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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 16, 19, 22, 25, 27, and 28 are objected to because of the following informalities:
Regarding claims 16 and 22, each instance of “the slot” should be “the at least one slot”
Regarding claims 16, 19, 25, 27, and 28, each instance of “the first and second leg portions” should be “the first leg portion and the second leg portion”
Regarding claim 16, line 14-15: “the housing, and a second retaining structure)” should be “the housing and a second retaining structure” (delete comma and parenthesis)
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 16-21, 23-25, and 27-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soerensen et al (US 2016/0114107).
Regarding claim 16, Soerensen discloses:
A sub-assembly for a medicament delivery device (101; Fig. 3) configured to expel medicament from a medicament container (380), the sub-assembly comprising: a housing (310) having a proximal end and a distal end; and a medicament container carrier (330) extending along a longitudinal axis from a proximal end to a distal end, the medicament container carrier (330) comprising a carrier wall having an open proximal end (end with jaws 335; Fig. 4), at least one slot (334) extending from the open proximal end (end with jaws 335) in a distal direction, and at least a first leg portion (331) and a second leg portion (opposite leg 331) radially separated by the slot (334) at least at the open proximal end (Fig. 4) such that the first and second leg portions (331) are radially movable relative each other (¶0053), wherein a first retaining structure (317) extends from an inner surface of the housing (310) and a second retaining structure (337) extends from an outer surface of each one of the first and second leg portions (331) at the open proximal end of the carrier wall (¶0053), wherein the first retaining structure (317) exerts a force on the second retaining structure (337) at least in the circumferential direction to prevent the first and second leg portions (331) from moving radially outwards (¶0053).
Regarding claim 17, Soerensen discloses:
The sub-assembly according to claim 16, wherein the first retaining structure (317) comprises first and second housing contact surfaces (Fig. 4; ¶0053 – the first and second contact surfaces are distinct protrusions 317) arranged at different radial positions (across from one another) within the inner surface of the housing (310), and wherein the second retaining structure (337) comprises first and second carrier contact surfaces (Fig. 4; ¶0053 – surfaces 337 are one surface on each leg 331) arranged on the first leg portion and the second leg portion (331), respectively, such that the first retaining structure (317) exerts a force on the second retaining structure (337) by exerting a first force at least in the circumferential direction from the first housing contact surface (317) to the first carrier contact surface (337) (¶0053), and by exerting a second force at least in the circumferential direction from the second housing contact surface (317) to the second carrier contact surface (337), the second force being at least partly opposite to the first force (Fig. 4 – the forces push the legs 331 inwardly and are therefore equal and opposite to one another).
Regarding claim 18, Soerensen discloses:
The sub-assembly according to claim 17, wherein the first retaining structure (317) extends in the radial direction from the inner surface of the housing (310) such that each one of the first and second housing contact surfaces (317) has a normal deviating from the radial direction (the retaining structures 317 extend radially inward, which makes the normal of these curved pieces tangential to (and therefore deviated from) the circumference of the housing 310).
Regarding claim 19, Soerensen discloses:
The sub-assembly according to claim 17, wherein the second retaining structure (337) extends in the radial direction from the outer surface of each one of the first and second leg portions (331) such that each one of the first and second carrier contact surfaces (337) has normal deviating from the radial direction (the retaining structures 337 extend radially outward, which makes the normal of these curved pieces tangential to (and therefore deviated from) the circumference of the carrier 330).
Regarding claim 20, Soerensen discloses:
The sub-assembly according to claim 16, wherein the first retaining structure (317) comprises at least two axially and radially extending protrusions (the protrusions extend radially inwardly and have a thickness along the axial axis, which means they also extend axially), and the second retaining structure (337) comprises at least two axially and radially extending protrusions (the protrusions extend radially outwardly and have a thickness along the axial axis, which means they also extend axially), or recesses, configured to engage with the at least two protrusions of the first retaining structure (317) (¶0053).
Regarding claim 22, Soerensen discloses:
The sub-assembly according to claim 16, wherein the carrier wall comprises a distal end portion (portion with protrusions 333) with an open distal end (Fig. 4), and wherein the at least one slot (334) extends from the open proximal end to the distal end portion (see Fig. 4), the slot (334) ending in the distal end portion prior the open distal end (the slot 334 does not extend all the way across the length of the carrier 330).
Regarding claim 23, Soerensen discloses:
The sub-assembly according to claim 22, wherein the open distal end comprises a distal supporting collar (333) arranged around an outer periphery of the carrier wall (330) (the collar 333 is used for assembly and alignment but is fully capable of supporting a flange of a medicament container, which is functionally claimed, when the medicament container is arranged in a final proximal position within the housing).
Regarding claim 24, Soerensen discloses:
The sub-assembly according to claim 16, wherein the carrier wall comprises a proximal supporting collar (335) arranged around an inner periphery of the carrier wall to support a neck of the medicament container (380) when the medicament container (380) is arranged in a final proximal position within the housing (310) (¶0053; Fig. 1A).
Regarding claim 25, Soerensen discloses:
The sub-assembly according to claim 16, wherein the at least one slot (334) of the medicament container carrier (330) is a first slot (¶0053 – “opposed slots between the arms”), and the medicament container carrier (330) comprises a second slot extending from the open proximal end in a distal direction opposite to the first slot (¶0053), and wherein the first and second leg portions (331) are radially separated by the first slot and the second slot at least at the open proximal end (¶0053).
Regarding claim 27, Soerensen discloses:
The sub-assembly according to claim 16, wherein the first retaining structure (317) further exerts a radial force on the second retaining structure (337) to radially press the first and second leg portions (331) inwards (¶0053).
Regarding claim 28, Soerensen discloses:
A method for assembling a medicament container (380; Fig. 3) into a sub-assembly according to claim 16 (see rejection of claim 16), the medicament container (380) comprising a delivery member for expelling a medicament and a shield covering the delivery member (¶0035), wherein the method comprises: inserting the medicament container (380) in the medicament container carrier (330) to provide a medicament container sub-assembly (330, 380); and inserting the medicament container sub-assembly (330, 380) into the housing (310) such that the medicament container (310) is arranged in a final proximal position (Fig. 1A) within the housing (310), wherein the first retaining structure (317) of the housing (310) exerts a force at least in the circumferential direction on the second retaining structure (337) of the medicament container carrier (330) to prevent the first and second leg portions (331) from moving radially outwards (¶0053).
Regarding claim 29, Soerensen discloses:
The method according to claim 28, wherein the carrier wall comprises a proximal supporting collar (335) arranged around an inner periphery of the carrier wall (¶0053), and wherein the step of inserting the medicament container (380) in the medicament container carrier (330) is performed such that the shield passes the open proximal end and a neck of the medicament container (380) is supported by the proximal supporting collar (335) (¶0053).
Regarding claim 30, Soerensen discloses:
A medicament delivery device (101; Fig. 3) for expelling medicament from a medicament container (380), the medicament delivery device (101) comprising a sub-assembly according to claim 16 (see rejection of claim 16).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Soerensen.
Regarding claim 21, Soerensen discloses the sub-assembly according to claim 16 and further discloses the second retaining structure (337) comprises at least two axially and radially extending protrusions (the protrusions extend radially outwardly and have a thickness along the axial axis, which means they also extend axially) that engages with the first retaining structure (317). Soerensen is silent regarding “the first retaining structure comprises at least two axially and radially extending recesses.” However, when forming abutting surfaces, a person of ordinary skill in the art would know that the options for structure are a protrusion, a flat surface, or a recess. It would have been obvious to try as one of a finite number of identified, predictable solutions for forming an abutting surface. Furthermore, it has been held that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liu et al (US 2025/0001081) is the publication of copending application 18/708,029, which claims similar but not the same subject matter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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