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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/22/2025 has been entered.
Response to Amendment
Applicant’s amendments filed 07/22/2025 have been fully considered. Claims 1, 3, 5-14, and 16-17 are pending in this application. Claims 1 and 11-12 are amended. Claim 17 is newly added. Claims 2, 4, and 15 are cancelled.
Response to Arguments
Applicant’s arguments with respect to amended independent claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The argument that Kumar ‘663 does not teach the claim limitation of claim 1, stating, “the flexible plastic bag is adapted to maintain stability of the aqueous, ready-to-use solution of midazolam or the pharmaceutically acceptable salt of midazolam during a storage term of 18 months to 24 months and at room temperature”, is unpersuasive. The invention of Kumar ‘663 is a stable and sterile solution stored in a perfusion container (Abstract), where the term “stable” in Kumar ‘663 is defined to be “that the aqueous perfusion solution filled in the container is physically as well as chemically stable as demonstrated by compliance to acceptable specification, when the dosage form is stored at room temperature (about 25° C. and 40% relative humidity) for twelve months, preferably eighteen months, more preferably 24 months or longer” (Paragraph 0025; Claim 1). The drug midazolam is taught to be a drug that can be stored stably in the perfusion container (Paragraph 0033; Claim 2), meaning that this drug is fully taught by Kumar ‘663 to meet the claim limitation, as stated (see rejection of claim 1 below).
The amendment of independent claim 1 and request for continued examination necessitated a new ground of the rejection since it incorporates the claim limitations of amended claim 11. The newly added claim 17 additionally necessitated a new ground of rejection.
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 11 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. The claim limitation of claim 11 restates the claim limitation of independent claim 1 and does not further limit the product 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.
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, 3, 5-9, 12-14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. (Publication No. US 2016/0058663 A1), hereby referenced as “Kumar ‘663”, in view of Choi et al. (Publication No. US 2010/0280485 A1).
Regarding claim 1, Kumar ‘663 teaches a medicinal product comprising a flexible plastic bag (perfusion container can be a flexible plastic pouch; Paragraph 0060), wherein:
the flexible plastic bag has a wall comprising a polypropylene (bag has wall made of polypropylene; Paragraph 0060-0061);
the wall is a multi-layered wall (wall is multi-layered with outer layer of polypropylene polymer with styrene-ethylene-butylene (SEB) block copolymer and a middle and inner layer made up of polypropylene based polyolefin polymer with styrene-ethylene butylene block copolymer; Paragraph 0060);
at least an innermost layer of the multi-layered wall comprises the polypropylene (inner layer made up of polypropylene based polyolefin polymer with styrene-ethylene butylene block copolymer; Paragraph 0061).
The embodiment of Paragraph 0061 of Kumar ‘663 does not teach that the flexible container of the embodiment of Paragraph 0061 contains an aqueous, ready-to-use solution of midazolam or a pharmaceutically acceptable salt of midazolam.
However, alternative embodiments of Kumar ‘663 teaches that the drug contained in the perfusion container can be an analgesic or anesthetic agent such as midazolam, propofol, fentanyl, remifentanil, thiopental (Paragraph 0026 and 0033; Claims 1 and 2).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted one known element (drug in the perfusion container of the embodiment of Paragraph 0061 in Kumar ’663) for another (midazolam drug of the alternative embodiment of Paragraph 0033 of Kumar ‘663) since the substitution of the drug that is held within the perfusion container would have yielded predictable results, namely, a stable and secure storage of the drug in the perfusion container for perfusion treatment. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)B).
The modified Kumar ‘663 further teaches the flexible plastic bag is adapted to maintain stability of the aqueous, ready-to-use solution of midazolam or the pharmaceutically acceptable salt of midazolam during a storage term of 18 months to 24 months and at room temperature (“aqueous perfusion solution filled in the container is physically as well as chemically stable as demonstrated by compliance to acceptable specification, when the dosage form is stored at room temperature (about 25° C. and 40% relative humidity) for twelve months, preferably eighteen months, more preferably 24 months or longer”; Paragraph 0025-0026, and 0033; Claim 1 and 2; see combination above).
The modified Kumar ‘663 does not teach wherein the polypropylene comprises: atactic polypropylene, heterotactic polypropylene, or a blend of atactic polypropylene and heterotactic polypropylene.
However, Choi teaches the polypropylene layer of the container can be isotactic, syndiotactic or atactic structure (Paragraph 0035; Abstract).
Choi is analogous to the claimed invention, therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted one known element (polypropylene layer of Kumar ’663) for another (atactic polypropylene of Choi) since the substitution of the polypropylene in the wall of perfusion container would have yielded predictable results, namely, a stable and secure storage of the drug in the perfusion container for perfusion treatment (Choi; Abstract). The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)B).
Regarding claim 3, Kumar ’663 in view of Choi the medicinal product of claim 1. The combination of Kumar ‘663 in view of Choi does not teach wherein the multi-layered wall comprises co-extruded layers.
However, Choi teaches wherein the multi-layered wall comprises co-extruded layers (Paragraph 0057-0059).
Choi is analogous to the claimed invention, therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kumar ‘663 in view of Choi to incorporate the teachings of Choi and have the multi-layered propylene wall of Kumar ‘663 in view of Choi to be co-extruded layers, as taught by Choi. This allows for the extruded layers would be uniform and maintain the transparency and the flexibility of each layer (Choi; Paragraph 0058).
Regarding claim 5, Kumar ’663 in view of Choi the medicinal product of claim 1. Kumar ‘663 further teaches wherein a middle layer of the multi-layered wall further comprises the polypropylene (wall is multi-layered with a middle and inner layer made up of polypropylene based polyolefin polymer with styrene-ethylene butylene block copolymer; Paragraph 0060).
Regarding claim 6, Kumar ’663 in view of Choi the medicinal product of claim 1. Kumar ‘663 further teaches wherein an outermost layer of the multi-layered wall further comprises the polypropylene (wall is multi-layered with outer layer of polypropylene polymer with styrene-ethylene-butylene (SEB) block copolymer; Paragraph 0060).
Regarding claim 7, Kumar ’663 in view of Choi teaches the medicinal product of claim 1. Kumar ‘663 further teaches wherein all layers of the multi-layered wall comprise the polypropylene (wall is multi-layered with outer layer of polypropylene polymer with styrene-ethylene-butylene (SEB) block copolymer and a middle and inner layer made up of polypropylene based polyolefin polymer with styrene-ethylene butylene block copolymer; Paragraph 0060).
Regarding claim 8, Kumar ’663 in view of Choi teaches the medicinal product of claim 1. Kumar ‘663 further teaches wherein all layers of the multi-layered wall consist of the polypropylene (wall is multi-layered with outer layer of polypropylene polymer with styrene-ethylene-butylene (SEB) block copolymer and a middle and inner layer made up of polypropylene based polyolefin polymer with styrene-ethylene butylene block copolymer; Paragraph 0060).
Regarding claim 9, Kumar ’663 in view of Choi teaches the medicinal product of claim 1. Kumar ‘663 further teaches wherein the multi-layered wall is a three-layered wall (wall is multi-layered with outer layer, middle layer, and inner layer; Paragraph 0060).
Regarding claim 11, Kumar ’663 in view of Choi teaches the medicinal product of claim 1. The combination of Kumar ‘663 in view of Choi further teaches wherein the propylene consists of: atactic polypropylene; heterotactic polypropylene; or a blend of atactic polypropylene and heterotactic polypropylene (Choi; Paragraph 0035; Abstract).
Regarding claim 12, Kumar ’663 in view of Choi teaches the medicinal product of claim 1. The combination of Kumar ‘663 in view of Choi does not teach wherein the wall comprises at least one further polymer comprising one or more of: high density polyethylene, ethylene propylene copolymer, ethylene alpha olefin copolymer, or acrylonitrile butadiene styrene.
However, Choi teaches that the inner layer comprises a mix of polypropylene and polyethylene, wherein the polyethylene can be high density polyethylene (HDPE) (Paragraph 0049-0051; Figure 1).
Choi is analogous to the claimed invention, therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kumar ‘663 in view of Choi to incorporate the teachings of Choi and have the inner propylene wall of Kumar ‘663 in view of Choi to include high-density polyethylene with the propylene wall, as taught by Choi. This allows for the inner layer to have anti-blocking properties (Choi; Paragraph 0051).
Regarding claim 13, Kumar ’663 in view of Choi teaches the medicinal product of claim 1. Kumar ‘663 further teaches wherein the flexible plastic bag is overwrapped by an overwrap pouch (overwrap aluminum pouch 2 is overwrapping bag 1; Figure 1; Paragraph 0018).
Regarding claim 14, Kumar ’663 in view of Choi teaches the medicinal product of claim 1. Kumar ‘663 further teaches wherein the flexible plastic bag is a flexible plastic infusion bag (perfusion container can be a flexible plastic pouch that can be used for infusion; Paragraph 0060).
Regarding claim 16, Kumar ’663 in view of Choi teaches the medicinal product of claim 1. Kumar ‘663 further teaches wherein at least the innermost layer of the multi-layered wall is free of cyclo-olefin polymer or cyclo-olefin co-polymer (wall is multi-layered with outer layer of polypropylene polymer with styrene-ethylene-butylene (SEB) block copolymer and a middle and inner layer made up of polypropylene based polyolefin polymer with styrene-ethylene butylene block copolymer – does not have cyclo-olefin; Paragraph 0060).
Regarding claim 17, Kumar ’663 in view of Choi teaches the medicinal product of claim 1. Kumar ‘663 further teaches wherein the wall comprises at least one further polymer comprising one or more of polyamide 11, polyvinyl chloride, ethylene- vinyl acetate, polycarbonate, low density polyethylene, linear low density polyethylene, cyclo-olefin polymer, cyclo-olefin copolymer, styrene-ethylene-butylene (SEB) block copolymer, styrene- ethylene-propylene block copolymer, styrene-ethylene-butylene-styrene block copolymer, styrene- ethylene-butadiene-styrene block copolymer, or poly cyclohexane dimethylcyclohexane dicarboxylate elastomer (wall is multi-layered with outer layer of polypropylene polymer with styrene-ethylene-butylene (SEB) block copolymer and a middle and inner layer made up of polypropylene based polyolefin polymer with styrene-ethylene butylene block copolymer; Paragraph 0060).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. (Publication No. US 2016/0058663 A1) in view of Choi et al. (Publication No. US 2010/0280485 A1), as applied to claim 1 above, and further in view of Dusci (Publication No. US 2019/0388432 A1).
Regarding claim 10, Kumar ‘663 in view of Choi teaches the medicinal product according to claim 1. The combination of Kumar ‘663 in view of Choi does not teach wherein the aqueous, ready-to-use solution of midazolam or the pharmaceutically acceptable salt of midazolam has a concentration of 0.5 mg/ml to 5 mg/ml.
However, Dusci teaches wherein the aqueous, ready-to-use solution of midazolam or the pharmaceutically acceptable salt of midazolam has a concentration of 0.5 mg/ml to 5 mg/ml (midazolam solution in a flexible bag has a concentration of about 0.5 mg/ml to about 1.0 ml/mg; Paragraph 0012). Dusci further discusses flexible plastic containers having three-layered ethylene-polypropylene that can contain midazolam solution (Paragraph 0019) and a shelf-life that exceeds 24 months (Paragraph 0005).
Dusci and Kumar ‘663 in view of Choi are both considered to be analogous to the claimed invention because they are in the same field of infusion bags for intravenous use. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kumar ‘663 in view of Choi to incorporate the teachings of Dusci and have the solution of midazolam with the concentration range of Dusci to be placed in the flexible bag of Kumar ‘663 in view of Choi. This allows for the administered midazolam to control the infusion to achieve the desired dosing per patient (Dusci; Paragraph 0012).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781