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 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

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