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 Objections
Claim(s) 31 is/are objected to because of the following informalities:
Claim 31, line 1, “comprisingthe” should be amended as “comprising the”
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.
Claim(s) 16, 17, 21, 28, 29, 34, 35 is/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
Regarding claim 16, the phrase "the housing" in line 6 renders the claim indefinite because it is unclear whether “the housing” in line 6 prefers to “an elongate housing” recited in line 2 or “a needle housing” recited in line 4.
Regarding claim 17, the phrase "the housing" in line 3 renders the claim indefinite because it is unclear whether “the housing” in claim 17 prefers to “an elongate housing” recited in claim 16 or “a needle housing” recited in claim 16.
Regarding claim 17, the phrase "the housing" in line 5 renders the claim indefinite because it is unclear whether “the housing” in claim 17 prefers to “an elongate housing” recited in claim 16 or “a needle housing” recited in claim 16.
Regarding claim 21, the phrase "the housing" in line 3 renders the claim indefinite because it is unclear whether “the housing” in claim 21 prefers to “an elongate housing” recited in claim 16 or “a needle housing” recited in claim 16.
Regarding claim 28, the phrase "the housing" in line 2 renders the claim indefinite because it is unclear whether “the housing” in claim 28 prefers to “an elongate housing” recited in claim 16 or “a needle housing” recited in claim 16.
Regarding claim 28, the phrase "the housing" in line 3 renders the claim indefinite because it is unclear whether “the housing” in claim 28 prefers to “an elongate housing” recited in claim 16 or “a needle housing” recited in claim 16.
Regarding claim 28, the phrase "the housing" in line 4 renders the claim indefinite because it is unclear whether “the housing” in claim 28 prefers to “an elongate housing” recited in claim 16 or “a needle housing” recited in claim 16.
Regarding claim 28, the phrase "a container of medicament" in line 4 renders the claim indefinite because it is unclear whether this limitation is the same as or different from “a container of medicament” recited in claim 16 line 3.
Regarding claim 29, the phrase "the housing" in line 2 renders the claim indefinite because it is unclear whether “the housing” in claim 29 prefers to “an elongate housing” recited in claim 16 or “a needle housing” recited in claim 16.
Regarding claim 29, the phrase "the housing" in line 3 renders the claim indefinite because it is unclear whether “the housing” in claim 29 prefers to “an elongate housing” recited in claim 16 or “a needle housing” recited in claim 16.
Regarding claim 29, the phrase "the housing" in line 4 renders the claim indefinite because it is unclear whether “the housing” in claim 29 prefers to “an elongate housing” recited in claim 16 or “a needle housing” recited in claim 16.
Regarding claim 34, the phrase "the method of claim 31" renders the claim indefinite. Claim 31 is a device claim, not a method claim.
Regarding claim 35, the phrase "the method of claim 31" renders the claim indefinite. Claim 31 is a device claim, not a method claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-19, 25-26, 28, 30-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanofi (EP 2 468 330).
Regarding claim 16, Sanofi discloses
An injector device (1, figs. 1A-6B and pars. 0032-0056) comprising:
an elongate housing (2, fig. 1A and par. 0032) having a proximal end (proximal end of 2- further away from the injection site, fig. 1A) and a distal end (distal end of 2 – closer to the injection site, fig. 1A), the elongate housing (2) being configured to receive a container of medicament (see fig. 1A for container 11 containing a dose of a medicament M);
a needle housing (4) for holding a needle (12) in a position at the distal end of the elongate housing (distal end of 2, see fig. 1A for distal portion of 5 holding 12 within 2); and
a needle sleeve (14) mounted within the housing (2, see fig. 1A), wherein the needle sleeve (14) and the needle housing (4) are moveable relative to one another by a user action between a first configuration in which the needle sleeve would enclose a needle held in the needle housing (see fig. 1A for the advanced position PA of the system), and a second configuration in which the needle held in the needle housing would extend from the needle sleeve in a distal direction (see fig. 4A for the retracted position PR of the system) (Examiner notes: see pars. 0045-0046 for the user pushing 3 against the skin to move 3 to the retracted position PR from the advanced position PA),
wherein the needle sleeve (14) comprises a portion (portion of 14) configured to vibrate and/or rotate using energy from the user action during motion between the first configuration and the second configuration (see par. 0039 for 14 rotates around the axis of 1 when 3 is longitudinally displaced in the proximal and/or distal direction to advance or retract the needle with respect to the housing 2).
Regarding claim 17, Sanofi discloses
The injection device of claim 16, wherein:
in the first configuration the needle sleeve is in an extended position in which the needle sleeve at least partially extends from the distal end of the housing (see fig. 1A); and
in the second configuration the needle sleeve is in a retracted position in which the needle sleeve is received further within the housing than in the extended position (see fig. 4A).
Regarding claim 18, Sanofi discloses
The injector device of claim 17, wherein the needle housing (4) is substantially fixed relative to the elongate housing (2) (see par. 0048 for 4 being locked to 2) such that the needle (12) is shrouded when the needle sleeve (14) is in the extended position (fig. 1A) and the needle is exposed when the needle sleeve is in the retracted position (fig. 4A).
Regarding claim 19, Sanofi discloses
The injector device of claim 17, wherein the needle sleeve (14) comprises an outer sleeve (14) and an inner sleeve (3), the inner sleeve (3) comprising the portion (portion with feature 3.2) configured to vibrate and/or rotate (see par. 0055 for 3.2 configured to rotate 14).
Regarding claim 25, Sanofi discloses
The injection device of claim 16, wherein the portion of the needle sleeve (14) configured to vibrate and/or rotate comprises one or more brushes (14.1) extending in the distal direction (see fig. 4A).
Regarding claim 26, Sanofi discloses
The injection device of claim 16, wherein the portion of the needle sleeve (14) configured to vibrate and/or rotate comprises one or more protrusions (14.1) and/or ridges extending in the distal direction (see fig. 4A).
Regarding claim 28, Sanofi discloses
The injection device of claim 16, wherein the injection device further comprises:
a piston rod (9, fig. 1A and par. 0035) moveable longitudinally within the housing (2); and
a piston spring (8, fig. 1A and pars. 0033-0034) configured to bias the piston rod (9, par. 0037) towards a distal end of the housing (distal end of 2) to engage a container (11) of medicament (M, par. 0035) when received within the housing (see figs. 1A-6B),
wherein the needle sleeve (14) is configured to suppress vibration and/or rotation of the portion during longitudinal motion of the piston rod in the distal direction (see pars. 0047-0048 for movement of 9).
Regarding claim 30, Sanofi discloses
The injection device of claim 16, wherein the needle sleeve (14) is fixed relative to the elongate housing (2), and wherein:
in the first configuration the needle housing (4) is in a retracted position (fig. 1A) in which the needle (12) held in the needle housing (4) is shrouded by the needle sleeve (14) (Examiner notes: see par. 0044 for 3 being clipped to 2 such that 3 and 14 is fixed relative to 2); and
in the second configuration the needle housing (4) is in an extended position (fig. 4A) in which the needle (12) in the needle housing (4) extends beyond the needle sleeve (14) in the distal direction (Examiner notes: see pars. 0047-0048 for 3/14 being fixed to 2 during the release of 8).
Regarding claim 31, Sanofi discloses
The injection device of claim 16, further comprising the needle (12) for expelling medicament from the injection device (see par. 0035), the needle (12) held in a position at the distal end of the elongate housing (2, see fig. 1A) that is substantially fixed relative to the elongate housing (2) such that the needle (12) is shrouded when the needle sleeve (14) is in the extended position (see fig. 1A. Examiner notes: when the device is in the advanced position, 3 is clipped to 2 and configured to prevent any movement of any elements within the device) and the needle (12) is exposed when the needle sleeve (14) is in the retracted position (see fig. 4A. Examiner notes: see pars. 0047-0048 for 4 being locked to 2).
Regarding claim 32, Sanofi discloses
A method of using the injection device of claim 16, the method comprising:
preparing the injection device in the first configuration (see fig. 1A); and
applying a user action to change the configuration of the user device from the first configuration to the second configuration (see pars. 0046-0048).
Regarding claim 33, Sanofi discloses
A method (see figs. 1A-6B and pars. 0032-0056) for causing vibration and/or rotation of a portion (portion of 14) of a distal end of an injection device (distal end of 1), the injection device (1) having a distal end (distal end of 1 – closer to the injection site, fig. 1A) and a proximate end (proximal end of 1 – further away from the injection site, fig. 1A), the distal end (distal end of 1) comprising a needle sleeve (14) and a needle (12), the method comprising:
moving, under a user action, the injection device (1) between a first configuration (see fig. 1A), in which a needle sleeve (14) encloses the needle (12), and a second configuration (see fig. 4A), in which the needle (12) extends beyond the needle sleeve (14) in the distal direction (see pars. 0046-0048); and
vibrating and/or rotating the portion (portion of 14) of the distal end of the injection device during motion between the first configuration and the second configuration using energy from the user action (see par. 0039 for 14 rotates around the axis of 1 when 3 is longitudinally displaced in the proximal and/or distal direction to advance or retract the needle with respect to the housing 2).
Regarding claim 34, Sanofi discloses
The method of claim 31, wherein moving the injection device (1) between the first configuration (see fig. 1A) and the second configuration (see fig. 4A) comprises retracting the needle sleeve (14) from an extended position (see fig. 1A) in which the needle sleeve (14) at least partially extends from a housing (2) of the injection device (1) (see pars. 0046-0048).
Regarding claim 35, Sanofi discloses
The method of claim 31, wherein moving the injection device (1) between the first configuration (see fig. 1A) and the second configuration (see fig. 4A) comprises extending the needle (12) from a retracted position (see fig. 1A) in which the needle (12) held in the needle housing (4) is shrouded by the needle sleeve (14) (see pars. 0046-0048), wherein the needle sleeve (14) is fixed relative to a housing (2) of the injection device (see pars. 0046-0048 for 14 being fixed relative to 2 during injection).
Allowable Subject Matter
Claim(s) 20-24, 27, 29 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and overcome the 112(b) rejection as set forth above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
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/DUNG T ULSH/Examiner, Art Unit 3783