DETAILED ACTION
Notice of Pre-AIA or AIA Status
Claim(s) 1-20 is/are pending.
Claim(s) 1-7, 9, 11-20 is/are rejected.
Claim(s) 8, 10 is/are withdrawn from consideration.
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.
Response to Election/Restrictions
Applicant’s election without traverse of Species (a)(ii) and (b)(ii) in the reply filed on 05/14/2026 is acknowledged.
Claim(s) 8, 10 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/14/2026.
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) 1-7, 9, 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• FOGTMANN ET AL (US 2022/0250373), or
• FOGTMANN ET AL (US 2022/0274392),
in view of WO 95/15992 (NG-WO ‘992),
FOGTMANN ET AL ‘373 and FOGTMANN ET AL ‘392 discloses packaging laminates, wherein the packaging laminate comprises:
• a product (e.g., drug) contact layer (e.g., polyamide, etc.) with an illustrative, non-limiting thickness of 40 microns, wherein the contact layer can be weldable / sealable (corresponding to the recited “polyamide sealing layer configured to contact a drug”) and wherein the contact layer optionally comprises two or more sublayers -- for example:
• a product-facing contact seal sublayer (corresponding to the recited “sealing sublayer” of claim 2) comprising polyamide;
• a base layer-facing sublayer (corresponding to the recited backing sublayer” of claim 2) comprising amorphous polyamide;
wherein the sublayers can be coextruded;
• an optional adhesive or tie layer (corresponding to the recited “first lamination layer”);
• a base layer (e.g., aluminum foil, etc.) with a typical thickness of 5-15 microns;
• an optional adhesive tie layer (corresponding to the recited “second lamination layer”);
• a first outer layer (corresponding to the recited “support layer”) (e.g., polyethylene terephthalate (PET); polyethylene (PE); polyamide (PA); etc.) with an illustrative, non-limiting thickness of 23 microns;
wherein the packaging laminate has a typical total thickness of 70-140 microns. The packaging laminates are suitable for packaging drugs (e.g., nicotine; fentanyl; lidocaine, etc.). (FOGTMANN ET AL ‘373, entire document, e.g., paragraph 0010-0014, 0019-0023, 0037-0043, 0053-0059, 0069-0079, 0082, 0087, 0090, 0097-0103, 0105-0107, 0121, 0126, etc.) (see corresponding portions of FOGTMANN ET AL ‘392) However, the reference does not discuss specific details of polyamide sealing layers.
NG-WO ‘992 disclose that it is well known in the art to utilize heat-sealable polyamide resin compositions to form packaging materials which exhibit heat-sealability in combination with other known desirable properties associated with polyamide (i.e., nylon) films (e.g., good oxygen and flavor barrier properties, low temperature durability, thermal stability, etc.), wherein the heat-sealable compositions comprise:
• a polyamide resin with a melting point of 120-180C -- for example, derived from:
• at least dicarboxylic acid (e.g., 1,6-hexanedicarboxylic acid (adipic acid); 1,12-dodecanedioic acid; etc.);
• at least diamine (e.g., 1,6-hexamethylene diamine; etc.);
• optionally other polyamide resins (nylon 6; nylon 6,6; nylon 12, etc.);
The heat-sealable polyamide resin composition can be used as a heat-seal layer in multilayer structures (e.g., via adhesion lamination, coextrusion, etc.). (line 3-15, page 2; line 12-21, page 3; line 30, page 3 to line 2, page 4; line 9, page 6 to line 6, page 8; line 13, col. 9 to line 28, col. 10; page 22-22; etc.)
Regarding claims 1-2, 4-5, 12-16, 18, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use known heat-sealable polyamide-based resin compositions (as disclosed in NG-WO ‘992) to form at least the product (e.g., drug) contact layer or the product-facing contact seal sublayer in the packaging laminates of FOGTMANN ET AL ‘373 or FOGTMANN ET AL ‘392 in order to produce drug packaging laminates with excellent barrier and/or anti-scalping in combination with useful heat-sealing characteristics.
Regarding claim 3, 19, one of ordinary skill in the art would have selected the melting point of the product-facing contact seal sublayer to be less than the melting point of the base layer-facing sublayer in the packaging laminates of FOGTMANN ET AL ‘373 or FOGTMANN ET AL ‘392 in order to allow the base layer-facing sublayer to remain intact at temperatures experienced during heat-sealing operations and thereby prevent rupture or defects in the contact layer.
Regarding claims 6, 20, one of ordinary skill in the art would have selected the melting point of the first outer layer (corresponding to the recited “support layer”) of to be greater than the melting point of base layer-facing sublayer (corresponding to the recited backing sublayer” of claim 2) in the packaging laminates of FOGTMANN ET AL ‘373 or FOGTMANN ET AL ‘392 in order to maintain overall structural integrity of the packaging laminate during heat-sealing operations.
Regarding claim 7, one of ordinary skill in the art would have utilize known abuse-resistant polymeric materials (e.g., polyesters, polyamides, etc.) with relatively high melting temperatures (as represented by a melting point of about 200-250 °C) for the first outer layer (corresponding to the recited “support layer”) in the packaging laminates of FOGTMANN ET AL ‘373 or FOGTMANN ET AL ‘392 in order to produce packaging laminates capable of retaining structural overall structural integrity during heat-sealing, retort, or other heat-related operations.
Regarding claims 9, 17, one of ordinary skill in the art would have subjected the product (e.g., drug) contact layer (corresponding to the recited “polyamide sealing layer configured to contact a drug”) of FOGTMANN ET AL ‘373 or FOGTMANN ET AL ‘392 to conventional thermoplastic film-forming processes such as biaxial orientation in order to improve various performance properties (e.g., barrier properties; mechanical properties, etc.) because it is well known in the art that orientation of polymeric films (e.g., in particular, semi-crystallizable polymeric films) generally provides improvements in mechanical properties (e.g., tensile strength, etc.) and/or barrier properties and/or heat-resistance and/or dimensional stability due to improved alignment of crystalline structures within the film.
Regarding claim 11, one of ordinary skill in the art would have used known abuse-resistant film materials (e.g., biaxially oriented PET films) as the first outer layer (corresponding to the recited “support layer”) of FOGTMANN ET AL ‘373 or FOGTMANN ET AL ‘392 in order to provide drug packaging with good abuse-resistance and durability.
Claim(s) 9, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• FOGTMANN ET AL (US 2022/0250373), or • FOGTMANN ET AL (US 2022/0274392), in view of WO 95/15992 (NG-WO ‘992),
as applied to claim 1 above,
and further in view of FILMS - ULLMANN’S ENCYCLOPEDIA OF INDUSTRIAL CHEMISTRY (FILMS - ULLMANN’S).
FILMS - ULLMANN’S discloses that it is well known in the art to stretch polymer films in order to improve modulus of elasticity, strength, barrier properties, and other performance properties. The reference further discloses that it is well known in the art to biaxially orient polyamide (nylon) film in order improve various properties. (sections 2.3; section 2.3.2; section 6.7; etc.)
Regarding claims 9, 17, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to subject the product (e.g., drug) contact layer (corresponding to the recited “polyamide sealing layer configured to contact a drug”) of FOGTMANN ET AL ‘373 or FOGTMANN ET AL ‘392 to conventional thermoplastic film-forming processes such as biaxial orientation in order to improve various performance properties (e.g., barrier properties; mechanical properties, etc.) (as suggested in FILMS - ULLMANN’S) because it is well known in the art that orientation of polymeric films (e.g., in particular, semi-crystallizable polymeric films) generally provides improvements in mechanical properties (e.g., tensile strength, etc.) and/or barrier properties and/or heat-resistance and/or dimensional stability due to improved alignment of crystalline structures within the film.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
• FOGTMANN ET AL (US 2022/0250373), or • FOGTMANN ET AL (US 2022/0274392), in view of WO 95/15992 (NG-WO ‘992),
as applied to claim 1 above,
and further in view of JAIN ET AL (US 2020/0155473).
JAIN ET AL ‘473 discloses that it is well known in the art to utilize biaxially oriented polyester (e.g., polyethylene terephthalate (PET), etc.) film layers as outer layers of drug packaging laminates in order to provide good abuse-resistance and durability. (paragraph 0039, etc.)
Regarding claim 11, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use known abuse-resistant film materials (e.g., biaxially oriented PET films, as suggested in JAIN ET AL ‘473) as the first outer layer (corresponding to the recited “support layer”) of FOGTMANN ET AL ‘373 or FOGTMANN ET AL ‘392 in order to provide drug packaging with good abuse-resistance and durability.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
ALFONSO ALEGRE ET AL (US 2023/0039785) disclose heat-sealable polyamide materials.
ENDO ET AL (US 2017/0210105) disclose polyamide-based packaging materials.
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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July 25, 2026
/VIVIAN CHEN/
Primary Examiner, Art Unit 1787
Prosecution Insights