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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/7/25 has been entered.
Acknowledgments
This office action is in response to the reply filed on 6/18/25 (RCE 7/7/25). In the reply, the applicant amended claims 11-13, 15-16, 20, 22-23; added new claims 27-28. Claims 11-28 are pending.
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 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.
Claims 11-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fiser et al (US 7,361,159) (“Fiser”). Fiser discloses:
A safety shield 40 for a needle, comprising (Fig. 8), a base member 48 fixed to a proximal end 42 of a needle 44; an enclosure housing 56 movably connected at a distal end 76 of the needle and slidable along a length of the needle, the enclosure housing adapted to contact a skin of a patient and guide the needle into the patient during insertion of the needle into the patient; and
an arm 58/65 hinged at a proximal end to the base member (arm configured to hinge at approximately a midpoint thereof) and extending axially from the needle, the arm configured to connect the base member to the enclosure housing at a distal end of the arm (Fig. 8), the arm being preloaded such that the arm is self-biased toward an extended position, wherein, when the arm moves toward the extended position, the arm is configured to advance the enclosure housing towards the distal end of the needle (see abstract) (Fig. 8).
(claims 12-16,21-23) the arm and the enclosure housing in Fiser is capable of performing the functional language in these claims: configured to displace a buckling load off of the needle to prevent it from bending during use; configured to guide the needle in a straight line through the enclosure housing; enclosure housing configured to slide down the needle towards the base member as the needle penetrates the skin; arm configured to bend to accommodate the sliding motion of the enclosure housing along the needle; arm pushes the enclosure housing back to the distal end of the needle using an elastic force of the arm as the patient pulls the needle out of the skin.
A locking mechanism 50 to prevent the enclosure housing from sliding proximally from the distal end of the needle after a use. C5L36-47, C6L53-57
The safety shield is formed in a single shot molding process and comprises plastic. C5L64-C6L15
(claims 27-28) in a pre-use state, the enclosure housing 56 is configured to cover 76 the distal end of the needle, see Fig. 5
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues that the arm of Fiser is not self-biased. This argument is not persuasive. Fiser in C2L25-26 describes both the extensible frame being resiliently biased from a retracted position to an extended position and C40-44 a resilient member configured to bias the extensible frame from a retracted position to an extended position. Further, the locking cover operates automatically in C3L13-15. Thus, three points, either the arm of Fiser is self-biased, the leaf spring 80 of Fiser is said to be a part of the arm itself (Fig. 8), thus self-biasing, and applicant does not fully describe how the invention as claimed is self-biased itself. Most notably, applicant describes “biased” as being spring loaded [0029] or “spring or other biasing means”. Rejections are maintained that Fiser’s arm is self-biased toward an extended position.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 9:00am-5:30pm est.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783