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 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.
Claim 19 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Recitation of “the intravenous immunoglobulin” in line 1 lacks a positive antecedent basis.
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 1-7 and 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by European Patent Application No. 2638918 A1 to Grifols Lucas et al. (hereinafter “Grifols”).
Grifols discloses a method for treating blood cholesterol disorders in an individual by using plasmapheresis to reduce a substance e.g. total cholesterol, low density lipoprotein cholesterol (LDL) and/or high density lipoprotein cholesterol (HDL) in the individual having abnormal levels of total cholesterol, LDL and/or HDL (see paragraph [0001]) comprising the steps of:
(a) measuring, before an administration of plasmapheresis, a pretreatment level of total cholesterol, LDL and/or HDL;
(b) administering the plasmapheresis to the individual;
(c) measuring, following step (b), the level of total cholesterol, LDL and/or HDL;
(d) repeating steps (b) and (c) until the level of total cholesterol, LDL and/or HDL in the individual reaches a target level (paragraphs [0008], [0011], [0027]).
Regarding claim 2, total cholesterol, LDL and/or HDL is a non-cellular substance.
Regarding claims 3-5, Grifols disclose repeating steps (a)-(c) until a specific value is achieved for an improvement in the condition of cholesterol disorders (see paragraphs [0011]-[0012], [0027]).
Regarding claim 6, cholesterol disorders causes an inflammatory condition.
Regarding claim 7, Grifols teaches determining that the level in the individual is reduced (see paragraphs [0027], [0030]).
Regarding claim 9, Grifols teaches that step (a) occurs implicitly within 24 hours of the administering of the plasmapheresis to the individual in step (b) (see paragraph [0008).
Regarding claim 10, Grifols teaches that the plasmapheresis administered in step (b) exchanges at least one unit of plasma volume (see paragraph [0010]: a saline solution (10) added after the plasma separation; paragraph [0026]: a low-volume plasmapheresis in which less than about 1000 mL of blood is treated).
Regarding claim 11, Grifols teaches that the plasmapheresis is administered in step (b) is administered over a plurality of treatment session (see paragraph [0011]: plasmapheresis could be done twice a week).
Regarding claim 12, Grifols teaches that the plasmapheresis is administered in step (b) is administered over a single treatment session (see paragraph [0008]: the subsequent round of plasmapheresis could be conducted about 2 to about 14 days after a previous round of plasmapheresis).
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.
Claim 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Grifols.
Grifols discloses a method for treating blood cholesterol disorders in an individual by using plasmapheresis as described above.
Claim 8 differs from Grifols in reciting decreasing the substance by at least 70% following administering plasmapheresis.
Grifols teaches that the first and/or subsequent plasmapheresis treatment reduces LDL levels in patients having abnormal LDL levels prior to the first treatment regime by at least about 5 mg/dL to about 45 mg/dL (see paragraph [0027]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize the reduction of the substance by at least 70% following administering plasmapheresis depending on desired removal of LDL in patient, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 18 differs from Grifols in reciting that the performing steps (a)-(d) on the individual at least two times per month for at least three months, wherein two of the at least two times per month are within the same week of the month.
Grifols teaches that each plasmapheresis treatment could be done twice a week, preferably with at least 2 days between sessions and less frequent plasmapheresis would be acceptable up to 10 days between treatments (see paragraph [0011]) and each treatment last for at least about 22 weeks or more (about 5 months) (see paragraph [0029]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize the frequency of performing plasmapheresis at least two times per month for at least three months, wherein two of the at least two times per month are within the same week of the month depending on desired rejuvenation of the patient, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 13-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Grifols as applied to claim 1 or 18 above, and further in view of US 2015/0153357 A1 to Darashkevich et al. (hereinafter “Darashkevich”).
Grifols discloses a method for treating blood cholesterol disorders in an individual by using plasmapheresis as described above.
Claims 13-15 differs from Grifols in reciting administering intravenous immunoglobulin (IVIG) to the individual following plasmapheresis.
Darashkevich teaches infusing IVIG to a patient after plasmapheresis to restore the immune system of the patient (see abstract; paragraph [0030]).
It would have been obvious to a person of ordinary skill in the art to include administering intravenous immunoglobulin (IVIG) to the individual following plasmapheresis tin the method of Grifols to restore the immune system of the patient as suggested by Darashkevich.
Claim 16 differs from Grifols in reciting that IVIG is administered in an amount of about 2 grams per kilogram of a body weight of the individual.
Darashkevich teaches administering IVIG to the patient in an amount totaling from about 2.5 g to about 200 g (see paragraph [0031]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize IVIG administered in an amount of about 2 grams per kilogram of a body weight of the individual depending on desired effectiveness, safety and comfort to patient, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 17 differs from Grifols in reciting that IVIG is administered during the same treatment session in plasmapheresis.
It would have been obvious to a person of ordinary skill in the art to administer IVIG during the plasmapheresis of Grifols to immediately replenish IVIG to restore immune system as suggested by Darashkevich.
Claim 18 differs from Grifols in reciting that IVIG is administered to the individual at each of the at least two times per month.
Darashkevich teaches administering IVIG over a total of one day to 10 days (see paragraph 0031).
It would have been obvious to a person of ordinary skill in the art to administer IVIG to the individual at each of the at least two times per month in the method of Grifols to restore immune system in terms of effectiveness, safety and comfort of the patient as suggested by Darashkevich (see paragraph [0031]).
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11-13, and 17-18 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.
Claims 1-4, 7, 9 and 10-12 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.
Claims 1-19 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 (reference application). 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 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. 19/365,144 (reference application). 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. 19/365,144 anticipates the instant claims of Application No. 19/365,163.
Claims of
Application No. 19/365,163
Claims of copending
Application No. 19//365,144
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
17/14/1
Narrow claim 17/14/1 anticipates broad instant claim 16 and contains all the limitation of claim 16.
17
18/14/1
Narrow claim 18/14/1 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 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 (reference application). 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1777
JK
2/7/26