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 .
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 1-6, 8-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DIIANNI et al. (US 2017/0128664).
Regarding claim 1, DIIANNI discloses a wearable drug delivery device, comprising:
a reservoir 130 configured to store a fluid, the reservoir 130 comprising a housing 130 defining an interior chamber (an interior space of the reservoir 130);
a drive mechanism 150 for driving the fluid from the reservoir 130, the drive mechanism comprising:
a plunger 136 in the interior chamber of the reservoir 130;
a leadscrew 152 & 154 extending from the plunger 136; and
a clutch mechanism 160 engaged with the leadscrew 152, wherein the clutch mechanism 160 is configured to allow the leadscrew 154 to pass through the clutch mechanism 160 when disengaged (e.g., para [0031], … the clutch mechanism 160 remains disengaged to allow the tube nut154 to pass into an elongated cylindrical bore along the drive axis of a hub of the drive wheel 156, also see para [008] & Fig. 9) and configured to grip the leadscrew 154 when engaged such that the clutch mechanism 160 rotates to advance the leadscrew and the plunger in the reservoir (e.g. para [0031], … The clutch mechanism 160 may then be engaged (FIGS. 10-12) such that rotation of the drive wheel 156 causes the clutch mechanism 160 to rotate the tube nut 154, which causes the leadscrew 152 to advance the plunger into the reservoir 130 to deliver the fluid from the reservoir 130, also see para [0008]).
Regarding claim 2, wherein the clutch mechanism 160 comprises a clutch spring 162, and wherein the clutch spring 162 is in direct physical contact with an exterior of the leadscrew 152 & 154 when the clutch mechanism 160 is engaged with the leadscrew 152 &154, see Figs. 10-12.
Regarding claim 3, wherein the clutch mechanism 160 further includes a spring latch 164 operable to hold the clutch spring 162 in a disengaged position (Figs. 7-9) and configured to release the clutch spring 162 such that the clutch spring 162 moves to an engaged position (Figs. 10-12).
Regarding claim 4, wherein the spring latch 164 is operable to release the clutch spring 162 in response to movement of the drive wheel 156, see Figs. 11-12 & also claims 5 & 12.
Regarding claims 5-6, further comprising a slider (see marked up Fig. 8 below) connected with the clutch spring 162; wherein the clutch spring 162 is provided along an interior of the slider.
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Regarding claim 8, further comprising a drive wheel 156, wherein the drive wheel 156 is operable with the clutch mechanism 160 to rotate and advance the leadscrew.
Regarding claim 9, DIIANNI discloses a wearable drug delivery device, comprising:
a reservoir 130 configured to store a liquid drug, the reservoir 130 comprising a housing 130 including an outer wall defining an interior chamber (an interior space of the housing 130);
a drive mechanism 150 for driving the liquid drug from the reservoir, the drive mechanism 150 comprising: a plunger 136 in the interior chamber of the reservoir;
a leadscrew 152 & 154 extending from the plunger 136; and
a drive wheel 156 operable with a clutch mechanism 160 to rotate a clutch spring 162 to advance the leadscrew 152 & 154, wherein the clutch mechanism160 is configured to allow the leadscrew 152 & 154 to pass through the clutch spring 162 when in a disengaged position (e.g., para [0031], … the clutch mechanism 160 remains disengaged to allow the tube nut154 to pass into an elongated cylindrical bore along the drive axis of a hub of the drive wheel 156, also see para [0008] & Fig. 7-9) and configured to grip the leadscrew by the clutch spring when in an engaged position (Figs. 10-12) such that the drive wheel 156 rotates the clutch spring 162 to advance the leadscrew and the plunger into the reservoir (e.g. para [0031], … The clutch mechanism 160 may then be engaged (FIGS. 10-12) such that rotation of the drive wheel 156 causes the clutch mechanism 160 to rotate the tube nut 154, which causes the leadscrew 152 to advance the plunger into the reservoir 130 to deliver the fluid from the reservoir 130, also see para [0008]).
Regarding claim 10, wherein the clutch spring 162 is in direct physical contact with an exterior of the leadscrew when the clutch mechanism is in the engaged position, see Fig. 12.
Regarding claim 11, wherein the clutch mechanism 160 further includes a spring latch 164 operable to engage (Fig. 9) and disengage (Figs. 11-12) the clutch spring 162.
Regarding claim 12, wherein the spring latch 164 is operable to release the clutch spring 162 in response to movement of the drive wheel 154.
Regarding claim 13, further comprising a slider (see marked up Fig. 8 above in the rejection of claims 5-6) connected with the clutch spring 162; wherein the clutch spring 162 is provided along an interior of the slider.
Regarding claims 15-20, they encompass the same scope of the invention as to that of claims 1-4, 8-12 except they are drafted in method format instead of apparatus format. The claims 15-20 are therefore rejected for the same reason as set forth above.
It is noted that Examiner believes that claims 1-14 and 15-20 are not patentable distinguish from each other. In other words, if the device/apparatus claim (or method claim) is unpatentable and rejected over the prior art, the evidence or admission may be used in a rejection under method claim (or device/apparatus claim) as well. Therefore, the device claims 1-14 and method claims 15-20 are examined together. However, if Applicant believes that the device and method claims are patentable distinguishable, then the claims would be subject to further Election/Restriction.
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.
Claims 7 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over DIIANNI et al. (US 2017/0128664).
DIIANNI discloses the claimed invention as required in the claims 1-2 above. The clutch spring 162 appears to have an elliptical profile. However, it would have been an obvious matter of design choice to obtain other shape-profile, i.e., square profile or triangular profile, since applicant has not disclosed that the other shapes (square, triangular) solve(s) any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the circular or elliptical profile as shown in DIIANNI.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4, 7-12, 14-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3-4, 8-9, 11-12, 15-16, 18-20 of U.S 10,420,883; claims 1-4, 8-12, 15-20 of US 11,229,741 & claims 1-4, 8-12, 15-20 of US 12,329,928. Although the conflicting claims are not identical, they are not patentably distinct from each other because they are not structurally distinguishable from the claims in the patents.
Prior art US 10,420,883
Regarding claim 1, US’883 discloses a wearable drug delivery device, see line 1 in claim 1 in US’ 883, comprising:
a reservoir configured to store a fluid, see line 1 in claim 1. It is well-known in the art that the reservoir comprising a housing defining an interior chamber;
a drive mechanism for driving the fluid from the reservoir, see line 3 in claim 1, the drive mechanism comprising:
a plunger in the interior chamber of the reservoir, see lines 4-5 in claim 1;
a leadscrew (equivalent to a first elongated member, see in lines 7-8 of claim 1) extending from the plunger; and
a clutch mechanism engaged with the leadscrew (e.g., the clutch mechanism … is configured to grip the second elongated member, line 10-14 in claim 1. It is noted that the second elongated member is coupled to the first elongated member, i.e., the leadscrew. Therefore, the clutch mechanism is engaged with first elongated member, i.e., the leadscrew), wherein the clutch mechanism is configured to allow the leadscrew to pass through the clutch mechanism when disengaged and configured to grip the leadscrew when engaged such that the clutch mechanism rotates to advance the leadscrew and the plunger in the reservoir, see lines 9-16 in claim 1).
Regarding claim 3, see claim 6 in US’883.
Regarding claim 4, see claim 7 in US’883
Regarding claim 8, see lines 14-16 in claim 1 & lines 9-11 in claim 2 in US’883
Regarding claim 9, US’ 883 discloses a wearable drug delivery device, see line 1 in claim 1 comprising:
a reservoir configured to store a liquid drug, see line 1 in claim 1, the reservoir comprising a housing including an outer wall defining an interior chamber. It is well-known in the art that the reservoir includes a housing to protect the drug delivery device;
a drive mechanism for driving the liquid drug from the reservoir, see lines 3-5 in claim 1; the drive mechanism comprising: a plunger in the interior chamber of the reservoir, see lines 4-5 in claim 1;
a leadscrew a leadscrew (equivalent to a first elongated member, see in lines 7-8 of claim 1) extending from the plunger; and
a drive wheel operable with a clutch mechanism to rotate a clutch spring to advance the leadscrew, wherein the clutch mechanism is configured to allow the leadscrew to pass through the clutch spring when in a disengaged position and configured to grip the leadscrew by the clutch spring when in an engaged position such that the drive wheel rotates the clutch spring to advance the leadscrew and the plunger into the reservoir, see lines 9-16 in claim 1.
Regarding claim 11, see claim 6 in US’883
Regarding claim 12, see claim 7 in US’883
Regarding claim 15, US’883 discloses a method comprising, see line 1 in claim 8:
providing a reservoir configured to store a liquid drug, see lines 2-3 in claim 8; the reservoir comprising a housing defining an interior chamber. It is well-known in the art that the reservoir includes a housing with the interior chamber for accommodating the reservoir;
providing a drive mechanism for driving the liquid drug from the reservoir, see lines 4-5 in claim 8; the drive mechanism comprising: a plunger in the interior chamber of the reservoir (e.g., plunger into the fluid reservoir, see line 18 in claim 8);
a leadscrew (equivalent to including a first elongated member & second elongated member, in lines 7-8 in claim 8) extending from the plunger; and
a drive wheel operable with a clutch mechanism, see lines 10-11 in claim 8; wherein the clutch mechanism is coupled to the leadscrew, see lines 10-11 in claim 8; and
rotating a clutch spring of the clutch mechanism to advance the leadscrew, see claim 15 in US’883;
wherein the clutch mechanism is configured to allow the leadscrew (i.e., the second elongated member) to pass through the clutch spring when in a disengaged position and is configured to grip the leadscrew by the clutch spring when in an engaged position, see lines 18-24 in claim 8.
Regarding claim 16, this claim is equivalent to the limitation, i.e., the drive wheel rotates the second threaded member to advance the first threaded member and the plunger into the fluid reservoir, in claim 9 in US’883.
Regarding claim 18, see claims 12-13 in US’883
Regarding claim 19, see claim 7 in US’883
Regarding claim 20, see claim 15 in US’883
Prior art US 11,229,741
Regarding claim 1, US’741 discloses a wearable drug delivery device, comprising:
a reservoir configured to store a fluid, see line 2 in claim 4 & see line 2 in claim 11; it is well-known in the art that the reservoir comprising a housing defining an interior chamber;
a drive mechanism for driving the fluid from the reservoir, see lines 3-4 in claim 4 & lines 3-4 in claim 11; the drive mechanism comprising, see line 4 in claim 4 & line 5 in claim 11:
a plunger in the interior chamber of the reservoir, see line 5 in claim 4 & line 5 in claim 11;
a leadscrew (defined by a first elongated and second elongated member, see lines 6-8 in claim 4; a leadscrew is formed by a drive rod and a nut, in lines 5-7 in claim 11) extending from the plunger, also see liens 7-8 in claim 4 & line 6 in claim 11; and
a clutch mechanism engaged with the leadscrew (e.g. the clutch mechanism including a clutch spring configured to engage the second elongated member, see lines 11-15 in claim 4; Note: in claim 11 says: the clutch mechanism is configured to grip the nut, see lines 12-13. In other words, the clutch mechanism engaged with the leadscrew, because the nut is a part of the leadscrew)
wherein the clutch mechanism is configured to allow the leadscrew to pass through the clutch mechanism when disengaged (e.g., the second elongated member comprises a second thread member; … the clutch mechanism is configured to allow the second thread member to pass through when disengaged, lines 4-9 in claim 6; lines 9-12 in claim 11) and configured to grip the leadscrew when engaged such that the clutch mechanism rotates to advance the leadscrew and the plunger in the reservoir (see lines 10-13 in claim 6 & lines 12-16 in claim 11).
Regarding claim 2, see claims 5 & 13 in US’741. Note: claim 5 states that the clutch spring extends helically around an exterior of the second elongated member which is a part of the leadscrew. In other words, the clutch spring is in direct physical contact with an exterior of the second elongated member which is a part of the leadscrew when the clutch mechanism is engaged with the leadscrew. Claim 13 states that the clutch mechanism includes a clutch spring that grips the tube nut (or the nut). In other words, the clutch spring is in directly physical contact with an exterior of the nut (wherein the nut is a part of the leadscrew) when the clutch mechanism is engaged with the leadscrew.
Regarding claim 3, see claim 14 in US’741
Regarding claim 4, see claim 15 in US’741
Regarding claim 8, lines 8 & 14-16 in claim 11 in US’741
Regarding claims 9-12, these claims are being rejected using the prior art US’741 with same analysis as noted above in claims 1-4.
Regarding claim 15, US’741 discloses a method in claim 1 comprising:
providing a reservoir configured to store a liquid drug, line 3 in claim 1; the reservoir comprising a housing defining an interior chamber (it is well-known in the art that the reservoir including a housing for protection the device);
providing a drive mechanism for driving the liquid drug from the reservoir, lines 6-7 in claim 1, the drive mechanism comprising: a plunger in the interior chamber of the reservoir, line 20 in claim 1;
a leadscrew extending from the plunger (the leadscrew is formed by a first and second elongated member, wherein the first elongated extending from a plunger, in line 10 in claim 1); and
a drive wheel operable with a clutch mechanism, lines 13-15 in claim 1, wherein the clutch mechanism is coupled to the leadscrew, (e.g. the clutch spring is a part of the clutch mechanism, line 14 in claim 1; wherein engaging the second elongated member with the clutch spring, see lines 24-25 in claim 1. It is noted that the second elongated member is a part of the leadscrew); and
rotating a clutch spring of the clutch mechanism to advance the leadscrew,
wherein the clutch mechanism is configured to allow the leadscrew to pass through the clutch spring when in a disengaged position (see claim 17 in US’741) and is configured to grip the leadscrew by the clutch spring when in an engaged position (see lines 24-25 in claim 1 & claim 14 in US’741).
Regarding claim 16, see claim 18 in US’741
Regarding claim 17, see claim 2 in US’741
Regarding claim 18, see claim 2 in US’741
Regarding claim 19, see claims 17-19 in US’741
Regarding claim 20, see claim 19 in US’741
Prior art US 12,329,928
Regarding claim 1, US’928 discloses a wearable drug delivery device, comprising:
a reservoir configured to store a fluid, see line 3 in claim 1; the reservoir comprising a housing defining an interior chamber (it is well-known in the art to include a housing for protecting the device);
a drive mechanism for driving the fluid from the reservoir, see line 1 in claim 1, the drive mechanism comprising:
a plunger in the interior chamber of the reservoir, see line 3 in claim 1;
a leadscrew extending from the plunger, see line 4 in claim 1; and
a clutch mechanism engaged with the leadscrew (e.g., a nut threadably engaged with the leadscrew, in line 5 in claim 1; wherein a clutch mechanism coupled to the drive wheel, in line 7 in claim 1. Therefore, the clutch mechanism engaged with the leadscrew), wherein the clutch mechanism is configured to allow the leadscrew to pass through the clutch mechanism when disengaged (see lines 7-10 in claim 1), and configured to grip the leadscrew when engaged such that the clutch mechanism rotates to advance the leadscrew and the plunger in the reservoir (see lines 10-12 in claim 1).
Regarding claim 2, see claims 2-3 in US’928
Regarding claim 3, see claim 4 in US’928
Regarding claim 4, see claim 5 in US’928
Regarding claim 8, see lines 7-12 in claim 1 in US’928
Regarding claims 9-12, these claims are being rejected using the prior art US’928 with same analysis as noted above in claims 1-4.
Regarding claims 15-20, they encompass the same scope of the invention as to that of claims 1-4, 8-12 except they are drafted in method format instead of apparatus format. The claims 15-20 are therefore rejected for the same reason as set forth above.
Response to Arguments
Applicant's arguments filed 10/31/25 have been fully considered but they are not persuasive.
Applicant argues that DIIANNI fails to disclose or suggest limitations that: a clutch mechanism engaged with the leadscrew, wherein the clutch mechanism is configured to allow the leadscrew to pass through the clutch mechanism when disengaged and configured to grip the leadscrew when engaged such that the clutch mechanism rotates to advance the leadscrew and the plunger in the reservoir, as recited in claims 1, 9 & 15.
In response, as discussed in the rejection in the claims 1, 9 & 15 above, DIIANNI clearly discloses that a clutch mechanism 160 engaged with the leadscrew 152, wherein the clutch mechanism 160 is configured to allow the leadscrew 154 to pass through the clutch mechanism 160 when disengaged (e.g., para [0031], … the clutch mechanism 160 remains disengaged to allow the tube nut 154 to pass into an elongated cylindrical bore along the drive axis of a hub of the drive wheel 156, also see para [008] & Fig. 9) and configured to grip the leadscrew 154 when engaged such that the clutch mechanism 160 rotates to advance the leadscrew and the plunger in the reservoir (e.g. para [0031], … The clutch mechanism 160 may then be engaged (FIGS. 10-12) such that rotation of the drive wheel 156 causes the clutch mechanism 160 to rotate the tube nut 154, which causes the leadscrew 152 to advance the plunger into the reservoir 130 to deliver the fluid from the reservoir 130, also see para [0008]).
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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783