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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on April 10, 2026. As directed by the amendment: claims 16-35 have been amended and claims 36-38 have been added. Thus, claims 16-38 are presently pending in this application.
Response to Arguments
Applicant's arguments filed April 10, 2026 have been fully considered but they are not persuasive.
Applicant argues on pg. 8 of the Remarks that the cylinder of Morimoto “is not disclosed as one of two connectable elongated housing components of a pen-type injector. Its disclosed purpose is…not serving as a distal cartridge holder connectable to a proximal elongated housing component in a pen-type injector housing architecture”. The examiner respectfully notes that the proximal elongated housing component is entirely functional and not positively recited. The shielding cylinder of Morimoto is fully capable of being attached to an elongated proximal housing component since the specifics of the proximal component are not further claimed.
Applicant argues on pg. 8 of the Remarks that the wing (4) and fixing cap (5) is not an elongated housing component. The examiner agrees that neither structure can reasonably considered to be “elongated” housing components; however, as discussed above, the proximal housing component is functional and not positively recited. As such, the examiner maintains that the cylinder of Morimoto is fully capable of being connected to an elongated proximal housing component since the proximal housing component is not positively recited nor are the particulars of the proximal housing component further claimed.
With respect to claim 32, Applicant argues on pg. 9 of the Remarks that “Claim 32 therefore requires not only the two-part pen-type injector housing architecture discussed above with respect to claim 16, but also requires that the proximal housing component is sized or configured to accommodate a drive mechanism that engages with the medicament container….Morimoto's cap (5) is not disclosed as being sized or configured to accommodate a drive mechanism”. The examiner notes that claim 32 does not presently require that the proximal housing component be an “elongated” housing component. The examiner further notes that the claim does not presently require that the proximal housing component is configured to entirely accommodate the drive mechanism. Morimoto teaches a proximal housing component (cap 5 in fig. 3) which comprises an opening which accommodates the drive mechanism (plunger 9) therethrough. As such, the examiner maintains that Morimoto anticipates the present claim language.
Claim Objections
Claim 32 is objected to because of the following informalities:
Regarding claim 32, the claim should be amended to recite “the elongated cartridge housing” in line 6 to keep claim terminology consistent.
Appropriate correction is required.
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)(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) 16-21, 28, 29, and 32-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morimoto (JP 2578380).
Regarding claim 16, Morimoto discloses a cartridge holder for a pen-type injector (cylinder 3 in fig. 3), wherein the cartridge holder constitutes a distal housing component of the pen-type injector (cylinder 3 is a distal housing component of an elongated, slender injector to as to be a “pen-type” injector), which is connectable to a proximal housing component of the pen-type injector (cylinder 3 is capable of being connected to a proximal housing component since the particulars are not further claimed), wherein the cartridge holder and the proximal housing component are implemented as elongated housing components extending along a longitudinal direction (cylinder 3 in fig. 3 is capable of being connected to an elongated proximal housing component since the particulars of the proximal housing component are not further claimed), the cartridge holder comprising:
a body (body of cylinder 3 in fig. 3) comprising a first longitudinal end (see below), 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),
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wherein the body comprises a sidewall extending from the first longitudinal end to the second longitudinal end (see above), the sidewall confining a hollow interior space sized to accommodate a medicament container (the sidewall of cylinder 3 receives syringe 6 in fig. 3), and
a magnifier extending through the sidewall or integrated into the sidewall to increase a visual appearance of at least a portion of the medicament container when the medicament container is inside the hollow interior space (cover 1 and lead glass 2 in fig. 3 form the “magnifier”; paragraph 5 of translation discloses that “a lens covers lead glass and has a transparent surface on which the inside of the radiation shielding device is magnified”).
Regarding claim 17, Morimoto discloses the magnifier comprises a bulged section extending outwardly from the sidewall (fig. 2).
Regarding claim 18, Morimoto discloses the magnifier is elongated and extends in a direction parallel to a longitudinal axis of the body (fig. 3).
Regarding claim 19, Morimoto discloses the magnifier is located in the intermediate section of the body (see annotated figure above).
Regarding claim 20, Morimoto discloses the magnifier extends along the intermediate section of the body (see annotated figure above).
Regarding claim 21, Morimoto discloses the intermediate section comprises a first outer diameter (see below), the second longitudinal end comprises a second outer diameter (see below; the examiner notes that “diameter” is defined by Merriam-Webster as “the length of a straight line through the center of an object”; the diameter below is the length of the straight line extending through wing 4 which is part of the second longitudinal end), and the first outer diameter is smaller than the second outer diameter (see below).
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Regarding claim 28, Morimoto discloses the second longitudinal end comprises a connector operable to mechanically connect to a corresponding counter-connector of the proximal housing component of the injection device (wing 4 in fig. 6 is functionally capable of connecting counter connector since the particulars of the proximal housing are not further claimed, as discussed above).
Regarding claim 29, Morimoto discloses the magnifier (i) comprises a bulged section extending outwardly from the sidewall (fig. 2), (ii) is elongated and extends in a direction parallel to a longitudinal axis of the body (fig. 3), (iii) is located in the intermediate section of the body (fig. 3 and see annotated figure above), and (iv) extends along the intermediate section of the body (fig. 3 and see annotated figure above).
Regarding claim 32, Morimoto discloses a pen-type injector for injecting of a dose of a liquid medicament (fig. 3 shows an elongated, handheld device for injector so as to be a “pen-type” injector), the pen-type injector comprising:
a distal housing (cylinder 3 and wing 4 in fig. 6 are the “first housing”) comprising an elongated cartridge holder (cylinder 3 in fig. 3) configured to accommodate a medicament container at least partially filled with the liquid medicament (fig. 3 shows cylinder receiving syringe 6);
a magnifier extending through a sidewall of the cartridge holder component 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 (cover 1 and glass 2 in fig. 2 and 3 form the “magnifier”; paragraph 5 of translation discloses that “a lens covers lead glass and has a transparent surface on which the inside of the radiation shielding device is magnified”); and
a proximal housing component connectable or connected to the elongated cartridge holder (cap 5 is connected to cylinder 3 in fig. 3), the 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. 3 shows that cap 5 comprises a hole 8 which accommodates plunger 9 therethrough which engages with the syringe 6 to expel the fluid within syringe 6; see response to arguments above).
Regarding claim 33, Morimoto discloses the medicament container arranged inside the elongated cartridge holder (syringe 6 in fig. 3), the medicament container at least partially filled with the liquid medicament (paragraph 5 of the provided translation discloses the syringe “is pre-filled with a radiopharmaceutical solution”).
Regarding claim 34, Morimoto discloses the magnifier comprises a bulged section extending outwardly from the sidewall of the elongated cartridge holder (fig. 2).
Regarding claim 35, Morimoto discloses the magnifier is configured to magnify at least the portion of the medicament container (paragraph 5 of the provided translation discloses “a lens that covers the lead glass and has a transparent surface on which the inside of the radiation shielding device is magnified”).
Regarding claim 36, Morimoto discloses the proximal housing component is configured to accommodate a drive mechanism, which is operable to engage with a medicament container to expel or to withdraw a dose of a liquid medicament from the medicament container (the examiner notes that the proximal housing component is functional and not positively recited; as such, the device of Morimoto is capable of being connected to the claimed proximal housing component since there is nothing about the structure which would prevent such function).
Regarding claim 37, Morimoto discloses the connector comprises an insert section configured for a longitudinal insertion into a complementary shaped receptacle of the proximal housing component (the connector further comprises cap 5 in fig. 3/6, equated to the claimed “insert section”, which is capable of longitudinal insertion into the claimed receptacle).
Regarding claim 38, Morimoto discloses 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 (wing 4 in fig. 6 is a flange protruding outwardly at the distal end of cap 5).
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) 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morimoto, as applied to claim 16 above, and further in view of Sexton (US 20200101232) and in view of Jensen (US 6312413).
Regarding claim 22, Morimoto discloses all of the claimed limitations set forth in claim 16, 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 Morimoto 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 23, in the modified device of Morimoto, 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 24, in the modified device of Morimoto, the magnifier of Morimoto (cover 1 and glass 2 in fig. 3) extend along a minor part of the circumference of the perimeter of the body (cylindrical body 3 in fig. 1). The examiner asserts that POSITA would recognize that modifying the body of Morimoto (i.e. cylindrical body 3 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 being considered the “first sidewall section”.
Claim(s) 25 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morimoto in view of Sexton and in view of Jensen, as applied to claims 16, 22, and 29 above, and further in view of Oakley (US 20160166775).
Regarding claim 25, modified Morimoto teaches all of the claimed limitations set forth in claims 16 and 22, 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 Morimoto 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).
Regarding claim 31, Morimoto discloses all of the claimed limitations set forth in claims 16 and 29, 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, the first sidewall section adjoins in a 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 a second tangential direction to the third sidewall section along a third ridge portion, the second tangential direction is opposite to the first tangential direction, the magnifier is located on the first sidewall section between the first ridge portion and the third ridge portion, and at least the first sidewall section has a convex shape along the first tangential direction.
As discussed previously, 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 first sidewall section, a second sidewall section, and a third sidewall section (see below), and 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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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 Morimoto 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 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, 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).
The examiner notes that the magnifier of Morimoto (cover 1 and glass 2 in fig. 3) extend along a minor part of the circumference of the perimeter of the body (cylindrical body 3 in fig. 1). The examiner asserts that POSITA would recognize that modifying the body of Morimoto (i.e. cylindrical body 3 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 being considered the “first sidewall section”.
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 Morimoto 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).
Claim(s) 26, 27, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morimoto, as applied to claims 16 and 29 above, and further in view of Shonfeld (US 5891104).
Regarding claim 26, Morimoto discloses all of the claimed limitations set forth in claim 16, 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.
Shonfeld 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). Shonfeld 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). Shonfeld 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 device of Morimoto 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 Shonfeld, in order to prevent accidental needle sticks (2:1-3).
Regarding claim 27, in the modified device of Morimoto, Shonfeld 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 30, Morimoto discloses all of the claimed limitations set forth in claims 16 and 29, as discussed above, but does not teach or disclose the body comprises a first through opening and a second through opening, the first through opening and the second through opening extending through the sidewall to provide access to the medicament container when the medicament container is in the body, and the first through opening being located diametrically opposite to the second through opening.
As discussed above, Shonfeld 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). Shonfeld further teaches that the body a first through opening and a second through opening, the first through opening and the second through opening extending through the sidewall to provide access to the medicament container when the medicament container is in the body, and the first through opening being located diametrically opposite to the second through opening (see annotated figure for claim 27 above; notches 17 in fig. 1A/B are shown to extend through the sidewall of barrel 10 and would allow for access to a portion of the ampoule 40). Shonfeld 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 device of Morimoto to allow for needle retraction by modifying the body to comprise the claimed first and second through openings extending through the sidewall as well as a track which can engage a needle head of the device, as taught by Shonfeld, in order to prevent accidental needle sticks (2:1-3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Denning (US 20140074023) appears capable of being used in a 102(a)(1) rejection for the independent claims and several dependent claims. For example, Dennings discloses a pen-type injector (fig. 1) comprising a cartridge holder (1979 in fig. 169) comprising a magnifier extending through a sidewall of the cartridge holder (Fresnel lens 1997 in fig. 170) which is used to increase a visual appearance of the medicament container when the medicament container is inside the cartridge holder (paragraph 346).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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