DETAILED ACTION
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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “laminate conveying means” in claim 9; “film composite conveying means” in claim 9; and “separating device” in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The limitation “laminate conveying means” recites the generic placeholder “means” coupled with the functional modifier “conveying” without reciting sufficient structure to perform the function claimed. This will be interpreted as: structure 12, shown in figure 4, and equivalents thereof.
The limitation “film composite conveying means” recites the generic placeholder “means” coupled with the functional modifier “conveying” without reciting sufficient structure to perform the function claimed. This will be interpreted as: structure 16, shown in figure 4, and equivalents thereof.
The limitation “separating device” recites the generic placeholder “device” coupled with the functional modifier “separating” without reciting sufficient structure to perform the function claimed. This will be interpreted as: structure 20, shown in figure 3, and equivalents thereof.
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.
Claim(s) 1, 4, 6-9, and 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over GRADER et al. (US 2017/0225442) in view of NEEPER et al. (US 2010/0089537).
Regarding claims 1, 7, and 21, GRADER teaches providing a laminate 10 comprising two films 11 and 12 with a pharmaceutically active adherent formulation therebetween, feeding the laminate, separating the first film 12 with the formulation from the second film 11 by feeding the first film obliquely to the feeding direction of the second film, the first film rotating around an axis while feeding (paras. 16, 31, 32, 40, and 42; fig. 1). GRADER does not teach that the first film is fed out at an angle from 60 to 90 degrees relative to the feeding direction by rotating about its longitudinal axis at an angle from 90 to 270 degrees. NEEPER teaches another method of peeling a film from a laminate via feeding the first film obliquely to the feeding direction from the second film, wherein the first film is fed out at an angle of 90 degrees relative to the feeding direction via rotating the first film upward approximately 180 degrees about its longitudinal axis, and that it would have been obvious to one of ordinary skill in the art at the time of the invention to utilize a peeling direction at an angle to the feeding direction in order to avoid the need to overcome the strength of the adhesive along the entire width of the leading edge of the film (NEEPER; paras. 32 and 34; figs. 4-5). While NEEPER does not teach the range of feed angle between 60 and 120 degrees or a rotation angle between 90 and 270 degrees. It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize the claimed ranges because the angle of the prior art overlaps those ranges claimed (MPEP 2144.05), and there would have been a reasonable expectation of producing the same peeling within the ranges claimed as would be produced by the 90 degree peeling disclosed by NEEPER (MPEP 2141; KSR).
Regarding claim 4, GRADER teaches feeding the laminate on a plane different from the feeding out plane (fig. 1).
Regarding claims 6 and 18, GRADER teaches applying silicone to a film (para. 36), which is an adherence reducer.
Regarding claim 8, GRADER teaches utilizing a device (para. 39).
Regarding claims 9 and 19-20, GRADER teaches a laminate conveying means 23, film composite conveying means 60, and separation device 40 (fig. 1) capable of performing the functions claimed. GRADER teaches separating device 40 has a bending edge adjacent and parallel to the plane of the feeding path (fig. 1). NEEPER teaches arranging the bending edge at 45 degrees so the feeding-out direction is approximately 90 degrees relative to the feeding direction, and it would have been obvious to one of ordinary skill in the art at the time of the invention to utilize a peeling direction at an angle to the feeding direction, as disclosed by NEEPER, in the method of GRADER in order to avoid the need to overcome the strength of the adhesive along the entire width of the leading edge of the film (NEEPER; para. 34; fig. 5). While NEEPER does not teach the ranges of bending edge and feeding-out directions claimed, it would have been obvious to one of ordinary skill in the art at the time of the invention to arrange the bending edge at an angle between 30 and 60 degrees and a feeding out direction angle between 60 and 120 degrees because the ranges claimed overlap the angles disclosed by the prior art (MPEP 2144.05) and there would have been a reasonable expectation of producing the same peeling within the ranges as that produced by NEEPER (MPEP 2141; KSR).
Regarding claim 17, GRADER teaches the feeding plane, passing plane, and feeding-out plane are parallel (fig. 1).
Regarding claim 22, GRADER teaches providing a laminate 10 comprising two films 11 and 12 with a pharmaceutically active adherent formulation therebetween, feeding the laminate, separating the first film 12 with the formulation from the second film 11 by feeding the first film obliquely to the feeding direction of the second film, the first film rotating around an axis while feeding (paras. 16, 31, 32, 40, and 42; fig. 1). GRADER does not teach that the first film is fed out at an angle from 60 to 90 degrees relative to the feeding direction by rotating about its longitudinal axis at an angle from 90 to 270 degrees. NEEPER teaches another method of peeling a film from a laminate via feeding the first film obliquely to the feeding direction from the second film, wherein the first film is fed out at an angle of 90 degrees relative to the feeding direction via rotating the first film upward approximately 180 degrees about its longitudinal axis, and that it would have been obvious to one of ordinary skill in the art at the time of the invention to utilize a peeling direction at an angle to the feeding direction in order to avoid the need to overcome the strength of the adhesive along the entire width of the leading edge of the film (NEEPER; paras. 32 and 34; figs. 4-5). While NEEPER does not teach the range of feed angle between 60 and 120 degrees or a rotation angle between 90 and 270 degrees. It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize the claimed ranges because the angle of the prior art overlaps those ranges claimed (MPEP 2144.05), and there would have been a reasonable expectation of producing the same peeling within the ranges claimed as would be produced by the 90 degree peeling disclosed by NEEPER (MPEP 2141; KSR). GRADER teaches feeding the laminate on a plane different from the feeding out plane (fig. 1). GRADER teaches the feeding plane, passing plane, and feeding-out plane are parallel (fig. 1).
Response to Arguments
Applicant's arguments filed 4/1/2026 have been fully considered but they are not persuasive.
Applicant argues that the “means” limitations of claim 9 should not be interpreted under 35 U.S.C. 112(f) because the scope has been adequately defined. The limitations claimed recite only the generic placeholders coupled with functional language, and not any particular structural limitations, which is not sufficient definition for an apparatus structure.
Applicant argues that NEEPER does not teach the ranges of feed angles and film rotations claimed. It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize the claimed ranges because the angles disclosed by the prior art overlap those ranges claimed (MPEP 2144.05), and there would have been a reasonable expectation of producing the same peeling utilizing the ranges claimed (MPEP 2141; KSR). Applicant does not appear to disclose any unexpected results or criticality that would differ from the prior art angles disclosed.
Conclusion
THIS ACTION IS MADE FINAL. 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 Nickolas R Harm whose telephone number is (571)270-7605. The examiner can normally be reached 10:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phillip Tucker can be reached at 571-272-1095. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICKOLAS R HARM/ Examiner, Art Unit 1745
/PHILIP C TUCKER/ Supervisory Patent Examiner, Art Unit 1745
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