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 01/28/26 has been entered. Claims 1, 5, 8, 10, 14, and 16 have been amended. Claims 2-3, 6-7, 9, 11-13, 15, and 17 are in the original/previously presented form. Claim 4 is cancelled. Thus, claims 1-3 and 5-17 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed 10/01/25. Further, the amendment to claim 8 has recited structure of “a bulge” such that claim 8 is no longer interpreted under 112f as previously set forth in the Non-Final Office Action mailed 10/01/25.
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:
Claim 1 line 8: “a release element configured to move the needle cover”. Therefore, claim 1 is interpreted under 112(f) according to the 3-prong test.
Prong 1: means or generic placeholder is recited—“a release element” is considered a generic placeholder for “means” because “a release element” has no specific structural meaning
Prong 2: functional language—configured to move the needle cover
Prong 3: not modified by other structural language in the claims—no structure is recited for how the release element moves the needle cover. Only the desired outcome of “move” is recited.
According to Applicant’s disclosure under 112(f), the “a release element” configured to move the needle cover is interpreted as a spring or equivalent (spring 6, see FIG. 16A and [0064]: a release element 6 such as a spring).
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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5-8, 12, 14, 15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jansen et al. (U.S. Patent No. 6,319,233), hereinafter Jansen.
Regarding claim 1, Jansen discloses a safety device (14, see FIG-1 and col. 3 lines 60-63: a medical device 10 comprising a syringe 12==medical container and shield system 14.) for mounting onto a medical container (syringe 12, see mounted position of safety device onto the medical container in FIG-2) provided with a flange (24) and an injection needle (18, see col. 3 line 64- col. 4 line 14: syringe includes flange 24 and needle 18), the safety device (14, see ‘Modified FIG-1 below’ and col 4 lines 14-20: shield system 14 includes holder 26== a tubular body, shield 28==a needle cover, and a fitting 32== a retainer engaging a spring 30 ==a release element)
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comprising:
a tubular body (26) extending along a longitudinal axis (see longitudinal axis extending horizontally through center of needle 18 in FIG-2), the tubular body (26) being configured to receive (as seen in FIG-2 and see col. 3 line 60-col.4 line 13 & col. 6 lines 23-31: system is designed to receive a syringe) the medical container (12),
a needle cover (28) movable relative to (see col. 6 lines 3-6: needle cover 28 slidably mounted==movable within holder 26) said body (30) between a retracted position (see FIG-3), and an extended position (see FIG-4) in which the needle cover (28) distally extends from (see distal position of needle cover 28 in FIG-4 compared to Fig-3) the retracted position (as shown in FIG-3) in order to shield the injection needle (18) after activation of the safety device (see col. 6 lines 40-65: needle cover 28 slides axially to position as shown in at least FIG. 4 after a user applies distal force to fitting that displaces the end fitting==after activation of the safety device, aligning with Applicant disclosure of device activation as in at least [0007]),
a release element (30) configured to move the needle cover (28, see col. 6 lines 54-65: spring 30 expands causing shield 28 to slide axially) from the retracted (as shown in FIG-3) to the extended position (as shown in FIG.-4) after activation of the safety device (see col. 6 lines 40-65: spring expands after user applies distal force to fitting==after activation of safety device),
a retainer (32), the retainer (32) being configured to transmit an activation force applied to the retainer (32) in a distal axial direction (see col. 6 lines 40-65: user-applied force causes axial displacement of retainer 32 with force enough to move spring and needle cover past stop members to cover needle as in FIG-4) to the needle cover (28) once an injection operation is completed (see col. 6 lines 40-65: following removal of needle from patient==once injection operation is completed, a user applies distal force on fitting==retainer 32, which subsequently releases the spring to move the needle cover. Therefore, the retainer 32 is ‘configured to’ transmit a user’s activation force—the distally applied force on fitting 32-- to the needle cover), such that the activation force transmitted (as described in col 6 lines 40-65) to the needle cover (28) causes the needle cover (28) to move from the retracted position (as seen in FIG-3) to the extended position (as seen in FIG-4),
wherein the needle cover (28) comprises a distal abutment surface (distal face of 58 marked by black solid line, see ‘Modified FIG-3’ below),
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said distal abutment surface (distal face of 58) abutting against a proximal abutment surface (proximal face of 48 marked by solid gray line, see ‘Modified FIG-3’ above, proximal face of 48 marked in ‘Modified FIG-3’ above on ‘lower’ portion of bump 48, but the same proximal face of 48 exists on the ‘upper’ bump where the distal face of 58 is lined in black. Distal abutment surface an proximal abutment surfaces labeled on opposing structures for visual clarity, but the surfaces do both “abut” against one another in each of the lower and upper combinations) of a bump (48) protruding from the body (26) in the retracted position (see ‘Modified FIG-3’ above) of the needle cover (28), and
wherein the body (26) has a first axial slot (46A) and a second axial slot (46B, see col. 4 lines 45-62: openings 46A, B formed in holder body in opposing relation), the first axial slot (46A) and the second axial slot (46B) extending on both sides (46A on a ‘left’ side and 46B on a ‘right’ side of the bump relative to the longitudinal axis, see ‘Modified FIG-1’ below. Therefore, the slots extend on “both” sides. Further see col. 4 lines 57-62: 46A/B “interrupt” the bump) of the bump (48)
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to allow (see col 4 lines 45-52: slots 46A/B provide flexibility to the body and thus “allow”/ do not prevent the body from flexing outward and “allow”/ do not prevent the needle cover from passing over the bump) the body (26) having the bump (48, slots 46A/B and bump 48) to flex outward and the distal abutment surface (distal face of 58) of the needle cover (28) to pass over (see col 6 lines 40-65: needle cover 28 with 58 “allowed” to move over bump 48) the bump (48) to move from the retracted position (as seen in FIG-3) to the extended position (as seen in FIG-4), and
wherein the body (26) comprises a locking window (50, see FIG. 12a and col 4 lines 63-67: detents at first end) for accommodating a locking element (58, see col. 6 lines 54-65: 58 engages 50 such that the shield cannot be retracted) of the needle cover (28), and the second axial slot (46B) is positioned circumferentially between (see the modified figure below. FIG. 12a shows a front view of the locking window 50 at the first end of the tubular body 26—see col 6 lines 54-65. Fig. 1 shows an isometric view of the tubular body 26. As seen in the modified figure below, second slot 46B is positioned circumferentially between at least the bottom locking window and the top half of the bump) the locking window (50) and the bump (48)
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to allow (positioning of slot does not impede motion as described in col 4 lines 63-67 and therefore “allows” elements to engage) the locking element (58) to engage the locking window (50) when the needle cover (28) moves to the extended position (see FIG. 4 and col 4 lines 63-67) to provide a locking engagement (best seen in FIG-8 with locking window 50 labeled) between the body (26) and the needle cover (28) in the extended position (see FIG.4 or FIG. 8).
Regarding claim 5, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the bump (48, see ‘Modified FIG-1v’ below) of the body (26)
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has two bumps (see ‘upper bump’==first bump traced in black and ‘lower bump’==second bump traced in gray) and the first axial slot (46A) is positioned between said two bumps (see ‘Modified FIG-1v’ above).
Regarding claim 6, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein at least one of the proximal abutment surface (proximal face of bump 48, see ‘Modified FIG-3’ above) and the distal abutment surface (distal face of 58, see ‘Modified FIG-3’ above) comprises a chamfer (see col. 5 lines 15-19: 48 and 58 comprise inclined surfaces==a chamfer which is a slanted edge) configured to ease passage of the needle cover (28, see col. 6 lines 49-51: inclined surfaces of 48/58 slide past each other and therefore are ‘configured to ease passage’ of the needle cover) over the bump (48) when the needle cover (48) moves distally to the extended position (as seen in FIG-4).
Regarding claim 7, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the distal abutment surface (distal face of 58, see ‘Modified FIG-3’ above) is located on a reduced thickness portion (see reduced thickness portion, marked in gray for visual clarity, in ‘Modified FIG-4i’ below. reduced thickness portion is a smaller thickness than at least the region of the needle cover comprising structure 62) of the needle cover (28).
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Regarding claim 8, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the distal abutment surface (distal face of 58, see ‘Modified FIG-3’ above) of the needle cover (28) is located on a radial protrusion (protruding collar of 58, see FIG-1 and see col. 5 lines 15-17: 58 is a radially outwardly extending collar==radial protrusion) of the needle cover (28), and the radial protrusion (protruding collar of 58) has a bulge configured to reinforce (see col. 5 lines 15-19: 58 comprises an inclined surface and therefore reasonably comprises a ‘bulge’ configured to reinforce) a proximal side (proximal face of 58) of this radial protrusion (protruding collar of 58).
Regarding claim 12, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the bump (48, see FIG-1) of the body (26) has a first end (see proximal abutment surface/ first end as shown in ‘Modified FIG-3’ above) provided with a chamfer (see col. 5 lines 15-19: 48 and 58 comprise inclined surfaces==a chamfer which is a slanted edge) extending in a circumferential direction (48 extends circumferentially and therefore the chamfer extends in a circumferential direction along structure of bump 48).
Regarding claim 14, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the bump (48, see Fig-1) of the device comprises only two bumps (see ‘upper bump’==first bump traced in black and ‘lower bump’==second bump traced in gray of ‘Modified Fig-1v’ above).
Regarding claim 15, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the bump (48, see FIG-1) has a first end (“right” side/ proximal end in ‘Modified FIG-3’ provided again for reference below)
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and an opposite second end (“left” side/ distal end in ‘Modified FIG-3’ above), and the proximal abutment surface (proximal face of bump 48, see ‘Modified FIG-3’ above) of said bump (48) has a ramp portion (inclined surface outlined in gray in ‘Modified FIG-3’ above and see col. 5 lines 15-19: 48 comprises an inclined surface==a ramp as seen by outline of proximal abutment surface in ‘Modified FIG-3’ above), said ramp portion (inclined surface) having a decreasing slope (surface inclined in direction toward proximal/ first end and therefore has a ‘decreasing’/ negative slope due to a negative change in ‘height’ of the inclined surface) towards the first end (proximal end) of said bump (48).
Regarding claim 17, Jansen discloses an injection device (10, see FIG-1) comprising a medical container (12) having an injection needle (18) and the safety device (14) of claim 1, said safety device (14) being mounted onto said medical container (12, as seen in Fig-2 and described in at least see col. 3 line 60-col.4 line 13 and col. 6 lines 23-31).
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 2-3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen (U.S. Patent No. 6,319,233).
Regarding claim 2, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the first axial slot (46A) is U-shaped and the second axial slot (46B) is U-shaped (see ‘Modified FIG. 1ii’ below with U-shaped outlines of slots).
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In the embodiment of FIG. 1, Jansen is silent to wherein the first axial slot is “V-shaped”.
However, Jansen teaches that the size of the axial slots will change the amount of flexibility of the tubular body (see col.4 lines 45-56: “The sizes of the openings are selected based upon the amount of flexibility desired in the holder body”). Therefore, a person of ordinary skill in the art would consider the flexibility of the tubular body to be a result effect variable that is optimized through routine experimentation of changing/modifying the size of the slot to obtain a desired flexibility of the tubular body.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the first axial slot disclosed in Jansen FIG.1 by decreasing the size of the slot (see “Modified FIG. 1iii’ below)
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to obtain a desired flexibility of the tubular body as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), thus achieving wherein the first axial slot is “V-shaped”.
Regarding claim 3, Jansen discloses the safety device of claim 1, but, in the embodiment of FIG.1, Jansen is silent to “wherein the second axial slot is longer than the first axial slot.”
However, Jansen teaches that the size of the axial slots will change the amount of flexibility of the tubular body (see col.4 lines 45-56: “The sizes of the openings are selected based upon the amount of flexibility desired in the holder body”). Therefore, a person of ordinary skill in the art would consider the flexibility of the tubular body to be a result effect variable that is optimized through routine experimentation of changing/modifying the size of the slot to obtain a desired flexibility of the tubular body.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the second axial slot disclosed in Jansen FIG.1 by increasing the size of the slot (see “Modified FIG. 1iv’ below)
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to obtain a desired flexibility of the tubular body as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), thus achieving wherein the first axial slot is “wherein the second axial slot is longer than the first axial slot.”
Regarding claim 11, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the bump (48, see FIG. 1) extends in a circumferential direction (as outlined for each portion of the bump shown below in ‘Modified FIG. 1vi’)
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according to a central angle (see ‘Modified FIG. 1vi’ above), but in the embodiment of FIG.1, Jansen is silent to the central angle “comprised between 22.5°- 45°”.
However, Jansen teaches that the bump is interrupted by the axial slots and therefore the slot size will modify a circumferential length of the bump (see col. 4 lines 56-62). Therefore, a person of ordinary skill in the art would consider the circumferential length of the bump comprising a central angle to be a result effect variable that is optimized through routine experimentation of changing/modifying the size of the first and second axial slot to obtain the circumferential length of the bump such that it comprises a central angle “between 22.5°- 45°”.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the central angle forming the circumferential length of the bump by modifying the size (such as the width) of each axial slot to obtain a central angle “between 22.5°- 45°” associated with a desired flexibility of the device defined by the slot size (see col 4 lines 45-56) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen as applied to claim 1 above, and further in view of Srinivasan et al. (U.S. Patent No. 9,649,452), hereinafter Srinivasan.
Regarding claim 9, Jansen discloses the safety device of claim 1, but Jansen is silent to “wherein the bump has a cantilevered portion.”
However, Srinivasan teaches a safety device (see FIG. 14 and col 2 lines 50-67) comprising a tubular body (18) and a needle cover (14), wherein the body (18) has a bump (40) and the needle cover (14) has a distal abutment surface (46, see col. 3 lines 1-10: ramped surface 46 on needle carrier 14 and is in sliding engagement with 40. Structure 46 seen in FIG. 8) abutting the bump (40) and wherein the bump (40) has a cantilevered portion (44, see col 2 lines 61-62: cantilevered arm 44).
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 bump of the body disclosed in Jansen to include a cantilevered portion as taught by Srinivasan for the purpose of creating a snap-engagement (see col. 2 lines 56-59) that allows the bump to by-pass the abutting surface in a preferred direction while inhibiting movement in the other (see col. 3 lines 1-10), thus achieving “wherein the bump has a cantilevered portion.”
Regarding claim 13, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the bump (48, see ‘Modified FIG-3’ provided again for reference below)
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of the body (26) has a first end (portion of bump extending in a ‘rightward’/ proximal direction of Fig-3), an opposite second end (portion of bump extending in a ‘leftward’/ distal direction of Fig-3).
Jansen is silent to “a decreasing height from said second end to said first end.”
However, Srinivasan teaches a safety device (see FIG. 14 and col 2 lines 50-67) comprising a tubular body (18) and a needle cover (14), wherein the body (18) has a bump (40), wherein the bump (40) of the body (18) has a first end (see ‘Modified FIG. 11’ below and see assembly of FIG. 13 showing ‘first end’ of bump as shown in ‘Modified FIG. 11’ below as a proximal end side of the bump, similar to the structure as cited for Jansen above),
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an opposite second end (see ‘Modified FIG. 11 above), and a decreasing height from said second end to said first end (see ‘second end height’ greater than ‘first end height’ in ‘Modified FIG.11’ above. Therefore, there is a ‘decreasing height’ from second to first end).
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 bump disclosed in Jansen to include a decreasing height from the second to first end as taught by Srinivasan for the purpose of forming the bump with a cantilevered arm structure for creating a snap-engagement (see col. 2 lines 56-59) that allows the bump to by-pass the abutting surface in a preferred direction while inhibiting movement in the other (see col. 3 lines 1-10),, thus achieving “a decreasing height from said second end to said first end”.
Claim 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen as applied to claim 1 above, and further in view of Brunel (U.S. Patent No. 5,855,839).
Regarding claim 10, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the body (26, see FIG-1) has the first axial slot (46A) extending from an end (end formed by finger flange 38) of the body (26), and the bump (48) is circumferentially distant (see col 4 lines 57-62: bump 48 ‘interrupted’ by slot 46A and see FIG-1—bump does not extend into slots 46A/B and therefore the slots must be ‘circumferentially distant’ or separated by a circumference) from said first axial slot (46A).
Jansen is silent to the first axial slot extending from a “distal” end of the body
However, Brunel teaches a safety device with a body (101, see Fig. 10) comprising a first axial slot (102, see col. 8 lines 56-59) extending from a distal end (see slot extending all the way through distal end/ upward direction in FIG. 10) of the body (101).
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 place the first axial slot on the body disclosed in Jansen at the distal end of the body as taught by Brunel for the purpose of providing the distal end of the device with a desired radial flexibility (see Brunel Figs 10-11, col. 9 lines 64-col. 10 line 27), which would be advantageous to Jansen because radial flexibility at the distal end of the body would aid in the assembly of the device when the syringe is inserted from a proximal end of the tubular body (see col 6 lines 23-24: safety system receives syringe at second end and see col. 4 lines 21-29: second open end of the holder has the flange and thus the second open end==proximal end), thus achieving the first axial slot extending from a “distal” end of the body.
Further, 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 slot provided at a proximal end of a safety device as disclosed in Jansen) for another known element (a slot provided at a distal end of a safety device taught by Brunel) in the art to obtain the predictable result of providing a degree of flexibility to a chosen end of a safety device (see MPEP § 2143.I.B).
Regarding claim 16, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the body (26, see FIG-1) has the first axial slot (46A) extending from an end (end formed by finger flange 38) of the body (26), and the first axial slot (46A) having a predetermined length (see col. 4 lines 51-52: size of slot selected==has a predetermined length for amount of desired flexibility).
Jansen, in the embodiment of FIG.1, is silent to the first axial slot extending from a “distal” end of said body and the first axial slot having a predetermined length “comprised between 1 mm - 6 mm.”
However, Jansen teaches that the size of the axial slots will change the amount of flexibility of the tubular body (see col.4 lines 45-56: “The sizes of the openings are selected based upon the amount of flexibility desired in the holder body”). Therefore, a person of ordinary skill in the art would consider the flexibility of the tubular body to be a result effect variable that is optimized through routine experimentation of changing/modifying the size of the slot, such as the length, to obtain a desired flexibility of the tubular body.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the first axial slot disclosed in Jansen FIG.1 by selecting the predetermined length of the slot to be between 1 and 6mm to obtain a desired flexibility of the tubular body as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), thus achieving wherein the first axial slot has a predetermined length “comprised between 1 mm - 6 mm.”
Jansen remains silent to the first axial slot extending from a “distal” end of said body
However, Brunel teaches a safety device with a body (101, see Fig. 10) comprising a first axial slot (102, see col. 8 lines 56-59) extending from a distal end (see slot extending all the way through distal end/ upward direction in FIG. 10) of the body (101).
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 place the first axial slot on the body disclosed in Jansen at the distal end of the body as taught by Brunel for the purpose of providing the distal end of the device with a desired radial flexibility (see Brunel Figs 10-11, col. 9 lines 64-col. 10 line 27), which would be advantageous to Jansen because radial flexibility at the distal end of the body would aid in the assembly of the device when the syringe is inserted from a proximal end of the tubular body (see col 6 lines 23-24: safety system receives syringe at second end and see col. 4 lines 21-29: second open end of the holder has the flange and thus the second open end==proximal end), thus achieving the first axial slot extending from a “distal” end of the body.
Further, 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 slot provided at a proximal end of a safety device as disclosed in Jansen) for another known element (a slot provided at a distal end of a safety device taught by Brunel) in the art to obtain the predictable result of providing a degree of flexibility to a chosen end of a safety device (see MPEP § 2143.I.B).
Response to Arguments
Applicant's arguments filed 01/28/26 have been fully considered but they are not persuasive.
First on pages 8-9, Applicant argues that the retainer is not “configured to transmit an activation force applied to the retainer in a distal axial direction…” and therefore the 35 U.S.C. § 102 claim rejection of at least claim 1 should be withdrawn. The examiner disagrees and maintains the 35 U.S.C. § 102 claim rejection of claim 1 under Jansen.
To support the argument on pages 8-9, Applicant submits that Jansen col 6 lines 40-65 discloses that only the spring 30 transmits the force to move the needle cover, not the retainer. First, the examiner disagrees with this summary because it appears to be a mischaracterization of the prior art reference. Jansen Col 6 lines 40-65 discloses that a force is applied to the retainer and then the retainer is axially displaced to force the other components—i.e. spring and needle cover—to move past the stop members. Therefore, the force transmission starts at the retainer and reasonably discloses the argued limitation. Second, it appears that the Applicant argues that the retainer MUST apply some kind of force directly to the needle cover and therefore the breadth of the claims is not as argued by Applicant on pages 8-9. The limitation as argued begins with “a retainer, the retainer being CONFIGURED TO transmit an activation force applied to the retainer in a distal axial direction…”. Thus, the limitation as argued by Applicant is only functionally recited. In response to applicant's argument that the retainer must directly apply a force to the needle cover, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Jansen’s retainer transmits a force as described in col 6 lines 40-65 and therefore meets the limitation of “being configured to” transmit an activation force applied to the retainer in a distal axial direction to the needle cover. Therefore the examiner was not persuaded by this argument and has maintained the 35 U.S.C. § 102 claim rejection of claim 1 under Jansen.
On pages 9-10, Applicant argues that the second axial slot is not disposed “circumferentially” between the bump and locking window because the second axial slot is only disposed longitudinally between said structures and therefore the 35 U.S.C. § 102 claim rejection of at least claim 1 should be withdrawn. The examiner disagrees and maintains the 35 U.S.C. § 102 claim rejection of claim 1 under Jansen.
Applicant points to a modified figure used in the rejection of claim 4 (see non-final office action mailed 10/01/25 on page 14) to support this argument. However, claim 4, now cancelled, only required that the slot be “between” the locking window and bump, not circumferentially between. Therefore, the previous “Modified FIG.4” is not an accurate representation of Jansen applied to the current limitation requiring the circumferential recitation and therefore the examiner was not persuaded by this argument. The examiner maintains that Jansen does disclose the second slot circumferentially between the locking window and bump as shown and set forth in the rejection of claim 1 above, such as in the new modified figure of FIGs.12a and FIG.1. Thus, the examiner maintains the 35 U.S.C. § 102 claim rejection of claim 1 under Jansen.
On page 10, Applicant argues that Jansen fails to disclose the axial slots “allow” the body to flex outward and therefore the 35 U.S.C. § 102 claim rejection of at least claim 1 should be withdrawn. Applicant does not seem to elaborate or explain more of this position. It seems that Applicant wants the breadth of the term “allow” to be interpreted more narrowly. However, according to Merriam-webster dictionary, “allow” means “to permit” or “to fail to restrain or prevent” (see verb definitions 1a and 1b). Therefore, the examiner maintains that Jansen discloses the argued limitation by definition of “allow” and as applied in the rejection of claim 1 above. Therefore, the examiner disagrees and maintains the 35 U.S.C. § 102 claim rejection of claim 1 under Jansen.
There do not appear to be any other arguments presented other than the secondary references do not cure to deficiencies of Jansen (see bottom of page 10 of Applicant remarks). Thus, because the 35 U.S.C. § 102 claim rejections under Jansen were maintained by the examiner, all subsequent depending claim rejections have also been maintained.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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