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 .
Priority
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(a-d) with reference to Application Number: GB2117043.6 filed on 11/25/2021.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
Claim Objections
Claim 12 is objected to because of the following informalities: the claim recites “to towards”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 – 6 and 8 – 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison (US 20110114671) in view of Smith (US 5740794).
1. Harrison discloses a medicament delivery device [0112] comprising: a casing defining a volume (2, see volume illustrated in Fig. 2a) for receiving a rupturable container containing a medicament and a propellant (3, see [0082], [0063, 0064]); and a needle hub assembly (42) comprising a needle having a longitudinal axis (46, see [0160 – 0161], longitudinal axis in Fig. 2b), and a needle hub to which the needle is affixed (43, see [0160], see Figs. 2a – 2b), wherein the needle hub is engageable with the casing (see [0160]) such that the needle extends into the volume for receiving the rupturable container (see Figs. 2a, 2b, [0165]).
However, Harrison does not disclose wherein the needle hub has a profile such that circumferential interference between the needle hub and the casing prevents rotation of the needle hub relative to the casing about an axis parallel to the longitudinal axis when the needle hub is engaged with the casing. Nonetheless, Smith discloses a medicament delivery device (c. 3: 27 – 29) comprising: a casing defining a volume (302) for receiving a container containing a medicament (342, c. 18: 22 – 24); and a needle hub assembly (see Fig. 17, 306) comprising a needle having a longitudinal axis (370, see Fig. 18), and a needle hub to which the needle is affixed (358, see Fig. 17), wherein the needle hub is engageable with the casing such that the needle extends into the volume for receiving the rupturable container (see Fig. 20, c. 20: 63 – 66); wherein the needle hub has a profile such that circumferential interference between the needle hub and the casing prevents rotation of the needle hub relative to the casing about an axis parallel to the longitudinal axis when the needle hub is engaged with the casing (see Fig. 15, c. 20: 7 – 27, the keyed slot 350 receiving the inserted key portion 352 along the longitudinal axis keeps the needle hub in a known circumferential orientation when placed in the casing to ensure appropriate use of the device; the use is further described in c. 20: 42 – 50, c. 21: 62 – 65, and Fig. 19; the key portion is also illustrated on hub 358 in Fig. 21, showing the left side edge contiguous with a resting top ridge, versus the non-keyed right side edge indented under the resting top ridge; note also general teaching in Fig. 7, c. 16: 61 - 63). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the needle hub 43 of Harrison with circumferential interference between the needle hub and casing as taught in Smith for the benefit of ensuring the needle hub is placed in the appropriate orientation, see c. 20: 13 – 16, c. 8: 59 - 60. Harrison discloses that the container ruptures along a small zone of weakness, see [0152], with the end-most point of the needle aligned to the zone to enable appropriate entry of the quill within the confined chamber, see [0161 – 0162, 0164]. Appropriate orientation of the needle hub 43 would ensure proper assembly and operation of the medicament device whether removably or permanently fixedly mounted.
2. Harrison discloses a medicament delivery device according to claim 1, where the needle hub has a radial internal or external profile such that circumferential interference between the needle hub and the casing prevents rotation of the needle hub relative to the casing about an axis parallel to the longitudinal axis when the needle hub is engaged with the casing (see Fig. 15, c. 20: 7 – 27, the keyed slot 350 receiving the inserted key portion 352 along the longitudinal axis keeps the needle hub in a known circumferential orientation when placed in the casing to ensure appropriate use of the device; the use is further described in c. 20: 42 – 50, c. 21: 62 – 65, and Fig. 19; the key portion is also illustrated on hub 358 in Fig. 21, showing the left side edge contiguous with a resting top ridge, versus the non-keyed right side edge indented under the resting top ridge; note also general teaching in Fig. 7, c. 16: 61 - 63).
3. Harrison discloses a medicament delivery device according to claim 1, wherein one of the needle hub and the casing includes a protrusion that extends radially relative to the longitudinal axis, and the other of the needle hub and the casing includes a recess for receiving the protrusion when the needle hub is engaged with the casing, wherein circumferential interference between the protrusion and the recess prevents rotation of the needle hub relative to the casing about an axis parallel to the longitudinal axis (see Fig. 15, c. 20: 7 – 27, the keyed slot 350 receiving the inserted key portion 352 along the longitudinal axis keeps the needle hub in a known circumferential orientation when placed in the casing to ensure appropriate use of the device; the use is further described in c. 20: 42 – 50, c. 21: 62 – 65, and Fig. 19; the key portion is also illustrated on hub 358 in Fig. 21, showing the left side edge contiguous with a resting top ridge, versus the non-keyed right side edge indented under the resting top ridge; note also general teaching in Fig. 7, c. 16: 61 - 63).
4. Harrison discloses a medicament delivery device according to claim 3, wherein the protrusion comprises an axially extending rib and the recess comprises an axially extending slot for receiving the axially extending rib (see Fig. 15, c. 20: 7 – 27, the keyed slot 350 receiving the inserted key portion 352 along the longitudinal axis keeps the needle hub in a known circumferential orientation when placed in the casing to ensure appropriate use of the device; the use is further described in c. 20: 42 – 50, c. 21: 62 – 65, and Fig. 19; the key portion is also illustrated on hub 358 in Fig. 21, showing the left side edge contiguous with a resting top ridge, versus the non-keyed right side edge indented under the resting top ridge; note also general teaching in Fig. 7, c. 16: 61 - 63).
5. Harrison discloses a medicament delivery device according to claim 3, wherein the recess includes a stop that limits the axial extent to which the protrusion may be received in the recess (see 402, Fig. 21, Fig. 24, c. 21: 62 – c. 22: 10, general teaching in c. 16: 61 – 63).
6. Harrison discloses a medicament delivery device according to claim 1, wherein the needle hub is affixed to the casing ([0160]).
8. Harrison discloses a medicament delivery device according to claim 1, further comprising a cover that is engageable with the casing (4, [0163 – 165]), and wherein the cover is moveable between a closed configuration in which the volume cannot be accessed, and an open configuration in which the volume can be accessed (see [0145], [0169, 0170], Fig. 1 versus Fig. 5).
9. Harrison discloses a medicament delivery device according to claim 8, wherein the cover may be manipulated by a user to cause a rupturable container received in the volume to move relative to the needle such that the needle may rupture the rupturable container ([0163 – 0165]).
10. Harrison discloses a medicament delivery device according to claim 1, wherein each of the needle and the needle hub comprise a bore such that medicament and propellant may pass therethrough and out of the medicament delivery device when the rupturable container is ruptured by the needle (see [0160], [0168]).
11. Harrison discloses a medicament delivery device according to claim 10, wherein the bore of the needle hub has an internal diameter that increases in a direction out of the medicament delivery device (see Figs. 2a, 2b).
12. Harrison discloses a medicament delivery device according to claim 1, wherein the casing comprises a plurality of guide ribs that guide at least a portion of the rupturable container to towards the needle when a force is applied to the rupturable container (see Fig. 2a, [0147, 0149]).
13. Harrison discloses a medicament delivery device according to claim 1, comprising a rupturable container received in the volume, wherein the rupturable container contains a medicament and a propellant (3, see [0082], [0063, 0064]).
14. Harrison discloses a medicament delivery device according to claim 13, wherein the propellant is a gas or a liquid [0018].
15. Harrison discloses a medicament delivery device according to claim 13, wherein the propellant comprises one or more of: air, nitrogen, water, carbon dioxide, butane, hydrofluorocarbon (HFC), or hydrofluoroalkane (HFA) (see [0018]).
16. Harrison as modified by Smith discloses a method of assembling a medicament delivery device comprising the steps: (i) providing a medicament delivery device according to any preceding claim (see claim 1 above); (ii) rotationally aligning the needle hub in a desired rotational alignment configuration relative to the casing (see Smith in claim 1 above, slot 350 and inserted key portion 352 require rotational alignment along the needle hub circumference in order to achieve the desired alignment; see Fig. 15, c. 20: 7 – 27, the keyed slot 350 receiving the inserted key portion 352 along the longitudinal axis keeps the needle hub in a known circumferential orientation when placed in the casing to ensure appropriate use of the device; the use is further described in c. 20: 42 – 50, c. 21: 62 – 65, and Fig. 19; the key portion is also illustrated on hub 358 in Fig. 21, showing the left side edge contiguous with a resting top ridge, versus the non-keyed right side edge indented under the resting top ridge; note also general teaching in Fig. 7, c. 16: 61 - 63) and (iii) engaging the needle hub with the casing whilst the needle hub is in the desired rotational alignment configuration relative to the casing (see Smith, Fig. 19, Fig. 21, c. 20: 7 – 27, c. 20: 42 – 50, c. 20: 63 – 66, c. 21: 62 – 65).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrison (US 20110114671) in view of Smith (US 5740794) in view of Fuchs (US 6997357).
7. Harrison in view of Smith discloses a medicament delivery device according to claim 6, including disclosing wherein the needle hub is affixed to the casing, see [0160], but does not disclose doing so with an adhesive. Nonetheless, Fuchs discloses an inner tubular component (analogous to the inner tubular needle hub of Harrison) and an outer tubular component (analogous to the outer tubular casing of Harrison) affixed with an adhesive (see c. 6: 8 – 24, c. 3: 23 – 39). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to affix the needle hub to the casing of Harrison using adhesive as taught in Fuchs for the predictable result of properly securing the two mechanical components together during assembly of the medicament delivery device. Examiner notes that appropriate orientation of the needle hub 43 in Harrison would ensure proper assembly and operation of the medicament device upon permanently fixing the component.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20040188458 – alignment of needle hub for aerosol delivery
US 20150314077 – alignment of needle hub with casing
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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, Brandy Lee can be reached at (571) 270-7410. 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.
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
Prosecution Insights