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 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:
(A) 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;
(B) 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
(C) 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “attachment mechanism configured to secure the device to an adjacent surface” in claim 12, which has been interpreted to cover “one or more attachment mechanisms are positioned on a bottom planar surface of the base 130, such as an adhesive, suction cups, Velcro, or the like” as disclosed in paragraph [0012].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-2, 6-8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Levenson (USPN 4915698) in view of Bonomo (US 20210077746) in further view of Meittunen (US 20070191769).
Regarding claim 1, Levenson discloses a needle uncapping device (device 10) comprising: a top planar surface (forming open end of cylindrical wall 22) positioned above an elongated body (cylindrical wall 22 of tubular portion 14) configured to be held by a user of the device, the top planar surface comprising: a rounded opening (cylindrical cavity 30); a ledge (tab 32) positioned above the top planar surface and including a lip (tab 32), the lip configured to securely engage with a lid of a needle placed in the opening (“To remove the cover section 42, the individual need only tilt the syringe and cover section 42 upwardly toward tab 32 to the position shown in FIG. 4. In this position, tab 32 engages shoulder 48 on cover section 42 and maintains cover section 42 within the cylindrical cavity 30 as the syringe is withdrawn therefrom. Once the needle 50 has been withdrawn from the cover section 42, cover section 42 settles within cavity 30 and is retained therein.” [Col 4, lines 42-50]);
Levenson fails to explicitly teach the lip comprises a notch; and wherein the top planar surface protrudes outward and downward from the elongated body to shield a hand of a user holding the device.
Bonomo teaches a needle uncapping device (Figure 1) comprising a top planar surface (device top 2) comprising a rounded opening (tunnel 5) and a ledge (capture core 4) including a lip comprising a notch (see annotated Figure 3 below) positioned over the opening (Figure 4).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the lip of the ledge of the needle uncapping device of Levenson to include a notch based on the teachings of Bonomo to ensure that the ledge is able to grip and retain the lid of the needle during uncapping of the needle to allow for “safe uncapping recapping, interchanging and storage of needles” (Bonomo [0043]).
Levenson fails to explicitly teach the top planar surface protrudes outward and downward from the elongated body to shield a hand of a user holding the device.
Meittunen teaches a needle uncapping device (Figure 1) comprising a top planar surface (shield 1) positioned above an elongated body (main housing apparatus 2) configured to be held by a user of the device (“the device is held during use” [0019]), the top planar surface comprising a rounded opening (circular opening 3); wherein the top planar surface protrudes outward and downward from the elongated body to shield a hand of a user holding the device (Figure 1; “The sharps protection shield is the appropriate size and shape to cover the medical personnel's hand in order to prevent injuries if the device is held during use.” [0019]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the top planar surface of the device of Levenson to protrudes outward and downward from the elongated body based on the teachings of Meittunen to protect the users hand and prevent accidental needle sticks when the needle uncapping device is held during use (Meittunen [0019]).
Regarding claim 2, modified Levenson discloses the needle uncapping device of claim 1.
Modified Levenson fails to explicitly disclose the top planar surface includes a second rounded opening having a uniform size with the rounded opening, and the lip further comprises a second notch configured to securely engage with a lid of a needle placed in the second opening.
Bonomo teaches a needle uncapping device (Figure 9) comprising a top planar surface (device top 2) including a rounded opening (left-most tunnel 5) and a second rounded opening (second tunnel 5) having a uniform size with the rounded opening (Figure 9), and the lip (capture core 4) further comprises a second notch (second capture core 4) configured to securely engage with a lid of a needle placed in the second opening (Figure 9).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the needle uncapping device of Levenson include a second rounded opening having a uniform size with the rounded opening, and the lip further comprises a second notch configured to securely engage with a lid of a needle placed in the second opening based on the teachings of Bonomo to allow for simultaneous usage of multiple needles (Bonomo [0038]).
Regarding claim 6, modified Levenson discloses the needle uncapping device of claim 1.
Modified Levenson fails to explicitly disclose the elongated body includes a grip on a front or back of the elongated body, the grip sized to engage with the hand of the user holding the device.
Meittunen teaches a needle uncapping device (Figure 1) comprising a top planar surface (shield 1) positioned above an elongated body (main housing apparatus 2), the elongated body includes a grip on a front or back of the elongated body, the grip sized to engage with the hand of the user holding the device (“the device is held during use” [0019]; “The device has a main housing apparatus that is large enough to allow for a built-in handle. This handle facilitates placement, carry, and transportation” [0020]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the elongated body of the device of Levenson to include a grip on a front or back of the elongated body based on the teachings of Meittunen to facilitate placement and holding of the device during use (Meittunen [0019-0020]).
Regarding claim 7, modified Levenson discloses the needle uncapping device of claim 1, wherein the needle uncapping device is a unibody construction (Figure 3).
Regarding claim 8, modified Levenson discloses the needle uncapping device of claim 1, wherein the needle uncapping device is comprised of nylon, acrylonitrile butadiene styrene plastic, thermoplastic polymer, or other rigid material (“Device 10 may be formed from a metallic material or molded from a hard durable plastic material.” [Col 3, lines 43-44]).
Regarding claim 11, modified Levenson discloses the needle uncapping device of claim 10, further comprising an attachment mechanism (“a strip 15 of a double-sided, adhesive foam material is attached to planar surface 18.” [Col 3, lines 57-59]) on a bottom surface of the base (planar surface 18), the attachment mechanism configured to secure the device to an adjacent surface (“a base member having a generally planar bottom surface and securing means for affixing the bottom surface to a stationary flat surface.” [Col 2, lines 15-17]).
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Levenson (USPN 4915698) in view of Bonomo (US 20210077746) in further view of Meittunen (US 20070191769) as applied to claim 1 above, and further in view of Carrigan (US 20130023829)
Regarding claims 3 and 5, modified Levenson discloses the needle uncapping device of claim 1.
Modified Levenson fails to explicitly teach the top planar surface includes a second rounded opening having a different size than the rounded opening and the lip further comprises a second notch configured to securely engage with a lid of a needle placed in the second opening, as required by claim 3; and wherein the notch and the second notch are of different sizes, a size of the notch being based on a size of the rounded opening and a size of the second notch being based on a size of the second rounded opening, as required by claim 5.
Carrigan teaches a needle uncapping device (recapper 40; Figure 4) comprising a top planar surface (front wall 42) comprising a rounded opening (opening 46) and a second rounded opening (openings 48, 50) having a different size than the rounded opening (Figure 4; “Multiple openings of different shapes and sizes, with or without flaps, may be used for retaining a needle cap 20” [0027]) and a lip comprising a notch (“The flaps, if used, may be full flaps that extend entirely to the center of the opening, as shown by opening 46” [0027], notch formed between flaps 14) and further comprises a second notch (“the flaps may be shortened into flap segments similar to flaps 14 shown in FIG. 3B, leaving a small diameter center through hole, as shown by openings 48 and 50.” [0027], notch formed between flaps 14) configured to securely engage with a lid of a needle placed in the second opening (“By use of the opening 12 with flaps, the recapper 8 is able to receive the cap of any standard size syringe.” [0025]); and wherein the notch and the second notch are of different sizes, a size of the notch being based on a size of the rounded opening and a size of the second notch being based on a size of the second rounded opening (“Multiple openings of different shapes and sizes, with or without flaps, may be used for retaining a needle cap 20. The flaps, if used, may be full flaps that extend entirely to the center of the opening, as shown by opening 46, or the flaps may be shortened into flap segments similar to flaps 14 shown in FIG. 3B, leaving a small diameter center through hole, as shown by openings 48 and 50.” [0027]; Figure 4).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the elongated body of the device of Levenson to include the top planar surface includes a second rounded opening having a different size than the rounded opening and the lip further comprises a second notch configured to securely engage with a lid of a needle placed in the second opening, wherein the notch and the second notch are of different sizes, a size of the notch being based on a size of the rounded opening and a size of the second notch being based on a size of the second rounded opening based on the teachings of Carrigan to ensure that needles having lids of varying dimensions are able to be uncapped by the needle uncapping device in a manner that secures the lids within the needle uncapping device (Carrigan [0027]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Levenson (USPN 4915698) in view of Bonomo (US 20210077746) in further view of Meittunen (US 20070191769) in further view of Carrigan (US 20130023829) as applied to claim 3 above, and further in view of Nicklas (WO 9607357).
Regarding claim 4, modified Levenson discloses the needle uncapping device of claim 3.
Modified Levenson fails to explicitly disclose, wherein the rounded opening and the second rounded opening are color coded or otherwise visually distinguished.
Nicklas discloses a needle uncapping device (device 10) comprising: a top planar surface (planar top wall member 12) positioned above an elongated body (side walls 14) configured to be held by a user of the device, the top planar surface comprising: a rounded opening (aperture 16a) and a second rounded opening (aperture 16b) having a different size than the rounded opening (“Two apertures may have the same shape but different sizes; note for examples circular apertures 16a, 16b” [Page 4, lines 1-2]), wherein the rounded opening and the second rounded opening are color coded or otherwise visually distinguished (“Printed indicia 20 may be provided on the top face of the top wall member 12 as an aid to the user in placing a hypodermic needle sheath, hypodermic needle and attached syringe after use, in the correct hole. These indicia will typically include, beside each aperture 16a through 16f, information which will aid the user in selecting the correct aperture for a given hypodermic needle sheath and for the hypodermic needle and syringe after use.” [Page 4, lines 13-18]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the needle uncapping device of Levenson to include the rounded opening and the second rounded opening are color coded or otherwise visually distinguished based on the teachings of Nicklas to assist the user in placing the different size lids of different needles in the correct rounded opening so as to secure multiple lids (Nicklas [Page 4, lines 13-18]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Levenson (USPN 4915698) in view of Bonomo (US 20210077746) in further view of Meittunen (US 20070191769) as applied to claim 1 above, and further in view of Nicklas (WO 9607357).
Regarding claim 9, modified Levenson discloses the needle uncapping device of claim 1.
Modified Levenson fails to explicitly disclose the top planar surface is angled downward at an approximately 10- to 30-degree angle.
Nicklas teaches a needle uncapping device (device 10) comprising: a top planar surface (planar top wall member 12) positioned above an elongated body (side walls 14) configured to be held by a user of the device, the top planar surface comprising a rounded opening (aperture 16a); wherein the top planar surface is angled downward at an approximately 10- to 30-degree angle (“The top wall member 12 is preferably inclined at an angle to the horizontal for ease of use…The angle of inclination may vary from about 5° to about 20°; an angle of about 15° is preferred.” [Page 3, lines 18-23]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the top planar surface of the device of Levenson to be angled downward at an approximately 10- to 30-degree angle based on the teachings of Nicklas to facilitate ergonomic one-handed use of the needle uncapping device by allowing the user to easily view the top planar surface (Nicklas [Page 3, line 18-23]).
Regarding claim 10, modified Levenson discloses the needle uncapping device of claim 1, the device includes a base (base portion 12) that protrudes outward from a front and back of the elongated body (Figure 3).
Modified Levenson fails to explicitly disclose the base protrudes outward from a front and back of the elongated body at an approximately 40- to 70-degree angle.
Nicklas teaches a needle uncapping device (device 10) comprising: a top planar surface (planar top wall member 12) comprising a rounded opening (aperture 16a) and a base (bottom wall 18) protrudes outward from a front and back of the elongated body (top portion of sides 14) at an approximately 40- to 70-degree angle (“The slight outward slope of the side walls 14 provides device 10 with a base which is larger in cross-sectional area than the top, resulting in improved stability of the device on a planar supporting surface. The slope angle of side walls 14…will not exceed 45° in virtually any case.” [Page 3, line 1-5]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the base of the device of Levenson to protrude outward from a front and back of the elongated body at an approximately 40- to 70-degree angle based on the teachings of Nicklas to improve the stability of the device when secured to an adjacent surface (Nicklas [Page 2, line 1-5]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Levenson (USPN 4915698) in view of Bonomo (US 20210077746) in further view of Meittunen (US 20070191769) as applied to claim 1 above, and further in view of Capaccio (USPN 5183469).
Regarding claim 12, modified Levenson discloses the needle uncapping device of claim 1.
Modified Levenson fails to explicitly disclose the rounded opening has a first diameter at the top planar surface of the device and a second diameter at a base of the opening, the first diameter larger than the second diameter.
Capaccio discloses a needle uncapping device (device 20) comprising a top planar surface (rim of proximal end 29) comprising a rounded opening (bore 32 and frusto-conical shaped guide surface 35) having a first diameter at the top planar surface of the device (diameter of frusto-conical shaped guide surface 35) and a second diameter at a base of the opening (diameter of bore 32), the first diameter larger than the second diameter (Figure 3).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the rounded opening of Levenson to include a first diameter at the top planar surface of the device larger than a second diameter at a base of the opening based on the teachings of Capaccio to guide the lid of the needle into the rounded opening of the needle uncapping device (Capaccio [Col 5, lines 35-37]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kretzschmar et al. (USPN 5607403) discloses a needle uncapping device (10) comprising a top planner surface (18) positioned above an elongated body (14), the top planar surface comprising a rounded opening (20)
Farrar, Jr. et al. (USPN 5078695) discloses a needle uncapping device (1) comprising a top planner surface positioned above an elongated body (Figure 1), the top planar surface comprising a rounded opening (3, 4), the top planar surface protruding outward from the elongated body (Figure 1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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