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 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.
Claim 10 is 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.
In claim 10, “wherein a plurality of fiducial markers is provided on the cap from the fiducial marker on each of the plurality of sidewall sections” does not make sense. The examiner suggests amending claim 10 (to be allowable and addressed below) to “wherein the fiducial marker comprises a plurality of fiducial markers and each of the plurality of sidewalls includes a different (or separate) one of the plurality of fiducial markers”
Claim Rejections - 35 USC § 102
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 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sathe (US 2016/0089530).
Regarding claim 1, Sathe discloses a disinfecting cap 40 engageable with a catheter connection (fig 6), the disinfecting cap comprising: a housing 42 defining an inner cavity 48, the housing comprising: a top wall (top of figs 1 and 4); a multi-sided sidewall structure extending down from the top wall (fig 1, each side of the side-wall is considered spaces between ribs 28 that overlap with marker 50, see annotated figure below), the multi-sided sidewall structure comprising a plurality of sidewall sections (fig 1, annotated figure); and an open bottom end (fig 4, received catheter port); and a disinfecting member 54 configured to disinfect portions of the catheter connection (figs 4 and 5); wherein each of the plurality of sidewall sections includes a fiducial marker 50 thereon, the fiducial marker containing a unique identifier for the disinfecting cap (fig 2A, ¶36).
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Regarding claim 2, wherein the fiducial marker comprises a marked data matrix containing the unique identifier (fig 2A).
Regarding claim 5, wherein the plurality of sidewall sections comprises between four and six sidewall sections (four, see above).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sathe (US 2016/0089530) in view of Bradski et al (US 2019/0014310).
Regarding claim 3, while Sathe substantially discloses the invention as claimed, it does not disclose the fiducial marker includes an AprilTag that provides position information for the disinfecting cap when detected by an associated image capture device, the position information comprising a three-dimensional (3D) position and orientation of the disinfecting cap relative to the image capture device.
Bradski discloses AprilTags are similar to QR codes (Sathe showing a QR code in figs 2A and 2B) but are more efficient for pattern recognition applications and enable optical detection at longer ranges (¶58). Additionally, they allow for the determination of the position and orientation of an AprilTag using a sensor (¶58).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sathe such that the fiducial marker includes an AprilTag that provides position information for the disinfecting cap when detected by an associated image capture device, the position information comprising a three-dimensional (3D) position and orientation of the disinfecting cap relative to the image capture device as taught by Bradski to allow for more efficient pattern recognition and optical detection at longer ranges.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sathe (US 2016/0089530) in view of DeSalvo et al (US 2017/0312457).
Regarding claim 4, while Sathe substantially discloses the invention as claimed, it does not disclose wherein the fiducial marker is formed directly on a respective sidewall section of the multi-sided sidewall structure via a laser marked UV laser, continuous inkjet, or IR technology.
Sathe has not established how the fiducial marker is placed on the device.
DeSalvo discloses a medical device that uses a variety of means to place visually-identifiable features on the device, including a QR code, infrared ink, others, and combinations thereof (reference claim 2). Infrared ink being used as a covert means to verify authenticity of the device (¶48).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sathe to print the marker barcode/QR code in infrared ink (IR technology) to allow for covert means to verify authenticity of the device.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sathe (US 2016/0089530) in view of Keefe et al (US 2020/0105393).
Regarding claim 7, wherein the housing is formed of a polymeric material (¶31).
While Sathe substantially discloses the invention as claimed, it does not disclose that includes color additives configured to enhance contrast marking of the fiducial marker.
Keefe discloses it was contrast was a known in issue in medical devices (¶22), and uses colors that have optimized contrast (as opposed to pure white and black).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sathe such that the housing has a color (via color additives) and the marking has a color that complement each other as taught by Keefe to prevent misreads.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sathe (US 2016/0089530) in view of Follman et al (US 2018/0256880).
Regarding claim 11, while Sathe substantially discloses the invention as claimed, it does not disclose wherein the multi-sided sidewall structure includes a cylindrical threaded inner surface configured to interlock with a mating feature of the catheter connector.
Follman discloses a disinfecting cap with has an inner surface with threads to attach to a port (¶78).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sathe such that the multi-sided sidewall structure includes a cylindrical threaded inner surface configured to interlock with a mating feature of the catheter connector as taught by Follman to better connect the cap to the catheter.
Regarding claims 12 and 13 while Sathe substantially discloses the invention as claimed, it does not disclose the housing comprises an outer housing, and wherein the disinfecting cap further comprises an inner cap member positioned within the outer housing, the inner cap member including a threaded inner surface configured to interlock with a mating feature of the catheter connector, nor the inner cap member is joined to the outer housing via an adhesive, laser welding, or a snap feature.
Follman discloses a disinfecting cap where the housing comprises an outer housing 100, and wherein the disinfecting cap further comprises an inner cap member 200 positioned within the outer housing (fig 3D), the inner cap member including a threaded inner surface configured to interlock with a mating feature of the catheter connector (¶78), and the inner cap member is joined to the outer housing via a snap feature 202 (¶79; legs 202 flex to be received in outer cap 300 and permit protrusions 204 to enter, then flex/snap back to their original shape; fig 8D). Among other advantages the cap is desired to be able to be sued for different types of ports (¶3) and prevent re-use (¶2 and ¶4).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Sathe such that the housing comprises an outer housing, and wherein the disinfecting cap further comprises an inner cap member positioned within the outer housing, the inner cap member including a threaded inner surface configured to interlock with a mating feature of the catheter connector, and the inner cap member is joined to the outer housing via a snap feature as taught by Follman to prevent re-use of the cap.
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The examiner did not find a teaching or suggestion for modifying closest art Sathe such that the plurality of sidewall sections comprises five sidewall sections, such that the housing has a pentagonal geometry absent impermissible hindsight.
Claims 8 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The examiner did not find a teaching or suggestion for modifying closest art Sathe such that each of the sidewall sections comprises a flat surface onto which the fiducial marker is applied absent impermissible hindsight.
Claim 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. The examiner did not find a teaching or suggestion for modifying closest art Sathe such that the fiducial marker comprises a plurality of fiducial markers and each of the plurality of sidewall sections has a different one of the fiducial markers.
Claim 14 is allowed. The examiner did not find a teaching or suggestion for modifying closest art Sathe such that it also includes the steps of determining, with the at least one processor, based on the one or more images, a presence of the disinfecting cap in the plurality of medical devices; determining, with at least one processor, based on the one or more images, position information associated with a three-dimensional (3D) position of the disinfecting cap relative to the image capture device, when it is determined that the disinfecting cap is present in the plurality of medical devices; and determining, with the at least one processor, based on the determined presence and/or the position information of the disinfecting cap, a status of the disinfecting cap absent impermissible hindsight.
Claim 22 is allowed. The examiner did not find a teaching or suggestion for modifying closest art Sathe such that it includes at least one processor programmed and/or configured to: obtain one or more images of the plurality of medical devices captured by the image capture device; determine, based on the one or more images, a presence of the disinfecting cap in the plurality of medical devices; when it is determined that the disinfecting cap is present in the plurality of medical devices, determine, based on the one or more images, position information associated with a three-dimensional (3D) position of the disinfecting cap relative to the image capture device; and determine, based on the determined presence and/or the position information of the disinfecting cap, a status of the disinfecting cap, absent impermissible hindsight.
Response to Arguments
Applicant’s arguments 11/25/2025 are not persuasive. Applicant argues Sathe does not teach or suggest a fiducial marker on each of the plurality of sidewall sections. The examiner disagrees, claims are given their broadest reasonable interpretation. They are also interpreted in light of the specification, but no limitations are read into the claims from the specification. In the instant application, four sidewall sections of the reference comprise “a fiducial marker”. While the examiner agrees there is not a different fiducial marker on each of the four sections illustrated, the claim is still interpretable as only requiring a single fiducial marker, so long as it spans a plurality of sidewall sections.
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783