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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/12/26 has been entered.
Response to Amendment
The amendment filed 06/12/26 has been entered. Claim 1 has been amended. Claims 2-16 are in the original/ previously presented form. Thus, claims 1-16 remain pending in the application. There were no objections or 112 rejections previously set forth in the Final Office Action mailed 03/26/26. Therefore, there are no objections or 112 rejections withstanding.
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 7, lines 2-3 recite “the radial protrusion has reinforcing means configured to reinforce a proximal side of this radial protrusion”. Therefore, claim 7 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 [0073]: 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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-16 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, lines 13-15 read “wherein the safety device requires a user to exert the activation force on the retainer in order to cause movement of the needle cover from the retracted position to the extended position”, which appear to be directed to a human organism/ user by stating the device “requires a user”. Due to claim dependency, claims 2-16 are subsequently rejected under 35 U.S.C. 101.
In order to overcome this rejection, Applicant could amend claim 1 lines 13-15 to read “wherein the safety device requires [[a user to]] exertion of the activation force on the retainer in order to cause movement of the needle cover from the retracted position to the extended position” or “wherein the safety device [[requires]] is configured to allow a user to exert the activation force on the retainer in order to cause movement of the needle cover from the retracted position to the extended position”.
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 1-7, 9, 11-12, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen et al. (U.S. Patent No. 6,319,233), hereinafter Jansen, in view of Yin et al. (U.S. PGPUB No. 2024/0082505: all subject matter relied upon for this rejection is supported by provisional application 63/250313 filed August 2021), hereinafter Yin.
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 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); and
a retainer (32), the retainer (32) being configured to retain the release element (30) inside the safety device (see col. 5 lines 40-53: retainer 32 holds spring 30 at one end and is inserted into device and thus ‘is configured to retain’ the spring in the device. See also col4 lines 14-17) and to transmit an activation force 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 an activation force—the distally applied force on fitting 32-- to the needle cover),
wherein the safety device requires a user to exert the actuation force (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) on the retainer (32) in order to cause movement of the needle cover (28) from the retracted position (as in FIG-3 ) to the extended position (as 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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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 body (26) in the retracted position (see ‘Modified FIG-3’ above) of the needle cover (28), and
wherein the bump (48) has a first end (rightward end of bump, see ‘Modified FIG. 1i’ below)
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and an opposite second end (leftward end of bump, see ‘Modified FIG. 1i’ 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 and has a ‘decreasing’/ negative slope due to a negative change in ‘height’ of the inclined surface. This decreasing slope is formed along the edge of the bump and therefore the decreasing slope is ‘toward’ the first end and toward the second end) towards the first end (rightward end of bump, see ‘Modified FIG. 1i’ above) of said bump (48), so as to ease passage (see col. 6 lines 49-51: inclined surfaces of 48/58 slide past each other and therefore ‘ease passage’ of the needle cover by way of the inclined surfaces and see col. 5 lines 15-19: 48 and 58 comprise inclined surfaces) of the needle cover (28) over the bump (48) when the needle cover (28) moves (see col. 6 lines 40-65) from the retracted position (as in FIG-3) to the extended position (as in FIG-4), and
wherein an axial dimension (measured from the peak to the bottom of the inclined surface) of the 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) is at the first end and at the second end of the bump (48).
Jansen is silent to wherein an axial dimension of the ramp portion “is greater at the first end than at the second end of the bump such that the ramp portion gradually widens towards the first end, while tapering towards the second end of the bump.”
However, Yin teaches a safety device (see Fig. 2) comprising a tubular body (20) and a needle cover (21, see [0005]: delivery member guard covers needle and [0132]: protrusion 214 of delivery member guard 21 rides along inclined surface 222’), the tubular body (20, see [0123]: 22, which has bump as shown in ‘Modified FIG. 4b’ below, is irremovably attached to body 20) having a bump (protrusion comprising inclined surface 222’, see ‘Modified FIG. 4B’ below)
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comprising a ramp portion (surfaces of bump including inclined surface 222’, see ‘Modified FIG. 4B’ above). Yin further teaches wherein an axial dimension (axial dimension measured from bottom/ flat surface of bump to inclined surface 222’) of the ramp portion (surfaces of bump including inclined surface 222’) is greater (see axial dimension larger at first end as shown in ‘Modified FIG. 4B’ above) at a first end than at a second end of the bump such that the ramp portion gradually widens (see gradual increase in width from first end to second end as shown in ‘Modified FIG. 4B’ above) towards the first end, while tapering towards the second end of the bump (see ‘Modified FIG. 4B’ above, FIG. 4B, and [0132]: bump with inclined surface 222’ extends in circumferential and longitudinal direction in helical manner==tapering and gradual widening).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have substituted the ramp portion formed of an inclined surface disclosed in Jansen with the ramp portion formed of an inclined surface wherein an axial dimension of the ramp portion is greater at the first end than at the second end of the bump such that the ramp portion gradually widens towards the first end, while tapering towards the second end of the bump as taught in Yin.
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 tubular body comprising a bump having a ramp portion formed of an inclined surface for engaging a needle cover as disclosed in Jansen) for another known element (a tubular body comprising a bump having a ramp portion formed of a tapering inclined surface for engaging a needle cover as taught in Yin) in the art to obtain the predictable result of coupling tubular elements that are telescopically and concentrically arranged to form a safety device over a needle (see MPEP § 2143.I.B), thus achieving wherein an axial dimension of the ramp portion “is greater at the first end than at the second end of the bump such that the ramp portion gradually widens towards the first end, while tapering towards the second end of the bump.”
Additionally, 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 substituted the ramp portion formed of an inclined surface disclosed in Jansen with the ramp portion formed of an inclined surface wherein an axial dimension of the ramp portion is greater at the first end than at the second end of the bump such that the ramp portion gradually widens towards the first end, while tapering towards the second end of the bump as taught in Yin for the purpose of imparting rotational movement to the telescopically arranged needle cover (see Yin [0132] & [0134]).
Regarding claim 2, the modified system of Jansen teaches the safety device of claim 1, and Jansen further discloses wherein the slope (inclined surface with slope due to change in ‘height’ of the inclined surface, see at least ‘Modified FIG.-3’ above) continuously decreases (the slope does not ever increase in height along the edge of the bump and therefore “continuously” decreases) from the second end (leftward side in ‘Modified FIG. 1i’ above) to the first end (rightward side in ‘Modified FIG. 1i’ above) of the bump (48).
Regarding claim 3, the modified system of Jansen teaches the safety device of claim 1, and Jansen further discloses wherein the 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) delimits a twisted contact surface (see col. 5 lines 15-19: bump 48 has inclined surface and therefore delimits a twisted contact surface as much as is disclosed by Applicant disclosure in [0020], [0035], and [0073]: inclined surfaces delimit the contact surface).
Regarding claim 4, the modified system of Jansen teaches the safety device of claim 1, and Jansen further discloses wherein the second end (leftward side of the bump in ‘Modified FIG.1a’ above) of the bump (48) is adjacent to a first axial slot (46A, see Fig-1 and col 4 lines 57-62: bump 48 interrupted by slot 46A and therefore second end “adjacent”).
Regarding claim 5, the modified system of Jansen teaches 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, the modified system of Jansen teaches 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 7, the modified system of Jansen teaches 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 this radial protrusion (58).
Regarding claim 9, the modified system of Jansen teaches the safety device of claim 1, and Jansen further discloses 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-1i’ 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, the modified system of Jansen teaches 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°and 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° and 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° and 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).
Regarding claim 12, the modified system of Jansen teaches the safety device of claim 1, and Jansen further discloses wherein the first end (rightward side in ‘Modified Fig.1i’ of rejection of claim 1 above) of the bump (48, see FIG-1) of the body (26) is 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, the modified system of Jansen teaches the safety device of claim 1, and Jansen further discloses wherein the bump (48, see Fig-1) of the device includes only two bumps (see ‘upper bump’==first bump traced in black and ‘lower bump’==second bump traced in gray of ‘Modified Fig-1vi’ below).
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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 the modified system of claim 1, and Jansen further discloses wherein the safety device (14) is 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).
Claims 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Yin 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 8, 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, the modified system of Jansen teaches the safety device of claim 1, but Modified Jansen is silent to “wherein the bump of the body has 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),
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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 the second end to the first end.”
Claims 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Yin as applied to claim 1 above, and further in view of Brunel (U.S. Patent No. 5,855,839).
Regarding claim 10, the modified system of Jansen teaches 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, the modified system of Jansen teaches 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), 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 the body and the first axial slot having a predetermined length “comprised between 1 mm and 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 and 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 with respect to claim 1 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.
A new 35 U.S.C. § 103 rejection under Jansen in view of Yin has been used to meet the newly amended and argued claim limitation, rendering the arguments moot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Alheidt et al. (U.S. PGPUB No. 2006/0189933) teaches a bump (685, see FIG. 23) of a tubular body (682) having a ramping portion (see cutouts shown near 685 in FIG.22). the bump retains a needle cover (622, see FIG. 25)
Peruzzo (U.S. PGPUB No. 2010/0324492) teaches a tubular element with a bump (412, see FIG. 14A-B) with a ramping portion (see spiral configuration in FIG. 14A)
Koch et al. (U.S. PGPUB No. 2002/0128609) teaches a tubular element with a bump (40’, see FIG. 6) with a tapering/narrowing ramping portion (37, see [0046]: see narrowing of ramping portion described)
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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