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) 32, 33, 35-36, 39-40, 46-49 is/are objected to because of the following informalities:
Claim 32, line 6, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 32, line 9, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 32, line 11, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 33, line 6, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 35, line 4, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 36, line 3, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 39, line 2, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 40, line 2, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 46, line 2, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 47, line 6, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 47, line 9, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 47, line 11, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 48, line 2, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 48, line 3, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 49, line 7, “the dose skirt”. It should be amended as “the dose dial skirt”.
Claim 49, line 12, “the dose skirt”. It should be amended as “the dose dial skirt”.
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) 39, 49-51 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.
Claim 39 recites the limitations "the first contact" and “the second contact” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 49 recites the phrase "for attachment to a medication delivery device", then claim 49 further recites the structure of the medication delivery device as “the medication delivery device comprising a pen body, a dose setting assembly to dose set and dose deliver a dose of a medication from a reservoir of the medication delivery device, the dose setting assembly comprising a dose dial member having dose indicator markings and a dose dial skirt, wherein a portion of the dose dial member is visible through a window formed in an outer housing of the pen body to display the actually dose set, wherein the dose dial member and the dose skirt are rotatable relative to the pen body during dose setting and wherein the dose dial member is rotatable relative to the pen body during dose delivery”. It renders the claim indefinite because it is unclear whether the limitation “a medication delivery device” and its structures are positively recited in claim 49.
Claims 50-51 are rejected by virtue of depending on claim 49.
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) 32-37, 39-41, 43-44, 48-49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Butler et al. (US 2014/0171879).
Regarding claim 32, Butler discloses
A medication delivery device (100, fig. 1), comprising a pen body (body of 100, fig. 1), a dose setting assembly (400, pars. 0061-0068) to dose set and dose deliver a dose of a medication from a reservoir (drug cartridge disclosed in par. 0054) of the medication delivery device (100, fig. 1), the dose setting assembly (400) comprising a dose dial member (406) having dose indicator markings (300 and 302, see fig. 7) and a dose dial skirt (402, fig. 3), wherein a portion of the dose dial member is visible through a window (442, fig. 3 and par. 0073) formed in an outer housing (404) of the pen body (see fig. 3) to display the actually dose set (Examiner notes: the limitation “to display the actually dose set” is interpreted as functional limitation. See par. 0073 for window/recess 442 configured to receive an insert or electronic module with display electronics to determine the rotational position of 406), wherein the dose dial member (406) and the dose skirt (402) are rotatable relative to the pen body during dose setting (see par. 0066) and wherein the dose dial member (406) is rotatable relative to the pen body during dose delivery (see par. 0067 for 406 and 405 rotating relative from each other),
wherein at least one of the dose dial member (406) and the dose skirt (Examiner notes: since claim 1 recites the limitation “at least one of”, one of the parts in that limitation is not positively required in claim 1) is provided with a series of circumferentially spaced conductive portions (conductive segments of 300/302 – shown in black segments in fig. 7, see also par. 0079) distributed around an outer circumference of the dose dial member (see fig. 7) or the dose skirt, and a series of contacts (212, fig. 9 and par. 0083) configured to abut the conductive portions (par. 0083).
Regarding claim 33, Butler discloses
The medication delivery device of claim 32, wherein the conductive portions (conductive segments of 300/302 – shown in black segments in fig. 7, see also par. 0079) form a pattern (see fig. 7), and wherein the contacts (212) and the conductive portions (conductive segments of 300/302) together form a detector arrangement (pars. 0092-0094) comprising at least one electric sensor (sensor of 202) being operable to detect a change in position of the pattern relative to the contacts and to generate at least one electric signal in response to the change in position of the pattern during at least one of the movements of the dose dial member (406) and/or the dose skirt during dose setting and dose delivery relative to the pen body (see pars. 0092-0094).
Regarding claim 34, Butler discloses
The medication delivery device of claim 33, wherein the pattern (see fig. 7) comprises at least a first pattern portion that is electrically conductive (black segments) and at least a second pattern portion in between the conductive portions that is not electrically conductive (white segments).
Regarding claim 35, Butler discloses
The medication delivery device of claim 34, wherein the contacts (212) of the detector arrangement are operable to alternately connect to the first pattern portion and the second pattern portion of the pattern during at least one of the movements of the dose dial member and/or the dose skirt during dose setting and dose delivery relative to the pen body (see fig. 8, and pars. 0081-0091).
Regarding claim 36, Butler discloses
The medication delivery device of claim 34, wherein the first pattern of the conductive portions (black segments, fig. 7) slanted relative to an axis of rotation of the dose dial member (406) and/or the dose skirt (Examiner notes: see fig. 7 for the orientation of black segments being slanted along the circumference of 406 and the axis of rotation of 406).
Regarding claim 37, Butler discloses
The medication delivery device of claim 32, wherein the contacts (212, fig. 9) comprise a first contact (first 212) and a second contact (second 212. Examiner notes: see fig. 9 for a plurality of 212).
Regarding claim 39, Butler discloses
The medication delivery device of claim 32, wherein, in response to the dose dial member (406) and/or the dose skirt being at a first angular position relative to the pen body, each of the first contact (first 212) and the second contact (second 212) is in contact with one of the conductive portions to accomplish direct electrical communication between the first and second contacts (see fig. 8 and pars. 0081-0091 for both 212 in the black segments).
Regarding claim 40, Butler discloses
The medication delivery device of claim 39, wherein, in response to the dose dial member (406) and/or the dose skirt being at a second angular position relative to the pen body, only one of the first contact and the second contact is in contact the one of the conductive portions to accomplish no direct electrical communication between the first and second contacts (see fig. 8 and pars. 0081-0091 for one 212 in the black segment and one 212 in the white segment).
Regarding claim 41, Butler discloses
The medication delivery device of claim 32, wherein the conductive portions (conductive segments of 300/302 – shown in black segments in fig. 7, see also par. 0079) are co-molded with a support material (tracks of 300/302) having a predetermined conductivity (conductivity of 300/302, par. 0079).
Regarding claim 43, Butler discloses
The medication delivery device of claim 32, wherein each of the contacts (212, fig. 9) comprises a spring biased arms (see fig. 9).
Regarding claim 44, Butler discloses
The medication delivery device of claim 32, further comprising a module (an insert or electronic module 200 in fig. 2 and disclosed in par. 0073) that is attachable to the pen body (body of 100, fig. 2 and par. 0073), and a sensor system (sensor of 202, pars. 0092-0094) contained within the module (see fig. 2), the sensor system comprising the contacts (212) operably coupled to a printed circuit board (PCB of 202, pars. 0056-0060, 0073, 0092-0094).
Regarding claim 48, Butler discloses
The medication delivery device of claim 37, wherein the conductive portions (conductive segments of 300/302 – shown in black segments in fig. 7, see also par. 0079) are arranged to an axis of rotation of the dose dial member (406) and/or the dose skirt such that in response to the dose dial member (406) and/or the dose skirt being at a first angular position relative to the pen body, only one of the first contact and the second contact is in contact with one of the conductive portions to accomplish no direct electrical communication between the first and second contacts (see fig. 8 and pars. 0081-0091 for one 212 in the black segment and one 212 in the white segment).
Regarding claim 49, Butler discloses
A dose detection module (200 with segments of 300/302, figs. 1-11) for attachment to a medication delivery device (100, fig. 1), the medication delivery device (100) comprising a pen body (body of 100), a dose setting assembly (400, pars. 0061-0068) to dose set and dose deliver a dose of a medication from a reservoir (drug cartridge disclosed in par. 0054) of the medication delivery device (100, fig. 1), the dose setting assembly (400) comprising a dose dial member (406) having dose indicator markings (300 and 302, see fig. 7) and a dose dial skirt (402, fig. 3), wherein a portion of the dose dial member is visible through a window (442, fig. 3 and par. 0073) formed in an outer housing (404) of the pen body (see fig. 3) to display the actually dose set (Examiner notes: the limitation “to display the actually dose set” is interpreted as functional limitation. See par. 0073 for window/recess 442 configured to receive an insert or electronic module with display electronics to determine the rotational position of 406), wherein the dose dial member (406) and the dose skirt (402) are rotatable relative to the pen body during dose setting (see par. 0066) and wherein the dose dial member (406) is rotatable relative to the pen body during dose delivery (see par. 0067 for 406 and 405 rotating relative from each other), the module (200 with segments of 300/302) comprising a sensor system (sensor of 202, pars. 0092-0094) attached to the pen body (body of 100), the sensor system including a printed circuit board (PCB of 202, pars. 0056-0060, 0073, 0092-0094), a battery (214, fig. 2), and a first electrical conductor (first 212, fig. 9 and par. 0083) and a second electrical conductor (second 212, fig. 9) each operably connected with the printed circuit board (pars. 0056-0060, 0073, 0092-0094), a sensed element (segments of 300/302) attached to the dose skirt (402), the sensed element (segments of 300/302) comprising radially spaced conductive portions (conductive segments of 300/302 – shown in black segments in fig. 7, see also par. 0079) that are operable with the first and second electrical conductors (212) to enable the sensor system to detect relative rotation of the dose setting assembly (pars. 0092-0094).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (US 2014/0171879) in view of Despa et al. (US 2016/0243318).
Regarding claim 46, Butler discloses the medication delivery device of claim 44, as set forth above, except for wherein the module comprises tabs configured for attachment of the module to the dose skirt.
Butler only discloses the module configured to attached to the medication delivery device via its recess in the outer housing. Since the medication delivery device comprises the dose dial skirt, when the module is attached to the medication delivery device, it is also attached to the dose dial skirt.
However, Despa teaches a smart module including tabs, snaps, brackets or other means for mounting to the outside of an autoinjector (par. 0085).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Butler module by adding tabs, as taught by Despa, for the purpose of providing sufficient structure to allow the module to mount and secure to the medication delivery device (par. 0085 of Despa).
Allowable Subject Matter
Claim(s) 38, 42, 45, 47, 50-51 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.
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
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