DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendments after Non-final office action filed on 6/10/2026 and 6/18/2026 are acknowledged.
3. Claim filed on 6/10/2026 is acknowledged.
4. Claims 2 and 3 have been cancelled.
5. Claims 1 and 4-15 are pending in this application.
6. Claims 5, 6, 10 and 12-15 remain withdrawn from consideration as being drawn to non-elected species.
7. Applicant elected without traverse of acute phase Wilson Disease as species of Wilson Disease; First phase: 4 days or more consecutive days, single dose once or twice daily and Second phase: 8 weeks or more as species of administering scheme; and mb-SB2 (formula (V)) as species of methanobactin in the reply filed on 1/16/2026.
Restriction requirement was deemed proper and made FINAL in the previous office action. The instant claims 1 and 4-15 are drawn to a method of treating Wilson Disease in a subject in need thereof, the treatment comprising at least one treatment cycle of (a) a first phase of a Methylocystis sp. SB2 methanobactin (mb-SB2) administration followed by (b) a second phase of non-treatment, wherein the second phase lasts for 2 weeks or more and exceeds the first phase, wherein the first phase lasts for 1, 2, 3, 4, or more consecutive days and said mb-SB2 is administered once or twice daily, with each administration being a single dose. A search was conducted on the elected species; and prior art was found. Claims 5, 6, 10 and 12-15 remain withdrawn from consideration as being drawn to non-elected species. Claims 1, 4, 7-9 and 11 are examined on the merits in this office action.
Withdrawn Objections and Rejections
8. Objection to claim 8 is hereby withdrawn in view of Applicant's amendment to the claim.
9. Rejection to claim 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is hereby withdrawn in view of Applicant's amendment to the claim.
10. Rejection to claim 8 under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph is hereby withdrawn in view of Applicant's amendment to the claim.
11. Rejection to claim 4 under 35 U.S.C. 102(a)(1) as being anticipated by Lichtmannegger et al (The Journal of Clinical Investigation, 2016, 126, pages 2721-2735, filed with IDS) is hereby withdrawn in view of Applicant's amendment to the claim.
12. Rejection to claims 1-3, 7-9 and 11 under 35 U.S.C. 102(a)(1) as being anticipated by Summer et al (Journal of Trace Elements in Medicine and Biology, 2011, 25, pages 36-41, filed with IDS), and as evidenced by Bandow et al (Journal of Inorganic Biochemistry, 2012, 110, pages 72-82) is hereby withdrawn in view of Applicant's amendment to the claim.
13. Rejections to claims 1-4, 7-9 and 11 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 and 26-28 of US patent 7199099 B2, and claims 2 and 4 of co-pending Application No. 18/274981; and in view of Summer et al (Journal of Trace Elements in Medicine and Biology, 2011, 25, pages 36-41, filed with IDS), Bandow et al (Journal of Inorganic Biochemistry, 2012, 110, pages 72-82) and Tanguay (Designing Safe and Efficient Phase I Studies to Expedite Clinical Development, from PharmaNet Development Group, Inc., 2010, pages 1-34) are hereby withdrawn in view of Applicant's amendment to the claim and claims of co-pending Application No. 18/274981.
Maintained/Revised Objections
14. (Revised due to Applicant’s amendment to the specification) The specification remains objected to for the following minor informality: The chemical structures of formulae (IV) and (V) disclosed on pages 26 and 27 of instant specification are in extremely poor quality. Applicant is required to provide clear and readable chemical structures for these formulae.
Please note: The specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01).
15. (Revised due to Applicant’s amendment to the drawings) The drawings remain objected to for the following minor informality:
Figures 3C, 4E, 7A, 11 and 15 are described with respect to color. Reference to specific colors in the description of the drawings should be removed.
Figures 1, 2, 4, 5, 7, 9, 11, 14 and 16: The quality of these figures is extremely poor. It is almost impossible to read the words and numbers in these figures.
Figure 15 discloses various peptide sequences. However, these peptides are missing their respective sequence identifier. Applicant is required to amend the drawings to comply with 37 CFR 1.821(d).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
16. (Revised due to Applicant’s amendment to the claim) Claim 1 remains objected to for the following minor informality: Applicant is suggested to amend claim 1 as “A method of treating Wilson Disease in a subject in need thereof, wherein the method comprises at least one treatment cycle of (a) a first phase of a Methylocystis sp. SB2 methanobactin (mb-SB2) administration followed by (b) a second phase of non-treatment, wherein the second phase lasts for 2 weeks or more and exceeds the first phase, wherein the first phase lasts for 1 or more consecutive days, and wherein said mb-S82 is administered once or twice daily at a single dose”.
17. (Revised due to Applicant’s amendment to the claim) Claim 7 remains objected to for the following minor informality: Applicant is suggested to amend claim 7 as "… wherein the Wilson Disease is acute phase Wilson Disease manifested as acute liver failure”.
18. (Revised due to Applicant’s amendment to the claim) Claim 11 remains objected to for the following minor informality: The chemical structure of the recited formula is in extremely poor quality. Applicant is required to amend claim 11 to recite clear and readable chemical structure of the recited formula.
Response to Applicant's Arguments
19. Applicant either fails to address all the minor issues, and/or Applicant’s amendment to the claim introduces additional minor issues in these claims. Therefore, these objections are deemed proper and are hereby maintained.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
20. The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
21. (Revised due to Applicant’s amendment to the claim) Claim 7 remains rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
22. Claim 7 recites the limitation “wherein the Wilson Disease is acute phase Wilson Disease, wherein the acute phase of the Wilson Disease manifests as acute liver failure”. With regards to the term “acute liver failure” recited in instant claim 7, the instant specification discloses that “Acute liver failure is defined as the rapid development of hepatocellular dysfunction (i.e. within less than 26 weeks from the onset of the first hepatic symptoms), optionally accompanied by coagulopathy and hepatic encephalopathy in a patient.” (see page 90, the 3nd paragraph in Section “Acute WD” of instant specification). Since the disclosure of “(i.e. within less than 26 weeks from the onset of the first hepatic symptoms)” is an example of the rapid development of hepatocellular dysfunction, it is unclear what would be considered as “the rapid development of hepatocellular dysfunction”. Therefore, it is clear what is encompassed within the term “acute liver failure” recited in instant claim 7. Thus, the metes and bounds of instant claim 7 is vague and indefinite.
Response to Applicant's Arguments
23. Applicant argues that “Claim 7 has been amended to recite "Wilson Disease is acute phase Wilson Disease, wherein the acute phase of the Wilson Disease manifests as acute liver failure." Thus, the amended claim expressly links the acute phase of Wilson Disease to acute liver failure, consistent with the Examiner's interpretation of the instant specification.”
24. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about instant rejection, the Examiner understands that instant claim 7 has been amended to link the acute phase of Wilson Disease to acute liver failure. However, in the instant case, as stated in Section 22 above, it is clear what is encompassed within the term “acute liver failure” recited in instant claim 7. Therefore, the rejection is deemed proper and is hereby maintained.
Claim Rejections - 35 U.S.C. § 103
25. 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 of this title, 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.
26. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
27. (Revised due to Applicant’s amendment to the claim) Claims 1, 4, 7-9 and 11 remain rejected under 35 U.S.C. 103 as being unpatentable over Summer et al (Journal of Trace Elements in Medicine and Biology, 2011, 25, pages 36-41, filed with IDS) in view of Bandow et al (Journal of Inorganic Biochemistry, 2012, 110, pages 72-82, cited and enclosed in the previous office) and Tanguay (Designing Safe and Efficient Phase I Studies to Expedite Clinical Development, from PharmaNet Development Group, Inc., 2010, pages 1-34, cited and enclosed in the previous office).
The instant claims 1, 4, 7-9 and 11 are drawn to a method of treating Wilson Disease in a subject in need thereof, the treatment comprising at least one treatment cycle of (a) a first phase of a Methylocystis sp. SB2 methanobactin (mb-SB2) administration followed by (b) a second phase of non-treatment, wherein the second phase lasts for 2 weeks or more and exceeds the first phase, wherein the first phase lasts for 1, 2, 3, 4, or more consecutive days and said mb-SB2 is administered once or twice daily, with each administration being a single dose.
Summer et al, throughout the literature, teach a method of treating acute Wilson Disease characterized by acute liver failure in a subject in need thereof, wherein the method comprises at least one treatment cycle of: administering Methylosinus trichosporium OB3b methanobactin (mb-OB3b) at a single dose of 200 mg/kg body weight once daily for 5 consecutive days, another dose after 2 days and killed 2 day later, for example, Title; Abstract; page 37, left column, Sections “Isolation and purification of methanobactin” and “Animals and treatment”; and page 39, left column, the 2nd paragraph in Section “Copper in bile”; and right column, Figure 3. It reads on acute phase Wilson Disease as the elected species of Wilson Disease; and meets the limitations of the subject and the first phase recited in instant claim 1 and the limitations of instant claims 7-9.
The difference between the reference and instant claims 1, 4, 7-9 and 11 is that the reference does not teach First phase: 4 days or more consecutive days, single dose once or twice daily and Second phase: 8 weeks or more as the elected species of administering scheme; mb-SB2 (formula (V)) as the elected species of methanobactin; the mb-SB2 and the second phase recited in instant claim 1; and the limitations of instant claim 4.
However, Bandow et al, throughout the literature, teach that similar to the mb-OB3b used in the method in Summer et al, mb-SB2 with the structure
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is a copper-binding methanobactin (identical to the mb-SB2 of instant formula (V) recited in instant claim 11), for example, Title; Abstract; page 73, Figure 1; and page 80, Table 3 and “4. Conclusions”. It reads on mb-SB2 (formula (V)) as the elected species of methanobactin.
Furthermore, Tanguay teaches that in the field of clinical development, administration scheme and duration play important roles in the designing of a safe and efficient phase I clinical trial, for example, pages 2, 7, 15, 16 and 31. Therefore, in view of the teachings of Tanguay as a whole, one of ordinary skilled in the art would have been motivated to optimize the administration scheme and duration for effectively treating acute WD, including First phase: 4 days or more consecutive days, single dose once or twice daily and Second phase: 8 weeks or more. It reads on First phase: 4 days or more consecutive days, single dose once or twice daily and Second phase: 8 weeks or more as the elected species of administering scheme; and meets the limitation of the second phase recited in instant claim 1 and the limitations of instant claim 4. And, the MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“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.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see 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 II).
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Summer et al, Bandow et al and Tanguay with routine optimization to develop a method of treating acute Wilson Disease characterized by acute liver failure in a subject in need thereof, wherein the method comprises at least one treatment cycle of: administering mb-SB2 with the structure
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(identical to instant formula (V)) at a dose of at least 1 mg/kg body weight to the subject, and wherein the method comprise at least one treatment cycle of First phase of treatment: 4 days or more consecutive days, single dose once or twice daily and Second phase of non-treatment: 8 weeks or more.
One of ordinary skilled in the art would have been motivated to combine the teachings of Summer et al, Bandow et al and Tanguay with routine optimization to develop a method of treating acute Wilson Disease characterized by acute liver failure in a subject in need thereof, wherein the method comprises at least one treatment cycle of: administering mb-SB2 with the structure
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(identical to instant formula (V)) at a dose of at least 1 mg/kg body weight to the subject, and wherein the method comprise at least one treatment cycle of First phase of treatment: 4 days or more consecutive days, single dose once or twice daily and Second phase of non-treatment: 8 weeks or more, because Bandow et al, throughout the literature, teach that similar to the mb-OB3b used in the method in Summer et al, mb-SB2 with the structure
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is a copper-binding methanobactin. Tanguay teaches that in the field of clinical development, administration scheme and duration play important roles in the designing of a safe and efficient phase I clinical trial. Therefore, in view of the teachings of Tanguay as a whole, one of ordinary skilled in the art would have been motivated to optimize the administration scheme and duration for effectively treating acute WD, including First phase: 4 days or more consecutive days, single dose once or twice daily and Second phase: 8 weeks or more. And, the MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art (see MPEP § 2144.05 II).
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Summer et al, Bandow et al and Tanguay with routine optimization to develop a method of treating acute Wilson Disease characterized by acute liver failure in a subject in need thereof, wherein the method comprises at least one treatment cycle of: administering mb-SB2 with the structure
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(identical to instant formula (V)) at a dose of at least 1 mg/kg body weight to the subject, and wherein the method comprise at least one treatment cycle of First phase of treatment: 4 days or more consecutive days, single dose once or twice daily and Second phase of non-treatment: 8 weeks or more.
Response to Applicant's Arguments
28. Applicant argues about each of the cited Summer et al, Bandow et al and Tanguay references individually; and further argues that “The proposed combination would require one of ordinary skill in the art to select a structurally and chemically different methanobactin, substitute it for the mb-OB3b used in the WD treatment references, and then further select the presently claimed treatment/non-treatment cycle…These structural differences would not have provided a reasonable expectation that mbS82 would safely and effectively treat acute Wilson Disease or support prolonged nontreatment intervals after a short first dosing phase.” Applicant also argues about unexpected results.
29. Applicant's arguments have been fully considered but have not been found persuasive.
First, the Examiner would like to point out that instant claims 1, 4, 7-9 and 11 are rejected under 35 U.S.C. 103 (obviousness type); and the rejection is based on the combined teachings of Summer et al, Bandow et al and Tanguay with routine optimization. Therefore, it is not necessary for each of the cited prior art references to teach all the limitations of instant claims 1, 4, 7-9 and 11. Furthermore, the Examiner would like to point out that the MPEP states "One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references…" (see MPEP § 2145 IV).
In response to Applicant’s arguments about each of the cited Summer et al, Bandow et al and Tanguay references individually; and “The proposed combination would require one of ordinary skill in the art to select a structurally and chemically different methanobactin, substitute it for the mb-OB3b used in the WD treatment references, and then further select the presently claimed treatment/non-treatment cycle…These structural differences would not have provided a reasonable expectation that mbS82 would safely and effectively treat acute Wilson Disease or support prolonged nontreatment intervals after a short first dosing phase.”:
First, as stated above, instant claims 1, 4, 7-9 and 11 are rejected under 35 U.S.C. 103 (obviousness type); and the rejection is based on the combined teachings of Summer et al, Bandow et al and Tanguay with routine optimization. Therefore, it is not necessary for each of the cited prior art references to teach all the limitations of instant claims 1, 4, 7-9 and 11. And in the instant case, the combined teachings of Summer et al, Bandow et al and Tanguay with routine optimization as set forth in Section 27 above teach each and every limitations recited in instant claims 1, 4, 7-9 and 11.
Second, with regards to Applicant’s arguments about the differences between mb-OB3b in the cited Summer et al refence and the instant claimed mb-SB2, the Examiner understands that they do not have the same structure. However, in the instant case, in view of the teachings of Summer et al as a whole, one of ordinary skilled in the art would understand and reasonably expect that the mechanism of action of mb-OB3b for treating acute Wilson Disease is due to mb-OB3b being an effective chelator for copper. And as stated in Section 27 above, Bandow et al explicitly teach that similar to the mb-OB3b used in the method in Summer et al, the mb-SB2 of instant formula (V) is a copper-binding methanobactin. Furthermore, Bandow et al explicitly state “the core features to mb to consist of: [1] two 5-membered rings, either oxazolone or imidazolone rings, [2] an enethiolate associated with each ring, and [3] separation of the rings by 3 to 5 amino acids…the high binding constant for copper associated with mb from both M. trichosporium OB3b and Methylocystis strain SB2 is a consequence of these core features” (see page 80, Section “4. Conclusions”)”. Therefore, in the instant case, in view of the combined teachings of Summer et al and Bandow et al, one of ordinary skilled in the art would understand and reasonably expect that the mb-SB2 of instant formula (V) would be effective in treating acute Wilson Disease, since both mb-OB3b and mb-SB2 are effective chelator for copper.
In response to Applicant’s arguments about the unexpected superior results indicated in instant specification, the Examiner would like to point out that as stated in MPEP: “An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness.” (see MPEP § 716.02(e)). In the instant case, the closest prior art is the cited Summer et al reference. It is unclear to the Examiner which part of instant specification presents such comparison. Further clarification is required. Therefore, Applicant’s arguments about the unexpected superior results is insufficiently to overcome instant rejection.
Taken all these together, the rejection is still deemed proper and is hereby maintained.
Obviousness Double Patenting
30. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
31. (Revised due to Applicant’s amendment to the claim) Claims 1, 4, 7-9 and 11 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11, 14, 16-28 and 31 of US patent 11000568 B2.
32. Instant claims 1-4, 7-9 and 11 are drawn to a method of treating Wilson Disease in a subject in need thereof, the treatment comprising at least one treatment cycle of (a) a first phase of a Methylocystis sp. SB2 methanobactin (mb-SB2) administration followed by (b) a second phase of non-treatment, wherein the second phase lasts for 2 weeks or more and exceeds the first phase, wherein the first phase lasts for 1, 2, 3, 4, or more consecutive days and said mb-SB2 is administered once or twice daily, with each administration being a single dose.
33. Claims 1-11, 14, 16-28 and 31 of US patent 11000568 B2 are drawn to methods of treating Wilson Disease in a subject, the treatment comprising at least one treatment cycle of (a) a first phase of a copper-binding methanobactin administration followed by (b) a second phase of non-treatment, wherein the second phase exceeds the first phase lasting for a period of at least 2 weeks and wherein said methanobactin comprises the following general formula (I); and a method of treating Wilson Disease in a subject, wherein the treatment comprising at least one treatment cycle of (a) a first phase of methanobactin administration followed by (b) a second phase of non-treatment, wherein the second phase exceeds the first phase, wherein said methanobactin comprises a Methylocystis strain SB2 (mb-SB2).
In the instant case, in view of the combined teachings of claims 1-11, 14, 16-28 and 31 of US patent 11000568 B2, it would have been obvious to one of ordinary skilled in the art to develop the method recited in instant claims 1, 4, 7-9 and 11.
34. (Revised due to Applicant’s amendment to the claim) Claims 1, 4, 7-9 and 11 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-31 of US patent 8629239 B2, and in view of Summer et al (Journal of Trace Elements in Medicine and Biology, 2011, 25, pages 36-41, filed with IDS), Bandow et al (Journal of Inorganic Biochemistry, 2012, 110, pages 72-82, cited and enclosed in the previous office action) and Tanguay (Designing Safe and Efficient Phase I Studies to Expedite Clinical Development, from PharmaNet Development Group, Inc., 2010, pages 1-34, cited and enclosed in the previous office action).
35. Instant claims 1-4, 7-9 and 11 are drawn to a method of treating Wilson Disease in a subject in need thereof, the treatment comprising at least one treatment cycle of (a) a first phase of a Methylocystis sp. SB2 methanobactin (mb-SB2) administration followed by (b) a second phase of non-treatment, wherein the second phase lasts for 2 weeks or more and exceeds the first phase, wherein the first phase lasts for 1, 2, 3, 4, or more consecutive days and said mb-SB2 is administered once or twice daily, with each administration being a single dose.
36. Claims 1-31 of US patent 8629239 B2 are drawn to an isolated or purified compound having a molecular weight of less than 1 kDa and comprising at least four amino acids, a first metal binding moiety comprising a substituted imidazolone ring (M1), and a second metal binding moiety comprising a substituted oxazolone ring (M2), wherein M1 and M2 are linked by a dipeptide, and wherein M1 and M2 bind to a single metal atom; an isolated or purified complex comprising the compound in accordance with claim 1, wherein M1 and M2 are bound to a single metal atom; a conjugate comprising a compound of claim 1 linked to a heterologous moiety; a method of reducing the concentration of a metal atom from a liquid system, comprising contacting the system with the compound of claim L to form complexes comprising the compound bound to the metal atom form in the system, and removing the complexes from the system; and a method of producing the complex of claim 24 comprising a metal atom, comprising incubating a solution comprising a metal atom with the compound of claim 1.
37. The difference between instant claims 1, 4, 7-9 and 11 and claims 1-31 of US patent 8629239 B2 is that claims 1-31 of US patent 8629239 B2 do not teach the method recited in instant claims 1, 4, 7-9 and 11.
However, in view of the combined teachings of Summer et al, Bandow et al and Tanguay with routine optimization as set forth in Section 27 above, it would have been obvious to one of ordinary skilled in the art to select an isolated or purified compound of instant formula (V) from claims of US patent 8629239 B2 and develop the method recited in instant claims 1, 4, 7-9 and 11.
38. (Revised due to Applicant’s amendment to the claim) For the same and/or similar reasoning/rational as the rejection set forth in Sections 34-37 above, instant claims 1, 4, 7-9 and 11 remain provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 10, 21 and 27 of co-pending Application No. 19/165436; and in view of the combined teachings of Summer et al (Journal of Trace Elements in Medicine and Biology, 2011, 25, pages 36-41, filed with IDS), Bandow et al (Journal of Inorganic Biochemistry, 2012, 110, pages 72-82, cited and enclosed in the previous office action) and Tanguay (Designing Safe and Efficient Phase I Studies to Expedite Clinical Development, from PharmaNet Development Group, Inc., 2010, pages 1-34, cited and enclosed in the previous office action) with routine optimization as set forth in Section 27 above.
In the instant case, claims 1, 10, 21 and 27 of co-pending Application No. 19/165436 is in possession of the copper-binding methanobactin used in the method recited in instant claims 1, 4, 7-9 and 11.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Applicant's Arguments
39. Applicant argues that “The claims are now limited to a specific mb-SB2 treatment regimen…Further, as discussed above, the unexpected effects of the instantly claimed invention are not predictable from the art of record.”
40. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about these ODP rejections, first, the Examiner would like to point out that Applicant’s amendments to the claim is insufficient to overcome these ODP rejections. Second, Applicant’s arguments about unexpected results/effects have been addressed in Section 29 above.
Taken all these together, until a proper terminal disclaimer is filed and approved by the Office, these double patenting rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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