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 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 recites the limitation “the end” line 7. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same end as the “first end” in line 6.
Claims 2-10 are similarly rejected by virtue of their dependency upon 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.
(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 1-5, 7-10, 11-14, 16, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Butler et al. (U.S. Patent No. 11612696), hereinafter Butler.
Regarding claim 1, Butler discloses an autoinjector medical device (device 1) comprising:
a housing (unit 2);
a leadscrew (rod body 19) disposed within the housing, the leadscrew being rotatable and axially translatable within the housing along an axis of the leadscrew (see Col 11 Lines 21-32); and
a leadscrew tip (bearing 18) coupled to an end of the leadscrew (see FIG. 6), the leadscrew tip comprising:
a first end (distal end face 20) with at least one extension (sidewalls 40) extending away from the first end in a direction parallel to a central axis (axis 46) of the leadscrew tip, wherein the end of the leadscrew coupled to the leadscrew tip is rotatable within and relative to the leadscrew tip (piston rod body to rotate relative to the bearing.”, Col 2 Lines 65-66).
Regarding claim 2, Butler discloses the claimed invention as discussed above concerning the rejection of claim 1, and Butler further discloses comprising a cassette (cartridge 4) disposed within the housing (unit 2), the cassette including: a syringe (body of cartridge 4) with a needle (needle unit 17) disposed at an end of the syringe; and a plunger (bung 10) disposed within the syringe, the plunger being axially translatable within the syringe along an axis of the syringe (see Col 9 Lines 56-62).
Regarding claim 3, Butler discloses the claimed invention as discussed above concerning the rejection of claim 2, and Butler further discloses wherein the leadscrew tip (bearing 18) is configured to engage the plunger (bung 10) to cause the plunger to axially translate within the syringe (Col 10 Lines 13-21).
Regarding claim 4, Butler discloses the claimed invention as discussed above concerning the rejection of claim 3, and Butler further discloses wherein engagement between the leadscrew tip (bearing 18) and the plunger (bung 10) is a non-rotatable engagement, such that the leadscrew tip is rotationally fixed relative to the plunger (Col 11 Line 66 – Col 12 Line 13).
Regarding claim 5, Butler discloses the claimed invention as discussed above concerning the rejection of claim 1, and Butler further discloses wherein the axis (axis 46) of the leadscrew (rod body 19) is axially aligned with the central axis (axis 46) of the leadscrew tip (bearing 18).
Regarding claim 7, Butler discloses the claimed invention as discussed above concerning the rejection of claim 1, and Butler further discloses wherein the end of the leadscrew (rod body 19) coupled to the leadscrew tip (bearing 18) abuts a stop (surface 39) disposed within the leadscrew tip (see FIG .4).
Regarding claim 8, Butler discloses the claimed invention as discussed above concerning the rejection of claim 7, and Butler further discloses wherein the stop (surface 39) is a protrusion extending from the first end (distal end face 20) of the leadscrew tip (bearing 18) into an interior of the leadscrew tip, and the stop is axially aligned with the central axis (axis 46) of the leadscrew tip (the Examiner notes FIG. 4 which depicts interior surface of bearing 18 extending and protruding from distal end face 20 towards to opposite end of bearing 18, with a surface 39 extending radially towards the central axis acting as a stop for rod body 19).
Regarding claim 9, Butler discloses the claimed invention as discussed above concerning the rejection of claim 7, and Butler further discloses wherein the end of the leadscrew (rod body 19) coupled to the leadscrew tip (bearing 18) is disposed axially between the stop (surface 39) and a protrusion (insertion slant 47) extending from the at least one extension (sidewalls 40; see FIG. 6).
Regarding claim 10, Butler discloses the claimed invention as discussed above concerning the rejection of claim 1, and Butler further discloses wherein the leadscrew tip (bearing 18) has a greater outer diameter than an outer diameter (see FIG. 10) of the leadscrew (rod body 19).
Regarding claim 11, Butler discloses a leadscrew tip (bearing 18; see FIG. 6) comprising:
a first end (distal end face 20) and a second end (proximal end face of bearing 18) positioned at an opposite end of the leadscrew tip as the first end;
at least one extension (sidewalls 40) extending from the first end to the second end in a direction parallel to a central axis (axis 46) of the leadscrew tip (see FIGS. 4-5);
a stop (surface 39) extending from the first end into an interior of the leadscrew tip, the stop being axially aligned with the central axis of the leadscrew tip (see FIG. 4); and
a protrusion (insertion slant 47) extending from each of the at least one extension toward the central axis (axis 46) of the leadscrew tip (see FIG. 5).
Regarding claim 12, Butler discloses the claimed invention as discussed above concerning the rejection of claim 11, and Butler further discloses wherein the at least one extension (sidewalls 40) includes a plurality of extensions extending from the first end to the second end (see FIG. 5).
Regarding claim 13, Butler discloses the claimed invention as discussed above concerning the rejection of claim 12, and Butler further discloses wherein each of the plurality of extensions are circumferentially connected at the first end (the Examiner notes circular ring shape of distal end face 20 connecting the ends of sidewalls 40 in FIGS. 4-5), and each of the plurality of extensions are circumferentially separated at the second end (the Examiner notes separation of side walls 40 at the proximal end of bearing 18 opposite to the distal end face 20 in FIGS. 4-5).
Regarding claim 14, Butler discloses the claimed invention as discussed above concerning the rejection of claim 11, and Butler further discloses wherein each protrusion (insertion slant 47) extending from each of the at least one extension is oriented perpendicular to the central axis (axis 46; see FIGS. 4-5).
Regarding claim 16, Butler discloses the claimed invention as discussed above concerning the rejection of claim 11, and Butler further discloses wherein the first end (distal end face 20) of the leadscrew tip (bearing 18) has a generally circular cross-sectional shape, with respect to the central axis (see FIG. 4).
Regarding claim 18, Butler discloses the claimed invention as discussed above concerning the rejection of claim 11, and Butler further discloses wherein the leadscrew tip (bearing 18) is configured to be coupled to an end of a leadscrew (rod body 19; see FIG. 6) of an autoinjector medical device (device 1).
Regarding claim 19, Butler discloses the claimed invention as discussed above concerning the rejection of claim 18, and Butler further discloses wherein the end of the leadscrew (rod body 19) coupled to the leadscrew tip (bearing 18) is rotatable within and relative to the leadscrew tip (“piston rod body to rotate relative to the bearing.”, Col 2 Lines 65-66).
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 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (U.S. Patent No. 11612696), hereinafter Butler, in further view of Steenfeldt-Jensen et al. (U.S. Patent Pub. 20050015057), hereinafter Jensen.
Regarding claim 6, Butler discloses the claimed invention as discussed above concerning the rejection of claim 1, however, Burler does not expressly state wherein the leadscrew tip is coupled to the end of the leadscrew through a snap-fit connection.
Jensen teaches a piston foot and coupling device made for a liquid medication device (Abstract) wherein the leadscrew tip is coupled to the end of the leadscrew through a snap-fit connection (See [0011]; see Claims 4 and 5).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the device of Butler to have the leadscrew tip coupled to the end of the leadscrew through a snap-fit connection. Doing so provides a press foot that can be used to mount a spindle, or leadscrew, as taught by Butler ([0017]).
Regarding claim 15, Butler discloses the claimed invention as discussed above concerning the rejection of claim 11, and Butler further discloses wherein each protrusion (insertion slant 47) extending from each of the at least one extension (sidewalls 40) includes an angled surface (see convex surface and curved shape detailed in Col 13 Lines 8-39) disposed adjacent the second end of the leadscrew tip (see FIG. 4). However, Burler does not expressly state an angled surface being non-parallel and non-perpendicular with respect to the central axis.
Jensen teaches a piston foot and coupling device made for a liquid medication device (Abstract) wherein the extension (tongues 6) has an angled surface being non-parallel and non-perpendicular with respect to the central axis (the Examiner notes angled surface of the end of tongues 6 are neither parallel or perpendicular to the central axis of spindle 1, see FIGS. 1-2).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the extensions of Butler to have an angled surface being non-parallel and non-perpendicular with respect to the central axis. Doing so provides a press foot that can be used to mount a spindle, or leadscrew, as taught by Jensen ([0017]).
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (U.S. Patent No. 11612696), hereinafter Butler.
Regarding claim 17, Butler discloses the claimed invention as discussed above concerning the rejection of claim 11, however, Butler does not expressly state wherein the leadscrew tip is constructed from a low-friction polymeric material.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to construct the leadscrew tip from a low-friction polymeric material. since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 20, Butler discloses the claimed invention as discussed above concerning the rejection of claim 18, however, Butler does not expressly state wherein a coefficient of friction between the leadscrew tip and the end of the leadscrew is in a range between 0.1 and 0.4.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have a coefficient of friction between the leadscrew tip and the end of the leadscrew in a range between 0.1 and 0.4., since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
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
09/21/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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