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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a first slot and a second slot located at axial ends therof” (as recited in claim 4) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “102-2” has been used to designate both a proximal end of the tubular body (figures 1, 2, and 3a) and a distal end of the tubular body (figure 5). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 7 is objected to because of the following informalities: The claim recites the limitation of “the first end” in the 2nd line of the claim. There is a lack of antecedent basis for this limitation in the claims. The limitation should be corrected to recite “a first end.” Appropriate correction is required.
Claim 9 is objected to because of the following informalities: The claim recites the limitation of “the form” in the 2nd line of the claim. There is a lack of antecedent basis for this limitation in the claims. The limitation should be corrected to recite “a form.” Appropriate correction is required.
Claim 10 is objected to because of the following informalities: The claim recites the limitation of “the first flange” in the 3rd and 4th lines of the claim. There is a lack of antecedent basis for this limitation in the claims. The limitation should be corrected to recite “a first flange.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
[Claim 1] The claim recites “A safety device for a syringe assembly.” As such, the “syringe assembly” and associated components are not positively recited claim structures. However, the claim further recites “a needle of the syringe assembly is positioned inside the hollow cavity of the tubular body.” Given this recitation, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if the “syringe assembly” is intended to be functionally or positively recited. For purposes of the examination, it is interpreted that the “syringe assembly” and associated components are only functionally recited, and that the last limitation of the claim should recite “wherein the hollow cavity of the tubular body is configured to contain a needle of the syringe assembly.”
[Claim 4] The claim recites the limitation of “wherein the spring-loaded cap comprises a first slot and a second slot located at axial ends thereof.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear how the term “slot” is intended to be interpreted. If the term lot is intended to refer to a narrow slit within the cap; such a structure is not shown or described within the drawings and written specification. However, if the term “slot” is intended to refer to an aperture on opposite axial ends of the cap, such a structure would be supported by the drawings. For purposes of examination, it is interpreted that terms “slot,” relative to the structure of the cap, are referring to apertures on opposite axial ends of the cap.
[Claim 6] The claim recites the limitation of “wherein the spring-loaded cap is biased with respect to the proximal end of the tubular body by a spring, to enable the spring-loaded cap to remain in the retracted position.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear how the “spring” is biasing the cap to remain in the retracted position. As described in the written specification and drawings, it would appear that the cap is biasing the spring in the retracted position. However, when the actuation member releases the cap, the spring is then capable of biasing the cap into the extended position. For purposes of examination, it is interpreted that the limitation should recite “wherein a spring is biased with respect to the proximal end of the tubular body by the spring-loaded cap, to enable the spring-loaded cap to remain in the retracted position.”
[Claim 9] The claim recites the limitation of “wherein the actuation member is in the form of a link” in the 2nd line of the claim. The examiner is unable to determine the meets and bounds of the claim, since it is unclear what type of structure is intended to be claimed by this limitation. In other words, it is unclear if this term is intended as a relationship (connection/coupling) of the actuation member with the tubular body or if a particular structure is intended to be claimed. For purposes of examination, it is interpreted that any structure that has “a curved profile between the actuation end and the free end” meets the limitations of the claim.
[Claim 10] The claim recites the limitation of “wherein when the spring-loaded cap is present in the extended position, the syringe assembly is positioned at a finger flange area located at the proximal end of the tubular body, in which the first flange is engaged with a latch of the tubular body, to prevent the syringe assembly from moving towards the distal end of the tubular body.” The examiner is unable to determine the metes and bounds of the claim, as it is unclear how the syringe assembly could be positioned at the proximal end of the tubular body, when the cap is in the extended position. For purposes of examination, it is interpreted that the claim intends to recite the syringe assembly is functionally capable of being at a finger flange area located at the distal end of the tubular body.
[Claims 2-10] The claims are rejected based upon their dependency from independent claim 1.
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.
Claims 1-3, 6, and 7, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petrussa (USPN 5,376,080).
[Claim 1] Petrussa teaches a safety device (figure 1, item 10) for a syringe assembly (figure 1, item 14) (the examiner notes the “syringe assembly” is only functionally recited), comprising:
a tubular body (figure 1, item 20) having a distal end (figure 1, at item 23) and a proximal end (figure 1, at item 27), wherein the tubular body (figure 1, item 20) includes a hollow cavity (as shown in figure 1) for receiving the syringe assembly (figure 1, item 14) through the distal end (figure 1, at item 23) thereof (column 2, lines 22-28);
a spring-loaded (via spring 12) cap (figure 1, item 35) inserted into the hollow cavity at the proximal end (figure 1, at item 27) of the tubular body (figure 1, item 20) (column 4, lines 14-17); and
an actuation member (figure 1, items 23/26) configured to move the spring-loaded cap (figure 1, item 35) between a retracted position (figure 1) and an extended position (figure 2), wherein in the retracted position (figure 1), the spring-loaded cap (figure 1, item 35) is restricted to move with respect to the proximal end (figure 1, at item 27) of the tubular body (figure 1, item 20) (column 4, lines 14-22), and in the extended position (figure 2) of the spring-loaded cap (figure 1, item 35), a needle (figure 2, item 11) of the syringe assembly (figure 1, item 14) is (see 112b interpretation above) positioned inside the hollow cavity of the tubular body (figure 1, item 20) (figure 2).
[Claim 2] Petrussa teaches the limitations of claim 1, upon which claim 2 depends. In addition, Petrussa discloses the tubular body (figure 1, item 20) comprises a plurality of internal lugs at the distal end (figure 1, item 24) for fixedly holding the syringe assembly (figure 1, item 14) (figure 1; column 4, lines 33-42).
[Claim 3] Petrussa teaches the limitations of claim 1, upon which claim 3 depends. As stated above, the “syringe assembly” is only functionally recited. As such, the prior art taught by Petrussa is functionally capable of containing the functionally recited structure and the functionally recited components of said structure.
[Claim 6] Petrussa teaches the limitations of claim 1, upon which claim 6 depends. Petrussa also teaches a spring (figure 2, item 12) is biased with respect to the proximal end (figure 1, at item 27) of the tubular body (figure 1, item 20) by the spring-loaded cap (figure 1, item 35) (see 112b interpretation above), to enable the spring-loaded cap (figure 1, item 35) to remain in the retracted position (figure 1).
[Claim 7] Petrussa teaches the limitations of claim 6, upon which claim 7 depends. Petrussa further discloses the spring (figure 2, item 12) is supported by a first flange (figure 1, items 17/18) positioned at the first end of the spring-loaded cap (figure 1, item 35) and a second flange (figure 1, item 27) located at the proximal end (figure 1, at item 27) of the tubular body (figure 1, item 20), such that in the retracted position, the spring-loaded cap (figure 1, item 35) is restricted to move with respect to the proximal end (figure 1, at item 27) of the tubular body (figure 1, item 20) (column 4, lines 3-63).
Claims 1 and 3-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malenchek (PGPub 2004/0230158).
[Claim 1] Malenchek teaches a safety device (figure 1) for a syringe assembly (figure 1, items 12/18) (the examiner notes the “syringe assembly” is only functionally recited), comprising:
a tubular body (figure 1, item 22) having a distal end (figure 1, item 54) and a proximal end (figure 1, item 52), wherein the tubular body (figure 1, item 22) includes a hollow cavity (figure 1, item 48) for receiving the syringe assembly (figure 1, items 12/18) through the distal end (figure 1, item 54) thereof (figure 5);
a spring-loaded (via item 24) cap (figure 1, item 28) inserted into the hollow cavity (figure 1, item 48) at the proximal end (figure 1, item 52) of the tubular body (figure 1, item 22) (figure 5); and
an actuation member (figure 1, item 30/88) configured to move the spring-loaded cap (figure 1, item 28) between a retracted position (figure 5) and an extended position (figure 4) (paragraphs [0026], [0036]-[0043]), wherein in the retracted position (figure 5), the spring-loaded cap (figure 1, item 28) is restricted to move with respect to the proximal end (figure 1, item 52) of the tubular body (figure 1, item 22) (paragraph [0038]), and in the extended position (figure 4) of the spring-loaded cap (figure 1, item 28), a needle (figure 1, item 42) of the syringe assembly (figure 1, items 12/18) is (see 112b interpretation above) positioned inside the hollow cavity (figure 1, item 48) of the tubular body (figure 1, item 22) (figure 4; paragraph [0041]).
[Claim 3] Malenchek teaches the limitations of claim 1, upon which claim 3 depends. As stated above, the “syringe assembly” is only functionally recited. As such, the prior art taught by Malenchek is functionally capable of containing the functionally recited structure and the functionally recited components of said structure.
[Claim 4] Malenchek teaches the limitations of claim 3, upon which claim 4 depends. Malenchek further discloses the spring-loaded cap (figure 1, item 28) comprises a first slot (opening at 86) and a second slot (opening at 68) located at axial ends thereof (see 112b interpretation above) (figure 2; paragraph [0024]), and a plurality of teeth (figure 2, item 80) adapted to scratch an outer surface of the luer slip and prevent the luer slip from moving out of the spring-loaded cap (figure 1, item 28) (the examiner notes the “luer slip” is part of the functionally claimed syringe assembly) (figure 2; paragraph [0024]).
[Claim 5] Malenchek teaches the limitations of claim 4, upon which claim 5 depends. In addition, Malenchek teaches the first slot (opening at 86) has a larger diameter than the second slot (opening at 68) (as shown in figures 2 and 3).
[Claim 6] Malenchek teaches the limitations of claim 1, upon which claim 6 depends. Malenchek also teaches a spring (figure 1, item 24) is biased with respect to the proximal end (figure 1, item 52) of the tubular body (figure 1, item 22) by the spring-loaded cap (figure 1, item 28) (see 112b interpretation above), to enable the spring-loaded cap (figure 1, item 28) to remain in the retracted position (figure 5) (paragraphs [0038]-[0043]).
[Claim 7] Malenchek teaches the limitations of claim 6, upon which claim 7 depends. Malenchek further discloses the spring (figure 1, item 24) is supported by a first flange (ring portion of ring 30) positioned at the first end of the spring-loaded cap (figure 1, item 28) (paragraphs [0026], [0035]-[0040]) and a second flange (flange shown in figure 1 near item 52) located at the proximal end (figure 1, item 52) of the tubular body (figure 1, item 22) (paragraphs [0022], [0035]), such that in the retracted position (figure 5), the spring-loaded cap (figure 1, item 28) is restricted to move with respect to the proximal end (figure 1, item 52) of the tubular body (figure 1, item 22) (figure 5) (paragraph [0038]).
Allowable Subject Matter
Claims 8-10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 08/30/2026
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