DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims in the reply filed on 6/1/2026 is acknowledged.
Applicant's election with traverse of Group I in the reply filed on 6/1/2026 is acknowledged. The traversal is on the ground(s) that Macielag in view of U.S. Pharmacopeial Convention. This is not found persuasive because (a) the argument is not commensurate in scope of the base claim and (b) the argument is not applied to the current rejection based on Bandyopadhyay et al. (WO 2020/185518 A1) and evidenced by Kumar et al. (WO 2021/024237 A1) in the following.
The requirement is still deemed proper and is therefore made FINAL.
The non-elected Groups III-VII, claims 26-30 and 32-33, are withdrawn.
Claim Status
Claims 1-3, 5-6, 8-30, and 32-33 are pending.
Claims 4, 7, and 31 are cancelled.
Claims 26-30 and 32-33 are withdrawn as being directed to a non-elected invention, the election having been made on 6/1/2026.
Claims 1-3 5-6, and 8-25 have been examined.
Priority
This application is a 371 of PCT/IB2022/050956 filed on 02/03/2022, which claims foreign priority of INDIA 202121004764 filed on 02/03/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/2/2023 and 12/9/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 10 is objected to because of the following informalities:
The term “a sugar” is duplicated at lines 2 and 3 in claim 10.
Appropriate correction is required.
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 1, 5, and 25 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 5, and 25 disclosed percentage (%) of an assay, but a unit is missing. In one claim interpretation the claim is interpreted as a weight percentage; in another claim interpretation, the claim is interpreted as a percentage related to activity or molar ratio. MPEP 2173.02 (I) states “During examination, after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear, the claim is indefinite and should be rejected. Zletz, 893 F.2d at 322, 13 USPQ2d at 1322. For example, if the language of a claim, given its broadest reasonable interpretation, is such that a person of ordinary skill in the relevant art would read it with more than one reasonable interpretation, then a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph is appropriate.” Claims 2-3 and 6-24 are further rejected as depending on claim 1.
With respect to claim 10, it is unclear for the phrase “other inorganic salts”. Neither the specification nor claim 10 distinctly defines the scope of “other inorganic salts”, rendering the metes and bounds of the phrase “other inorganic salts” indefinite.
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 3 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.
With respect to claim 3, claim 1 refers to “a stable aqueous solution” in the preamble. The term 'stable' means that the dosage form does not physically change and about 80 to about 120 percent of oxytocin remains after storage under refrigerated conditions (2-8°C) for at least 3 months of storage as defined in the SPEC (p8, 7-10). Thus, the limitation of “a residual oxytocin may be 80% after storage at 2-8°C according to an assay” in claim 3, fails to further limit the subject matter of a stable aqueous solution in the claim 1 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.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 5-6, and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bandyopadhyay et al. (WO 2020/185518 A1) and evidenced by Kumar et al. (WO 2021/024237 A1).
Claim 1 is drawn to an aqueous parenteral dosage solution comprising:
(a) oxytocin or a pharmaceutical acceptable salt thereof; and
(b) a disaccharide;
wherein, oxytocin in the solution is at least 90% and the pH of the aqueous solution is
about 3.0 to about 5.0 according to an assay.
Bandyopadhyay et al. teach stable pharmaceutical formulation of cyclic peptides in solution [Abstract, 11, 44, claim 10]. Bandyopadhyay et al. teach a cyclic peptide as oxytocin [21, line 32; 22, line 11; claim 2), reading on the limitation (a). Bandyopadhyay et al. further teach the cyclic peptide (e.g., oxytocin) composition further comprising ethanol and sucrose [32, line 26], reading on the limitation (b). Bandyopadhyay et al. teach stable pharmaceutical formulation loss of purity no more that 0.05% per day from about 20 to about 25°C [52], equivalent to at most loss of about 9% for 6 months at room temperature. Furthermore, Bandyopadhyay et al. teach stable pharmaceutical formulation loss of purity no more that 0.005% per day between about 3 and 8°C [53], equivalent to at most loss of about 0.9% for 6 months, reading on oxytocin in the solution is at least 90% in the wherein clause. Bandyopadhyay et al. teach the purity of the pharmaceutically active protein and/or peptide was determined by HPLC assay [50, line 18-19]. Bandyopadhyay et al. further teach the pH of the composition is between 3 and 5 [39, line 3].
With respect to claims 2 and 5, Bandyopadhyay et al. teach stable pharmaceutical formulation loss of purity no more that 0.05% per day from about 20 to about 25°C [52], equivalent to at most loss of about 9% for 6 months. The 9% loss of oxytocin is equivalent to 91% activity of oxytocin.
With respect to claims 3 and 5, Bandyopadhyay et al. teach stable pharmaceutical formulation loss of purity no more that 0.005% per day between about 3 and 8°C [53], equivalent to at most loss of about 0.9% for 6 months. The 0.9% loss of activity is equivalent to 99.1% activity of oxytocin.
With respect to claims 6 and 10-13, Kumar et al. is cited as evidence to show osmogene same as 'tonicity adjusting agent' or 'osmotic agent' and a disaccharide of sucrose is an osmogene (p14, line 26-32). Thus, Bandyopadhyay’s stable solution of pharmaceutical formulation comprising oxytocin and sucrose inherently comprising an osmogene of sucrose in claim 6, a sugar in claim 10, a disaccharide in claims 11-13.
Claim Rejections - 35 USC § 103
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.
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.
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.
1. Claims 1-3, 5-6, 8-14, and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay et al. and evidenced by Kumar et al. as applied to claims 1-3, 5-6, 10-13 and further in view of Macielag et al. (WO 2018/091375 A1, previously cited 1/28/2026), Arvinte et al. (US 7,662,393 B2), and U.S. Pharmacopeial Convention (referred to USP 2018, previously cited 1/28/2026).
Bandyopadhyay et al. and evidenced by Kumar et al. teach a stable aqueous oxytocin formulation comprising oxytocin and sucrose with pH between 3 and 5.
Bandyopadhyay et al. and evidenced by Kumar et al. do not specify any single known impurity in the solution is less than 3% by weight when stored at 2-8°C or at 25°C/40% RH.
Macielag et al. teach therapeutic peptide liquid composition [00125] comprising oxytocin [00205]. Macielag et al. teach the pharmaceutical composition comprising stabilizer including one or more aggregation inhibitors, one or more oxidation inhibitors, one or more surfactants, and/or one or more protease inhibitors [00135]. Macielag et al. teach the pharmaceutical composition further comprises one or more isotonic agents comprising sodium chloride and a disaccharide of sucrose or sugar alcohol [00133]. Macielag et al. teach the isotonic agent may be present in a concentration from about 0.01 mg/ml to about 50 mg/ml [p35/00133, line 8].
Similarly, Arvinte et al. teach sodium chloride and sucrose are commonly known stabilizer for peptide formulation well-known in the art (col 12, line 12-15) consistent with Macielag et al. Arvinte et al. further teach preferred stabilizer or isotonicity agent is sucrose (col 12, line 21-22). Arvinte et al. further suggest sucrose in a concentration ranging from 10 mg/ml to 100 mg/ml (col 12, line 24-25), consistent with Macielag et al.
USP-2018 is further cited to show oxytocin for injection in 1 ml ampoules comprising 10
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units at pH range 3 to 5 (p2, Sec 2.2 Oxytocin Injection Formulation). USP-2018 teaches WHO and IDA suggested the following guidelines for the shelf life of oxytocin injections at higher temperatures (p10) according to the recommendation of different pharmacopoeias (p5, Table 2). USP-2018 shows Products Manufactured of oxytocin in Different Countries are in compliance with the recommendation of WHO and IDA (p6, Table 3), demonstrating storage and shelf life of oxytocin formulation well-known in the art. Based on the cited prior art references and commonly known knowledge of using stabilizers and/or isotonic agents (e.g., sucrose) in formulation of 10 units of oxytocin at pH range 3 to 5 taught by the cited references, one of ordinary skill in the art would expect that a stable aqueous formulation of oxytocin is in compliance with the recommended pharmacopoeias listed in Table 2 of USP-2018 (p5) with limited loss of oxytocin to satisfy the limitations of stability in claims 5, 8-9, 19, and 22-25 supported by Tables 2 and 3 of USP-2018 as well as the use of stabilizers and isotonic agents (osmogen) in producing an aqueous stable oxytocin composition taught by other cited references.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Bandyopadhyay et al. and evidenced by Kumar et al. with (ii) Macielag et al. in view of Arvinte et al. and USP-2018 because (a) Bandyopadhyay et al. and evidenced by Kumar et al. teach a stable aqueous oxytocin formulation comprising oxytocin and sucrose with pH between 3 and 5, (b) Macielag et al. teach a pharmaceutical composition of oxytocin comprising stabilizer including one or more aggregation inhibitors, one or more oxidation inhibitors, one or more surfactants, and/or one or more protease inhibitors [00135]. Macielag et al. teach the pharmaceutical composition further comprises one or more isotonic agents comprising sodium chloride and a disaccharide of sucrose or sugar alcohol [00133], (c) Arvinte et al. teach sodium chloride and sucrose are commonly known stabilizers for peptide formulation in the art (col 12, line 12-15) consistent with Macielag et al. and (d) USP-2018 shows Products Manufactured of oxytocin in Different Countries are in compliance with the recommendation of WHO and IDA (p6, Table 3), demonstrating storage and shelf life of oxytocin formulation well known in the art. The combination would have reasonable expectation of success because addition of known stabilizers and isotonic agents of sucrose and sodium chloride in aqueous formulation of oxytocin has reasonable expectation of success to stabilize oxytocin in the aqueous formulation as taught by the cited prior art references of Macielag et al. in view of Arvinte et al.
With respect to claim 14, Arvinte et al. teach a stable peptide composition comprising an isotonicity agent of sucrose (col 12, line 15) and a stabilizer of sucrose and/or mannitol (col 12, line 19). Similarly, Macielag et al. teach a stable oxytocin formulation comprising an isotonic agent of sucrose [00133, line 31] and/or sugar alcohol including mannitol [p35, 00133, line 2-4].
With respect to claim 20, Macielag et al. teach isotonic agent (reading on an osmogen) in concentration from about 0.01 mg/ml to 50 mg/ml [p35, 00133, line 7-8].
With respect to claim 21, Arvinte et al. teach sucrose in a concentration from 20 mg/ml to 80 mg/ml (col 12, line 24-25).
2. Claims 1-3, 5-6, and 8-25 are rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay et al., evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., and U.S. Pharmacopeial Convention as applied to claims 1-3, 5-6, 8-14, and 19-25 and further in view of Kumar et al. (US 2018/0036310 A1).
Claim 15 is drawn to the oxytocin composition filled in an infusion container.
Bandyopadhyay et al. [58] and Macielag et al. [00126] teach administration of aqueous oxytocin composition via infusion.
Bandyopadhyay et al., evidenced by Kumar et al. in view of Macielag et al., Arvinte et al., and USP-2018 do not specify using an infusion container for infusion of aqueous oxytocin.
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Kumar et al. teach intravenous infusion dosage form of pemetrexed (Abstract), a peptide analog compound as shown follows. Kumar et al. teach the lyophilized or freeze-dried preparations have considerable disadvantages [0002] and suggest beneficial formulation of a desired peptide drug with osmogent and inert gas in a flexible infusion container [0003-0006] as shown in figure 3, reading on claim 15.
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With respect to claim 16, Kumar et al. teach a flexible infusion container includes an infusion bag, a flexible infusion pouch, a soft bag, an infusion bottle, a film, or a plastic pre-filled syringe [0047].
With respect to claim 17, Kumar et al. teach the infusion container comprising an overwrap that surrounds the infusion container, not only able to provide protection to the desired drug solution from light, but also protect the infusion container from being tampered or misused [0061].
With respect to claim 18, Kumar et al. teach an infusion container containing a multilayered overwrap pouch having one layer made up of oxygen scavenging material and aluminum pouches [0062, 0065, 0105].
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Bandyopadhyay et al., evidenced by Kumar et al. in view of Macielag et al., Arvinte et al., and USP-2018 with (ii) Kumar’s infusion container because (a) Bandyopadhyay et al., evidenced by Kumar et al. in view of Macielag et al., Arvinte et al., and USP-2018 teach administration of an aqueous oxytocin formulation via infusion (Bandyopadhyay et al. [58] and Macielag et al. [00126] ) and (b) Kumar et al. teach beneficial administration of a formulated peptide drug with osmogent and inert gas in a flexible infusion container [0003-0006] as shown in figure 3 comprising an overwrap that surrounds the infusion container, not only able to provide protection to the desired drug solution from light, but also protect the infusion container from being tampered or misused [0061]. The combination would have reasonable expectation of success because the references teach administration of aqueous peptide composition via infusion.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-6, and 8-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,869,867 (the ‘867 patent) in view of Bandyopadhyay et al. (WO 2020/185518 A1) evidenced by Kumar et al. (WO 2021/024237 A1), Macielag et al. (WO 2018/091375 A1), Arvinte et al. (US 7,662,393 B2),a U.S. Pharmacopeial Convention (referred to USP 2018) and Kumar et al. (US 2018/0036310 A1, referred as Kumar-2018).
Claim 1 of the ‘867 patent disclosed the use of a infusion container for preparation of a peptide analog drug in intravenous infusion dosage form.
Claim 1 of the ‘867 patent does not specify a peptide drug of oxytocin in a infusion container.
The relevancy of Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 is described above not repeated here.
Because Kumar-2018 teaches beneficial use of an infusion container comprising an overwrap that surrounds the infusion container, not only able to provide protection to the desired drug solution from light, but also protect the infusion container from being tampered or misused, one of ordinary skill in the art would have found it obvious to beneficially combine the infusion container taught by claim 1 of the ‘867 patent with Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018.
Thus, claim 1 of the ‘867 patent in view of Bandyopadhyay et al. evidenced by Kumar et al., Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 are obvious to the instant claims 1-3, 5-6, and 8-25.
Claims 1-3, 5-6, and 8-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 7 of U.S. Patent No. 11,166,923 (the ‘923 patent) in view of Bandyopadhyay et al. (WO 2020/185518 A1) evidenced by Kumar et al. (WO 2021/024237 A1), Macielag et al. (WO 2018/091375 A1), Arvinte et al. (US 7,662,393 B2),a U.S. Pharmacopeial Convention (referred to USP 2018) and Kumar et al. (US 2018/0036310 A1, referred as Kumar-2018).
Claims 1-2 of the ‘923 patent disclosed the use of a container for administration of ready-to-use therapeutic agent in infusion solution.
Claim 7 of the ‘923 patent disclosed the container is designed to protect the solution of therapeutic agent from light.
Claims 1-2 and 7 of the ‘923 patent do not specify a peptide drug of oxytocin in the infusion container.
The relevancy of Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 is described above not repeated here.
Because Kumar-2018 teaches beneficial use of an infusion container comprising an overwrap that surrounds the infusion container, not only able to provide protection to the desired drug solution from light, but also protect the infusion container from being tampered or misused, one of ordinary skill in the art would have found it obvious to beneficially combine the infusion container taught by claims 1-2 and 7 of the ‘923 patent with Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018.
Thus, claims 1-2 and 7 of the ‘923 patent in view of Bandyopadhyay et al. evidenced by Kumar et al., Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 are obvious to the instant claims 1-3, 5-6, and 8-25.
Claims 1-3, 5-6, and 8-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 15-17 of U.S. Patent No. 11,197,838 (the ‘838 patent) in view of Bandyopadhyay et al. (WO 2020/185518 A1) evidenced by Kumar et al. (WO 2021/024237 A1), Macielag et al. (WO 2018/091375 A1), Arvinte et al. (US 7,662,393 B2),a U.S. Pharmacopeial Convention (referred to USP 2018) and Kumar et al. (US 2018/0036310 A1, referred as Kumar-2018).
Claims 1 and 15 the ‘838 patent disclosed a ready to infuse drug formulation filled in an infusion container.
Claim 2 of the ‘838 patent disclosed the ready to infuse drug composition further comprising osmogen.
Claims 16-17 of the ‘838 patent disclosed ready to infuse drug container comprising an aluminum pouch.
Claims 1-2 and 15-17 of the ‘838 patent do not specify a peptide drug of oxytocin in the infusion container.
The relevancy of Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 is described above not repeated here.
Because Kumar-2018 teaches beneficial use of an infusion container comprising an overwrap that surrounds the infusion container, not only able to provide protection to the desired drug solution from light, but also protect the infusion container from being tampered or misused, one of ordinary skill in the art would have found it obvious to beneficially combine the infusion container taught by claims 1-2 and 15-17 of the ‘838 patent with Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018.
Thus, claims 1-2 and 15-17 of the ‘838 patent in view of Bandyopadhyay et al. evidenced by Kumar et al., Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 are obvious to the instant claims 1-3, 5-6, and 8-25.
Claims 1-3, 5-6, and 8-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of U.S. Patent No. 11,793,719 (the ‘719 patent) in view of Bandyopadhyay et al. (WO 2020/185518 A1) evidenced by Kumar et al. (WO 2021/024237 A1), Macielag et al. (WO 2018/091375 A1), Arvinte et al. (US 7,662,393 B2),a U.S. Pharmacopeial Convention (referred to USP 2018) and Kumar et al. (US 2018/0036310 A1, referred as Kumar-2018).
Claim 1 of the ‘719 patent disclosed a ready-to-infuse aqueous drug formulation with a tonicity adjusting agent in a flexible container.
Claim 13 of the ‘719 patent disclosed the container comprising an aluminum pouch.
Claims 1 and 13 of the ‘719 patent do not specify a peptide drug of oxytocin in the infusion container.
The relevancy of Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 is described above not repeated here.
Because Kumar-2018 teaches beneficial use of an infusion container comprising an overwrap that surrounds the infusion container, not only able to provide protection to the desired drug solution from light, but also protect the infusion container from being tampered or misused, one of ordinary skill in the art would have found it obvious to beneficially combine the infusion container taught by claims 1 and 13 of the ‘719 patent with Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018.
Thus, claims 1 and 13 of the ‘719 patent in view of Bandyopadhyay et al. evidenced by Kumar et al., Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 are obvious to the instant claims 1-3, 5-6, and 8-25.
Claims 1-3, 5-6, and 8-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, and 19-22 of U.S. Patent No. 11,865,089 (the ‘089 patent) in view of Bandyopadhyay et al. (WO 2020/185518 A1) evidenced by Kumar et al. (WO 2021/024237 A1), Macielag et al. (WO 2018/091375 A1), Arvinte et al. (US 7,662,393 B2),a U.S. Pharmacopeial Convention (referred to USP 2018) and Kumar et al. (US 2018/0036310 A1, referred as Kumar-2018).
Claim 1 of the ‘089 patent disclosed an aqueous ready to infuse stable drug composition.
Claims 6-7 of the ‘089 patent disclosed the drug composition further comprising an osmogene of sucrose.
Claims 19-20 of the ‘089 patent disclosed the aqueous ready to infuse stable drug composition filled in an infusion container.
Claims 21-22 of the ‘089 patent disclosed the container comprising an aluminum pouch.
Claims 1, 6-7, and 19-22 of the ‘089 patent do not specify a peptide drug of oxytocin in the infusion container.
The relevancy of Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 is described above not repeated here.
Because Kumar-2018 teaches beneficial use of an infusion container comprising an overwrap that surrounds the infusion container, not only able to provide protection to the desired drug solution from light, but also protect the infusion container from being tampered or misused, one of ordinary skill in the art would have found it obvious to beneficially combine the infusion container taught by claims 1, 6-7, and 19-22 of the ‘089 patent with Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018.
Thus, claims 1, 6-7, and 19-22 of the ‘089 patent in view of Bandyopadhyay et al. evidenced by Kumar et al., Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 are obvious to the instant claims 1-3, 5-6, and 8-25.
Claims 1-3, 5-6, and 8-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,102,594 (the ‘594 patent) in view of Bandyopadhyay et al. (WO 2020/185518 A1) evidenced by Kumar et al. (WO 2021/024237 A1), Macielag et al. (WO 2018/091375 A1), Arvinte et al. (US 7,662,393 B2),a U.S. Pharmacopeial Convention (referred to USP 2018) and Kumar et al. (US 2018/0036310 A1, referred as Kumar-2018).
Claim 1 of the ‘594 patent disclosed a ready-to-use stable aqueous drug solution comprising tonicity adjusting agent and pH adjusting agent filled in a container of syringe.
Claim 1 of the ‘594 patent does not specify a peptide drug of oxytocin can be filled in the container.
The relevancy of Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 is described above not repeated here.
Because Kumar-2018 teaches beneficial use of an infusion container comprising an overwrap that surrounds the infusion container, not only able to provide protection to the desired drug solution from light, but also protect the infusion container (including a prefilled syringe) from being tampered or misused, one of ordinary skill in the art would have found it obvious to beneficially combine the infusion container taught by claim 1 of the ‘594 patent with Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018.
Thus, claim 1 of the ‘594 patent in view of Bandyopadhyay et al. evidenced by Kumar et al., Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 are obvious to the instant claims 1-3, 5-6, and 8-25.
Claims 1-3, 5-6, and 8-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,156,855 (the ‘855 patent) in view of Bandyopadhyay et al. (WO 2020/185518 A1) evidenced by Kumar et al. (WO 2021/024237 A1), Macielag et al. (WO 2018/091375 A1), Arvinte et al. (US 7,662,393 B2),a U.S. Pharmacopeial Convention (referred to USP 2018) and Kumar et al. (US 2018/0036310 A1, referred as Kumar-2018).
Claim 1 of the ‘855 patent disclosed an infusion container filled with an aqueous drug solution.
Claim 5 of the ‘855 patent disclosed the infusion container is in the form of a bag, a pouch, a bottle, or a syringe.
Claims 1 and 5 of the ‘855 patent do not specify a peptide drug of oxytocin in the infusion container.
The relevancy of Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 is described above not repeated here.
Because Kumar-2018 teaches beneficial use of an infusion container comprising an overwrap that surrounds the infusion container, not only able to provide protection to the desired drug solution from light, but also protect the infusion container from being tampered or misused, one of ordinary skill in the art would have found it obvious to beneficially combine the infusion container taught by claims 1 and 5 of the ‘855 patent with Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018.
Thus, claims 1 and 5 of the ‘855 patent in view of Bandyopadhyay et al. evidenced by Kumar et al., Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 are obvious to the instant claims 1-3, 5-6, and 8-25.
Claims 1-3, 5-6, and 8-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,642,828 (the ‘828 patent) in view of Bandyopadhyay et al. (WO 2020/185518 A1) evidenced by Kumar et al. (WO 2021/024237 A1), Macielag et al. (WO 2018/091375 A1), Arvinte et al. (US 7,662,393 B2),a U.S. Pharmacopeial Convention (referred to USP 2018) and Kumar et al. (US 2018/0036310 A1, referred as Kumar-2018).
Claim 1 of the ‘828 patent disclosed a stable and ready to administer aqueous drug solution filled in a plastic container.
Claim 2 of the ‘828 patent disclosed the drug the plastic container is a barrel of the pre-filled syringe.
Claim 5 of the ‘828 patent disclosed the plastic container is a flexible infusion bag.
Claims 1-2 and 5 of the ‘828 patent do not specify a peptide drug of oxytocin in the infusion container.
The relevancy of Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 is described above not repeated here.
Because Kumar-2018 teaches beneficial use of an infusion container comprising an overwrap that surrounds the infusion container, not only able to provide protection to the desired drug solution from light, but also protect the infusion container from being tampered or misused, one of ordinary skill in the art would have found it obvious to beneficially combine the infusion container taught by claims 1-2 and 5 of the ‘828 patent with Bandyopadhyay et al. evidenced by Kumar et al. and further in view of Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018.
Thus, claims 1-2 and 15-17 of the ‘838 patent in view of Bandyopadhyay et al. evidenced by Kumar et al., Macielag et al., Arvinte et al., U.S. Pharmacopeial Convention, and Kumar-2018 are obvious to the instant claims 1-3, 5-6, and 8-25.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
14-august-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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