DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/31/2025 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Markussen (USPGPub 2010/0280460) in view of Bergens et al. (USPGPub 2001/0005781) and Larsen et al. (USPGPub 2002/0095120).
Re Claim 2, Markussen teaches a method comprising: placing, by a user, a proximal end of an auto-injector (200) (Markussen Figs. 2a-7b) against an injection site on the user (Markussen ¶ 0066); while holding the proximal end of the auto-injector (200) against the injection site, depressing, by the user, a trigger button (218) to allow a plunger (214) to move in a proximal direction towards a stopper (206) within a syringe (204) while limiting a rotation of the plunger (214) using a non-cylindrical axially-extending rod (216) (Markussen ¶ 0055-0068), wherein the non-cylindrical axially-extending rod (216) limits the rotation of the plunger (214) during the entire proximal movement of the plunger (214) (Markussen ¶ 0063 - wherein continued proximal movement of plunger occurs along needle advancement groove part 244, as seen in Fig. 10b), such that (i) the plunger (214) pushes on the stopper (206) to drive the syringe (204) in the proximal direction to insert a needle (212) into the injection site (Markussen ¶ 0068-0070), then (ii) once an injection depth of the needle (212) has been reached, substantially all medicament within the syringe (204) is injected into the injection site by continued proximal movement of the plunger (214) within the syringe (204) (Markussen Figs. 6a-7b).
Markussen further teaches wherein, (iii) once substantially all of the medicament has been injected into the injection site, the auto-injector (200) produces an audible indication to indicate that substantially all medicament has been injected into the injection site (Markussen ¶ 0004); and after the audible indication has been produced, removing the auto-injector (200) from the injection site, wherein the auto-injector (200) is configured such that after at least a portion of the medicament has been dispensed from the syringe (204) a torsion spring (208) rotates a part (234) within the auto-injector (200) to allow the needle (212) to become circumferentially covered within the auto-injector (200) to protect the user from accidental needle stick injuries after the auto-injector (200) has been removed from the injection site (Markussen ¶ 0019, 0073).
Markussen fails to teach holding the proximal end of the auto-injector against the injection site for approximately 10 seconds. Markussen fails to provide any specific amount of time for holding the auto-injector against the skin of the user. Bergen teaches an auto-injector wherein the injection time is between 0.5 to 30 seconds (Bergen 1 0023). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005) (anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of 0.5 to 30 seconds substantially overlaps and thus anticipates the claimed range of approximately 10 seconds.
Markussen also fails to teach removing, by a user, a cap from a proximal end of an auto-injector to remove a protective needle shield from a needle of a syringe disposed within the auto-injector while the needle remains a safe distance from the proximal end of the auto injector. Larsen teaches an auto-injector (Larsen Fig. 1) comprising removing, by a user, a cap (8) from a proximal end of an auto-injector to remove a protective needle shield (23) from a needle (9) of a syringe disposed within the auto-injector while the needle (9) remains a safe distance from the proximal end of the auto-injector wherein both the for simultaneous removal of both the cap and protective shield while preventing needle sticks (Larsen Fig. 1; ¶ 0028).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the method of Markussen to include removing, by a user, a cap from a proximal end of an auto-injector to remove a protective needle shield from a needle of a syringe disposed within the auto-injector while the needle remains a safe distance from the proximal end of the auto-injector as disclosed by Larsen for simultaneous removal of both the cap and protective shield while preventing needle sticks (Larsen Fig. 1; ¶ 0028).
Re Claim 3, Markussen in view of Bergens and Larsen teach all of the limitations of Claim 2. Markussen further teaches wherein the auto-injector (200) is configured to allow the auto injector (200) to be removed from the injection site prior to injecting substantially all of the medicament from the syringe (wherein the auto-injector can be removed prior to an end of injection).
Re Claim 4, Markussen in view of Bergens and Larsen teach all of the limitations of Claim 6. Markussen teaches wherein the auto-injector is configured for single-use (wherein the auto-
injector can be disposed after a single use).
Re Claims 5 and 6, Markussen in view of Bergens and Larsen teach all of the limitations of Claim 2. Markussen fails to teach wherein the non-cylindrical axially-extending rod has two or more flat surfaces that slidably engage an opening defined by two or more correspondingly shaped flat surfaces; and wherein the non-cylindrical axially-extending rod has a rectangularly-shaped cross-section. However, Markussen does teach wherein the housing has two or more flat surfaces (surfaces of protrusion 238) that slidably engage an opening defined by two or more correspondingly-shaped flat surfaces (walls of groove 236); and wherein the non-cylindrical axially-extending rod (216) has a rectangularly-shaped cross-section (wherein a cross-section of the groove 236 is rectangular) (Markussen Figs. 8 and 9a). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have had the two or more flat surfaces on the non-cylindrical axially-extending rod and the opening defined by two or more correspondingly-shaped flat surfaces on the housing, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Re Claim 7, Markussen in view of Bergens and Larsen teach all of the limitations of Claim 2. Markussen teaches wherein the non-cylindrical axially-extending rod (216) is distinct from the plunger (214) (Markussen Figs. 9a-9e).
Response to Arguments
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive. Applicant has amended independent Claim 2 to include language wherein "the non-cylindrical axially-extending rod limits rotation of the plunger during the entire proximal movement of the plunger" as opposed to "the non-cylindrical axially extending rod limits the rotation of the plunger during the continued proximal movement of the plunger." In the arguments, starting at the top of Page 11 of the response, applicant argues Markussen fails to disclose or suggest the limitation "wherein the non-cylindrical axially-extending rod limits the rotation of the plunger during the entire proximal movement of the plunger. In support of this argument, applicant states primary reference Markussen "requires rotational movement of the plunger 214 during phases of its operation." Examiner does not deny that the plunger of Markussen rotates at a phase of its operation. However, this rotation does not occur during proximal movement of the plunger, exemplified by Fig. 10b. Furthermore, applicant’s amendment limits rotation, it does not prevent it. One of ordinary skill in the art would recognize that the Markussen embodiment of Figs. 2a-7b does not prevent rotation, but rather, limits rotation.
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.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783