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 .
Status of Claims
This office action is responsive to claims filed on 05/01/2025.
Claims 1-20 are currently pending in this office action.
Election/Restrictions
Applicant’s election without traverse of Group I drawn to claims 1-16 in the reply filed on 01/20/2026 is acknowledged.
Claim 17-20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-15 of U.S. Patent No. US 12378053 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims encompass the same subject matter presented in the instant claims with only minor grammatical changes or synonym usage.
Regarding Claim 1 of application: ‘053 claims system for producing a strip of pouches, comprising: a guide device configured to receive a packaging material web, the packaging material web comprising: a plurality of cover sections extending in a longitudinal direction of the packaging material web; a transparent material area extending in the longitudinal direction parallel to the cover sections, the plurality of cover sections having a transmission in a visible frequency range less than the transmission in the visible frequency range of the transparent material area; and a plurality of data sections; a printing device configured to apply data to the data sections; an application device configured to apply an information unit to the cover sections; and a cover section device configured to apply the plurality of cover sections to the packaging material web (Col 13 lines 55-67 to Col 14 lines 1-6).
Regarding Claims 2-16: Claims 2-15 of US 12378053 B2 recite essentially each feature of the claims and/or the claimed features patentably indistinct in view of the claimed invention of Claims 2-15 of US 12378053 B2.
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:
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;
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
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.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-5, 9-11, and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chudy (US 20170057682 A1).
Regarding claim 1, Chudy a system (10) for producing a strip of pouches ([0064]), comprising:
a guide device configured to receive a packaging material web ([0067]-[0075] and [0090]-[0091]; The web material 103 is received from supply roll 101 and guided through rollers which guide and advance the webs through the system…see also Fig. 7…se also guides 95), the packaging material web comprising:
a plurality of cover sections extending in a longitudinal direction of the packaging material web ([0071] pouch package web 103 may include an opaque or semi-opaque portion 129 which receives printed information 131 thereon…See also Fig. 18)
a transparent material area extending in the longitudinal direction parallel to the cover sections ([0071] The pouch package web 103 may include…a transparent portion 133), the plurality of cover sections having a transmission in a visible frequency range less than the transmission in the visible frequency range of the transparent material area (the opaque/semi-opaque portions have lower visible transmission for contrast with printed information compared to the transparent portion; See also Fig. 18, showing opaque printed areas parallel to transparent viewing areas); and
a plurality of data sections ([0071]-[0072], Fig. 18; see at least 131);
a printing device (117) configured to apply data to the data sections (Fig. 18);
an application device (117 and/or 155, 233) configured to apply an information unit to the cover sections ([0072]; printer 117 applies information units (e.g., printed labels with data) to the opaque cover sections; see Fig. 18, showing printed information on opaque portion…see also ([0100]-[0103] and [0129]); and
a cover section device ([0075]-[0077] sealer and perforation unit 119 seals the opaque cover sections to the transparent sections of the web 103 via heated rollers, applying and securing the cover sections longitudinally) configured to apply the plurality of cover sections to the packaging material web (see also 161; [0068], [0126]-[0129]).
Regarding claim 2, wherein the guide device is configured so that the data sections are assigned to the printing device and the cover sections are assigned to the application device ([0072], Guide rollers (104-115) advance and position web 103 such that the data sections on opaque portions are assigned to and printed by printer 117; the opaque cover sections are similarly assigned to printer 117 for application of information units; see also Fig. 7 and 18).
Regarding claim 4, further comprising: a shaping device configured to receive the packaging material web ([0107] web is folded to form a pocket 127; the folding mechanism that creates the pouch cavity is a shaping device…see Fig. 7).
Regarding claim 5, wherein the shaping device is configured to continuously shape in a running direction the packaging material web into a receiving area suitable for receiving small piece goods ([0070]-[0074]).
Regarding claim 9, wherein the printing device (117) and the application device (117/155/233) are each arranged downstream of the guide device ([0070]-[0072] and [0101]-[0103]).
Regarding claim 10, wherein the strip of pouches comprises a plurality of pouches (33; Figs. 18-19) provided with information over a large area and optimized for an inspection system ([0071] “Opaque portion 129 preferably contrasts with printed information 131 applied thereto and facilitates reading or machine detection (e.g., barcode recognition or optical character recognition) of the printed information 131” and [0095]-[0099] imaging device 227 and camera 321).
Regarding claim 11, wherein the printing device is a first printing device (117) and the application device (233) is a second printing device ([0072] and [0101]-[0102]).
Regarding claim 15, wherein the data section and the cover section are arranged on the same side of the strip of pouches ([0069]-[0071]; Fig. 18).
Regarding claim 16, wherein the packaging material web (103) received by the guide device comprises one of: a single layer (Fig. 18) comprising an inner layer portion (133) and a cover layer portion (layer of 129), the cover layer portion defining the cover section (Fig. 18- see 133, 129, 131).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 3, and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chudy (US 20170057682 A1) in view of Gross (US 20180290775 A1).
Regarding claim 3, Chudy discloses the guide device but is silent regarding comprises a deflection roller.
Gross in a related invention teaches guide device comprising a deflection roller ([0044] and [0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide device of Chudy by incorporating guide device comprising a deflection roller as taught by Gross in order to guide and tension the web.
Regarding claim 6, Chudy discloses web folded into pockets (127; [0069]-[0071], sealing by sealing unit (119) but is silent regarding further comprising: a joining device configured to join the shaped packaging material web to form a pouch of the strip of pouches.
Gross in a related invention teaches a joining device configured to join the shaped packaging material web to form a pouch of the strip of pouches ([0034]-[0041] and Figs. 4-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Chudy by incorporating a joining device as taught by Gross in order to join shaped web portions to formed sealed pouch compartments and improve pouch integrity and manufacturing reliability. Both references are directed to web based pharmaceutical packaging systems, and substituting one known web joining sealing technique for another represents the predictable use of prior art elements according to their established functions.
Regarding claim 7, further comprising: a feed device (69) configured to feed drug portions to the pouch ([0050]-[0058] and [0074]).
Regarding claim 8, Chudy discloses the system according to claim 4 but is silent regarding comprises a deflection roller a deflection roller configured to feed the packaging material web to the shaping device.
Gross in a related invention teaches deflection roller configured to feed the packaging material web to the shaping device ([0044] and [0060]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide device of Chudy by incorporating guide device comprising a deflection roller as taught by Gross in order to guide and tension the web.
Claims 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chudy (US 20170057682 A1) in view of Tampieri et al. (US 20110126495 A1).
Regarding claim 12, Chudy discloses cover section device including multiple printing devices (117, 233) as rejected above but is silent regarding the cover section device is a third printing device.
Tampieri in a related invention teaches a blister packaging system a cover section device is a third printing device (Tampieri teaches multiple printing stations-6, 13, 66, and 74).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cover section device of Chudy by incorporating a third printing device as taught by Tampieri in order to apply different types of information at different stages of packaging in order to improve traceability, coding flexibility, and reduce production downtime by distributing printing operations ([0031]-[0033]).
Claims 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chudy (US 20170057682 A1).
Regarding claim 13, Chudy discloses the cover section device, guide device, printing device, and the application device as explained above but does not disclose
wherein the cover section device is arranged downstream of the guide device, the printing device is arranged downstream of the cover section device and the application device is arranged downstream of the printing device.
However, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to rearrange the cover section device, guide device, printing device, and the application device as described in claim 13, since it has been held that the rearrangement of parts of a device involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). This maintains flow of operations and sequencing of web operations and can be achieved through routine design optimization in packaging lines.
Regarding claim 14, Chudy discloses the plurality of cover sections including having an opaque 129 and transparent portion 133 which constitute visibility to light ([0067]-[0071]) and the web material being a polyethylene which inherently exhibits electromagnetic radiation across a spectrum that extends beyond visible range, including near-infrared, but is silent regarding wherein each of the plurality of cover sections is permeable to light in the near infrared range.
Therefore, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to select select the material composition and/or thickness of the cover section of Chudy such that it is permeable to near infrared range, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice yielding a predictable result. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS E IGBOKWE whose telephone number is (571)272-1124. The examiner can normally be reached M-F 8 a.m. - 5 p.m..
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/NICHOLAS E IGBOKWE/Examiner, Art Unit 3731
/ANDREW M TECCO/Primary Examiner, Art Unit 3731