contains all the limitation of claim 1.
2
2/1
Narrow claim 2/1 anticipates broad instant claim 2 and contains all the limitation of claim 2.
3
1
Narrow claim 1 anticipates broad instant claim 3 and contains all the limitation of claim 3.
4
1
Narrow claim 1 anticipates broad instant claim 4 and contains all the limitation of claim 4.
5
3/1
Narrow claim 3/1 anticipates broad instant claim 5 and contains all the limitation of claim 5.
6
4/1
Narrow claim 4/1 anticipates broad instant claim 6 and contains all the limitation of claim 6.
7
5/1
Narrow claim 5/1 anticipates broad instant claim 7 and contains all the limitation of claim 7.
8
6/1
Narrow claim 6/1 anticipates broad instant claim 8 and contains all the limitation of claim 8.
9
7/1
Narrow claim 7/1 anticipates broad instant claim 9 and contains all the limitation of claim 9.
10
8/1
Narrow claim 8/1 anticipates broad instant claim 10 and contains all the limitation of claim 10.
11
9/1
Narrow claim 9/1 anticipates broad instant claim 11 and contains all the limitation of claim 11.
12
10/1
Narrow claim 10/1 anticipates broad instant claim 12 and contains all the limitation of claim 12.
13
13/1
Narrow claim 13/1 anticipates broad instant claim 13 and contains all the limitation of claim 13.
14
14/1
Narrow claim 14/1 anticipates broad instant claim 14 and contains all the limitation of claim 14.
15
15/13/1
Narrow claim 15/13/1 anticipates broad instant claim 15 and contains all the limitation of claim 15.
16
16/13/1
Narrow claim 16/13/1 anticipates broad instant claim 16 and contains all the limitation of claim 16.
17
17/1
Narrow claim 17/1 anticipates broad instant claim 17 and contains all the limitation of claim 17.
18
18/1
Narrow claim 18/1 anticipates broad instant claim 18 and contains all the limitation of claim 18.
19
19/18/1
Narrow claim 19/18/1 anticipates broad instant claim 19 and contains all the limitation of claim 19.
20
10/1
Narrow claim 10/1 anticipates broad instant claim 20 and contains all the limitation of claim 20.
21
9/1
Narrow claim 9/1 anticipates broad instant claim 21 and contains all the limitation of claim 21.
22
1
Narrow claim 1 anticipates broad instant claim 22 and contains all the limitation of claim 22.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to claims 1-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1772
JK
8/31/26
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