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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 8/17/2026 is acknowledged. The Examiner notes that claim 8 was incorrectly identified as being in Group II, but should be in Group I. The traversal is on the grounds that (a) “the Examiner is wrong to assess that claims 13 and 14 would relate to an invention different from claim 1”, (b) “the Examiner is wrong to assess that claims 7 and 16 would relate to an invention different from claim 1”, and (c) “the Examiner is wrong to assess that claims 15 and 17 would relate to an invention different from claim 1”. This is not found persuasive.
Regarding argument (a), Applicant argues that claims 13 and 14 require the device of claim 1 and, therefore, share the same special technical feature of claim 1. However, the shared technical feature of claims 1, 13 and 14 (that is, the device of claim 1) is not a “special” technical feature as it is fully disclosed by both Trocki and Hasegawa (as set forth in the 102 rejections of claim 1 below). Therefore, lack of unity of invention among claims 1, 13 and 14 is evident a posteriori.
Regarding argument (b), Applicant argues that the special technical feature of claim 1 (the folding portion) and the special technical feature of claim 7 (the first coupling organ) are “corresponding special technical features”. Specifically, Applicant argues that the special technical features of claims 1 and 7 are “corresponding” because they “solve the same technical problem” since “both features contribute to meeting the need identified in the patent application, namely that for an injection device able to receive a syringe and connect a drive member to the syringe’s piston in a single step, in a simple and easy way, allowing also an easy removal of the syringe, regardless of the position of the drive member, without any active part”. This is not persuasive because the “folding portion” of claim 1 pertains to securement and release of the syringe flange while the “first coupling organ” of claim 7 pertains to coupling and decoupling the piston. These two special technical features are not corresponding as they serve completely different purposes (one purpose being for engaging the syringe flange and the other purpose being for engaging the piston), even if those purposes contribute to the overall need identified in the patent application.
Regarding argument (c), Applicant argues that claims 15 and 17 require the device of claim 7 and do not relate to an invention different from claim 1 based on argument (b). Since argument (b) is not persuasive (see above), this argument is not persuasive either.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 7 and 9-18 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 1 is objected to because of the following informalities: The term “A” in the phrase “A injection device” on line 1 should be replaced with the term “An” in order to be grammatically correct. The term “and” should be inserted at the end of line 4 in order to be grammatically correct. In order to be grammatically correct, the comma on line 14 should be removed. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: In order to be grammatically correct, a comma should be inserted before the phrase “with respect to the longitudinal axis” on line 2. In order to maintain consistency of claim language, the term “first” should be inserted before the term “radial” on line 2. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: In order to be grammatically correct, the comma on line 3 should be removed. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: In order to be grammatically correct, the comma on line 3 should be removed. In order to ensure proper antecedent basis, either the phrase “a clamping position” on line 3 should be amended to recite “a clamping configuration” (to match the language on line 4) or the phrase “the clamping configuration” on line 4 should be amended to recite “the clamping position” (to match the language on line 3). 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 2-5 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.
Claim 2 recites “the folding portion of the supporting member” on lines 1-2 and claim 3 recites “the supporting surface formed by the folding portion” on lines 1-2. Since claim 1 introduces “two supporting members” wherein “each supporting member comprises a folding portion” and each folding portion “forms a supporting surface”, but claims 2 and 3 only refer to one of these folding portions (and its respect supporting member and supporting surface), it is unclear if the limitations of claims 2 and 3 are truly intended to only apply to one of the “two supporting members” or if they are intended to apply to both of the supporting members. For the sake of examination, the claims are interpreted as referring to both of the supporting members. Accordingly, it is suggested to amend claim 2 to recite “the folding portion of each of the supporting members” and to amend claim 3 to recite “the supporting surface formed by each of the folding portions”.
Claim 4 recites “the folding portion of a supporting member is formed by a hinged door” on lines 1-2 and claim 5 recites “the hinged door is biased into the supporting position by a biasing member”. It is unclear if the “supporting member” is one of the “two supporting members” introduced in claim 1 or not (due to the recitation of “the folding portion” but “a supporting member”). Additionally, it is unclear if limitations of claims 4 and 5 truly intended to only apply to one of the “two supporting members” or if they intended to apply to both of the supporting members. For the sake of examination, the claims are interpreted as referring to both of the supporting members. Accordingly, it is suggested to amend claim 4 to recite “the folding portion of [[a]] each of the supporting members” and to amend claim 5 to recite “[[the]] each hinged door is biased into the supporting position by a respective biasing member”.
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trocki et al. (PG PUB 2001/0047153).
Re claim 1, Trocki discloses an injection device 10 (Fig 1 comprising the interface module 1814 of Fig 43A-43I instead of interface module 14 of Fig 1 and comprising the drive member 1242 of Fig 35 instead of the drive member 42 of Fig 1; it is noted that all reference characters cited below refer to Fig 1, Fig 35 and/or Fig 43A-43I unless otherwise noted) for delivering a medical fluid (it is noted that the italicized text constitutes a functional limitation and, therefore, “a medical fluid” is not a part of the claimed invention; this limitation is met in view of Para 10), comprising: an interface module 1814 configured to receive a syringe (it is noted that the italicized text constitutes a functional limitation and, therefore, “a syringe” is not a part of the claimed invention; this limitation is met in view of Fig 43D, the interface module is structurally capable of receiving syringe 1512), the interface module defining a reception space (extending between the semi-circular portions of supporting members 1832,1832, labeled in Fig B below) adapted to receive a flange in the outer periphery of a barrel of the syringe (it is noted that the italicized text constitutes a functional limitation; as set forth above, the “syringe” is not a part of the claimed invention and, therefore, a “flange” and a “barrel” are not a part of the claimed invention; this limitation is met in view of Fig 43D), and a drive member 1242 configured to couple to a piston of the syringe (it is noted that the italicized text constitutes a functional limitation; as set forth above, the “syringe” is not a part of the claimed invention and, therefore, a “piston” is not a part of the claimed invention; this limitation is met in view of Para 258), wherein said drive member is configured to translate along a longitudinal axis (wherein the longitudinal axis extends along the center of drive member 1242 and along the center of syringe 1512) through the reception space (Para 258), wherein the interface module comprises a lateral opening (extending between the pivot ends (labeled in Fig B below) corresponding to pivot ends 1751 of Fig 42A) defined between two supporting members 1832,1832 of the interface module and extending radially in a first radial direction (upward in Fig 43B) from the longitudinal axis (as seen in Fig 43B), said lateral opening being adapted for a radial translation of the syringe in the first radial direction to a loaded position in which the flange of the syringe is received in the reception space and the barrel of the syringe extends along the longitudinal axis (it is noted that the italicized text constitutes a functional limitation; as set forth above, the “syringe” and its “flange” are not a part of the claimed invention; this limitation is met in view of Fig 43E and Para 283 which sets forth that the syringe can move along the direction of arrow D in Fig 42B and described in 280), and wherein each supporting member comprises a folded portion (the bodies of the supporting members 1832 themselves are folded portions due to their rotation around axis 1831, Para 279) pivotable between a supporting position (seen in Fig 43D) in which said folding portion forms a supporting surface for the flange of the syringe (as seen in Fig 43D) and an open position (seen in Fig 43F) in which said folding portion opens a passage parallel to the longitudinal axis for the flange of the flange (as seen in Fig 43F), thereby allowing a longitudinal translation of the syringe out of the loaded position (it is noted that the italicized text constitutes a functional limitation; as set forth above, the “syringe” is not a part of the claimed invention; this limitation is met in view of Para 285 which sets forth that the syringe can move along the direction opposite from arrow E in Fig 43C).
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Re claim 2, Trocki discloses that the folding portion of the supporting member is radially offset with respect to the longitudinal axis in the first radial direction of the lateral opening (as best seen in Fig 43B).
Re claim 3, Trocki discloses that the supporting surface formed by the folding portion extends in a second radial direction, opposite the first radial direction, beyond the reception space towards the lateral opening (as best seen in Fig 43B).
Re claim 4, Trocki discloses that the folding portion of each supporting member is formed by a hinged door (the folding portions 1832,1832 themselves) pivotable perpendicularly (via pivot point 1831 – comparable to pivot point 1631, Para 275) with respect to the longitudinal axis between the supporting position and the opening position (Para 282; as seen in Fig 43C, the hinged doors move out of and into the page while the longitudinal axis extends horizontally on the page).
Re claim 5, Trocki discloses that each hinged door is biased into the supporting portion by a biasing member (Para 282, “the spring force holding the retaining members 1832 in the closed position”).
Re claim 6, Trocki discloses that the drive member 1242 (Fig 35) comprises a head (the distal end thereof, to the right in Fig 35) providing a first coupling organ 1202 (Fig 35) configured to couple to a second coupling organ of the piston when said first coupling organ is pressed on said second coupling organ (it is noted that the italicized text constitutes a functional limitation; as set forth above, the “piston” is not a part of the claimed invention and, therefore, the “second coupling organ” is also not a part of the claimed invention; this limitation is met in view of Para 258 which discloses the first coupling organ 1202 being structurally capable of coupling to a second coupling organ 1214 of a piston 1238), wherein the first coupling organ is configured to retain said second coupling organ along the longitudinal axis without retaining said second coupling organ in a second radial direction opposite the first radial direction (Para 258 sets forth that the diameter of the second coupling organ 1214 is larger than the diameter of the first coupling organ 1202).
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hasegawa (PG PUB 2011/0184383).
Re claim 1, Hasegawa discloses an injection device 10 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 and/or Fig 2 unless otherwise noted) for delivering a medical fluid (it is noted that the italicized text constitutes a functional limitation and, therefore, “a medical fluid” is not a part of the claimed invention; this limitation is met in view of Para 2,3), comprising: an interface module (the entirety of pump 10 except for the drive mechanism which comprises the “box body” of slider 60 (Para 66 – labeled in Fig A below), the driving rod 63, the motor 128 and the motor driver 134, seen in Fig 5) configured to receive a syringe (it is noted that the italicized text constitutes a functional limitation and, therefore, “a syringe” is not a part of the claimed invention; this limitation is met in view of Fig 2 and Para 62 which show and describe receipt of a syringe 12a), the interface module defining a reception space (the space between the box body (Para 66) of slider 60 and clamp 50) adapted to receive a flange in the outer periphery of a barrel of the syringe (it is noted that the italicized text constitutes a functional limitation; as set forth above, the “syringe” is not a part of the claimed invention and, therefore, a “flange” and a “barrel” are not a part of the claimed invention; this limitation is met in view of Fig 2 and Para 62), and a drive member (the box body (Para 66) of slider 60) configured to couple to a piston of the syringe (it is noted that the italicized text constitutes a functional limitation; as set forth above, the “syringe” is not a part of the claimed invention and, therefore, a “piston” is not a part of the claimed invention; this limitation is met in view of Fig 2 and Para 66), wherein said drive member is configured to translate along a longitudinal axis (wherein the longitudinal axis extends along the center of plunger 16 in Fig 2) through the reception space (Para 71), wherein the interface module comprises a lateral opening (extending between the straight, upper section of members 66,66 as seen in Fig 2 and Fig 7, labeled in Fig A below) defined between two supporting members 66,66 (Fig 1,2,7) of the interface module and extending radially in a first radial direction (upward along the Z axis in Fig 1) from the longitudinal axis (as seen in Fig 2), said lateral opening being adapted for a radial translation of the syringe in the first radial direction to a loaded position in which the flange of the syringe is received in the reception space and the barrel of the syringe extends along the longitudinal axis (it is noted that the italicized text constitutes a functional limitation; as set forth above, the “syringe” and its “flange” are not a part of the claimed invention; this limitation is met in view of Fig 2 and Para 69), and wherein each supporting member comprises a folded portion (the bodies of the supporting members 66,66 themselves are folded portions due to their rotation around axes 66a,66a, Para 69) pivotable between a supporting position (seen in Fig 2) in which said folding portion forms a supporting surface for the flange of the syringe (although not directly in contact with the flange of the syringe (which is not required by the claim), the folding portions form a supporting surface of the syringe flange indirectly via engagement of the plunger flange) and an open position (seen in Fig 7) in which said folding portion opens a passage parallel to the longitudinal axis for the flange of the flange (as seen in Fig 7), thereby allowing a longitudinal translation of the syringe out of the loaded position (it is noted that the italicized text constitutes a functional limitation; as set forth above, the “syringe” is not a part of the claimed invention; this limitation is met in view of Fig 7 and Para 69).
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Re claim 2, Hasegawa discloses that the folding portion of the supporting member is radially offset with respect to the longitudinal axis in the first radial direction of the lateral opening (as best seen in Fig 7).
Re claim 3, Hasegawa discloses that the supporting surface formed by the folding portion extends in a second radial direction, opposite the first radial direction, beyond the reception space towards the lateral opening (as best seen in Fig 2).
Re claim 4, Hasegawa discloses that the folding portion of each supporting member is formed by a hinged door (the folding portions 66,66 themselves) pivotable perpendicularly (via axes 66a,66a) with respect to the longitudinal axis between the supporting position and the opening position (Para 69; as seen in Fig 1 vs Fig 2, they pivot along the plane defined by the Y and X axes which is perpendicular to the longitudinal axis that lies on the X axis).
Re claim 5, Hasegawa discloses that each hinged door is biased into the supporting portion by a biasing member (Para 69, “elastically closed”).
Allowable Subject Matter
Claim 8 is 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 subject matter of claim 8 could not be found nor was suggested in the prior art of record (in combination with the subject matter of claim 1). Claim 8 requires the interface module to comprise “a pair of jaws flanking the reception space, the jaws being pivotable between a clamping position in which the jaws are closed in the reception space and an open configuration in which the jaws are open, wherein the pair of jaws are maintained in the clamping configuration by a biasing force, and wherein said pair of jaws are maintained in the open configuration by a biasing force”. Trocki (cited above) does not disclose a pair of jaws. Hasegawa (cited above) discloses such a pair of jaws 38,54, wherein the jaws are pivotable (relative to each other since jaw 54 can rotate 90 degrees, Para 62) between a clamping position (seen in Fig 2) in which the jaws are closed in the reception space (as seen in Fig 2) and an open configuration (seen in Fig 1) in which the jaws are open (as seen in Fig 1), wherein said pair of jaws are maintained in the clamping configuration by a biasing force (Para 62); but Hasegawa does not disclose that the pair of jaws are maintained in the open configuration by a biasing force. Rather, Hasegawa discloses that the pair of jaws are only biased toward clamping configuration (Para 61,62); therefore, it would not have been obvious to one of ordinary skill in the art to modify Hasegawa to also maintain the pair of jaws in the open configuration by a biasing force as required by claim 8. Additionally, the subject matter of claim 8 (in combination with the subject matter of claim 1) could not be found elsewhere in the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. PG PUB 2001/0021823 to Nemoto, PG PUB 2004/0024361 to Fago et al., PG PUB 2017/0189608 to Stultz et al. and EP 0919251 to Ziemba et al. each disclose an injection device including an interface module comprising support members having folding portions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
