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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 13, 2026 has been entered.
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
3. Applicant’s amendment filed April 13, 2026 is acknowledged. Claims 1-34, 36, 38-43, 46-47, 49, 51, 54-56, 58 and 60-64 are cancelled. Claims 35, 37, 44-45, 48, 50, 52-53, 57, 59 and 65-69 are pending in this application and under examination in this office action.
4. Applicant’s arguments filed on April 13, 2026 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Priority
5. The priority for instant claims (i.e. a total weekly dose of 0.2g/kg patient weight for 24 months) is April 21, 2017.
Claim Rejections/Objections Withdrawn
6. The rejection of claims 35, 37, 44-45, 48, 50, 52-53, 57, 59 and 65-69 the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US Patent No. 12325738 in view of NCT01545076, Kirch et al. (2010), NCT02549170 and Teschner and evidentiary references: the factsheet of Hizentra and van Schaik’2016 is withdrawn in response to Applicant’s approved terminal disclaimer.
Claim Rejections/Objections Maintained
In view of the amendment filed on April 13, 2026, the following rejections are maintained.
Claim Objections
7. Claim 35 is objected to because of the following informalities: The recitations “INCAT” “R-ODS” “MRC” recited in claim 35 are not unique or common abbreviations in the art. Applicants are required to spell out “INCAT” “R-ODS” “MRC” at the first usage. Appropriate correction is required.
Claim Rejections - 35 USC § 103
8. 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.
Claims 35, 37, 44-45, 48, 52-53, 57, 59 and 69 stand rejected under 35 U.S.C. 103 as being unpatentable over NCT01545076 as evidenced by the factsheet of Hizentra and van Schaik’2016 (Trials, 2016; 17:345) in view of Kirch et al. (Med Klin 105, 647–651 (2010)-English translated version). The rejection is maintained for the reasons of record and the reasons set forth below.
Claims 35, 37, 44-45, 48, 52-53, 57, 59 and 69 as amended are drawn to a method for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in a patient in need thereof and having an INCAT score of at least 1, the method comprising subcutaneously administering an immunoglobulin G (IgG) product to the patient to (i) maintain a total weekly dose of 0.2 g/kg patient weight for 24 months; and (ii) produce an improvement in one or more of INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment.
Briefly, NCT01545076 teaches a method for treating CIDP, comprising subcutaneously administering to a patient in need thereof an IgG product (i.e. Hizentra) at a dose of 0.2 g/kg patient weight per week (which can maintain the total weekly dose of the IgG product at 0.2g/kg patient weight), wherein 20% IgG liquid formulation of human normal Ig (200mg/ml) (see p. 4) for up to 25 or 28 weeks (i.e. (6-7months) and an improvement in one or more of INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo (p. 5-8), which meet the limitations recited in claim 35 except the limitation “for 24 months” and also meets the limitations “wherein the IgG product is administered every week” recited in claim 37, “over the course of 1-7 days” recited in claim 44, “over the course of one day” recited in claim 45, “the IgG product is a liquid ready-for-use product and/or the IgG product does not require reconstitution to liquid form prior to administration” recited in claim 48, “the IgG product has a concentration of 10-30% or 20% IgG” recited in claims 52-53, “the IgG product comprises a stabilizer that is an amino acid, including proline” recited in claims 57 and 69, “the IgG product is derived from human plasma or a human plasma concentrate” claim 59 because the IgG product used in the method of NCT01545076 has the features recited in claims 48, 52-53, 57, 59 and 69 as evidenced by the factsheet of Hizentra (see p 13) and the patients in the method of NCT01545076 include patients having an INCAT score of at least 1, which is also evidenced by van Schaik’2016 listed in NCT01545076 (see p. 3, 2nd col, section “IgG dependency test period”, lines 5-13; and p. 3, section “IVIg restabilization period” to p. 4, section “SC treatment period”; van Schaik et al., Trials, 2016; 17:345).
The difference between the claimed method and NCT01545076 is the length of duration for treatment: 24 months in the claimed method versus 25-28 weeks (6-7 months).
While NCT01545076 does not teach the limitation “for 24 months” recited in claim 35, Kirch et al. teach that the treatment of CIDP with the IgG product need at least 2 years (see p. 647, summary; p. 648, 2nd col. of the abstract). A person of ordinary skill in the art would have recognized that selecting and applying the known treatment regimen and the known technique disclosed by Kirch to the method of NCT01545076 would have yielded the predictable result of treating CIDP and resulted in an improvement in one or more INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment because the treatment of CIDP with the IgG product should be at least 2 years as taught by Kirch. Thus, it would have been obvious to a skilled artisan before the effective filing date of the claimed invention to select and apply the known treatment regimen of CIDP using an IgG product for 2years, and the known technique disclosed by Kirch to the method of NCT01545076 to treat CIDP and yield the predictable result of treating CIDP and resulting in an improvement in one or more INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment.
Response to Arguments
On p. 5-9 of the response, Applicant argues that i) the cited references do not provide any reasonable expectation of success because NCT01545076 does not provide any therapeutic data and cites Sanofi v. Watson Lab. Inc.in support of the arguments; ii) the instant specification provides unexpected results because the instant specification reports nearly identical outcomes and there is no statistically significant difference between the 0.2g/kg/week and 0.4g/kg/week (see 17:2-4; 19:14-15 and 22:12-14 and tables 2-3), which provides better-than-expected results than what is predicted by van Schaik’2016 because van Schaik’2016 teaches nearly 1.5-fold difference between (IgPro20 low dose) and 0.4g/kg/week (IgPro20 high dose) even if the numbers described in van Shaik-2016 are predicted based on Hughes et al. (Lancet Neurol.2008;7:136-144). Applicant further cites In re Corkill, MPEP§ 716.02(a), and van Schaik’2018 (p. 42, left col.; Tables 2-4) in support of arguments.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. Based on MPEP, an actual working example is not required for compliance with the enablement requirement of 35 U.S.C. 112, first paragraph.
“An example may be ‘working' or ‘prophetic.' A working example is based on work actually performed. A prophetic example describes an embodiment of the invention based on predicted results rather than work actually conducted or results actually achieved.”
and also In in re Borkowski, the court held that
“The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970)”. See MPEP § 2164.02.
ii. The difference between the claimed method and NCT01545076 is the length of duration for treatment: 24 months in the claimed method versus 25-28 weeks (6-7months) in the method of NCT01545076.
The method disclosed by NCT01545076 uses the same material (i.e. IgG product of Hizentra) at the same dose of 0.2g/kg/week (see p. 4) and the same active step (i.e. subcutaneously administering) in the same patient population (i.e CIDP) recited in instant claims except the limitation “for 24 months” recited in claim 35.
The teaching of NCT01545076 also meets the limitations recited in claim 37 (i.e. wherein the IgG product is administered every week), claim 44 (i.e. over 1-7 days), claim 45 (i.e. over one day), claim 48 (i.e. the IgG product is a liquid ready-for-use product and/or the IgG product does not require reconstitution to liquid form prior to administration), claims 52-53 (i.e. the IgG product has a concentration of 10-30% or 20% IgG), claims 57 and 69 (i.e. the IgG product comprises a stabilizer that is an amino acid, including proline as evidenced by the factsheet of Hizentra (see p 8, 10-11)), claim 59 (i.e. the IgG product is derived from human plasma or a human plasma concentrate as evidenced by the factsheet of Hizentra (see p 13). The patients in the method for treating CIDP disclosed by NCT01545076 include patients having an INCAT score of at least 1, which is also evidenced by van Schaik’2016 listed in NCT01545076 (see p. 3, 2nd col, section “IgG dependency test period”, lines 5-13; and p. 3, section “IVIg restabilization period” to p. 4, section “SC treatment period”; van Schaik et al., Trials, 2016; 17:345).
While NCT01545076 does not teach the limitation “for 24 months” recited in claim 35, Kirch teaches this limitation and provides motivation and an expectation of success in administering an IgG product in the method of NCT01545076 and to maintain a total weekly dose of 0.2g/kg/ patient weight for 24 month because Kirch teaches that the treatment of CIDP with the IgG product needs at least 2 years (see p. 647, summary; p. 648, 2nd col. of the abstract). A person of ordinary skill in the art would have recognized that selecting and applying the known treatment regimen and the known technique disclosed by Kirch to the method of NCT01545076 would have yielded the predictable result of treating CIDP and resulted in an improvement in one or more INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment.
Using the known treatment regimen of an IgG product at a dose of 0.2g/kg per for 2 years or 24 months in the method of NCT01545076 would treat CIDP and improve one or more INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment, and would expand application of the method of NCT01545076, and increase patient’s satisfaction and patient compliance with recommended treatment regimens because the treatment of CIDP with the IgG product should be at least 2 years as taught by Kirch. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known treatment regimen and the known technique disclosed by Kirch to the method of NCT01545076 to treat CIDP and yield the predictable result of treating CIDP and resulting in an improvement in one or more INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment.
Accordingly, the rejection of claims 35, 37, 44-45, 48, 52-53, 57, 59 and 69 under 35 U.S.C. 103 as being unpatentable over NCT01545076 as evidenced by the factsheet of Hizentra and van Schaik’2016 in view of Kirch et al. (2010) is maintained.
iii. Applicant provides no support to demonstrate unexpected results between the claimed method and the method of NCT01545076 and Kirch.
The method disclosed by NCT01545076 uses the same material (i.e. IgG product of Hizentra) at the same dose of 0.2g/kg/week (see p. 4) and the same active step (i.e. subcutaneously administering) in the same patient population (i.e. CIDP) recited in instant claims except the limitation “for 24 months” recited in claim 35.
The difference between the claimed method and NCT01545076 is the length of duration for treatment: “24 months” in the claimed method versus “25-28 weeks (6-7months)” in the method of NCT01545076.
Applicant’s arguments related to unexpected results are not valid and not related to the difference between the claimed method and the method disclosed by NCT01545076 or the combined teachings of NCT01545076 with Kirch.
Note that “Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).” See MPEP 716.02(c)-I
In this case, NCT01545076 teaches a method of treating CIDP using the same material (i.e. the same IgG product of Hizentra) at the same dose of 0.2g/kg/week (see p. 4) and the same active step (i.e. subcutaneously administering) in the same patient population (i.e. CIDP) recited in claim 35 except the limitation “for 24 months” recited in claim 15.
While NCT01545076 does not teach the limitation “for 24 months” recited in claim 35, Kirch teaches this limitation and provides motivation and an expectation of success in administering an IgG product in the method of NCT01545076 and to maintain a total weekly dose of 0.2g/kg/ patient weight for 24 month because Kirch teaches that the treatment of CIDP with the IgG product needs at least 2 years (see p. 647, summary; p. 648, 2nd col. of the abstract).
Thus, it would have been obvious to a skilled artisan before the effective filing date of the claimed invention to select and apply the known treatment regimen and the known technique disclosed by Kirch to the method of NCT01545076 to treat CIDP and yield the predictable result of treating CIDP and resulting in an improvement in one or more INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment.
Since Applicant fails to provide any evidence as discussed above to support any unexpected results as claimed, the claimed method is obvious over the prior art, absent evidence to the contrary.
Accordingly, the rejection of claims 35, 37, 44-45, 48, 52-53, 57, 59 and 69 under 35 U.S.C. 103 as being unpatentable over NCT01545076 in view of Kirch et al. and evidentiary references: the factsheet of Hizentra and van Schaik’2016 is maintained.
Claim Rejections - 35 USC § 103
8. Claims 50 and 65-68 stand rejected under 35 U.S.C. 103 as being unpatentable over NCT01545076 as evidenced by the factsheet of Hizentra and van Schaik’2016 in view of Kirch et al. (2010) n) as applied to claims 35, 37, 44-45, 48, 52-53, 57, 59 and 69 above, and further in view of NCT02549170 and Teschner et al. (US9084743). The rejection is maintained for the reasons of record and the reasons set forth below.
Briefly, while NCT01545076 and Kirch do not explicitly teach self-administers the IgG product as in claim 50, administered biweekly and the total weekly dose multiplied by 2 as in claim 65, every 3 weeks and the total week dose multiplied by 3 as in claim 66, twice a week and the total weekly dose divided by 2 as in claim 67 or 2-7 times per week and total weekly dose as in claim 68, NCT02549170 and Teschner (US9084743) teach these limitations and provide motivation and an expectation of success. In particular, NCT02549170 teaches a flexible dosing regimen including every two, three or four weeks for 6 months and the total weekly dose multiplied by 2 as in claim 65, every 3 weeks and the total week dose multiplied by 3 as in claim 66, twice a week and the total weekly dose divided by 2 as in claim 67 or 2-7 times per week and total weekly dose as in claim 68 (see p.2; p. 5-12) as evidenced by Teschner (US9084743). Teschner teaches different doses including 100-200mg/kg/wk (i.e. 0.1-0.2g/kg/wk) as a single dose or divided into multiple doses given daily, weekly, once a week, every two, three or four weeks, which are different flexible dosing regimens including every two, three or four weeks for 6 months and the total weekly dose multiplied by 2 as in claim 65, every 3 weeks and the total week dose multiplied by 3 as in claim 66, twice a week and the total weekly dose divided by 2 as in claim 67 or 2-7 times per week and total weekly dose as in claim 68 (see col. 4, line 11; col.22, lines18-40; col. 23, lines 8-21; col. 24, lines 1-28; col.46, lines 55-67; col. 47, line 66-col. 48, line 36; col. 54, lines 18-28; col. 50,lines 1-16;).
A person of ordinary skill in the art would have recognized that selecting and applying the known technique of self-administering, the known doses and the known flexible dosing regimens disclosed by NCT02549170 and Teschner to the method of NCT01545076 and Kirch would have yielded the predictable result of treating CIDP and wherein the treatment results in an improvement in one or more INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment because NCT02549170 and Teschner teach treating patients with CIDP using a flexible dosing regimen including every two weeks at a dose of 0.4g/kg/every two weeks or every 3 weeks at a dose of 0.6g/kg/every 3 weeks as in claims 65-66, or twice a week at a dose of 0.1g/kg as in claim 67 or 2-7 times per week and total weekly dose of 0.2g/kg/ per week as in claim 68. Thus, it would have been obvious to a skilled artisan before the effective filing date of the claimed invention to select and apply the known technique of self-administering, the known doses and the known flexible dosing regimens disclosed by NCT02549170 and Teschner to the method of NCT01545076 and Kirch to treat CIDP and yield the predictable result of treating CIDP and an improvement in one or more INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment.
Further, routine optimization of NCT01545076, NCT02549170 and Teschner’s dosing regimens would have led to the claimed dosing regimens including biweekly and the total weekly dose multiplied by 2, every 3 weeks and the total week dose multiplied by 3, twice a week and the total weekly dose divided by 2 or 2-7 times per week and total weekly dose because NCT01545076 teaches treating CIDP in a patient in need thereof and having an INCAT score of at least 1 by subcutaneously administering an IgG product (i.e. Hizentra) to the patient at a dose of 0.2 g/kg patient weight per week for up to 25 weeks (i.e. at least 3 months), NCT02549170 and Teschner teach self-administration and using different doses including 0.4g/kg/per week, 0.1g/kg/per week, 0.2g/kg/per week, and different flexible dosing regimens including twice a week and the total weekly dose multiplied by 2 (0.4g/kg/per week), or every two weeks and the total week dose multiplied by 2, every 3 weeks and the total week dose multiplied by 3, twice a week and the total weekly dose divided by 2 or 2-7 times per week and total weekly dose to treat CIDP. The person of ordinary skill in the art would have found it obvious to optimize the dosing regimens taught by NCT01545076, NCT02549170 and Teschner because NCT02549170 and Teschner teaches self-administration and different doses and different flexible dosing regimens including the claimed dosing regimens and that these different flexible dosing regiments treat CIDP and also teach how to optimize the flexible dosing regimens. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955);“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.” see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories 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). See MPEP § 2144.05.
Response to Arguments
On p. 9-10 of the response, Applicant argues that i) for the reasons set forth above, the instant claims are not obvious over NCT01545076 and Kirch and evidentiary references: the Hizentra factsheet and van Schaik’2016; and ii) NCT02549170 and Teschner do not cure the deficiencies of NCT01545076 and Kirch and evidentiary references: the Hizentra factsheet and van Schaik’2016 because both references are silent regarding treatment of CIDP with SCIG or why the claimed 0.2g/kg/week SCIG would provide better efficacy in treating CIDP.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. For the reasons set forth above, NCT01545076 and Kirch do teach the limitations of claims 35, 37, 44-45, 48, 52-53, 57, 59 and 69 and render the claimed method of claims 35, 37, 44-45, 48, 52-53, 57, 59 and 69 obvious. In addition, for the reasons set forth above, Applicant provides no support to demonstrate unexpected results because NCT01545076 teach a method of treating CIDP using the same material (i.e. the same IgG product of Hizentra) at the same dose of 0.2g/kg/week (see p. 4) and the same active step (i.e. subcutaneously administering) in the same patient population (i.e. CIDP) as recited in claim 35 except the limitation “for 24 months” and Kirch teaches this limitation because Kirch teaches that the treatment of CIDP with the IgG product needs at least 2 years. Thus, it is obvious to a skilled artisan to treat CIDP using the same IgG product of Hizentra at the same dose of 0.2g/kg/week for 24 months in view of the combined teachings of NCT01545076 and Kirch.
ii. Applicant cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, NCT02549170 and Teschner (US9084743) are cited to support the limitations “self-administer the IgG product” in claim 50 and different flexible dosing regimens including different dosing regimens recited in claims 65-68.
While NCT01545076 and Kirch do not explicitly teach self-administers the IgG product as in claim 50, administered biweekly and the total weekly dose multiplied by 2 as in claim 65, every 3 weeks and the total week dose multiplied by 3 as in claim 66, twice a week and the total weekly dose divided by 2 as in claim 67 or 2-7 times per week and total weekly dose as in claim 68, NCT02549170 and Teschner (US9084743) teach these limitations and provide motivation and an expectation of success because NCT02549170 teaches a flexible dosing regimen including every two, three or four weeks for 6 months and the total weekly dose multiplied by 2 as in claim 65, every 3 weeks and the total week dose multiplied by 3 as in claim 66, twice a week and the total weekly dose divided by 2 as in claim 67 or 2-7 times per week and total weekly dose as in claim 68 (see p.2; p. 5-12), and Teschner teaches that the patient self-administers the IgG product (col. 52, lines 19-20) and different doses including 100-200mg/kg/wk (i.e. 0.1-0.2g/kg/wk) as a single dose or divided into multiple doses given daily, weekly, once a week, every two, three or four weeks, which are different flexible dosing regimens including every two, three or four weeks for 6 months and the total weekly dose multiplied by 2 as in claim 65, every 3 weeks and the total week dose multiplied by 3 as in claim 66, twice a week and the total weekly dose divided by 2 as in claim 67 or 2-7 times per week and total weekly dose as in claim 68 (see col. 4, line 11; col.22, lines18-40; col. 23, lines 8-21; col. 24, lines 1-28; col.46, lines 55-67; col. 47, line 66-col. 48, line 36; col. 54, lines 18-28; col. 50,lines 1-16).
A person of ordinary skill in the art would have recognized that selecting and applying the known technique of self-administering, the known doses and the known flexible dosing regimens disclosed by NCT02549170 and Teschner to the method of NCT01545076 and Kirch would have yielded the predictable result of treating CIDP and wherein the treatment results in an improvement in one or more INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment because self-administering an IgG product at a dose of 0.2g/kg per week for 24 months or using flexible dosing regimens including biweekly at a dose of 0.4g/kg/every two weeks (0.2g/kg x2) or every 3 weeks at a dose of 0.6g/kg/every 3 weeks (0.2g/kg x3) as in claims 65-66, or twice a week at a dose of 0.1g/kg (0.2g/kg ÷ 2) in claim 67 or 2-7 times per week and total weekly dose of 0.2g/kg/ per week in claim 68 has been taught by NCT02549170 and Teschner for treating CIDP. Thus, it would have been obvious to a skilled artisan before the effective filing date of the claimed invention to select and apply the known technique of self-administering, the known doses and the known flexible dosing regimens disclosed by NCT02549170 and Teschner to the method of NCT01545076 and Kirch to treat CIDP and yield the predictable result of treating CIDP and an improvement in one or more INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment.
Further, routine optimization of NCT01545076, NCT02549170 and Teschner’s dosing regimens would have led to the claimed dosing regimens including biweekly and the total weekly dose multiplied by 2, every 3 weeks and the total week dose multiplied by 3, twice a week and the total weekly dose divided by 2 or 2-7 times per week and total weekly dose because i) NCT01545076 teaches treating CIDP in a patient in need thereof and having an INCAT score of at least 1 by subcutaneously administering an IgG product (i.e. Hizentra) to the patient at a dose of 0.2 g/kg patient weight per week for up to 25-28 weeks, and ii) NCT02549170 and Teschner teach self-administration and using different doses including 0.2g/kg/per week, and different flexible dosing regimens including twice a week and the total weekly dose multiplied by 2 (0.4g/kg/per week), or every two weeks and the total week dose multiplied by 2, every 3 weeks and the total week dose multiplied by 3, twice a week and the total weekly dose divided by 2 or 2-7 times per week and total weekly dose to treat CIDP. The skilled artisan would have found it obvious to optimize the dosing regimens taught by NCT01545076, NCT02549170 and Teschner because NCT02549170 and Teschner teaches self-administration and different flexible dosing regimens including the claimed dosing regimens and that these different flexible dosing regiments treat CIDP and also teach how to optimize the flexible dosing regimens. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955);“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.” see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories 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). See MPEP § 2144.05.
Accordingly, the rejection of claims 50 and 65-68 under 35 U.S.C. 103 as being unpatentable over NCT01545076 in view of Kirch (2010) and evidentiary references: the factsheet of Hizentra and van Schaik’2016 as applied to claims 35, 37, 44-45, 48, 52-53, 57, 59 and 69 above, and further in view of NCT02549170 and Teschner (US9084743) is maintained.
Double Patenting
9. 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 35, 37, 44-45, 48, 50, 52-53, 57, 59 and 65-69 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-26 of copending Application No. 19/205303 in view of NCT01545076, Kirch et al. (2010), NCT02549170 and Teschner and evidentiary references: the Hizentra factsheet and van Schaik’2016. The rejection is maintained for the reasons of record and the reasons set forth below.
Briefly, claims 17-26 of Application No. 19/205303 (the ‘303 Application) claims a method or treating chronic inflammatory demyelinating polyneuropathy (CIDP) in a patient in need thereof, comprising administering to the patient an immunoglobulin product, wherein the patient has non-axonal damage or mild axonal damage by assessment of a compound muscle action potential including higher than 1mV at foot, higher 2mV at the wrist and/or at least 50% of the mean compound muscle action potential measured in a healthy subject.
While the claims of the ‘303 Application do not recite that the CIDP patient has an INCAT score of at least 1 or subcutaneously administering a dose and duration sufficient to maintain the total weekly dose of the IgG at 0.2g/kg patient weight for 24 months and produce an improvement in one or more of INCAT score, RODS score, Mean grip strength, MRC sum score and electrophysiology parameters by at least 20% compared to placebo treatment as in instant claim 35 or different dosing regiments as in claims 50 and 65-68, NCT01545076, Kirch et al., NCT02549170 and Teschner et al. (US9084743) and the evidentiary references: the Hizentra factsheet and van Schaik’2016 teach these limitations for the reasons set forth above under the 103 rejections. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known patients, the known technique of self-administering, the known doses and the known dosing regimens disclosed by NCT01545076, Kirch et al., NCT02549170 and Teschner and and the evidentiary references: the Hizentra factsheet and van Schaik’2016 to the method of the ‘303 Application, and yield the predictable result of treating CIDP and resulting in an improvement in one or more INCAT score, R-ODS score, Mean grip strength, MRC sum score, and electrophysiology parameters by at least 20% compared to placebo treatment.
Response to Arguments
On p. 11 of the response, Applicant requests to withdraw the double patenting rejection because for the reasons set forth above, the provisional rejection is the only rejection remaining and instant application has an earlier filing date than Application No. 19/205303 (the ‘303 Application).
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the instant double patenting rejection is not the only rejection remaining because the instant claims are still rejected under 35 U.S.C. 103 for the reasons set forth above.
Accordingly, the provisional rejection of claims 35, 37, 44-45, 48, 50, 52-53, 57, 59 and 65-69 on the ground of nonstatutory double patenting as being unpatentable over claims 17-26 of copending Application No. 19/205303 in view of NCT01545076, Kirch et al. (2010), NCT02549170 and Teschner and evidentiary references: the Hizentra factsheet and van Schaik’2016 is maintained.
Conclusion
10. NO CLAIM IS ALLOWED.
11. All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANG-YU WANG whose telephone number is (571)272-4521. The examiner can normally be reached Monday-Thursday, 7:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Chang-Yu Wang
May 28, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
Prosecution Insights