Office Action 2: Final Rejection (2024-08-30)
Rejection types: 103 - Obviousness

CLAIMS:
AMENDMENTS TO THE CLAIMS:

This listing of claims will replace all prior versions and listings of claims in the application:

1.-16. (Canceled)215

17\. (Currently Amended) A method for treating chronic inflammatory demyelinating polyneuropathy (CIDP) , comprising administering to \[\[the\]\] a CIDP patient who has been diagnosed as having non-axonal damage or mild axonal damage an effective amount of an immunoglobulin G product, .

18\. (Previously Presented) The method of claim 17, wherein axonal damage is assessed by an electrophysiology measurement.

19\. (Previously Presented) The method of claim 18, wherein the electrophysiology measurement comprises:
(i) supramaximal nerve stimulation using a stimulation electrode, and
(ii) recording the amplitude of the compound muscle action potential using a recording electrode.

20\. (Previously Presented) The method of claim 19, wherein axonal damage is assessed based on a predetermined cut-off amplitude for the compound muscle action potential.

21\. (Previously Presented) The method of claim 20, wherein the electrophysiology measurements are carried out at the wrist and/or at the foot.

22\. (Previously Presented) The method of claim 20, wherein the electrophysiology measurements are carried out at the foot.

23\. (Previously Presented) The method of claim 21, wherein the pre-determined amplitude is > 2 mV for the wrist and/or > 1 mV for the foot.

24\. (Previously Presented) The method of claim 22, wherein the pre-determined amplitude is > 1 mV for the foot.

25\. (Previously Presented) The method of claim 21, wherein the pre-determined amplitude is at least 50% of the mean amplitude measured in a healthy subject.

26\. (Previously Presented) The method of claim 25, wherein the electrophysiology measurements are carried out at the ulnar motor nerve, at the median motor nerve, and/or at the peroneal motor nerve.

27\. (Previously Presented) The method of claim 26, wherein the electrophysiology measurements are carried out at the wrist at the ulnar motor nerve, at the wrist at the median motor nerve, and/or at the foot at the peroneal motor nerve.

28\. (Currently Amended) The method of claim 26, wherein the distance between the stimulation electrode and the recording electrode is:
(i) between 55 and 75 mm for the ulnar motor nerve,
(ii) between 60 and 80 mm for the median motor nerve, and/or (iii) between 80 and 100 mm for the peroneal motor nerve.

29\. (Previously Presented) The method of claim 18, wherein the electrophysiology measurement is carried out at a temperature between 30-36 C.

30\. (Previously Presented) The method of claim 17, wherein the non-axonal damage has been determined by nerve biopsy.

31\. (Previously Presented) The method of claim 17, wherein the immunoglobulin product is administered at a dose of 0.1-0.4 g/kg patient weight per 5-10 days.

32\. (Previously Presented) The method of claim 31, wherein the immunoglobulin product is administered subcutaneously at a dose of 0.4 g/kg patient weight per week.

33\. (Previously Presented) The method of claim 17, wherein the CIPD relapse rate is reduced by more than 30 % when compared to placebo.


34\. (New) The method of claim 26, wherein the distance between the stimulation electrode and the recording electrode is 65 mm for the ulnar motor nerve, 70 mm for the median motor nerve, and/or 90 mm for the peroneal motor nerve.

OFFICE ACTION:
Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of Application, Amendments, and/or Claims
Applicant's amendment filed on 08/06/2024 has been entered. Claims 17-34 are pending and currently under consideration.
Withdrawn Objections and/or Rejections
The rejection of claim 28 under 35 U.S.C. 112 (b) is withdrawn in view of amended claim.
The rejection of claims 17-33 under 35 U.S.C. 112(a) is withdrawn in view of amended claim 17.
Claim Rejections under 35 USC § 103(a)
(i). The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.  Patentability shall not be negatived by the manner in which the invention was made.
(ii). Claims 17-33 are rejected under 35 U.S.C. 103(a) as being unpatentable over van Schaik et al. (Trials 17:345, pages 1-15, 2016) in view of Grüter et al. (Eur J Neurol. 29:583–592, 2022).
van Schaik et al. teach a method of treating chronic inflammatory demyelinating polyneuropathy (CIDP) in a patient in need thereof, comprising administering subcutaneously to the patient an immunoglobulin product, Ig (SCIg) at (0.2 g/kg bw or 0.4 g/kg bw), wherein the patient has non-axonal damage or mild axonal damage. Nerve conduction studies will be performed by an electrophysiology measurement (page 5, right column, the 4th paragraph).
van Schaik et al. do not (i) explicitly teach the limitation recited in claim 17, “a CIDP patient who has been diagnosed as having non-axonal damage or mild axonal damage”; and (ii) the limitations recited in claims 19-30.
It would have been obvious to one of ordinary skill in the art to assess the overall axonal damage in a patient to determine whether a patient has either no or mild axonal damage, or severe axonal damage as taught by Grüter et al. (page 3, right column, 4th paragraph) and to apply the method of Schaik et al. to treat the CIDP patient with a reasonable expectation of success. One would have been motivated to do so because (i). axonal damage determines clinical disability in CIDP; and (ii). Grüter et al. teach a method of treating CIDP patients in general, whereas CIDP is known to occur with or without axonal damage as taught by Grüter et al.
It would also have been obvious to one of ordinary skill in the art to apply these experimental procures to assess axonal damage by an electrophysiology measurement in a CIDP patient with a reasonable expectation of success. One would have been motivated to do so because these experimental details are all well-known in the art and routinely practiced in the field as evidenced by Grüter et al.
Applicant argues that Schaik et al. do not teach or suggest treating a CIDP patient who has been diagnosed as having non-axonal damage or mild axonal damage. Nor does the reference provide any motivation for determining whether a CIDP patient has non-axonal damage or mild axonal damage before treating the patient with an IgG product. As such, Applicant respectfully requests withdrawal of this rejection. Applicant’s argument has been fully considered but is not deemed to be persuasive for the reasons set forth in the rejection above.
Conclusion
No claims are allowed.
Advisory Information
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 extension fee 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 date of this final action.

APPLICANT REBUTTAL: REMARKS
I.    Claim Status
Upon entry of this paper, claims 17-34 will be pending.
Claims 1-16 were canceled previously. Claims 17 and 28 are amended herein.
Claim 34 is new. All cancellations and amendments were/are made without prejudice or
disclaimer. The new claim and all amendments find support throughout the as-filed
specification and in the original claims. As such, no new matter has been added. II.    Rejection under 35 U.S.C. § 112(a)
The Office rejected claims 17-33 under 35 U.S.C. § 112(a) for allegedly failing to
comply with the written description requirement. Office Action at 2-4. The Office
alleges that "the claims encompass a huge genus of immunoglobulin products without
any structural features," and concluded that "the specification does not provide
adequate support for the broad genus of immunoglobulin products." Id. at 3. Applicant
respectfully disagrees. Nevertheless, without acquiescing to the Office's rejection and solely to expedite prosecution, Applicant has amended claim 17 to recite a method for
treating CIDP with "an immunoglobulin G product" and submits that the written
description requirement has been met in view of the amended claims. As such,
Applicant respectfully requests withdrawal of this rejection. III.   Rejection under 35 U.S.C. § 112(b)
The Office rejected claims 28 under 35 U.S.C. § 112(b) as allegedly being
indefinite for reciting a broad range (e.g., "between 80 and 100 mm") together with a narrow range (e.g., "preferably 90 mm"). Office Action at 4-5. Applicant respectfully
disagrees. Nevertheless, without acquiescing to the Office's rejection and solely to
expedite prosecution, Applicant has amended claim 28 to recite only the broad range
and has moved the narrower recitations to new claim 34. As such, Applicant
respectfully requests withdrawal of this rejection. IV.    Rejection under 35 U.S.C. § 102(a)(1)
The Office rejected claims 17, 18, and 31-33 under 35 U.S.C. § 102(a)(1) as
allegedly being anticipated by van Schaik et al. ("Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The
PATH Study): study protocol for a randomized controlled trial," Trials, 2016, 17(1):345; "van Schaik"). Office Action at 5-6. The Office cited van Schaik for allegedly teaching
treatment of CIDP in a patient with SCIg at 0.2 or 0.4 g/kg bw. Id. at 5. While
acknowledging that van Schaik does not explicitly teach the patient having non-axonal
damage or mild axonal damage as recited in claim 17 (id. at 5-6), the Office further cited
GrOter et al. ("Axonal damage determines clinical disability in chronic inflammatory
demyelinating polyradiculoneuropathy (CIDP): A prospective cohort study of different CIDP subtypes and disease stages," Eur J Neurol, 2022, 29(2):583-592; "GrOter") for
allegedly teaching that CIDP is known to occur with or without axonal damage (id. at 6).
Applicant respectfully disagrees.
Nevertheless, without acquiescing to the Office's rejection and solely to expedite
prosecution, Applicant has amended claim 17 to recite a method for treating "a CIDP
patient who has been diagnosed as having non-axonal damage or mild axonal damage"
with an effective amount of an immunoglobulin G product. The amended claims are not
anticipated by the cited combination of references because neither reference teaches or
suggests treating a CIDP patient who has been diagnosed as having non-axonal
damage or mild axonal damage. As such, Applicant respectfully requests withdrawal of
this rejection.
V.
Rejection under 35 U.S.C. § 103
The Office rejected claims 19-30 under 35 U.S.C. § 103 as allegedly being
unpatentable over van Schaik. Office Action at 6. While acknowledging that van Schaik
"do[es] not explicitly teach the experimental details recited in claims 19-30" (id.), the
Office contends that it would have been obvious for one skilled in the art to apply these experimental procedures, which are well-known in the art and routinely practiced in the field, to access axonal damage by an electrophysiology measurement in a CIDP patient with a reasonable expectation of success (id.). Applicant respectfully disagrees.
Nevertheless, without acquiescing to the Office's rejection and solely to expedite
prosecution, Applicant has amended claim 17 to recite a method for treating "a CIDP
patient who has been diagnosed as having non-axonal damage or mild axonal damage" with an effective amount of an immunoglobulin G product. As discussed above, van Schaik does not teach or suggest treating a CIDP patient who has been diagnosed as
having non-axonal damage or mild axonal damage. Nor does the reference provide any
motivation for determining whether a CIDP patient has non-axonal damage or mild axonal damage before treating the patient with an IgG product. As such, Applicant
respectfully requests withdrawal of this rejection.
VI.    Conclusions

NEXT OFFICE ACTION: Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
EXAMINER’S AMENDMENT/COMMENT
Examiner’s Amendment
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee. Authorization for this examiner’s amendment was given in a telephone interview with Amanda K. Murphy on February 3, 2025.
(i). Claim 1, in line 5, replace “by assessment” with – by an electrophysiology measurement --.
(ii). Claim 26,
in line 1, replace “claim 18” with – claim 17 -;
in line 3, after “and/or at the peroneal motor nerve”, insert -- using a stimulation electrode and a recording electrode --.
Conclusion
Claims 17 and 26-34 are allowed.
Advisory Information