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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 12, 2026, that includes a response to the Final Office Action mailed September 12, 2026, has been entered. Claims 1, 14, 18, 20, and 28 have been amended; and claims 5, 12, 15, 16, 29, and 30 have been canceled. Claims 4, 21, 24, 25, and 32 have been withdrawn. Claims 1-3, 6-11, 13, 14, 17-20, 22, 23, 26-28, and 31 are currently under examination in the application.
Non-compliant Amendment
Applicant’s amendment filed February 12, 2026 is non-compliant. The elected species of polymer is “maleic anhydride grafted polyethylene”, not “poly(ethylene-co-1-octene” and not the combination of the two. However, as a courtesy, in the interest of furthering compact prosecution, and since Applicant is clearly trying to patent the claimed product based on the specific infusion bag the sodium bicarbonate solution is contained in, the amendment has been entered and examined.
Withdrawal of Prior Claim Rejections - 35 USC § 112(b)
The claims have been satisfactorily amended. Therefore, the 35 USC 112(b) rejection presented in the Final Office Action mailed September 12, 2025 is hereby withdrawn.
Claim Objections
Claims 25 and 32 are objected to because of the following:
i). Claims 25 and 32 contain improper status identification. These claims have been withdrawn, and should thus be properly identified accordingly.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
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 20 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 20, which depends from claim 18, provides that the maleic anhydride grafted polyethylene can be in one or more layers, which layers include an outer layer, a middle layer, and a fluid contact layer. However, claim 18 excludes maleic anhydride grafted polyethylene from the outer layer. Claim 20 therefore is broader in scope than claim 18 from which it depends.
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.
Claims 1-3, 6-11, 13, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sayre et al. (Hosp Pharm. 2012; 47(7): 538-543), in view of Hingorami et al. (U.S. Patent Application Pub. No. 2020/0330411), Xu et al. (U.S. Patent Application Pub. No. 2023/0321962), and Zhiguo (Coacechem [online]; 2023).
Applicant Claims
Applicant’s elected subject matter is directed to a sterile product comprising a sodium bicarbonate solution in an infusion bag; wherein the sodium bicarbonate solution comprises 0.15 mEq/mL sodium bicarbonate, 50 mg/mL dextrose, and water, wherein the solution has pH 7.8-8.5, and is “substantially free” of preservatives; and wherein the infusion bag comprises a flexible, 3-layer film that does not comprise silicon oxide, wherein at least one layer comprises maleic anhydride grafted polyethylene and at least one layer comprises poly(ethylene-co-1-octene); less than 5% of the total fill volume of the infusion bag comprises headspace; the infusion bag has a carbon dioxide permeability of less than 0.2 cm3/m2/day/bar; and the infusion bag is packaged in an overwrap film comprising aluminum.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Sayre et al. disclose a sterile product comprising a sodium bicarbonate solution in a polyolefin infusion bag; wherein the sodium bicarbonate solution comprises 0.15 mEq/mL sodium bicarbonate, 5% (i.e. 50 mg/mL) dextrose, and water, wherein the solution has pH 8.15, or 7.0-8.5, and can be “substantially free” of preservatives.
Hingorani et al. disclose a sterile, ready-to-use product comprising a solution of an active (API) in a flexible infusion bag; wherein the API solution can further comprise e.g. 1-20% (i.e. 10-200 mg/mL) dextrose, and water, wherein the solution e.g. has pH 4-8, and can be “substantially free” of preservatives; and wherein the flexible infusion bag can comprise a film comprising composite layers and contain e.g. polypropylene (i.e. a polyolefin) and need not comprise silicon oxide, more specifically can be the TECHNOFLEX infusion bag (i.e. composed of 3 layers); less than 5% of the total fill volume of the infusion bag comprises headspace; and the infusion bag can be packaged in an overwrap film comprising aluminum (abstract; paragraphs 0002, 0023, 0025-0031; examples).
Xu et al. disclose multilayer, e.g. 3-layer, film structures attached to an outer metal layer (i.e. overwrap); wherein one layer can contain polyethylene based elastomers (POE), the outer layer of the film contains the combination of maleic anhydride grafted polyethylene and polypropylene (i.e. polyolefins), wherein the metal layer (i.e. overwrap) can be aluminum, and wherein the multilayer film structure can be employed in flexible articles such as packages or pouches (i.e. bags) (abstract; paragraphs 0001-0004, 0012, 0019, 0033, 0034, 0039, 0040).
Zhiguo discloses that POE is poly(ethylene-co-octene).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Sayre et al. do not explicitly disclose that the polyolefin infusion bag comprises a 3-layer film, with at least one layer comprising poly(ethylene-co-1-octene) and at least one layer comprising maleic anhydride grafted polyethylene; and that the infusion bag is packaged in an overwrap film comprising aluminum. These deficiencies are cured by the teachings of Hingorani et al., Xu et al., and Zhiguo.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Sayre et al., Hingorani et al., Xu et al., and Zhiguo, outlined supra, to devise Applicant’s claimed product.
Sayre et al. disclose a sterile product comprising a sodium bicarbonate solution in a polyolefin infusion bag; wherein the sodium bicarbonate solution comprises 0.15 mEq/mL sodium bicarbonate, 5% (i.e. 50 mg/mL) dextrose, and water, wherein the solution has pH 8.15, or 7.0-8.5. Since Hingorani et al. disclose that a sterile solution containing an active, dextrose, and water, with pH e.g. 4-8, for parenteral infusion can be kept stable in a flexible polyolefin (e.g. polypropylene) bag comprising composite film layers, such as the TECHNOFLEX infusion bag (i.e. composed of 3 layers), wherein the infusion bag can be packaged in an overwrap film comprising aluminum for enhanced barrier properties; and since Xu et al. confirms that polypropylene (i.e. polyolefin) films can be “metalized” to improve barrier properties, such as by adding an aluminum overwrap layer, but due to polypropylene’s non-polar properties the bonding strength between the polyolefin film and the metal layer can be poor (see paragraphs 0002, 0033, 0034), and that a multilayer, e.g. 3-layer, film for an article, such as a flexible pouch (i.e. bag), can contain one layer of POE and can be readily attached to an outer aluminum overwrap layer when the outer layer of the film contains the combination of maleic anhydride grafted polyethylene and polypropylene; and since Zhiguo discloses that POE is poly(ethylene-co-1-octene); one of ordinary skill in the art would thus be motivated to employ a 3-layer polyolefin film, in which the outer layer of the film contains poly(ethylene-co-1-octene) and one layer of the film contains maleic anhydride grafted polyethylene, and to further package the infusion bag in an overwrap film comprising aluminum, with the reasonable expectation that the resulting product will exhibit enhanced stability due at least in part to enhanced barrier properties.
Since the product one of ordinary skill in the art would thus arrive at in following the teachings and reasonable suggestions of the cited prior art would thus be the same as the claimed product, it can only be reasonably concluded that the properties must be the same as well, absent evidence to the contrary.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed February 12, 2026 have been fully considered but they are moot in view of the new grounds of rejection.
Conclusion
Claims 18, 19, 22, 23, 26, 27, 28, and 31 appear to be in condition for allowance.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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