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 .
Response to Amendment
The amendment filed 2/17/2026 has been entered:
Claim 1 is currently amended. Claims 2-3, 7, and 9-10 are canceled. Claims 1-2, 4-6, 8, and 11-13 are pending in the present application and are examined on the merits.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1,2, 4-6, 8, 11 and 12 have been considered but are not found persuasive.
Applicant argues Hörmann does not teach any sort of three-film-layer structure. However, Hörmann clearly describes three distinct layers (bag 1, film strip 5, and markings 7, which are shown as having a height, and are further described as being ink or adhesively bonded). Applicant does not define or otherwise provide further specificity regarding the term “film”, and further appears to refer to their own markings (code 40 or text 50) as a film. Thus, the markings of Hörmann may be reasonably interpreted as a film, even if one of said films are not necessarily a “thermal transfer film”.
Applicant further argues Ishioroshi only discloses two layer based on Fig. 2 as Applicant states the label space “L” is not a film nor a layer, but is rather a surface.
The definition of a “surface” and a “layer” would appear largely analogous in this context.
Further, the instant rejection cites Figs. 6B-6C, and does not rely solely on Fig. 2 of Ishioroshi as Fig. 2 shows a top-down view making it difficult to view distinct layers. The cited figures 6B-6C clearly show at least two film layers (base layer 31 and surface layer 32) making up the label. Thus, Applicant’s interpretation that the label (11) must be one layer is not persuasive.
Further, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the instant case, the entirety of Ishioroshi (i.e. the cassette surface) is not incorporated, nor is it required. Rather, Ishioroshi demonstrates that a label can be made of two films (i.e. layers) applied to a thermal transfer film (¶ 44). Thus, Hörmann, with its first bag film, would comprise a three-film-layer structure in combination with the label of Ishioroshi.
Applicant further argues portions of the surface layer (32) of Ishioroshi are removed, which would result in a one-film-layer structure. However, Applicant has not claimed nor defined such features of the films of the instant invention that would require a more specific interpretation of the term “film” (such as to be completely without removed materials, or in a manner that would otherwise render the surface layer of Ishioroshi unsuitable to be interpreted as a film).
Further, cited paragraph 44 of Ishioroshi clearly states that the layers 31 and 32 may be applied to a thermal transfer film, together and without laser evaporation.
Applicant further argues one of ordinary skill in the art would have doubted the laser markings used for Ishioroshi would be applicable to the bag of Hörmann.
However, both Hörmann and Ishioroshi are clearly within the same field of endeavor of label making. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. See MPEP 2141.03. In the instant case, neither Hörmann nor Ishioroshi indicate that their labeling methods are exclusive only to their individually disclosed substrates. In fact, Ishioroshi discloses different material substrates such as plastic, metallic, or ceramics (¶ 48).
Further, Applicant’s own information disclosure statement is not restricted to only medical bags (for instance, DE 102018132321 appears to relate to banknotes and ID documents in ¶ 2).
Applicant also argues there is no teaching in Ishioroshi to suggest remove the label structure from the surface of the video tape cassette and labelling a medical bag. However, the instant combination is founded on Ishioroshi demonstrating known/equivalent label making techniques. It is not based on the particular manufacturing process put forth by Applicant, nor does it require a specific teaching in Ishioroshi for the modification of medical bags containing a fresh dialysis solution.
Applicant’s arguments regarding claim 13 is moot as claim 1 remains rejected as set forth below.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 4-6, 8, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hörmann et al. (WO 2016/046388 A1, citations made to previously attached translation), in view of Ishioroshi (US 2004/0200902 A1) and Yamagishi (EP 2 806 004 A1).
Regarding claim 1, Hörmann teaches a medical bag (Fig. 1, bag 1; Abstract), comprising a first film layer (film 9) having a transparent region (¶s 63-64 indicate the bag films are transparent a hot stamping film located on the transparent region (film strip 5 is applied to bag film 9, which is transparent, as shown in Figs. 1-3; ¶ 62 indicates the use of hot stamping); and a thermal transfer label, applied to the hot stamping film (¶ 62 describes marking 7 being applied by hot stamping or thermal transfer; ¶ 68 describes the markings contain information, codes, etc. thus also comprising a label), wherein
the medical bag contains a fresh dialysis solution (¶s 28, 33, and 112),
the hot stamping film is of a first color,
the label is of a different color than the first color, (¶s 64-66 and 73-77 describe having different color foils and labels for good readability, e.g. black code on a white background), and
the label comprises a serialization information (¶ 68 describes context of serialization).
Hörmann does not explicitly disclose the thermal transfer label forms a three-film-layer structure where the thermal transfer film comprises a label, or is configured to withstand a sterilization process of the medical device.
However, Ishioroshi teaches a method of making a multi-layer label laminate (Fig. 2; Abstract), in which the label may be made using a number of different processes including hot-stamp printing and thermal transfer printing (¶ 36; ¶ 44 also explicitly states the use of a thermal transfer film in combination with hot-stamping; a multi-layer structure can also be seen in Figs. 6B-6C) where the thermal transfer film comprises a label (¶ 44).
Thus, Ishioroshi shows that a label using a thermal transfer film is an equivalent structure known in the art. Therefore, because these label were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the thermal transfer label of Hörmann with the thermal transfer film of Ishioroshi. Doing so would thus comprise a three-film-layer structure, wherein the thermal transfer film comprises a label (as applying base layer 31 and surface layer 32 of Ishioroshi to the label of Hörmann would thus comprise at least three film layers, i.e. top of the bag 1).
The combination still does not explicitly disclose the label is configured to withstand a sterilization process of the medical device.
However, Yamagishi discloses a medical bag (Abstract and ¶s 1-2 describe a blood bag) having a label (adhesive sheet described in ¶s 2-5), thus being in the same field of endeavor, comprising a thermal transfer film (¶ 55 describes the heat-sensitive adhesive layer, i.e. thermal transfer film, having printed on characters to serve as a label), which is configured to withstand a sterilization processes (¶s 19, 21, and 31 describe autoclaving the adhesive sheet).
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 label of Hörmann and Ishioroshi to withstand a sterilization process, as taught by Yamagishi. Doing so would be advantageous in preventing lifting or delamination of the label when the device is autoclaved, allowing the entire device to be sterilized for medical purpose (¶s 3 and 21 of Yamagishi).
Regarding claim 2, Hörmann further teaches the device wherein the transparent region is a film (¶s 2-7 and 10 describe the device as a bag or film; ¶s 114-115 indicate the bag 1 is made of film 9).
Regarding claim 4, Hörmann further teaches wherein the label comprises a code (¶s 66-68 describe the markings being in the forms of codes).
Regarding claim 5, Hörmann further teaches the label comprises clear text information (¶s 66-68 describes the markings can be in the form of plain text).
Regarding claim 6, Hörmann further teaches the hot stamping film has a lighter color that the label (i.e. having a white film and black text label; ¶s 64-66 and 73-77).
Regarding claim 8, Hörmann further teaches the hot stamping film is white overall and that the label is black overall (i.e. having a white film and black text label; ¶s 64-66 and 73-77).
Regarding claim 11, Hörmann teaches a method of manufacturing the device according to claim 1 (Figs. 4-6) wherein the hot stamping film is first applied to the transparent region of the medical bag in a hot stamping process; and then the thermal transfer film is applied to the hot stamping film (steps 23 and 25 in Figs. 4-6 show the thermal transfer film being applied first, and the hot stamping film and thermal transfer film then being applied to the bag; however, ¶s 155-157 indicate the process may be applied in the reverse order).
Regarding claim 12, Hörmann further teaches the hot stamping film has comprises a white background, the label comprises a code, and the method comprises printing the code in a black color, on the white background, using a thermal transfer process (i.e. having a black code on a white background; ¶s 64-66 and 73-77; ¶s 61-62 describes a thermal transfer process).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hörmann, Ishioroshi, and Yamagishi, as applied to claim 1 above, and further as evidenced by Steam Sterilization (Guideline for Disinfection and Sterilization in Healthcare Facilities provided by the CDC).
Regarding claim 13, Yamagishi teaches the label and medical device configured to withstand autoclaving (¶s 3-4 and 9).
As previously stated, 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 label of Hörmann and Ishioroshi to withstand a sterilization process, as taught by Yamagishi. Doing so would thus comprise the label configured to withstand a sterilization treatment at a temperature of 124oC or more (the second paragraph of Steam Sterilization indicates temperatures of 121oC, 132oC, and higher temperatures are typically used for autoclave sterilization, thus the autoclave configured label of Yamagishi would be configured to withstand autoclaving temperatures of 121oC, 132oC, and higher). Doing so would be advantageous in preventing lifting or delamination of the label when the device is autoclaved, allowing the entire device to be sterilized for medical purpose (¶s 3 and 21 of Yamagishi).
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 ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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