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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/03/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 01/27/2026. As directed by the amendment: claims 1 & 4 have been amended. Claim 2 has been cancelled.
Thus, claims 1, 3-5 are pending in this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an engagement releasing mechanism configured…” in claim 1. Presumption is rebutted because no structure is recited that can perform the limiting function. The word “mechanism” is a generic placeholder that does not denote a sufficient structure to release engagement between the plunger and the engagement member.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification discloses in paragraph 0009 that the engagement releasing mechanism includes a rotary engaging portion provided on the plunger and a rotary engaged portion provided on the barrel to release the engagement between the plunger and the engaging member. The language in claim 1 will be interpreted as requiring the disclosed structure in paragraph 0009, or equivalents.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Bom et al (US 20120184917 A1) in view of Dugand et al (US 20200238010 A1).
Regarding claim 1, Bom et al disclose an injection device (200) comprising: a syringe (203) including a barrel (204) provided with an injection needle (206) at a distal end thereof (fig 20a) and a plunger (207) inserted into the barrel so as to be capable of reciprocating between a proximal end side of the barrel as a start point and the injection needle as an end point (para 0148); a housing (202) formed in a tubular shape to accommodate the syringe (fig 20a), and a plunger accommodating portion (upper portion of housing 202) formed on another side relative to the barrel accommodating portion and accommodating the plunger protruding from the proximal end side of the barrel (fig 20a); an engaging member (210/290) disposed in the plunger accommodating portion (fig 20a) and configured to be retainably engaged with the plunger until the engagement between the plunger and the engaging member is released (para 0146-148); a plunger urging portion (211) engaged with the engaging member (para 0145) and urging the plunger from the start point toward the end point (para 0150); a trigger portion (205) configured to hold urging of the plunger urging portion (para 0145) and a state where the plunger resists against an urging force of the plunger urging portion and a distal end of the plunger is located at a position of the start point (fig 20a and para 0145 and 0147), and to release the holding by performing a predetermined operation (para 0149-150), and an engagement releasing mechanism (280 and teeth of plunger, see fig 20ab) configured to release engagement between the plunger (207) and the engaging member (210/290) and to cause the plunger to be located at the end point (para 0148, examiner notes: engagement between nut 280 coverts rotation of piston 207 to move toward needle 241 which is the end point) in a manner that the plunger moves from the start point toward the end point by the urging force of the plunger urging portion and the plunger and the engaging member rotate relative to each other around the central axis (para 0148 and 0150), wherein the engagement releasing mechanism includes a rotary engaging portion (teeth of piston 207) provided on the plunger (fig 20b) and a rotary engaged portion (280) provided on the barrel (fig 20a-b, nut 280 is provided on the distal end of 204), wherein the plunger (207) is configured to move from the start point toward the end point (para 0148), the rotary engaging portion and the rotary engaged portion are engaged with each other (piston teeth and nut 280, figs 20a-b), and the plunger is configured to rotate around the central axis to release the engagement between the plunger and the engaging member (para 0148-150, due to the threaded interface with the nut 280, advances the piston 208 in the cartridge 204-examiner notes: piston 207 rotates while engaging with nut 280 to move in the cartridge 204, thus engagement between the plunger and the engaging member is released when piston 207 is moved to needle 241), and the rotary engaging portion (teeth of piston 207) comprises a pair of rotary engaging portions provided in a direction orthogonal to the central axis (figs 18 and 20a-b, teeth of piston are provided in a direction orthogonal to the central axis).
Bom et al fail to teach the housing including a barrel accommodating portion formed on one side in a direction of a central axis and accommodating the barrel to be movable between a state where the injection needle is accommodated and a state where the injection needle protrudes from one side of the housing at a predetermined distance from the accommodated state to one side and a barrel urging portion provided in the barrel accommodating portion and urging the barrel from the one side to the other side of the housing; and wherein said trigger potion to hold urging of the plunger urging portion so as not to release the urging in a state where the barrel accommodates the injection needle by the barrel urging portion.
Bom et al disclose a removable cap is adapted to be mounted on the injection device 200 to protect the cartridge 204 and to cover the drug outlet 241 when the injection device 200 is not in use (para 0144).
However, Dugand et al disclose an injection device (22) comprising: a syringe (24, fig 4) including a barrel (26) provided with an injection needle (28), a housing (92), a plunger (58), a trigger portion(47), and a plunger urging portion (128); and wherein housing including a barrel accommodating portion (portion of casing 92 accommodates barrel 26 and end sleeve 46) formed on one side in a direction of a central axis and accommodating the barrel to be movable (para 0058) between a state where the injection needle is accommodated (figs 4-5) and a state where the injection needle protrudes from one side of the housing at a predetermined distance from the accommodated state to one side (figs 14-16) and a barrel urging portion (para 0085, retraction spring) provided in the barrel accommodating portion and urging the barrel from the one side to the other side of the housing (para 0085); and wherein said trigger potion to hold urging of the plunger urging portion so as not to release the urging in a state where the barrel accommodates the injection needle by the barrel urging portion (para 0088 and fig 9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Bom et al and incorporate the teaching of Dugand et al to have the housing including a barrel accommodating portion formed on one side in a direction of a central axis and accommodating the barrel to be movable between a state where the injection needle is accommodated and a state where the injection needle protrudes from one side of the housing at a predetermined distance from the accommodated state to one side and a barrel urging portion provided in the barrel accommodating portion and urging the barrel from the one side to the other side of the housing; and wherein said trigger potion to hold urging of the plunger urging portion so as not to release the urging in a state where the barrel accommodates the injection needle by the barrel urging portion. This would provide the benefit of having a barrel accommodating portion in which the barrel is movable by the urging of a barrel urging portion and replacing said cap with the barrel accommodating portion to protect said needle against any inadvertent contact with an element of its environment when the injection device is not used and moves forward for the injection needle to protrude when the device is in use. This ensures that the removable cap would never be lost after operating the injection device (para 0058 and 0085). Having the trigger potion to hold urging of the plunger urging portion so as not to release the urging in a state where the barrel accommodates the injection needle by the barrel urging portion is beneficial until the device is triggered and ready for use.
Regarding claim 3, Bom et al in view of Dugand et al disclose the injection device according to claim 1,
Bom et al further disclose wherein when the plunger (207) moves from the start point to a position immediately before the end point, the rotary engaging portion (teeth of piston 207) and the rotary engaged portion (280) are engaged with each other, and thus the plunger rotates around the central axis to release the engagement between the plunger and the engaging member (para 0148-150, piston 207 rotates while engaged with nut 280 to move axially before reaching end point).
Regarding claim 4, Bom et al disclose an injection device (200) comprising: a syringe (203) including a barrel (204) provided with an injection needle (206) at a distal end thereof (fig 20a) and a plunger (207) inserted into the barrel so as to be capable of reciprocating between a proximal end side of the barrel as a start point and the injection needle as an end point (para 0148); a housing (202) formed in a tubular shape to accommodate the syringe (fig 20a), and a plunger accommodating portion (portion of 202 that accommodate piston 207) formed on another side relative to the barrel accommodating portion and accommodating the plunger protruding from the proximal end side of the barrel (fig 20a); an engaging member (210/290) disposed in the plunger accommodating portion and engaged with the plunger (fig 20a); a plunger urging portion (211) engaged with the engaging member and urging the plunger from the start point toward the end point (para 0145-148); a trigger portion (205) configured to hold urging of the plunger urging portion and a state where the plunger resists against an urging force of the plunger urging portion and a distal end of the plunger is located at a position of the start point (fig 20a and para 0145 and 0147), and to release the holding by performing a predetermined operation (para 0149-150), and an engagement releasing mechanism (280 and teeth of plunger, see fig 20ab) configured to release engagement between the plunger (207) and the engaging member (210/290) and to cause the plunger to be located at the end point (para 0148, examiner notes: engagement between nut 280 coverts rotation of piston 207 to move toward needle 241 which is the end point) in a manner that the plunger moves from the start point toward the end point by the urging force of the plunger urging portion and the plunger and the engaging member rotate relative to each other around the central axis (para 0148 and 0150), wherein the plunger urging portion (211) is configured to urge the engaging member in a direction in which the engaging member rotates around the central axis by circumferential urging force of the plunger urging portion (para 0150) and the engagement releasing mechanism is configured to release the engagement between the plunger and the engaging member by rotating the engaging member around the central axis with respect to the plunger by the circumferential urging force of the plunger urging portion (para 0150).
Bom et al fail to teach the housing including a barrel accommodating portion formed on one side in a direction of a central axis and accommodating the barrel to be movable between a state where the injection needle is accommodated and a state where the injection needle protrudes from one side of the housing at a predetermined distance from the accommodated state to one side and a barrel urging portion provided in the barrel accommodating portion and urging the barrel from the one side to the other side of the housing; and wherein said trigger potion to hold urging of the plunger urging portion so as not to release the urging in a state where the barrel accommodates the injection needle by the barrel urging portion.
Bom et al disclose a removable cap is adapted to be mounted on the injection device 200 to protect the cartridge 204 and to cover the drug outlet 241 when the injection device 200 is not in use (para 0144).
However, Dugand et al disclose an injection device (22) comprising: a syringe (24, fig 4) including a barrel (26) provided with an injection needle (28), a housing (92), a plunger (58), a trigger portion(47), and a plunger urging portion (128); and wherein housing including a barrel accommodating portion (portion of casing 92 accommodates barrel 26 and end sleeve 46) formed on one side in a direction of a central axis and accommodating the barrel to be movable (para 0058) between a state where the injection needle is accommodated (figs 4-5) and a state where the injection needle protrudes from one side of the housing at a predetermined distance from the accommodated state to one side (figs 14-16) and a barrel urging portion (para 0085, retraction spring) provided in the barrel accommodating portion and urging the barrel from the one side to the other side of the housing (para 0085); and wherein said trigger potion to hold urging of the plunger urging portion so as not to release the urging in a state where the barrel accommodates the injection needle by the barrel urging portion (para 0088 and fig 9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Bom et al and incorporate the teaching of Dugand et al to have the housing including a barrel accommodating portion formed on one side in a direction of a central axis and accommodating the barrel to be movable between a state where the injection needle is accommodated and a state where the injection needle protrudes from one side of the housing at a predetermined distance from the accommodated state to one side and a barrel urging portion provided in the barrel accommodating portion and urging the barrel from the one side to the other side of the housing; and wherein said trigger potion to hold urging of the plunger urging portion so as not to release the urging in a state where the barrel accommodates the injection needle by the barrel urging portion. This would provide the benefit of having a barrel accommodating portion in which the barrel is movable by the urging of a barrel urging portion and replacing said cap with the barrel accommodating portion to protect said needle against any inadvertent contact with an element of its environment when the injection device is not used and moves forward for the injection needle to protrude when the device is in use. This ensures that the removable cap would never be lost after operating the injection device (para 0058 and 0085). Having the trigger potion to hold urging of the plunger urging portion so as not to release the urging in a state where the barrel accommodates the injection needle by the barrel urging portion is beneficial until the device is triggered and ready for use.
Regarding claim 5, Bom et al in view of Dugand et al disclose the injection device according to claim 4,
Bom et al further disclose wherein the plunger urging portion is a torsion spring (para 0145, line 16), and is configured to rotate the engaging member by an urging force generated by twisting of the torsion spring (para 0150).
Response to Arguments
Applicant’s arguments, see Remarks, filed on 01/27/2026, with respect to the rejection(s) of claim(s) 1, 3-5 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bom et al (US 20120184917 A1) in view of Dugand et al (US 20200238010 A1).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783