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.
Claim 16 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.
Claim 16 recites “wherein one of the mechanical coding feature and the mechanical counter coding features comprises a protrusion extending and protruding in the longitudinal direction”. It is unclear if the limitation of “extending and protruding” refers to the mechanical coding feature/mechanical counter coding feature or if it refers to the protrusion. For purposes of examination, the extending and protruding can be interpreted to relate to any of the three elements. Claims can be amended to clearly indicate which element is designed to extend and protrude longitudinally.
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.
Claim(s) 16-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Byerly et al. (WO 2018/013419 A1).
With regard to claim 16, Byerly discloses An electronic module (Fig. 5, element 20, see also Fig. 6) configured for attachment to a proximal end of a drug delivery device (Fig. 2 showing the entire system, the drug delivery device is 10) in a predefined fastening configuration (see Fig. 2), the drug delivery device comprising an elongated housing (12) extending in a longitudinal direction and comprising a distal end (at 24) and the proximal end (shown in Fig. 5), the electronic module comprising: a mechanical coding (108) comprising a mechanical coding feature (108/110, 108 extends in the longitudinal direction to engaged with the drug delivery device) to engage with a mechanical counter coding feature (39/41) of a mechanical counter coding (38) provided at the proximal end of the drug delivery device (p.6, line 30 to p. 7, line 16), wherein one of the mechanical coding feature (110) and the mechanical counter coding feature (39/41) comprises a protrusion (mechanical coding 108 is considered a protrusion) extending and protruding in the longitudinal direction (110 is a strip directed along the longitudinal axis and there is considered to extend and protrude in the longitudinal direction), and wherein the other one of the mechanical coding feature and the mechanical counter coding feature comprises a recess (39 are a plurality of ridges that create recesses for holding protrusion 110 of the mechanical coding feature. See Fig. 3, showing the recesses 39), and wherein when a geometric shape of the protrusion is not matching with a geometric shape of the recess (p. 10, lines 9-15), or when a position of the protrusion in a plane transverse to the longitudinal direction is not matching with a position of the recess in the transverse plane, or when a longitudinal extent of the protrusion is larger than a longitudinal extent of the recess, the mechanical coding and the mechanical counter coding being operable to prevent a fastening of the electronic module to the proximal end of the drug delivery device in a predefined fastening configuration (p.10, lines 9-15, keyed features define the connection between a specific module with the drug delivery device and prevents the connection of the incorrect module to the proximal end of an incorrect drug delivery device).
(ALTERNATE INTERPRETAITON)
With regard to claim 16, Byerly discloses An electronic module (Fig. 5, element 20, see also Fig. 6) configured for attachment to a proximal end of a drug delivery device (Fig. 2 showing the entire system, the drug delivery device is 10) in a predefined fastening configuration (see Fig. 2), the drug delivery device comprising an elongated housing (12) extending in a longitudinal direction and comprising a distal end (at 24) and the proximal end (shown in Fig. 5), the electronic module (100) comprising: a mechanical coding comprising a mechanical coding feature (42/48) to engage with a mechanical counter coding feature (47) of a mechanical counter coding provided at the proximal end of the drug delivery device (see Fig. 5), wherein one of the mechanical coding feature (42/48) and the mechanical counter coding feature (47) comprises a protrusion (see annotated drawing below) extending and protruding in the longitudinal direction (see annotated drawing below), and wherein the other one of the mechanical coding feature and the mechanical counter coding feature comprises a recess (47 is a recess that can house the protrusion), and wherein when a geometric shape of the protrusion is not matching with a geometric shape of the recess (if the protrusion was a different shape it would necessarily not fit in the recess formed by 47), or when a position of the protrusion in a plane transverse to the longitudinal direction is not matching with a position of the recess in the transverse plane, or when a longitudinal extent of the protrusion is larger than a longitudinal extent of the recess (if the protrusion was larger than the extend of the recess it would necessarily not fit in the recess), the mechanical coding and the mechanical counter coding being operable to prevent a fastening of the electronic module to the proximal end of the drug delivery device in a predefined fastening configuration (if the protrusion is unable to be placed in the recess of the drug delivery the electronic module would not be able to be connected fully).
With regard to claim 17, Byerly discloses further comprising a fastening element (edge surface of 110 that contacts ridge 41) configured to mechanically engage with a complementary shaped counter fastening element (41) of the drug delivery device in the predefined fastening configuration (see Fig. 5).
With regard to claim 18, Byerly discloses wherein the mechanical coding (108) is defined by at least one of a position, an orientation and a longitudinal extent of the mechanical coding feature relative to the fastening element (p. 10, lines 9-15, p. 9, line 28-p.10, line 8).
With regard to claim 19, Byerly discloses further comprising at least one longitudinal extension (Fig. 6, element 106) extending distally from a distal end of the electronic module and configured to extend into or through an aperture at the proximal end of the drug delivery device (extends into the skirt 38 apertures 39).
With regard to claim 20, Byerly discloses wherein the mechanical coding is defined by at least one of a position, an orientation and a longitudinal extent of the mechanical coding feature relative to the longitudinal extension (p. 10, lines 9-15, p. 9, line 28-p.10, line 8).
With regard to claim 21, Byerly discloses wherein the mechanical coding feature (108/110) comprises the protrusion protruding in a longitudinal distal direction (108 is considered longitudinal as it extends up and down along the side of the electronic module) from a distally facing surface (distal surface of the cap 120 as shown in Fig. 5) of the electronic module and configured to engage with the recess (39) of the mechanical counter coding feature, wherein the recess is complementarily shaped with respect to the protrusion.
With regard to claim 22, Byerly discloses wherein the distally facing (the side wall 120 of the electronic module having a distal face, facing the drug delivery device) surface of the electronic module is in longitudinal abutment with a complementary shaped proximally facing surface of the drug delivery device (the claims do not require direct contact and therefore the distal face of 120 is considered is abutment with the drug delivery device via element 108).
With regard to claim 23, Byerly discloses wherein the mechanical coding (108/110) comprises a coding section comprising a number of n discrete spatially non-overlapping coding feature positions (where each of 110 are located) and a number of k mechanical coding features ( each of 110) each one of which located on one of the coding feature positions, wherein n and k are integer numbers and wherein k less than or equal to n, (they are equal as 110 the coding features are considered located at specific positions equal to the number of coding features).
With regard to claim 24, Byerly discloses A drug delivery device (Fig. 2 and 5) comprising: a housing (12) comprising a distal end (at 24) and a proximal end (at end 102), wherein the proximal end is configured for attachment of an electronic module (20, also see Fig. 5) in a predefined fastening configuration (the location where it is fastened is considered predefined without further limitations), wherein the electronic module comprises: a mechanical coding (108) comprising a mechanical coding feature (110 can be considered a feature or any other portion of 108 can be considered a feature as the term is broad and does not impart any specific structure) to engage with a mechanical counter coding feature (38/39) of a mechanical counter coding (38) provided at the proximal end of the drug delivery device, wherein one of the mechanical coding feature and the mechanical counter coding feature comprises a protrusion extending and protruding in the longitudinal direction (110 is a strip directed along the longitudinal axis and there is considered to extend and protrude in the longitudinal direction), and wherein the other one of the mechanical coding feature and the mechanical counter coding feature comprises a recess (39 is a recess which is better seen in Fig. 3), and wherein when a geometric shape of the protrusion is not matching with a geometric shape of the recess (p. 10, lines 9-15, p. 9, line 28-p.10, line 8), or when a position of the protrusion in a plane transverse to the longitudinal direction is not matching with a position of the recess in the transverse plane, or when a longitudinal extent of the protrusion is larger than a longitudinal extent of the recess, the mechanical coding and the mechanical counter coding being operable to prevent a fastening of the electronic module to the proximal end of the drug delivery device in a predefined fastening configuration (p. 10, lines 9-15, p. 9, line 28-p.10, line 8, if the incorrect module is used with the incorrect drug delivery device the module is improperly fastened and therefore not in the predefined configuration), the drug delivery device comprising: a drive mechanism (30, Fig. 2) configured to set and/or to deliver a dose of a drug out of the distal end (p. 6, lines 11-21); and wherein the mechanical counter coding (38) is provided at the proximal end and comprises the mechanical counter coding feature (39) to engage with the mechanical coding feature (110) of the mechanical coding of the electronic module (as shown in Fig. 5).
(ALTERNATE INTERPRETATION)
With regard to claim 24, Byerly discloses A drug delivery device (Fig. 2 and 5) comprising: a housing (12) comprising a distal end (at 24) and a proximal end (at end 102), wherein the proximal end is configured for attachment of an electronic module (20, also see Fig. 5) in a predefined fastening configuration (the location where it is fastened is considered predefined without further limitations), wherein the electronic module comprises: a mechanical coding comprising a mechanical coding feature (42/49) to engage with a mechanical counter coding feature of a mechanical counter coding (47) provided at the proximal end of the drug delivery device (12), wherein one of the mechanical coding feature and the mechanical counter coding feature comprises a protrusion (see annotated drawing below) extending and protruding in the longitudinal direction (see Fig. 5), and wherein the other one of the mechanical coding feature and the mechanical counter coding feature comprises a recess (47 is a recess), and wherein when a geometric shape of the protrusion is not matching with a geometric shape of the recess (if the shape of the protrusion is not the same as the recess it would necessarily not fit in the recess), or when a position of the protrusion in a plane transverse to the longitudinal direction is not matching with a position of the recess in the transverse plane, or when a longitudinal extent of the protrusion is larger than a longitudinal extent of the recess (the protrusion is larger than the recess it would necessarily not fit in the recess), the mechanical coding and the mechanical counter coding being operable to prevent a fastening of the electronic module to the proximal end of the drug delivery device in a predefined fastening configuration (the term “operable” is functional and therefor the device must only be capable of preventing fastening. As outlined above if the protrusion is a different shape or of a different size, the attachment of the electronic module would be prevented), the drug delivery device comprising: a drive mechanism (30, Fig. 2) configured to set and/or to deliver a dose of a drug out of the distal end (p. 6, lines 11-21); and wherein the mechanical counter coding (47) is provided at the proximal end and comprises the mechanical counter coding feature (47) to engage with the mechanical coding feature (42/49) of the mechanical coding of the electronic module (as shown in Fig. 5).
With regard to claim 25, Byerly discloses further comprising a counter fastening element (the surface of 110 which contacts the ridge 41 for holding the module in place is considered the fastening element as read in light of the specification, further definition of the fastening element would be needed to overcome the current rejection) configured to mechanically engage with a complementary shaped fastening element (41) of the electronic module in the predefined fastening configuration (as shown in Fig. 5).
With regard to claim 26, Byerly discloses wherein the mechanical counter coding (38) is defined by at least one of a position, an orientation, and a longitudinal extent of the mechanical counter coding feature relative to the counter fastening element (p. 10, lines 9-15, p. 9, line 28-p.10, line 8, if the incorrect module is used with the incorrect drug delivery device the module is improperly fastened and therefore not in the predefined configuration).
With regard to claim 27, Byerly discloses wherein the mechanical counter coding feature comprises the recess (39) configured to receive or to engage with a complementary shaped and distally extending protrusion (110 which is part of the distally extending protrusion 108) of the coding feature of the mechanical coding when in the predefined fastening configuration (as shown in Fig. 5).
With regard to claim 28, Byerly discloses wherein the recess (39) is provided in at least one of a proximal facing surface (38 is a proximal facing surface as it extends in a proximal direction as shown in Fig. 5, the recess 39 is formed in the side of 38 and therefore considered to be in at least a proximal facing surface) of the drug delivery device, an outside surface of a sidewall of the drug delivery device and an inside surface of the sidewall of the drug delivery device.
With regard to claim 29, Byerly discloses further comprising a drug container filled with the drug (in 22 as shown in Fig. 2).
With regard to claim 30, Byerly discloses A modular system (Fig. 2 and 5) comprising: an electronic module (20) configured for attachment to a proximal end of a drug delivery device (as shown in Fig. 5) in a predefined fastening configuration (the location where it is fastened is considered predefined without further limitations), the drug delivery device comprising an elongated housing (12/14) extending in a longitudinal direction and comprising a distal end (at 24) and the proximal end (generally where 102 is pointing), the electronic module comprising: a mechanical coding comprising a mechanical coding feature (108/110) to engage with a mechanical counter coding feature (38/39) of a mechanical counter coding (38) provided at the proximal end of the drug delivery device, wherein one of the mechanical coding feature and the mechanical counter coding feature comprises a protrusion (the distal end of 108 is considered a feature) extending protruding in the longitudinal direction (110 is a strip directed along the longitudinal axis and there is considered to extend and protrude in the longitudinal direction), and wherein the other one of the mechanical coding feature and the mechanical counter coding feature comprises a recess (39 is a recess, better seen in Fig. 3), and wherein when a geometric shape of the protrusion is not matching with a geometric shape of the recess (p. 10, lines 9-15, p. 9, line 28-p.10, line 8, if the incorrect module is used with the incorrect drug delivery device the module is improperly fastened and therefore not in the predefined configuration), or when a position of the protrusion in a plane transverse to the longitudinal direction is not matching with a position of the recess in the transverse plane, or when a longitudinal extent of the protrusion is larger than a longitudinal extent of the recess, the mechanical coding and the mechanical counter coding being operable to prevent a fastening of the electronic module to the proximal end of the drug delivery device in a predefined fastening configuration (p. 10, lines 9-15, p. 9, line 28-p.10, line 8, if the incorrect module is used with the incorrect drug delivery device the module is improperly fastened and therefore not in the predefined configuration), and the drug delivery device; wherein the mechanical coding (108/110) of the electronic module matches with the mechanical counter coding (39) of the drug delivery device (as shown in Fig. 5, the two components fit together), and wherein the mechanical coding mechanically engages with the mechanical counter coding when the electronic module and the drug delivery device are in the predefined fastening configuration (as shown in Fig. 5).
(ALTERNATE INTERPRETATION)
With regard to claim 30, Byerly discloses A modular system (Fig. 2 and 5) comprising: an electronic module (20) configured for attachment to a proximal end of a drug delivery device (as shown in Fig. 5) in a predefined fastening configuration (the location where it is fastened is considered predefined without further limitations), the drug delivery device comprising an elongated housing (12/14) extending in a longitudinal direction and comprising a distal end (at 24) and the proximal end (generally where 102 is pointing), the electronic module comprising: a mechanical coding comprising a mechanical coding feature (42/49) to engage with a mechanical counter coding feature (47) of a mechanical counter coding (44) provided at the proximal end of the drug delivery device, wherein one of the mechanical coding feature and the mechanical counter coding feature comprises a protrusion (see the annotated drawing below) extending protruding in the longitudinal direction (see Fig below), and wherein the other one of the mechanical coding feature and the mechanical counter coding feature comprises a recess (47 is a recess), and wherein when a geometric shape of the protrusion is not matching with a geometric shape of the recess ((if the shape of the protrusion is not the same as the recess it would necessarily not fit in the recess), or when a position of the protrusion in a plane transverse to the longitudinal direction is not matching with a position of the recess in the transverse plane, or when a longitudinal extent of the protrusion is larger than a longitudinal extent of the recess (the protrusion is larger than the recess it would necessarily not fit in the recess), the mechanical coding and the mechanical counter coding being operable to prevent a fastening of the electronic module to the proximal end of the drug delivery device in a predefined fastening configuration ((the term “operable” is functional and therefor the device must only be capable of preventing fastening. As outlined above if the protrusion is a different shape or of a different size, the attachment of the electronic module would be prevented), the drug delivery device comprising: a drive mechanism (30, Fig. 2)), and the drug delivery device; wherein the mechanical coding (42/48) of the electronic module matches with the mechanical counter coding (47) of the drug delivery device (as shown in Fig. 5, the two components fit together), and wherein the mechanical coding mechanically engages with the mechanical counter coding when the electronic module and the drug delivery device are in the predefined fastening configuration (as shown in Fig. 5).
With regard to claim 31, Byerly discloses further comprising a counter fastening element (the surface of 110 which contacts the ridge 41 for holding the module in place is considered the fastening element as read in light of the specification, further definition of the fastening element would be needed to overcome the current rejection) configured to mechanically engage with a complementary shaped fastening element (41) of the electronic module in the predefined fastening configuration (as shown in Fig. 5).
With regard to claim 32, Byerly discloses wherein the mechanical coding (108) is defined by at least one of a position, an orientation and a longitudinal extent of the mechanical coding feature relative to the fastening element (p. 10, lines 9-15, p. 9, line 28-p.10, line 8).
With regard to claim 33, Byerly discloses further comprising at least one longitudinal extension (Fig. 6, element 106) extending distally from a distal end of the electronic module and configured to extend into or through an aperture at the proximal end of the drug delivery device (extends into the skirt 38 apertures 39).
With regard to claim 34, Byerly discloses wherein the mechanical coding is defined by at least one of a position, an orientation and a longitudinal extent of the mechanical coding feature relative to the longitudinal extension (p. 10, lines 9-15, p. 9, line 28-p.10, line 8).
With regard to claim 35, Byerly discloses wherein the mechanical coding feature (108/110) comprises the protrusion protruding in a longitudinal distal direction (108 is considered longitudinal as it extends up and down along the side of the electronic module) from a distally facing surface (distal surface of the cap 120 as shown in Fig. 5) of the electronic module and configured to engage with a complementary shaped recess (39) of the mechanical counter coding feature.
Response to Arguments
Applicant’s arguments with respect to claim(s) 16-35 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The claims are still taught by Byerly under the alternate interpretation. The mechanical coding and the counter coding features are generally broad and don’t provide any specific limitations on what they are used for or any additional structure other than that the two have a complementary shape in order to fit one into the other. Further limitations regarding the mechanical coding or the counter coding would be necessary to overcome the current rejection. Examiner is willing to conduct an interview to discuss possible claim amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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