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
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
2. Applicant’s amendment filed June 24, 2025 is acknowledged. Claims 1-34, 36, 38-43, 46-47, 49, 51, 54-56, 58 and 60-64 are cancelled. Claims 35 and 44-45 are amended. 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.
3. Applicant’s arguments filed on June 24, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Priority
4. The priority for instant claims (i.e. a total weekly dose of 0.2g/kg patient weight for 24 months) is April 21, 2017.
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Claim Rejections/Objections Withdrawn
5. The rejection of claims 35, 37, 44-46, 48, 50, 52-53, 57, 59 and 65-69 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in response to Applicant’s amendment to the claims.
The rejection of claims 35, 37, 44-46, 48, 50, 52-53, 57, 59 and 65-69 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement due to new matter is withdrawn in response to Applicant’s amendment to the claims and cancelation of claim 46.
The rejection of claim 46 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, 2010; 105: 647–651. doi.org/10.1007/s00063-010-1105-8; English translated version) is moot because the claim is canceled.
The rejection of claim 46 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-33 of copending Application No. 17/056632 in view of NCT01545076, Kirch et al. (2010), Markvardsen, NCT02549170 and Teschner and evidentiary references: the factsheet of Hizentra and van Schaik’2016 is moot because the claim is canceled.
Claim Rejections/Objections Maintained
In view of the amendment filed on June 24, 2025, the following rejections are maintained.
Claim Rejections - 35 USC § 103
6. 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.
Response to Arguments
On p. 9-13 of the response, Applicant acknowledges that NCT01545076 teaches two doses: 0.2g/kg body weight and 0.4g/kg body weight (p. 9) and weekly dosing of an IgG, which can maintain the total weekly dose of 0.2g/kg patient weight (p. 11). But Applicant argues that i) NCT01545076 does not teaches the low dose would have maintained a total weekly dose of 0.2g/kg patient weight for 24 months and produced an improvement in one or more of INCAT score, R-ODS score Mean grip strength, MRC sum score and electrophysiology paraments by at least 20%; ii) Kirch does not cure the deficiency; iii) a skilled artisan would have expected high dose arm would be required to achieve therapeutic efficacy in CIDP patients because van Shaik-2026 teaches that CIDP patents receiving SCIg at 0.4g/kg/week were expected to have a much lower relapse/withdrawal rate compared to those receiving 0.2g/kg/week; iv) Teschner teaches administering an IgG at dosages equivalent to once monthly IgG doses (p. 23, lines 6-10); v) the claimed method has unexpected results because van Shaik-2016 teaches an expected relapse/withdrawal rate from administering 0.2g/kg/week SCIg for treating CIPD of 52% whereas the observed relapse/withdrawal rate in the instant application is 39% and no statistically significance observed in any measures between two doses (see p. 17, lines 2-4; p. 19, lines 14-15; p. 22, lines 12-14 and tables 2-3).
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. 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).
Applicant’s arguments related to 0.4g/kg or monthly dose are irrelevant because
NCT01545076 teaches a method for treating chronic inflammatory demyelinating polyneuropathy (CIDP) using the same material (i.e. IgG product/Hizentra) at the same dose (0.2g/kg patient weight per week) and the same active step (subcutaneously administering to the patient) in the same patient population (patients with CIDP).
The teaching of NCT01545076 meets the limitations recited in claim 35 except the limitation “for 24 months”, and 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 chronic inflammatory demyelinating polyneuropathy (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).
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).
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.
ii. In response to Applicant’s arguments related to unexpected results, note that Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. See: MPEP §716.02. In addition, “A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue.” In re Corkill, 711 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). See MPEP 716.02(a)-I. Further, evidence of unexpected results is frequently in the form of a direct comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See: e.g., In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). In this case, the cited percentages from van Shaik-2016 are irrelevant to unexpected results because they are not real data. Applicants fails to provide evidence of side-by-side comparisons to demonstrate unexpected results as claimed. “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. 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.
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. (Med Klin 105, 647–651 (2010). English translated version) as applied to claims 35, 37, 44-45, 48, 52-53, 57, 59 and 69 above, and further in view of NCT02549170 (published Sep 15, 2015) and Teschner et al. (US9084743). The reference of Markvardsen et al. (J. Neurol. sci. 2017; IDS Ref # 12) is withdrawn in response to Applicant’s amendment to the claims. The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Arguments
On p. 9 of the response, Applicant argues that Markvardson does not quality as prior art because instant claims are entitled the benefits of US62/488219 filed Apr 21, 2017. On p. 11-13 of the response, Applicant argue that Teschner teaches administering an IgG at dosages equivalent to once monthly IgG doses (p. 23, lines 6-10).
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 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.
ii. The reference of Markvardson is withdrawn.
iii. while NCT01545076 and Kirch are set forth above but does 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 treating patients with CIDP using a flexible dosing regimen including biweekly at a dose of 2x0.2g/kg/every two weeks or every 3 weeks at a dose of 3x0.2g/kg/every 3 weeks as in claims 65-66, or twice a week at a dose of 0.2/2g/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.
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 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.
Using a method of 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 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 Kirch, and increase patient’s satisfaction with treatment of CIDP using the IgG product.
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 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 25-28 weeks, 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 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 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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US Patent No. 12325738 (Application No. 17/056632) in view of NCT01545076, Kirch et al. (2010), NCT02549170 and Teschner and evidentiary references: the factsheet of Hizentra and van Schaik’2016. The rejection is maintained for the reasons of record and the reasons set forth below.
On p. 13-14 of the response, Applicant argues that instant claims are not obvious over the issued patent US12325738 (Application No. 17/056632).
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 § 804, §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. The claims 1-10 of US12325738 (the ‘738 patent) claims a method or treating 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 ‘738 patent 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 claim 1. NCT01545076, Kirch, NCT02549170 and Teschner (US9084743) and evidentiary references: the factsheet of Hizentra 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, NCT02549170 and Teschner and evidentiary references: the factsheet of Hizentra and van Schaik’2016 to the method of the ‘738 patent, 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, 50, 52-53, 57, 59 and 65-69 on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US12325738 in view of NCT01545076, Kirch et al. (2010), NCT02549170 and Teschner and evidentiary references: the factsheet of Hizentra and van Schaik’2016 is maintained.
New Grounds of Rejection Necessitated by the Amendment
The following rejections are new grounds of rejections necessitated by the amendment filed on June 24, 2025.
Double Patenting
10. Claims 35, 37, 44-45, 48, 50, 52-53, 57, 59 and 65-69 are 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 factsheet of Hizentra and van Schaik’2016.
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 (claim 17).
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. NCT01545076, Kirch et al., the factsheet of Hizentra, van Schaik’2016, NCT02549170 and Teschner et al. (US9084743) 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., the factsheet of Hizentra, van Schaik’2016, NCT02549170 and Teschner 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.
This is a provisional nonstatutory double patenting rejection.
Conclusion
11. NO CLAIM IS ALLOWED.
12. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
13. 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 on Monday-Thursday, 7:00am-5:30pm EST.
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Chang-Yu Wang
October 20, 2025
/CHANG-YU WANG/Primary Examiner, Art Unit 1675