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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: an opening unit, a safety unit, an assembly unit, and a guiding unit in claims 4, 6, 8, and 10.
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 § 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.
Claim(s) 1 and 4-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carrel et al. (WO 2019/053112 A1) in view of Sweeney et al. (US 5,746,726).
With regard to claims 1, 11, and 12, Carrel et al. teach a safety device for a needle of a medical device, the safety device comprising: a ring arranged to be fixed with regard to the needle (Fig. 1 member 22) a shield arranged to be mounted on the ring (Fig. 1 member 60) by a pivot link (Fig. 1 pivot connection at 64 and 30) so as to define a closed position in which the shield covers the needle (Pg. 10 lines 26-27) and an open position in which the shield does not cover the needle (Pg. 10 lines 35-36) a protective cap configured to surround the needle and to accommodate at least part of the shield in the closed position (Fig. 1 member 80). Carrel et al. do not disclose a locking and release unit. However, Sweeney et al. teach locking a shield to a ring via a recess on the ring and a projection on the shield (Figs. 4-6 recesses formed in 58, projection 56 attached to an arm taken as a wing) which is released via 60 (Fig. 4 which is a protrusion with a deflecting surface) to provide releasable latching (Col. 2 lines 58-64). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a lock and release in Carrel et al. as in Sweeney et al. as this would ensure the shield remains securely attached to enhance safety and prevent injury.
With regard to claims 4 and 5, see pusher 83 and cam 66 (Figs. 1 and 7 of Carrel et al. Pg. 10 lines 29-34).
With regard to claims 6 and 7, as combined the arm attached to 56 is taken as a wing, the sloped surface of 58 is adapted to deflect the wing.
With regard to claims 8-10, see Reference Figure 1 below.
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With regard to claim 13, see Reference Figure 1 above and needle cap 50 (Fig. 1).
With regard to claim 14, Carrel et al. teach a safety needle hub adapted to be fixed on a medical device, the safety needle hub comprising a needle (Fig. 1 member 102) and a safety device according to claim 1 (see the rejection of claim 1 above).
With regard to claims 15 and 16, Carrel et al. teach a medical device adapted to inject and/or remove a fluid from a body, the medical device comprising a needle (Fig. 1 member 102) and a safety device according to claim 1 (see the rejection of claim 1 above).
Response to Arguments
Applicant's arguments filed March 18, 2026 have been fully considered but they are not persuasive. Applicant argues 56 and 58 are disengaged by a practitioner’s finger causing deflection of 60 and as such the arm attached to 56 is taken as rigid and stationary. The Examiner maintains that when 56 and 58 disengaged the arm with 56 deflects as shown in Fig. 6, the arm changes position. The claim does not recite a particular point or plane about which the wing is flexible/deflectable relative to or degree of flexion/deflection. The Examiner finds the arm/wing to be flexible as it moves with the cap and also due to the narrowed connection between 56 and the cap there would be some flexibility to the structure. Applicant argues if combined portions 58 and 60 would be provided to 22 of Carrel not cap 70. The claim does not recite structurally how the components are provided on the cap. Member 22 surrounds the cap and thus the components are placed on the cap. Applicant argues that due to the manipulation of components by a practitioner this does not read on the components being released during a portion of a removal movement of the protective cap. Such movement by a practitioner is considered as a portion of the removal process of the cap. There is no specific recitation as to structurally what occurs during the removal movement to cause disengagement or bounds placed on the removal.
The amendments are sufficient to overcome the previous objections and rejections under 35 U.S.C. 112.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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