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 of the following:
Figure 20 includes reference numeral “605.” The Examiner believes this is a typographical error and should instead recite “1605” as this figure shows serial dosing system 1600 rather than serial dosing system 600.
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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because of the following:
Reference character “26” has been used to designate both a “retractable needle” and a “retraction motion”. See [0005] and Figures 4A – 4B.
Reference character “36” has been used to designate both a “stopper” and a “plunger tip.” See at least [0006].
Reference numeral “37” has been used to designate the “distal end” of the plunger tip or the “open distal end” of the system body. See at least [0006] and [0047].
Reference character “1636” has been used to designate “ratchet contact patch” and “leaf springs.” See at least [0066] and [0070].
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. 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.
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:
640-1 as shown in Fig. 8.
1622 as shown in Fig. 46.
1624 as shown in Fig. 46.
4826 as shown in Fig. 48.
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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
1614-C as recited in [0085].
3614 as recited in [0085].
4626 as recited in [0094].
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. 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.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0006] is suggested to be amended to recite “Figure 5B has the cap removed to illustrate the Luer interface (14))” and (i.e., so that a plunger tip (36) having a circular cross-sectional shape may establish a seal against the syringe body (34))” to improve the consistency for how reference numerals are referred to throughout the Specification.
Paragraph [0031] is suggested to be amended to recite “Figures 25 to 27B are distal (Figure 25) and proximal (Figures 26, 27A and 27B)” because currently the Drawings dated 5 April 2024 do not include a Figure 27. Rather the Drawings include Figures 27A – 27B.
Paragraph [0039] is suggested to be amended to recite “Figures 43 and 44 [[our]] are detailed” to improve the understanding and clarity of the paragraph.
Paragraph [0075] is suggested to be amended to recite” FIGS. 25 to 27A-B are distal (FIG. 25) and proximal (FIGS. 26 and 27A-B)…(see FIGS. 26 and 27A-B) … FIGS. 26 and 27A-B …” because currently the Drawings dated 5 April 2024 do not include a Figure 27. Rather the Drawings include Figures 27A – 27B.
[0076] is suggested to be amended to recite “…plunger member [[45] 44…” to correct the reference numeral for the plunger member.
[0077] is suggested to be amended to recite “…plunger member [[45] 44…” to correct the reference numeral for the plunger member.
[0079] is suggested to be amended to recite “with each distal advancement of the thumbpad member 1601 and [[does]] dose delivery” to correct the misspelling of the word “dose.”
[0090] is suggested to be amended to recite “couple the cap [[3822]] 3820” to correct the reference numeral for the “cap.”
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.
Claim 3 is 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 3 recites the limitation "the finger flange body.” There is insufficient antecedent basis for this limitation in the claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 – 3, 5, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 2012/0010575 A1) (hereinafter referred to as “Jones”) in view of Shanley et al. (US 2020/0147323 A1) (hereinafter referred to as “Shanley”).
With regards to claim 1, Jones (see Figs. 13 – 13E) a system (50) for medication dispensing (see [0241]), comprising:
a syringe body (53) (see [0252]) having proximal and distal ends (see Fig. 13B), a syringe interior (see Fig. 13B and [0244]),
a drug disposed in the syringe interior (see [0244] “medicament to be dispensed from the cartridge 53”);
a finger flange (2) (see [0135]) defining a finger flange interior (see Fig. 13B at 2) and a side window (15)(see [0149]) therethrough;
a stopper member (54) (see [0242]) disposed in the syringe interior (see Fig. 13B);
a plunger member (6) (see [0261]) coupled to the stopper member and disposed at least partially within the finger flange (see Fig. 13b);
a thumbpad (31) (see [0248] “The drive member 31 comprises a rack part 63 and an activation part 64.”) slidably disposed in a proximal end of the finger flange (see Figures 13B – 13C and [0260]) and operatively coupled to the plunger member (see [0260]);
a cam (5) (see [0135]) configured to rotate a predetermined angular distance with each full advancement of the thumbpad into the finger flange (see [0151], [0263], and [0264]); and
a ratchet (61) (see [0247] and [0260] “pawl arms of the carrier 61 of the gear 60 are engaged with the second set of indentations 58 of the piston rod 6, the piston rod 6 is caused to move longitudinally in the distal direction with respect to the main housing 2”) configured to advance the plunger member a predetermined longitudinal distance with each full advancement of the thumbpad into the finger flange (see [0246] and [0260]).
Jones is silent with regards to the following:
the syringe body having a syringe flange at the proximal end thereof;
the finger flange being coupled to the syringe flange.
Nonetheless Shanley, which is within the analogous art of system and method for multiple site injections (see abstract and title), teaches the syringe body (510) (see [0042]) having a syringe flange at the proximal end thereof (see Fig. 7 at the right side of the syringe body 510);
the finger flange (540) (see [0042]) being coupled to the syringe flange (see Figs. 6 and 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the syringe body and finger flange of the system of Jones in view of a teaching of Shanley such that the syringe body having a syringe flange at the proximal end thereof; and the finger flange being coupled to the syringe flange. One of ordinary skill in the art would have been motivated to make this modification because Shanley teaches this structure provides for an easy connection/disconnection of a prefilled and pre-stoppered syringe. See [0046] and [0064] of Shanley.
Here, the distal end 4 of the housing 2 of Jones will be modified to incorporate the structure of the finger flange 540 of Shanley such that a prefilled and pre-stoppered syringe could be quickly and easily attached. The cartridge 53 of Jones would be replaced with the syringe 510 of Shanley.
The system of Jones modified in view of Shanley will hereinafter be referred to as the system of Jones and Shanley.
With regards to claim 2, the system of Jones and Shanley teaches the claimed invention of claim 1, and Jones further teaches (see Figs. 13 – 13E) wherein the finger flange (2) (see [0135]) further comprises a stator (56) (see [0245]) operatively coupled to the thumbpad (31) (see [0250]) and the cam (5) (see [0135] and [0253]), and configured to rotate the cam with advancement of the thumbpad into the finger flange (see [0260] and [0262]).
With regards to claim 3, the system of Jones and Shanley teaches the claimed invention of claim 1, and Jones further teaches (see Figs. 13 – 13E) wherein the cam (5) (see [0135]) includes at least one rotation indicia (14) (see [0147]) visible through the window (15)(see [0149]) in the finger flange body (see at 2 in Fig. 13) (see [0135]), and configured to indicate a number of full advancements of the thumbpad (31) (see [0248]) into the finger flange (see [0148] “Index elements 14 can be adapted to provide information linked to the number of doses of a drug remaining in a drug delivery device or dispensed from a drug delivery device”).
With regards to claim 5, the system of Jones and Shanley teaches the claimed invention of claim 1, and Jones further teaches (see Figs. 13 – 13E) wherein the finger flange (2) (see [0135] and [0245]) is configured to emit an audible indicator for each full depression of the thumbpad (31) (see [0248]) into the finger flange (see [0259] “The action of the pawl arms of the carrier 61 positively engaging the second set of indentations 58 of the piston rod 6 creates an audible and tactile feedback to the user to indicate that the dose has been set. The indicator does not rotate during dose setting” and [0262]).
With regards to claim 8, the system of Jones and Shanley teaches the claimed invention of claim 1, and the system of Jones and Shanley further teaches (see Figs. 13 – 13E) the system further comprising a needle coupled to a distal end of the syringe body (see [0244] and [0261] of Jones and [0046] of Shanley).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones and Shanley as applied to claim 1 above, and further in view of Spenser et al. (US 2015/0025502 A1) (hereinafter referred to as “Spenser”).
With regards to claim 4, the system of Jones and Shanley teaches the claimed invention of claim 1, however, Jones is silent with regards to the system further comprising a spring configured to return the thumbpad proximally after distal depression of the thumbpad into the finger flange.
Nonetheless Spenser, which is within the analogous art of syringe cradle (see abstract and title), teaches (see Fig. 3) a spring (39) (see [0037]) configured to return the thumbpad (4) (see [0037]) proximally after distal depression of the thumbpad into the finger flange (3) (see [0037], [0047], and [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Jones and Shanley in view of a teaching of Spenser such that a spring configured to return the thumbpad proximally after distal depression of the thumbpad into the finger flange. One of ordinary skill in the art would have been motivated to make this modification because Spenser teaches that including a spring within the system assists with urging the thumbpad proximally after distal depression of the thumbpad into the finger flange (see [0014], [0037], and [0047] of Spenser). The spring assists with returning the thumbpad into the pre-delivery position such that it can then be depressed again for continued delivery of medication.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones and Shanley as applied to claim 1 above, and further in view of Madsen et al. (US 2014/0257197 A1).
With regards to claim 6, the system of Jones and Shanley teaches the claimed invention of claim 1, however Jones is silent with regards to wherein the finger flange is configured to prevent depression of the thumbpad into the finger flange after a predetermined number of full depressions of the thumbpad into the finger flange.
Nonetheless Madsen, which is within the analogous art of multiple dosage injector with rack and pinion dosage systems (see abstract and title), teaches the finger flange (102) (see [0055]) is configured to prevent depression of the thumbpad (104) into the finger flange after a predetermined number of full depressions of the thumbpad into the finger flange (see [0080] “after the final dose of medicament is expelled from the injection device, ram shaft 1086 is sufficiently distally translated so that when push button 104 reaches the fired state, protrusion 1094 and lockout aperture 1046g are aligned. In one embodiment, protrusion 1094 slides into lockout aperture 1046g thereby restricting movement of push button 104, e.g., push button 104 cannot reset because it is connected to ram shaft 1086 which is prevented from moving proximally relative to the housing by pawl 1026.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the finger flange of the system of Jones and Shanley in view of Madsen such that the finger flange is configured to prevent depression of the thumbpad into the finger flange after a predetermined number of full depressions of the thumbpad into the finger flange. One of ordinary skill in the art would have been motivated to make this modification because Madsen teaches the inclusion of a lock-out feature prevents a push button from resetting from its fired position upon completion of the allotted medicament doses. See [0080] of Madsen. This feature prevents the device from being used further until it is reset. See [0081] of Madsen.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones and Shanley as applied to claim 1 above, and further in view of Courteix (US 2002/0062108 A1).
With regards to claim 7, the system of Jones and Shanley teaches the claimed invention of claim 1, however, Jones is silent with regards to the system further comprising a semi-rigid distal cap comprising: a shield body; and an undulating elastic member disposed in the shield body.
Nonetheless Courteix, which is within the analogous art of protection device for syringe needle (see abstract and title), teaches (see Figs. 6 – 10) a semi-rigid distal cap (see Fig. 6) comprising:
a shield body (80) (see [0076]); and
an undulating elastic member (20) (see [0076]) disposed in the shield body.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the system of Jones and Shanley in view of a teaching of Courteix such that the system further comprises a semi-rigid distal cap comprising: a shield body; and an undulating elastic member disposed in the shield body. One of ordinary skill in the art would have been motivated to make this modification because Courteix teaches this cap protects all persons who successively manipulate the syringe from an accidental prick with the needle if the free end of the needle. See [0024] and [0025] of Courteix.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hewson et al. (US 11,324,893 B2).
Broennimann et al. (US 2005/0177115 A1).
Burren et al. (US 2007/0106227 A1).
Cox et al. (US 2010/0036320 A1).
Boyd et al. (US 2010/0137792 A1).
Radmer et al. (US 2011/0046565 A1).
Cronenberg et al. (US 2011/0172640 A1).
Holmqvist (US 2012/0172815 A1).
Veasey et al. (US 2012/0283649 A1).
Veasey et al. (US 2012/0283651 A1).
Nicholls et al. (US 2012/0296276 A1).
Cammish et al. (US 2016/0038686 A1).
Franklin et al. (US 2017/0000949 A1).
Carrel et al. (US 2020/0188594 A1).
Quinn et al. (US 2020/0282147 A1).
Gabriel (US 6,048,336 A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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.
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/ROBERT F ALLEN/Examiner, Art Unit 3783 .
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
06/12/2026
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