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
The drawings are objected to because:
The Figs. 5 & 6 are not matched to each other, please see the marked-up Figs. 5-6 below.
PNG
media_image1.png
541
712
media_image1.png
Greyscale
PNG
media_image2.png
556
925
media_image2.png
Greyscale
Note: The number 38 in Fig. 6 is designated as a third pathway. Meanwhile, the rectangular box in the marked-up Fig. 5 above is equivalent to #38 (in Fig. 6); however, the oval box #38 is not shown as a pathway. Applicant is required to show all the numbers in Fig. 5 same as the numbers in Fig. 6.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claim 16, the limitation, i.e., a first section of the two sections is delimited in the distal direction by a portion of the one or more ridges, and a second section of the two sections is connected to the second pathway at a distal end of the second section, is failing to comply with the written description requirement.
Based on para [0044], the track 32 can be thought of as a combination of three separate pathways, namely a first pathway 34, a second pathway 36 and a third pathway 38, ... The first pathway therefore comprises three portions, namely a first section (locking portion 33) (as described in more detail above), a second section or main portion, and a third section (transition portion 35). See the marked-up Figs. 5-6 below.
In other words, the third section 35 of the first pathway is connected to the second pathway 36 at distal end of the third section 35. The Figs. 5-6 do not show that the second section 34 being connected to the second pathway 36 at a distal end of the second section 34.
PNG
media_image2.png
556
925
media_image2.png
Greyscale
PNG
media_image3.png
527
686
media_image3.png
Greyscale
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 20- 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.
In claim 20, the limitation “wherein a proximal face of the portion of the one or more ridges is curved” is vague. There are more than one portions being curved. It is unclear to Examiner that which element is designated to “a proximal face”.
In claim 21, it is unclear to Examiner that which element is designated to “a first portion”, “a second portion”, as recited in claim 21.
In claim 25, the limitation “... a third pathway connected to the second pathway, wherein the third pathway is at the proximal end of the track”, is vague. The Fig. 6 shows the diagram that the third pathway 38 is being connected to the second pathway 36. However, the Fig. 5 shows that there is not pathway located at proximal end of the track. The marked-up Fig. 5 shows the oval box (adjacent to #50) is not a pathway. Therefore, it is unclear to Examiner that which element is being designated to “a third pathway”, as required in the claim 25.
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.
Claims 16-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hautaviita et al. (US2018/0008779).
Regarding claim 1, Hautaviita discloses a rotator 38, see marked-up Fig. 3 below, for a medicament delivery device, the rotator comprising:
a tubular body 38 extending from a proximal end to a distal end in an axial direction relative to an axis and in a circumferential direction relative to the axis; and
one or more ridges 42 extending from a surface of the tubular body, the one or more ridges 42 defining a track 42i on the surface of the tubular body, the track extending in the axial direction from a distal end of the track to a proximal end of the track,
wherein the track comprises a first pathway and a second pathway connected to the first pathway, wherein the first pathway is at the proximal end of the track and the second pathway is at the distal end of the track, wherein the first pathway comprises two sections adjacent to one another in the circumferential direction, and
wherein a first section of the two sections is delimited in the distal direction by a portion A, B & C (see marked-up Fig. 3) of the one or more ridges, and a second section of the two sections is connected to the second pathway at a distal end of the second section.
PNG
media_image4.png
751
993
media_image4.png
Greyscale
Regarding claim 17, wherein the one or more ridges 42 comprise a protrusion extending in the proximal direction, the protrusion 42 extending between the first section of the first pathway and the second section of the first pathway.
Regarding claim 18, wherein the portion A, B & C of the one or more ridges extends in the circumferential direction.
Regarding claim 19, wherein the portion A, B & C of one or more ridges extends perpendicular to the axis, see marked-up Fig. 2b above.
Regarding claim 20, wherein a proximal face (at proximal end of the ridge portion A or B, or portion D) of the portion of the one or more ridges is curved.
Regarding claims 21-24, wherein the portion A, B & C of the one or more ridges is a first portion A, and the one or more ridges comprises a second portion B arranged proximal to the first portion A; wherein the second portion B is angle relative to the axis; wherein the second portion B extends from a proximal end to a distal end, and wherein the proximal end of the second portion B is adjacent to the second section of the first pathway; wherein the second portion B is linear.
Regarding claims 25-26, wherein the rotator 38 comprises a third pathway (see marked-up Fig. 3 above) connected to the second pathway, wherein the third pathway is at the proximal end of the track; wherein the first pathway and the third pathway are separated by at least one of the one or more ridges (line A or the ridge 42).
Regarding claim 27, wherein the one or more ridges extend from an outer surface of the rotator.
Regarding claim 28, Hautaviita discloses a medicament delivery in Fig. 1 comprising the rotator 38 of claim 16, see Fig. 3.
Regarding claim 29, wherein the medicament delivery device comprises a medicament delivery member guard 30; wherein the delivery member guard 30 comprising a protrusion 36; wherein the protrusion 36 is in the track 42 of the rotator 38, para [0042]
Regarding claim 30, wherein the protrusion 36 is configured to be in the first section of the first pathway prior to device activation, para [0032] & marked-up Fig. 11, in the second section of the first pathway after device activation (e.g., para [0037], when the medicament delivery device is pressed against a dose delivery site. This in turn cases the protrusions 36 of the delivery member guard 30 to move along the guide ridges 42 of the rotator 38 such that the protrusions will come in contact with the inclined section. Note the included section is located at second section of 1st pathway, see marked-up Fig. 3).
PNG
media_image5.png
385
762
media_image5.png
Greyscale
Claims 16-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hautaviita et al. (EP 3184134).
Regarding claim 1, Hautaviita discloses a rotator 15, see marked-up Fig. 2b below, for a medicament delivery device, the rotator comprising:
a tubular body 15 extending from a proximal end 15a to a distal end 15d in an axial direction relative to an axis and in a circumferential direction relative to the axis; and
one or more ridges 16d (see marked-up Fig. 2) extending from a surface of the tubular body, the one or more ridges defining a track 16b on the surface of the tubular body, the track extending in the axial direction from a distal end of the track to a proximal end of the track,
wherein the track comprises a first pathway and a second pathway connected to the first pathway, wherein the first pathway is at the proximal end of the track and the second pathway is at the distal end of the track, wherein the first pathway comprises two sections adjacent to one another in the circumferential direction, and
wherein a first section of the two sections is delimited in the distal direction by a portion 16d & 16e of the one or more ridges, and a second section of the two sections is connected to the second pathway at a distal end of the second section.
PNG
media_image6.png
430
781
media_image6.png
Greyscale
Regarding claim 17, wherein the one or more ridges comprise a protrusion extending in the proximal direction, the protrusion 16d & 16e extending between the first section of the first pathway and the second section of the first pathway.
Regarding claim 18, wherein the portion 16d-e of the one or more ridges extends in the circumferential direction.
Regarding claim 19, wherein the portion 16e of one or more ridges extends perpendicular to the axis, see marked-up Fig. 2b above.
Regarding claim 20, wherein a proximal face of the portion of the one or more ridges is curved.
Regarding claims 21-24, wherein the portion 16d-e of the one or more ridges is a first portion 16e, and the one or more ridges comprises a second portion 16d arranged proximal (situated close to) to the first portion 16e; wherein the second portion 16d is angle relative to the axis; wherein the second portion 16d extends from a proximal end to a distal end, and wherein the proximal end (adjacent to element #16a in Fig. 2b) of the second portion 16d is adjacent to the second section of the first pathway; wherein the second portion is linear.
PNG
media_image7.png
372
622
media_image7.png
Greyscale
Regarding claims 25-26, wherein the rotator 15 comprises a third pathway 16c (see marked-up Fig. 2b in the rejection of claim 16 above) connected to the second pathway 16b, wherein the third pathway is at the proximal end of the track; wherein the first pathway and the third pathway are separated by at least one of the one or more ridges (e.g., separated by ridges 16e).
Regarding claim 27, wherein the one or more ridges extend from an outer surface of the rotator.
Regarding claim 28, Hautaviita discloses a medicament delivery 1-1 comprising the rotator 15 of claim 16.
Regarding claims 29-30, wherein the medicament delivery device 1-1 comprises a medicament delivery member guard 16f; wherein the delivery member guard 9a (Figs. 3a-c, or 9b in para [0053]) comprising a protrusion; wherein the protrusion is in the track of the rotator; wherein the protrusion 9a is configured to be in the first section of the first pathway prior to device activation, see Fig. 3a, in the second section of the first pathway after device activation (Fig. 3b) and in the second pathway during medicament delivery (Fig. 3b)
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights