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 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of copending Application No. 15/575527 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference Application anticipate the claims of the current Application (i.e. they teach at least all the limitations of the current application). Note the difference of the syringe limitations between the claims are covered by the standard definition of a syringe.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “316”.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: distal skin contact surface 405; and injector release member opening 322.
The drawings are objected to because of the following:
Reference “318” of Fig 14A appears to be incorrect because it could not possibly mate with 334 as described on p.32 of the Specification; whereas the apertures “318” of Fig 14C appear to be correct.
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 disclosure is objected to because of the following informalities:
“proximal opening 207” on p.32 appears to be incorrect and likely referring to –proximal opening 306--
“distal end 602” on o.33 appears to incorrect and likely referring to –distal end 604--
“a first radially extending part 522, which may be part of the first radially extending part 522 as shown most clearly in figures 4a-I” (p.35) is confusing for referring to a part 522 being part of itself 522
Appropriate correction is required.
Claim Objections
Claims are objected to because of the following informalities:
Cl.1: “removable received” is believed to be in error for --removably received--
Cl.17: “and wherein the clutch is configured for moving” is believed to be in error for --and wherein the clutch is configured for: moving--
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.
Claims 1-11, 13-17, and 20-23 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 pre-AIA the applicant regards as the invention.
Regarding Claim 1, the second recitation(s) of “a syringe compartment” is unclear whether it is the same compartment or a new and different compartment.
Furthermore, “the longitudinal direction” lacks clear antecedent basis because although there was a longitudinal axis recited, it is unclear that these two recitations are specifically related.
Regarding claim 2, “into in the cassette” is not idiomatic English and it is not clear whether the “into in” is in error for extraneous words or missing words (i.e. into “something” in the cassette).
Furthermore the “index ring rotates the first rotational position” renders the claim indefinite because it is unclear whether the ring is rotating the position or rotating from the position.
Regarding claims 5, 8, 10, and 13, “the release member” is unclear because “one or more release members” were previously claimed.
Regarding claim 6, “the track” renders the claim indefinite because it lacks antecedent basis in the claims.
Regarding claim 9, “the initial position” lacks antecedent basis in the claims.
Regarding claim 11, “the proximal longitudinal position” lacks antecedent basis in the claims.
Furthermore, the second recitation of “a proximal direction” is unclear whether is the same direction or a different direction.
Regarding claim 13, “the delivery site” lacks antecedent basis.
Furthermore, it is unclear whether “the final longitudinal position” is the same as, or different from, the previously claimed final locked position.
Regarding claims 20-21, recitations of the second coupling “surfaces” renders the claim indefinite because the original recitation was “one or more second coupling surfaces” and it is unclear whether claims 20-21 are now requiring at least two of the second coupling surfaces, or if one second coupling surface suffices.
Dependent Claims 2-11, 13-17, and 20-23 are also rejected for relying on at least one rejected claim above.
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.
(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) 1-8, 15-17, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bechmann 9186459.
Regarding Claim 1, Bechmann teaches a system for administration of medicament (904 held in 20, 900), the system comprising a cassette (incl. 900, 20, 902, 908, 800, 600, 500) and an auto injector (incl. 1800, 1400, 1700, 1500, 1600, 1100) adapted for receiving the cassette (all assembled together per Fig 1);
wherein the cassette comprises:
a syringe (900, 20) comprising:
a syringe medicament compartment (900);
an outlet (needle 902) at the proximal end (at 902) of the syringe medicament compartment (Fig 1); and
a stopper (908) positioned inside the syringe compartment (Fig 6A), wherein the stopper is movable from a distal end (toward 1510) of the syringe compartment towards the proximal end of the syringe compartment for emptying the medicament in the syringe compartment through the outlet (Figs 6A-B);
a syringe holder (800, fixed with 1100) for receiving the syringe (Figs 1, 9);
a skin sensor (600) longitudinally movable relative to the syringe holder (800 fixed with 1100 comprising 1112; Figs 9-10) between two or more longitudinal positions selected from:
a distal position (Fig 10C);
a final locked position (Figs 10D; “the two clips of the skin sensor are resting on a shelf on the syringe lock, locking them in position to protect the needle” col.26 ll.43-45);
an initial locked position (10A) between the final locked position and the distal position (relative position of 600 and 800 in Fig 10A is axially between the relative positions in Fig 10C and Fig 10D; also in Fig 10A, 1112 locked against proximal axial translation); and
an intermediate position (at least Fig 10B) between the initial locked position and the final locked position (relative position of 600 and 800 being axially between the relative positions of Figs 10A and 10D);
an index ring (500) rotatable relative to the skin sensor (Fig 10) between two or more rotational positions selected from:
a first rotational position (Figs 10A and 10E);
a delivery rotational position (Fig 10C-D) in which the skin sensor is moveable between the distal position and the final locked position;
a cap-release (the term cap-release is considered mostly nominal, there being no cap or other cap-release limitations recited in the claim; nevertheless, it can be seen that in Fig 10B any cap on the device has been released, thus satisfying the term “cap-release”) rotational position (Fig 10B) positioned between the first rotational position and the delivery rotational position (compare Figs 10A-E);
wherein the auto injector is extending from a proximal end (at 1510) to a distal end (at 1800) along a longitudinal axis (Figs 1, 6), wherein the cassette is removable received in the auto injector along the longitudinal direction (cassette portions must be removable from auto-injector portions in order to replace the syringe; col.15 l.65 – col.16 l.3);
wherein the auto injector comprises an injector housing (incl. 1800 and parts of 1400; may also include at least part of 400) and a multiple of internal injector parts (incl. 1400, 1700, 1500, 1600, 1100 incl. 11112) positioned inside the injector housing (Figs 1 and 6A show all the components at least partially within 1800), wherein the internal injector parts includes at least:
a plunger rod (1500) configured for proximal movement of the stopper inside the cassette (Fig 6);
a drive module (incl. 1600) adapted for moving the plunger rod proximately (Figs 1, 6); and
one or more release members (semi-annular members of 1100 at 1101 from which 1112 extend radially) configured for rotating the index ring (Fig 10) between the two or more rotational positions when the one or more release members moves proximally (Fig 10).
Regarding Claim 2, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches wherein the internal injector parts of the auto injector includes a skin sensor spring system (incl. 700) adapted for pushing the skin sensor proximal (col.22 ll.3-7), wherein when the one or more release members travels proximally into in the cassette and comes in contact with the index ring (at 506; Fig 10A), the index ring rotates the first rotational position (Fig 10A) towards the cap-release rotational position (Fig 10B), whereby the skin sensor spring system pushes the skin sensor proximally (spring 700 still compressed in Fig 10B and pushing proximally on skin sensor 600).
Regarding Claim 3, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches when the skin sensor is in the distal longitudinal position (Fig 10C), the syringe outlet (902) is exposed, and wherein the skin sensor covers the syringe outlet when the skin sensor is in either of:
the initial locked position (Fig 10A);
the intermediate position (Fig 10B); and
the final locked position (Fig 10D).
Regarding Claim 4, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches the index ring is configured for moving from the cap-release rotational position to the delivery rotational position preparing the system for medicament delivery when the skin sensor is in the distal longitudinal position (Fig 10C).
Regarding Claim 5, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches the index ring comprises a track (incl. 506, 510) extending in a sloping direction (Fig 10), and wherein the one or more release members is configured for traveling inside the track (Fig 10), and wherein the index ring is rotated when the release member travels proximally inside the track (Fig 10).
Regarding Claim 6, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches each of the one or more release members comprises a track-guide protrusion (1112), and wherein the track-guide protrusion is configured for traveling inside the track (Fig 10).
Regarding Claim 7, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches the injector housing comprises: a cassette covering section (proximal portion including 402 in Fig 2C) extending to cover at least a part of the cassette (Fig 1) when received inside the injector (Figs 1-2); and a distal housing section (distal portion toward and/or including 1800) extending to cover the internal injector parts inside the injector housing before the cassette is secured inside the injector (Fig 1).
Regarding Claim 8, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches
Regarding Claim 15, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches the internal injector parts further includes a clutch (incl. 1420, 1422, 1108, 1110, 1508) configured for being movable between:
a first clutch position where the plunger rod and the one or more release members are longitudinally coupled for proximal movement together (Figs 7A-D); and
a second clutch position where the plunger rod is decoupled from the one or more release members allowing the plunger rod to move longitudinally while the one or more release members are longitudinally stationary (Figs 7C-F).
Regarding Claim 16, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches the one or more release members are coupled to the injector housing in the second clutch position (release members are always contained in the injector housing 400, 1800 and therefor, coupled – albeit perhaps indirectly – thereto).
Regarding Claim 17, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches the clutch is in the first clutch position prior to use (Fig 7A-B; col.23 ll.36-39) and wherein the clutch is configured for moving from the first clutch position to the second clutch position when the index ring is rotated to the delivery rotational position by proximal movement of the one or more release members (7C-F at least one of which corresponding to at least Fig 10C).
Regarding Claim 20, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches the clutch is a tubular clutch (incl. tubular parts of 1110 and 1400, including 1108,1110 and 1420,1422, respectively) having one or more clutch tabs (1108, 1110; or 1508) with a first rotation surface (cylinder of 1100 at the axial location of 1110; or Fig 7N below) and a second rotation surface (cylinder of 1100 at the axial location of 1108; or Fig 7N below), and
PNG
media_image1.png
540
911
media_image1.png
Greyscale
wherein the internal injector parts comprises a proximal chassis part (axially extended, smaller diameter portion of 1400 including 1420 and 1422; or axially extended, smaller diameter portion of 1100) having a clutch coupling part (cylindrical part including 1420 and 1422; or portion of 1100 depicted in Fig 7N) with one or more first coupling surfaces (cylinder of 1400 at 1422; or 1109) and one or more second coupling surfaces (cylinder of 1400 at 1420; or Fig 7N above), wherein:
when the second rotation surface on the clutch is abutting the second coupling surfaces (interpreted under 112b above) on the clutch coupling part, the clutch is in the second clutch position (when the cylindrical parts of 1108 and 1420 abut/coincide, the clutch is in the second position; when 1508 passes 1109, the second rotation surface abuts the second coupling surface and the rod 1500 slides relative to 1100 per Figs 7A-F); and
when the second rotation surface on the clutch is not in contact with the second coupling surfaces (interpreted under 112b above) on the clutch coupling part, the clutch is in the first clutch position (Figs 7A-7B and 7M; when the cylindrical parts of 1108 and 1420 are not abutting/coinciding; in the first clutch position, the second rotation surface of 1508 does not abut the second coupling surface of 1100).
Regarding Claim 21, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches the plunger rod is configured for moving in the longitudinal direction relative to the clutch (when the clutch is in the second clutch position), wherein the clutch is configured for:
moving proximally with the one or more release members before the second rotation surface comes into contact with the second coupling surfaces (1508 is engaged with 1109,1108 to move together with 1100 until 1108 aligns with 1420 and 1508 slips past 1109 for the second rotation surface to contact the second coupling surface);
axial rotation when the second rotation surface comes into contact with the second coupling surfaces, thereby moving from the first clutch position to the second clutch position (1108 and 1109 rotate radially outward when they align with 1420 and 1508/1509 slips past 1108/1109 for the second rotation surface to contact the second coupling surface; thus switching from the first to the second clutch position).
Regarding Claim 22, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches the clutch coupling part comprises a clutch stopping surface (cylinder of 1400 axially between 1420 and 1422) abutting the clutch when the clutch is in the second clutch position (cylinder of 1400 axially between 1420, 1422 abuts the clutch component 1108 when the clutch is in the second clutch position) thereby preventing the clutch and the one or more release members from moving longitudinally with the plunger rod (7C-F).
Regarding Claim 22, Bechmann teaches all the limitations of the claimed invention as discussed above. Bechmann further teaches the plunger rod comprises a stopping clutch tab (1508), wherein a distal surface (1509 ;distal relative to the following claimed proximal surface) of the stopping clutch tab is abutting a proximal surface (1109) of the one or more release members when the clutch is in the first clutch position (Fig 7M),
wherein the stopping clutch tab is configured for moving the clutch from the second clutch position to the first clutch position upon distal movement of the plunger rod bringing the distal surface of the stopping clutch tab in contact with the proximal surface of the one or more release members (based on the structural features and operation of the clutch from Figs 7A-F, physically moving the plunger distally would result in a change from the second clutch position to the first clutch position).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE SEBASCO CHENG whose telephone number is (469) 295-9153. The examiner can normally be reached on 1000-1600 Eastern.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached on (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STEPHANIE SEBASCO CHENG/Primary Examiner, Art Unit 3741