DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 05/27/25 has been entered. Claims 2-8 and 13-17 have been amended. Claims 9-12 and 18 are in the original/ previously presented form. Claims 1 and 19-20 are cancelled. Claims 21-23 are newly presented. Thus, claims 2-18 and 21-23 remain pending in the application. There were no objections of 112 rejections set forth in the Non-Final Office Action mailed 02/26/25. Therefore, there are no objections or 112 rejections withstanding.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 reads “wherein the side wall of the rotatable sleeve has two linear notches with the blocking bay and the start bay located at the first end of the two linear notches” and should likely read “wherein the side wall of the rotatable sleeve has two linear notches with the blocking bay and the start bay located at the first end of each of the two linear notches” for grammatical reasons
Appropriate correction is required.
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.
Regarding claim 2, line 3 recites “means for connecting” the hub to the housing. Therefore, claim 2 is interpreted under 112(f) according the 3-prong test:
Prong 1: “means”
Prong 2: functional language—for connecting
Prong 3: not modified by other structural language in the claims—no structure is recited for how the hub is connected to the housing by the “means for connecting”. Only the desired outcome of “connecting” is recited.
According to Applicant’s disclosure under 112(f), the means for connecting the hub to the housing is interpreted as a snap-mount or equivalent (see [0101]: A plastic housing 9 is inserted over the circumferential wall 8 and snap-mounted to the hub 4.)
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:
Claim 21 lines 12-14: “A first device… configured to push the hollow slider away from the hub”. Therefore, claim 21 is interpreted under 112(f) according the 3-prong test:
Prong 1: means or generic placeholder is recited--“a first device” is considered a generic placeholder for “means” because “a first device” has no specific structural meaning
Prong 2: functional language—configured to push the hollow slider away from the hub
Prong 3: not modified by other structural language in the claims—no structure is recited for how the first device pushes the hollow slider away from the hub. Only the desired outcome of “push” is recited.
According to Applicant’s disclosure under 112(f), the a first device configured to push the hollow slider away from the hub is interpreted as a spring or equivalent (see [0103-0106]: spring biases slider and claim 21 reciting the first device at a highest and lowest level of tension as described in [0002] for the spring. Spring 18 of the current application is shown in at least Fig. 6).
Claim 13 lines 2-3: “an indicator… configured to show when the hollow slider is blocked…”. Therefore, claim 21 is interpreted under 112(f) according the 3-prong test:
Prong 1: means or generic placeholder is recited--“an indicator” is considered a generic placeholder for “means” because “an indicator” has no specific structural meaning
Prong 2: functional language—configured to show when the slider is blocked
Prong 3: not modified by other structural language in the claims—no structure is recited for how the indicator “shows” that the slider is blocked. Only the desired outcome of “show” is recited.
According to Applicant’s disclosure under 112(f), the indicator configured to show when the slider is blocked is interpreted as a window (see [0103]: state of use indicator is checked through the window 26, see FIG. 43).
Claim 22 lines 12-13 and claim 23 lines 12-13: “A first device… configured to push the hollow slider away from the hub”. Therefore, claims 22 and 23 are interpreted under 112(f) according the 3-prong test as explained in reference to claim 21 lines 12-14 above, similarly reciting a first device interpreted under 112(f). Again, According to Applicant’s disclosure under 112(f), the a first device configured to push the hollow slider away from the hub is interpreted as a spring or equivalent (see [0103-0106]: spring biases slider and claim 22 reciting the first device at a highest and lowest level of tension as described in [0002] for the spring. Spring 18 of the current application is shown in at least Fig. 6).
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function.
Such claim limitation(s) is/are:
“the first device” in claim 3 because the first device is modified by further structural language of “a compression helical spring” and therefore claim 3 recites sufficient structure at prong 3
“the indicator” in claim 14 because the indicator is modified by further structural language of one window and one mark and therefore claim 14 recites sufficient structure at prong 3
“a second device” in claims 21, 22, and 23 because the second device is modified by further structural language of “at least one pin” and therefore claim 21 recites sufficient structure at prong 3
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 21, 2-5, 7, 9-10, 15-17, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al. (U.S. PGPUB No. 20180161515), hereinafter Sanders, in view of Spencer (U.S. Patent No. 4,702,738).
Regarding claim 21, Sanders discloses a safety needle device (see FIG. 4), comprising:
a housing (20), comprising a first end (see ‘Modified FIG. 4’ below),
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a second end (see ‘Modified FIG. 4’ above), and a cylindrical channel (see [0079]: internal hollow region of housing body 23) having a first axis (see ‘Modified FIG. 4’ above) between the first and second ends (as seen in ‘Modified FIG. 4’ above) of the housing (20);
a hub (40), comprising an axial channel (see [0072]: hub permits fluid communication and therefore must have an axial channel), fixed to (see [0072]: hub may be integrally formed with housing or removable) the second end (see ‘Modified FIG. 4’ above) of the housing (20);
a rotatable sleeve (30, see [0080]: 30 rotates), internal to the housing (see [0076]: 30 slidable disposed in housing), so that an operator of the safety needle device does not directly contact the rotatable sleeve (see [0077]: 30 designed to prevent contact from user and thus does not directly contact the rotatable sleeve 30);
a hollow slider (50), at least partly in (seen best in FIG.1 and [0079]: slider 50 moves within housing and therefore is partly ‘in’ at least the first end and see [0082]: slider 50 keyed to housing 20) the first end (as labeled in ‘Modified FIG. 4’ above) of the housing (20), configured to move in a direction parallel to the first axis of the cylindrical channel (see [0079]: slider 50 moves in proximal/distal direction relative housing and therefore moves in a direction parallel to the first axis of the cylindrical channel as shown in ‘Modified FIG. 4’ above);
an elongated needle (42, numeral seen in FIG. 1), at least partly in (see [0071]: proximal end of needle coupled to hub and therefore extends proximally through housing) the housing (20) and at least partly in (distal end of needle covered by slider 50 as seen in ‘Modified FIG. 4’ above and see [0081]: length of slider 50 permitted to fully cover needle 42 in extended position) the hollow slider (50), having a second axis (longitudinal axis extending through center of needle) parallel to the first axis (first axis as shown in ‘Modified FIG. 4’ above extends through the longitudinal axis of the needle and therefore the first and second axis are parallel) of the cylindrical channel and comprising a first end (distal end 44), a second end (proximal end 43, see [0071]), and an in-axis channel (see [0072]: fluid communication through needle back to hub 40 and therefore there must be an in-axis channel within the needle in order to enable fluid communication through the device);
a first device (90, see [0079]: a spring and [0103]: for example a compression spring), at least partly in (see [0104] & [0108]) the housing (20), in contact with the hollow slider (50, see [0079]: spring biases slider and therefore must be in contact such as seen in FIG. 8) and in contact with the hub (40) in an area of the second end (see [0104]: spring extends to proximal end of the housing and is therefore in contact with the hub in an “area” of the second end of the housing) of the housing (20), configured to push the hollow slider (50) away from the hub (40, see [0097]: 90 biases slider 50 distally and thus is pushing slider away from hub, which is located at a proximal end of the safety device); and
a second device (52), at least partly in the housing (20), configured to block movement (see [0089-0098]: protrusions guide movement of slider along path and thus blocks movement in any undesired direction not defined by path. Therefore, the second device is “configured to” block movement at any time such as when the slider is in a position most extended out of the housing) of the hollow slider (50) toward the hub (40) when the hollow slider (50) is in a position most extended out of (as seen in FIG. 4) the housing (20);
wherein the hub (40) is configured to allow connection of the in-axis channel of the elongated needle (42) with a vessel (see [0071-0072]: a syringe) configured to supply an injectable substance or configured to receive a sample (see [0071-0072]: hub provides fluid channel to syringe through needle),
wherein the hollow slider (50) comprises a first end (see ‘Modified FIG. 4’ above), directed toward an outside (see FIGs.1-4 with first end of hollow slider always directed outside of housing) of the housing (20), and a second end (see ‘Modified FIG. 4’ above), directed toward the hub (40),
wherein the second end (see ‘Modified FIG. 4’ above) of the hollow slider (50) is configured to move within (see progression movement of slider 50 into housing from FIG. 1 to FIG. 3 and see [0079]: slider 50 moves into internal cavity of housing body 23 and [0086]) the housing (20), but is prevented from rotating relative to the housing (see [0082]: rotatable sleeve 30 rotates while slider 50 only slides throughout all positions of FIGs.1-4) or sliding out of the housing (see [0089-0091]: protrusion 52 of slider 50 coupled to inside surface of housing body and is therefore prevented from sliding out of the housing),
wherein the first end (44) of the elongated needle (42) is configured to be inserted into a body of a patient (see [0092]: distal tip 44 of needle is exposed to penetrate injection site and is therefore configured to be inserted into a body of a patient),
wherein the rotatable sleeve (30) is configured to rotate even when the first end (see ‘Modified FIG. 4’ above) of the hollow slider (50) contacts the body of the patient (see [0094-0096]: rotatable sleeve 30 causes protrusion 52 to move to second guide path to selectively expose needle while sleeve 50 is pressed against skin.),
wherein the elongated needle (42) is connected to the hub (40) in an area of the second end (43, see [0071]: proximal end of needle coupled to hub. Therefore needle and hub connected in “an area” of the second/ proximal end) of the elongated needle (42),
wherein when the first device (90) is at a lowest level of tension (see FIG.4 and [0097-0098]: extended position occurs after stored energy of spring is released. Therefore, spring is at the lowest level of tension in the extended position such as shown in FIG. 4), the rotatable sleeve (30) surrounds at least part of (portion of needle 42 circumferentially surrounded by sleeve 30 as shown in FIG. 4) the elongated needle (42), at least part of (see [0108]: spring 90 in housing body and biases slider 50. Therefore, sleeve 30 must surround at least part of the spring because the spring would have to extend through the rotatable sleeve to bias the slider 50. See FIG. 9 for visual because 90 is not shown in FIGs.1-4) the first device (90), and at least part of (slider 50 retained within sleeve 30 at second end and therefore sleeve always surrounds at least part of the second end) the second end (see ‘Modified FIG. 4’ above) of the hollow slider (50),
wherein when the first device (90) is at a highest level of tension (see FIG. 3 and [0102]: user must provide force on spring==highest level of tension to move safety device to fully retracted position of FIG. 3, see [0022]), the rotatable sleeve (30) surrounds at least part of (portion of needle 42 circumferentially surrounded by sleeve 30 as shown in FIG. 3) the elongated needle (42), at least part of (see [0108]: spring 90 in housing body and biases slider 50. Therefore, sleeve 30 must surround at least part of the spring because the spring would have to extend through the rotatable sleeve to bias the slider 50) the first device (90), and at least part of (slider 50 retained within sleeve 30 at second end and therefore sleeve always surrounds at least part of the second end) the second end (see ‘Modified FIG. 4’ above for location of second end) of the hollow slider (50),
wherein a side wall (see ‘Modified FIG. 2’ below) of the rotatable sleeve (30)
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comprises at least one linear notch (32, see [0076]: rotatable sleeve 30 has guide path 32) having a third axis (axis of linear notch 31 extends along longitudinal axis of device) parallel to (both third and second axis extend longitudinally and are therefore parallel) the second axis (longitudinal axis extending through center of needle) of the elongated needle (42),
wherein the at least one linear notch (32) comprises a first end (end of notch 32 comprising blocking bay, see ‘Modified FIG. 2’ above), a second end (see ‘Modified FIG. 2’ above), a start bay (31a, see [0076]: a lead ramp), and a blocking bay (see ‘Modified FIG. 2’ above and [0082]: device protrusion 52 moves distally along 32 to position as shown in FIG. 4),
wherein the first end (end of notch 32 comprising blocking bay, see ‘Modified FIG. 2’ above) of the at least one linear notch (32) is closer to (as seen in at least FIG. 4, first end of notch closer to distal end of needle than proximal end of sleeve 30) the first end (44) of the elongated needle (42) than to the second end (see ‘Modified FIG. 2’ above) of the at least one linear notch (32),
wherein the second device (52) comprises, in an area of the second end (see ‘Modified FIG. 4’ above: 52 extends from slider 50 near where the second end is labeled and is therefore ‘in an area of’ the second end. See also [0085]: 52 at proximal end of sleeve 50) of the hollow slider (50), at least one pin (see [0082]: 52 described as a protrusion==pin) located transversely (52 extends vertically/ transverse to longitudinal axis of needle and device) to the second axis (longitudinal axis through needle 42) of the elongated needle (42),
wherein the at least one pin (52) is mechanically coupled (see [0082]: 52 moves through guide paths, including 32, of rotatable sleeve 30 and therefore the pin 52 is mechanically coupled thereto) to the at least one linear notch (32) in the side wall (see ‘Modified FIG. 2’ above) of the rotatable sleeve (30),
wherein movement (see [0082]) of the at least one pin (52) from the start bay (31a, see FIG. 2) through the at least one linear notch (32) causes rotation of (see [0082]: rotatable sleeve 30 rotates such that pin 52 moves from guide path 31 to guide path 32) the rotatable sleeve (30) in a first rotation direction (see rotation arrow in ‘Modified FIG. 2’ above. See also [0082]: sleeve rotates such that pin 52 moves from guide path 31 to guide path 32. Therefore, 30 MUST rotate in the direction as indicated by the examiner in order to enable functionality as described in [0082]).
Sanders further discloses the at least one pin (52) moving through the at least one linear notch (32) to the blocking bay (see [0082]: pin 52 follows guide path 32 and then moves distally to blocking bay position as in FIG. 4), but Sanders is silent to wherein movement of the at least one pin through the at least one linear notch to the blocking bay “causes further rotation of the rotatable sleeve in the first rotation direction.”
However, Spencer teaches a safety needle device a safety needle device (see FIG. 20 and col. 6 line 56- col. 7 line 12) comprising a rotatable sleeve (42) and at least one pin (52), a start bay (86), a linear notch (84), and a blocking bay (88), wherein movement of the at least one pin (52) from the start bay (86) through the at least one linear notch (84) causes rotation of the rotatable sleeve (42) in a first rotation direction (see ‘Modified FIG. 20’ below and col. 6 line 56- col. 7 line 12: pin 52 starts in channel 86 and then the sleeve 42 is turned==rotated to move the pin to the linear branch 84. Therefore, the sleeve 42 MUST rotate in a first rotation direction as shown on ‘Modified FIG. 20’ below in order to enable movement of the pin 52 from branch 86 to branch 84), and
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wherein movement of the at least one pin (52) through the at least one linear notch (84) to the blocking bay (88) causes further rotation of the rotatable sleeve (42) in the first rotation direction (see ‘Modified FIG. 20’ above and col. 6 line 56- col. 7 line 12: pin 52 moves from linear branch 84 and then the sleeve 42 is turned==rotated to move the pin to the branch 88. Therefore, the sleeve 42 MUST rotate again in a first rotation direction as shown on ‘Modified FIG. 20’ above in order to enable movement of the pin 52 from linear branch 84 to branch 88).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blocking bay aligned with the longitudinal axis disclosed in Sanders to be disposed laterally offset from the longitudinal axis of the linear notch and on an opposite lateral side of the start bay as taught by Spencer (see ‘Modification of Sanders in view of Spencer’ below for clarity).
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A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (Movement of a pin from a start bay, through a linear notch, and to a blocking bay—the start bay located on a first side of a linear notch and the blocking bay located in line with the linear notch as disclosed in Sanders-- to actuate the safety needle device between in-use and safety positions) for another known element (Movement of a pin from a start bay, through a linear notch, and to a blocking bay—the start bay located on a first side of a linear notch and the blocking bay located on a second side of the linear notch as taught in Spencer-- to actuate the safety needle device between in-use and safety positions) in the art to obtain the predictable result of rotating a sleeve of a safety needle device to transition the device to a safety position that shields a user from a needle (see MPEP § 2143.I.B), thus achieving wherein movement of the at least one pin through the at least one linear notch to the blocking bay “causes further rotation of the rotatable sleeve in the first rotation direction.”
Regarding claim 2, the modified system of Sanders teaches the safety needle device of claim 21, and Sanders discloses wherein the hub (40, see FIG. 4) further comprises:
means for connecting (see [0072]: hub may include suitable couplings to housing, such as an external snap fit as interpreted under 112(f) above) the hub (40) to the housing (20), located on a circumference (see [0072]: external snap fit would be located on a circumference of the hub) of the hub (40);
an axial central member (see cylinder hub-like formation protruding from proximal face of housing wherein proximal end of needle is retained as shown in FIG. 4), in which the second end (43) of the elongated needle (42) is placed (see [0071]: proximal end 43 of needle attached to hub); and
a retaining element (see [0108]: spring 90 inserted into housing body 23 and must have a retaining element, such as the proximal surface of the housing body for maintaining spring in place in order for spring to function as described in [0097]), for the second end (proximal end of spring) of the first device (90), surrounding the axial central member (see FIG. 9 for example visual).
Regarding claim 3, the modified system of Sanders teaches the safety needle device of claim 2, and Sanders further discloses wherein the first device (90) is a compression helical spring (see [0103]: for example a compression spring) coaxial in relation to (see [0104] & [0108]: spring biases movement along longitudinal axis and therefore must be coaxial along the longitudinal axis of the needle) the elongated needle (42) and surrounding the axial central member (surrounding as shown in FIG. 9 for visual).
Regarding claim 4, the modified system of Sanders teaches the safety needle device of claim 2, and Sanders further discloses wherein the start bay (31a, see Fig. 2) of the at least one linear notch (32) is located at the first end (see ‘Modified FIG. 2’ above in the rejection of claim 21) of the at least one linear notch (32), and wherein the start bay (31a) is offset (see start bay 31a on a ‘side’ relative to third axis) relative to the third axis (axis of linear notch 31 extends along longitudinal axis of device) of the at least one linear notch (32).
Regarding claim 5, the modified system of Sanders teaches the safety needle device of claim 4, and Sanders further discloses wherein the blocking bay (see ‘Modified FIG. 2’ above in the rejection of claim 21) of the at least one linear notch (32) is next to (see start and blocking bay both located at a ‘first end’ of the linear notch and are therefore ‘next to’ each other) the start bay (31a) of the at least one linear notch (32), and wherein the blocking bay (see ‘Modified FIG. 2’ above), the start bay (31a), and the at least one linear notch (32) form a Y-shaped notch (see overall Y-shape of notch formed in sidewall shown in FIG. 2) in the side wall of the rotatable sleeve (30).
Regarding claim 7, the modified system of Sanders teaches the safety needle device of claim 2, and Sanders further discloses wherein the blocking bay (see ‘Modified FIG. 2’ in the rejection of claim 21 above) of the at least one linear notch (32) is located at the first end (see ‘Modified FIG. 2’ above) of the at least one linear notch (32) and wherein the start bay (31a) is located between (see 31a ‘between’ ends because pin 52 located distally of 31a in extended position as shown in FIG. 4) the first end (see ‘Modified FIG. 2’ above) of the at least one linear notch (32) and the second end (see ‘Modified FIG. 2’ above) of the at least one linear notch (32), but Sanders is silent to the blocking bay “is offset relative to the third axis of the at least one linear notch.”
However, Spencer teaches a safety needle device a safety needle device (see FIG. 20 and col. 6 line 56- col. 7 line 12) comprising at least one pin (52), a start bay (86), a linear notch (84), and a blocking bay (88), wherein the blocking bay (88) is offset (see ‘Modified FIG. 20’ above under rejection of claim 21) relative to an axis (the longitudinal axis of the linear notch as shown in ‘Modified FIG. 20’ above) of the at least one linear notch (84).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blocking bay aligned with the longitudinal axis disclosed in Sanders to be disposed laterally offset from the longitudinal axis of the linear notch and on an opposite lateral side of the start bay as taught by Spencer (see ‘Modification of Sanders in view of Spencer’ above under the rejection of claim 21 for clarity).
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (Movement of a pin from a start bay, through a linear notch, and to a blocking bay—the start bay located on a first side of a linear notch and the blocking bay located in line with the linear notch as disclosed in Sanders-- to actuate the safety needle device between in-use and safety positions) for another known element (Movement of a pin from a start bay, through a linear notch, and to a blocking bay—the start bay located on a first side of a linear notch and the blocking bay located on a second side of the linear notch as taught in Spencer-- to actuate the safety needle device between in-use and safety positions) in the art to obtain the predictable result of rotating a sleeve of a safety needle device to transition the device to a safety position that shields a user from a needle (see MPEP § 2143.I.B), thus achieving the blocking bay “is offset relative to the third axis of the at least one linear notch.”
Regarding claim 9, the modified system of Sanders teaches the safety needle device of claim 5, and Sanders further discloses wherein the hollow slider (50, see FIG. 5) has at least one longitudinal guide (horizontal surfaces of protrusions 52a, 52b) on an outer surface (as seen in FIG. 5) of the hollow slider (50), and wherein the housing (20) has at least one guide notch corresponding to (see [0113]: protrusions 52a, 52b “key” to housing and therefore the housing must have notches for each protrusion to enable the “keying” feature—see FIG. 6 for visual clarity of at least one notch of the housing) the at least one longitudinal guide (horizontal surfaces of protrusions 52a, 52b) on the outer surface (as seen in FIG. 5) of the hollow slider (50).
Regarding claim 10, the modified system of Sanders teaches the safety needle device of claim 9, and Sanders further discloses wherein the hollow slider (50, see FIG. 5) has two opposing longitudinal guides (horizontal surfaces of protrusions 52a, 52b) on the outer surface (as seen in FIG. 5) of the hollow slider (50), and wherein the housing (20) has two opposite guide notches corresponding to (see [0113]: protrusions 52a, 52b “key” to housing and therefore the housing must have notches for each protrusion to enable the “keying” feature—see FIG. 6 for visual clarity of at least one notch of the housing) the two opposing longitudinal guides (horizontal surfaces of protrusions 52a, 52b) on the outer surface (as seen in FIG. 5) of the hollow slider (50).
Regarding claim 15, the modified system of Sanders teaches the safety needle device of claim 21, and Sanders further discloses wherein the hollow slider (50, see FIG. 4) further comprises a narrowed section (70) supporting (see [0098]: 70 rides along needle and thus ‘supports’ the needle by surface contact) the elongated needle (42).
Regarding claim 16, the modified system of Sanders teaches the safety needle device of claim 21, and Sanders further discloses wherein the hollow slider (50, see FIG. 4) further comprises transparent plastic (see [0106]: components such as the slider are formed of plastic and are translucent).
Regarding claim 17, the modified system of Sanders teaches the safety needle device of claim 21, and Sanders further discloses wherein the second end (proximal end 43, see [0071]) of the elongated needle (42, see FIG. 4) protrudes into a socket (see [0071-0072]: proximal end of needle disposed “in” hub==socket) of the hub (40) on a side of the hub (40) opposite to the first end (44) of the elongated needle (42).
Regarding claim 22, Sanders discloses a safety needle device (see FIG. 4), comprising:
a housing (20), comprising a first end (see ‘Modified FIG. 4’ above in the rejection of claim 21), a second end (see ‘Modified FIG. 4’ above), and a cylindrical channel (see [0079]: internal hollow region of housing body 23) having a first axis (see ‘Modified FIG. 4’ above) between the first and second ends (as seen in ‘Modified FIG. 4’ above) of the housing (20);
a hub (40), comprising an axial channel (see [0072]: hub permits fluid communication and therefore must have an axial channel), fixed to (see [0072]: hub may be integrally formed with housing or removable) the second end (see ‘Modified FIG. 4’ above) of the housing (20);
a rotatable sleeve (30, see [0080]: 30 rotates), internal to the housing (see [0076]: 30 slidable disposed in housing), so that an operator of the safety needle device does not directly contact the rotatable sleeve (see [0077]: 30 designed to prevent contact from user and thus does not directly contact the rotatable sleeve 30);
a hollow slider (50), at least partly in (seen best in FIG.1 and [0079]: slider 50 moves within housing and therefore is partly ‘in’ at least the first end and see [0082]: slider 50 keyed to housing 20) the first end (as labeled in ‘Modified FIG. 4’ above) of the housing (20), configured to move in a direction parallel to the first axis of the cylindrical channel (see [0079]: slider 50 moves in proximal/distal direction relative housing and therefore moves in a direction parallel to the first axis of the cylindrical channel as shown in ‘Modified FIG. 4’ above);
an elongated needle (42, numeral seen in FIG. 1), at least partly in (see [0071]: proximal end of needle coupled to hub and therefore extends proximally through housing) the housing (20) and at least partly in (distal end of needle covered by slider 50 as seen in ‘Modified FIG. 4’ above and see [0081]: length of slider 50 permitted to fully cover needle 42 in extended position) the hollow slider (50), having a second axis (longitudinal axis extending through center of needle) parallel to the first axis (first axis as shown in ‘Modified FIG. 4’ above extends through the longitudinal axis of the needle and therefore the first and second axis are parallel) of the cylindrical channel and comprising a first end (distal end 44), a second end (proximal end 43, see [0071]), and an in-axis channel (see [0072]: fluid communication through needle back to hub 40 and therefore there must be an in-axis channel within the needle in order to enable fluid communication through the device);
a first device (90, see [0079]: a spring and [0103]: for example a compression spring), at least partly in (see [0104] & [0108]) the housing (20), configured to push the hollow slider (50) away from the hub (40, see [0097]: 90 biases slider 50 distally and thus is pushing slider away from hub, which is located at a proximal end of the safety device); and
a second device (52), at least partly in the housing (20), configured to block movement (see [0089-0098]: protrusions guide movement of slider along path and thus blocks movement in any undesired direction not defined by path. Therefore, the second device is “configured to” block movement at any time such as when the slider is in a position most extended out of the housing) of the hollow slider (50) toward the hub (40) when the hollow slider (50) is in a position most extended out of (as seen in FIG. 4) the housing (20);
wherein the hub (40) is configured to allow connection of the in-axis channel of the elongated needle (42) with a vessel (see [0071-0072]: a syringe) configured to supply an injectable substance or configured to receive a sample (see [0071-0072]: hub provides fluid channel to syringe through needle),
wherein the hollow slider (50) comprises a first end (see ‘Modified FIG. 4’ above), directed toward an outside (see FIGs.1-4 with first end of hollow slider always directed outside of housing) of the housing (20), and a second end (see ‘Modified FIG. 4’ above), directed toward the hub (40),
wherein the second end (see ‘Modified FIG. 4’ above) of the hollow slider (50) is configured to move within (see progression movement of slider 50 into housing from FIG. 1 to FIG. 3 and see [0079]: slider 50 moves into internal cavity of housing body 23 and [0086]) the housing (20), but is prevented from rotating relative to the housing (see [0082]: rotatable sleeve 30 rotates while slider 50 only slides throughout all positions of FIGs.1-4) or sliding out of the housing (see [0089-0091]: protrusion 52 of slider 50 coupled to inside surface of housing body and is therefore prevented from sliding out of the housing),
wherein the first end (44) of the elongated needle (42) is configured to be inserted into a body of a patient (see [0092]: distal tip 44 of needle is exposed to penetrate injection site and is therefore configured to be inserted into a body of a patient),
wherein the rotatable sleeve (30) is configured to rotate even when the first end (see ‘Modified FIG. 4’ above) of the hollow slider (50) contacts the body of the patient (see [0094-0096]: rotatable sleeve 30 causes protrusion 52 to move to second guide path to selectively expose needle while sleeve 50 is pressed against skin.),
wherein the elongated needle (42) is connected to the hub (40) in an area of the second end (43, see [0071]: proximal end of needle coupled to hub. Therefore needle and hub connected in “an area” of the second/ proximal end) of the elongated needle (42) and in an area of (see [0071-0072]: needle connected to hub and subsequently housing at proximal end as shown in FIG. 4) the second end (see ‘Modified FIG. 4’ above for location of second end) of the housing (20),
wherein when the first device (90) is at a lowest level of tension (see FIG.4 and [0097-0098]: extended position occurs after stored energy of spring is released. Therefore, spring is at the lowest level of tension in the extended position such as shown in FIG. 4), the rotatable sleeve (30) surrounds at least part of (portion of needle 42 circumferentially surrounded by sleeve 30 as shown in FIG. 4) the elongated needle (42), at least part of (see [0108]: spring 90 in housing body and biases slider 50. Therefore, sleeve 30 must surround at least part of the spring because the spring would have to extend through the rotatable sleeve to bias the slider 50. See FIG. 9 for visual because 90 is not shown in FIGs.1-4) the first device (90), and at least part of (slider 50 retained within sleeve 30 at second end and therefore sleeve always surrounds at least part of the second end) the second end (see ‘Modified FIG. 4’ above) of the hollow slider (50),
wherein when the first device (90) is at a highest level of tension (see FIG. 3 and [0102]: user must provide force on spring==highest level of tension to move safety device to fully retracted position of FIG. 3, see [0022]), the rotatable sleeve (30) surrounds at least part of (portion of needle 42 circumferentially surrounded by sleeve 30 as shown in FIG. 3) the elongated needle (42), at least part of (see [0108]: spring 90 in housing body and biases slider 50. Therefore, sleeve 30 must surround at least part of the spring because the spring would have to extend through the rotatable sleeve to bias the slider 50) the first device (90), and at least part of (slider 50 retained within sleeve 30 at second end and therefore sleeve always surrounds at least part of the second end) the second end (see ‘Modified FIG. 4’ above for location of second end) of the hollow slider (50),
wherein a side wall (see ‘Modified FIG. 2’ above in the rejection of claim 21) of the rotatable sleeve (30) comprises at least one linear notch (32, see [0076]: rotatable sleeve 30 has guide path 32) having a third axis (axis of linear notch 31 extends along longitudinal axis of device) parallel to (both third and second axis extend longitudinally and are therefore parallel) the second axis (longitudinal axis extending through center of needle) of the elongated needle (42),
wherein the at least one linear notch (32) comprises a first end (end of notch 32 comprising blocking bay, see ‘Modified FIG. 2’ above), a second end (see ‘Modified FIG. 2’ above), a start bay (31a, see [0076]: a lead ramp), and a blocking bay (see ‘Modified FIG. 2’ above and [0082]: device protrusion 52 moves distally along 32 to position as shown in FIG. 4),
wherein the first end (end of notch 32 comprising blocking bay, see ‘Modified FIG. 2’ above) of the at least one linear notch (32) is closer to (as seen in at least FIG. 4, first end of notch closer to distal end of needle than proximal end of sleeve 30) the first end (44) of the elongated needle (42) than to the second end (see ‘Modified FIG. 2’ above) of the at least one linear notch (32),
wherein the second device (52) comprises, in an area of the second end (see ‘Modified FIG. 4’ above: 52 extends from slider 50 near where the second end is labeled and is therefore ‘in an area of’ the second end. See also [0085]: 52 at proximal end of sleeve 50) of the hollow slider (50), at least one pin (see [0082]: 52 described as a protrusion==pin) located transversely (52 extends vertically/ transverse to longitudinal axis of needle and device) to the second axis (longitudinal axis through needle 42) of the elongated needle (42),
wherein the at least one pin (52) is mechanically coupled (see [0082]: 52 moves through guide paths, including 32, of rotatable sleeve 30 and therefore the pin 52 is mechanically coupled thereto) to the at least one linear notch (32) in the side wall (see ‘Modified FIG. 2’ above) of the rotatable sleeve (30),
wherein movement (see [0082]) of the at least one pin (52) from the start bay (31a, see FIG. 2) through the at least one linear notch (32) causes rotation of (see [0082]: rotatable sleeve 30 rotates such that pin 52 moves from guide path 31 to guide path 32) the rotatable sleeve (30) in a first rotation direction (see rotation arrow in ‘Modified FIG. 2’ above. See also [0082]: sleeve rotates such that pin 52 moves from guide path 31 to guide path 32. Therefore, 30 MUST rotate in the direction as indicated by the examiner in order to enable functionality as described in [0082]).
Sanders further discloses the at least one pin (52) moving through the at least one linear notch (32) to the blocking bay (see [0082]: pin 52 follows guide path 32 and then moves distally to blocking bay position as in FIG. 4), but Sanders is silent to wherein movement of the at least one pin through the at least one linear notch to the blocking bay “causes further rotation of the rotatable sleeve in the first rotation direction.”
However, Spencer teaches a safety needle device a safety needle device (see FIG. 20 and col. 6 line 56- col. 7 line 12) comprising a rotatable sleeve (42) and at least one pin (52), a start bay (86), a linear notch (84), and a blocking bay (88), wherein movement of the at least one pin (52) from the start bay (86) through the at least one linear notch (84) causes rotation of the rotatable sleeve (42) in a first rotation direction (see ‘Modified FIG. 20’ below and col. 6 line 56- col. 7 line 12: pin 52 starts in channel 86 and then the sleeve 42 is turned==rotated to move the pin to the linear branch 84. Therefore, the sleeve 42 MUST rotate in a first rotation direction as shown on ‘Modified FIG. 20’ below in order to enable movement of the pin 52 from branch 86 to branch 84), and
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wherein movement of the at least one pin (52) through the at least one linear notch (84) to the blocking bay (88) causes further rotation of the rotatable sleeve (42) in the first rotation direction (see ‘Modified FIG. 20’ above and col. 6 line 56- col. 7 line 12: pin 52 moves from linear branch 84 and then the sleeve 42 is turned==rotated to move the pin to the branch 88. Therefore, the sleeve 42 MUST rotate again in a first rotation direction as shown on ‘Modified FIG. 20’ above in order to enable movement of the pin 52 from linear branch 84 to branch 88).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blocking bay aligned with the longitudinal axis disclosed in Sanders to be disposed laterally offset from the longitudinal axis of the linear notch and on an opposite lateral side of the start bay as taught by Spencer (see ‘Modification of Sanders in view of Spencer’ above in the rejection of claim 21 for clarity).
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (Movement of a pin from a start bay, through a linear notch, and to a blocking bay—the start bay located on a first side of a linear notch and the blocking bay located in line with the linear notch as disclosed in Sanders-- to actuate the safety needle device between in-use and safety positions) for another known element (Movement of a pin from a start bay, through a linear notch, and to a blocking bay—the start bay located on a first side of a linear notch and the blocking bay located on a second side of the linear notch as taught in Spencer-- to actuate the safety needle device between in-use and safety positions) in the art to obtain the predictable result of rotating a sleeve of a safety needle device to transition the device to a safety position that shields a user from a needle (see MPEP § 2143.I.B), thus achieving wherein movement of the at least one pin through the at least one linear notch to the blocking bay “causes further rotation of the rotatable sleeve in the first rotation direction.”
Regarding claim 23, Sanders discloses a safety needle device (see FIG. 4), comprising:
a housing (20), comprising a first end (see ‘Modified FIG. 4’ above in the rejection of claim 21), a second end (see ‘Modified FIG. 4’ above), and a cylindrical channel (see [0079]: internal hollow region of housing body 23) having a first axis (see ‘Modified FIG. 4’ above) between the first and second ends (as seen in ‘Modified FIG. 4’ above) of the housing (20);
a hub (40), comprising an axial channel (see [0072]: hub permits fluid communication and therefore must have an axial channel), fixed to (see [0072]: hub may be integrally formed with housing or removable) the second end (see ‘Modified FIG. 4’ above) of the housing (20);
a rotatable sleeve (30, see [0080]: 30 rotates), internal to the housing (see [0076]: 30 slidable disposed in housing), so that an operator of the safety needle device does not directly contact the rotatable sleeve (see [0077]: 30 designed to prevent contact from user and thus does not directly contact the rotatable sleeve 30);
a hollow slider (50), at least partly in (seen best in FIG.1 and [0079]: slider 50 moves within housing and therefore is partly ‘in’ at least the first end and see [0082]: slider 50 keyed to housing 20) the first end (as labeled in ‘Modified FIG. 4’ above) of the housing (20), configured to move in a direction parallel to the first axis of the cylindrical channel (see [0079]: slider 50 moves in proximal/distal direction relative housing and therefore moves in a direction parallel to the first axis of the cylindrical channel as shown in ‘Modified FIG. 4’ above);
an elongated needle (42, numeral seen in FIG. 1), at least partly in (see [0071]: proximal end of needle coupled to hub and therefore extends proximally through housing) the housing (20) and at least partly in (distal end of needle covered by slider 50 as seen in ‘Modified FIG. 4’ above and see [0081]: length of slider 50 permitted to fully cover needle 42 in extended position) the hollow slider (50), having a second axis (longitudinal axis extending through center of needle) parallel to the first axis (first axis as shown in ‘Modified FIG. 4’ above extends through the longitudinal axis of the needle and therefore the first and second axis are parallel) of the cylindrical channel and comprising a first end (distal end 44), a second end (proximal end 43, see [0071]), and an in-axis channel (see [0072]: fluid communication through needle back to hub 40 and therefore there must be an in-axis channel within the needle in order to enable fluid communication through the device);
a first device (90, see [0079]: a spring and [0103]: for example a compression spring), at least partly in (see [0104] & [0108]) the housing (20), configured to push the hollow slider (50) away from the hub (40, see [0097]: 90 biases slider 50 distally and thus is pushing slider away from hub, which is located at a proximal end of the safety device); and
a second device (52), at least partly in the housing (20), configured to block movement (see [0089-0098]: protrusions guide movement of slider along path and thus blocks movement in any undesired direction not defined by path. Therefore, the second device is “configured to” block movement at any time such as when the slider is in a position most extended out of the housing) of the hollow slider (50) toward the hub (40) when the hollow slider (50) is in a position most extended out of (as seen in FIG. 4) the housing (20);
wherein the hub (40), in an area of (see [0071-0072]: hub and housing connected at proximal ends) the second end (see ‘Modified FIG. 4’ above for location of second end of housing) of the housing (20), is configured to allow connection of the in-axis channel of the elongated needle (42) with a vessel (see [0071-0072]: a syringe) configured to supply an injectable substance or configured to receive a sample (see [0071-0072]: hub provides fluid channel to syringe through needle),
wherein the hollow slider (50) comprises a first end (see ‘Modified FIG. 4’ above), directed toward an outside (see FIGs.1-4 with first end of hollow slider always directed outside of housing) of the housing (20), and a second end (see ‘Modified FIG. 4’ above), directed toward the hub (40),
wherein the second end (see ‘Modified FIG. 4’ above) of the hollow slider (50) is configured to move within (see progression movement of slider 50 into housing from FIG. 1 to FIG. 3 and see [0079]: slider 50 moves into internal cavity of housing body 23 and [0086]) the housing (20), but is prevented from rotating relative to the housing (see [0082]: rotatable sleeve 30 rotates while slider 50 only slides throughout all positions of FIGs.1-4) or sliding out of the housing (see [0089-0091]: protrusion 52 of slider 50 coupled to inside surface of housing body and is therefore prevented from sliding out of the housing),
wherein the first end (44) of the elongated needle (42) is configured to be inserted into a body of a patient (see [0092]: distal tip 44 of needle is exposed to penetrate injection site and is therefore configured to be inserted into a body of a patient),
wherein the rotatable sleeve (30) is configured to rotate even when the first end (see ‘Modified FIG. 4’ above) of the hollow slider (50) contacts the body of the patient (see [0094-0096]: rotatable sleeve 30 causes protrusion 52 to move to second guide path to selectively expose needle while sleeve 50 is pressed against skin.),
wherein the elongated needle (42) is connected to the hub (40) in an area of the second end (43, see [0071]: proximal end of needle coupled to hub. Therefore needle and hub connected in “an area” of the second/ proximal end) of the elongated needle (42),
wherein when the first device (90) is at a lowest level of tension (see FIG.4 and [0097-0098]: extended position occurs after stored energy of spring is released. Therefore, spring is at the lowest level of tension in the extended position such as shown in FIG. 4), the rotatable sleeve (30) surrounds at least part of (portion of needle 42 circumferentially surrounded by sleeve 30 as shown in FIG. 4) the elongated needle (42), at least part of (see [0108]: spring 90 in housing body and biases slider 50. Therefore, sleeve 30 must surround at least part of the spring because the spring would have to extend through the rotatable sleeve to bias the slider 50. See FIG. 9 for visual because 90 is not shown in FIGs.1-4) the first device (90), and at least part of (slider 50 retained within sleeve 30 at second end and therefore sleeve always surrounds at least part of the second end) the second end (see ‘Modified FIG. 4’ above) of the hollow slider (50),
wherein when the first device (90) is at a highest level of tension (see FIG. 3 and [0102]: user must provide force on spring==highest level of tension to move safety device to fully retracted position of FIG. 3, see [0022]), the rotatable sleeve (30) surrounds at least part of (portion of needle 42 circumferentially surrounded by sleeve 30 as shown in FIG. 3) the elongated needle (42), at least part of (see [0108]: spring 90 in housing body and biases slider 50. Therefore, sleeve 30 must surround at least part of the spring because the spring would have to extend through the rotatable sleeve to bias the slider 50) the first device (90), and at least part of (slider 50 retained within sleeve 30 at second end and therefore sleeve always surrounds at least part of the second end) the second end (see ‘Modified FIG. 4’ above for location of second end) of the hollow slider (50),
wherein a side wall (see ‘Modified FIG. 2’ in the rejection of claim 21 above) of the rotatable sleeve (30) comprises at least one linear notch (32, see [0076]: rotatable sleeve 30 has guide path 32) having a third axis (axis of linear notch 31 extends along longitudinal axis of device) parallel to (both third and second axis extend longitudinally and are therefore parallel) the second axis (longitudinal axis extending through center of needle) of the elongated needle (42),
wherein the at least one linear notch (32) comprises a first end (end of notch 32 comprising blocking bay, see ‘Modified FIG. 2’ above), a second end (see ‘Modified FIG. 2’ above), a start bay (31a, see [0076]: a lead ramp), and a blocking bay (see ‘Modified FIG. 2’ above and [0082]: device protrusion 52 moves distally along 32 to position as shown in FIG. 4),
wherein the first end (end of notch 32 comprising blocking bay, see ‘Modified FIG. 2’ above) of the at least one linear notch (32) is closer to (as seen in at least FIG. 4, first end of notch closer to distal end of needle than proximal end of sleeve 30) the first end (44) of the elongated needle (42) than to the second end (see ‘Modified FIG. 2’ above) of the at least one linear notch (32),
wherein the second device (52) comprises, in an area of the second end (see ‘Modified FIG. 4’ above: 52 extends from slider 50 near where the second end is labeled and is therefore ‘in an area of’ the second end. See also [0085]: 52 at proximal end of sleeve 50) of the hollow slider (50), at least one pin (see [0082]: 52 described as a protrusion==pin) located transversely (52 extends vertically/ transverse to longitudinal axis of needle and device) to the second axis (longitudinal axis through needle 42) of the elongated needle (42),
wherein the at least one pin (52) is mechanically coupled (see [0082]: 52 moves through guide paths, including 32, of rotatable sleeve 30 and therefore the pin 52 is mechanically coupled thereto) to the at least one linear notch (32) in the side wall (see ‘Modified FIG. 2’ above) of the rotatable sleeve (30),
wherein movement (see [0082]) of the at least one pin (52) from the start bay (31a, see FIG. 2) through the at least one linear notch (32) causes rotation of (see [0082]: rotatable sleeve 30 rotates such that pin 52 moves from guide path 31 to guide path 32) the rotatable sleeve (30) in a first rotation direction (see rotation arrow in ‘Modified FIG. 2’ above. See also [0082]: sleeve rotates such that pin 52 moves from guide path 31 to guide path 32. Therefore, 30 MUST rotate in the direction as indicated by the examiner in order to enable functionality as described in [0082]).
Sanders further discloses the at least one pin (52) moving through the at least one linear notch (32) to the blocking bay (see [0082]: pin 52 follows guide path 32 and then moves distally to blocking bay position as in FIG. 4), but Sanders is silent to wherein movement of the at least one pin through the at least one linear notch to the blocking bay “causes further rotation of the rotatable sleeve in the first rotation direction.”
However, Spencer teaches a safety needle device a safety needle device (see FIG. 20 and col. 6 line 56- col. 7 line 12) comprising a rotatable sleeve (42) and at least one pin (52), a start bay (86), a linear notch (84), and a blocking bay (88), wherein movement of the at least one pin (52) from the start bay (86) through the at least one linear notch (84) causes rotation of the rotatable sleeve (42) in a first rotation direction (see ‘Modified FIG. 20’ below and col. 6 line 56- col. 7 line 12: pin 52 starts in channel 86 and then the sleeve 42 is turned==rotated to move the pin to the linear branch 84. Therefore, the sleeve 42 MUST rotate in a first rotation direction as shown on ‘Modified FIG. 20’ below in order to enable movement of the pin 52 from branch 86 to branch 84), and
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wherein movement of the at least one pin (52) through the at least one linear notch (84) to the blocking bay (88) causes further rotation of the rotatable sleeve (42) in the first rotation direction (see ‘Modified FIG. 20’ above and col. 6 line 56- col. 7 line 12: pin 52 moves from linear branch 84 and then the sleeve 42 is turned==rotated to move the pin to the branch 88. Therefore, the sleeve 42 MUST rotate again in a first rotation direction as shown on ‘Modified FIG. 20’ above in order to enable movement of the pin 52 from linear branch 84 to branch 88).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the blocking bay aligned with the longitudinal axis disclosed in Sanders to be disposed laterally offset from the longitudinal axis of the linear notch and on an opposite lateral side of the start bay as taught by Spencer (see ‘Modification of Sanders in view of Spencer’ above in the rejection of claim 21 for clarity).
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (Movement of a pin from a start bay, through a linear notch, and to a blocking bay—the start bay located on a first side of a linear notch and the blocking bay located in line with the linear notch as disclosed in Sanders-- to actuate the safety needle device between in-use and safety positions) for another known element (Movement of a pin from a start bay, through a linear notch, and to a blocking bay—the start bay located on a first side of a linear notch and the blocking bay located on a second side of the linear notch as taught in Spencer-- to actuate the safety needle device between in-use and safety positions) in the art to obtain the predictable result of rotating a sleeve of a safety needle device to transition the device to a safety position that shields a user from a needle (see MPEP § 2143.I.B), thus achieving wherein movement of the at least one pin through the at least one linear notch to the blocking bay “causes further rotation of the rotatable sleeve in the first rotation direction.”
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Spencer as applied to claim 5 above, and further in view of Daily et al. (U.S. PGPUB No. 2019/0125978), hereinafter Daily.
Regarding claim 6, the modified system of Sanders teaches the safety needle device of claim 5, but Modified Sanders is silent to “wherein the side wall of the rotatable sleeve has two linear notches with the blocking bay and the start bay located at the first end of the two linear notches.”
However, Daily teaches a safety needle device (see FIG. 7F) with a sleeve (420, see FIG. 7D), wherein the side wall (see [0168]: slot 422 formed in sleeve 420) of the sleeve (420) has two linear notches (see FIG. 7A with two separate formations of FIG. 7D on each half of the sleeve 420 and see [0174]: slots 422) with a blocking bay (434) and a start bay (424) located at the first end (leftward half of notch 422) of the two linear notches (422).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the linear notch disposed in the rotatable sleeve and comprising the start and blocking bay at a first end of the linear notch as disclosed in Sanders such that a linear notch, start bay, and blocking bay structure is located in two places of the sleeve side wall as taught by Daily.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a linear notch with a start and blocking bay to guide a pin to move the safety device through positions) for another known element (two linear notches, each with a start and blocking bay to guide multiple pins to move the safety device through positions) in the art to obtain the predictable result of using pins guided along labyrinth paths to move a safety needle device in between desired needle positions (see MPEP § 2143.I.B), thus achieving “wherein the side wall of the rotatable sleeve has two linear notches with the blocking bay and the start bay located at the first end of the two linear notches.”
Further, mere duplication of parts (i.e.: duplicating the linear notch/ start bay/ blocking bay structure of Sanders to achieve “two” such structures) has no patentable significance unless a new and unexpected result is produced (see MPEP § 2144.04.VI.B).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Spencer as applied to claim 7 above, and further in view of Daily (U.S. PGPUB No. 2019/0125978).
Regarding claim 8, the modified system of Sanders teaches the safety needle device of claim 7, but Sanders is silent to “wherein the side wall of the rotatable sleeve has two opposing linear notches, each with the start bay and the blocking bay, and wherein the second device further comprises two opposite pins.”
However, Daily teaches a safety needle device (see FIG. 7F) with a sleeve (420, see FIG. 7D), wherein the side wall of the rotatable sleeve (420) has two (see each half of the sleeve 420 in FIG. 7A with notches 422 labeled on each side) opposing linear notches (422, best view in FIG. 7D), each with the start bay (424, see FIG. 7D) and the blocking bay (434, see FIG. 7D), and wherein a second device (446, best seen in FIG. 7E) further comprises two opposite pins (see [0174]: guiding pins 446 engage notch 422).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the linear notch disposed in the side wall of the rotatable sleeve and comprising the start and blocking bay at a first end of the linear notch as disclosed in Sanders such that a linear notch, start bay, and blocking bay structure is located in two places of the sleeve side wall as taught by Daily.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a linear notch with a start and blocking bay to guide a pin to move the safety device through positions disclosed in Sanders) for another known element (two linear notches, each with a start and blocking bay to guide multiple pins to move the safety device through positions taught in Daily) in the art to obtain the predictable result of using pins guided along labyrinth paths to move a safety needle device in between desired needle positions (see MPEP § 2143.I.B), thus achieving “wherein the side wall of the rotatable sleeve has two opposing linear notches, each with the start bay and the blocking bay”
Further, mere duplication of parts (i.e.: duplicating the linear notch/ start bay/ blocking bay structure of Sanders to achieve “two” such structures) has no patentable significance unless a new and unexpected result is produced (see MPEP § 2144.04.VI.B).
Next, therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the pin of the second device disclosed in Sanders such the pin comprises two opposing pins for engaging the two linear notches as taught by Daily.
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a linear notch with a start and blocking bay to guide a pin to move the safety device through positions disclosed in Sanders) for another known element (two linear notches, each with a start and blocking bay to guide two opposing pins to move the safety device through positions taught in Daily) in the art to obtain the predictable result of using pins guided along labyrinth paths to move a safety needle device in between desired needle positions (see MPEP § 2143.I.B), thus achieving and wherein the second device further comprises two opposite pins.”
Further, mere duplication of parts (i.e.: duplicating the second device pin structure of Sanders to achieve “two” such structures) has no patentable significance unless a new and unexpected result is produced (see MPEP § 2144.04.VI.B).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Spencer as applied to claim 5 above, and further in view of Caizza (U.S. Patent No. 5,755,696).
Regarding claim 11, the modified system of Sanders teaches the safety needle device of claim 5, and Sanders discloses the axial central member (see Modified FIG. 4i below) of the hub (40).
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Sanders is silent to “wherein the axial central member of the hub has at least one longitudinal guide, and wherein the hollow slider has, at the second end of the hollow slider, at least one guide notch corresponding to the at least one longitudinal guide of the axial central member of the hub.”
However, Caizza teaches a needle hub (30, see FIG-2) for coupling to a syringe (50, see FIG-3) with an axial central member (29, see FIG-4), wherein the axial central member (29, see FIG-4) of the hub has at least one longitudinal guide (39), and wherein an oversleeve (40) has, at the second end (a proximal end) of the oversleeve (40), at least one guide notch (24, see FIG-4) corresponding to the at least one longitudinal guide (39) of the axial central member (29) of the hub (30).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hub and the hollow slider oversleeve disclosed in Sanders to be fitted with corresponding longitudinal guides and guide notches, respectively as taught by Caizza for the purpose of forming a torque transmitting fit between the hub and the oversleeve such that torque is transmitted to the hub and subsequently the syringe barrel when fitting a syringe to the hub (see col. 5 line 65- col. 6 line30), thus achieving “wherein the axial central member of the hub has at least one longitudinal guide, and wherein the hollow slider has, at the second end of the hollow slider, at least one guide notch corresponding to the at least one longitudinal guide of the axial central member of the hub.”
Regarding claim 12, the modified system of Sanders teaches the safety needle device of claim 11, but Sanders is silent to “wherein the axial central member of the hub has four longitudinal guides spaced at regular intervals from each other, and wherein the hollow slider has four guide notches corresponding to the four longitudinal guides of the axial central member of the hub.”
However, Caizza teaches a needle hub (30, see FIG-2) for coupling to a syringe (50, see FIG-3) with an axial central member (29, see FIG-4), wherein the axial central member (29) of the hub has four longitudinal guides (39, see FIG-4) spaced at regular intervals from each other (depicted at 90degree intervals in FIG-4), and wherein the oversleeve (40) has at least one guide notch (24) corresponding to the four longitudinal guides (39) of the axial central member (29) of the hub (30).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hub and the hollow slider oversleeve disclosed in Sanders to be fitted with corresponding longitudinal guides and guide notches, respectively as taught by Caizza for the purpose of forming a torque transmitting fit between the hub and the oversleeve such that torque is transmitted to the hub and subsequently the syringe barrel when fitting a syringe to the hub (see col. 5 line 65- col. 6 line30), thus achieving “wherein the axial central member of the hub has four longitudinal guides spaced at regular intervals from each other, and wherein the hollow slider has” at least one guide notch “corresponding to the four longitudinal guides of the axial central member of the hub.”
Modified Sanders in view of Caizza remain silent to “four guide notches” corresponding to the four longitudinal guides.
However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the corresponding guide notches of the hollow slider taught by Modified Sanders in view of Caizza such that there were four guide notches to each correspond with a respective longitudinal guide of the hub for the purpose of increasing the torque transmitted to hub during syringe attachment (see col. 5 line 65- col. 6 line30: rib 39 engages 24 to transmit torque. Any combination of protuberances and recesses can be used which are capable of transmitting “sufficient” torque. More notches 24 would increase transmitted torque via increased surface area at each interference fit between 39/24 and would therefore transmit more torque), thus achieving “four guide notches” corresponding to the four longitudinal guides.
Lastly, mere duplication of parts (i.e.: duplicating the guide notch structure of Modified Sanders in view of Caizza to achieve “four” such structures) has no patentable significance unless a new and unexpected result is produced (see MPEP § 2144.04.VI.B).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Spencer as applied to claim 21 above, and further in view of Takemoto (U.S. Patent Application No. 2015/0190586).
Regarding claim 13, the modified system of Sanders teaches the safety needle device of claim 21, but Modified Sanders is silent to “further comprising: an indicator configured to show when the hollow slider is blocked in the position most extended out of the housing.”
However, Takemoto teaches a safety needle device comprising an indicator (window 186 provided on housing 174, see FIG. 20) configured to show when a hollow sleeve (170) is blocked in the position most extended out of a housing (174, see [0190-0191]: window 186 visualizes inner sleeve 170 at all times and therefore is ‘configured to show’ when the sleeve is blocked in an extended position).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the housing disclosed in Sanders to include an indicator in the form of a window as taught by Takemoto for the purpose of visualizing the phases of the window portion relative the needle hub to visual recognize the state of the device (see [0190-0191]), thus achieving “further comprising: an indicator configured to show when the hollow slider is blocked in the position most extended out of the housing.”
Regarding claim 14, the modified system of Sanders teaches the safety needle device of claim 13, but Sanders in view of Spencer is silent to “wherein the indicator comprises at least one window in a side wall of the housing and at least one mark on an outer surface of the rotatable sleeve.”
However, Takemoto teaches a safety needle device comprising an indicator (window 186 provided on housing 174, see FIG. 20), wherein the indicator (186) comprises at least one window (see [0190]: 186 described as a window) in a side wall (see wall forming tubular shape of 174) of a housing (174) and at least one mark on an outer surface (see [0189]: 172 may be colored a different color==a mark) of a rotatable sleeve (172).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the housing disclosed in Sanders to include an indicator in the form of a window as taught by Takemoto for the purpose of visualizing the phases of the window portion relative the needle hub to visual recognize the state of the device (see [0190-0191]), thus achieving “wherein the indicator comprises at least one window in a side wall of the housing”
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rotatable sleeve disclosed in Sanders to include a marking of a different color as taught by Takemoto for the purpose of visually recognizing certain states of the device (see [0189] and [0201]), thus achieving “and at least one mark on an outer surface of the rotatable sleeve.”
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Spencer as applied to claim 17 above, and further in view of Caizza (U.S. Patent No. 5,755,696).
Regarding claim 18, the modified system of Sanders teaches the safety needle device of claim 17, but Modified Sanders is silent to “further comprising: a stabilizer of the second end of the elongated needle; wherein the stabilizer surrounds a portion of the elongated needle, and wherein the stabilizer is axially embedded in a base of the hub.”
However, Caizza teaches a needle hub (30, see FIG-2) for coupling to a syringe (55) with a second end (23) of an elongate needle (22), further comprising: a stabilizer (36) of the second end (23) of the elongated needle (22); wherein the stabilizer (36) surrounds (see 36 circumferentially surrounding needle in FIG-2) a portion (proximal tip of needle extends into 36, see FIG-6) of the elongated needle (22), and wherein the stabilizer (36) is axially embedded in a base (see col 6 lines 20-30: barrier wall formed on distal end of hub base and is therefore ‘axially embedded’) of the hub (30).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second end of the needle disclosed in Sanders to include a stabilizer surrounding the second end and the stabilizer embedded in a base of the hub as taught by Caizza for the purpose of preventing separation of the interconnected components (see col 6 lines 20-30), thus achieving “further comprising: a stabilizer of the second end of the elongated needle; wherein the stabilizer surrounds a portion of the elongated needle, and wherein the stabilizer is axially embedded in a base of the hub.”
Response to Arguments
Applicant’s arguments with respect to claims 21-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783