Prosecution Insights
Last updated: April 19, 2026
Application No. 17/621,722

LAMINATE METHODS AND PRODUCTS

Final Rejection §103§112§DP
Filed
Dec 22, 2021
Examiner
ZACHARIA, RAMSEY E
Art Unit
1787
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Adapa Flexibles Denmark Slagelse A/S
OA Round
6 (Final)
78%
Grant Probability
Favorable
7-8
OA Rounds
2y 10m
To Grant
99%
With Interview

Examiner Intelligence

Grants 78% — above average
78%
Career Allow Rate
701 granted / 895 resolved
+13.3% vs TC avg
Strong +29% interview lift
Without
With
+29.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
34 currently pending
Career history
929
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
40.1%
+0.1% vs TC avg
§102
24.7%
-15.3% vs TC avg
§112
22.5%
-17.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 895 resolved cases

Office Action

§103 §112 §DP
DETAILED ACTION The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Election/Restrictions Claims 1 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 April 2023. Claim Rejections - 35 USC § 112 Claim 17 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim 17 is rendered indefinite because the manner in which the laminate film is resistant to an aggressive chemical is unclear. Claim Rejections - 35 USC § 103 Claims 15, 17, 24, 26-29, and 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Merical et al. (US 2006/0269708 A1) in view of Leplatois et al. (US 2011/0005961 A1). Merical et al. is directed to a polymeric film used to form packaging for moisture sensitive products, such as pharmaceutical products (paragraph 0026). The film may be a multilayer film comprising: a product contact layer, a barrier layer, tie or adhesive layers, and an outer layer (Figure 2 and paragraph 0055). The product contact layer corresponds to the contact layer of the claims; the barrier layer corresponds to the base layer that is water and/or oxygen resistant of the claims; tie/adhesive layer corresponds to the tie layer of the claims; the outer layer corresponds to the first outer layer of claim 34. The product contacting layer may be a layer formed of high density polyethylene having a thickness of approximately 100 micron (paragraph 0069). The film structure may be formed by coextrusion (paragraph 0071). The tie layer may a monolayer formed from a blend of low density polyethylene and ethylene acrylic acid copolymer (paragraph 0061) or bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056). The film may be used as lidding (paragraphs 0089-0093). Merical et al. do not specifying the loading, or coating weight, of the tie layer. Leplatois et al. is directed to an extrusion coated lidding foil used in blister packaging (paragraph 0001). The lidding comprises a foil on which one or more tie layers and sealant layers are extrusion coated (paragraph 0019). The one or more tie layers are applied in an amount of about 3 to 8 g/m2 (claim 10). It would have been obvious to one of ordinary skill in the art to apply the tie layer(s) of Merical et al. at about 3 to 8 g/m2 because the courts have held the selection of a known material (e.g., tie layer(s) of about 3 to 8 g/m2) based on its suitability for its intended use (e.g. bonding layers together in films used for blister packaging) supported a prima facie obviousness determination. See MPEP 2144.07. Regarding claim 17, a pharmaceutical product reads on an aggressive chemical substance. Regarding claim 26, since contact layer of the instant invention typically comprises a thickness of 18-22 m (see paragraph 0026 on page 5 of the instant specification), one of ordinary skill in the art would expect a contact layer having a thickness of approximately 100 m to inherently satisfy the loading - i.e. coating weight - limitations of this claim. Regarding claim 33, Merical et al. illustrates a pouch formed by sealing two laminates together such that the product contact layer is the innermost layer of each laminate that would be expected to be in contact with the product (206) (Figure 4). Regarding claim 35, based on the thickness ranges recited for the product contact layer (paragraph 0069) and the barrier layer (paragraph 0070), the one of ordinary skill in the art would expect the overall thickness of the film of Merical et al. to overlap the range recited in claim 35. This is further supported by Examples 1 and 2, illustrating embodiments wherein the film has a total thickness of about 85-110 m (Tables 1 and 2). Since the thickness range of the film of Merical et al. overlaps the range recited in claim 35, the courts have held that a prima facie case of obviousness exists. See MPEP 2144.05. Regarding claim 36, the heat sealing layer (i.e., layer corresponding to the contact layer of the claims) is bonded to the barrier layer (i.e., layer corresponding to the base layer of the claims) by means of an adhesive layer (112). Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Merical et al. (US 2006/0269708 A1) in view of Leplatois et al. (US 2011/0005961 A1) as applied to claim 15 above, and further in view of Liu et al. (WO 2017/100182 A1). Merical et al. taken in view of Leplatois et al. suggest all the limitations of claim 18, as outlined above, except for specifying the pharmaceutical product contained in the packaging. However, the package of Merical et al. may be a blister package (paragraph 0041). Liu et al. is directed to a package for pharmaceutical products (paragraph 0002), such as a blister package (paragraph 0012). The pharmaceutical products to be packaged maybe one containing nicotine (paragraph 0088). Liu et al. illustrate that nicotine containing products may be contained in blister packages designed for pharmaceutical products. Therefore, it would have been obvious to one of ordinary skill in the art to use the blister package of Merical et al. for nicotine products since the courts have held the selection of a known material (e.g., blister packaging suitable for pharmaceutical) based on its suitability for its intended use (e.g., containing nicotine products) supported a prima facie obviousness determination. See MPEP 2144.07 Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Merical et al. (US 2006/0269708 A1) in view of Leplatois et al. (US 2011/0005961 A1) as applied to claim 15 above, and further in view of Christensen et al. (WO 2017/114922 A1). Merical et al. taken in view of Leplatois et al. suggest all the limitations of claims 30 and 31, as outlined above, except for the specific materials of the tie layer. However, Merical et al. do teach that the tie layer by a bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056). Christensen et al. is directed to a chemically resistant film comprising a tie and contact layer coextruded with a base layer for use as packaging for aggressive chemicals (page 1, lines 4-8). The tie layer may be composed to 1 to 5 layers (page 6, lines 8-11), such as a layer comprising a copolymer of ethylene and methacrylic acid as well as a copolymer of ethylene and acrylic acid (page 6, lines 15-21) or a bi-layer of a layer of ethylene acrylic acid and a layer of polyethylene. Regarding claim 30, Christensen et al. show that a single layer comprising a copolymer of ethylene and methacrylic acid and a bi-layer of a layer of ethylene acrylic acid and a layer of polyethylene are known in the art as functionally equivalent tie layers for pharmaceutical packaging. Therefore, because these two tie layers were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute single layer comprising a copolymer of ethylene and methacrylic acid for the bi-layer of a layer of ethylene acrylic acid and a layer of polyethylene taught by Merical et al. Regarding claim 31, Christensen et al. teach that the tie layer may be 1 to 5 layer and may be formed of a composition comprising a copolymer of ethylene and methacrylic acid and a copolymer of ethylene and acrylic acid. As such and in the absence of a showing of criticality or unexpected results, it would have been obvious to one of ordinary skill in the art to use a tie layer having at least two layers wherein each layer is a composition comprising a copolymer of ethylene and methacrylic acid and a copolymer of ethylene and acrylic acid. Double Patenting Claims 15, 17, 18, 24, 26-31, and 33-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-6 of U.S. Patent No. 11,325,350 B2 in view of Mehta et al. (US 2018/0361724 A1). Claims 1 and 3-6 of U.S. Patent No. 11,325,350 B2 recite a laminate film comprising a base layer and a coextrusion layer which itself comprises a tie layer and a contract layer meeting the limitations of claims 15, 17, 18, 24, 26-31, and 33-35 except for a contact layer comprising CBC, PVDF, COP, HDPE, or EMAA. However, claim 1 of U.S. Patent No. 11,325,350 B2 does recite the use of a cyclic olefin copolymer as the contact layer. Mehta et al. is directed to a packaging laminate for pharmaceutical products (paragraph 0001). The laminate comprises a product-contact layer that may be formed from high density polyethylene or cyclic olefin copolymer (paragraph 0021). In addition to a barrier layer adhered to the interior layer of the film by a tie layer, the film further comprises an outer abuse layer adhered to the other side of the barrier layer (paragraph 0032). In the embodiments of Examples 1 and 2, the film has a total thickness of about 85-110 m (Tables 1 and 2). Mehta et al. show that high density polyethylene and cyclic olefin copolymer are known in the art as functionally equivalent materials for the product-contact layer of a packaging film. Therefore, because these two polymers were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute high density polyethylene for cyclic olefin copolymer in the packaging film recited in claims 1 and 3-6 of U.S. Patent No. 11,325,350 B2. Regarding claim 34, it would have been obvious to one of ordinary skill in the art to provide an outer abuse layer on the other side of the base layer recited in claim 1 of U.S. Patent No. 11,325,350 B2 to provide the resulting packaging with additional protection. Regarding claim 35, it would have been obvious to one of ordinary skill in the art to form the film with a total thickness of about 85-110 mm since Mehta et al. illustrate that films of such a thickness may be used as packaging films for pharmaceutical products and the courts have held that the selection of a known material (e.g. film with total thickness of 85-110 m) based on its suitability for its intended use (i.e. packaging film for pharmaceutical product) supported a prima facie obviousness determination. Regarding claim 36, it would have been obvious to one of ordinary skill in the art to use the tie layer of the co-extrusion layer to bond the contact layer to the base layer of the laminate since the contact layer is designed to contact an aggressive chemical and would therefore be an outermost layer. Claims 15, 17, 18, 24, 26-31, and 33-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-27 and 32 of U.S. Patent No. 11,376,814 B2 in view of Mehta et al. (US 2018/0361724 A1) and Christensen et al. (WO 2017/114922 A1). Claims 25-27 and 32 of U.S. Patent No. 11,376,814 B2 recite a laminate comprising an outer layer and a chemical resistant film which itself comprises a tie layer-contact layer coextrusion meeting the limitations of claims 15, 17, 18, 24, 26-31, and 33-35 except for a contact layer comprising CBC, PVDF, COP, HDPE, or EMAA and the coating weight of the tie layer. However, claim 25 of U.S. Patent No. 11,376,814 B2 does recite the use of a polyamide or ethylene vinyl alcohol copolymer as the contact layer. Mehta et al. is directed to a packaging laminate for food and pharmaceutical products (paragraph 0001). The laminate comprises a product-contact layer that may be formed from high density polyethylene or cyclic olefin copolymer (paragraph 0021). In addition to a barrier layer adhered to the interior layer of the film by a tie layer (paragraph 0055) the film further comprises an outer abuse layer adhered to the other side of the barrier layer (paragraph 0057). The tie layer may a monolayer formed from a blend of low density polyethylene and ethylene acrylic acid copolymer (paragraph 0061) or bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056). The film may be used as lidding (paragraphs 0089-0093). In the embodiments of Examples 1 and 2, the film has a total thickness of about 85-110 m (Tables 1 and 2). Christensen et al. is directed to a packaging film for aggressive pharmaceutical products comprising a contact layer, tie layer, and base layer (page 1, lines 4-15). The contact layer may be a cyclic olefin copolymer, a polyamide, or an ethylene vinyl alcohol copolymer (page 7, lines 1-3). The tie layer may be a single layer or multiple layers; the tie layer has a loading in the range of 7 to 20 g/m2 while the contact layer has a loading of in the range of 4 to 20 g/m2 (page 8, lines 32-35). Mehta et al. and Christensen et al. illustrate that high density polyethylene, cyclic olefin copolymer, a polyamide, and ethylene vinyl alcohol copolymer are known in the art as functionally equivalent polymers for forming the contact layer of a packaging for pharmaceutical products. Therefore, because these polymers were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute high density polyethylene for polyamide or ethylene vinyl alcohol copolymer in the packaging film recited in claims 25-27 and 32 of U.S. Patent No. 11,376,814 B2. Moreover, it would have been obvious to one of ordinary skill in the art to employ the tie layer at a loading of 7 to 20 g/m2 since Christensen et al. show the suitability of using tie layers at that loading and the courts have held the selection of a known material (e.g. an adhesive layer at a loading of 7 to 20 g/m2) based on its suitability for its intended use (e.g. tie layer in a pharmaceutical packaging film) supported a prima facie obviousness determination. See MPEP 2144.07. Regarding claim 31, Mehta et al. teach that the functional equivalence of a monolayer tie layer formed from a blend of low density polyethylene and ethylene acrylic acid copolymer (paragraph 0061) and bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056). Therefore, it would have been obvious to one of ordinary skill in the art to use a tie layer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer in place of the single layer tie layer of claim 32 in U.S. Patent No. 11,376,814 B2. Regarding claim 33, it would have been obvious to use the film of recited in the claims of U.S. Patent No. 11,376,814 B2 as lidding since Mehta et al. show that these packaging films are suitable for the lidding of the packaging. Regarding claim 34, it would have been obvious to one of ordinary skill in the art to provide an outer abuse layer on the other side of the base layer recited in claim 25 of U.S. Patent No. 11,376,814 B2 to provide the resulting packaging with additional protection. Regarding claim 35, it would have been obvious to one of ordinary skill in the art to form the film recited in claim 25 of U.S. Patent No. 11,376,814 with a total thickness of about 85-110 mm since Mehta et al. illustrate that films of such a thickness may be used as packaging films for pharmaceutical products and the courts have held that the selection of a known material (e.g. film with total thickness of 85-110 m) based on its suitability for its intended use (i.e. packaging film for pharmaceutical product) supported a prima facie obviousness determination. Regarding claim 36, it would have been obvious to one of ordinary skill in the art to use the tie layer of the co-extrusion layer to bond the contact layer to the base layer of the laminate since the contact layer is designed to contact an aggressive chemical and would therefore be an outermost layer. Claims 15, 17, 18, 24, 26-31, and 33-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,122,139 B2 in view of Mehta et al. (US 2018/0361724 A1). Note: U.S. Patent No. 12,122,139 issued from Application No. 17/675,647. Claims 1-13 of U.S. Patent No. 12,122,139 B2 differ from instant claims 15, 17, 18, 24, 26-31, and 33-35 in that they do not specify the material from which the contact layer is formed. Mehta et al. is directed to a packaging laminate for pharmaceutical products (paragraph 0001). The laminate comprises a product-contact layer that may be formed from high density polyethylene or cyclic olefin copolymer (paragraph 0021). In addition to a barrier layer adhered to the interior layer of the film by a tie layer (paragraph 0055) the film further comprises an outer abuse layer adhered to the other side of the barrier layer (paragraph 0057). The tie layer may a monolayer formed from a blend of low density polyethylene and ethylene acrylic acid copolymer (paragraph 0061) or bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056). In the embodiments of Examples 1 and 2, the film has a total thickness of about 85-110 m (Tables 1 and 2). The film may be used as lidding (paragraphs 0089-0093). Mehta et al. show that high density polyethylene and cyclic olefin copolymer are known in the art as functionally equivalent materials for the product-contact layer of a packaging film. Therefore, because these two polymers were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute high density polyethylene for cyclic olefin copolymer in the packaging film recited in claims 1-13 of U.S. Patent No. 12,122,139 B2. Regarding claims 17 and 18, it would have been obvious to form packaging for nicotine, fentanyl, lidocaine, or rivastigmine out of the film recited in the claims of U.S. Patent No. 12,122,139 B2 since the film has a layer designated as a contact layer and is designed to be resistant to nicotine, fentanyl, lidocaine, or rivastigmine. Regarding claim 30, since Mehta et al. show the functional equivalence of monolayer and bilayer adhesive films in packaging films for pharmaceutical products, it would have been obvious to one of ordinary skill in the art to use a single adhesive layer in place of the multi-layer tie layer recited in the claims of U.S. Patent No. 12,122,139 B2. Regarding claim 31, it would have been obvious to use low density polyethylene layer and ethylene acrylic acid copolymer as the material for the tie layers recited in the claims of U.S. Patent No. 12,122,139 B2 since the courts have held the selection of known materials based on their suitability for their intended use supported a prima facie obviousness determination. See MPEP 2144.07. Regarding claim 33, it would have been obvious to use the film of recited in the claims of U.S. Patent No. 12,122,139 B2 as lidding since Mehta et al. show that these packaging films are suitable for the lidding of the packaging. Regarding claim 34, it would have been obvious to one of ordinary skill in the art to provide an outer abuse layer on the other side of the base layer recited in the claims of U.S. Patent No. 12,122,139 B2 to provide the resulting packaging with additional protection. Regarding claim 35, it would have been obvious to one of ordinary skill in the art to form the film with a total thickness of about 85-110 mm since Mehta et al. illustrate that films of such a thickness may be used as packaging films for pharmaceutical products and the courts have held that the selection of a known material (e.g. film with total thickness of 85-110 m) based on its suitability for its intended use (i.e., packaging film for pharmaceutical product) supported a prima facie obviousness determination. Regarding claim 36, the limitations of this claim are taken to be met since the tie layer is positioned between the contact layer and the base layer. Claims 15, 17, 18, 24, 26-29, 33, 34, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 28, 30, and 31 of copending Application No. 17/621,591 in view of Liu et al. (WO 2017/100182 A1) and Christensen et al. (WO 2017/114922 A1). Claims 27, 28, 30, and 31 of copending Application No. 17/621,591 are directed to a laminate film comprising a base layer and a contact layer differ from instant claims 15, 17, 18, 24, 26-31, 33, and 34 in that they do not specify that the contact layer is adhesively bound to the base layer by means of a coextruded tie layer nor the coating weight of the tie layer. Liu et al. is directed to a package for pharmaceutical products formed from a film comprising a contact layer of cyclic olefin copolymer (paragraph 0002). The film comprises exterior and gas barrier layers in addition to the product contact layer (Figure 1 and paragraph 0044). The exterior layer is configured to prevent damage due to handling and other external influences (paragraph 0064). The layers are combined by coextrusion (paragraph 0045). Adhesive layers may be added between the layers (paragraph 0046). The film may be formed into a pouch or lidding of a blister package (paragraphs 0010-0018) to package pharmaceutical products containing nicotine (paragraph 0088). Christensen et al. is directed to a packaging film for aggressive pharmaceutical products comprising a contact layer, tie layer, and base layer (page 1, lines 4-15). The tie layer may be a single layer or multiple layers; the tie layer has a loading in the range of 7 to 20 g/m2 while the contact layer has a loading of in the range of 4 to 20 g/m2 (page 8, lines 32-35). It would have been obvious to one of ordinary skill in the art to bond adhesive and contact layers to the base layer recited in claims 27, 28, 30, and 31 of copending Application No. 17/621,591 via coextrusion since Liu et al. illustrate that coextrusion may be used to bond barrier and contact layers in packaging films and the courts have held the selection of a known technique based on its suitability for its intended use supported a prima facie obviousness determination. See MPEP 2144.07. Moreover, it would have been obvious to one of ordinary skill in the art to employ the tie layer at a loading of 7 to 20 g/m2 since Christensen et al. show the suitability of using tie layers at that loading and the courts have held the selection of a known material (e.g. an adhesive layer at a loading of 7 to 20 g/m2) based on its suitability for its intended use (e.g. tie layer in a pharmaceutical packaging film) supported a prima facie obviousness determination. See MPEP 2144.07. Regarding claim 26, it would have been obvious to one of ordinary skill in the art to employ the contact layer at a loading of 4 to 20 g/m2 since Christensen et al. show the suitability of using a contact layer at that loading and the courts have held the selection of a known material (e.g. a contact layer at a loading of 4 to 20 g/m2) based on its suitability for its intended use (e.g. contact layer in a pharmaceutical packaging film) supported a prima facie obviousness determination. See MPEP 2144.07. Regarding claim 33, it would have been obvious to form the packaging as a pouch or a blister pad with lidding since Lui et al. show that it is known to form pouches and lidding out of packaging film for the purpose of packaging nicotine products. Regarding claim 36, it would have been obvious to one of ordinary skill in the art to use the tie layer of the co-extrusion layer to bond the contact layer to the base layer of the laminate since the contact layer must be an outermost layer if it is to contact external component(s). Claims 30, 31, and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 28, 30, and 31 of copending Application No. 17/621,591 in view of Liu et al. (WO 2017/100182 A1) and Christensen et al. (WO 2017/114922 A1), as applied to claim 15 above, and further in view of Mehta et al. (US 2018/0361724 A1). Claims 27, 28, 30, and 31 of copending Application No. 17/621,591 taken in view of Liu et al. and Christensen et al. suggest all the limitations of claims 30, 31, and 35, as outlined above, except for details regarding the tie layer material and the overall thickness of the film. Mehta et al. is directed to a packaging laminate for pharmaceutical products (paragraph 0001). The tie layer may a monolayer formed from a blend of low density polyethylene and ethylene acrylic acid copolymer (paragraph 0061) or bilayer having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer (paragraph 0056). In the embodiments of Examples 1 and 2, the film has a total thickness of about 85-110 m (Tables 1 and 2). Regarding claims 30 and 31, it would have been obvious to one of ordinary skill in the art to use a tie layer having a single layer constructure formed from a blend of low density polyethylene and ethylene acrylic acid copolymer or bilayer construction having a layer of low density polyethylene layer and a layer of ethylene acrylic acid copolymer since it has been held that the selection of a known material (e.g. the adhesive configurations of Mehta et al.) based on its suitability for its intended use (e.g. bonding a contact layer to a base material) supported a prima facie obviousness determination. See MPEP 2144.07. Regarding claim 35, it would have been obvious to one of ordinary skill in the art to form the film with a total thickness of about 85-110 mm since Mehta et al. illustrate that films of such a thickness may be used as packaging films for pharmaceutical products and the courts have held that the selection of a known material (e.g. film with total thickness of 85-110 m) based on its suitability for its intended use (i.e. packaging film for pharmaceutical product) supported a prima facie obviousness determination. Response to Arguments Applicant's arguments filed 23 October 2025 have been fully considered but they are not persuasive. The applicant argues that Merical et al. is silent to any discussion of nicotine, fentanyl, lidocaine and rivastigmine do not teach that their HDPE has a relative energy difference value of greater than 1. This is not persuasive for the following reasons. According to paragraph 0124, the relative energy difference value is calculated from Hansen solubility parameter as described in Hansen Solubility Parameters, A User's Handbook and is based on polar and hydrogen bonding properties. According to the referenced Handbook, the solubility parameter may be determined based on contributions provided by groups present in the structure of the compound, for example -CH2- (see attached Table 1.1). Since there is no indication that the high density polyethylene used by the applicant has been treated in any way to alter its structure in a way that would influence its Hansen solubility parameter, and thus its relative energy difference value, one of ordinary skill in the art would expect the relative energy difference value of the high density polyethylene of Merical et al. to be about the same as that of the HDPE of the invention such that it would be greater than 1 in relationship to one or more of nicotine, fentanyl, lidocaine and rivastigmine. Conclusion 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 RAMSEY E ZACHARIA whose telephone number is (571)272-1518. The best time to reach the examiner is weekday afternoons, Eastern time. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /RAMSEY ZACHARIA/Primary Examiner, Art Unit 1787
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Prosecution Timeline

Dec 22, 2021
Application Filed
Apr 21, 2023
Non-Final Rejection — §103, §112, §DP
Aug 25, 2023
Response Filed
Oct 24, 2023
Final Rejection — §103, §112, §DP
Apr 26, 2024
Request for Continued Examination
Apr 29, 2024
Response after Non-Final Action
May 21, 2024
Non-Final Rejection — §103, §112, §DP
Nov 07, 2024
Response Filed
Dec 02, 2024
Final Rejection — §103, §112, §DP
Apr 04, 2025
Request for Continued Examination
Apr 07, 2025
Response after Non-Final Action
May 21, 2025
Non-Final Rejection — §103, §112, §DP
Oct 23, 2025
Response Filed
Jan 27, 2026
Final Rejection — §103, §112, §DP (current)

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Prosecution Projections

7-8
Expected OA Rounds
78%
Grant Probability
99%
With Interview (+29.3%)
2y 10m
Median Time to Grant
High
PTA Risk
Based on 895 resolved cases by this examiner. Grant probability derived from career allow rate.

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