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 .
Drawings
Figures 1 – 2 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated and paragraphs [0022] and [0023] of the Specification dated 9 July 2024 recites that Figures 1 and 2 shows a perspective view of a prior art medicament delivery device. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
136a in Figure 8.
136b in Figure 8.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the abstract exceeds the word range of 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
[0047] of the Specification dated 9 July 2024 recites “plunger rod 111.” This is the incorrect reference numeral for the plunger rod. The correct reference numeral is “110” for the plunger rod.
[0080] of the Specification dated 9 July 2024 recites “before or after the sub-assembly of is assembled…”. It appears that a word is inadvertently left out within this sentence. The Examiner requests the Applicant to review the paragraph and amend the paragraph to clarify what this passage means.
Appropriate correction is required.
Claim Objections
Claims 22 and 24 are objected to because of the following informalities:
Claim 22 recites “the first snap-in-member.” However, previously this limitation has been recited as “the first snap-in member.” The Examiner requests that the Applicant use one nomenclature when referring to this structure.
Claim 24 recites “the third snap-in-member.” However, previously this limitation has been recited as “the third snap-in member.” The Examiner requests that the Applicant use one nomenclature when referring to this structure.
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.
Claim(s) 14 – 26 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 14 recites the limitations "the first locking member," “the second locking member,” “the axial cut out,” and “the third locking member.” There is insufficient antecedent basis for these limitation in the claim. The first recitation of each of these limitations used the language “at least one” first locking member, second locking member, axial cut out, and third locking member. Therefore there is a lack of antecedent basis because the claim language is not consistent with regards to the number of these components being claimed.
Claims 15 – 26 are rejected under 35 U.S.C. § 112(b) based on their dependency on rejected Claim 14.
Claim 16 recites the limitations "the syringe support” and “the rear end of the syringe carrier.” There is insufficient antecedent basis for these limitations in the claim.
Claim 17 recites the limitation "the first locking member” and “the second locking member.” There is insufficient antecedent basis for these limitations in the claim. The first recitation of these limitations used the language “at least one” first locking member and second locking member.” Therefore there is a lack of antecedent basis because the claim language is not consistent with regards to the number of these components being claimed.
Claim 18 recites the limitation "the second locking member.” There is insufficient antecedent basis for this limitation in the claim. The first recitation of this limitation in the claims used the language “at least one” second locking member. Therefore there is a lack of antecedent basis because the claim language is not consistent with regards to the number of these components being claimed.
Claim 19 recites the limitation "the third locking member.” There is insufficient antecedent basis for this limitation in the claim. The first recitation of this limitation in the claims used the language “at least one” third locking member. Therefore there is a lack of antecedent basis because the claim language is not consistent with regards to the number of these components being claimed.
Claim 21 recites “an interior of the front outer shell.” It is unclear if this interior is referring to the “an interior of the front outer shell” recited in Claim 21 upon which Claim 20 depends or if this interior is a separate interior of the front outer shell. Based on this indefiniteness, Claim 21 is rejected.
Claim 22 recites “the first snap-in-member.” There is insufficient antecedent basis for this limitation in the claim. The first recitation of this limitation in the claims used the language “at least one” first snap-in member. Therefore there is a lack of antecedent basis because the claim language is not consistent with regards to the number of components being claimed.
Claim 23 recites “the first snap-in-member” and “the second snap-in member.” There is insufficient antecedent basis for these limitations in the claim. The first recitation of each of these limitations in the claims used the language “at least one” first snap-in member and second snap-in member. Therefore there is a lack of antecedent basis because the claim language is not consistent with regards to the number of components being claimed.
Claim 24 recites “the third snap-in-member.” There is insufficient antecedent basis for this limitation in the claim. The first recitation of this limitation in the claims used the language “at least one” third snap-in member. Therefore there is a lack of antecedent basis because the claim language is not consistent with regards to the number of components being claimed.
Claim 25 recites “the third snap-in-member” and “the fourth snap-in member.” There is insufficient antecedent basis for these limitations in the claim. The first recitation of each of these limitations in the claims used the language “at least one” third snap-in member and fourth snap-in member. Therefore there is a lack of antecedent basis because the claim language is not consistent with regards to the number of components being claimed.
Allowable Subject Matter
Claim(s) 18 and 21 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.
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.
Claim(s) 14, 17, 19, 20, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takemoto (US 2014/0025006 A1).
With regards to claim 14, Takemoto discloses a sub-assembly of a medicament delivery device (1) (see [0050]), comprising:
a syringe carrier (25) (see [0053]) comprising at least one first locking member (254) (see [0059]);
a front outer shell (6) (see [0052]) comprising at least one second locking member (65) (see [0101]) and at least one third locking member (63) (see [0098]), the first locking member configured to move into locking engagement with the second locking member for locking the syringe carrier inside the front outer shell upon the syringe carrier being axially aligned with and inserted into the front outer shell (see [0101] “A distal surface of the guide portion 254 abuts against a proximal surface of this protrusion 65. Due to this, the engagement member 25 and the cylindrical body 21 are clamped by the protrusions 65 of the grip member 6 and the first restricting member 71 fixed to the grip member 6 to thereby be fixed in the grip member 6.”); and
a needle cover (3) (see [0052]) accommodating a needle cover spring (5) (see [0052]) abutting an interior front end (351) of the needle cover in a first end (see [0085] “Furthermore, a distal end 51 of the coil spring 5 abuts against a proximal side of the rim part 351 of the distal opening 35 of the protector 3 and a proximal end 52 abuts against the engagement member 25.”), the needle cover comprising a fourth locking member (33, 34) (see [0078]) and at least one cut out (32) (see [0099]) extending axially from a rear end (see at 311 in Fig. 6) of the needle cover, the needle cover being arranged to be axially aligned with and inserted into the front outer shell via a front opening (61) (see [0097]) of the front outer shell (see the insertion of the needle cover 3 into the front outer shell 6 via the front opening 61 with the movement of the needle cover 3 shown in Figures 2 – 3), the axial cut out allowing the needle cover to axially slide over the syringe carrier and have the first and second locking members, whilst in a locking engagement, move relative to the needle cover in said axial cut out until the fourth locking member of the needle cover moves into locking engagement with the third locking member of the front outer shell (see [0082], [0101], [0120], and Figures 2 – 5), wherein a second end (52) of the needle cover spring moves into abutment with a front end (see where the proximal end 52 of the coil spring 5 contacts the engagement member 25 in Figure 2) of the syringe carrier (see [0085] “Furthermore, a distal end 51 of the coil spring 5 abuts against a proximal side of the rim part 351 of the distal opening 35 of the protector 3 and a proximal end 52 abuts against the engagement member 25.”).
With regards to claim 17, Takemoto discloses the claimed invention of claim 14, and Takemoto further discloses wherein:
the first locking member (254) (see [0059]) of the syringe carrier (25) (see [0053]) comprises a radially protruding ledge (see at 254 in Figure 6) and the second locking member (65) (see [0101]) of the front outer shell (6) (see [0052]) comprises an indentation (see at 65 in Figure 11) with which the ledge moves into locking engagement (see [0101] “A distal surface of the guide portion 254 abuts against a proximal surface of this protrusion 65. Due to this, the engagement member 25 and the cylindrical body 21 are clamped by the protrusions 65 of the grip member 6 and the first restricting member 71 fixed to the grip member 6 to thereby be fixed in the grip member 6.”).
With regards to claim 19, Takemoto discloses the claimed invention of claim 14, and Takemoto further discloses wherein:
the third locking member (63) (see [0098]) of the front outer shell (6) (see [0052]) comprises an axially extending guide rail (see at 63 in Figure 11) and the fourth locking member (33, 34) (see [0078]) of the needle cover (3) (see [0052]) comprises an axially extending assembly track (see at 33, 34 in Figure 6), wherein the assembly track moves into locking engagement with the guide rail upon the assembly track being axially aligned with the guide rail and the needle cover being inserted into the front outer shell (see [0098] and Figures 2 – 5).
With regards to claim 20, Takemoto discloses the claimed invention of claim 19, and Takemoto further discloses wherein:
the axially extending guide rail (see at 63 in Figure 11) protrudes radially from an interior of the front outer shell (6) (see [0052]) and the axially extending assembly track (see at 33, 34 in Figure 6) is formed by an axially extending opening (see at 34 in Figure 6) in the needle cover (3) (see [0052]).
With regards to claim 26, Takemoto discloses the claimed invention of claim 14, and Takemoto further discloses wherein:
the syringe carrier (25) (see [0053]) is configured to be inserted into the front outer shell (6) (see [0052]) via a rear opening (see at 63 in Figure 6) of the front outer shell.
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.
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.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takemoto and Mehawej et al. (US 2017/0239427 A1) (hereinafter referred to as “Mehawej”).
With regards to claim 15, Takemoto discloses the claimed invention of claim 14, however Takemoto is silent with regards to the sub-assembly further comprising:
a syringe support configured to be inserted into a rear end of the syringe carrier.
Nonetheless Mehawej which is within the analogous art of injection devices (see abstract and title), teaches the sub-assembly further comprising:
a syringe support (1166) (see [0076]) configured to be inserted into a rear end of the syringe carrier (116) (see [0076] “a proximal end of sleeve 116 can include a medicament chamber support 1166 configured to support and secure a proximal portion of medicament chamber 110.” Note that proximal according to Mehawej is opposite to the meaning of proximal in the current application. In other words, the proximal means away from the injection site while distal means towards the injection site).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sub-assembly of Takemoto in view of a teaching of Mehawej such that the sub-assembly further comprises a syringe support configured to be inserted into a rear end of the syringe carrier. One of ordinary skill in the art would have been motivated to make this modification because Mehawej teaches that including a syringe support within the sub-assembly is beneficial because it holds a proximal end of a syringe and can support the medicament chamber during forces exerted on it during firing. See [0076] of Mehawej.
With regards to claim 16, Takemoto discloses the claimed invention of claim 14, however Takemoto is silent with regards to wherein:
the syringe carrier comprises a rear section where an interior diameter of the syringe carrier decreases in a proximal direction, the decrease in diameter creating an annular surface at said rear section which the syringe support is configured to abut upon being inserted into the rear end of the syringe carrier.
Nonetheless Mehawej which is within the analogous art of injection devices (see abstract and title), teaches the syringe carrier (116) (see [0076]) comprises a rear section (see [0076] “a proximal end of sleeve 116” Note that proximal according to Mehawej is opposite to the meaning of proximal in the current application. In other words, the proximal means away from the injection site while distal means towards the injection site) where an interior diameter of the syringe carrier decreases in a proximal direction (see Examiner annotated Figure 1 below; hereinafter referred to as “Fig. A”), the decrease in diameter creating an annular surface (see Fig. A below) at said rear section which the syringe support is configured to abut upon being inserted into the rear end of the syringe carrier (see Fig. 1 and Figure A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sub-assembly of Takemoto in view of a teaching of Mehawej such that the syringe carrier comprises a rear section where an interior diameter of the syringe carrier decreases in a proximal direction, the decrease in diameter creating an annular surface at said rear section which the syringe support is configured to abut upon being inserted into the rear end of the syringe carrier. One of ordinary skill in the art would have been motivated to make this modification because Mehawej teaches that including a syringe support within the sub-assembly is beneficial because it holds a proximal end of a syringe and can support the medicament chamber during forces exerted on it during firing. See [0076] of Mehawej.
Claim(s) 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takemoto and Schrul et al. (US 2021/0353862 A1) (hereinafter referred to as “Schrul”).
With regards to claim 22, Takemoto discloses the claimed invention of claim 14, however Takemoto is silent with regards to wherein:
the front outer shell comprises at least one first snap-in member at a front section; the sub-assembly further comprising:
a front cap comprises at least one second snap-in member configured to move into snap engagement with the first snap-in-member upon the front cap being axially moved into abutment with the front outer shell.
Nonetheless Schrul, which is within the analogous art of syringe assemblies (see abstract and title), teaches the front outer shell (10) (see [0044]) comprises at least one first snap-in member (10c) (see [0066]) at a front section (see Fig. 7a); the sub-assembly further comprising:
a front cap (12) (see [0066]) comprises at least one second snap-in member (12a) (see [0066]) configured to move into snap engagement with the first snap-in-member upon the front cap being axially moved into abutment with the front outer shell (see [0066] “For this purpose, the housing 10 may include snap elements 10c, which may engage in openings or recesses 12a of the end cap 12 (FIG. 7b) and may ensure at least an axial locking”) .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the cap of the sub-assembly of Takemoto in view of a teaching of Schrul such that the front outer shell comprises at least one first snap-in member at a front section; the sub-assembly further comprising: a front cap comprises at least one second snap-in member configured to move into snap engagement with the first snap-in-member upon the front cap being axially moved into abutment with the front outer shell. One of ordinary skill in the art would have been motivated to make this modification because Schrul teaches that incorporating first and second snap-in members into the cap is beneficial because they ensure axial locking. See [0066] and [0068] of Schrul.
The sub-assembly of Takemoto modified in view of Schrul will hereinafter be referred to as the sub-assembly of Takemoto and Schrul.
With regards to claim 23, the sub-assembly of Takemoto and Schrul teaches the claimed invention of claim 22, however, Takemoto is silent with regards to wherein:
the first snap-in member of the front outer shell comprises a radially protruding bump and the second snap-in member of the front cap comprises a first opening with which the bump moves into snap engagement.
Nonetheless Schrul, which is within the analogous art of syringe assemblies (see abstract and title), further teaches wherein:
the first snap-in member (10c) (see [0066]) of the front outer shell (10) (see [0044]) comprises a radially protruding bump (see at 10c in Figure 7a) and the second snap-in member (12a) (see [0066]) of the front cap (12) (see [0066]) comprises a first opening (see at 12a in Figure 7a) with which the bump moves into snap engagement (see [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the sub-assembly of Takemoto and Schrul in view of a further teaching of Schrul such that the first snap-in member of the front outer shell comprises a radially protruding bump and the second snap-in member of the front cap comprises a first opening with which the bump moves into snap engagement. One of ordinary skill in the art would have been motivated to make this modification because Schrul teaches that incorporating first and second snap-in members into the cap is beneficial because they ensure axial locking. See [0066] and [0068] of Schrul.
Claim(s) 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takemoto and Schrul as applied to claim 22 above and further in view of Stefanov et al. (SU 2018/0272075 A1) (hereinafter referred to as “Stefanov”).
With regards to claim 24, the sub-assembly of Takemoto and Schrul teaches the claimed invention of claim 22, however, Takemoto is silent with regards to wherein:
the needle cover comprises at least one third snap-in member at a front section; and the front cap comprises at least one fourth snap-in member configured to move into snap engagement with the third snap-in-member upon the front cap being axially moved into abutment with the needle cover.
Nonetheless Stefanov, which is within the analogous art of medical delivery devices (see abstract and title), teaches the needle cover (40) (see [0031]) comprises at least one third snap-in member (44) (see [0033]) at a front section (see Figures 6 and 7); and the front cap (6) (see [0037]) comprises at least one fourth snap-in member (6b) (see [0037]) configured to move into snap engagement with the third snap-in-member upon the front cap being axially moved into abutment with the needle cover (see [0037] “the cap 6 engages the cap nib 44 through snap connector 6b”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle cover and cap of the sub-assembly of Takemoto and Schrul in view of a teaching of Stefanov such that the needle cover comprises at least one third snap-in member at a front section; and the front cap comprises at least one fourth snap-in member configured to move into snap engagement with the third snap-in-member upon the front cap being axially moved into abutment with the needle cover. One of ordinary skill in the art would have been motivated to make this modification because Stefanov teaches that the third and fourth snap-in members releasable snap lock the cap assembly with the injector. See [0037] of Stefanov.
The sub-assembly of Takemoto and Schrul modified in view of a teaching of Stefanov will hereinafter be referred to as the sub-assembly of Takemoto, Schrul, and Stefanov.
With regards to claim 25, the sub-assembly of Takemoto, Schrul, and Stefanov teaches the claimed invention of claim 24, however Takemoto is silent with regards to wherein:
the third snap-in member of the needle cover comprises a radially protruding prong and the fourth snap-in member of the front cap comprises a second opening with which the prong moves into snap engagement.
Nonetheless Stefanov, which is within the analogous art of medical delivery devices (see abstract and title), further teaches the third snap-in member (44) (see [0033]) of the needle cover (40) (see [0031]) comprises a radially protruding prong (see at 44 in Figure 7) and the fourth snap-in member (6b) (see [0037]) of the front cap (6) (see [0037]) comprises a second opening (see Figure 7) with which the prong moves into snap engagement (see [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle cover and front cap of the sub-assembly of Takemoto, Schrul, and Stefanov in view of a further teaching of Stefanov such that the third snap-in member of the needle cover comprises a radially protruding prong and the fourth snap-in member of the front cap comprises a second opening with which the prong moves into snap engagement. One of ordinary skill in the art would have been motivated to make this modification because Stefanov teaches that the third and fourth snap-in members releasable snap lock the cap assembly with the injector. See [0037] of Stefanov.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
07/27/2026
Prosecution Insights