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
The amendment after non-final office action filed July 13, 2026 is acknowledged. Claims 2-4, 10, 13, 16, 19, 21, 26 were cancelled, claims 1, 5-8, 11-12, 14, 17-18, 20, 22-25 were amended, claims 27-30 were newly added and claims 1, 5-9, 11-12, 14-15, 17-18, 20, 22-25, 27-30 are pending.
Election/Restrictions
The restriction requirement was deemed proper and made FINAL previously. Claims 20, 28-30 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 1, 5-9, 11-12, 14-15, 17-18, 22-25, 27 are examined on the merits of this office action.
Withdrawn Objections/Rejections
The rejection of claims 1, 3-9, 11-12, 14-15, 17-18, 22-26 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, scope of enablement, is withdrawn in view of amendment of the claims filed July 13, 2026.
The rejection of claims 1, 3-9, 11-12, 14-15, 17-18, 22-25 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matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), is withdrawn in view of amendment of the claims filed July 13, 2026.
The rejection of claim 4 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 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the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends, is withdrawn in view of amendment of the claims filed July 13, 2026.
The rejection of claims 1, 3-9, 11-12, 14-15, 17-18, 22-26 on the ground of nonstatutory double patenting as being unpatentable over claims 33-37 of copending Application No. 16/427593 (reference application) is withdrawn in view filing and approval of the terminal disclaimer on July 13, 2026.
The rejection of Claim 26 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9803185 as evidenced by Yun (International Journal of Molecular science, 2018, 19, pages 3-18) is withdrawn in view of amendment of the claims filed July 13, 2026.
The rejection of claim 26 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. RE48805E1 as evidenced by Yun (International Journal of Molecular science, 2018, 19, pages 3-18, cited previously) is withdrawn in view of amendment of the claims filed July 13, 2026.
The rejection of claim 26 on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11751050 as evidenced by Yun (International Journal of Molecular science, 2018, 19, pages 3-18) is withdrawn in view of amendment of the claims filed July 13, 2026.
The rejection of claim 26 on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 7951366 as evidenced by Yun (International Journal of Molecular science, 2018, 19, pages 3-18) is withdrawn in view of amendment of the claims filed July 13, 2026.
The rejection of claim 26 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2-3, 6-10 of copending Application No. 18/416322 (reference application) as evidenced by Yun (see reference above) due to abandonment of the co-pending Application.
The rejection of claim 26 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. RE47233 as evidenced by Yun (International Journal of Molecular science, 2018, 19, pages 3-18) in view of Wong (US20140255377 A1) ) is withdrawn in view of amendment of the claims filed July 13, 2026.
The rejection of claim 26 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9255262 as evidenced by Yun (International Journal of Molecular science, 2018, 19, pages 3-18) in view of Wong (US20140255377 A1) is withdrawn in view of amendment of the claims filed July 13, 2026.
Terminal Disclaimer
The terminal disclaimer filed on July 13, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of co-pending AN16/427593 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Maintained/Revised Rejections
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) for the rejection 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.
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.
Claim(s) 1, 5-7, 12, 14-15, 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Debosch (WO2020009740A2, priority date of 4/25/20218).
*Regarding the term “intermittent fasting”, it is understood to occur as a physiological result of administering the arginine-depleting agent, rather than as a separate affirmative dietary intervention. The specification demonstrates that administration of the arginine-depleting agent inherently leads to repeated periods of reduced food intake followed by refeeding, i.e., intermittent fasting cycles (see, e.g., paragraphs [0034], [0053]–[0054], and [0076]). Accordingly, for purposes of this rejection, intermittent fasting is treated as an inherent outcome of administering the arginine-depleting agent.
Debosch teaches “A method for treating a metabolic disease or related disorder in a subject in need thereof comprising administering to the subject a composition comprising a therapeutically effective amount of an arginine deprivation agent” (see claim 1). Debosch teaches treatment of obese and diabetic patients (see abstract, paragraph 0003). Regarding claim 1, Debosch teaches wherein the arginine deprivation agent is one or more of an arginase, an arginine deiminase or an arginine decarboxylase (see claim 2) and is Arginase I (see claim 11, SEQ ID NO:1 is human arginase I, also claims 1, 9-11). In particular, Debosch teaches use of human ArgI and II (see paragraph 0042). Regarding claim 1, Debosch teaches administering a second therapeutic agent such as metformin (see paragraph 0149) thus meeting the limitations of a autophagy inducing agent as evidenced by instant claim 12 .
Regarding claim 1, Debosch teaches the same method of the instant claims including administering the same agent (human arginase I) for the same purpose (reducing arginine and treating obese patients) and thus the concentration in the subjects serum will be maintained below the levels listed in instant claim 1 given the inherent properties of the arginine depleting compound. Regarding claim 7, Debosch teaches linking the arginine degrading enzyme to Fc or albumin from human serum (see claim 14, also paragraph 0061). Regarding claims 6, 22, Debosch teaches wherein the arginine deprivation agent is Arginase I (see claim 11, SEQ ID NO:1 is human arginase I which is identical to instant SEQ ID NO:103, also claims 1, 9-11). Regarding claims 5 and 23, Debosch additionally teaches one or more PEG groups (see claim 15) thus meeting the limitations of instant SEQ ID NO:3 with a PEG group. Regarding claims 12, 14, 15, Debosch teaches wherein an additional agent is metformin which is a biguanide and an autophagy inducing agent (see paragraph 0149). Debosch teaches multiple additional agents including metformin and alpha glucosidase inhibitor (see second paragraph in paragraph 0149).
Response to Applicant’s Arguments
Applicant argues “All of the rejections under 35 U.S.C. 102 and 103 use DeBosch as a base reference. In making the rejection, it is alleged that DeBosch teaches administration of arginase and an optional administration of liraglutide in paragraph [0095].
Claim 1 has been amended to delete "glucose lowering agent" from the list of "second therapeutic agent." DeBosch is silent as to the administration of the remaining listed second therapeutic agents.
New claim 28 has been amended to recite the co-administration of an arginine-depleting agent and a second therapeutic agent selected from "an alpha-glucosidase inhibitor, a biguanide, bile acid sequestrant, a dopamine-2 agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a meglitinide, a sodium-glucose transport protein 2 (SGLT2) inhibitor, a sulfonylurea, a thiazolidinedione, or a combination thereof." None of these second therapeutic agents are taught or suggested by DeBosch.
Claim 1 has also been amended to delete the reference to a retinoid derivative; therefore the rejection of certain claims over the combination of DeBosch and Barry is moot.
In view of the amendments to claim 1 and new claim 28, it is respectfully requested that these rejections be withdrawn.”
Applicant’s arguments have been fully considered but not found persuasive. Although claim 1 has been amended to delete “a glucose lowering agent” from the recited group of second therapeutic agents, claim 1 continues to encompass “an autophagy inducing agent”. Debosch teaches co administering a second therapeutic agent such as metformin (see paragraph 0149) thus meeting the limitations of a autophagy inducing agent as evidenced by instant claim 12 which defines metformin as an autophagy inducing agent. Accordingly, deletion of “a glucose lowering agent” does not distinguish the second therapeutic agent of claim 1 from the second therapeutic agent taught by DeBosch.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) for the rejection 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.
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, 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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5-9, 12, 14-15, 22-24, 27 remain rejected under 35 U.S.C. 103 as being unpatentable over Debosch (WO2020009740A2, priority date of 4/25/20218) in view of Wong (US20140255377 A1, cited previously).
*Regarding the term “intermittent fasting”, it is understood to occur as a physiological result of administering the arginine-depleting agent, rather than as a separate affirmative dietary intervention. The specification demonstrates that administration of the arginine-depleting agent inherently leads to repeated periods of reduced food intake followed by refeeding, i.e., intermittent fasting cycles (see, e.g., paragraphs [0034], [0053]–[0054], and [0076]). Accordingly, for purposes of this rejection, intermittent fasting is treated as an inherent outcome of administering the arginine-depleting agent.
Debosch teaches “A method for treating a metabolic disease or related disorder in a subject in need thereof comprising administering to the subject a composition comprising a therapeutically effective amount of an arginine deprivation agent” (see claim 1). Debosch teaches treatment of obese and diabetic patients (see abstract, paragraph 0003). Regarding claim 1, Debosch teaches wherein the arginine deprivation agent is one or more of an arginase, an arginine deiminase or an arginine decarboxylase (see claim 2) and is Arginase I (see claim 11, SEQ ID NO:1 is human arginase I, also claims 1, 9-11). In particular, Debosch teaches use of human ArgI and II (see paragraph 0042). Regarding claim 1, Debosch teaches administering a second therapeutic agent such as metformin (see paragraph 0149) thus meeting the limitations of a autophagy inducing agent as evidenced by instant claim 12 .
Regarding claim 1, Debosch teaches the same method of the instant claims including administering the same agent (human arginase I) for the same purpose (reducing arginine and treating obese patients) and thus the concentration in the subjects serum will be maintained below the levels listed in instant claim 1 given the inherent properties of the arginine depleting compound. Regarding claim 7, Debosch teaches linking the arginine degrading enzyme to Fc or albumin from human serum (see claim 14, also paragraph 0061). Regarding claims 6, 22, Debosch teaches wherein the arginine deprivation agent is Arginase I (see claim 11, SEQ ID NO:1 is human arginase I which is identical to instant SEQ ID NO:103, also claims 1, 9-11). Regarding claims 5 and 23, Debosch additionally teaches one or more PEG groups (see claim 15) thus meeting the limitations of instant SEQ ID NO:3 with a PEG group. Regarding claims 12, 14, 15, Debosch teaches wherein an additional agent is metformin which is a biguanide and an autophagy inducing agent (see paragraph 0149). Debosch teaches multiple additional agents including metformin and alpha glucosidase inhibitor (see second paragraph in paragraph 0149).
Debosch is silent to wherein the arginine depleting enzyme (arginase I or arginine deiminase) is fused to an Albumin binding domain.
Wong discloses a method of treating arginine-dependent diseases (see claim 17) comprising administering a therapeutically effective amount of an arginine depleting agent fused to albumin binding domain (see claims 15 and 1). Wong teaches wherein the arginine level is below 50 µm (see figure 11). Wong teaches wherein the arginine depleting agents is an arginine catabolic enzyme and in particular, an arginine deiminase protein (see claim 1). Wong teaches fusing an albumin binding domain to the arginine depleting agent to create high activity and prolonged half-life (see abstract).
It would have been obvious before the effective filing date of the claimed invention to fuse the arginine depleting enzyme of Debosch (which is inclusive to human arginase I and arginine deiminase). One of ordinary skill in the art would have been motivated to do so improve half life and activity (arginine depletion) of the agent in patients. There is a reasonable expectation of success given that Wong teaches fusion with ABD and that it is effective in depleting arginine with a prolonged half life.
Regarding claims 8-9, 22-24, 27, instant SEQ ID NO:49 is an ABD linked to human arginase I with a 6XHis tag. Debosch in view of Wong teach instant SEQ ID NO:49 given that SEQ ID NO:40 of Wong teaches the same 6XHis Tag, linker, ABD and Poly-N (see Figure 3, SEQ ID NO:40). Debosch teaches the human arginase I peptide found in instant SEQ ID NO:49 (see SEQ ID NO:1). Thus, the combined teachings of Debosch in view of Wong teach instant SEQ ID NO:49. Furthermore, regarding claim 24, Debosch teaches that the arginine depleting agent can comprise one or more PEG groups (see claim 15). Furthermore, Debosch teaches wherein the arginine deprivation agent is Arginase I (see claim 11, SEQ ID NO:1 is human arginase I which is identical to instant SEQ ID NO:103, also claims 1, 9-11). Debosch additionally teaches one or more PEG groups (see claim 15) thus meeting the limitations of instant SEQ ID NO:3 with a PEG group. The combination of Debosch in view of Wong render obvious instant SEQ ID NO:103 (human arginase I) fused to an ABD.
Response to Applicant’s Arguments
Applicants reiterate the aforementioned arguments with respect to the instant rejection. The Office’s rebuttal of these arguments remains the same and is incorporated herein by reference.
Claim(s) 1, 5-7, 11-12, 14-15, 17-18, 22-23, 25 remain rejected under 35 U.S.C. 103 as being unpatentable over Debosch (WO2020009740A2, priority date of 4/25/20218) in view of Berry (Mol Cell Biol . 2009 Jun;29(12):3286-96, Epub 2009 Apr 13).
*Regarding the term “intermittent fasting”, it is understood to occur as a physiological result of administering the arginine-depleting agent, rather than as a separate affirmative dietary intervention. The specification demonstrates that administration of the arginine-depleting agent inherently leads to repeated periods of reduced food intake followed by refeeding, i.e., intermittent fasting cycles (see, e.g., paragraphs [0034], [0053]–[0054], and [0076]). Accordingly, for purposes of this rejection, intermittent fasting is treated as an inherent outcome of administering the arginine-depleting agent.
Debosch teaches “A method for treating a metabolic disease or related disorder in a subject in need thereof comprising administering to the subject a composition comprising a therapeutically effective amount of an arginine deprivation agent” (see claim 1). Debosch teaches treatment of obese and diabetic patients (see abstract, paragraph 0003). Regarding claim 1, Debosch teaches wherein the arginine deprivation agent is one or more of an arginase, an arginine deiminase or an arginine decarboxylase (see claim 2) and is Arginase I (see claim 11, SEQ ID NO:1 is human arginase I, also claims 1, 9-11). In particular, Debosch teaches use of human ArgI and II (see paragraph 0042). Regarding claim 1, Debosch teaches administering a second therapeutic agent such as metformin (see paragraph 0149) thus meeting the limitations of a autophagy inducing agent as evidenced by instant claim 12 .
Regarding claim 1, Debosch teaches the same method of the instant claims including administering the same agent (human arginase I) for the same purpose (reducing arginine and treating obese patients) and thus the concentration in the subjects serum will be maintained below the levels listed in instant claim 1 given the inherent properties of the arginine depleting compound. Regarding claim 7, Debosch teaches linking the arginine degrading enzyme to Fc or albumin from human serum (see claim 14, also paragraph 0061). Regarding claims 6, 22, Debosch teaches wherein the arginine deprivation agent is Arginase I (see claim 11, SEQ ID NO:1 is human arginase I which is identical to instant SEQ ID NO:103, also claims 1, 9-11). Regarding claims 5 and 23, Debosch additionally teaches one or more PEG groups (see claim 15) thus meeting the limitations of instant SEQ ID NO:3 with a PEG group. Regarding claims 12, 14, 15, Debosch teaches wherein an additional agent is metformin which is a biguanide and an autophagy inducing agent (see paragraph 0149). Debosch teaches multiple additional agents including metformin and alpha glucosidase inhibitor (see second paragraph in paragraph 0149). Furthermore, Regarding claims 1, 6, 22-23, Debosch teaches wherein the arginine deprivation agent is Arginase I (see claim 11, SEQ ID NO:1 is human arginase I which is identical to instant SEQ ID NO:103, also claims 1, 9-11). Debosch additionally teaches one or more PEG groups (see claim 15) thus meeting the limitations of instant SEQ ID NO:3 with a PEG group.
Debosch is silent to wherein the secondary therapeutic is retinoic acid (instant claims 11, 17-18).
However, Berry teaches retinoic acid (RA) represses obesity and insulin resistance by activating both peroxisome proliferation-activated receptor beta/delta and retinoic acid receptor (see abstract). Berry teaches “RA treatment of obese mice induced expression of PPARbeta/delta and RAR target genes involved in regulation of lipid homeostasis, leading to weight loss and improved insulin responsiveness. RA treatment also restored adipose PPARbeta/delta expression (see abstract).
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose (treating diabetes/obesity), in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). But see In re Geiger, 815 F.2d 686, 2 USPQ2d 1276 (Fed. Cir. 1987) (“Based upon the prior art and the fact that each of the three components of the composition used in the claimed method is conventionally employed in the art for treating cooling water systems, the board held that it would have been prima facie obvious, within the meaning of 35 U.S.C. 103, to employ these components in combination for their known functions and to optimize the amount of each
additive....Appellant argues... hindsight reconstruction or at best,... obvious to try’.... We agree with appellant.”). One of ordinary skilled in the art would have been motivated to combine the two (retinoic acid with arginine depleting agent) each known to be useful for the same purpose (treating diabetes/obesity), with a reasonable expectation that at least here will be an additive effect.
Response to Applicant’s Arguments
Applicants reiterate the aforementioned arguments with respect to the instant rejection. The Office’s rebuttal of these arguments remains the same and is incorporated herein by reference
New Rejections
Claim Rejections - 35 USC § 112
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.
Claims 11 and 14-15, 17-18 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 requires the second therapeutic agent to be “selected from the group consisting of an autophagy inducing agent, an EGCG derivative, and a rapamycin derivative”, whereas claims 11 and 17 recite that “the second therapeutic agent further comprises a retinoid derivative”. It is unclear whether the retinoid derivative is intended to be an additional therapeutic agent outside the closed Markush group of claim 1, or is intended to further limit one of the alternatives recited in claim 1. A suggested amendment if Applicant are wanting a different additional agent could be “The method of claim 1, further comprising administering a retinoid derivative to the subject”. Claim 18 is also rejected due to its dependence on claim 17 and not clarifying this point of confusion.
Claim 1 requires the second therapeutic agent to be “selected from the group consisting of an autophagy inducing agent, an EGCG derivative, and a rapamycin derivative”, whereas claim 14 recites that “the second therapeutic agent further comprises a glucose lowering agent” selected from the cited group. It is unclear whether the glucose lowering agent is intended to be part of the second therapeutic agent selected from the closed Markush group of claim 1 or a separate additional therapeutic agent. A suggested amendment if Applicant are wanting a different additional agent could be “The method of claim 1, further comprising administering a glucose lower agent….” Claim 15 is also rejected due to its dependence on claim 14 and not further clarifying this point of confusion.
Claim Rejections - 35 USC § 112
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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 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.
Claim 1 requires the second therapeutic agent to be selected from the group consisting of an autophagy inducing agent, an EGCG derivative, and a rapamycin derivative. Claim 25, however, recites that the second therapeutic agent is a retinoid derivative. Thus, claim 25 does not further limit the second therapeutic agent recited in claim 1, but instead appears to substitute a different therapeutic agent outside the closed Markush group of claim 1.
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.
Conclusion
No claims are allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/ERINNE R DABKOWSKI/ Primary Examiner, Art Unit 1654
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