Office Action 3: Notice of Allowance (2025-02-18)

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 an effective amount of an immunoglobulin G product to a CIDP patient who has been diagnosed as having non-axonal damage or mild axonal damage by assessment of a compound muscle action potential in the CIDP patient, wherein the compound muscle action potential in the CIDP patient is (1) higher than 1 mV at the foot,
(2) higher than 2 mV at the wrist, and/or (3) at least 50% of the mean compound muscle action potential measured in a healthy subject.

18.-25. (Canceled)1924

26\. (Currently Amended) The method of claim \[\[25\]\]18, 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\. (Previously Presented) 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\. (Currently Amended) The method of claim \[\[18\]\]17, 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\. (Previously Presented) 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 .
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

APPLICANT REBUTTAL: REMARKS
I.   Claim Status
Upon entry of this paper, claims 17 and 26-34 will be pending.
Claims 1-16 were canceled previously. Claims 18-25 are canceled herein.
Claim 17 is amended herein to incorporate limitations from claims 18-25, and claims 26 and 29 are amended herein to update their dependency. All cancellations and amendments are/were made without prejudice or disclaimer. All amendments find support throughout the as-filed specification (see, e.g., instant specification, 4:29-34) and in the original claims. As such, no new matter has been added. II.  Rejection under 35 U.S.C. § 103(a)
The Office rejected claims 17-33 under 35 U.S.C. § 103(a) as allegedly
unpatentable over van Shaik (Trials, 2016, 17(1):345; "van Shaik") in view of GrOter (Eur J Neurol, 2022, 29(2):583-592; "GrOter"). Office Action at 2-4. The Office cited van Shaik for allegedly teaching a method of treating CIDP in a patient in need thereof comprising administration of SCIg at 0.2 or 0.4 g/kg and nerve conduction studies performed by an electrophysiology measurement. Id. at 3. While acknowledging that van Shaik does not explicitly teach treating a CIDP patient diagnosed as having non- axonal damage or mild axonal damage, the Office contends that GrOter cures van Shaik's deficiency by allegedly teaching that "CIDP is known to occur with or without axonal damage." Id. Applicant respectfully disagrees.
Contrary to what the Office asserts, GrOter does not teach or suggest that CIDP may occur with or without axonal damage. Instead, GrOter expressly teaches that "[a]ssessment of overall axonal damage using an ordinal five-step score (none to very
severe) showed that no [CIDP] patients had either no or mild axonal damage in the overall cohort or in the ID group." GrOter at 585, right col.; emphasis added.
Moreover, neither of the two cited references teaches or suggests that a CIDP patient is diagnosed as having non-axonal damage or mild axonal damage when the compound muscle action potential assessed in the patient is (1) higher than 1 mV at the foot, (2) higher than 2 mV at the wrist, and/or (3) at least 50% of the mean compound muscle action potential measured in a healthy subject, as recited in previous claims 23- 25, and which are now incorporated into claim 17.
Therefore, Applicant submits that the cited references, indivudually or combined, do not teach or suggest all limitations recited in the amended claims and thus do not render the amended claims obvious. See M.P.E.P. § 2143.03 ("Examiners must consider all claim limitations when determining patentability of an invention over the prior art."). As such, Applicant respectfully requests withdrawal of this rejection. III.  Conclusions