DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2 April 2026 has been entered.
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 Objections
Claims 1, 18, 20 are objected to because of the following informalities:
-Claim 1 recites “the kit” in line 10. Examiner recommends amending to –the medical procedure kit—
-Claim 18 recites “the kit” in line 7. Examiner recommends amending to –the medical procedure kit—
-Claim 20 recites “a medical procedure kit” in line 1. Examiner recommends amending to –the medical procedure kit—
Appropriate correction is required.
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 1-3, 5, 7-20 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.
-Claim 1 recites “fluid” in line 10. It is unclear whether this is the same or different from fluid originally referenced in claim 1, line 9.
-Claim 18 recites “said waste” in lines 14-15. There is insufficient antecedent basis for this limitation in the claim. Should possibly read –said biological material— or –said fluid—
-Claim 20 recites “the subset of the plurality of medical procedure tools” in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1, 2, 3, 9, 12, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkinson (U.S. 20040163982) in view of Berndt (U.S. 5038938).
Regarding Claim 1, Wilkinson teaches a medical procedure kit, comprising: a tray defining a plurality of compartments [Fig. 1, elements 12 (carrier tray) and 16 (plurality of compartments)]; a medical waste basin removably supported within a first compartment of the plurality of compartments [0025; “Medical waste disposal container 14 is interengagably mated with carrier tray 12 …and is desirably removably mated with carrier tray 12.”]; and a plurality of medical procedure tools located within another compartment of the plurality of compartments [0024]-describes compartments housing medical supplies and provides embodiments of such medical supplies; wherein a lid of the medical waste basin defines an aperture sized to accommodate a tip portion of at least one of the plurality of medical procedure tools whereby fluid may be discharged from said tip portion into said medical waste basin [0029]—In this interpretation, the plurality of medical procedure tools are interpreted to be sharps, in which this paragraph describes the openings and lids being designed to contain sharps for disposal. Therefore, the lid or covering would be understood to be able to accommodate a sharp being passed through it.
Wilkinson is silent on and wherein the kit is configured such that fluid maybe discharged into the medical waste basin without passing through the first compartment. Berndt teaches and wherein the kit is configured such that fluid may be discharged into the medical waste basin without passing through the first compartment [Fig. 2, elements 23 (chamber/medical waste basin), 11 (base portion/first compartment), 24 (upper wall/lid)] and [Col 3, lines 6-17]—describing the needle inserted through a plug, 26, which the syringe is depressed and the fluids are discharged into a capsule 31/33 and then to into the interior of compartment, 23.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an aperture that allows for fluid discharge without first passing through the first compartment as taught by Berndt to follow safety procedures in regards to disposable needles as suggested by Wilkinson, as Wilkinson discusses regulations and safety procedures calling for needle holder disposal and limitations of the prior art oftentimes being too small to contain significant amounts of disposable waste [0006] with Berndt because Berndt teaches disposal regulations requiring contaminated medical waste via ancillary disposal means separate from discharging into waste lines of hospitals [Col 1, lines 13-34].
Regarding Claim 2, Wilkinson further teaches wherein the medical waste basin defines a gap between at least a position of the first compartment and a bottom of the medical waste basin when the medical waste basin is supported within the first compartment [0028]-includes description of carrier tray having an open slot area (interpreted to be the gap), and handle of the medical waste disposal container that fits and aligns with the open slot area.
Regarding Claim 3, Wilkinson teaches wherein the first compartment defines an access opening to manually engage the medical waste basin [0033]-Details an opening of the medical waste disposal container that can include securing and automation of allow covering and access to contents.
Regarding Claim 9, Wilkinson teaches wherein the medical waste basin comprises a plurality of protrusions that engage with side walls of the first compartment, to secure the medical waste basin within the tray [0026]—describes latch 18 engaging with rib 19 to lock carrier tray and medical waste disposal container together. And [0033; “securing mechanisms such as hinges, tabs, and the like to secure the contents within medical waste disposal container 14.”]
Regarding Claim 12, Wilkinson teaches wherein the access opening comprises a lateral recess that enables access to the medical waste basin through a top of the tray [0028]-describes lateral recess on the top surface of the waste disposal container, and [0034]-opening 20 acts as the opening in the tray with alternative description of the handle acting as the protective covering.
Regarding Claim 17, Wilkinson teaches wherein the plurality of medical procedure tools includes a needle receptacle, [0025; “waste disposal container 14, which is configured and designed for containing and disposing of used medical instruments such as sharps.”]
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkinson (U.S. 20040163982) in view of Berndt (U.S. 5038938) and in further view of Finnestad (U.S. 20120037627).
Regarding Claim 5, Wilkinson and Berndt are silent on wherein the lid includes a first lip, and the medical waste basin includes a second lip, the first lip mates with the second lip to removably attach the lid to the medical waste basin.
Finnestad teaches wherein the lid includes a first lip, [0005]-details the resiliently compliant lip.
and the medical waste basin includes a second lip, [0005; “The lip engages the carriers…”]-where the carriers are considered the second lip.
wherein the first lip mates with the second lip to removeably attach the lid to the medical waste basin [0005; “to center the closure between the carriers for guiding the closure into alignment with the opening”]-where the closure is interpreted as the lid of the waste receptable.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included mating attachments incorporated into the lid as taught by Finnestad to allow for detachable features as suggested by Wilkinson and Berndt, as Wilkinson discusses the use of securing mechanisms such as hinges, tabs, etc. to secure the contents [0033] and Berndt which discloses a thin membrane portion to separate the recess from an exterior of the tray [Col 2, lines 46-48] with Finnestad because Finnestad teaches altering the dimensions and positioning of the lip to change centering forces provided by this structure [0025].
Claim(s) 7, 8, 11, 13, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkinson (U.S. 20040163982), in view of Berndt (U.S. 5038938) and in further view of Misra (U.S. 6012586).
Regarding Claim 7, Wilkinson and Berndt are silent on wherein the lid includes a section that slopes toward the aperture.
Misra teaches wherein the lid includes a section that slopes toward the aperture [Fig. 2, element 66 (sloped surface) and 70 (opening)].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included this surface feature on the lid as taught by Misra to allow for fluid movement and ancillary sealed disposal means as suggested by Wilkinson and Berndt, as Wilkinson discusses the use of directing medical waste accordingly to be disposed of [0037] and Berndt which discusses the physician being required to dispose of fluids via ancillary sealed means [Col 1, lines 29-31] with Misra because Misra teaches the surface of the tray being sloped toward the opening so blood and other waste fluids that run off instruments drains into a contained area [Col 2-3, 66-3].
Regarding Claim 8, Wilkinson and Berndt are silent on wherein the medical waste basin includes a bottom and a plurality of sidewalls extending from the bottom, and a first side wall of the plurality of sidewalls is shorter than all other of the plurality of sidewalls and is located opposite the access opening. Misra teaches wherein the medical waste basin includes a bottom and a plurality of sidewalls extending from the bottom, [Fig. 3, element 66 (bottom)] See annotated Fig. 3 below.
and a first side wall of the plurality of sidewalls is shorter than all other of the plurality of sidewalls and is located opposite the access opening. [Fig. 3, element 68 (access opening)] See annotated Fig. 3 below.
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have varied the slope of the waste basin as taught by Misra to direct movement of medical waste as suggested by Wilkinson and Berndt, as Wilkinson discusses the use of directing medical waste accordingly to be disposed of [0037] and Berndt which discloses physicians being required to dispose of fluids and needles via ancillary sealed disposal means [Col 1, lines 29-34] with Misra because Misra teaches the surface of the tray being sloped toward the opening so blood and other waste fluids that run off instruments drains into a contained area [Col 2-3, 66-3].
Regarding Claim 11, Wilkinson and Berndt are silent on wherein the access opening comprises a passage extending from the first compartment to a neighboring compartment of the plurality of compartments.
Misra teaches wherein the access opening comprises a passage extending from the first compartment to a neighboring compartment of the plurality of compartments [Col 4, lines 48-52; “a drain 68 which includes and opening 70 extending through tray 50 and into the interior of central compartment 14.”]
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have connected the compartments to one another as taught by Misra to allow for access and passage of operator and medical tools throughout the body as suggested by Wilkinson and Berndt, as Wilkinson discusses the connecting passageway [0010] and Berndt which discloses a flange that connects to a base about a continuous seal line [Col 2, lines 33-36] with Misra because Misra teaches promoting accessibility of medical tools and the tray to medical providers during procedures [Col 1, lines 10-17].
Regarding Claim 13, Wilkinson and Berndt are silent on wherein the plurality of medical procedure tools includes gauze and the medical waste basin is sized to receive the gauze.
Misra teaches wherein the plurality of medical procedure tools includes gauze and the medical waste basin is sized to receive the gauze [Col 5, lines 44-46; “one of the inserts 92 may be used to hold saline solution for glove washing during the procedure. Others may be used to hold supplies of wet and dry gauze.”]
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included gauze in the tray as taught by Misra to include various types of medical supplies as suggested by Wilkinson and Berndt, as Wilkinson discusses the use of bandages stored within the tray [0004] and Berndt which also discusses operative elements of the kit including sterile bandages [Col 2, lines 22-28] with Misra because Misra teaches the instruments originally contained within the kit being disposed of within the kit and discarded [Col 3, lines 6-10].
Regarding Claim 14, Wilkinson and Berndt are silent on further comprising a sterile wrap that encloses the tray, the medical waste basin, and the plurality of medical procedure tools.
Misra teaches further comprising a sterile wrap that encloses the tray, the medical waste basin, and the plurality of medical procedure tools [Col 6, lines 63-65; “The entire kit is then sealed in an airtight plastic wrapper (not shown) to keep the materials therein sterile.”]
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included sterile wrap to enclose the tray as taught by Misra to include various types of medical supplies as suggested by Wilkinson and Berndt, as Wilkinson discusses disposing of medical waste separately to keep conditions sterile [0036] and Berndt which discloses the use of an impervious sleeve to maintain sanitary conditions within the kit prior to use [Col 2, lines 62-65] with Misra because Misra teaches the kit placed within an airtight plastic wrapper [Col 6, lines 64-65].
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkinson (U.S. 20040163982) in view of Berndt (U.S. 5038938) and in further view of Parker (U.S. 20110192744).
Regarding Claim 10, Wilkinson and Berndt are silent on wherein the plurality of protrusions are positioned under a lip and at corners of the medical waste basin.
Parker teaches wherein the plurality of protrusions are positioned under a lip and at corners of the medical waste basin [0087; “In order to facilitate attachment and removal of the cover 34, a manually graspable ear 36 is provided at each corner thereof.”] and [Fig. 5, elements 36 (ears) and 15 (peripheral lip portion)].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added protrusion features to the medical waste basin components as suggested by Parker to allow for removal and attachment of the system as taught by Wilkinson and Berndt, as Wilkinson includes a means to secure the medical waste basin within the tray [0026] and Berndt which discloses flange protrusions that allow for connection between parts of the disposable tray [Col 2, lines 29-36] with Parker because Parker teaches providing a protective cover to secure and protect medical equipment within the tray [0021].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkinson (U.S. 20040163982) in view of Berndt (U.S. 5038938) and in further view of Misra (U.S. 6012586) and in even further view of Glithero (U.S. 10758705).
Regarding Claim 15, Wilkinson, Berndt, and Misra are silent on further comprising at least one medical procedure guidance indicator located on an exterior of the sterile wrap.
Glithero teaches further comprising at least one medical procedure guidance indicator located on an exterior of the sterile wrap [Col 22, lines 16-18; “The belly band/indicator wrapper 46 may include instructions/procedural indicators and/or other information thereon.”]
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to factor in design considerations for the system as taught by Glithero to allow for ease of preparation of materials as suggested by Wilkinson, Berndt and Misra, as Wilkinson which describes the procedures required by phlebotomists to prepare materials and supplies for said procedures [0004], Berndt which discusses the use of a impervious sleeve [Col 2, lines 62-65] and Misra which discloses the complexity involved with different procedures and the requirements of instruments and drugs for these procedures [Col 1, lines 17-21] with Glithero because Glithero teaches these instructions providing an overall improvement in packaging for ease of use [Col 8, lines 45-54].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkinson (U.S. 20040163982) in view of Berndt (U.S. 5038938) and in further view of Glithero (U. S. 10758705).
Regarding Claim 16, Wilkinson and Berndt are silent on wherein the plurality of medical procedure tools includes a sterile drape having a treatment area opening and a plurality of medical procedure guidance indicators located around the treatment area opening.
Glithero teaches wherein the plurality of medical procedure tools includes a sterile drape having a treatment area opening [Col 37, lines 40-42]-includes reference to a fenestrated drape.
and a plurality of medical procedure guidance indicators located around the treatment area opening [Fig. 20] and [Col 22, lines 27-33].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a sterile drape within the system as taught by Glithero to allow for ease of preparation of materials as suggested by Wilkinson and Berndt, as Wilkinson describes the procedures required by phlebotomists to prepare materials and supplies for said procedures [0004] and Berndt which discloses convenient means to hold specimen vials and a sealed receptacle for fluids aspirated [Col 2, lines 1-3] with Glithero because Glithero teaches these instructions providing an overall improvement in packaging for ease of use [Col 8, lines 45-54].
Claim(s) 18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (U.S. 20200383741) in view of Berndt (U.S. 5038938).
Regarding Claim 18, Lin teaches a method for using a medical procedure kit, the method comprising: [Abstract; “A pocket and drape system which provides multiple ( e.g., at least two) sterile fields and the methodology for employing said pocket and drape system is provided.”]
unwrapping a tray of the medical procedure kit from a sterile wrap, [0183]-references to removing the system from sterilization packaging which is previously described to be a wrap.
the tray defining a plurality of compartments, [Fig. 2, element 104 (first zone of pockets), 106 (second zone of pockets)].
a medical waste basin supported within a first compartment of the plurality of compartments, [Table 4, “Instrument: Needle Holder”]
and a plurality of medical procedure tools located within another compartment of the plurality of compartments; [Table 4, see all other supplies listed]
removing a one or more of the plurality of the medical procedure tools from the plurality of compartments; [0187]-reference to accessing the zones containing the tools and [0188-0197]-reference to using supplies within the system.
performing a medical procedure using one or more of the plurality of medical procedure tools; [0197]-details changing the Central venous catheter dressing interpreted as the medical procedure
and expelling biological material that accumulated in one or more of the plurality of medical procedure tools into the medical waste basin [0197; “discard supplies.”]
wherein the plurality of medical procedure tools includes a syringe [0075; “syringes”].
Lin is silent on wherein the kit is configured such that fluid maybe expelled into the medical waste basin without passing through the first compartment; without expelling said waste through said first compartment; and expelling the biological material into the medical waste basin includes placing a tip portion of the syringe into an aperture defined in a lid of the medical waste basin and depressing a plunger of the syringe.
Berndt teaches wherein the kit is configured such that fluid maybe expelled into the medical waste basin without passing through the first compartment; without expelling said waste through said first compartment [Fig. 2, elements 23 (chamber/medical waste basin), 11 (base portion/first compartment), 24 (upper wall/lid)] and [Col 3, lines 6-17]—describing the needle inserted through a plug, 26, which the syringe is depressed and the fluids are discharged into a capsule 31/33 and then to into the interior of compartment, 23;
wherein expelling the biological material into the medical waste basin includes placing a tip portion of a syringe of the subset of the plurality of medical procedure tools into an aperture defined in a lid of the medical waste basin and depressing a plunger of the syringe [Col 3, lines 1-17]-includes reference to the user filling the syringe with fluid (presumed to be biological fluid or material), inserting the needle through a membrane (interpreted to be an aperture), of a capsule aperture (interpreted to be the lid), and depressing the plunger, “the plunger of the syringe is depressed to discharge the remaining fluids into the disinfectant composition and through the capsule apertures.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an aperture that allows for fluid discharge without first passing through the first compartment as taught by Berndt to follow procedures in regards to disposable of supplies as suggested by Lin, as Lin discusses disposing of supplies per facility policy [0256] with Berndt because Berndt teaches disposal regulations requiring contaminated medical waste via ancillary disposal means separate from discharging into waste lines of hospitals [Col 1, lines 13-34].
Regarding Claim 20, Lin further teaches wherein the medical procedure includes opening an incision for a central line catheter [0214]-includes reference to using a scalpel to enlarge insertion site for PIIC insertion procedure.
and wherein removing the subset of the plurality of medical procedure tools from the plurality of compartments includes removing the subset of the plurality of medical procedure tools in a sequenced order dictated by the medical procedure, [0200]-reference to accessing the zones containing the tools and [0201-0229]-reference to using supplies within the system in sequential order i.e. steps 1-31.
wherein the sequenced order is indicated by the plurality of compartments that contain the subset of the plurality of medical procedure tools [0297, Claim 15; “wherein the first zone of pockets and the second zone of pockets contain instruments, medical supplies, or a combination thereof to be used in a multi-step sequential procedure;”]
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (U.S. 20200383741) in view of Berndt (U.S. 5038938) and in further view of Wilkinson (U.S. 20040163982).
Regarding Claim 19, Lin teaches depositing the medical waste basin in a disposal location remote of the tray [0104]-includes depositing needle in sharps container. Lin and Berndt are silent on further comprising: removing the medical waste basin from the tray through an access opening in the tray.
Wilkinson teaches further comprising: removing the medical waste basin from the tray through an access opening in the tray; [0025; “Medical waste disposal container 14 is interengagably mated with carrier tray 12 …and is desirably removably mated with carrier tray 12.”] with the access opening interpreted as element 20a [0039; “elevated portion 36 of medical waste disposal container 14a has opening 20a located on a top surface of elevated portion 36.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to dispose of the basin in a location remote from the tray as taught by Wilkinson to follow procedures in regards to disposable of supplies as suggested by Berndt and Lin, as Lin discusses disposing of supplies per facility policy [0256] and Berndt which discloses disposal regulations requiring contaminated medical waste via ancillary disposal means separate from discharging into waste lines of hospitals [Col 1, lines 13-34] with Wilkinson because Wilkinson teaches regulations and safety procedures calling for needle holder disposal and limitations of the prior art oftentimes being too small to contain significant amounts of disposable waste [0006].
Response to Arguments
Applicant's arguments filed 2 April 2026 with respect to the claim objections have been fully considered and are persuasive however, new objections are presented in light of the amendments.
Applicant's arguments filed 2 April 2026 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive however, new rejections are
presented in light of the amendments.
Applicant’s arguments filed 2 April 2026 with respect to the rejection of claims 1, 2, 3, 9, 12, 17 under 35 U.S.C.102(a)(1) have been fully considered and are persuasive, however, new 35 U.S.C. 103 rejections are presented above in light of the amendments for these claims citing Wilkinson in view of Berndt.
Applicant’s arguments filed 2 April 2026 with respect to the rejection of claims 5, 7-11 and 13-20 under 35 U.S.C.103 have been fully considered and are persuasive, however, new 35 U.S.C. 103 rejections are presented above in light of the amendments citing Wilkinson in view of Berndt and in further view of Misra for claims 7-8, 11, 13-14, citing Wilkinson in view of Berndt and in further view of Finnestad for claim 5, citing Wilkinson in view of Berndt and in further view of Parker for claim 10, citing Wilkinson in view of Berndt and in further view of Glithero for claim 16, citing Wilkinson in view of Berndt in further view of Misra and in even further view of Glithero for claim 15, citing Lin in view of Berndt for claims 18 and 20, and citing Lin in view of Berndt and in further view of Wilkinson for claim 19.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Zink (U.S. 20200069437)-references a packing tray that includes means for inserting a tip of a needle
-Geist (U.S. 6488666)-includes a medical tool kit including syringe and aperture for discharge of fluids
-Ross (U.S. 20170105808)—discusses a medical waste container with apertures to accommodate tips of sharps
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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