DETAILED ACTION
Claim Status
Claim(s) 1-2, 4-9 is/are pending.
Claim(s) 1-2, 4-9 is/are rejected.
Claim(s) 3 is/are cancelled by Applicant.
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 .
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 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.
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.
The rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, in the previous Office Action mailed 10/22/2025 have been withdrawn in view of the Claim Amendments filed 03/20/2026.
Claim Rejections - 35 USC § 103 (AIA )
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.
Claim(s) 1-2, 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• SUMIYOSHI ET AL (US 2010/0092446),
in view of SYNCHEMIA - PBT CYCLIC DIMER,
and in view of GOTO ET AL (US 2020/0009777),
and in view of TAN (US 2018/0371180);
and in view of MORI ET AL (US 2008/0063825).
SUMIYOSHI ET AL ‘446 discloses flexible multilayer films, wherein the multilayer film comprises (in the listed order):
• an outer protective layer (5) (e.g., polybutylene terephthalate (PBT), etc.) (corresponding to the recited “layer (1)”);
• an optional adhesive layer (7) (e.g., adhesive polyolefins, such as modified polyethylene (PE) (corresponding to an additional recited “layer (3)” of claim 8);
• a polyol resin barrier oxygen barrier layer (4);
• an optional adhesive layer (7) (e.g., adhesive polyolefins, such as modified polyethylene (PE);
• a cycloolefin-based polymer (COP) layer (3) with reduced water-absorption (e.g., containing ethylene / dicyclopentadiene compound copolymers; ethylene / norbornene compound copolymers; etc.) (corresponding to the recited “layer (2)”);
• a polyethylene (PE) layer (2) (corresponding to the recited “layer (3)”);
• an inner polyolefin heat-sealing layer (1) (e.g., polyethylene (PE), polypropylene (PP), etc., or blends thereof) (corresponding to the recited “layer (4)”).
The flexible multilayer films are suitable for forming medical packaging and containers (e.g., bags, bottles, etc.) for liquid drug solutions. (entire document, e.g., Figure 1-3, etc.; paragraph 0001-0002, 0050, 0135, 0144, 0147-0161, 0166-0171, 0175, etc.) However, the reference does not specifically discuss the recited compound of layer (1).
SYNCHEMIA - PBT CYCLIC DIMER provides evidence that the recited “a compound represented by the following formula” in claim 1 is also identified in the art as:
(i) polybutylene terephthalate (PBT) cyclic dimer;
(ii) cyclobis(1,4-butylene terephthalate);
(iii) CAS No. 63440-93-7.
(entire document)
GOTO ET AL ‘777 discloses that it is well known in the art to utilize polybutylene terephthalate (PBT) resins with controlled oligomer (e.g., cyclic dimer, cyclic trimer, etc.) contents of 2000-12000 ppm (0.2-1.2 wt%), wherein an oligomer content of at least 2000 ppm provides improvements in low elution or aroma retention. (paragraph 0032-0037, 0088-0089, etc.)
TAN ‘180 disclose that it is well known in the art that commercial PBT resins contain minor amounts of PBT cyclic oligomers (e.g., cyclic dimer, cyclic trimer, etc.), wherein an illustrative, non-limiting examples include commercially available PBT resin with cyclic dimer contents of 0.1-1.5 wt%. (paragraph 0025, 0047, etc.)
MORI ET AL ‘825 discloses that it is well known in the art to utilize ethylene / cyclic olefin copolymer conforming to recited Formula (2) with a Tg of about 70-150 ºC as moisture barrier layers in medical packaging films (e.g., for infusion solution bags, etc.). The reference further discloses that it is known in the art to utilize commercially available polyethylene resins with a typical density of 0.930 g/cm3 and a melt flow rate (MFR) of 2.1 g/10 min to form heat-sealing layers for medical packaging films. (paragraph 0001-0002, 0069-0076, 0130-0132, etc.)
Regarding claims 1-2, 7-9, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize known and/or commercially available PBT resins containing minor amounts of PBT cyclic dimers (corresponding to the recited “a compound represented by the following formula” in claim 1, as evidenced by SYNCHEMIA - PBT CYCLIC DIMER) (as disclosed in GOTO ET AL ‘777 and TAN ‘180) as the PBT resin for the outer protective layer (5) (corresponding to the recited “layer (1)”) of the multilayer films of SUMIYOSHI ET AL ‘446 in order to produce useful elution-resistant (as suggested in GOTO ET AL ‘777) medical packaging materials (e.g., for liquid drug solutions, etc.)
Further regarding claim 1, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize known and/or commercially available COP resins as suggested in MORI ET AL ‘825 as the cycloolefin-based polymer (COP) layer (3) (corresponding to the recited “layer (2)”) in the multilayer films of SUMIYOSHI ET AL ‘446 in order to produce useful medical packaging materials (e.g., for liquid drug solutions, etc.).
Regarding claim 6, one of ordinary skill in the art would have utilized known and/or commercially available heat-sealable polyolefin resins (as suggested in MORI ET AL ‘825) to form the polyolefin heat-sealing layer (1) (corresponding to the recited “layer (4)”) in the multilayer films of SUMIYOSHI ET AL ‘446 in order to produce useful medical packaging materials with useful and desirable heat-seal characteristics.
Regarding SYNCHEMIA - PBT CYCLIC DIMER, in certain circumstances, references cited to show a universal fact need not be available as prior art before the effective filing date of applicant’s claimed invention. In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962). Such facts include the characteristics and properties of a material or a scientific truism. (see MPEP 2124).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• SUMIYOSHI ET AL (US 2010/0092446), in view of SYNCHEMIA - PBT CYCLIC DIMER, and in view of GOTO ET AL (US 2020/0009777), and in view of TAN (US 2018/0371180), and in view of MORI ET AL (US 2008/0063825),
as applied to claims 1-2, 6-9 above,
and further in view of JP 2018-172554 (SUZUKI-JP ‘554).
SUZUKI-JP ‘554 discloses that it is well known in the art to utilize ethylene-based resins with a Ht value which satisfies the Formulas (1) and (2)
Ht ≦ 0.0133 × e 0.0350 × t Formula (1)
Ht ≧ 0.0025 × e 0.0450 × t Formula (2)
wherein Ht = ht / ΔHm, wherein the ethylene-based resin preferably has: (i) a melt flow rate of 0.05-20 g/10 min (at 190 °C under a load of 2.16 kg); and (ii) a density of 900-980 kg/m3; to produce useful flexible liquid drug packaging (e.g., bottles, bags, single-layer, multilayer, etc.) which is transparent, deformation-resistant, and/or free of large wrinkles, even when subjected to high temperature sterilization conditions. (Figures for Examples 1-22; paragraph 0002, 0007-0010, 0013, 0018-0019, 0021, 0029-0031, 0035-0036, etc.)
Regarding claims 4-5, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize known ethylene-based resins as disclosed in SUZUKI-JP ‘554 as the interior polyethylene (PE) layer (2) (corresponding to the recited “layer (3)”) in the multilayer films of SUMIYOSHI ET AL ‘446 in order to produce useful drug solution packaging with excellent transparency, sterilization resistance, and/or absence of large wrinkles.
Further regarding claim 4, the Examiner has reason to believe that ethylene-based resins with Ht values which satisfies the Formulas (1) and (2) of SUZUKI-JP ‘554 would exhibit Ht values at t=107 ºC and t=121 ºC and t=127 ºC as recited in claim 4, therefore the Examiner has basis for shifting the burden of proof to applicant as in In re Fitzgerald et al., 205 USPQ 594.
For example, see the region bounded by the lines representing Formulas (1) and (2) in the Figures for Examples 1-22 in SUZUKI-JP ‘554.
Response to Arguments
Applicant’s arguments filed 03/20/2026 have been considered but are moot because of the new grounds of rejection necessitated by the Claim Amendments filed 03/20/2026.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
HAMANO ET AL (US 2009/0264611) and NODA ET AL (US 2009/0054618) disclose PBT resins containing controlled amounts of PBT cyclic dimer.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vivian Chen (Vivian.chen@uspto.gov) whose telephone number is (571) 272-1506. The examiner can normally be reached on Monday through Thursday from 8:30 AM to 6 PM. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Callie Shosho, can be reached on (571) 272-1123. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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June 10, 2026
/VIVIAN CHEN/Primary Examiner, Art Unit 1787
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