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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. GB 2019965.9, filed on 12/17/2020.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application for the following:
Figs. 1-18 do not meet the 37 CFR 1.84(a) standards, in which all lines in the drawings must, ordinarily, be drawn with the aid of a drafting instrument and must be executed in black, uniformly thick and well-defined lines, or the 37 CFR 1.84(m) standards, in which spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings.
Figs. 1-18 do not meet the 37 CFR 1.84(a) standards, in which all lines in the drawings must, ordinarily, be drawn with the aid of a drafting instrument and must be executed in black, uniformly thick and well-defined lines, rather than shaded 3D renderings.
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claims 31-36 is objected to because of the following informalities: the acronym “PFS” is not defined in independent claim 31. Additionally, claims 32-36 should be included in the objection because any claims that depend on an objected claim inherit the problems of their parent claims. 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 24-26, 33 and 35 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 35 recites the limitation “it will not come by itself.” It is unclear what the bounds and scope of this limitation is, as it is unclear exactly what is being described. For the purposes of examination, this limitation is interpreted to mean that the needle shield and PFS holder move together.
Claim 24 recites the limitation "the rear body.” There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation is interpreted to mean a distal end of the device. Additionally, claims 25 and 26 should be included in the rejection because claims that depend on a rejected claim inherit the problems of their parent claims.
Claim 25 recites the limitation "the mechanism.” There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation is interpreted to mean sliding out of its original position.
Claim 33 recites the limitations "the shield hook member.” There is insufficient antecedent basis for this limitation in the claim, as only a “shield lock” is recited in the preceding independent claim 31. For the purposes of examination, this limitation is interpreted to mean the “shield lock”.
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.
Claims 19-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kris (WO 2020143991).
Regarding claim 19, Kris discloses a medication delivery device comprising a housing (Fig. 1: 10), a plunger within the said housing (Figs. 11 and 21: plunger 162 within 10), a plunger hook (Fig. 21: 148), and a button (Fig. 21: 126), the button connects to a safety sleeve (Fig. 21: safety sleeve 114 connected to button via 148 and 122), disengaging safety sleeve from the plunger hook (page 10, lines 20-26), thereafter the button engages with the plunger hook to push release the plunger (page 11, lines 9-15) held under spring pressure (Fig. 15: plunger 162 held under pressure of spring 164; page 9, lines 26-30), the device further comprises a shield lock member (Fig. 26: 119) to connect a pre-filled syringe (PFS) holder (Fig. 21: 78) and a needle shield (Fig. 26: 52) together (Fig. 26: 52 and syringe holder connected due to 119 acting on 154) in which the shield lock member is activated after the dose is delivered (page 12, line 29 – page 13, line 2).
Regarding claim 20, Kris discloses the medication delivery device of claim 19, as described above, wherein plunger hook legs (180 and 154) are configured to hold the plunger by self-strength (Fig. 23: plunger 162 held by the protrusions 158 of hook legs 154; page 11, lines 11-18).
Regarding claim 21, Kris discloses the medication delivery device of claim 19, as described above, wherein the button is configured to release the plunger (page 11, lines 13-15).
Regarding claim 22, Kris discloses the medication delivery device of claim 21, as described above, wherein the button is configured to push plunger hook legs to release the plunger (page 11, lines 13-20).
Regarding claim 23, Kris discloses the medication delivery device of claim 19, as described above, wherein the plunger hook is supported by a safety sleeve to be held in place, when not in use (Fig. 21: 148 supported by 114; page 8, line 4).
Regarding claim 24, Kris discloses the medication delivery device of claim 19, as described above, wherein a shield hook (Fig. 6: 76 and 70) is hung onto the rear body (Fig. 14: 76 is located within the distal/rear of the body of the device; page 7, lines 6-7).
Regarding claim 25, Kris discloses the medication delivery device of claim 24, as described above, wherein the shield hook is released when the plunger slides out of the mechanism (page 7, lines 6-10: 76 is released from position as it moves with 114 after the plunger sliding is initiated).
Regarding claim 26, Kris discloses the medication delivery device of claim 24, as described above, wherein the shield hook latches onto the PFS holder and holds the needle shield in place thus linking the needle shield and PFS holder together after drug delivery, to avoid needle stick injury (page 6, lines 17-20: 70 is latched to 78, such that 52 covers the needle).
Regarding claim 27, Kris discloses the medication delivery device of claim 19, as described above, wherein a plunger holder (Fig. 21: 184) is configured to move out of a trigger sleeve (Fig. 18: trigger sleeve 190+160; 184 moves out from 190: page 12, lines 10-12).
Regarding claim 28, Kris discloses the medication delivery device of claim 19, as described above, wherein compressed spring force is configured to release the plunger (page 2, lines 10-13).
Regarding claim 29, Kris discloses the medication delivery device of claim 19, as described above, wherein the plunger is configured to move into the PFS and is configured to push a rubber bung (Fig. 10: 108) to deliver medication (page 12, lines 14-15).
Regarding claim 30, Kris discloses an auto-injector comprising a housing (Fig. 1: 10), a plunger within the said housing (Figs. 11 and 21: plunger 162 within 10), a plunger hook (Fig. 21: 148), and a button (Fig. 21: 126), wherein the button connects to a safety sleeve (Fig. 21: safety sleeve 114 connected to button via 148 and 122), wherein the safety sleeve is configured to disengage from the plunger hook (page 10, lines 20-26), and thereafter the button is configured to engage with the plunger hook to push release the plunger (page 11, lines 9-15) held under spring pressure (Fig. 15: plunger 162 held under pressure of spring 164; page 9, lines 26-30), wherein the auto-injector further comprises a locking element as shield lock member (Fig. 26: 119) to connect a pre filled syringe (PFS) holder and the needle shield together (Fig. 26: 52 and syringe holder connected due to 119 acting on 154), wherein the shield lock member is activated only after a dose is delivered (page 12, line 31 – page 13, line 3; activation being the locking/abutting of 52 occurring).
Regarding claim 31, Kris discloses a pen injector device, which comprises: a housing (Fig. 1: 10), a plunger within said housing (Figs. 11 and 21: plunger 162 within 10), a plunger hook (Fig. 21: 148), a locking member provided within a rear housing the locking member comprises the plunger (Figs. 11 and 21: 162), the plunger hook (Fig. 21: 148) and a safety sleeve (Fig. 21: 114), a locking element comprising a shield lock (Fig. 6: 70 + 76 +119) to hold a PFS holder (Fig. 21: 78) and a needle shield together (Fig. 26: 52 and syringe holder connected due to 119 acting on 154); wherein plunger hook legs (180 and 154) hold the plunger by self-strength (Fig. 23: plunger 162 held by the protrusions 158 of hook legs 154; page 11, lines 11-18), wherein a button (Fig. 21: 126) pushes the plunger hook legs to release the plunger (page 11, lines 9-20), wherein a spring guide (Fig. 11: 168+170 guide spring 164) sits within the plunger (Fig. 14: 168+170 and spring 164 sit within 162), wherein a cap sleeve is provided (Fig. 4: 22), wherein the plunger hook is supported by the safety sleeve to be held in place when not in use (Fig. 21: 148 supported by 114; page 8, line 4), wherein the shield lock is hung onto the rear housing (Fig. 14: 76 is located within the distal/rear of the body of the device; page 7, lines 6-7), wherein the shield lock is released when the plunger slides out of the mechanism (page 7, lines 6-10: 76 is released from position as it moves with 114 after the plunger sliding is initiated), wherein the shield lock latches onto the PFS holder and holds the needle shield in place thus linking the needle shield and PFS holder together after dose delivery (page 6, lines 17-20: 70 is latched to 78, such that 52 covers the needle), to avoid needle stick injury, and wherein the shield lock is activated only after the dose is delivered from the PFS in use (page 12, line 31 – page 13, line 3; activation being the locking/abutting of 52 occurring).
Regarding claim 32, the device of claim 31, further comprising four separate springs (coiled springs 164 and 122 and flexing arm springs 20 and 180).
Regarding claim 33, the device of claim 31, further comprising four separate springs, including: i) a delivery spring that pushes the plunger forwards (Fig. 15: 164; page 11, lines 23-24); ii) a needle shield spring that pushes the needle shield forwards (Fig. 12: flexing springs 180; page 8, lines 33 – page 9, line 4; page 10, lines 24-26; springs 180 of 148 interact with elements of 114 and 52 to connect to and push 52); iii) a shield hook spring that pushes the shield hook member forwards (Fig. 20: flexing springs 120; page 7, lines 11-14; page 10, lines 24-26; the springs 120 of 114 interact with 182 to be pushed, pushing 119 of the shield lock); and iv) a safety sleeve spring that pushes the safety sleeve forwards (Fig. 26: 122; page 7, lines 16-19).
Regarding claim 34, the device of claim 31, wherein in use the plunger moves inside the PFS (page 12, lines 14-15) and when this happens the shield lock moves along with the plunger and hooks into the PFS holder (page 6, lines 13-20).
Regarding claim 35, the device of claim 31, wherein once the shield lock hooks onto the PFS holder the needle shield is locked down and it will not come by itself and wherein the needle shield pulls the shield lock and the PFS holder along with it such that they are interlocked (page 6, lines 13-20; Figs. 6-9: 78 is interlocked within 52 via 90, 80, and 70).
Regarding claim 36, the device of claim 31, wherein the safety sleeve slides out of the plunger hook and after this the button engages with the plunger hook and pushes the plunger hook legs to release the plunger (page 11, lines 9-15), and wherein the plunger is under delivery spring pressure whereby this pressure pushes the plunger forward into the PFS (Fig. 15: plunger 162 held under pressure of spring 164; page 9, lines 26-30).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL TSAI can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783