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 Species I (Claims 1-3, 6-10, 12-13 and 15) in the reply filed on 05/29/2026 is acknowledged. The traversal is on the ground(s) that a serious burden does not exist for examiner with regard to examination of both Species I and II. This is not found persuasive where the details of the drug delivery device upon which the plunger operates may effect the scope of the claim. It is entirely possible and likely the drug delivery device with plunger and the plunger alone will diverge from one another. With that said, examiner recommends not cancelling the Claim 16 species and amending said species similar to that of Species I. Where Species I is found allowable independent of the device upon which the plunger resides, Species II could possibly be rejoined. Examiner is available for interview to discuss this issue further.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16, 19-23, 25-26 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/29/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: Line 7 reading “the distal end of the drug storage container” should read --a distal end of the drug storage container--. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: Line 3 reading “the plunger body portion” should read --the body portion--. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: Lines 2-3 reading “the plunger body portion” should read --the body portion--. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: Lines 3-4 reading “the plunger body” should read --the body portion--. Appropriate correction is required.
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 1-3, 6-10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dashbach et al. (USPGPub 2021/0113775).
Re Claim 1, Dashbach teaches a drug delivery device (100) comprising: a housing defining a longitudinal axis and having an opening (as seen in Dashbach Figs. 3a-3b); a drug storage container including a barrel (102), a stopper (108) and a delivery member (110) (Dashbach ¶ 0032-0036), the stopper (108) movably positioned within the barrel (102), the delivery member (110) positioned at a distal end of the barrel (102) and having an insertion end configured to extend at least partially through the opening during a delivery state (Dashbach ¶ 0041-0042); a plunger (116) moveable toward the distal end of the drug storage container to engage the stopper (108) and expel a drug from the drug storage container through the delivery member (110) (Dashbach ¶ 0041-0042), the plunger (116) including a body portion and a shock absorbing portion (112) (Dashbach ¶ 0041-0042); and a plunger biasing member (Proximal end of plunger 110 configured to be pressed by a user) coupled with the plunger (116) and configured to urge the plunger toward the distal end of the drug storage container (Dashbach ¶ 0036).
Re Claim 2, Dashbach teaches wherein the shock absorbing portion (112) includes a collapsible portion (Dashbach Figs. 2a-2b; ¶ 0041).
Re Claim 3, Dashbach teaches wherein the collapsible portion (112) includes at least one collapsible leg (124) or at least two collapsible legs (124) (Dashbach ¶ 0044; Fig. 2a).
Re Claims 6-10: As to Claim 6, Dashbach teaches wherein the shock absorbing portion (112) includes a foot (122) coupled with the collapsible portion (112) (Dashbach ¶ 0043). As to Claim 7, Dashbach teaches wherein the foot (122) defines a distal end of the plunger (116) configured to engage the stopper (108) and wherein the collapsible portion (112) is positioned between and operatively couples the foot (122) and the body portion (Dashbach ¶ 0043). As to Claim 8, Dashbach teaches wherein the shock absorbing portion (112) has an extended position defining a first distance (Dashbach Fig. 2a) between the foot (122) and the body portion and a collapsed position (Dashbach Fig. 2b) defining a second distance between the foot (122) and the plunger body, wherein the first distance is larger than the second distance (as seen in Dashbach Figs. 2a-2b). As to Claim 9, Dashbach teaches wherein the shock absorbing portion (112) includes a hard stop (120, 134) defining the collapsed position (as seen in Dashbach Fig. 2b; ¶ 0049). As to Claim 10, Dashbach teaches wherein the hard stop (120, 134) includes at least one pair of protrusions (126, 136) extending towards each other along the longitudinal axis (Dashbach Fig. 2b; ¶ 0049).
Re Claim 12, Dashbach teaches wherein the body portion has a hollow tubular shape (as seen in Dashbach Figs. 2a-2c).
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.
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Dashbach et al. (USPGPub 2021/0113775).
Re Claim 13, Dashbach teaches all of the limitations of Claim 1. Dashbach fails to explicitly teaches wherein the body portion includes a non-metal material, and wherein the shock absorbing portion is defined by the non-metal material. However, the examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Re Claim 15, Dashbach teaches all of the limitations of Claim 1. Dashbach fails to explicitly teaches wherein the non-metal material is a thermoplastic material. However, the examiner notes that the selection of a known material based upon its suitability for the intended use is a design consideration well within the ordinary skill of the art. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/WILLIAM R FREHE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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