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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 23, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on September 14, 2026. As directed by the amendment: claims 32 and 36 have been amended, claims 16-31 and 37-38 have been cancelled, and claims 39-52 have been added. Thus, claims 32-36 and 39-52 are presently pending in this application.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection previously set forth in the Final Office Action mailed July 14, 2026.
Response to Arguments
Applicant’s arguments, filed September 14, 2026, with respect to the rejection(s) of claim(s) 32 under 102(a)(1) have been fully considered and are persuasive, specifically in regards to Morimoto not teaching or disclosing the claimed elongated proximal housing component. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
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 39-47 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.
Regarding claim 39, the claim is directed towards a “body”. It is unclear whether this body is same as the cartridge holder or a separate component of the injector. For examination purposes, the first interpretation was used as this interpretation appears consistent with Applicant’s invention (see fig. 8-10; paragraph 116 of the published application).
Claims 40-47 are also rejected by virtue of being dependent on claim 39.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 32, 33, 36, 39, and 43 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tschirren (US 20230050314).
Regarding claim 32, a pen-type injector for injecting of a dose of a liquid medicament (fig. 2 shows a pen-type injector), the pen-type injector comprising:
a distal housing component (syringe holder 12 in fig. 1) comprising an elongated cartridge holder extending along a longitudinal direction (syringe holder 12 is an elongated cartridge holder), the elongated cartridge holder configured to accommodate a medicament container at least partially filled with the liquid medicament (fig. 1 and 2 shows the syringe holder 12 accommodates syringe 11);
a magnifier extending through a sidewall of the elongated cartridge holder or integrated into the sidewall to increase a visual appearance of at least a portion of the medicament container when the medicament container is arranged in the elongated cartridge holder (paragraph 48 discloses a “magnifying glass” integrated into the sidewall of the syringe holder); and
an elongated proximal housing component extending along the longitudinal direction (housing 10a and cap 10b in fig. 1 together from the “elongated proximal housing”; the examiner notes that a portion of the housing extends proximally from the syringe holder 12), the elongated proximal housing component connectable or connected to the elongated cartridge holder (fig. 2) , the elongated proximal housing component being sized or configured to accommodate a drive mechanism configured to engage with the medicament container to expel or to withdraw the dose of the liquid medicament from the medicament container (fig. 2 shows the housing 10a/b receiving a threaded rod 21, equated to the claimed drive mechanism).
Regarding claim 33, Tschirren discloses the medicament container arranged inside the elongated cartridge holder (syringe 11 in fig. 1 and 2 is shown inside syringe holder 12), the medicament container at least partially filled with the liquid medicament (paragraph 48 discloses the syringe contains a “liquid product”).
Regarding claim 36, Tschirren discloses the elongated proximal housing component is configured to accommodate an entirety of the drive mechanism (fig. 2 shows housing 10a/b accommodating all of the rod 21).
Regarding claim 39, Tschirren discloses a body (body of syringe holder 12 in fig. 1; see 112(b) rejection/interpretation above) comprising a first longitudinal end, an intermediate section, and a second longitudinal end opposite to the first longitudinal end (see below), wherein the intermediate section is located longitudinally between the first longitudinal end and the second longitudinal end (see below), wherein the body comprises the sidewall extending from the first longitudinal end to the second longitudinal end (see below), the sidewall confining a hollow interior space sized to accommodate the medicament container (fig. 2).
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Regarding claim 43, Tschirren discloses the intermediate section comprises a first outer diameter (see above), the second longitudinal end comprises a second outer diameter (see the diameter of the flanged end above), and the first outer diameter is smaller than the second outer diameter (see above).
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) 34 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tschirren, as applied to claim 32 above, and further in view of Vallelunga.
Regarding claim 34, Tschirren discloses all of the claimed limitations set forth in claim 32, as discussed above, and further discloses that the magnifier comprises “variable thickness” in the sidewall (paragraph 48). However, Tschirren does not explicitly teach or disclose the magnifier comprises a bulged section extending outwardly from the sidewall of the elongated cartridge holder.
Vallelunga taches a magnifier comprises a bulged section (magnifying arrangement 52 in fig. 14) extending outwardly from a sidewall (shield 50 in fig. 14). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the magnifier of Tschirren to be a bulged section extending outwardly from the sidewall of the elongated cartridge holder, as taught by Vallelunga, since Tschirren appears to already suggest such feature and Vallelunga teaches that this configuration provides the function of magnification (3:40-45).
Regarding claim 35, in the modified injector of Tschirren, Tschirren discloses the magnifier is configured to magnify at least the portion of the medicament container (paragraph 48).
Claim(s) 32, 33, 39-42, and 48-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ervin (US 1607271) in view of Shonfield (US 5891104).
Regarding claim 32, Ervin discloses a pen-type injector for injecting of a dose of a liquid medicament, the pen-type injector comprising:
a distal housing component (barrel 16 and head 26 form the “distal housing component” in fig. 1) comprising an elongated cartridge holder extending along a longitudinal direction (barrel 16 in fig. 1), the elongated cartridge holder configured to accommodate a medicament container at least partially filled with the liquid medicament (fig. 1 shows the barrel 16 receiving ampule 5);
an elongated proximal housing component extending along the longitudinal direction (head 15a and cap 21 in fig. 1 form the “elongated proximal housing component”), the elongated proximal housing component connectable or connected to the elongated cartridge holder (fig. 1), the elongated proximal housing component being sized or configured to accommodate a drive mechanism configured to engage with the medicament container to expel or to withdraw the dose of the liquid medicament from the medicament container (fig. 1 shows the head/cap receiving a portion of the plunger rod 18 therein).
However, Ervin does not teach or disclose a magnifier extending through a sidewall of the elongated cartridge holder or integrated into the sidewall to increase a visual appearance of at least a portion of the medicament container when the medicament container is arranged in the elongated cartridge holder.
Shonfield teaches a elongated cartridge holder (barrel 10 in fig. 1A) which comprises a magnifier extending through a sidewall of the elongated cartridge holder or integrated into the sidewall to increase a visual appearance of at least a portion of the medicament container when the medicament container is arranged in the elongated cartridge holder (3:41-47 discloses transparent window 11-1 acts as a magnifier).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the window of Ervin (sight openings 15c in fig. 2) to comprise a magnifier, as taught by Shonfield, for the purpose of enabling the user to more clearly see the meniscus (3:41-47) to ensure proper dosing.
Regarding claim 33, in the modified injector of Ervin, Ervin discloses the medicament container arranged inside the elongated cartridge holder (ampule 5 in fig. 1), the medicament container at least partially filled with the liquid medicament (body of liquid 12 in fig. 1).
Regarding claim 39, in the modified injector of Ervin, Ervin discloses a body (body of barrel 15 in fig. 1; see 112(b) rejection/interpretation above) comprising a first longitudinal end (portion of barrel 15 which is received within cap 15a in fig. 1), an intermediate section (see below), and a second longitudinal end opposite to the first longitudinal end (see below), wherein the intermediate section is located longitudinally between the first longitudinal end and the second longitudinal end (see below), wherein the body comprises the sidewall extending from the first longitudinal end to the second longitudinal end (the intermediate section below has a sidewall which extends from the first to second ends around the window 15c), the sidewall confining a hollow interior space sized to accommodate the medicament container (fig. 1).
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Regarding claim 40, in the modified injector of Ervin, Ervin discloses the magnifier is elongated and extends in a direction parallel to a longitudinal axis of the body (in modified Ervin, the magnifier replaces window 15c which is shown to be elongated and extending in a direction parallel to a longitudinal axis in fig. 2).
Regarding claim 41, in the modified injector of Ervin, Ervin discloses the magnifier is located in the intermediate section of the body (see annotated figure above; the magnifier of modified Ervin replaces window 15c which is in the intermediate section defined above).
Regarding claim 42, in the modified injector of Ervin, Ervin discloses the magnifier extends along the intermediate section of the body (see annotated figure above; the magnifier of modified Ervin replaces window 15c which is along the intermediate section defined above).
Regarding claim 48, modified Ervin teaches all of the claimed limitations set forth in claim 32, as discussed above, but does not teach or disclose the body comprises at least one through opening extending through the sidewall to provide access to the medicament container when the medicament container is in the body.
Shonfield is directed towards an injection device (fig. 1A) comprising a body (barrel 10 in fig. 1B) which is adapted to receive a medicine container (ampoule 40 in fig. 1). Shonfield further teaches that the body comprises at least one through opening extending through the sidewall to provide access to the medicament container when the medicament container is in the body (notches 17 in fig. 1B are shown to extend through the sidewall of barrel 10 and would allow for access to a portion of the ampoule 40). Shonfield further teaches that these openings are part of a track (groove 16 in fig. 1B) which allows for needle retraction (fig. 4A/B).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the injector of modified Ervin to allow for needle retraction by modifying the body to comprise at least one through opening extending through the sidewall as well as a track which can engage a needle head of the device, as taught by Shonfield, in order to prevent accidental needle sticks (2:1-3).
Regarding claim 49, in the modified injector of Ervin, Shonfield discloses the at least one through opening comprises a first through opening and a second through opening (see below), the first through opening and the second through opening extending through the sidewall (see below), and the first through opening is located diametrically opposite to the second through opening (see below).
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Regarding claim 50, in the modified injector of Ervin, Ervin discloses the elongated cartridge holder comprises a connector at a proximal longitudinal end (section of barrel 15 which is inserted into cap 15a in fig. 1), wherein the elongated proximal housing component comprises a counter-connector at a distal longitudinal end (section of cap 15a which receives the section of barrel 15 in fig. 1) and wherein the connector of the elongated cartridge holder is configured to mechanically connect to the counter-connector of the elongated proximal housing component (fig. 2; lines 101-107 discloses a bayonet connection).
Regarding claim 51, in the modified injector of Ervin, Ervin discloses the connector comprises an insert section (section of barrel 15 which is received within cap 15a in fig. 1), wherein the elongated proximal housing component comprises a complementary shaped receptacle (space of cap 15a which receives section of barrel 15 in fig. 1), and wherein the insert section is configured for a longitudinal insertion into the complementary shaped receptacle of the elongated proximal housing component (fig. 1).
Claim(s) 34 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ervin in view of Shonfield, as applied to claim 32 above, and further in view of Vallelunga.
Regarding claim 34, modified Ervin teaches all of the claimed limitations set forth in claim 32, as discussed above, but does not explicitly teach or disclose the magnifier comprises a bulged section extending outwardly from the sidewall of the elongated cartridge holder.
Vallelunga taches a magnifier comprises a bulged section (magnifying arrangement 52 in fig. 14) extending outwardly from a sidewall (shield 50 in fig. 14). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the magnifier of modified Ervin to be a bulged section extending outwardly from the sidewall of the elongated cartridge holder, as taught by Vallelunga, since Vallelunga teaches that this configuration provides the function of magnification (3:40-45).
Regarding claim 35, in the modified injector of Ervin, Shonfield discloses the magnifier is configured to magnify at least the portion of the medicament container (3:40-44).
Claim(s) 44-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ervin in view of Shonfield, as applied to claims 32 and 39 above, and further in view of Sexton (US 20200101232) and in view of Jensen (US 6312413).
Regarding claim 44, modified Ervin teaches all of the claimed limitations set forth in claims 32and 39, as discussed above, but does not teach or disclose the intermediate section comprises a polygonal cross-section with at least a first sidewall section, a second sidewall section, and a third sidewall section, and the first sidewall section, the second sidewall section, and the third sidewall section are adjoined to each other along a first or second tangential direction.
Sexton is drawn to an elongated housing component (syringe body 60 in fig. 2) which is adapted to receive a medicament container (cartridge 22 in fig. 2). Sexton teaches that the length of the elongated housing component comprises a circular cross-section (fig. 2) but can alternatively be triangular (paragraph 30).
Jensen is directed towards an injection device comprising a triangular cross-section (fig. 1) and teaches that this type of cross-section comprises a first sidewall section, a second sidewall section, and a third sidewall section (see below), and the first sidewall section, the second sidewall section, and the third sidewall section are adjoined to each other along a first or second tangential direction (see below).
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Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the elongated housing component (cylindrical body 3 in fig. 3), including the intermediate section, and the medicament container (syringe 6 in fig. 3) of modified Ervin to be triangular, as taught by Sexton, so that the intermediate section comprises a polygonal cross-section with at least a first sidewall section, a second sidewall section, and a third sidewall section, and the first sidewall section, the second sidewall section, and the third sidewall section are adjoined to each other along a first or second tangential direction, as taught by Jensen. Jenson teaches that modifying the shape of the components to be triangular with the claimed sidewall sections will not impact operation of a device, specifically by providing an injection device which is configured to deliver a fluid. Additionally, it has been held that a change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 45, in the modified injector of Ervin, Jensen discloses the first sidewall section adjoins in the first tangential direction to the second sidewall section along a first ridge portion, the second sidewall section adjoins in the first tangential direction to the third sidewall section along a second ridge portion, the first sidewall section adjoins in the second tangential direction to the third sidewall section along a third ridge portion, and the second tangential direction is opposite to the first tangential direction (see below).
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Regarding claim 46, in the modified device of Ervin, the magnifier of Ervin (window 15c in fig. 1) extends along a substantial portion of the circumference of the cartridge holder (barrel 15). The examiner asserts that POSITA would recognize that modifying the body of Ervin (i.e. barrel 15 in fig. 1) to comprise a triangular shape taught by Sexton and Jenson above would encompass placing the magnifier on one of the sidewall sections between ridges with this sidewall since the sidewalls account for the majority of the perimeter of the cartridge holder with this sidewall which comprises the window considered the “first sidewall section”.
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ervin in view of Shonfield in view of Sexton and in view of Jensen, as applied to claims 32, 39, 44, and 45 above, and further in view of Oakley (US 20160166775).
Regarding claim 47, modified Ervin teaches all of the claimed limitations set forth in claims 32, 39, 44, and 45, as discussed above, but does not teach or disclose at least the first sidewall section has a convex shape along the first tangential direction.
Oakley is directed towards a drug delivery device (fig. 1) comprising an elongated body (housing 10 in fig. 1) which comprises a triangular cross-section paragraph 128; fig. 9 and 10) having first, second, and third sidewall sections (figs. 9 and 10) which are each convex along a first tangential direction (figs. 9 and 10; paragraph 128 discloses a “rounded” triangular shape).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the sidewall sections of modified Ervin to be convex along the first tangential direction, as taught by Oakley, since Oakley teaches that this shape is comfortable to hold and handle the device (paragraph 120).
Allowable Subject Matter
Claim 52 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 52, Ervin modified with Shonfield fails to teach or disclose the elongated cartridge holder further comprises a flange protruding radially outwardly at a distal end of the insert section to delimit an insert motion of the insert section into the complementary shaped receptacle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pommereau (US 20130131601) discloses a pen injector (fig. 1A) which comprises a magnifier to magnify certain elements of a drug cartridge (paragraph 104).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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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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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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