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 7/29/2025 is acknowledged.
4. Claim filed on 10/24/2022 is acknowledged.
5. Claims 3-6, 11, 12, 16, 17, 22-26, 28, 31, 34, 36-38 and 40-82 have been cancelled.
6. Claims 1, 2, 7-10, 13-15, 18-21, 27, 29, 30, 32, 33, 35 and 39 are pending in this application.
7. Claims 1, 2, 7-10, 13-15, 18, 19, 27, 29, 30, 32, 33, 35 and 39 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim.
8. Claims 20 and 21 are under examination.
Priority
9. The instant application is a 371 of PCT/US2020/045132 filed on 8/6/2020, which claims priority to US provisional application No. 62/883311 filed on 8/6/2019. US provisional application No. 62/883311 provides support to instant claims 20 and 21. Therefore, the effective filing date of instant claims 20 and 21 is 8/6/2019.
Election/Restrictions
10. Applicant’s election without traverse of Group 3 (claims 20 and 21) and election without traverse of compound 100 with the structure
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(a compound of Formula IV with M+ being Na+, n being 4, Z being a residue of pemetrexed having the formula of
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, and all glutamate units being in L-form) as species of alkali salt of Formula IV or IV-Alpha in the reply filed on 7/29/2025 is acknowledged. The requirement is made FINAL in this office action.
Group 3 is drawn to an alkali salt of Formula IV or IV-Alpha:
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, wherein: each glutamate unit is independently in an L-form or D-form (e.g., all glutamate units are in L-form or all glutamate units are in D-form); n is an integer of 0-20; and Z is a residue of an antifolate selected from methotrexate (MTX), pemetrexed (PMX), lometrexol (LTX), AG2034, raltitrexed (RTX), pralatrexate, GW1843, aminopterin, LY309887 and LY222306, wherein M+ is an alkali counterion. A search was conducted on the elected species; and prior art was found. Claims 20 and 21 are examined on the merits in this office action.
Objections
11. The specification is objected to for failing to comply with 37 CFR 1.821(d). The instant specification discloses the peptides RQIKIWFQNRRMKWKKRKKRRQRRR and RKKRRXRRRGC on page 134, paragraph [0311] of instant specification. However, they are missing their respective sequence identifiers. Applicant is therefore required to amend the specification to comply with 37 CFR 1.821(d).
12. The specification is objected to for the following minor informality: The instant specification recites “RKKRRXR RRGC” and “(SEQ ID NO:6))” on page 134, paragraph [0311] of instant specification. These recitations should be “RKKRRXRRRGC” and “(SEQ ID NO:6)”. Applicant is required to correct these errors.
13. The specification is objected to for the following minor informality: The quality of the chemical reaction recited on page 261, paragraph [0550]; and page 267, paragraph [0566] of instant specification is extremely poor. Applicant is required to provide clear image of these chemical reactions.
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).
14. Claim 20 is objected to for the following minor informality: Applicant is suggested to amend claim 20 as “…
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or
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, wherein…Z is a residue of an antifolate selected from the group consisting of methotrexate (MTX)…LY222306, and wherein M+ is an alkali counterion”.
15. Claim 21 is objected to for the following minor informality: Claim 21 contains the acronym “HPLC”. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, for example, high-performance liquid chromatography (HPLC). The abbreviation can be used thereafter.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
16. 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.
17. Claims 20 and 21 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.
18. Claim 20 recites the limitations “each glutamate unit is independently in an L-form or D-form (e.g., all glutamate units are in L-form or all glutamate units are in D-form)”. First, the metes and bounds of claim 20 is rendered vague and indefinite by the parenthetical recitations of “(e.g., all glutamate units are in L-form or all glutamate units are in D-form)” because it is unclear as to whether the limitation is part of the instantly claimed subject matter. Second, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention (see MPEP § 2173.05(d)). Taken all these together, the metes and bounds of instant claim 20 is vague and indefinite. Because claim 21 depends from indefinite claim 20 and none of the dependent claims clarifies the point of confusion, they must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim Rejections - 35 U.S.C. § 102(a)(1)
19. 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.
20. Please note: During the search for the elected species, prior art was found for the non-elected species of alkali salt of Formula IV or IV-Alpha.
Claims 20 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dervieux et al (US 2004/0175834 A1), and as evidenced by the Amino Acids document (from https://www.vanderbilt.edu/AnS/Chemistry/Rizzo/stuff/AA/AminoAcids.html, 2025, enclosed pages 1-2) and the Properties & reactions of alkali & bases document (2020, enclosed pages 1-8, from https://chemnotcheem.com/alkali-bases/#:~:text=During%20the%20reaction%2C%20hydroxide%20ions,%2C%20water%2C%20and%20ammonia%20gas).
The instant claims 20 and 21 are drawn to an alkali salt of Formula IV or IV-Alpha:
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, wherein: each glutamate unit is independently in an L-form or D-form (e.g., all glutamate units are in L-form or all glutamate units are in D-form); n is an integer of 0-20; and Z is a residue of an antifolate selected from methotrexate (MTX), pemetrexed (PMX), lometrexol (LTX), AG2034, raltitrexed (RTX), pralatrexate, GW1843, aminopterin, LY309887 and LY222306, wherein M+ is an alkali counterion.
Dervieux et al teach 4-amino-10-methylpteroyldi-glutamic acid (MTXPG2), 4-amino-10-methylpteroyltri-glutamic acid (MTXPG3), 4-amino-10-methylpteroyltetra-glutamic acid (MTXPG4), 4-amino-10-methylpteroylpenta-glutamic acid (MTXPG5), 4-amino-10-methylpteroylhexa-glutamic acid (MTXPG6), and 4-amino-10-methylpteroylhepata-glutamic acid (MTXPG7) in the form of ammonium salts with the structure
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, for example, Figure 1; and page 10, paragraph [0076]. It meets the limitations of instant claims 20 and 21, except the limitation “wherein M+ is an alkali counterion”. Dervieux et al further teach dissolving such methotrexate polyglutamate in 0.1 N potassium hydroxide, for example, page 10, paragraph [0077]. And as evidenced by the Amino Acids document, the carboxyl groups in Glu has a pKa of 2.10 or 4.07 (see page 1). And further as evidenced by the Properties & reactions of alkali & bases document, alkali reacts with ammonium salt to release ammonia gas (see page 4, Section “4. Alkali reacts with ammonium salt to release ammonia gas”). Therefore, one of ordinary skilled in the art would reasonably expect and at once envision the methotrexate polyglutamates as ammonium salts in 0.1 N potassium hydroxide is in the form of a methotrexate polyglutamates as potassium salt. It meets the limitations of instant claims 20 and 21.
Since the reference teaches all the limitations of instant claims 20 and 21; the reference anticipates instant claims 20 and 21.
Claim Rejections - 35 U.S.C. § 103
21. 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.
22. 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.
23. Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Niyikiza et al (WO 2018/031980 A1) in view of Saal et al (European Journal of Pharmaceutical Sciences, 2013, 49, pages 614-623) and Roberts et al (US 2008/0214585 A1).
The instant claims 20 and 21 are drawn to an alkali salt of Formula IV or IV-Alpha:
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, wherein: each glutamate unit is independently in an L-form or D-form (e.g., all glutamate units are in L-form or all glutamate units are in D-form); n is an integer of 0-20; and Z is a residue of an antifolate selected from methotrexate (MTX), pemetrexed (PMX), lometrexol (LTX), AG2034, raltitrexed (RTX), pralatrexate, GW1843, aminopterin, LY309887 and LY222306, wherein M+ is an alkali counterion.
Niyikiza et al, throughout the patent, teach L-gamma polyglutamated antifolate as a therapeutic agent for treating diseases including hyperproliferative diseases such as cancer, disorders of the immune system such as rheumatoid arthritis and infectious disease such as HIV, for example, Abstract; and page 1, paragraph [0002]. Niyikiza et al further teach such L-gamma polyglutamated antifolate can be L-gamma hexaglutamate pemetrexed (PMX), PMX-[L-glutamyl]n, MTX-[L-glutamyl]n, LTX-[L-glutamyl]n, RTX-[L-glutamyl]n, pralatrexate-[L-glutamyl]n, AG2034-[L-glutamyl]n, GW1843-[L-glutamyl]n, aminopterin-[L-glutamyl]n and LY309887-[L-glutamyl]n, wherein n=4, 5, 2-10, 4-6 or >5, for example, page 13, paragraphs [0039] and [0040]; and Figures 5 and 6. It meets the limitations of instant claims 20 and 21 except the limitation “wherein M+ is an alkali counterion”. In the instant case, the Examiner would like to point out that there is an error in the structure of L-gamma hexaglutamate pemetrexed (PMX) in Figure 5, it should be L-gamma hexaglutamate.
The difference between the reference and instant claims 20 and 21 is that the reference does not teach compound 100 with the structure
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as the elected species of alkali salt of Formula IV or IV-Alpha; and the limitation of “wherein M+ is an alkali counterion” recited in instant claims 20 and 21.
However, Saal et al, throughout the literature, teach “Salt formation is widely in used in the pharmaceutical industry to optimize properties of ionizable research compounds and development candidates…Selection of pharmaceutical salts provides a means to improve solubility, dissolution rate, supersaturation, drug absorption and bioavailability of drugs compared to the parent form of the drug molecule without changing the pharmacologically active moiety.”; and “First class salt formers can be used more or less without restriction as they represent physiologically ubiquitous ions or occur as metabolites in biochemical pathways. First class salt formers include e.g. chloride and sodium”, for example, page 615, left column, the 1st paragraph; and right column, the last paragraph.
Furthermore, Roberts et al, throughout the patent, teach antifolate compound as a therapeutic agent for treating conditions, including abnormal cell proliferation, inflammatory diseases, asthma, and arthritis, for example, Abstract; and page 3, paragraph [0015]. Roberts et al further teach the novel antifolate compounds are in the form of pharmaceutically acceptable salts, in particular, in the form of an alkali metal salt of formula (12) with the structure
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, wherein each carboxyl group is in the sodium salt form, for example, page 4, paragraph [0038], pages 9-10, paragraph [0128]; and claim 25.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Niyikiza et al, Saal et al and Roberts et al to develop a sodium salt form of L-gamma hexaglutamate pemetrexed (PMX), PMX-[L-glutamyl]n, MTX-[L-glutamyl]n, LTX-[L-glutamyl]n, RTX-[L-glutamyl]n, pralatrexate-[L-glutamyl]n, AG2034-[L-glutamyl]n, GW1843-[L-glutamyl]n, aminopterin-[L-glutamyl]n and LY309887-[L-glutamyl]n, wherein n=4, 5, 2-10, 4-6 or >5 taught in Niyikiza et al, wherein each carboxyl group with the structure
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in the gamma glutamate is in the sodium salt form with the structure
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. L-gamma hexaglutamate pemetrexed (PMX) with each carboxyl group with the structure
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in the gamma glutamate in the sodium salt form with the structure
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reads on compound 100 with the structure
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as the elected species of alkali salt of Formula IV or IV-Alpha.
One of ordinary skilled in the art would have been motivated to combine the teachings of Niyikiza et al, Saal et al and Roberts et al to develop a sodium salt form of L-gamma hexaglutamate pemetrexed (PMX), PMX-[L-glutamyl]n, MTX-[L-glutamyl]n, LTX-[L-glutamyl]n, RTX-[L-glutamyl]n, pralatrexate-[L-glutamyl]n, AG2034-[L-glutamyl]n, GW1843-[L-glutamyl]n, aminopterin-[L-glutamyl]n and LY309887-[L-glutamyl]n, wherein n=4, 5, 2-10, 4-6 or >5 taught in Niyikiza et al, wherein each carboxyl group with the structure
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in the gamma glutamate is in the sodium salt form with the structure
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, because Saal et al, throughout the literature, teach “Salt formation is widely in used in the pharmaceutical industry to optimize properties of ionizable research compounds and development candidates…Selection of pharmaceutical salts provides a means to improve solubility, dissolution rate, supersaturation, drug absorption and bioavailability of drugs compared to the parent form of the drug molecule without changing the pharmacologically active moiety.”; and “First class salt formers can be used more or less without restriction as they represent physiologically ubiquitous ions or occur as metabolites in biochemical pathways. First class salt formers include e.g. chloride and sodium”. Roberts et al, throughout the patent, teach antifolate compound as a therapeutic agent for treating conditions, including abnormal cell proliferation, inflammatory diseases, asthma, and arthritis. Roberts et al further teach the novel antifolate compounds are in the form of pharmaceutically acceptable salts, in particular, in the form of an alkali metal salt of formula (12) with the structure
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, wherein each carboxyl group is in the sodium salt form.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Niyikiza et al, Saal et al and Roberts et al to develop a sodium salt form of L-gamma hexaglutamate pemetrexed (PMX), PMX-[L-glutamyl]n, MTX-[L-glutamyl]n, LTX-[L-glutamyl]n, RTX-[L-glutamyl]n, pralatrexate-[L-glutamyl]n, AG2034-[L-glutamyl]n, GW1843-[L-glutamyl]n, aminopterin-[L-glutamyl]n and LY309887-[L-glutamyl]n, wherein n=4, 5, 2-10, 4-6 or >5 taught in Niyikiza et al, wherein each carboxyl group with the structure
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in the gamma glutamate is in the sodium salt form with the structure
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.
Obviousness Double Patenting
24. 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.
25. Claims 20 and 21 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7, 9-11, 26 and 27 of US patent 11344628 B2 in view of Saal et al (European Journal of Pharmaceutical Sciences, 2013, 49, pages 614-623) and Roberts et al (US 2008/0214585 A1).
26. The instant claims 20 and 21 are drawn to an alkali salt of Formula IV or IV-Alpha:
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, wherein: each glutamate unit is independently in an L-form or D-form (e.g., all glutamate units are in L-form or all glutamate units are in D-form); n is an integer of 0-20; and Z is a residue of an antifolate selected from methotrexate (MTX), pemetrexed (PMX), lometrexol (LTX), AG2034, raltitrexed (RTX), pralatrexate, GW1843, aminopterin, LY309887 and LY222306, wherein M+ is an alkali counterion.
27. Claims 1-7, 9-11, 26 and 27 of US patent 11344628 B2 are drawn to a liposomal composition comprising a polyglutamated antifolate encapsulated by a liposome, wherein the polyglutamated antifolate comprises at least 4 glutamate residues linked by alpha carboxyl group linkages and wherein the liposome does not contain a targeting moiety having specific affinity for a surface antigen on a target cell.
28. The difference between the polyglutamated antifolate recited in claims 1-7, 9-11, 26 and 27 of US patent 11344628 B2 and the alkali salt of Formula IV or IV-Alpha recited in instant claims 20 and 21 is that it does not teach such polyglutamated antifolate is in the form of alkali salt recited in instant claims 20 and 21.
However, in view of the combined teachings of Saal et al and Roberts et al as set forth in Section 23 above, it would have been obvious to one of ordinary skilled in the art to modify the polyglutamated antifolate recited in claims 1-7, 9-11, 26 and 27 of US patent 11344628 B2 and develop the alkali salt of Formula IV or IV-Alpha recited in instant claims 20 and 21.
29. For the same/similar reasoning/rational as the rejection set forth in Sections 25-28 above, instant claims 20 and 21 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 14, 20-23 and 27 of US patent 11534498 B2; claims 1-4 of US patent 11701432 B2; claims 1-8 of US patent 11730738 B2; claims 1-6 of US patent 11771700 B2; claims 1-38 of US patent 11779584 B2; claims 1-23 of US patent 12048767 B2; claims 1-10 and 13 of US patent 12076402 B2; claims 1-21 of US patent 12128046 B2; claims 1 and 28-30 of US patent 12161757 B2; claims 1-19 of US patent 12178882 B2; claims 1-10, 19 and 20 of US patent 12178883 B2; claims 1-7 of US patent 12201695 B2; claims 1-9 of US patent 12213981 B2; claims 1-9 of US patent US 12220431 B2; claims 1-21 of US patent US 12239734 B2; claims 1-26 of US patent 12246015 B2; claims 1-26 of US patent 12246018 B2; claims 1-20 of US patent 12246019 B2; claims 1-23 of US patent 12290518 B2; claims 1-10 and 25-27 of US patent 12296022 B2; claims 1-20 of US patent 12310966 B2; and claims 1-25 of US patent 12350271 B2; and in view of the combined teachings of Saal et al (European Journal of Pharmaceutical Sciences, 2013, 49, pages 614-623) and Roberts et al (US 2008/0214585 A1) as set forth in Section 23 above.
30. For the same/similar reasoning/rational as the rejection set forth in Sections 25-28 above, instant claims 20 and 21 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 25-27, 31, 35, 50-52, 54, 56, 57, 67, 68 and 100-110 of co-pending Application No. 18/204566; claims 1, 18-20, 24, 26, 27, 31, 34, 35, 38, 48, 50-52, 57, 68, 73, 75, 76, 78, 79 and 91 of co-pending Application No. 18/237151; claims 95-110 of co-pending Application No. 18/745749; claims 95-115 of co-pending Application No. 18/745801; claims 1, 3, 4, 6, 9, 10 and 17-20 of co-pending Application No. 18/755082; claims 8-14 and 76 of co-pending Application No. 18/790916; claims 1-10 of co-pending Application No. 18/902040; claims 1 and 23-25 of co-pending Application No. 18/931605; claims 1, 3, 4, 95-100 and 103 of co-pending Application No. 18/947593; claims 95-113 of co-pending Application No. 18/968387; claims 95-114 of co-pending Application No. 19/016832; claims 95-113 of co-pending Application No. 19/018165; claims 95-114 of co-pending Application No. 19/019919; claims 95-113 of co-pending Application No. 19/020538; claims 1, 3-5, 8, 10, 18-20, 30, 32, 40, 43, 54, 69, 73, 80, 81, 83, 84, 92, 93 and 96 of co-pending Application No. 19/022038; claims 1, 3, 4 and 95-114 of co-pending Application No. 19/024252; claims 95-114 of co-pending Application No. 19/027903; claims 1 and 83-87 of co-pending Application No. 19/069794; claims 95-119 of co-pending Application No. 19/071854; claims 1-94 of co-pending Application No. 19/194623; claims 1-94 of co-pending Application No. 19/194756; and claims 1-94 of co-pending Application No. 19/222066; and in view of the combined teachings of Saal et al (European Journal of Pharmaceutical Sciences, 2013, 49, pages 614-623) and Roberts et al (US 2008/0214585 A1) as set forth in Section 23 above.
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