DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed 08 January 2026 has been entered. Claims 2-17 are currently pending in the application. The rejections of record from the office action dated 09 October 2025 not repeated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is not support to recite “a depth having a dimension that extends form the opening at the first polymeric layer to a base defined by the third polymeric layer; introducing an article into at least one of the plurality of receptacle portions, the article having a thickness defined between the opening and the base that is less than the depth”. Applicant points to instant Figure 4 for support. However instant Figure 4 does not provide support for these features given that there is no indication that instant Figure 4 is drawn to scale and even if it were, it is unclear whether the thickness of the article is less than the depth having a dimension that extends from the opening at the first polymeric layer to a base defined by the third polymeric layer.
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.
Claims 2-17 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the phrase “a depth having a dimension that extends form the opening at the first polymeric layer to a base defined by the third polymeric layer; introducing an article into at least one of the plurality of receptacle portions, the article having a thickness defined between the opening and the base that is less than the depth” renders the claim indefinite because it is unclear what is meant by this. It is noted that it is unclear how the claim can recite an opening defined at the third polymeric layer (instant claim 2 line 12) and then recite that the depth extends from the opening at the first polymeric layer to a base defined by the third polymeric layer. Further, in light of this language, it is unclear whether the depth is referring to the depth of the receptacle or is reciting the thickness of the first polymeric layer to the third polymeric layer. For purposes of this office action it will be interpreted as the article has a thickness that is less than the depth of the receptacle.
Claims 3-17 are rejected as depending from claim 2.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-4, 6-14 and 16-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Merical et al. (US 2007/0160789 A1) in view of Intini (US 4,537,312).
Regarding claims 2-4, 6-14 and 16-17, Merical discloses a method of making a blister package for pharmaceuticals and nutraceuticals in the form of pills and tablets, comprising forming a multi-layer first film structure comprising forming a product contact layer, an adhesive layer, a desiccant layer, and adhesive layer and a barrier layer, sealed to a second film structure comprising a product contact layer, an adhesive layer, a desiccant layer, an adhesive layer and a barrier layer, wherein the first film structure comprises cavities for containing the products (abstract, [0022], [0086]-[0096], [0100], Fig. 9), wherein the barrier layers (i.e. the barrier layer of the first film could be considered the first polymeric layer) may comprise PET or metallized substrates such as metallized polyester (i.e. metalized layer is formed on the first polymeric layer; first polymeric layer includes metalized PET; forming a metalized layer on the first polymeric layer)([0058]-[0060]). Given that the product contact/sealant layers, adhesive layers and desiccant layers may comprise polymeric materials ([0050]-[0060]), it is the examiners position that the adhesive layers or desiccant layer or adhesive layer/desiccant layer, desiccant layer/adhesive layer of the first film structure could be considered to be the presently claimed second polymeric layer. It is the examiner’s position that the product contact layer of the first film could be considered to be the third polymeric layer. It is clear that the opening of the receptacle portions are defined at the product contact layer (third polymeric layer). It is the examiner’s position that it would have been obvious to one of ordinary skill in the art to use any of the materials recited including those claimed and thereby arrive at the claimed invention.
Merical teaches that the blister package may be thermoformed ([0065], [0089]).
Merical does not disclose a planar lid-stock film arranged on the multi-layer film structure, the planar lid-stock film being formed from a thermoplastic material bonded directly to the third polymeric layer covering the opening for each of the plurality of receptacle portions and a flat metallic film arranged on the planar lid stock film, the flat metallic film forming a frangible backing layer having a planar surface or the article having a thickness defined between the opening and the base that is less than the depth.
Intini discloses a blister package that is child-resistant and tamper-evident, having a flat rupturable aluminum foil layer and an outer back layer that may comprise cardboard that is securely adhered to the foil layer (i.e. flat metallic film arranged on the lid-stock film, the flat metallic film forming a frangible backing layer having a planar surface; flat film includes a laminated layer including a metal layer and a paper layer adhered to the metal layer) (abstract, C2/L8-15, C5/L1-45, Fig. 1-10).
Merical and Intini are analogous art because they both teach about blister packages. It would have been obvious to one of ordinary skill in the art to incorporate the backing layer of Intini into the structure or use the outer back layer of Intini in place of the second film structure of Merical in order to provide a blister package having the advantage of being child-resistant and tamper-evident and to use the structure of a planar side of the blister package of Intini because it is a well-known design for this type of packaging.
Regarding the planar lid stock film, it would have been obvious to add a product contact layer (planar lid stock film) to the outer back layer as taught by Intini in order to provide a layer that is safe for contacting the product contained in the package.
Given that the package of modified Merical will have the structure of Intini having a planar side and a side having the receptacles and given that the product (i.e. article) will be contained inside the receptacle, it is clear that the thickness of the article will be less than the depth of the receptacle or it would have been obvious to make the product (i.e. article) have a thickness less than the depth of the receptacle in order to fit in the package.
Further, it is noted that change in size and shape is not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). MPEP 2144.04[R-1].
Regarding claim 4, it is noted that the desiccant layers and product contact layers may comprise cyclic olefin copolymer ([0069], [0071]).
Regarding claim 6, it is noted that the product contact layers may comprise PVC ([0071]) and the adhesive layers may comprise polypropylene ([0058])
Regarding claims 7-8, Merical teaches that the blister package may be thermoformed ([0065], [0089]). It appears that the first film structure is domed as shown in Figure 9. Alternatively, while there is no specific disclosure that the cavities (i.e. receptacles) are dome shaped, it is the examiner’s position that it would have been obvious to make them domed shaped depending on the product to be packaged in the cavities and for aesthetic purposes.
Change in size and shape is not patently distinct over the prior art absent persuasive evidence that the particular configuration of the claimed invention is significant. See In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). MPEP 2144.04[R-1].
Regarding claims 9-11, the multilayer film structure may be coextruded (i.e. extruding the first polymeric layer to form the first polymeric layer, extruding the second polymeric layer to form the second polymeric layer, extruding the third polymeric layer to form the third polymeric layer; multilayer film structure is coextruded; wherein forming the first, second and third polymeric layers form a multilayer film structure having a laminated construction)([0051], [0073]).
Regarding claims 12-13, there are adhesive layers positioned between the product contact layers, the desiccant layers and the barrier layers and they may comprise polymeric material (positioning first tie layer between first polymeric layer and second polymeric layer and positioning second tie layer between second polymeric layer and third polymeric layer; adhesive lacquer)([0050]-[0060]).
Regarding claim 17, the product contact layer (lid-stock film) may comprise PVC, COC, HDPE ([0071])(i.e. polyolefin, poly(vinyl chloride)).
Claim 5 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Merical et al. (US 2007/0160789 A1) and Intini (US 4,537,312), as applied to claim 4 above, in view of Arjunan et al. (US 5,942,587).
Regarding claim 5, Merical discloses all of the claim limitations as set forth above. Merical does not disclose that the cyclic-olefin includes a copolymer of norbornene and ethylene.
Arjunan discloses that ethylene norbornene copolymers have improved toughness and processability (abstract).
Merical and Arjunan are analogous art because they both teach about cyclic olefins. It would have been obvious to one of ordinary skill in the art to use ethylene norbornene copolymer as taught by Arjunan as the cyclic olefin of Merical in order to provide a second polymeric layer having the advantage of improved toughness and processability.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Merical et al. (US 2007/0160789 A1) and Intini (US 4,537,312), as applied to claim 14 above, in view of Havens (US 5,175,033).
Regarding claim 15, Merical discloses all of the claim limitations as set forth above. Merical does not disclose that the metalized layer is formed by vacuum deposition, indirect metallization, electro-less plating, electrolytic plating, lacquer painting or any combination thereof.
Havens discloses that metalized PET is typically made by vacuum deposition (C5/L12-27).
Merical and Havens are analogous art because they both teach about metalized PET. It would have been obvious to one of ordinary skill in the art to use the method of forming the metalized layer of Havens in the method of forming the film structure of Merical because it is a well-known and common method for forming metalized layers and doing so would amount to nothing more than using a known technique in a known environment to accomplish an entirely expected result.
Response to Arguments
Applicant's arguments filed 08 January 2026 have been fully considered but they are not persuasive.
Applicant argues that Merical does not disclose a receptacle that can fully receive a product such that one side of the package remains planar.
Applicant’s argument is unpersuasive given that Intini is used to teach this limitation. It is the examiner’s position that it would have been obvious to use the structure of a planar side of the blister package of Intini because it is a well-known design for this type of packaging.
Applicant argues that the package of Merical is designed to sandwich a product between two desiccant layers with the bulbous protrusions providing headspace to absorb moisture and improve product life.
Applicant’s argument is unpersuasive given that the resulting package of the combination of Merical could still have two desiccant layers and would still have headspace by virtue of the dome shaped portion of the first film structure. There is no evidence to suggest having one side being planar would destroy the function and purpose of the packaging of Merical.
Applicant argues that the cited patent documents do not disclose a receptacle as recited in amended claim 2.
As set forth above, given that the package of modified Merical will have the structure of Intini having a planar side and a side having the receptacles and given that the product (i.e. article) will be contained inside the receptacle, it is clear that the thickness of the article will be less than the depth of the receptacle or it would have been obvious to make the product (i.e. article) have a thickness less than the depth of the receptacle in order to fit in the package.
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 JAMES C YAGER whose telephone number is (571)270-3880. The examiner can normally be reached 9-6 EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached at (571) 272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES C YAGER/Primary Examiner, Art Unit 1782