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. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the cited rejections will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
3. Response to Election/Restriction filed on 1/16/2026 is acknowledged.
4. Claim filed on 1/25/2023 is acknowledged.
5. Claims 1-15 are pending in this application.
6. Claims 5, 6, 10 and 12-15 are withdrawn from consideration as being drawn to non-elected species.
7. Claims 1-4, 7-9 and 11 are under examination.
Priority
8. The application is a CIP of US application No. 17/221675 filed on 4/2/2021 (ABN), which is a DIV of US application No. 16/063220 filed on 6/15/2018 (granted as US patent 11000568 B2), which is a 371 of PCT/EP2016/081407 filed on 12/16/2016, and claims foreign priority to EP 15201070.8 filed on 12/18/2015 and LU92979 filed on 2/19/2016. And in the instant case, both EP 15201070.8 and LUXEMBOURG 92979 are in English. Even though these various applications provide support to instant claims 1-3, 7-9 and 11, none of them provides support to instant claim 4. Therefore, the effective filing date of instant claims 1-3, 7-9 and 11 is 12/18/2015; and the effective filing date of instant claim 4 is 1/25/2023.
Election/Restrictions
9. Applicant’s election 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 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The requirement is made Final in this office action.
The instant claims 1-15 are drawn to a method 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, wherein said methanobactin is a Methylosinus trichosporium OB3b methanobactin (mb-OB3b) or a Methylocystis sp. SB2 methanobactin (mb-SB2). A search was conducted on the elected species; and prior art was found. Claims 5, 6, 10 and 12-15 are 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.
Claim Interpretations
10. With regards to the term “non-treatment” recited in instant claims, in view of the disclosure of instant specification and in the broadest reasonable interpretation, for the purpose of this examination, the Examiner is interpretating the term “non-treatment” as a period of time during which no methanobactin is administered (see page 89, the 2nd paragraph of instant specification).
With regards to the term “acute phase Wilson Disease” recited in instant claim 7 and the term “acute liver failure” recited in instant claim 8, the instant specification discloses that “Acute WD is defined herein as WD manifesting as acute liver failure (ALF), which may be the initial presentation of WD or can occur when WD treatment is stopped.” (see page 90, the 2nd paragraph in Section “Acute WD” of instant specification); and “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). Therefore, in view of the disclosure of instant specification and for the purpose of this examination, the Examiner is interpretating the term “acute liver failure” as development of hepatocellular dysfunction within less than 26 weeks from the onset of the first hepatic symptom; and the term “acute phase Wilson Disease” as WD patient with acute liver failure.
Such interpretations apply to all the rejections set forth below.
Objections
11. The specification is objected to for the following minor informality: First, Applicant is suggested to renumber the page number of instant specification with the first page being page 1 instead of page 73. Second, the chemical structures of the various formulae disclosed on pages 98 and 99 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).
12. The drawings are objected to for the following minor informality:
Figures 3B, 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 1-7, 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.
13. Claim 1 is 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 copper-binding methanobactin administration followed by (b) a second phase of non-treatment, wherein the second phase exceeds the first phase, and wherein said methanobactin is…”.
14. Claim 7 is objected to for the following minor informality: Applicant is suggested to amend claim 7 as "…wherein the Wilson Disease is acute phase Wilson Disease".
15. Claim 8 is objected to for the following minor informality: Applicant is suggested to amend claim 8 as "…wherein the acute Wilson Disease is…”.
16. Claim 11 is objected to for the following minor informality: First, claim 11 needs to end with a period. Second, the chemical structures of the recited formulae are in extremely poor quality. Applicant is required to amend claim 11 to recite clear and readable chemical structures of the recited formulae. Third, Applicant is suggested to add a “,” between the chemical structure of formula (IV) and the recited “or said mb-SB2 has the formula (V)…”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
17. 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.
18. Claims 7 and 8 are 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.
19. Claim 7 recites the term “acute phase Wilson Disease”, and claim 8 recites the term “acute liver failure”. With regards to the term “acute phase Wilson Disease” recited in instant claim 7 and the term “acute liver failure” recited in instant claim 8, the instant specification discloses that “Acute WD is defined herein as WD manifesting as acute liver failure (ALF), which may be the initial presentation of WD or can occur when WD treatment is stopped.” (see page 90, the 2nd paragraph in Section “Acute WD” of instant specification); and “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 unclear what is encompassed within the term “acute phase Wilson Disease” recited in instant claim 7 and the term “acute liver failure” recited in instant claim 8. Thus, the metes and bounds of instant claims 7 and 8 is vague and indefinite.
Claim Rejections - 35 U.S.C. § 112 paragraph (d)
20. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
21. Claim 8 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
22. Claim 8 depends on claim 7; and claim 8 recites “The method of claim 7, wherein acute phase Wilson Disease is characterized by acute liver failure”. However, with regards to the term “acute phase Wilson Disease” recited in instant claim 7, the instant specification discloses that “Acute WD is defined herein as WD manifesting as acute liver failure (ALF), which may be the initial presentation of WD or can occur when WD treatment is stopped.” (see page 90, the 2nd paragraph in Section “Acute WD” of instant specification). Therefore, the scope of the method recited in instant claim 8 is identical to that of the method recited in instant claim 7. Claim 8 does not further limit the scope of the method in claim 7; therefore, claim 8 is improper dependent forms for failing to further limit the subject matter of claim 7.
Claim Rejections - 35 U.S.C. § 102(a)(1)
23. 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.
24. Please note: during the search for the elected species, prior art was found for the non-elected species of methanobactin.
Claim 4 is rejected 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).
The instant claim 4 is drawn to a method 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, wherein said methanobactin is a Methylosinus trichosporium OB3b methanobactin (mb-OB3b) or a Methylocystis sp. SB2 methanobactin (mb-SB2), and wherein the second phase lasts for a period of at least about 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks or more.
Lichtmannegger et al, throughout the literature, teach a method of treating acute Wilson Disease in a subject in need thereof, wherein the method comprises at least one treatment cycle of (a) a first phase of a Methylosinus trichosporium OB3b methanobactin (mb-OB3b) administration at single dose of once daily for 5 consecutive days, followed by (b) a second phase of non-treatment lasts until experimental days 29, 36, or 85, for example, Title; Abstract; page 2728, Table 2, the paragraph bridging the left and right columns, and the paragraph bridging pages 2728 and 2729; and page 2730, Table 3. It reads on acute phase Wilson Disease as the elected species of Wilson Disease; and 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. It meets the limitation of instant claim 4.
Since the reference teaches all the limitations of instant claim 4; the reference anticipates instant claim 4.
25. Please note: during the search for the elected species, prior art was found for the non-elected species of administering scheme; and the non-elected species of methanobactin.
Claims 1-3, 7-9 and 11 are rejected 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).
The instant claims 1-3, 7-9 and 11 are drawn to a method 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, wherein said methanobactin is a Methylosinus trichosporium OB3b methanobactin (mb-OB3b) or a Methylocystis sp. SB2 methanobactin (mb-SB2).
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: either administering Methylosinus trichosporium OB3b methanobactin (mb-OB3b) at single dose of 200 mg/kg body weight once daily for 5 consecutive days, another dose after 2 days and killed 2 day later; or administering mb-OB3b at single dose of 200 mg/kg body weight as 13 doses, 3 times a week, every other day and without treatment during weekends, and killed 3 days after the last dose; and wherein mb-OB3b has a molecular weight of 1154 Da, 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. And as evidenced by Bandow et al, the mb-OB3b having a molecular weight of 1154 Da in Summer et al has the structure
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(see page 73, Figure 1A, identical to formula (IV) recited in instant claim 11). Therefore, the method in Summer et al reads on acute phase Wilson Disease as the elected species of Wilson Disease; and meets the limitations of instant claims 1-3, 7-9 and 11.
Since the reference teaches all the limitations of instant claims 1-3, 7-9 and 11; the reference anticipates instant claims 1-3, 7-9 and 11.
Claim Rejections - 35 U.S.C. § 103
26. 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.
27. 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.
28. Claims 1-4, 7-9 and 11 are 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) and Tanguay (Designing Safe and Efficient Phase I Studies to Expedite Clinical Development, from PharmaNet Development Group, Inc., 2010, pages 1-34).
The instant claims 1-4, 7-9 and 11 are drawn to a method 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, wherein said methanobactin is a Methylosinus trichosporium OB3b methanobactin (mb-OB3b) or a Methylocystis sp. SB2 methanobactin (mb-SB2).
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: either administering Methylosinus trichosporium OB3b methanobactin (mb-OB3b) at single dose of 200 mg/kg body weight once daily for 5 consecutive days, another dose after 2 days and killed 2 day later; or administering mb-OB3b at single dose of 200 mg/kg body weight as 13 doses, 3 times a week, every other day and without treatment during weekends, and killed 3 days after the last dose; and wherein mb-OB3b has a molecular weight of 1154 Da, 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. And as evidenced by Bandow et al, the mb-OB3b having a molecular weight of 1154 Da in Summer et al has the structure
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(see page 73, Figure 1A, identical to formula (IV) recited in instant claim 11). Therefore, the method in Summer et al reads on acute phase Wilson Disease as the elected species of Wilson Disease; and meets the limitations of instant claims 1-3, 7-9 and 11.
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; and the limitation 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 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: either administering either mb-OB3b with the structure
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(identical to instant formula (IV)) or 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: either administering either mb-OB3b with the structure
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(identical to instant formula (IV)) or 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: either administering either mb-OB3b with the structure
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(identical to instant formula (IV)) or 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.
Obviousness Double Patenting
29. 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.
30. Claims 1-4, 7-9 and 11 are 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.
31. Instant claims 1-4, 7-9 and 11 are drawn to a method 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, wherein said methanobactin is a Methylosinus trichosporium OB3b methanobactin (mb-OB3b) or a Methylocystis sp. SB2 methanobactin (mb-SB2).
32. 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).
33. Claims 1-4, 7-9 and 11 are rejected 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 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).
34. Instant claims 1-4, 7-9 and 11 are drawn to a method 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, wherein said methanobactin is a Methylosinus trichosporium OB3b methanobactin (mb-OB3b) or a Methylocystis sp. SB2 methanobactin (mb-SB2).
35. Claims 1-11 and 26-28 of US patent 7199099 B2 are drawn to an isolated copper binding protein having a sequence selected from the group consisting of N-2-isopropylester-(4-thionyl-5-hydroxy-imidazole)-Gly1-Ser2-Cys3-Tyr4-pyrrolidine-(4-thionyl-5-hydroxy-imidazole)-Ser5-Cys6-Met7 and N-2-isopropylester-(4-thiocarbonyl-5-hydroxy-imidazolate)-Gly1-Ser2-Cys3-Tyr4-pyrrolidine-(4hydroxy-5-thio-carbonyl-imidazolate)-Ser5-Cys6-Met7; and a method of chelating copper comprising: administering a copper-chelating effective amount of the copper binding protein of claim 1.
36. The difference between instant claims 1-4, 7-9 and 11 and claims 1-11 and 26-28 of US patent 7199099 B2 is that claims 1-11 and 26-28 of US patent 7199099 B2 do not teach apply the copper binding protein in 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 28 above, it would have been obvious to one of ordinary skilled in the art to apply the copper binding protein and/or modify the method recited in claims 1-11 and 26-28 of US patent 7199099 B2 and develop the method recited in instant claims 1-4, 7-9 and 11.
37. For the same and/or similar reasoning/rational as the rejection set forth in Sections 33-26 above, instant claims 1-4, 7-9 and 11 are 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 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) and Tanguay (Designing Safe and Efficient Phase I Studies to Expedite Clinical Development, from PharmaNet Development Group, Inc., 2010, pages 1-34) with routine optimization as set forth in Section 28 above.
38. For the same and/or similar reasoning/rational as the rejection set forth in Sections 33-26 above, instant claims 1-4, 7-9 and 11 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 2, 4 and 6 of co-pending Application No. 18/274981, and claims 27-29 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) and Tanguay (Designing Safe and Efficient Phase I Studies to Expedite Clinical Development, from PharmaNet Development Group, Inc., 2010, pages 1-34) with routine optimization as set forth in Section 28 above.
In the instant case, claims 27-29 of co-pending Application No. 19/165436 are in possession of the copper-binding methanobactin used in the method recited in instant claims 1-4, 7-9 and 11.
These are all provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658