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 with traverse of Species II applicant elects the device with windows, in the reply filed on April 30, 2026 is acknowledged.
Regarding the remaining arguments, the Applicant’s traversal is on the ground(s) of:
Argument(s): Applicant argues that there is no serious burden to continue examination of Species I and Species II together.
Applicant’s arguments have been fully considered but are not persuasive.
Applicant argues that there would be no serious search and/or examination burden, because Species I and Species II include common elements recited in the generic claims 1-8 and 10-11. Species II encompasses claims 1-11. Because claim 9 depends on claim 1, Species II incorporates all of the limitations of claim 1. Therefore, both Species I and Species II rely on the same core search and analysis, and no serious burden is present.
Applicant’s arguments are not persuasive because the present requirement is an election of species requirement issued during examination of a utility nonprovisional application under 35 U.S.C. § 111(a). The election requirement identified distinct species recited in the claims, including distinct with/without window configurations. These alternatives possess different structural and/or functional characteristics which require different classes/subclasses, employing different search strategies or search queries. These alternatives are not obvious variants of one another based on the current record. Applicant has not presented persuasive technical evidence demonstrating that these identified species are patentably indistinct or that examination of one species would necessarily encompass examination of the remaining species.
Applicant’s assertions that the Species I and Species II are directed to a safety shield, differing only in a form. As such, it would be reasonably expected that the search for Species I or Species II would necessarily produce results applicable to the other species, since the two species include a safety shield are unsupported and are insufficient to rebut the Examiner’s determination.
Accordingly, Applicant has not shown that the election requirement was improper, and the requirement for election of species is maintained. Therefore, the arguments as presented are not found persuasive because the requirement(s) for species election, as stated, are still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 13 and 212. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 Objections
Claim 1 is objected to because of the following informalities: the reference character "(20)" should be removed from line 15 since no other reference characters are recited in the claims. The formatting throughout the claim is not consistent. In order to maintain consistency in formatting, lines 15-16 should be indented to align with lines 13-14, line 17 should be provided with a dash, and lines 17-19 should be indented so that they align with lines 3-12. The term "and" should be inserted at the end of line 16 in order to be grammatically correct. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: claim 10 positively recites “a prefilled syringe” comprising the barrel and needle of claim 1. Claim 1 recites “a syringe” and claim 10 recites “a prefilled syringe”, one of these should be changed so that their language is the same and claim 10 should refer to “the” (prefilled) syringe since claim 1 functionally recited this syringe. It is suggested to amend claim 10 to recite “comprising the syringe comprising said barrel, said needle, a stopper and a plunger rod, wherein said syringe is prefilled.”
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 1 and 8 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 1, The preamble on lines 1-2 of claim 1 only functionally recites the syringe/barrel/needle (i.e. it’s not a part of the “shielding system”), but line 3 of the claim reads as if the barrel is positively recited (and a part of the “shielding system”). Because of this, it’s unclear if the syringe/barrel/needle are intended to be a part of the claimed “shielding system” or not. Since 10 does positively these features, it is believed that claim 1 is not intended to. So I would interpret claim 1 as only functionally reciting the syringe/barrel/needle. In order to overcome this rejection, line 3 could be amended to recite “a body defining an enclosure, the body configured such that said barrel can extend at least partially within said enclosure”.
Claim 8 suffers from similar issues because it appears to positively recite “the needle”. I would interpret claim 8 as only functionally reciting the needle. In order to overcome this rejection, claim 8 could be amended to recite “where the shielding system is configured so that the needle [[is]] can be covered by the safety shield in the activated position and the needle [[is]] can be not covered by the safety shield in the retracted position.
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 –
Claim(s) 1-3, 7-8, and 10-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fiard et al. (WO 2021/078605 A1).
Regarding claim 1, Fiard et al. discloses a shielding system (see shielding system with the assembly of Fig. 7 including needle shield 20A and locking unit 30A) for a syringe (p. 12, [0047], line 10, syringe) for use in medication delivery (p. 1, [0001], lines 1-3, the invention relates to a medical injection device to be used by a user to inject a substance into a body) comprising a barrel (Fig. 14 barrel 102) and a needle (Fig. 7 needle 101) at a distal end (see ‘Modified Fig. 7’ below, distal end) of the barrel (102), said shielding system (20A and 30A) comprising: - a body ([0045], lines 19-20, external case) defining an enclosure (see ‘Modified Fig. 7’ below, enclosure), said barrel (102) extending at least partially within said enclosure (see ‘Modified Fig. 7’ below, enclosure); - a safety shield (Fig. 7 needle shield 20A) for the needle, longitudinally movable (see Figures 7-8 as described in p. 14, [0054], lines 10-12, this allows the needle shield 20A to move freely from the initial shielding position to the retracted position and vice versa, as shown figure 7 and figure 8) with respect to the body ([0045], lines 19-20, external case) between a retracted position (p. 14, [0054], lines 10-12, retracted position) and an activated position (p. 14, [0054], lines 10-12, shielding position); - a spring (Fig. 11 spring 201) urging said safety shield (20A) towards said activated position (p. 14, [0054], lines 10-12, shielding position); - a first locking mechanism (see such locking mechanism with the assembly of Fig. 7 including first track portion 301, protrusion 303, and flexible leg 304) for locking (p. 14, [0054], lines 12-14, move from initial shielding position to the retracted position) the safety shield (20A) in the retracted position (p. 14, [0054], lines 10-12, retracted position), wherein the first locking mechanism (assembly including 301, 303, and 304 in Fig. 7) is manually releasable ([0054], lines 10-12, move freely) by a user so as to let the safety shield (20A) reach the activated position ([0054], lines 10-12, shielding position); - the first locking mechanism (assembly including 301, 303, and 304 in Fig. 7) comprising a trigger button (Fig. 7 protrusion 303) on the body ([0045], lines 19-20, external case), and a first engaging area (301) on the safety shield (20A); the trigger button presenting a default state (p.14, [0055], lines 17-18, non-actuating position) and a depressed state (p.14, [0055], lines 17-18, actuating position); - the first locking mechanism (assembly including 301, 303, and 304 in Fig. 7) being configured such that when the safety shield is (20A) in the retracted position (p. 14, [0054], lines 10-12, retracted position) and the trigger button (303) is in the default state (p.14, [0055], lines 17-18, non-actuating position), the trigger button (303) engages the first engaging area (301); when the trigger button is in the depressed state (p.14, [0055], lines 17-18, actuating position), the trigger button (303) does not engage the first engaging area (302); a second locking mechanism (40A) for permanently and non-reversingly locking the safety shield (20A) in the activated position ([0054], lines 10-12, shielding position) after the first locking mechanism (assembly including 301, 302, 303, and 304 in Fig. 7) is released, wherein the second locking mechanism (40A) comprises a second engaging area (p.13, [0052], line 3, track) on the safety shield (20A) and said trigger button (303) engaging in the second engaging area (p.13, [0052], line 3, track).
PNG
media_image1.png
398
607
media_image1.png
Greyscale
Regarding claim 2, Fiard et al. the first locking mechanism (assembly including 301, 302, 303, and 304 in Fig. 7) is configured such that when the safety shield (20A) is in the activated position ([0054], lines 10-12, shielding position) and the trigger button (303) is in the default state (p.14, [0055], lines 17-18, non-actuating position), the trigger button (303) engages the second engaging area (p.13, [0052], line 3, track).
Regarding claim 3, Fiard et al. discloses the first locking mechanism (assembly including 301, 302, 303, and 304 in Fig. 7) is further configured such that when the safety shield (20A) is in the activated position ([0054], lines 10-12, shielding position) and the trigger button (303) is in the depressed state (p.14, [0055], lines 17-18, actuating position), the trigger button (303) still engages the second engaging area (p.13, [0052], line 3, track).
Regarding claim 7, Fiard et al. discloses the trigger button (303) is configured such that it is urged toward the default state (p.14, [0055], lines 17-18, non-actuating position).
Regarding claim 8, Fiard et al. discloses the needle (101) is covered by the safety shield (20A) in the activated position ([0054], lines 10-12, shielding position) and the needle (101) is not covered by the safety shield (20A) in the retracted position (p. 14, [0054], lines 10-12, retracted position).
Regarding claim 10, Fiard et al. discloses comprising a prefilled syringe (see ‘Modified Fig. 7’ above, prefilled syringe) comprising said barrel (102), said needle (101), a stopper (Fig. 14 stopper 103a) and a plunger rod (Fig. 14 plunger rod 103).
Regarding claim 11, Fiard et al. discloses comprising a step of triggering release (see Figures 7-8 as described in p. 14, [0054], lines 10-12, this allows the needle shield 20A to move freely from the initial shielding position to the retracted position and vice versa, as shown figure 7 and figure 8) of the trigger button (303) by the first locking mechanism (assembly including 301, 302, 303, and 304 in Fig. 7) so that the spring (201) moves the safety shield (20A) from the retracted position (p. 14, [0054], lines 10-12, retracted position) towards the activated position (p. 14, [0054], lines 10-12, shielding position).
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 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Fiard et al. (WO 2021/078605 A1) in view of Gagnieux et al. (US 6679864 B2).
Regarding claim 4, Fiard et al. does not explicitly mention the first engaging area is a radial protrusion at a distal part of the safety shield, and the second engaging area is a radial protrusion at a proximal part of the safety shield. However, Gagnieux et al. teaches the first engaging area (Gagnieux et al., Fig. 2 stop member 58 at ‘Modified FIG. 2’, distal part) is a radial protrusion (Gagnieux et al., Fig. 2 stop member 58) at a distal part (Gagnieux et al., see ‘Modified Fig. 2’ below, distal part) of the safety shield (Gagnieux et al., Fig. 2 tubular shield 28), and the second engaging area (Gagnieux et al., Fig. 2 stop member 58 at ‘Modified FIG. 2’, proximal part) is a radial protrusion (Gagnieux et al., Fig. 2 stop member 59) at a proximal part (Gagnieux et al., see ‘Modified Fig. 2’ below, proximal part) of the safety shield (Gagnieux et al., 28).
It would have been obvious before the effective filing date of the claimed invention for a person of ordinary skill in the art to modify the safety shield system of Fiard et al. so the first engaging area is a radial protrusion at a distal part of the safety shield and the second engaging area is a radial protrusion at a proximal part of the safety shield, as taught by Gagnieux et al., as the shielding system being able to have such a radial protrusion on the safety shield is described in the embodiment of Fiard et al., Fig. 5, and Fiard et al., p.16, [0060], lines 2-8, a protruding ring 21 A provided on the needle shield 20A sticks out of the extremal skirt of external case 50 only when the needle shield 20A is in the safety position (figure 5 for example). The user can then see the protruding ring 21 A, and clearly notice that the injection device has been used and that the needle shield 20A is in the safety position. In particular, the protruding ring 21 A can be provided with a specific colour (red for example) to indicate clearly the safety position.
PNG
media_image2.png
715
593
media_image2.png
Greyscale
Regarding claim 5, the first modified device of Fiard et al. does not explicitly mention the trigger button comprises a jaw part for engaging the first and/or second engaging area through the body, and a pressure part for being pressed by the user so as to switch the trigger button from the default state to the depressed state. However, Gagnieux et al. teaches the trigger button (assembly including Gagnieux et al., Fig. 2 detents 52 and axially extending arm 54) comprises a jaw part (Gagnieux et al., Fig. 2 detents 52) for engaging the first (Gagnieux et al., Fig. 2 stop member 58 at ‘Modified FIG. 2’, proximal part) and/or second engaging area (Gagnieux et al., Fig. 2 stop member 58 at ‘Modified FIG. 2’, proximal part) through the body (Gagnieux et al., Fig. 2 tubular holder 26), and a pressure part (Gagnieux et al., Fig. 2 axially extending arm 54) for being pressed by the user (the movement of the detents 52 ultimately results from the force applied by the user to the plunger rod 22, although the force is transmitted through the syringe components and stop member 59 rather than by directly pressing the arm 54 or detents 52 as described in p. 7 lines 58-67 and p.8, lines 3-18, following removal of the needle 18 from the patient, the user applies a greater force to the plunger rod 22 than that applied during injection. Such force causes axial displacement of the syringe barrel 16, end fitting 32, the spring 30 and the shield 28 with respect to the holder 28. The distance between the annular wall or collar 66 of the end fitting (or the flange 24) is then sufficient to permit the second stop member rib 58 to move far enough axially to where its retention by the groove 48 is overcome by the force of the spring. The first stop member 48 may also be displaced radially inwardly as such sliding occurs if sufficient flexibility of the holder body is provided. Once the rib 58 and groove 48 are disengaged, the spring 30 expands rapidly, causing the shield 28 to slide axially or distally with respect to the holder 26 and syringe barrel. The collar 59 moves past the detents 54, causing them to deflect radially outwardly and then inwardly to their original positions. The collar 59 then engages the stop member 50 as shown in FIG. 7. The resiliently deformable projection or projections 70 on the fitting 32 damps vibration of syringe 12 during movement the shield 28 reducing damage to the flange 24. Upon such engagement, the needle cannula 18 is entirely and permanently enclosed and covered by the shield 28, as shown in FIGS. 4 and 7.The shield cannot be retracted sufficiently to expose the needle tip due to the engagement of the stop member or collar 59 with the detents 52. It cannot be removed from the holder as the collar 59 cannot move past the stop member 50) so as to switch the trigger button (assembly including Gagnieux et al., Fig. 2 detents 52 and axially extending arm 54) from the default state (Gagnieux et al., p. 8, lines 7-8, original positions) to the depressed state (see state during Gagnieux et al., p. 8, lines 6-7, deflect radially outwardly).
It would have been obvious before the effective filing date of the claimed invention for a person of ordinary skill in the art to modify the trigger button to comprise a jaw part for engaging the first and/or second engaging area through the body and a pressure part for being pressed by the user so as to switch the trigger button from the default state to the depressed state, as taught by Gagnieux et al., as Fiard et al describes in p. 4, [0010], lines 8-11, the locking unit in the present disclosure might typically comprise one or several parts or components, and/or might also comprise one or several portions of different components which cooperate together to lock the needle shield.
Regarding claim 6, the second modified device of Fiard et al. discloses the trigger button (assembly including Gagnieux et al., Fig. 2 detents 52 and axially extending arm 54) is configured such that when the pressure part (Gagnieux et al, 54) is pressed (axially extending arm 54 is actuated by user-applied force transmitted from plunger rod 22 through stop member 59 as described in p. 7 lines 58-67 and p.8, lines 3-18 above), the jaw part (detents 52) is lifted (Gagnieux et al., p. 8, lines 6-7, deflect radially outwardly).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Fiard et al. (WO 2021/078605 A1) in view of Francavilla (US 9789263 B2) and Westbye et al. (US 8372044 B2).
Regarding claim 9, Fiard et al. discloses the body (Fiard et al, [0045], lines 19-20, external case) presents at least one window (Fiard et al, Fig. 1 window 501).
Fiard et al. does not explicitly mention each of the body and the safety shield presents at least one window such that, when the safety shield is in the retracted position, the barrel is visible through said windows. However, Francavilla teaches each of the body (housing body 260) and the safety shield (see safety shield but without a window in Francavilla, Fig. 5 safety shield 220) presents at least one window (see window for body in Francavilla, Fig. 5 windows 216) such that, when the safety shield (220) is in the retracted position (see retracted position in Fig. 5 as described in Francavilla, p. 2, lines 47-49, prior to deployment of safety shield) the barrel (Francavilla, Fig. 5 syringe body 11) is visible through (“visible through” can be seen in Francavilla, Fig. 5 with the barrel (11) seen through the window (216)) said windows (216).
It would have been obvious before the effective filing date of the claimed invention to modify the device of Fiard et al. to incorporate the window arrangement taught by Francavilla so that the barrel is visible through the body window when the safety shield is in the retracted position. Fiard et al. teaches that a user benefits from a visual indication provided through a window, explaining that a radial protrusion 402 is aligned with window 501 in the actuating position so that the user can visually confirm completion of the injection as described in Fiard et al., p. 15, [0059], lines 16-27, between figures 7-8 and figures 10-11 , the locking actuator 40A has moved from the non-actuating position to the actuating position. As visible figure 12, the locking actuator 40A comprises a radial protrusion 402, arranged to cooperate with the window 501 visible figures 1 , 2, 6. In the non- actuating position of the locking actuator 40A, the radial protrusion 402 is not in regards of the window 501 , and a user cannot see the radial protrusion 402. In contrast, in the actuating position of the locking actuator 40A, the radial protrusion 402 is in regards of the window 501 , and a user can see the radial protrusion 402. This can be used to indicate an end of the injection. In particular, the radial protrusion 402 can be provided with a specific colour (red for example) to indicate clearly that all the dose of substance 105 is injected. A person of ordinary skill in the art would have recognized that the same design objective of providing a clear visual indication through a window would have motivated using Francavilla’s window configuration to permit visual observation of the barrel through the body window while the safety shield remains retracted, thereby improving the user’s ability to verify the device condition prior to deployment of the safety shield. Such a modification merely applies Francavilla’s known visual arrangement to Fiard et al.’s device to achieve the predictable benefit of enhanced visual confirmation without changing the basic operation of Fiard et al.’s injector.
Regarding the teaching of a safety shield presenting at least one window where the barrel is visible through the window in the retracted position of the safety shield, Westbye et al. teach each of the body (there is not a body enclosing a barrel) and the safety shield (see Westbye et al., Fig. 1 guard 14) presents at least one window (see window for safety shield in Westbye et al., Fig. 1 window 40) such that, when the safety shield (14) is in the retracted position (see retracted position in Fig. 5 as described in Westbye et al., p. 3, lines 38-40, retracted position) the barrel (Westbye et al., Fig. 1 barrel 16) is visible through (“visible through” can be seen in Westbye et al., Fig. 1 with the barrel (16) seen through the window (40)) said windows (40).
It would have been obvious before the effective filing date of the claimed invention to further modify the modified device of Fiard et al. to incorporate the window arrangement taught by Westbye et al’s, including the safety shield window, such that, when the safety shield is in the retracted position, the barrel is visible through the window. Fiard et al. teaches that a user benefits from a visual indication provided through a window, explaining that a radial protrusion 402 is aligned with window 501 in the actuating position so that the user can visually confirm completion of the injection as described in Fiard et al., p. 15, [0059], lines 16-27, between figures 7-8 and figures 10-11, the locking actuator 40A has moved from the non-actuating position to the actuating position. As visible figure 12, the locking actuator 40A comprises a radial protrusion 402, arranged to cooperate with the window 501 visible figures 1 , 2, 6. In the non- actuating position of the locking actuator 40A, the radial protrusion 402 is not in regards of the window 501 , and a user cannot see the radial protrusion 402. In contrast, in the actuating position of the locking actuator 40A, the radial protrusion 402 is in regards of the window 501 , and a user can see the radial protrusion 402. This can be used to indicate an end of the injection. In particular, the radial protrusion 402 can be provided with a specific colour (red for example) to indicate clearly that all the dose of substance 105 is injected. A person of ordinary skill in the art would have recognized that the same design objective of providing a clear visual indication through a window would have motivated using Westbye et al.’s window configuration to permit visual observation of the barrel through the safety shield window while the safety shield remains retracted, thereby improving the user’s ability to verify the device condition prior to deployment of the safety shield. Such a modification merely applies Westbye et al.’s known visual arrangement to Fiard et al.’s device to achieve the predictable benefit of enhanced visual confirmation without changing the basic operation of Fiard et al.’s injector.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISSA J GHANNOUM whose telephone number is (571) 272-
8591. The examiner can normally be reached Monday through Friday 6:30 AM to 3:00 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, Kevin Sirmons can be reached at 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.
/ISSA JAMIL GHANNOUM/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights