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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 C.F.R. § 1.84 because they include halftones instead of solid black lines. See Figs. 1-5. Halftone images are not the equivalent to black and white line drawings for the subject matter of the figures. 37 C.F.R. § 1.84(a)(1). Halftones are more similar to photographs than to drawings which use only solid black lines; photographs are normally not permitted, unless they are the “only practicable medium for illustrating the claimed invention.” 37 C.F.R. § 1.84(b)(1). Halftone images do not give the drawings satisfactory reproduction characteristics, 37 C.F.R. § 1.84(l), at least because the lines defining the features of the device are neither clean nor sufficiently dense and dark. Id. To the extent that the use of halftones in the instant drawings may qualify as “shading” within the meaning of 37 C.F.R. § 1.84(m), they detract, rather than aid in, an understanding of the invention and also reduce legibility of the drawings.
The record evidence, including patent publications disclosing subject matter similar to that disclosed in this application, demonstrates that neither photographs nor illustrations including halftones are the “only practicable medium for illustrating the claimed invention.” Accordingly, new drawings are required for the above-identified figures which do not include the use of halftones.
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.
Specification
The Abstract of the Disclosure (“Abstract”) is objected to because it is too long (186 words) and includes legal phraseology (“said”).
A corrected Abstract is required. See MPEP § 608.01(b). Any replacement Abstract must commence on a separate sheet, apart from any other text, 37 C.F.R. §§ 1.52(b)(4), 1.72(b), and include markings to show added and deleted text, 37 C.F.R. § 1.121(b)(2).
Claim Objections
Claims 3, 5, and 6 are objected to because of the following informalities:
In Claim 3, line 2, Claim 5, lines 2 and 3, and Claim 6, lines 2 and 3, the claims recite “the longitudinal slot,” while the antecedent basis for the slot is “at least one longitudinal slot” from Claim 1, at line 11. Because the broadest reasonable interpretation of “at least one longitudinal slot” is “one longitudinal slot” the claims’ scopes are reasonably clear; however, Applicant should rectify this problem.
In Claim 5, line 2, “protrudes” should be “protrude.”
While the foregoing issues with the claims do not, in the current view of the Examiner, rise to a level necessitating a rejection under 35 U.S.C. § 112(b), if Applicant asserts that the accused terms and phrases of the claim(s) are entirely unobjectionable and the Examiner disagrees, the objection may be changed to a rejection under sec. 112(b) because Applicant’s and the Examiner’s interpretations of the claims may therefore be at issue, and the scope of the claim would thus be unclear.
Appropriate correction is thus 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.
Claim 14 is 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.
The preamble of Claim 14 references the “shielding system of Claim 11,” which instead is directed to a “syringe assembly,” while Claim 12 is directed to a “shielding system;” thus, the scope of the claim is indefinite, because either the “shielding system” lacks a positive antecedent basis, or the dependency of the claim is in question. The claim has been treated as depending from Claim 11.
Claim Rejections - 35 USC § 102
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, 9, and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 4,923,447, by Morgan (“Morgan”).
Morgan describes a syringe assembly as claimed by Applicant, as follows.
Claim 1: A syringe assembly for use in medication delivery (Figs. 1-4) comprising:
- a syringe barrel (11) having a needle (12) at a distal end of the barrel;
- a tubular body (18) defining an enclosure (hollow interior), said barrel extending at least partially within said enclosure (Fig. 1);
- a safety shield (19) for the needle, longitudinally movable with respect to the tubular body between a retracted position and an activated position (shown with phantom lines in Figs. 1-3);
- a spring (28) urging said safety shield towards said activated position (note the two positions of the shield and the compression of the spring);
- a first locking mechanism (notch 26) for locking the safety shield in the retracted position, wherein the first locking mechanism is manually releasable by a user so as to let the safety shield reach the activated position (see col. 4, lines 10-17);
- the tubular body including at least one longitudinal slot (23), and the safety shield including at least radial pin (24) engaging the longitudinal slot such that the radial pin moves from a proximal part (at notch 26) of the longitudinal slot to a distal part (where notch 27 is located, shown in Fig. 1) of the longitudinal slot when the safety shield moves from the retracted position towards the activated position;
- the first locking mechanism being configured to hold the radial pin at the proximal part of the longitudinal slot (holds at least a de minimus amount).
Claim 9: (The syringe assembly of claim 1,) wherein the needle is covered by the safety shield in the activated position (Fig. 3, in phantom line) and the needle is not covered by the safety shield in the retracted position (Fig. 3, in solid line).
Claim 11: (The syringe assembly of claim 1,) comprising a prefilled syringe (15, filled when used) comprising said barrel, said needle, a stopper (14) and a plunger rod (16).
Claim 12: A shielding system (Figs. 1-4) for a syringe for use in medication delivery comprising a barrel and a needle at a distal end of the barrel, said shielding system comprising:
- a tubular body (18) defining an enclosure (its hollow interior), said barrel extending at least partially within said enclosure (Figs. 1-4);
- a safety shield (19) for the needle, longitudinally movable with respect to the tubular body between a retracted position and an activated position (see Figs. 1 and 3, showing the extended position in phantom lines);
- a spring (28; id.) urging said safety shield towards said activated position;
- a first locking mechanism (notch 26) for locking the safety shield in the retracted position (Fig. 1), wherein the first locking mechanism is manually releasable by a user so as to let the safety shield reach the activated position (col. 3, 48-59);
- the tubular body comprising a longitudinal slot (23), and the safety shield comprising a radial pin (24) engaging the longitudinal slot such that the radial pin moves from a proximal part of the longitudinal slot to a distal part of the longitudinal slot when the safety shield moves from the retracted position towards the activated position (id.);
- the first locking mechanism being configured to hold the radial pin at the proximal part of the longitudinal slot (holds at least a de minimus amount against longitudinal motion).
Claim 13: A method for operating the syringe assembly of claim 1, comprising a step of triggering release of the radial pin by the first locking mechanism so that the spring moves the safety shield from the retracted position towards the activated position (col. 4, lines 5-27).
Claim 14: A method for operating the shielding system of claim 11 (note treatment above), comprising a step of triggering release of the radial pin by the first locking mechanism so that the spring moves the safety shield from the retracted position towards the activated position (id.) (the structures of Claim 11 not manipulated by a process step in Claim 14 have no effect on the scope of the claim).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-4, 7, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Morgan as applied to Claim 1 above, and further in view of U.S. Patent App. Pub. No. 2011/0319832, by Chun (“Chun”).
Morgan describes an assembly substantially as claimed by Applicant; see above. It does not, however, describe that:
the syringe assembly further includes a second locking mechanism for permanently and non-reversingly locking the safety shield in the activated position after the first locking mechanism is released (Claim 2);
the second locking mechanism is configured to receive and then hold the radial pin at the distal part of the longitudinal slot (Claim 3);
the second locking mechanism comprises a locking leg which is forcedly deflected by the radial pin when the safety shield moves from the retracted position towards the activated position (Claim 4); and
the locking leg includes at a distal end thereof a cut configured and sized to receive the radial pin (Claim 7); and
the distal part of the longitudinal slot comprises a curved portion where the radial pin sits when the safety shield is in its activated position (Claim 8); and
the first locking mechanism is a bayonet mount (Claim 10).
Chun relates to telescoping syringe needle tip safety covers, which include a radial pin and a longitudinal track for the pin, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Chun teaches that the ends of the longitudinal track (46) can be provided with locking mechanisms (58, 60, in Fig. 5) to permanently and non-reversibly secure the pin, and therefore the needle shield, in the extended position, to further protect the user from needle stick injury. More specifically, Chun describes:
the syringe assembly further includes a second locking mechanism (58, 60) for permanently and non-reversingly locking the safety shield in the activated position after the first locking mechanism is released ([0036]: “This creates a one-way gate which immobilizes the projection 24 and hence the protective sleeve 14 in the deployed position covering the point 56 of the needle 44 . . . ,” [0041]) (Claim 2);
the second locking mechanism is configured to receive and then hold the radial pin at the distal part of the longitudinal slot (id.) (Claim 3);
the second locking mechanism comprises a locking leg (60) which is forcedly deflected by the radial pin when the safety shield moves from the retracted position towards the activated position (id. and Fig. 6) (Claim 4);
the locking leg includes at a distal end thereof a cut configured and sized to receive the radial pin (cut portion is the part of the leg 60 just proximal of the enlarged portion 64, receives the pin before deflecting the arm) (Claim 7);
the distal part of the longitudinal slot comprises a curved portion (at 58) where the radial pin sits when the safety shield is in its activated position (Claim 8); and
the first locking mechanism is a bayonet mount (66, 68 in Fig. 3) (Claim 10).
It 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, to provide Morgan’s assembly with the foregoing additional features of Claims 2-4, 7, 8, and 10, because Chun teaches doing so in a closely related device, in order to better protect the user from needle stick injury.
Concerning Claim 7, a person of ordinary skill in the art may not consider the aforementioned portion of Chun’s arm to be a “cut” as that term is used in this application. Nevertheless, Chun teaches that a locking portion (54, generally) of the same device can include a “cut” (66, 68, and the portion of the lock in which its pin resides in Fig. 3), in order to further inhibit movement of the pin-and-sleeve until desired by the user.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Morgan and Chun as applied to Claims 2 and 4 above, and further in view of U.S. Patent App. Pub. No. 2023/0076974, by Daily et al. (“Daily”)
Morgan and Chun together describe an assembly substantially as claimed by Applicant; see above. They do not, however, describe that:
the pin radially protrudes from the tubular body when it is at the proximal part of the longitudinal slot, and that the pin does not radially protrudes from the tubular body when it is at the distal part of the longitudinal slot (Claim 5); or
the longitudinal slot is provided with a rim enclosing the distal part of the longitudinal slot but not the proximal part of the longitudinal slot (Claim 6).
Daily relates to telescoping syringe needle tip safety covers, which include a radial pin and a longitudinal track for the pin, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Daily teaches that, in order to reduce access to the pin (222, shown in Fig. 4C, in the distal position, to be recessed in the slot relative to its protruding position in Fig. 3C) and thus better ensure that the device telescopes properly in use (as described at [0150]):
the pin radially protrudes from the tubular body when it is at the proximal part of the longitudinal slot (Fig. 3C), and that the pin does not radially protrudes from the tubular body when it is at the distal part of the longitudinal slot (Fig. 4C) (Claim 5); and
the longitudinal slot is provided with a rim enclosing the distal part of the longitudinal slot but not the proximal part of the longitudinal slot (the rim surrounding the widened distal slot, Fig. 3C, is a different rim from that surrounding the proximal portion of the slot, e.g., at 244, and thus does not enclose the proximal slot, as claimed).
It 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, to provide Morgan’s assembly with the foregoing additional features of Claims 5 and 6, because Daily teaches doing so in a closely related device, in order to reduce access to the pin and thus inhibit interference with its automatic sliding motion in the slot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent No. 8,128,594 describes bayonet locks for pins.
The balance of the documents cited with this Office Action relate generally to telescoping needle shields.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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:// patentcenter.uspto.gov.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 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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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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