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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract contains more than 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:
The reference character “31” has been used to refer to “shoulder” on page 11, line 6 and “shoulder part” on page 9, line 13.
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 18, 23, 25 and 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.
Regarding claim 18, the recitation “a fastener” in last line renders the claim indefinite because the claim is unclear if “a fastener” refers to “a fastener” recited in claim 1, line 5 or additional. For examination purposes, examiner construes “a fastener” recited in claim 18 as being referring to a connection between the hook and the cut-out/recess.
Regarding claim 23, the recitation “a distal ledge” in line 2 renders the claim indefinite because the claim is unclear if “a distal ledge” refers to “a ledge” recited in claim 1, line 9 or additional. For examination purposes, examiner construes that “a distal ledge” refers to “a ledge” recited in claim 16.
Regarding claim 23, the recitation “an inner surface” in line 2 renders the claim indefinite because the claim is unclear if “an inner surface” refers to “an inner surface” recited in claim 1, line 9 or additional. For examination purposes, examiner construes that “an inner surface” refers to “an inner surface” recited in claim 16.
Regarding claims 25 and 26, the recitation “the shoulders of medicament containers” renders the claim indefinite because the claim is unclear if claim is positively reciting the capability to support plurality of medicament containers at the same time and if “a medicament container” recited in claim 16 includes plurality of medicament containers. For examination purposes, examiner construes that the medicament container carrier is capable to provide support to one of the plurality of medicament containers.
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)(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.
Claims 16, 17, 22, 23, 24 and 27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jakobsen et al. (US 2020/0206428 A1).
Regarding claim 16, Jakobsen teaches a medicament container carrier (integrated structure formed by elements 2 and 12) of a medicament delivery device 1, the medicament container carrier 2, 12 comprising:
a tubular body (body of element 2) of receiving a medicament container 10, the tubular body (body of element 2) extending along a longitudinal axis (longitudinal axis of element 10) between a proximal open end (end where element 5 is present) and a distal open end (end where element 9.1 is present), wherein the tubular body (body of element 2) comprises a fastener (an engagement component that engages with element 14), and
a proximal cap 12 comprising a tubular cap body (body of element 12),
wherein the tubular cap body (body of element 12) extends along the longitudinal axis (longitudinal axis of element 2) between a proximal end (end of element 12 not connected to element 2) and a distal end (end of element 12 connected to element 2), wherein a slot (hollow portion inside element 12) extends on the tubular cap body (body of element 12) from the proximal end to the distal end, wherein the tubular cap body (body of element 12) comprises a ledge (see “L” in figure 8 below) extending from an inner surface (inner surface of element 12) of the tubular cap body (body of element 12), wherein the ledge (see “L” in figure 8 below) is radial relative to the longitudinal axis, wherein the ledge is configured to support a shoulder part (see “S” in figure 8 below) of the medicament container 10 of the medicament delivery device 1, wherein the proximal cap 12 comprises a counter fastener 14 offset relative to the ledge (see “L” in figure 8 below) in the direction of the longitudinal axis, and wherein the proximal cap 12 is attached to the proximal end of the tubular body (body of element 2) through an engagement between the fastener (paragraph 0055, lines 12-14) and the counter fastener 14.
PNG
media_image1.png
259
522
media_image1.png
Greyscale
Regarding claim 17, Jakobsen teaches wherein the fastener (paragraph 0055, lines 12-14, although not explicitly disclosed, the engaging portion has to be recess or cut-out in order for the arms to engage in a snap manner. Furthermore, figure 1, as shown below by “C”, appears to be showing cut-out with which element 14 engages although not explicitly recited. Therefore, Jakobsen is implicitly indicating the presence of cut-out/recess) is either a cut-out/recess or a hook, and wherein the counter fastener 14 is a hook 14 if the fastener is a cut-out/recess, or the counter fastener is a cut-out/recess if the fastener is a hook.
PNG
media_image2.png
786
572
media_image2.png
Greyscale
Regarding claim 22, Jakobsen teaches wherein the engagement between the fastener and the counter fastener 14 is a snap-fit engagement (paragraph 0055, lines 12-14).
Regarding claim 23, Jakobsen teaches wherein the tubular body (body of element 2) comprises a distal ledge (see “L” in figure 8 above) extending from an inner surface of the tubular body (body of element 2).
Regarding claim 24, Jakobsen teaches wherein the distal ledge (see “L” in figure 8 above) is an annular ledge (element “L” in figure 8 above is annular).
Regarding claim 27, Jakobsen teaches a medicament delivery device 1 comprises the medicament container carrier 2, 12.
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.
Claims 18, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Jakobsen et al. (US 2020/0206428 A1) in view of Knowles et al. (US 2021/0402099 A1).
Regarding claim 18, Jakobsen discloses the claimed invention substantially as claimed, as set forth above in claims 16 and 17. Jakobsen further discloses wherein the counter fastener 14 is the hook 14 extending from the tubular cap body (body of element 12) in the distal direction (see figure 1 where element 14 is extending in a direction away from the dosing site) relative to the tubular cap body (body of element 12), and wherein the proximal cap 12 is attached to the proximal end of the tubular body (body of element 2) through a fastener between the hook 14 and the cut-out/recess (paragraph 0055, lines 12-14) but fails to explicitly recite wherein the fastener is the cut-out/recess, wherein the cut-out/recess is arranged in a wall of the tubular body, wherein the cut-out/recess is open in a direction transverse to the longitudinal axis. However, one can construe that “C” in figure 1 above is implicitly indicating the fastener is the cut-out/recess, wherein the cut-out/recess is arranged in a wall of the tubular body, wherein the cut-out/recess is open in a direction transverse to the longitudinal axis.
Additionally, Knowles teaches a design of an injector comprising the fastener 26 (figure 3) is the cut-out/recess 26, wherein the cut-out/recess is arranged in a wall 24 of the tubular body 2, wherein the cut-out/recess 26 is open in a direction transverse (radial direction of the device shown in figure 3) to the longitudinal axis for the purpose of using a well-known snap feature to securely hold two structures together (paragraph 0026, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the fastener of Jakobsen to incorporate the fastener is the cut-out/recess, wherein the cut-out/recess is arranged in a wall of the tubular body, wherein the cut-out/recess is open in a direction transverse to the longitudinal axis as taught by Knowles for the purpose of using a well-known snap feature to securely hold two structures together (paragraph 0026, lines 1-9).
Regarding claim 20, Jakobsen discloses the claimed invention substantially as claimed, as set forth above in claims 16 and 17. Jakobsen further discloses wherein the hook 14 comprises a hook arm (see “A” in figure 1 above) and a hook tip (see “T” in figure 1 above), wherein the hook arm (see “A” in figure 1 above) extends the direction of the longitudinal axis, wherein the hook tip (see “T” in figure 1 above) extends from an end of the hook arm (see “A” in figure 1 above) in the direction transverse to the longitudinal axis, but fails to explicitly recite wherein the hook tip is arranged within the cut-out/recess. However, Jakobsen does disclose that element 14 engages with snap engagement in paragraph 0055, lines 12-14 and therefore, Jakobsen does appear to be implicitly discloses the presence of the cut-out/recess into which element “T” in figure 1 above is arranged.
Furthermore, Knowles teaches wherein the hook tip 28 (figure 3) is arranged within the cut-out/recess 26 (paragraph 0026, lines 1-9) for the purpose of using a well-known snap feature to securely hold two structures together (paragraph 0026, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the hook of Jakobsen to incorporate the hook tip is arranged within the cut-out/recess as taught by Knowles for the purpose of using a well-known snap feature to securely hold two structures together (paragraph 0026, lines 1-9).
Regarding claim 21, Jakobsen discloses the claimed invention substantially as claimed, as set forth above in claims 16 and 17. Jakobsen further discloses wherein the hook tip (see “T” in figure 1 above) extends in a circumferential direction (see “T” which is extending in circumferential direction) from a first end (one of the ends of “T” in figure 1 above) and a second end (other of the ends of “T” in figure 1 above), and wherein the hook tip (see “T” in figure 1 above) comprises a ramp surface (surface at element “T” in figure 1 above) angled to the hook arm (see “A” in figure 1 above) and arranged at the first end.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Jakobsen et al. (US 2020/0206428 A1) in view of Carlsson et al. (US 2021/0038817 A1).
Regarding claim 19, Jakobsen discloses the claimed invention substantially as claimed, as set forth above in claims 16 and 17. Jakobsen further discloses wherein the cut-out/recess (see “C” in figure 1 above) extends in a circumferential direction (element “C” extends in a portion of circumferential direction) relative to the longitudinal axis between a first end (one of the end of “C” in figure 1 above) and a second end (other of the end of “C” in figure 1 above), a surface (surface of “C” in figure 1 above) arranged at the first end (one of the end of “C” in figure 1 above), and wherein the surface extends from an inside portion (inside portion of “C” in figure 1 above) of the cut-out/recess to an outer edge (outer edge of “C” in figure 1 above) of the cut-out/recess but is silent regarding a surface being a ramp surface wherein the ramp surface is inclined from an inside portion to an outer edge.
However, Carlsson teaches a design of a medicament delivery device (figure 1) comprising a cut-out/recess 14’ comprising a ramp surface 14B wherein the ramp surface 14B is inclined from an inside portion (inner portion of element 1) to an outer edge (edge of element 14’ towards outer side) for the purpose being able to connect to the locking element via snap lock mechanism using a well-known alternative configuration (paragraph 0085, lines 4-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the surface of Jakobsen to incorporate a ramped surface wherein the ramped surface is inclined from an inside portion to an outer edge as taught by Carlsson for the purpose being able to connect to the locking element via snap lock mechanism using a well-known alternative configuration (paragraph 0085, lines 4-9).
Claims 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Jakobsen et al. (US 2020/0206428 A1) in view of Groetzbach et al. (US 2019/0151565 A1).
Regarding claim 25, Jakobsen discloses the claimed invention substantially as claimed as set forth above in claim 16. Jakobsen is silent regarding wherein the tubular cap body comprises multiple ledges extending from the inner surface of the tubular cap body, and wherein the multiple ledges are offset relative to one another in the direction of the longitudinal axis, so that the shoulders of medicament containers of the medicament delivery device with different lengths can be supported by one of the ledges.
However, Groetzbach teaches a design of an injection device comprising wherein the tubular cap body (body of element 6 in figure 2A) comprises multiple ledges (see “ML” in figure 2a below) extending from the inner surface (inner surface of element 6) of the tubular cap body (body of element 6), and wherein the multiple ledges (see “ML” in figure 2a below) are offset relative to one another in the direction of the longitudinal axis, so that the shoulders of medicament containers of the medicament delivery device with different lengths can be supported by one of the ledges (one of the “ML” will be able to provide support to the shoulder of medicament containers with different lengths) for the purpose of using an alternative design to frictionally retain the medicament container (paragraph 0088, lines 8-11).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the tubular cap body of Jakobsen to incorporate wherein the tubular cap body comprises multiple ledges extending from the inner surface of the tubular cap body, and wherein the multiple ledges are offset relative to one another in the direction of the longitudinal axis, so that the shoulders of medicament containers of the medicament delivery device with different lengths can be supported by one of the ledges as taught by Groetzbach for the purpose of using an alternative design to frictionally retain the medicament container (paragraph 0088, lines 8-11).
PNG
media_image3.png
271
752
media_image3.png
Greyscale
Regarding claim 26, Jakobsen discloses the claimed invention substantially as claimed, as set forth above in claim 16. Jakobsen further discloses the tubular cap body (body of element 12) has varied inner diameters (more than one inner diameters are present due to presence of “L” in figure 8 above), so that the shoulders of medicament containers of the medicament delivery device with different lengths and/or widths (appropriate changes in the width or length of the medicament containers could be placed inside element 12 with support of “L” in figure 8 above) can be supported by one of the ledges (see “L” in figure 8 above).
Claims 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Jakobsen et al. (US 2020/0206428 A1) in view of Holmqvist et al. (US 9,302,059 B2).
Regarding claims 28 and 29, Jakobsen discloses a method of assembling a medicament delivery device medicament container assembly (assembly formed by elements 2 and 12), the method comprising the following sequence of steps in the following order:
providing a tubular body (body of element 2) of a medicament container carrier 2, wherein the tubular body (body of element 2) extends along a longitudinal axis (axis along which length of element 2 extends) between a proximal end (end comprising element 5) and a distal end (end comprising element 9.1);
providing a medicament container 10,
providing a proximal cap 12 of the medicament container carrier 2;
inserting (paragraph 0055, lines 6-8) the medicament container 10 from the proximal end (end comprising element 5) of the tubular body (body of element 2) into the tubular body (body of element 2); and
moving (paragraph 0055, lines 12-14) the proximal cap 12 of the medicament container carrier 2 relative to the tubular body (body of element 2) in a direction relative to the longitudinal axis to attach the proximal cap 12 to the proximal end of the tubular body (body of element 2).
Jakobsen is silent regarding moving the proximal cap in a direction transverse to the longitudinal axis wherein the step of moving the proximal cap of the medicament container carrier in the direction transverse to the longitudinal axis comprises the step of linearly moving the proximal cap of the medicament container carrier in the direction transverse to the longitudinal axis. However, Holmqvist teaches a method of assembling a medicament delivery device including a step of moving (column 7, lines 51-61) the proximal cap 16 (figure 3) in a direction transverse to the longitudinal axis wherein the step of moving the proximal cap 16 in the direction transverse to the longitudinal axis comprises the step of linearly moving the proximal cap 16 in the direction transverse to the longitudinal axis for the purpose of attaching the proximal cap by inserting from sideways as an alternative well-known configuration (column 7, lines 51-61).
Jokobsen modified in view of Holmqvist will result in having wherein the step of moving the proximal cap of the medicament container carrier in the direction transverse to the longitudinal axis comprises the step of linearly moving the proximal cap of the medicament container carrier in the direction transverse to the longitudinal axis.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the method and proximal cap of Jakobsen to incorporate moving the proximal cap in a direction transverse to the longitudinal axis wherein the step of moving the proximal cap of the medicament container carrier in the direction transverse to the longitudinal axis comprises the step of linearly moving the proximal cap of the medicament container carrier in the direction transverse to the longitudinal axis as taught by Holmqvist for the purpose of attaching the proximal cap by inserting from sideways as an alternative well-known configuration (column 7, lines 51-61).
Regarding claim 30, Jakobsen teaches wherein the step of moving the proximal cap of the medicament container carrier relative to the tubular body in the direction relative to the longitudinal axis to attach the proximal cap 12 to the proximal end of the tubular body (body of element 2) comprises the step of snap-fitting (paragraph 0055, lines 12-14) the proximal cap 12 onto the tubular body (body of element 2).
Jakobsen modified in view of Holmqvist, as explained in rejection of claim 28 above, will result in wherein the step of moving the proximal cap of the medicament container carrier relative to the tubular body in the direction transverse to the longitudinal axis to attach the proximal cap to the proximal end of the tubular body comprises the step of snap-fitting the proximal cap onto the tubular body because the modification involves only the movement of the element 12 along with necessary cutouts to enable such movement without changing the connection mode between two structures.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Drunk et al. (US 2011/0152822 A1), Mori et al. (US 2011/0230827 A1): discloses a design of a carrier with a proximal cap comprising ledges extending from inner surface of the body of the proximal cap.
Holmqvist (US 2019/0307967 A1): discloses a design of a medicament container cap comprising a cut-out to allow assembly by moving the medicament container cap to move transverse to the longitudinal axis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NILAY J SHAH/Primary Examiner, Art Unit 3783
Prosecution Insights