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 03/31/26 has been entered. Claims 1-4, 6, 9, and 12-16 have been amended. Claims 5, 7-8, and 10-11 are in the original/previously presented form. Claim 17 is newly presented. Thus, claims 1-17 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 01/06/26.
Specification
The disclosure is objected to because of the following informalities: [0017] reads “the lateral may have a constant width” and should likely read “the lateral wall may have a constant width” as noted by Applicant as shown in the remarks filed 03/31/26 on page 7. 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 6, lines 2-3 recite “the radial protrusion has reinforcing means configured to reinforce a proximal side of this radial protrusion”. Therefore, claim 6 is interpreted under 112(f) according to the 3-prong test:
Prong 1: means is recited
Prong 2: functional language—configured to reinforce a proximal side of the radial protrusion
Prong 3: not modified by other structural language in the claims—no structure is recited for how the means configured to reinforce a proximal side of the radial protrusion reinforces the radial protrusion. Only the desired outcome of “reinforce” is recited.
According to Applicant’s disclosure under 112(f), the “means” configured to reinforce a proximal side of the radial protrusion is interpreted as a “bulge” or equivalent (bulge 410, see FIG. 4A and [0072]: the reinforcing means include a bulge).
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, 4-6, 8, 11, 13-14, and 16 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) the tubular body (26) 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 a user's activation force to the needle cover (28) once the 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 to the needle cover by way of the spring release.), 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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the 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 tubular body (26) in the retracted position (see ‘Modified FIG-3’ above) of the needle cover (28), and 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, see col 5 lines 12-22) of a lateral wall (reduced thickness portion as shown in ‘Modified FIG-4i’ on side/lateral wall of needle cover) of the needle cover (28).
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Regarding claim 4, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the reduced thickness portion (see ‘Modified FIG.-4i’ above) is at a distal portion (a distal portion is the length of the needle cover located distally of the proximal edge of the distal abutment surface 58) of the needle cover (28).
Regarding claim 5, 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 6, 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 (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 (58) has reinforcing means configured to reinforce (see col. 5 lines 15-19: 58 comprises an inclined surface and therefore reasonably comprises a ‘bulge’ as interpreted under 112f above) a proximal side (proximal face of 58) of the radial protrusion (58).
Regarding claim 8, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the body (30) 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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Regarding claim 11, 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 13, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the bump (48, see Fig-1) of the device includes 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 14, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the bump (48) has a first end (“right” side/ proximal end in ‘Modified FIG-3’ above) 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 the 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), the 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 the bump (48).
Regarding claim 16, 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, the safety device (14) being mounted onto the 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, 9, 15, and 17 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 2, Jansen discloses the safety device of claim 1, but Jansen is silent to “wherein the reduced thickness portion comprises one or several axial grooves.”
However, Brunel teaches a safety device comprising a tubular sleeve (121, see FIG. 12a) with a reduced thickness portion (124, see col. 10 lines 47-55: weakness zones 124 can be a “decreasing cross-section” or “lines of less thickness”), the tubular sleeve (121) housing a syringe (114, see Fig. 13a and col. 10 lines 60-62) and being surrounded by a tubular sheath (109, see col. 10 lines 41-67), and wherein the reduced thickness portion (124) comprises one or several axial grooves (see col. 10 lines 47-55: lines of less thickness around the cross section==grooves).
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 reduced thickness portion of the tubular sleeve needle cover disclosed in Jansen to comprise one or several axial grooves as taught by Brunel for the purpose of allowing the tubular sleeve comprising the reduced thickness portion to be fitted easily within the surrounding sheath (see col. 10 lines 50-65), which is advantageous to Jansen’s reduced thickness portion on a needle cover/tubular sleeve 28 housing a syringe 12 and being surrounded by a tubular sheath 26, thus achieving “wherein the reduced thickness portion comprises one or several axial grooves.”
Regarding claim 3, Jansen discloses the safety device of claim 1, but Jansen is silent to “wherein the reduced thickness portion has an inner diameter which is greater than an inner diameter of a rest of the needle cover.”
However, Brunel teaches a safety device comprising a tubular sleeve (121, see FIG. 12a) with a reduced thickness portion (124, see col. 10 lines 47-55: weakness zones 124 can be a “decreasing cross-section” or “lines of less thickness”), the tubular sleeve (121) housing a syringe (114, see Fig. 13a and col. 10 lines 60-62) and being surrounded by a tubular sheath (109, see col. 10 lines 41-67), and wherein the reduced thickness portion (124) has an inner diameter which is less than (inner diameter as shown in ‘Modified FIG. 12b’ below is smaller==less than the rest) an inner diameter of a rest of the (see col. 10 lines 47-55 and ‘Modified FIG. 12b’ below) tubular sleeve (121).
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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 reduced thickness portion of the tubular sleeve needle cover disclosed in Jansen to comprise one or several axial grooves as taught by Brunel for the purpose of allowing the tubular sleeve comprising the reduced thickness portion to be fitted easily within the surrounding sheath (see col. 10 lines 50-65), which is advantageous to Jansen’s reduced thickness portion on a needle cover/tubular sleeve 28 housing a syringe 12 and being surrounded by a tubular sheath 26, thus achieving “wherein the reduced thickness portion has an inner diameter which is” less “than an inner diameter of a rest of the needle cover.”
Jansen in view of Brunel (FIG. 12b) is silent to the reduced thickness portion has an inner diameter which is “greater” than an inner diameter of a rest of the needle cover.
However, Brunel teaches that the reduced thickness portion is formed of longitudinal lines/ grooves that have less thickness distributed round the axis of the sleeve body (see col. 10 lines 53-55). The longitudinal lines in FIG. 12b are shown distributed round the axis of the sleeve body and beginning from an outside circumferential edge (see ‘Modified FIG. 12bi’ below).
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However, while following the description of Brunel, the longitudinal lines could be formed beginning from an inside circumferential edge (see ‘Modified FIG. 12bii’ below)
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such that the reduced thickness portion has an inner diameter (inner diameter as shown in ‘Modified FIG. 12biii’ below is larger==greater than the rest) which is greater than an inner diameter of a rest of the sleeve (see col. 10 lines 53-55).
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Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have formed the grooves of the reduced thickness portion taught by Jansen in view of Brunel (Fig.12b) beginning from an inside circumferential edge of the sleeve as taught by Brunel (see ‘Modified FIG. 12bii’ above).
A person of ordinary skill in the art would have been motivated and capable of achieving this modification because it would have been obvious to try from the two identified (see Brunel col. 10 lines 53-55: “longitudinal lines of less thickness distributed around the axis of the sleeve 121”.), predictable (see col. 10 lines 50-65: these lines permit increased flexibility of tubular sleeve) solutions (There are only 2 ways to form “longitudinal lines of less thickness distributed around the axis of the sleeve 121”. A first way is depicted in FIG. 12b with the longitudinal lines of less thickness distributed around the axis and beginning from the outside circumferential edge as seen in ‘Modified Fig. 12bi’ above. The second way is shown in ‘Modified FIG. 12bii’ above with the longitudinal lines of less thickness distributed around the axis and beginning from the inside circumferential edge) with a reasonable expectation of success (50% chance on the first attempt) for forming the inner diameter of the grooves to be “greater” than the rest of the sleeve, thus achieving the reduced thickness portion has an inner diameter which is “greater” than an inner diameter of a rest of the needle cover.
Lastly, moving the location of the grooves to begin from an internal circumferential edge of the tubular sleeve instead of an outside circumferential edge is a simple rearrangement of parts, which has been held to be unpatentable over the prior art because the rearrangement does not modify the operation of the device (see MPEP § 2144.04.VI.C—in the instant case, both groove formations provide flexibility to the tubular sleeve such that an external sheath is fitted more easily over the tubular sleeve, maintaining device operation).
Regarding claim 9, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the body (26, see FIG-1) has a 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 the 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 15, Jansen discloses the safety device of claim 1, and Jansen further discloses wherein the body (26, see FIG-1) has a 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).
Regarding claim 17, the modified system of Jansen teaches the safety device of claim 2, and Jansen further discloses wherein the reduced thickness portion (see ‘Modified FIG. 4’ above) being located on an inner side of the lateral wall (reduced thickness portion is a smaller thickness at the inner side when compared to thicker region 62 that protrudes from the inner side of the lateral wall) of the needle cover (28).
Jansen is silent to “the one of several axial grooves” of the reduced thickness portion.
However, Brunel teaches a safety device comprising a tubular sleeve (121, see FIG. 12a) with a reduced thickness portion (124, see col. 10 lines 47-55: weakness zones 124 can be a “decreasing cross-section” or “lines of less thickness”), the tubular sleeve (121) housing a syringe (114, see Fig. 13a and col. 10 lines 60-62) and being surrounded by a tubular sheath (109, see col. 10 lines 41-67), and wherein the reduced thickness portion (124) comprises one or several axial grooves (see col. 10 lines 47-55: lines of less thickness around the cross section==grooves).
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 reduced thickness portion of the tubular sleeve needle cover disclosed in Jansen to comprise one or several axial grooves as taught by Brunel for the purpose of allowing the tubular sleeve comprising the reduced thickness portion to be fitted easily within the surrounding sheath (see col. 10 lines 50-65), which is advantageous to Jansen’s reduced thickness portion on a needle cover/tubular sleeve 28 housing a syringe 12 and being surrounded by a tubular sheath 26, thus achieving “the one of several axial grooves” of the reduced thickness portion.
Claims 7 and 12 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 7, 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 12, 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 the second end to the 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 the second end to the 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 the second end to the first end”.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jansen (U.S. Patent No. 6,319,233).
Regarding claim 10, 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 disclosed in Jansen 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).
Response to Arguments
Applicant's arguments filed 03/31/26 have been fully considered but they are not persuasive.
On page 6, Applicant submits that Jansen fails to disclose “a reduced thickness portion of a lateral wall of the needle cover” because the thickness of the needle cover at structure 62 is formed of the wall of the needle cover and a rib 62 and therefore is not a thickness of “only” the needle cover. The examiner disagrees and has maintained the 35 U.S.C. § 102 rejection of claim 1 under Jansen. In col 5 lines 12-22, Jansen discloses that the ribs 62 are provided on the interior surface of the entirety of the tubular body 56 forming the needle cover 28 (see rejection of claim 1 above). Jansen also shows the wall portion with rib 62 as a solid cross-section (see fig. 4) and therefore is a unitary structure. Therefore, the thickness of the body at the reduced thickness portion (see reduced thickness portion in ‘Modified FIG. 4i’ above) is still “reduced” in comparison to the unitary wall of 62. Further, forming a device as a one-piece structure has been held to be an obvious matter of design choice over prior art teaching separate components that rigidly form the device structure (see MPEP § 2144.04.V.B). Therefore, whether the rib 62 and wall of the needle cover are considered a single piece or multiple pieces, the device structure would not overcome the prior art of record.
On pages 2-3, Applicant asserts that the structure 58 must be interpreted as a portion of the thickness of the “reduced thickness portion” in order to meet the limitation that the “distal abutment surface is located on a reduced thickness portion of a lateral wall of the needle cover”. The examiner disagrees and has maintained the 35 U.S.C. § 102 rejection of claim 1 under Jansen. The examiner has measured the “thickness” from the outer surface of the lateral wall of the needle cover (identified as the substantially cylindrical body 56 in col 5 lines 12-22) to the inside surface of the same wall. A thickness measured from an outermost extension/ some other reference point as asserted by applicant is not in the claims. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a reduced thickness portion measured from certain landmarks/reference points of the tubular body structure) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, the examiner maintains the stop member 58 is “on” the reduced thickness portion as shown by the examiner in ‘Modified FIG. 4i’ above. Further, making separable a device structure has been held to be an obvious matter of design choice over prior art teaching one component that rigidly forms the device structure (see MPEP § 2144.04.V.C). Therefore, whether the stop member 58 and reduced thickness portion of the wall of the needle cover are considered a single piece (as argued by applicant) or multiple pieces (such as a wall with a collar 58 provided therearound and suggested in Jansen col 5 lines 12-22), the device structure would not overcome the prior art of record.
On page 7, Applicant appears to argue that Applicant has a special definition for the “width of the lateral wall” that the examiner has failed to apply. Applicant provided an excerpt from [0017] of Applicant’s specification, provided below:
“The lateral may have a constant width, except the portion of said lateral wall from which the distal abutment surface protrudes. The lateral wall may be cylindrical. The distal abutment surface, the activation ring and the locking ring are not part of the lateral wall but radially protrude from said lateral wall; thus by width of the lateral wall it is meant the width between an inner surface and an outer surface of said lateral wall, without considering the radial dimension of the distal abutment surface, activation ring or locking ring.”
Therefore, in [0017], Applicant discloses that the width of the wall is “the width between an inner surface and an outer surface of said lateral wall, without considering the radial dimension of the distal abutment surface” which is how the examiner has applied Jansen (see rejection of claim 1 and previous paragraphs in this response to arguments section). Thus, the examiner was not persuaded by this argument and has maintained the claim rejection under Jansen. Further, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the width of the wall is the width between an inner surface and an outer surface of said lateral wall, without considering the radial dimension of the distal abutment surface. Applicant argues a special definition for the “width” of the wall but only “a reduced thickness portion” is recited in claim 1 and therefore it does not appear that the special definition has been recited in the claim terms—see MPEP § 2173.01.I) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
On pages 7-8 Applicant argues against the reference Brunel and states that Brunel fails to disclose the reduced thickness portion because the decreased cross-section is a change in the shape. However, as explained in the rejection of claim 2 above, the reduced thickness portion taught in Brunel can be either the decreased cross section OR the lines of less thickness and the examiner relies on the lines of less thickness to teach the structure. Therefore, this argument is moot because it attacks a structure not relied upon for the rejection. Further, In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore the examiner was not persuaded by this argument and maintained the 35 U.S.C. § 103 rejection of claim 2 under Jansen in view of Brunel.
Lastly, on page 8, Applicant argued the double patenting rejections. However, the examiner has withdrawn the double patenting rejections in view of the current status of amended claims for both the current application and the reference application 18/088178, rendering this argument moot. However, should the current application be amended to again overlap in subject matter with 18088178 or other similar copending applications, a future provisional double patenting rejection may be applied by the examiner (pending future claim amendments to the claim scopes). Thus, even though the double patenting rejection has been withdrawn, Applicant is encouraged to keep 18088178 and other copending applications in mind when amending future claims to avoid a new double patenting rejection.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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