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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/11/2026 has been entered.
Response to Amendment
Claims 1 and 13 have been amended. Claims 1-15 remain pending. No new matter has been entered.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 is objected to for a typographical error where there is improper antecedent basis in the claim where it recites “provided in the U-shaped wall” and should instead recite “provided in a U-shaped wall”.
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 3 and 5 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 claims 3 and 5, the claims are indefinite where they are unclear where they each recite “the dose setting member comprises”. There is improper antecedent basis for the claim term “the dose setting member”, and it is unclear if the claims are meant to require that the dose setting assembly comprises the respective features, or if the claim is meant to refer to a particular one of the distal dose setting member or the proximal dose setting member, or if the claim is meant to refer to either of the proximal dose setting member or the distal dose setting member. For the purposes of compact prosecution, Examiner has understood the claim to require that the dose setting assembly must include the respective claimed features.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5, and 7-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moran et al. (US Pat. No. 4874385, henceforth Moran) in view of Diaz et al. (US 20180361080, henceforth Diaz, previously made of record) and Wyrick (US Pat. No. 5833669, henceforth Wyrick).
Regarding claim 1, Moran discloses a dose setting assembly (assembly of fig. 1) for a medical injection device (syringe 10, fig. 1) comprising a barrel (barrel 12, fig. 1) defining a reservoir (interior of barrel 12, fig. 1) adapted to contain a medical injection fluid (substance as in Col. 1 lines 6-8), an open proximal end (rear wall 14, fig. 1) and a distal end (end opposite rear wall 14, fig. 1) comprising a hub portion (this is the cylindrical tip shown at the distal end, see fig. 1), a flange (see fig. 1, rear wall 14 has a radial protrusion which is a flange) disposed at the proximal end of said barrel (see fig. 1), and an elongated plunger rod (plunger member 16, fig. 1) having a plunger flange (operator portion 20, fig. 1) at a proximal end (see fig. 1, the proximal end is the end with portion 20) and a stopper (piston portion 18, fig. 1) at a distal end (see fig. 1, the distal end is the end with portion 18), the plunger rod being able to slidably move within the barrel (see Abstract), said dose setting assembly comprising: a distal dose setting member (lock member 32, fig. 1) removably secured to the syringe (see Col. 1 lines 8-10, “The present device includes a locking member mounted on the plunger portion of the syringe”, meaning that locking member 32 can be removed) configured to maintain the plunger rod in a distal predetermined position (see Abstract, “The locking member is also shaped to move into abutment with the syringe housing where the plunger is moved to limit movement of the plunger when in its locked position.”), the distal dose setting member being removable from the syringe (see Col. 1 lines 8-10, “The present device includes a locking member mounted on the plunger portion of the syringe”, meaning that locking member 32 can be removed) to authorize the plunger rod to move towards the syringe (see fig. 1 and see Abstract, when the locking member is unlocked or is missing, the plunger rod can move distally towards the syringe barrel 12) and abut onto said syringe (if locking member 32 were to be removed from the assembly, plunger member 16 and piston portion 18 thereof could come into abutment with the distal end of barrel 12); wherein the distal dose setting member comprises a distal part (this is the part of locking member 32 which twist grip 58 does not extend longitudinally along, see fig. 4) provided with at least one external groove (this is the groove formed between outwardly extending projection 37 and twist grip 58, fig. 4) oriented perpendicularly to a dose setting member longitudinal axis (see fig. 4 and see fig. 2, the longitudinal axis as claimed extends coaxial to plunger member 16 and the called out groove extends perpendicular to this) and a proximal part (this is the part which twist grip 58 extends along, see fig. 4) provided with at least one internal groove (this is the chamfered grooved edge at the distal most edge of cam portion 40, fig. 4) oriented perpendicularly to the dose setting member longitudinal axis (see fig. 4 and see fig. 2, the longitudinal axis as claimed extends coaxial to plunger member 16 and the called out groove extends perpendicular to this), and wherein the proximal part extends along the longitudinal axis to a greater extent than the internal groove (see fig. 4).
Moran does not disclose the distal dose setting member being transversally removable from the syringe, a proximal dose setting member secured on the distal dose setting member, maintaining the plunger rod in a second predetermined position, the proximal dose setting member being transversally removable from the distal dose setting member, to authorize the plunger rod to move towards the distal dose setting member and abuts onto said distal dose setting member, wherein the proximal dose setting member comprises a distal part provided with at least one external groove oriented perpendicularly to a dose setting member longitudinal axis and a proximal part provided with at least one internal groove oriented perpendicularly to the dose setting member longitudinal axis. Wyrick teaches that dose setting members can be designed to be transversally removable (see Col. 9, lines 56-65, where collars 206 and 208 are dose setting members). Wyrick additionally teaches that dose setting members similar to those of Moran (collars 206 and 208, fig. 2) can be provided either as a single unit or in multiples (see Col. 9 lines 35-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the dose setting member of Moran transversally removable as in Wyrick as Wyrick teaches dose setting members to be preferably removable and that transverse removal is an acceptable and known means to provide such removability (see Col. 9 line 56-65).
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a second dose setting member of Moran for allowing for a second dose setting amount to be set as desired as Wyrick teaches that such dose setting members can be provided either alone or as multiples depending on the desired delivery amounts and characteristics (see Wyrick Col. 9 lines 35-42) and that having multiples of the dose setting members would have yielded the predictable result of allowing for multiple set doses to be configured prior to use as in Wyrick (see Col. 9 lines 35-42).
Thus, in the modified device, Moran as modified by Wyrick would have 2 identical dose setting members arranged along the plunger rod; the one which is closer to operator portion 20 is the proximal dose setting member, and the one which is closer to rear end 14 is the distal dose setting member, and since these members are identical in the modified device, the proximal dose setting member would be secured in the distal dose setting member where it is connected to the same structure, the plunger assembly 16, as the distal dose setting member. Additionally, the proximal dose setting member would be configure to maintain the plunger rod in a second predetermined position where it could be locked such as to limit the distal advancement of the plunger rod to a more proximal location than if the proximal dose setting member were to be removed, and its transversal removability would be to allow the plunger rod to move towards and abut onto the distal dose setting member as claimed where the distal dose setting member could be arranged to abut directly onto end wall portion 14, and removing the added proximal dose setting member would allow for portion 20 to be translated distally until it abuts the distal dose setting member. Finally, the proximal dose setting member would have the distal part and proximal part as claimed since it would be identical to the distal dose setting member which has the claimed structures as called out above.
Moran as modified by Wyrick does not disclose a backstop as claimed. Diaz teaches a backstop (finger flange 140, fig. 8) as a means of securing a removable device (combination of finger flanger 140 and removable plunger member 150, fig. 8, which are removable relative to syringe body 110, syringe flange 114, connection member 130, and removable cap 132) to a flange (syringe flange 114, fig. 8) of a barrel (syringe body 110, fig. 8) of a medicament injection device (syringe body 110, syringe flange 114, connection member 130, and removable cap 132 make up the claimed injection device), wherein a removable part of the removable device (plunger member 150, fig. 8) is removable from the backstop (see figs. 8 and 9, plunger 150 is shown as being removably arranged relative to the rest of the assembly).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the backstop of Diaz to the dose setting assembly of Moran for providing a means for a user to grasp the medical injection device with their fingers while pushing on the plunger (Diaz [0006], this is what finger flanges are used for). The modified device of Moran in view of Wyrick and Diaz (henceforth Moran as claimed) thus discloses that the distal dose setting member is transversally removable from the backstop to authorize the plunger rod to abut onto the added backstop (in the modified device, if the distal dose setting member was removed from the assembly of Moran with the added backstop of Diaz, the plunger assembly 16 of Moran would be functionally capable of coming into direct physical abutment with the added backstop of Diaz as there would be no added components which would prevent such an abutment).
{Examiner notes that all subsequent references are made to Moran unless otherwise noted.}
Regarding claim 2, Moran as modified discloses the dose setting assembly of claim 1 wherein the proximal dose setting member comprises at least one inner locking means (cams 40, 42, see fig. 3) configured to maintain the plunger flange in a concealed locked position (see Col. 5 lines 1-45, and note that the locked position is considered to be concealed as claimed where operator portion 20 is at least partially concealed from view by twist grips 58, 60 when viewed from the position of fig. 3).
Regarding claim 3, Moran as modified discloses the dose setting assembly of claim 1 wherein the dose setting member comprises an elongated U-shaped wall (see Wyrick fig. 2; in the modified device, the dose setting members of Moran have slit 252 which has been added to make them transversely removable, which causes the previously continuous circular members to now have a U-shaped wall as claimed) defining an enclosure (see Moran figs. 3 and 4, locking members 32 form an enclosure in their hollow interiors as shown).
Regarding claim 5, Moran as modified discloses the dose setting assembly of claim 1 wherein the dose setting member comprises an internal shoulder (cams 40 and 42, fig. 3) provided in the U-shaped wall (see fig. 3; see also Wyrick fig. 2; in the modified device, the dose setting members of Moran have slit 252 which has been added to make them transversely removable, which causes the previously continuous circular members to now have a U-shaped wall as claimed) and an external shoulder (outwardly extending projection 37, fig. 4) provided in the U-shaped wall (see figs. 3 and 4).
Regarding claim 7, Moran as modified discloses the dose setting assembly of claim 1 wherein the backstop comprises a distal plate (see Diaz fig. 10, the flat plate called out as finger flange 140 is a distal plate as claimed) and a proximal funnel (from Diaz: proximally opening funnel 148, fig. 10), which both define a longitudinal enclosure (see Diaz fig. 10, proximally opening funnel 148 and the called out distal plate 140 combine to define plunger member receiving opening 146 as shown).
Regarding claim 8, Moran as modified discloses the dose setting assembly of claim 7 wherein the backstop comprises a distal groove (from Diaz: side opening 144, fig. 10) adjacent the distal plate (from Diaz: see fig. 10, side opening 144 is directly next to the distal plate of finger flange 140) and two arcuate portions provided on the distal plate (from Diaz: see annotated fig. 10 and see fig. 9, the two extensions which protrude distally from the distal plate 140 form arcuate portions as claimed).
Regarding claim 9, Moran as modified discloses the assembly of claim 7 wherein the backstop comprises a proximal groove provided in the proximal funnel (from Diaz: the slanted opening provided in funnel 148 is a proximal groove as it is a groove proximal to the called out distal plate, see fig. 10).
Regarding claim 10, Moran as modified discloses the dose setting assembly of claim 7 wherein the distal plate extends radially from the funnel (from Diaz: see fig. 10).
Regarding claim 11, Moran as modified discloses a method of operating a medical injection device, comprising the steps of: providing a medical injection device (modified assembly of fig. 1 of Moran, Wyrick, and Diaz, see rejection of claim 1 above) having a dose setting assembly of claim 1 (modified dose setting assembly of Moran, Wyrick, and Diaz, see rejection of claim 1 above) and removing at least one of the distal dose setting member and the proximal dose setting member from the backstop (see Wyrick Col. 9 lines 25-55, the collars are removed to allow delivery of a subsequent dose).
Regarding claim 12, Moran as modified discloses the method of claim 11 further comprising the step of: moving the plunger rod into the syringe barrel towards the backstop (see Wyrick Col. 9 lines 25-55; in the modified device, the same steps are followed) until the barrel flange abuts against the backstop (see Wyrick Col. 9 lines 25-55; in the modified device, the same steps are followed, including removal of the second dose setting member such that the entire dose can be delivered as desired).
Regarding claim 15, Moran as modified discloses the method of claim 11 wherein the dose setting member is transversely removed from the medical injection device (see Wyrick Col. 9 lines 25-55; in the modified device, the same steps are followed).
Regarding claim 13, Moran as modified discloses a method of operating a medical injection device (modified assembly of fig. 1 of Moran, Wyrick, and Diaz, see rejection of claim 1 above), comprising the steps of: providing a medical device having a dose setting assembly of claim 1 (see the rejection of claim 1 above); removing the proximal dose setting member from the distal dose setting member (see Wyrick Col. 9 lines 25-55; in the modified device, the proximal dose setting member has its seal of its slit broken first and is thus first to be transversely removed such that the second portion of the dose can be administered when the plunger is advanced distally to the proximal most face of the distal dose setting member); moving the plunger rod into the syringe barrel towards the distal dose setting member until the plunger rod abuts onto the distal dose setting member (see Wyrick Col. 9 lines 25-55; in the modified device, the proximal dose setting member has its seal of its slit broken first and is thus first to be transversely removed such that the second portion of the dose can be administered when the plunger is advanced distally to the proximal most face of the distal dose setting member); and removing the distal dose setting member from the backstop (see Wyrick Col. 9 lines 25-55; in the modified device, once the seal has been broken for the distal dose setting member, it can also be removed to allow for full dose dispensing where the plunger is advanced until the operator portion 20 is indirect abutment with the added backstop of Diaz).
Regarding claim 14, Moran as modified discloses the method of claim 13 further comprising the step of: moving the plunger rod into the syringe barrel towards the backstop until the plunger rod abuts onto the backstop (see Wyrick Col. 9 lines 25-55; in the modified device, once the seal has been broken for the distal dose setting member, it can also be removed to allow for full dose dispensing where the plunger is advanced until the operator portion 20 is indirect abutment with the added backstop of Diaz).
Allowable Subject Matter
Claims 4 and 6 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not disclose or render obvious in combination the claimed dose setting assembly having proximal and distal dose setting members where the internal groove of the proximal part of the proximal dose setting member is configured and dimensioned to receive the plunger flange and where the external groove of the distal part of the proximal dose setting member is configured and dimensioned to engage the internal groove of the proximal part of the distal dose setting member as claimed.
The relied upon rejection of record above does not disclose or render obvious in combination the removable engagement of the internal and external grooves as claimed, but rather relies on the distal dose setting member and the proximal dose setting member each being arranged directly onto the plunger rod with the respective grooves abutting each other and directly adjacent to one another when arranged as shown in Wyrick (see figs. 3 and 8). Additional prior art made of record similarly does not disclose or provide teachings or motivations for such an arrangement, and modifying the relied upon assembly of Moran, Wyrick, and Diaz to provide grooves with such an engagement does not appear to be possible as the twist grips of Moran (58 and 60) would interfere with an overlapped, groove-engaging arrangement and thus would prevent such a system from being functional.
Claim 6 is objected to based on its dependency on, and thus requirements of the allowable subject matter of, objected to claim 4.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 11, and 13 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Berman et al. (US 20040015120) is considered relevant prior art regarding a removable backstop and dose setting assembly which has a plurality of internal and external grooves.
Samoskey et al. (US 20150379900) is considered relevant prior art regarding the use of a removable dose setting and sensing assembly which is transversally removable from a syringe and includes an interior groove but lacks an exterior groove.
Ando (US Pat. No. 4654035) is considered relevant prior art regarding use of a dose setting component similar to that relied on above from Moran, however the grooves which communicate and stack on top of one another similar to the claimed arrangement of fig. 4 are integrally molded on a plunger rod and not on an additional dose setting member.
Kubo et al. (US 20140303565) is considered relevant prior art regarding teaching a transversally removable backstop and dose setting assembly similar to that which is claimed in claims 1 and 4, however it lacks the plunger concealment as claimed in claim 4 and lacks the claimed external groove arrangement.
Wong et al. (US Pat. No. 10022502) is considered relevant prior art similar to the previously relied on Gerlett et al. reference (Gerlett, US 20190247585, previously made of record).
Moskowitz (US Pat. No. 4073321) is considered relevant prior art regarding a multi-part, radially stacked dose setting assembly which is arranged onto a plunger rod similar to the claimed system but lacking especially the exterior groove as claimed.
Kuczek et al. (US 20140180217) is considered relevant prior art regarding a dose setting assembly which is transversally attached to a plunger rod of a syringe and has a backstop portion and a dose setting portion where the plunger rod is distally advanced until it comes into direct abutment with a dose limiting feature.
Rolla (US 20050137532) is considered relevant prior art regarding teachings of using multiple removable dose limiting assemblies which are sequentially removed such as to deliver set doses of medicament from a syringe.
Meola (US 20190380913) is considered relevant prior art similar to Kuczek et al. cited above.
Sharp (US 20080065027) is considered relevant prior art regarding use of a dose setting member which is transversally attachable to a plunger rod and has an interior groove and an exterior groove (see especially figs. 8 and 11).
Locati et al. (US 20160144122) is considered relevant prior art where it teaches a backstop similar to the one claimed and similar to the relied upon Diaz reference above.
Kojima et al. (US 20150045740) is considered relevant prior art regarding teaching a clip which is transversely attachable to and concealing a syringe flange and plunger.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL J MARRISON/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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