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 Amendments
The Amendment filed 06/30/2026 has been entered.
Claim 2 is cancelled.
Claims 1 and 3-17 remain pending in the application.
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 8, lines 2-3 recite “the radial protrusion has reinforcing means configured to reinforce a proximal side of this radial protrusion”. Therefore, claim 8 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).
Claim Rejections - 35 USC § 103
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, 3-8, 10, 12, 13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen (U.S. Patent Pub. 20020120239), hereinafter Jansen, in view of Barrelle et al. (U.S. Patent Pub. 20030212380), hereinafter Barrelle.
Regarding claim 1, Jansen discloses a safety device (shield system 14; see FIG. 1; the Examiner notes that all reference characters cited below refer to FIG. 1 unless otherwise stated) for mounting onto a medical container (syringe 12) provided with a flange (flange 24) and an injection needle (needle 18), the safety device comprising:
a tubular body (holder 26) extending along a longitudinal axis (see axis demonstrated by dotted line of FIG. 1), the tubular body being configured to receive the medical container (see FIG. 2);
a needle cover (shield 28) movable relative to the body between a retracted position, and an extended position (“slidably mounted”, [0045]) in which the needle cover distally extends from the retracted position in order to shield the injection needle after activation of the safety device (see [0045]);
a release element (spring 30) configured to move the needle cover from the retracted to the extended position after activation of the safety device (“spring 30 expands rapidly, causing the shield to slide axially”, [0049]); and
a retainer (fitting 32), the retainer being configured to transmit an activation force to the needle cover once an injection operation is completed (see pressure exertion by user in [0056]), wherein
the needle cover comprises a distal abutment surface (stop member 58), the distal abutment surface abutting against a proximal abutment surface of a bump (stop member 48) protruding from the body in the retracted position of the needle cover,
wherein the body has a first axial slot (opening 46a).
Jansen does not expressly state the first axial slot having a predetermined length comprised between 1 mm and 6 mm.
Jansen does disclose “The sizes of the openings are selected based upon the amount of flexibility desired in the holder body” [0037]. The Examiner is of the position this is sufficient disclosure to teach or suggest a predetermined length comprised between 1 mm - 6 mm as claimed).
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 so that it has a predetermined length comprised between 1 mm - 6 mm. Doing so would 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).
Jansen does not expressly state wherein the first axial slot extends from a distal end of the body to a closed proximal end of the first axial slot, and wherein the closed proximal end of the first axial slot is proximally located with regard to a proximal abutment surface of a locking window.
Barrelle teaches a passive shield system for a syringe (Abstract) wherein the first axial slot extends (see slots 40 and openings adjacent groove 38 in FIG. 5) from a distal end of the body to a closed proximal end of the first axial slot (see [0044; 0051]), and wherein the closed proximal end of the first axial slot is proximally located with regard to a proximal abutment surface of a locking window (detents 48; see FIG. 5)
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Jansen wherein the first axial slot extends from a distal end of the body to a closed proximal end of the first axial slot, and wherein the closed proximal end of the first axial slot is proximally located with regard to a proximal abutment surface of a locking window. Doing so allows needle shield to be locked in an extended position, as taught by Barrelle (see [0053]).
Regarding claim 3, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Jansen does not expressly state wherein the first axial slot has a length equal to or lower than 4.5 mm.
Jansen teaches wherein the first axial slot has a length equal to or lower than 4.5 mm (“The sizes of the openings are selected based upon the amount of flexibility desired in the holder body”, [0037]; the Examiner notes the flexibility of the tubular body is 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 equal to or lower than 4.5 mm. Doing so would 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).
Regarding claim 4, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Jansen does not expressly state wherein the first axial slot has a length equal to or greater than 4.5 mm.
Jansen teaches wherein the first axial slot has a length equal to or greater than 4.5 mm (“The sizes of the openings are selected based upon the amount of flexibility desired in the holder body”, [0037]; the Examiner notes the flexibility of the tubular body is 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 equal to or greater than 4.5 mm. Doing so would 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).
Regarding claim 5, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen further teaches wherein the first axial slot (opening 46a) extends adjacent to a second end of the bump (member 48; the Examiner notes the stop member 48 and opening 46a interrupt one another, therefore must be adjacent.).
Regarding claim 6, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen further teaches wherein at least one of the proximal abutment surface (proximal face of bump 48) and the distal abutment surface (distal face of 58) comprises a chamfer (“inclined surfaces of the stop members”, [0048]; the Examiner notes a chamfer is defined as a slanted edge) configured to ease passage of the needle cover (shield 28, “inclined surfaces of the stop members slide past each other”, [0048]) over the bump when the needle cover moves distally to the extended position (see FIG. 4).
Regarding claim 7, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen further teaches wherein the distal abutment surface (distal face of 58) is located on a reduced thickness portion of the needle cover (shield 28; see Examiner annotated FIG. 4 below).
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Regarding claim 8, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen further teaches wherein the distal abutment surface (distal face of 58) of the needle cover (shield 28) is located on a radial protrusion (member 58) of the needle cover, and the radial protrusion has reinforcing means configured to reinforce a proximal side of this radial protrusion (“. A stop member 58 in the form of a radially outwardly extending collar is formed on the body 56 of the shield. This stop member has an inclined surface which is engageable with the inclined surface of the stop member 48 on the holder.”, [0041]; the Examiner notes member 58 can be defined as a bulge as interpreted under 112f above.).
Regarding claim 10, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen further teaches wherein the body (holder 26) has a first axial slot (opening 46a) and a second axial slot (opening 46b), the first axial slot and the second axial slot extending on both sides (see Examiner annotated FIG. 1 below) of the bump (member 48).
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Regarding claim 12, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen further teaches wherein the bump (member 48) extends in a circumferential direction (see Examiner annotated FIG. 1 below). However, Jansen does not expressly state extending in a circumferential direction according to a central angle comprised between 22.5° and 45°.
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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 [0038]). 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 [0037]) 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 13, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen further teaches wherein the bump (member 48) of the body (holder 26) has a first end (proximal face of bump 48) provided with a chamfer (“inclined surfaces of the stop members”, [0048]; the Examiner notes a chamfer is defined as a slanted edge) extending in a circumferential direction (the Examiner notes member 48 extends circumferentially and therefore the chamfer extends in a circumferential direction along structure of bump 48).
Regarding claim 15, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen further teaches wherein the device comprises only two bumps (member 48; see first bump traced in black and second bump traced in gray of Examiner annotated FIG. 1 below).
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Regarding claim 16, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen further teaches wherein the bump (member 48) has a first end (proximal face of bump 48) and an opposite second end (distal face of bump 48), and the proximal abutment surface of the bump has a ramp portion (inclined surface outlined in gray in Examiner annotated FIG.3 below), the ramp portion 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 a first end of the bump.
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Regarding claim 17, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen further teaches an injection device (device 100) comprising a medical container (syringe 12) having an injection needle (needle 18) and the safety device (shield system 14) of claim 1, the safety device being mounted onto the medical container (“syringe 12 and a shield system 14 coupled to the syringe”, [0032]).
Claims 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen (U.S. Patent Pub. 20020120239), hereinafter Jansen, in view of Barrelle et al. (U.S. Patent Pub. 20030212380), hereinafter Barrelle, and further in view of Srinivasan et al. (U.S. Patent Pub. 20150157807), hereinafter Srinivasan.
Regarding claim 9, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Jansen in view of Barrelle does not expressly state wherein the bump has a cantilevered portion.
Srinivasan teaches a safety pen needle assembly (Abstract) wherein the bump (detent 40; see FIG. 10 and 11) has a cantilevered portion (cantilevered arm 44).
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the bump of Jansen in view of Barrelle by including a cantilevered portion. Doing so would create a snap-engagement that allows the bump to by-pass the abutting surface in a preferred direction while inhibiting movement in the other, as taught by Srinivasan (see [0017;0022]).
Regarding claim 14, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen in view of Barrelle further teaches wherein the bump (member 48) of the body (holder 26) has a first end (proximally extending portion of member 48), an opposite second end (distally extending portion of member 48). However, Jansen in view of Barrelle does not expressly state wherein the bump of the body has a decreasing height from the second end to the first end.
Srinivasan teaches a safety pen needle assembly (Abstract) wherein the bump of the body has a decreasing height from the second end to the first end (see decreasing height in Examiner annotated FIG. 11 below).
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It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the bump of Jansen in view of Barrelle by including a decreasing height from the second end to the first end. Doing so would create a snap-engagement that allows the bump to by-pass the abutting surface in a preferred direction while inhibiting movement in the other, as taught by Srinivasan (see [0017;0022]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jansen (U.S. Patent Pub. 20020120239), hereinafter Jansen, in view of Barrelle et al. (U.S. Patent Pub. 20030212380), hereinafter Barrelle, and further in view of Brunel et al. (U.S. Patent No. 5855839), hereinafter Brunel.
Regarding claim 11, Jansen in view of Barrelle teaches the claimed invention as discussed above concerning the rejection of claim 1, and Jansen further teaches wherein the body (holder 26) has a first axial slot (opening 46a) extending from an end of the body (end formed by flange 38), and the bump (member 48) is circumferentially distant from the first axial slot (the Examiner notes member 48 does not extend into openings 46A/B and therefore the slots must be ‘circumferentially distant’ or separated by a circumference from the bump). However, Jansen in view of Barrelle doesn’t expressly state wherein the end is a distal end.
Brunel teaches a process for manufacturing an injection device (Abstract) wherein the body (body 101) has a the first axial slot (slot 102) extends from a distal end (see FIG. 10).
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the slot of Jansen in view of Barrelle by extending it from the distal end. Doing so would the distal end of the device with a desired radial flexibility, as taught by Brunel (see FIGS. 10-11; see Col 9 Lines 64 – Col 10 Lines 27).
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, see Remarks filed 06/30/2026, with respect to the rejection(s) of claim(s) 1-17 under 35 U.S.C. 103 as being unpatentable over Jansen (U.S. Patent Pub. 20020120239), have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Jansen (U.S. Patent Pub. 20020120239) in view of Barrelle (U.S. Patent Pub. 20030212380).
Conclusion
THIS ACTION IS MADE FINAL. 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 NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
08/19/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights