Office Action 1: Non-Final Rejection (2024-03-08)
Rejection types: 102 - Lack of Novelty, 103 - Obviousness, 112 - Written Description/Enablement

CLAIMS:
Claims

1\. An immunoglobulin product for use in a method of treating chronic inflammatory demyelinating polyneuropathy (CIDP), wherein the method comprises selecting a patient who has non-axonal damage or mild axonal damage for treatment with the immunoglobulin product.

2\. The immunoglobulin product for use of claim 1, wherein the selection of a patient with non- axonal damage or mild axonal damage involves an electrophysiology measurement.

3\. The immunoglobulin product for use of claim 2, wherein the electrophysiology measurement comprises the steps of (i) supramaximal nerve stimulation using a stimulation electrode, and
(ii) recording the amplitude of the compound muscle action potential using a recording electrode.

4\. The immunoglobulin product for use of claim 3, wherein the patient is selected based on a pre- determined cut-off amplitude for the compound muscle action potential.

5\. The immunoglobulin product for use of any one of claims 2-4, wherein the electrophysiology measurements are carried out at the wrist and/or at the foot.

6\. The immunoglobulin product for use of any one of claims 2-4, wherein the electrophysiology measurements are carried out at the foot.

7\. The immunoglobulin product for use of claim 5, wherein the pre-determined amplitude is > 2 mV for the wrist and/or > 1 mV for the foot.

8\. The immunoglobulin product for use of claim 6, wherein the pre-determined amplitude is > 1 mV for the foot.

35 9. The immunoglobulin product for use of any one of claims 1-5, wherein the pre-determined amplitude is at least 50 % of the mean amplitude measured in a healthy subject.

10\. The immunoglobulin product for use of any one of claims 1-9, wherein the electrophysiology measurements are carried out at the ulnar motor nerve, at the median motor nerve, and/or at the peroneal motor nerve.

11\. The immunoglobulin product for use of any one of claims 1-10, 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.

12\. The immunoglobulin product for use of claim 10 or claim 11, wherein the distance between the stimulation electrode and the recording electrode is (i) between 55 and 75 mm, preferably 65 mm for the ulnar motor nerve,
(ii) between 60 and 80 mm, preferably 70 mm for the median motor nerve, and/or
(iii) between 80 and 100 mm, preferably 90 mm for the peroneal motor nerve.

13\. The immunoglobulin product for use of any one of claims 1-12, wherein the electrophysiology measurement is carried out at a temperature between 30-36 0C, preferably between 32-34 \*C.

14\. The immunoglobulin product for use of claim 1, wherein the non-axonal damage has been determined by nerve biopsy.

15\. The immunoglobulin product for use of any one of claims 1-14, wherein the immunoglobulin product is to be administered at a fixed dose selected from the range of 0.1-0.4 g/kg patient weight per 5-10 days, preferably wherein the immunoglobulin product is to be administered subcutaneously at a fixed dose of 0.4 g/kg patient weight per week.

16\. The immunoglobulin product for use of any one of claims 1-15, wherein the CIPD relapse rate is reduced by more than 30 %, more than 40 % or even more than 50 % when compared to placebo. 5 10 15 20 25 30

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
1. Claims 17-33 are pending and currently under consideration.
Information Disclosure Statement
2. The information disclosure statement filed on 11/18/2020 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
3. The drawing filed on 11/18/2020 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
4. The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 17-33 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claim 17 is drawn to a method for 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. Claims 18-33 depend from claim 17. The claims do not require that the immunoglobulin product possess any particular conserved structure nor other disclosed distinguishing feature. The specification states that the term “immunoglobulin product” is intended to mean any polyclonal antibody fraction (page 6, line 6). Thus, the claims encompass a huge genus of immunoglobulin products without any structural features. However, the specification does not provide adequate support for the broad genus of immunoglobulin products.
For each claim drawn to a genus,  MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. In the instant case, the specification discloses an immunoglobulin product for subcutaneous administration, SCIG IgPro20 (Hizentra, CSL Behring) (page 24, lines 27-30) or VIVAGLOBIN (CSL Behring) and an immunoglobulin product for intravenous administration (IVIG), PRIVIGEN or SANDOGLOBULIN /CARIMUNE (CSL Behring) (page 7, last 2 paragraph). However, such a disclosure is insufficient to support the broad genus of immunoglobulin products. Moreover, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what other immunoglobulin products might be.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of and the instantly claimed method using the genus of anti-NRP1 antibody molecules to treat cancer comprises myeloid-derived suppressor cells.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
6. The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claim 28 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 28 recites the broad recitation “(iii) between 80 and 100 mmm” and the claim also recites “preferably 90 mm for the peroneal motor nerve” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(1)
8. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
9. Claims 17-18 and 31-33 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by van Schaik et al. (Trials 17:345, pages 1-15, 2016).
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 explicitly teach the limitation, “wherein the patient has non-axonal damage or mild axonal damage” recited in claim 17. However, CIDP is known to occur with or without axonal damage in the art (see, e.g., Grüter et al., Eur J Neurol. 29:583–592, 2022). Thus, the teachings of van Schaik et al. meet the limitations of claims 17-18 and 31-33.
Claim Rejections under 35 USC § 103(a)
10. 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.
11. Claims 19-30 are rejected under 35 U.S.C. 103(a) as being unpatentable over van Schaik et al. (Trials 17:345, pages 1-15, 2016) as applied to claims 17-18 and 31-33 above.
van Schaik et al. teach a method of treating chronic inflammatory demyelinating polyneuropathy (CIDP) in a patient in need thereof as applied to claims 17-18 and 31-33 above.
van Schaik et al. do not explicitly teach the experimental details recited in claims 19-30. However, It would 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.
Conclusion
12. No claims are allowed.
Advisory Information

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 .
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.