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 .
Summary
The Applicant arguments and claim amendments received on 11/07/2026 are entered into the file. Currently, claims 1-7 and 15-20 are withdrawn; claims 8 and 12 are amended; resulting in claims 8 through 14 pending for examination.
Claim Rejections - 35 USC § 112
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 12, 13 and 14 are 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 12, the limitation “wherein the user printed marking includes a user printed check mark printed onto the check box” is indefinite. Claim 8 is directed to a medical device system, comprising the different components of a packaged medical device and a sterile drape, wherein the sterile drape has a visual indicator printed thereon including printed instruction and a check box. The claimed medical device system is unused. Claim 12 further limits the intended use limitation of “configured to have a user printed marking disposed thereon” of claim 8. It is not clear what additional structure feature of the claimed medical device system is required by claim 12, and it will be treated as further limiting the intended use until additional clarification is provided by the Applicant.
Regarding claims 13 and 14, the limitation reciting “wherein the visual indicator includes one or more sets of grid lines” in claim 13 and “wherein the visual indicator includes a shadow board” in claim 14 are indefinite. Independent claim 8 requires that the visual indicator “include a check box disposed adjacent to a printed instruction”. Therefore, it is unclear how the visual indicator can be both a check box and gridlines or a check box and a shadow board, as the claims do not recite that the visual indicator “further comprises”.
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.
Claims 8, 9, 10, 11, 12, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Banerjee et al. (US 2023/0094714).
It is noted that in the previous office action, Banerjee et al. was listed in the heading as “WO 2023/0094714”, however, it should have read “US 2023/0094714” as was stated on the PTO-892 mailed out with the previous office action. The rejection headings now reflect the proper reference number.
Regarding claims 8, 9, 10 and 11, Banerjee et al. teaches medical product packaging (medical device system) as shown in Figures 1, 2, 3 and 5, comprising a packaged medical devices including gloves (302) and a tray portion (202, 502) comprising syringe, drainage bag, drain line, catheter (512, 508, 506, 504) and a sterile drape (304) for use with the packaged medical devices ([0024, 0027-0029, 0044]). Banerjee et al. further teaches that the sterile drape can include instructions printed thereon in the form of print or pictorial/graphic form ([0044]). As an example, Banerjee et al. teaches that the instructions for catheter prep and/or insertion may be printed on the sterile drape, which is draped over the patient, so that the instructions are visible during the procedure ([0044]).
While Banerjee et al. teaches that the sterile drape has printed instructions that can include pictorial and/or graphic form ([0044]), the reference does not expressly teach that the instructions include a check box as recited by amended claim 8. Such a modification would have been obvious to one of ordinary skill in the art before the effective filing date as an obvious matter of design choice based upon the desired information to be conveyed on the sterile drape. It would have been obvious to one of ordinary skill in the art to list the instructions in a format with checkboxes based upon the procedure being used and the instructions specific to that procedure based on the desired way to indicate a step has been completed (i.e. strike through vs. check box). See MPEP 2112.01(III).
The limitations reciting “the visual indicator being configured to assist a clinician in using the packaged medical device” and “configured to have a user printed markings disposed thereon” are considered functional language related to the intended use of the product and is accorded limited weight as the language does not further limit the structure or the process. The medical product packaging taught by Banerjee et al. is capable of performing in the manner claimed.
Regarding claim 12, Banerjee et al. teaches all the limitations of claim 1 above. The limitation reciting “wherein the user printed marking includes a user printed check mark printed onto the check box” is further limiting the intended use recited in lines 8-9 of claim 8, and further recites a method of using the claimed medical device system. The method of using the product is not germane to the issue of patentability of the product itself, unless Applicant presents evidence from which the Examiner could reasonably conclude that the claimed product differs in kind from those of the prior art. See MPEP § 2113. Furthermore, there does not appear to be a difference between the prior art structure and the structure resulting from the claimed method because Banerjee et al. discloses the structure of claim 8 as described above.
Regarding claims 13 and 14, Banerjee et al. teaches all the limitations of claim 8 above, and while the reference does not expressly teach that the sterile drape has printed instructions that can include pictorial and/or graphic form ([0044]), the reference does not expressly each that the instructions include one or more set of grid lines or a shadow board as recited by claims 13 and 14 respectively. Such a modification would have been obvious to one of ordinary skill in the art before the effective filing date as an obvious matter of design choice based upon the desired information to be conveyed on the sterile drape. It would have been obvious to one of ordinary skill in the art to list the instructions to include grid lines or shadowboxes based upon the procedure being used and the instructions specific to that procedure. See MPEP 2112.01(III).
Claims 8, 9, 10, 11, 12, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Banerjee et al. (US 2023/0094714) in view of Carlson, II (US 2003/0187458).
Regarding claims 8, 9, 10 and 11, Banerjee et al. teaches medical product packaging (medical device system) as shown in Figures 1, 2, 3 and 5, comprising a packaged medical devices including gloves (302) and a tray portion (202, 502) comprising syringe, drainage bag, drain line, catheter (512, 508, 506, 504) and a sterile drape (304) for use with the packaged medical devices ([0024, 0027-0029, 0044]). Banerjee et al. further teaches that the sterile drape can include instructions printed thereon in the form of print or pictorial/graphic form ([0044]). As an example, Banerjee et al. teaches that the instructions for catheter prep and/or insertion may be printed on the sterile drape, which is draped over the patient, so that the instructions are visible during the procedure ([0044]).
While Banerjee et al. teaches that the sterile drape has printed instructions that can include pictorial and/or graphic form ([0044]), the reference does not expressly teach that the instructions include a check box as recited by amended claim 8.
Carlson, II teaches a surgical site marking system for marking, correlating and verifying that the surgical site which is to undergo surgery has been properly identified (Abstract). The surgical site marking system comprising an incise material with an area adapted to receive data thereon ([0006, 0015-0022]). Carlson, II teaches that the material can comprise additional data that is useful to identify the surgical procedure, the patient and to verify the proper location of the surgery, including indicia for locating the incise material, indicia for locating surgical incisions, custom procedure tray number and check boxes serving as a check list of tasks to be performed prior to performance of the surgical procedure ([0022]).
As both Banerjee et al. and Carlson,II are in the field of surgical drapes, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the printed instructions of the surgical drape taught by Banerjee et al. to have check boxes as taught by the surgical drape of Carlson,II to keep track of a task check list prior to or during surgery.
The limitations reciting “the visual indicator being configured to assist a clinician in using the packaged medical device” and “configured to have a user printed markings disposed thereon” are considered functional language related to the intended use of the product and is accorded limited weight as the language does not further limit the structure or the process. The medical product packaging taught by Banerjee et al. in view of Carlson,II is capable of performing in the manner claimed.
Regarding claim 12, Banerjee et al. in view of Carlson,II teaches all the limitations of claim 1 above. The limitation reciting “wherein the user printed marking includes a user printed check mark printed onto the check box” is further limiting the intended use recited in lines 8-9 of claim 8, and further recites a method of using the claimed medical device system. The method of using the product is not germane to the issue of patentability of the product itself, unless Applicant presents evidence from which the Examiner could reasonably conclude that the claimed product differs in kind from those of the prior art. See MPEP § 2113. Furthermore, there does not appear to be a difference between the prior art structure and the structure resulting from the claimed method because Banerjee et al. in view of Carlson,II discloses the structure of claim 8 as described above.
Regarding claims 13 and 14, Banerjee et al. in view of Carlson,II teaches all the limitations of claim 8 above, and while Banerjee et al. teaches that the sterile drape has printed instructions that can include pictorial and/or graphic form ([0044]), the reference does not expressly each that the instructions include one or more set of grid lines or a shadow board as recited by claims 13 and 14 respectively. Such a modification would have been obvious to one of ordinary skill in the art before the effective filing date as an obvious matter of design choice based upon the desired information to be conveyed on the sterile drape. It would have been obvious to one of ordinary skill in the art to list the instructions to include grid lines or shadowboxes based upon the procedure being used and the instructions specific to that procedure. See MPEP 2112.01(III).
Claims 8, 9, 10, 11 12, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hultberg et al. (US 3,770,119) in view of Banerjee et al. (WO2023/0094714) and further in view of Carlson, II (US 2003/0187458).
Regarding claims 8, 9, 10 and 11, Hultberg et al. teaches a medical procedure tray (10; medical device system) comprising a compartment with instruments (20; packaged medical device) and a sterile drape (18) for use with the instruments (20; packaged medical device) (Figure 1-5, 8; col. 1 Ln. 54-col. 2 Ln. 18, col. 2 Ln. 43-col. 3 Ln. 45).
Hultberg et al. does not expressly teach that the sterile drape (18) comprise a visual indicator printed thereon. Banerjee et al. is in the same field of endeavor, and teaches a medical product packaging (medical device system) as shown in Figures 1, 2, 3 and 5, comprising a packaged medical devices including gloves (302) and a tray portion (202, 502) comprising syringe, drainage bag, drain line, catheter (512, 508, 506, 504) and a sterile drape (304) for use with the packaged medical devices ([0024, 0027-0029, 0044]). Banerjee et al. further teaches that the sterile drape can include instructions printed thereon in the form of print or pictorial/graphic form ([0044]). As an example, Banerjee et al. teaches that the instructions for catheter prep and/or insertion may be printed on the sterile drape, which is draped over the patient, so that the instructions are visible during the procedure ([0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sterile drape (18) taught by Hultberg et al. to include the printed instructions in the form of text, graphic and/or pictorial as taught by Banerjee et al. to provide instructions that are visible on the drape during the procedure.
While Banerjee et al. teaches that the sterile drape has printed instructions that can include pictorial and/or graphic form ([0044]), the reference does not expressly teach that the instructions include a check box as recited by amended claim 8.
Carlson, II teaches a surgical site marking system for marking, correlating and verifying that the surgical site which is to undergo surgery has been properly identified (Abstract). The surgical site marking system comprising an incise material with an area adapted to receive data thereon ([0006, 0015-0022]). Carlson, II teaches that the material can comprise additional data that is useful to identify the surgical procedure, the patient and to verify the proper location of the surgery, including indicia for locating the incise material, indicia for locating surgical incisions, custom procedure tray number and check boxes serving as a check list of tasks to be performed prior to performance of the surgical procedure ([0022]).
As Hultberg et al., Banerjee et al. and Carlson,II are in the field of surgical drapes, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the printed instructions of the surgical drape taught by Hultberg et al. in view of Banerjee et al. to have check boxes as taught by the surgical drape of Carlson,II to keep track of a task check list prior to or during surgery.
The limitations reciting “the visual indicator being configured to assist a clinician in using the packaged medical device” and “configured to have a user printed marking disposed thereon” are considered functional language related to the intended use of the product and is accorded limited weight as the language does not further limit the structure or the process. The medical product packaging taught by Hultberg et al. in view of Banerjee et al. is capable of performing in the manner claimed.
Regarding claim 12, Hultberg et al. in view of Banerjee et al. and Carlson,II teach all the limitations of claim 1 above. The limitation reciting “wherein the user printed marking includes a user printed check mark printed onto the check box” is further limiting the intended use recited in lines 8-9 of claim 8, and further recites a method of using the claimed medical device system. The method of using the product is not germane to the issue of patentability of the product itself, unless Applicant presents evidence from which the Examiner could reasonably conclude that the claimed product differs in kind from those of the prior art. See MPEP § 2113. Furthermore, there does not appear to be a difference between the prior art structure and the structure resulting from the claimed method because Hultberg et al. in view of Banerjee et al. and Carlson,II discloses the structure of claim 8 as described above.
Regarding claims 13 and 14, Hultberg et al. in view of Banerjee et al. and Carlson,II teach all the limitations of claim 8 above, and while the references teach that the sterile drape has printed instructions that can include pictorial and/or graphic form ([0044]), the references do not expressly each that the instructions include one or more set of grid lines or a shadow board as recited by claims 13 and 14 respectively. Such a modification would have been obvious to one of ordinary skill in the art before the effective filing date as an obvious matter of design choice based upon the desired information to be conveyed on the sterile drape. It would have been obvious to one of ordinary skill in the art to list the instructions in a format with include grid lines or shadowboxes based upon the procedure being used and the instructions specific to that procedure. See MPEP 2112.01(III).
Response to Arguments
Response-Drawings
The previous objection to the drawings as failing to comply with 37 CFR 1.84(p)(5) for failing to include reference character 126a (see Figure 5) in the description, is overcome by Applicants amendments to paragraph [0049] as shown on page 2 of the response filed 11/07/2025.
Response-Claim Rejections - 35 USC § 102 and 103
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive.
In light of the Applicants amendments to the claims, Banerjee et al. is used in the above rejections under 35 USC § 103 only. Applicants arguments will be addressed herein.
The Applicant argues on the bottom of the first page of remarks that Banerjee et al. does not appear to teach or suggest a visual indicator that includes a check box adjacent to printed instructions and/or that the check box has a surface area configured to have a user printed markings thereon.
This argument is not persuasive. As an initial matter, the limitation “the check box has a surface area configured to have a user printed markings thereon” recites the intended use of the medical device system and is accorded limited weight as the language does not further limit the structure or the process. The medical product packaging taught by Banerjee et al. is capable of performing in the manner claimed.
Banerjee et al., as previously stated, teaches a sterile drape that includes instructions printed thereon in the form of print or pictorial/graphic form ([0044]). As an example, Banerjee et al. teaches that the instructions for catheter prep and/or insertion may be printed on the sterile drape, which is draped over the patient, so that the instructions are visible during the procedure ([0044]).
While Banerjee et al does not expressly teach that the instructions include a check box as recited by amended claim 8, it is maintained that such a modification would have been obvious to one of ordinary skill in the art before the effective filing date as an obvious matter of design choice based upon the desired information to be conveyed on the sterile drape. It would have been obvious to one of ordinary skill in the art to list the instructions in a format with checkboxes based upon the procedure being used and the instructions specific to that procedure based upon the user’s preference to indicate the step as been completed (i.e. strike through vs. check box). See MPEP 2112.01(III).
Regarding the position that modifying the markings would be an obvious matter of design choice, the Applicant argues on the second page of the remarks that “Items such as instructions convey to a user certain pieces of information that may be useful for stepping through a treatment procedure”, further arguing that “a check box is not merely an aesthetic marking…a checkbox is a tactical tool that can be utilized by a clinician in order to carefully monitor progress during a procedure. These arguments are not persuasive
Banerjee et al. teaches a sterile drape has printed instructions that can include pictorial and/or graphic form ([0044]), as previously stated. Regarding the check boxes, it is maintained that such a modification would be an obvious matter of design choice to one of ordinary skill in the art. As stated in MPEP 2112.01 (III):
“Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.”
MPEP 2112.01(III) further states that the critical question to be asked in printed matter situations is whether there exists any new and unobvious functional relationship between the printed matter and the substrate. In the case of the check boxes recites by the instant claims, there is not a new or unobvious functional relationship between the checkboxes and the substrate, therefore, the check boxes are not functionally related to the product. See also MPEP 2111.05.
Furthermore, as shown by the inclusion of Carlson,II in a new set of rejections above, Carlson,II teaches a surgical site marking system for marking, correlating and verifying that the surgical site which is to undergo surgery has been properly identified (Abstract). The surgical site marking system comprising an incise material with an area adapted to receive data thereon ([0006, 0015-0022]). Carlson, II teaches that the material can comprise additional data that is useful to identify the surgical procedure, the patient and to verify the proper location of the surgery, including indicia for locating the incise material, indicia for locating surgical incisions, custom procedure tray number and check boxes serving as a check list of tasks to be performed prior to performance of the surgical procedure ([0022]). Therefore, as Banerjee et al. and Carlson,II are both in the same field of endeavor, (medical packaging products/surgical drapes) it would have been obvious to modify the printed instructions taught by Banerjee et al. to comprise checkboxes as taught by Carlson,II to serve as a checklist prior to and/or during surgery.
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.
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LAURA POWERS
Examiner
Art Unit 1785
/LAURA C POWERS/Primary Examiner, Art Unit 1785