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 .
Election/Restrictions
Applicant’s election without traverse of Claims 14-23, 27-33 in the reply filed on 10/07/2025 is acknowledged.
Examiner note: Claims 19 and 29 are not supported by the elected specie (specie B, Fig 7-8) and sub-species (B-i, B-1, B-a; Fig 7-8). Therefore have been withdrawn from consideration. Please see rationale below:
Claims 19 and 29 limitation of a surface formation of the indicator is representative of subspecies B-iii, Fig 10 as seen in [0126]. Elected sub-specie B-i, Fig 7-8 does not have surface formations.
Claims 19, 24-26, and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/07/2025.
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.
Claim 27 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.
Claim 27 recites the limitation "the distal end of the injector device " in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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.
(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 14-18, 20-23, 27-28, and 30-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jones et al. (US 20120010575 A1).
Regarding claim 14, Jones discloses an injector device (Fig 1) comprising: an elongate housing (housing 2, Fig 1) having a proximal end (proximal end 3, Fig 1) and a distal end (distal end 4, Fig 1), and configured to receive a container of medicament (cartridge 53, Fig 13; [0241]); a plunger rod (piston rod 6, Fig 1) moveable longitudinally within the housing (2) between a primed position (before dispensing of a dose) and a completed position (after dispensing of a dose) ([0144]), the plunger rod (6) being configured to be engageable with the container (53) ([0156]) of medicament (medicinal product; [0090]) when the container of medicament (53) is received in the housing (2); wherein the housing (2) comprises an indicator (Indicator 5, Fig 1) located in a proximal region (3) of the housing (2), the indicator (5) comprising a spindle (indicator part 12+ rotation member 7, Fig 1), the spindle (7+12) comprising a shaft (rotation member 7, Fig 1) and a dial (indicator part 12, Fig 1), wherein the shaft (7) of the spindle (7+12) comprises a threaded arrangement ([0153]: “indentation 17 can be a thread”) configured to engage with a threaded arrangement (protrusion 18, Fig 1) on the plunger rod (6) ([0153]) such that longitudinal movement of the plunger rod (6) from the primed position (before dispensing of a dose) towards the completed position (after dispensing of a dose) causes the dial (12) of the spindle (7+12) to rotate to provide a user with information associated with progress of an injection process dependent upon a longitudinal position of the plunger rod (6) ([0156]: “This distal movement of the piston rod 6, which is coupled to the indicator 5, causes the indicator 5 to rotate. Thus, movement of the piston rod along the axis is converted into rotational movement of the indicator. Piston rod 6 may drive a piston of a drug cartridge (not explicitly shown) in the distal direction resulting in dispensing a dose of a drug from the cartridge.”).
Regarding claim 15, Jones discloses the injector device according to claim 14, wherein the spindle (7+12) is constrained from movement in a longitudinal direction and is rotatable relative to the plunger rod (6) ([0156]).
Regarding claim 16, Jones discloses the injector device according to claim 14, wherein the spindle (7+12) is prevented from moving in a longitudinal direction by the housing (2) ([0178]; Fig 1A).
Regarding claim 17, Jones discloses the injector device according to claim 14, wherein the dial (7+12) is located at the proximal end (3)of the housing (2) such that a distal surface (1000, Annotated Fig 1) of the dial (7+12) contacts the proximal end (3) of the housing (2) and a proximal surface (indication surface 13, Fig 1) of the dial (7+12) faces outwardly of the device to provide the user with information associated with the progress of the injection process, in use ([0146], [0148]; Indication surface 13 faces radially outward).
Regarding claim 18, Jones discloses the injector device according to claim 14, wherein the dial (7+12) is located inside the housing (2) at the proximal end (3) of the housing (2) such that a proximal surface (indication surface 13, Fig 1) of the dial (7+12) faces out of the housing (2) to provide the user with information associated with the progress of the injection process ([0146, [0148]; indication surface 13 faces outward out of housing through window 15).
Regarding claim 20, Jones discloses the injector device according to claim 18, wherein the housing (3) comprises a cover (1001, Annotated Fig 1) extending from the proximal end (3) of the housing (2) and over the proximal surface (13) of the dial (7+12), the cover (1001, Annotated Fig 1) being configured such that the dial (7+12) can provide visual feedback associated with the progress of the injection progress to the user ([0146, [0148]; indication surface 13 faces outward out of housing through window 15 of cover 1001).
Regarding claim 21, Jones discloses the injector device according to claim 14, wherein the dial (7+12) is housed inside the proximal end (3) of the housing (2), and the housing (2) further comprises a display window (window 15, Fig 1) in its side face (Fig 1) through which a side face (indication surface 13, Fig 1) of the dial (7+12) can be seen, the side face (13) of the dial comprising indicia (index element 14, Fig 1) configured to provide visual feedback associated with the progress of the injection progress to the user ([0146, [0148];).
Regarding claim 22, Jones discloses the injector device according to claim 14, wherein the threaded arrangement of the spindle (7+12) comprises a continuous thread (indentation 17 can be a thread, Fig 1; [0153]) on the shaft (7) of the spindle (7+12), the continuous thread (17) being configured to provide constant feedback on the progress of the injection process ([0156]-[0157]).
Regarding claim 23, Jones discloses the injector device according to claim 14, wherein the threaded arrangement (protrusion 18, Fig 1) of the plunger rod (6) comprises a continuous thread on the plunger rod (6)(Fig 1), the continuous thread being configured to provide constant feedback on the progress of the injection process([0155]-[0157]).
Regarding claim 27, Jones discloses an injector device according to claim 14, further comprising the container (53) of medicament (medicinal product; [0090]) received within the housing (2) between the plunger rod (6) and the distal end of the injector device (distal end of injector at the dispensing end)(50, Fig 13A).
Regarding claim 28, Jones discloses a method of using an injector device (Fig 1, Fig 13 ) comprising an elongate housing (housing 2, Fig 1) having a proximal end (proximal end 3, Fig 1) and a distal end (distal end 4, Fig 1), and configured to receive a container of medicament (cartridge 53, Fig 13; [0241]); a plunger rod (piston rod 6, Fig 1) moveable longitudinally within the housing (2) between a primed position (before dispensing of a dose) and a completed position (after dispensing of a dose), the plunger rod (6) being configured to be engageable with the container (53) ([0156]) of medicament (medicinal product; [0090]) when received in the housing (2); wherein the housing (2) comprises an indicator (Indicator 5, Fig 1) located in a proximal region (proximal end 3, Fig 1) of the housing (2); the indicator (5) comprising a spindle (indicator part 12+ rotation member 7, Fig 1), the spindle (7+12) comprising a shaft (rotation member 7, Fig 1) and a dial (indicator part 12, Fig 1), wherein the shaft (7) of the spindle (7+12) comprises a threaded arrangement ([0153]: “indentation 17 can be a thread”) configured to engage with a threaded arrangement (protrusion 18, Fig 1) on the plunger rod (6) ([0153]) such that longitudinal movement of the plunger rod (6) from the primed position (before dispensing of a dose) towards the completed position (after dispensing of a dose) is configured to cause the dial (12) of the spindle (7+12) to rotate to provide a user with information associated with progress of an injection process dependent upon a longitudinal position of the plunger rod (6) ([0156]: “This distal movement of the piston rod 6, which is coupled to the indicator 5, causes the indicator 5 to rotate. Thus, movement of the piston rod along the axis is converted into rotational movement of the indicator. Piston rod 6 may drive a piston of a drug cartridge (not explicitly shown) in the distal direction resulting in dispensing a dose of a drug from the cartridge.”), the method comprising: actuating the injector device (50) such that the plunger rod (6) is moved longitudinally within the housing (2) from the primed position (before dispensing of a dose) to the completed position (after dispensing of a dose); providing information via the indicator (5) associated with the longitudinal position of the plunger rod (6) with the indicator (5)([0151]; [0156]).
Regarding claim 30 Jones discloses the method of claim 28, wherein providing the information comprises providing visual information via the dial (12) of the indicator (5) ([0151]).
Regarding claim 31 Jones discloses the method of claim 28, further compromising preventing movement of the spindle (7+12) in the longitudinal direction ([0155]).
Regarding claim 32 Jones discloses the method of claim 31, wherein preventing movement of the spindle (7+12)comprises preventing movement of the spindle (7+12) with the housing (2) ([0155]).
Regarding claim 33 Jones discloses the method of claim 28, wherein providing information via the indicator (5) comprises providing constant feedback ([0151]; [0155]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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, Kevin Sirmons can be reached on (571) 272-4965. 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.
/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783