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 without traverse of Invention I in the reply filed on 07/08/2026 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/08/2026.
Information Disclosure Statement
The Examiner notes that the Information Disclosure Statement (IDS) submissions (see attachments) are extremely long, citing over 70 references for consideration. The Examiner has considered all of the references submitted as part of the Information Disclosure Statements, but has not found any to be particular relevance. If Applicant is aware of pertinent material in the references, it should be stated in a response to this Office action. Applicant is reminded of MPEP § 2004, paragraph 13:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Moreover, an IDS should comply with 37 CFR 1.56 (b) which states that "information is material to patentability which is not cumulative to information already of record or being made of record in the application …" [emphasis added]. The cited references, in addition to being extensive in volume, also appear to be largely cumulative, therefore, based upon the large number of references cited, the initialed references have been considered in a cumulative manner. Examiner further notes that numerous cited references appear to have little or no relevance at all to the disclosed/claimed invention, many of which do not even mention an auto-injector or the use of a compression spring for injection.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s).
The compression spring housed in the housing central cavity
The fluid reservoir
The syringe holder body portion
The firing member first and second radii
No new matter should be entered.
The drawings are objected to because of the following.
It is not clear how to interpret Figure 3 due to what appear to be drawing errors, including what is described in the 112(b) rejection below, inconsistencies between Figure 3 and Figures 8A/8B, and it is not clear what the cross-hatched structure is in Figure 3
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 7-9 & 13 are objected to because of the following informalities.
Claim 7 should read --The auto-injector of claim 6, comprising a syringe holder configured to at least partially receive the syringeat least partially accept the body portion of the syringe holder
Claim 8 should read --The auto-injector of claim 1, wherein the actuation assembly includes a raised ridge around the internal surface, wherein the firing member defines a cylindrical shape having a first radius at a first end and a second radius at a second end, wherein in the unfired position, the second radius is larger than the first radius, wherein the second end of the firing member is formed by a plurality of legs , wherein each leg of the plurality of legs is configured to lodge against the raised ridge while the firing member is in the unfired position.--; the size of the second radius is determined by the state of the firing member
Claim 13 should read --The auto-injector of claim 1, comprising a safety clip removably positioned around a proximal end of the actuation assembly, wherein while the safety clip is positioned around [[a]]the proximal end of the actuation assembly the housing is restricted from translating proximally relative to the actuation assembly, wherein while the safety clip is removed from the proximal end of the actuation assembly the housing is permitted to translate proximally relative to the actuation assembly.—
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 1-17 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.
As to Claim 1, the phrase “a longitudinal axis defined spanning between opposing ends”, in Lines 2-3, should read --a longitudinal axis defined by spanning between the opposing ends.
The limitation “a needle selectively operable to eject a fluid therefrom”, in Line 20, is indefinite. It is not clear which structure the term “therefrom” is referring to, since multiple structures have been previously defined. For the purpose of examination, the limitation will be interpreted as a needle selectively operable to eject a fluid.
The term “a proximal end”, in Lines 21-22, is indefinite. It is not clear if the proximal end, defined in Lines 21-22 is part of the opposing ends, defined in Line 2, or if the proximal end is separate from the opposing ends, rendering the term indefinite. For the purpose of examination, the proximal end will be interpreted as one end of the opposing ends.
The limitation “while in the fired position, the compression spring is unrestricted into an expanded state, wherein the compression spring in the expanded state is operable to transition the needle outward from the central cavity of the housing”, in Lines 30-34, is indefinite in light of the specification. Instant application Figure 3 shows the claimed invention in the unfired position –see instant application Paragraph 0051. When considering instant application Figure 3, it is not clear how the claimed injector is capable of moving from the unfired position to the fired position.
Instant application Figure 3 shows the legs 166 in contact with an outer surface of head portion 172 of syringe holder 120, and in contact with ridge 142 of actuation assembly 116. As the initiation member 114 slides over firing member 118 to push legs 166 inward, it is not clear how the legs will move inward past the head portion, since instant application Figures 9A-9C show head portion 172 without any recesses which the legs may move into. Since the legs are blocked by the head portion, the claimed injector is not capable of moving into the fired position, preventing the needle from moving out of the housing cavity, and preventing any type of injection.
As to Claim 4, the limitation “the firing initiation member includes at least one third slot configured to accept the at least one second protrusion of the spring compression member”, is indefinite. Claim 1, Lines 17-19, describes the second protrusion as being coupled with the first slot. As such, it is not clear how the second protrusion may also be coupled with the third slot, as required in Claim 4, rendering the claim indefinite.
As to Claim 5, the limitation “The auto-injector of claim 4, wherein the firing initiation member is configured to be translated between the first position and the second position via the at least one first protrusion through the at least one third slot”, is indefinite in light of the specification. Instant application Paragraph 0057 states the third slot 158 couples with the protrusions 150 on spring compression member 110, which would be the second protrusion, not the first protrusion, as claimed.
As to Claim 14, the phrase “a longitudinal axis defined spanning between opposing ends”, in Lines 2-3, should read --a longitudinal axis defined by spanning between the opposing ends.
The limitation “a needle selectively operable to eject a fluid therefrom”, in Line 10, is indefinite. It is not clear which structure the term “therefrom” is referring to, since multiple structures have been previously defined. For the purpose of examination, the limitation will be interpreted as a needle selectively operable to eject a fluid.
The limitation “while in the fired position, the needle is extended outward from the central cavity of the housing”, in Lines 15-16, is indefinite in light of the specification. Instant application Figure 3 shows the claimed invention in the unfired position –see instant application Paragraph 0051. When considering instant application Figure 3, it is not clear how the claimed injector is capable of moving from the unfired position to the fired position.
Instant application Figure 3 shows the legs 166 in contact with an outer surface of head portion 172 of syringe holder 120, and in contact with ridge 142 of actuation assembly 116. As the initiation member 114 slides over firing member 118 to push legs 166 inward, it is not clear how the legs will move inward past the head portion, since instant application Figures 9A-9C show head portion 172 without any recesses which the legs may move into. Since the legs are blocked by the head portion, the claimed injector is not capable of moving into the fired position, preventing the needle from moving out of the housing cavity, and preventing any type of injection.
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, 8 & 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stamp (U.S. PGPub 2008/0228143).
As to Claim 1, Stamp teaches an auto-injector (Figure 15), comprising:
(a) a housing (30) having a central cavity (the volume within 30, as viewed in Figure 15), opposing ends (the left and right sides of 30, as viewed in Figure 15), and a longitudinal axis (the axis through the center of 30 –from left to right—as viewed in Figure 15) defined spanning between (as shown in Figure 15) opposing ends (the left and right sides of 30, as viewed in Figure 15), wherein the housing (30) includes at least one first protrusion (30B) extending toward (as shown in Figure 17) the central cavity (the volume within 30, as viewed in Figure 15) from (as shown in Figure 17) an inward facing surface (the surface of 30 in contact with 30B, as viewed in Figure 17) of the housing (30);
(b) an actuation assembly (41) shaped to position within (as shown in Figure 17) the central cavity (the volume within 30, as viewed in Figure 15) of the housing (30), wherein the actuation assembly (41) defines at least one first slot (41C) accessible from (as shown in Figure 17) an interior surface (the interior surface of 41, as viewed in Figure 17) of the actuation assembly (41) and at least one second slot (41B) accessible from (as shown in Figure 17) an exterior surface (the exterior surface of 41 in contact with housing 30, as viewed in Figures 16/17) of the actuation assembly (41), wherein the at least one first protrusion (30B) of the housing (30) is configured to align with and translate within (as shown in Figure 17; Paragraph 0109) the at least one second slot (41B), wherein the actuation assembly (41) is configured to at least partially internally house (as shown in Figure 15):
(i) a compression spring (40);
(ii) a spring compression member (4/42) configured to couple with (as shown in Figure 16) the actuation assembly (41) and contact (as shown in Figure 16; Paragraph 0108) the compression spring (40), wherein the spring compression member (4/42) includes at least one second protrusion (42) configured to translate within (Paragraph 0108) the at least one first slot (41C) of the actuation assembly (41);
(iii) a needle (10; shown on the left side of Figure 15) selectively operable to eject a fluid therefrom (Paragraph 0013), wherein the needle (10) is selectively operable to extend from (as shown between Figures 15/21) a proximal end (the left side of 30, as viewed in Figure15) of the housing (30);
(iv) a firing member (7) selectively translatable between an unfired position (as shown in Figure 15) and a fired position (as shown in Figure 21), wherein:
(A) while in the unfired position (as shown in Figure 15), the compression spring (40) is restricted into a compressed state (as shown in Figure 15), wherein the compression spring (40) in the compressed state (as shown in Figure 15) is operable to position (as shown in Figure 15) the needle (10) within (as shown in Figure 15) the central cavity (the volume within 30, as viewed in Figure 15) of the housing (30); and
(B) while in the fired position (as shown in Figure 21), the compression spring (40) is unrestricted into an expanded state (as shown in Figure 21), wherein the compression spring (40) in the expanded state (as shown in Figure 21) is operable to transition the needle (10) outward from (as shown in Figure 21) the central cavity (the volume within 30, as viewed in Figure 15) of the housing (30).
As to Claim 6, Stamp teaches all the limitations of Claim 1, and continues to teach a syringe (8/9/10; Paragraph 0083), wherein the syringe (8/9/10) includes the needle (10) fluidly coupled with (Paragraph 0083) a fluid reservoir (9).
As to Claim 8, Stamp teaches all the limitations of Claim 1, and continues to teach the actuation assembly (41) includes a raised ridge (see Figure 15 below) around (as shown in Figure 15) the internal surface (the interior surface of 41, as viewed in Figure 17), wherein the firing member (7) defines a cylindrical shape (as shown in Figure 15) having a first radius (see Figure 15 below) at a first end (the left end of 7, as viewed in Figure 15) and a second radius (see Figure 15 below) at a second end (the right end of 7, as viewed in Figure 15), wherein the second radius (see Figure 15 below) is larger than (as shown in Figure 15)the first radius (see Figure 15 below), wherein the second end (the right end of 7, as viewed in Figure 15) of the firing member (7) is formed by a plurality of legs (7A; Paragraph 0081), wherein each leg (7A; Paragraph 0081) of the plurality of legs (7A; Paragraph 0081) is configured to lodge against (as shown in Figure 15) the raised ridge (see Figure 15 below) while the firing member (7) is in the unfired position (as shown in Figure 15).
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Stampe Figure 15, Modified by Examiner
As to Claim 10, Stamp teaches all the limitations of Claim 1, and continues to teach an end cap (11) configured to removably couple with (via the tabs on 50, as viewed in Figure 19) the actuation assembly (41) at an end (the left end of 41, as viewed in Figure 19) of the actuation assembly (41) adjacent to (as shown in Figure 19) the needle (10).
As to Claim 11, Stamp teaches all the limitations of Claims 1 & 10, and continues to teach the needle (10) is configured to pass through (as shown in Figure 21) the end cap (11) while the firing member (7) is in the fired position (as shown in Figure 21).
As to Claim 12, Stamp teaches all the limitations of Claim 1, and continues to teach the housing (30) and actuation assembly (41) are restricted from being uncoupled (via 30B, as shown in Figure 17) while the firing member (7) is in the unfired position (as shown in Figure 15), wherein the housing (30) and actuation assembly (41) are able to be uncoupled (via removing 30B, as shown in Figure 17) while the firing member (7) is in the fired position (as shown in Figure 21).
As to Claim 13, Stamp teaches all the limitations of Claim 1, and continues to teach a safety clip (15) removably positioned around (Paragraph 0098) a proximal end (the left side of 41, as viewed in Figure 15) of the actuation assembly (41), wherein while the safety clip (15) is positioned around (as shown in Figure 15) a proximal end (the left side of 41, as viewed in Figure 15) of the actuation assembly (41) the housing (30) is restricted from translating proximally relative to (Paragraph 0094) the actuation assembly (41), wherein while the safety clip (15) is removed from (Figures 18/19) the proximal end (the left side of 41, as viewed in Figure 15) of the actuation assembly (41) the housing (30) is permitted to translate proximally relative to (as shown between Figures 18/19) the actuation assembly (41).
Allowable Subject Matter
Claims 2-5, 7, 9 & 14-17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As to Claims 2 & 9, the prior art of record teaches each of the limitations of Claim 1 (and Claim 8), but does not teach “a firing initiation member configured to couple between the spring compression member and the actuation assembly and translate parallel to the longitudinal axis between a first position and a second position relative to the housing”. Therefore, the prior art of record fails to disclose each of the limitations of Claims 2 & 9. The closest art of record is Stamp (cited above). However, Stamp fails to describe any structure which may be interpreted as the firing initiation member, as claimed. It would not be obvious to one of ordinary skill in the art to modify Stamp without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claims 2 & 9, is neither anticipated nor made obvious by the prior art of record.
Claims 3-5 depend on Claim 2, so would therefore also be found allowable.
As to Claim 7, the prior art of record teaches each of the limitations of Claims 1 & 6, but does not teach “a syringe holder configured to receive the syringe at least partially within”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 7. The closest art of record is Stamp (cited above). However, Stamp fails to describe any structure which may be interpreted as the syringe holder, as claimed. It would not be obvious to one of ordinary skill in the art to modify Stamp without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 7, is neither anticipated nor made obvious by the prior art of record.
As to Claim 14, the prior art of record teaches each of the limitations except for “a firing initiation member configured to couple between the spring compression member and the actuation assembly and translate parallel to the longitudinal axis between a first position and a second position relative to the housing”. Therefore, the prior art of record fails to disclose each of the limitations of Claim 14. The closest art of record is Stamp (cited above). However, Stamp fails to describe any structure which may be interpreted as the firing initiation member, as claimed. It would not be obvious to one of ordinary skill in the art to modify Stamp without significant structural modification and without the benefit of hindsight. Therefore, this limitation, as claimed in Claim 14, is neither anticipated nor made obvious by the prior art of record.
Claims 15-17 depend on Claim 14, so would therefore also be found allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Swanson (2019/0374717 – see Figure 6) describes an auto injector with similar legs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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