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 .
This is the first office action on the merits in response to the above identified patent application filed on 10/06/2023. Claims 1-29 are pending and being examined.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9, line 6: “and enables…” is believed to be in error for --and to enable…-- (to maintain parallel verb form with “configured to restrict”)
Appropriate correction is required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 21 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 13 of prior U.S. Patent No. 11,872,379. This is a statutory double patenting rejection.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 5-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,872,379. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application (18/285,956) claims use specific claim language that are obvious in terms of interchangeability with the claim language found in the patent (11,872,379) claims.
For claim 1:
The following comparison between the present application claims and the patent claims highlights (see underlined features in the patent claims) the differences in claim language between the two.
Patent (11,872,379) claim 1
Present application (18/285,956) claim 1
A drug delivery device, comprising:
a housing configured to connect to a dispensing unit, the dispensing unit comprising a compartment containing a fluid;
a piston rod configured to move in a proximal direction for ejecting the fluid; and
a dosing mechanism,
the dosing mechanism comprising an actuation member to be actuated by a user to advance the piston rod and to thereby eject a set dose out of the compartment and
a conversion mechanism configured to convert movement of the actuation member to movement of the piston rod,
the conversion mechanism comprising a dose selector member rotationally fixed to the housing and axially movable with respect to the housing, and a dosing member rotationally movable with respect to the dose selector member,
the dose selector member disposed between the actuation member and the dosing member, the drug delivery device comprising a friction reduction mechanism disposed between the dose selector member and the dosing member to reduce friction between the dose selector member and the dosing member upon relative rotational movement with respect to each other.
A drug delivery device, comprising:
a housing, configured to connect to a dispensing unit, the dispensing unit comprising a compartment containing a fluid;
a piston rod configured to move in a proximal direction for ejecting the fluid; and
a dosing mechanism,
the dosing mechanism comprising an actuation member to be actuated by a user to advance the piston rod and to thereby eject a set dose out of the compartment, and
a conversion mechanism configured to convert movement of the actuation member to a movement of the piston rod,
the conversion mechanism comprising a dosing member and an intermediate part disposed between the actuation member and the dosing member,
the intermediate part rotationally fixed to the housing and axially movable with respect to the housing during dose delivery,
the dosing member rotationally movable with respect to the intermediate part during dose delivery, and
a friction reduction mechanism disposed between the intermediate part and the dosing member to reduce friction between the intermediate part and the dosing member upon relative rotational movement with respect to each other.
Thus, it is apparent that the present application claim 1 uses the term “intermediate part” to recite essentially the same structural element as the term “dose selector member” of patent claim 1. Furthermore, since the present application claim limitation “intermediate part” would be anticipated by the patent claim limitation “dose selector member”, then present application claim 1 is obvious over patent claim 1.
For dependent claim 5, the recited limitations are contained in patent claim 2.
For dependent claims 6-7, the recited limitations are contained in patent claim 3.
For dependent claims 8-9, the recited limitations are contained in patent claim 4.
For dependent claims 10-11, the recited limitations are contained in patent claim 5.
For dependent claims 12-13, the recited limitations are contained in patent claim 6.
For dependent claims 14-15, the recited limitations are contained in patent claim 7.
For dependent claim 16, the recited limitations are contained in patent claim 8.
For dependent claim 17, the recited limitations are contained in patent claim 9.
For dependent claims 18-19, the recited limitations are contained in patent claim 10.
For dependent claim 20, the recited limitations are contained in patent claim 11.
Claims 22-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-17 of U.S. Patent No. 11,872,379. Although the claims at issue are not identical, they are not patentably distinct from each other because the present application (18/285,956) claims are broader in at least one aspect and do not recite additional features claimed in the patent (11,872,379) claims.
Regarding dependent claim 22, the claim contains all the limitations of patent claim 14, except for “the bearing element is a component separate from the nut or the driver”.
Regarding dependent claim 23, the claim contains all the limitations of patent claim 15, except for “the bearing element is a component separate from the nut or the driver” (from patent claim 14), “the bearing element is axially restrained between the nut and the driver”, and “the nut is connected to the driver by a connection configured to restrict relative movement between the nut and the driver in the axial direction”.
Regarding dependent claim 24, the claim contains all the limitations of patent claim 15, except for “the bearing element is a component separate from the nut or the driver” (from patent claim 14), “the bearing element is configured to rotate with respect to the nut or the driver”, and “the nut is connected to the driver by a connection configured to restrict relative movement between the nut and the driver in the axial direction”.
Regarding dependent claim 25, the claim contains all the limitations of patent claim 15, except for “the bearing element is a component separate from the nut or the driver” (from patent claim 14) and “the bearing element is configured to rotate with respect to the nut or the driver”.
Regarding dependent claim 26, the claim contains all the limitations of patent claim 16, except for “a proximal front surface of the driver rests against the friction reduction mechanism, or the friction reduction mechanism is provided at a proximal end of the nut, and the friction reduction mechanism rests against a proximal protrusion of the nut”.
Regarding dependent claim 27, the claim contains all the limitations of patent claim 16, except for “the friction reduction mechanism is provided at a proximal end of the driver, a proximal front surface of the driver rests against the friction reduction mechanism” and “the friction reduction mechanism rests against a proximal protrusion of the nut”.
Regarding dependent claim 28, the claim contains all the limitations of patent claim 17, except for “the connection provided at a distal end of the driver, and the connection is a snap fit connector”.
Regarding dependent claim 29, the claim contains all the limitations of patent claim 17, except for “the driver is connected to the nut via a connection configured to limit axial movement between the driver and the nut”.
Thus, it is apparent, for the broadening aspect, that the patent claims 14-17 includes features that are not in respective present application claims 22-29. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent of an application containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since the present application claims 22-29 are anticipated by the respective patent claims 14-17, with respect to the broadening aspect, then present application claims 22-29 are obvious over respective patent claims 14-17 with respect to the broadening aspect.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: “dosing mechanism”, “actuation member”, “conversion mechanism”, “dosing member”, and “friction reduction mechanism”
Claim 5: “bearing element”
Claim 16: “a driver”
Claim 17: “further friction reduction mechanism”
Claim 21: “dosing mechanism”, “actuation member”, “conversion mechanism”, “driver”, and “friction reduction mechanism”
Claim 22: “bearing element”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 29 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 29 recites the limitation "the connection" in line 3. 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.
Claims 1-8, 10-18, and 20-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kohlbrenner (US 2009/0247960 A1).
Regarding claim 1, Kohlbrenner teaches (Figs. 2-3) a drug delivery device, comprising:
a housing (comprising 10, 20, and 150), configured to connect to a dispensing unit (40 – Fig. 2), the dispensing unit (40) comprising a compartment (40) containing a fluid (¶ [0065], ll. 8-9);
a piston rod (90) configured to move in a proximal direction (to the left) for ejecting the fluid; and
a dosing mechanism (Fig. 3),
the dosing mechanism comprising an actuation member (80) to be actuated by a user to advance the piston rod (90) and to thereby eject a set dose out of the compartment (40), and
a conversion mechanism configured to convert movement of the actuation member (80) to a movement of the piston rod (90),
the conversion mechanism comprising a dosing member (comprising 230 and 270 – Fig. 3) and an intermediate part (82 – Fig. 3) disposed between the actuation member (80) and the dosing member (230, 270),
the intermediate part (82) rotationally fixed to the housing (10, 20, 150) and axially movable with respect to the housing (10, 20, 150) during dose delivery (82 moves as user pushes button 80 – see ¶ [0068], ll. 3-4),
the dosing member (230, 270) rotationally movable (¶ [0101], ll. 21-22 and ¶ [0122], l. 9) with respect to the intermediate part (82) during dose delivery, and
a friction reduction mechanism (bearing ring 83 – Fig. 3) disposed between the intermediate (82) part and the dosing member (230, 270) to reduce friction (inherent function of a bearing ring) between the intermediate part (82) and the dosing member (230, 270) upon relative rotational movement with respect to each other.
Regarding claim 2, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Fig. 3) the dosing member (230, 270) is configured to axially move together with the intermediate part (82) during dose delivery with respect to the housing (10, 20, 150) – (¶ [0114], ll. 3-6: “On pressing in of the push button 80, the coupling disc 270 and the coupling shaft 230, which is securely connected therewith, are displaced in the distal direction”. Note that pressing button 80 also axially moves intermediate part 82).
Regarding claim 3, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Fig. 3) the intermediate part (82) is configured to axially push onto the dosing member (230, 270) via the friction reduction mechanism (83) – (as discussed in ¶ [0101], ll. 7-10 and ¶ [0114], ll. 3-6).
Regarding claim 4, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Fig. 3) the intermediate part (82) an intermediate member that is separate from the actuation member (80) – (Fig. 3 shows 80 and 82 as separate parts), and
the intermediate part (82) is an extension member rotationally fixed and axially movable with respect to the housing (10, 20, 150) during both dose setting and dose delivery (82 is a spring which only moves axially when compressed, but does not rotate).
Regarding claim 5, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Fig. 3) the friction reduction mechanism (83) comprises a bearing element (¶ [0101], l. 10: “bearing ring 83”),
the bearing element (83) is an individual component separate from the intermediate part (82) or the dosing member (230, 270) – (Fig. 3 shows 83 as a separate part from 82 or 230, 270).
Regarding claim 6, Kohlbrenner teaches the invention as claimed and as discussed above for claim 5, and Kohlbrenner further teaches (Fig. 3) the bearing element (83) is configured to rotate with respect to the intermediate part (82) or the dosing member (230, 270) – (¶ [0101], ll. 21-22: “the coupling disc 270 rotates with respect to the bearing ring 83”. Thus, this is equivalent to bearing ring 83 rotating with respect to coupling disc 270).
Regarding claim 7, Kohlbrenner teaches the invention as claimed and as discussed above for claim 5, and Kohlbrenner further teaches (Fig. 3) the bearing element (83) is axially restrained between the intermediate part (82) and the dosing member (230, 270) – (as shown in Fig. 3).
Regarding claim 8, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Fig. 3) the intermediate part (82) is axially restrained with respect to the dosing member (230, 270) – (as shown in Fig. 3), and
the friction reduction mechanism (83) is sandwiched between the dosing member (230, 270) and the intermediate part (82) – (as shown in Fig. 3).
Regarding claim 10, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Fig. 3) the friction reduction mechanism (83) is disposed at a distal end (right end) of the dosing member (230, 270) – (as shown in Fig. 3), or
the intermediate part (82) comprises a contact surface (see annotated Fig. 3 below) which is in contact with the friction reduction mechanism (83).
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Regarding claim 11, Kohlbrenner teaches the invention as claimed and as discussed above for claim 10, and Kohlbrenner further teaches (Fig. 3) the contact surface is disposed at an inner surface (as shown in annotated Fig. 3 above) of the intermediate part (82).
Regarding claim 12, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Fig. 3) the dosing member (230, 270) is partially located inside the intermediate part (82) – (Fig. 3 shows proximal end 233 of dosing member 230 being located inside intermediate part 82).
Regarding claim 13, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Fig. 3) the dosing member (for this claim only, the dosing member shall comprise of 70, 210, 230, and 270 – see *Note below) is coupled to the housing (10, 20, 150) via a threaded connection (shown by threads 157, which are formed between 70 and 150 – see ¶ [0095], ll. 1-3) configured to translate rotation of the dosing member (70, 210, 230, 270) into axial movement of the dosing member (70, 210, 230, 270) with respect to the housing (in this case, it is with respect to housing 150. Per ¶ [0122], ll. 11-14, “The display drum 70, threadably guided on the mechanism holder 150, is additionally displaced axially in the proximal direction, and therefore performs as a whole a screw motion in the proximal direction”).
*Note: Per ¶ [0090], ll. 15-18, “the coupling shaft 230 and the transmission sleeve 210 are connected with each other so as to be locked against relative rotation and secured against displacement” – therefore, 210 is an extension of 230.
Per ¶ [0095], ll. 11-14, “a rotation of the transmission sleeve 210 leads to a combined rotation and longitudinal displacement of the display drum 70” – therefore, 70 is driven by 210, which is an extension of 230.
Overall, elements 70, 210, 230, and 270 are all drivingly connected to one another and may collectively be considered “the dosing member”.
Regarding claim 14, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Fig. 3) the actuation member (80) is axially movable with respect to the intermediate part (82) and configured to move towards the intermediate part (82) when actuated by a user (as discussed in ¶ [0101], ll. 7-10).
Regarding claim 15, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Fig. 3) the actuation member (80) is rotationally movable with respect to the intermediate part (82) – (¶ [0101], l. 3: “The push button 80 is rotatable”).
Regarding claim 16, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Figs. 3-4) the conversion mechanism comprises a nut (110) and a driver (120),
the nut (110) is threadedly engaged (via cams 91 – see also ¶ [0072]) with the piston rod (90 – Fig. 3) and rotationally fixed to the housing (10, 20, 150) during delivery of the set dose (¶ [0086] discusses that “The thrust sleeve 90 is locked against relative rotation with respect to the guide sleeve 110” and “the thrust sleeve 90 is advanced axially on a rotation of the external threaded rod 180”. Therefore, both 90 and 110 do not rotate with respect to the housing), and
the driver (120) is rotatable (¶ [0086], ll. 19-21: “a rotary movement of the coupling sleeve 120 is converted into an axial displacement of the thrust sleeve 90”) and axially movable with respect to the housing (10, 20, 150) during dose delivery and configured to axially advance the nut (110) during dose delivery (¶ [0081], ll. 18-20: “the unit of guide sleeve 110, bearing holder 130 and coupling sleeve 120 is moved in the proximal direction”).
Regarding claim 17, Kohlbrenner teaches the invention as claimed and as discussed above for claim 16, and Kohlbrenner further teaches (Fig. 4) the conversion mechanism comprises a further friction reduction mechanism (ball bearing ring 140 on the left), wherein the further friction reduction mechanism (140) is disposed between the nut (110) and the driver (120) to reduce friction (inherent function of a ball bearing ring) therebetween during dose delivery.
Regarding claim 18, Kohlbrenner teaches the invention as claimed and as discussed above for claim 16, and Kohlbrenner further teaches (Fig. 4) the driver (120) is connected to the nut (110) via a connection (bearing holder 130) which limits axial movement between the driver (120) and the nut (110) – (as shown in Fig. 4, 130 locks 120 in place relative to 110. Additionally, ¶ [0081], ll. 18-20 teaches “the unit of guide sleeve 110, bearing holder 130 and coupling sleeve 120 is moved in the proximal direction”).
Regarding claim 20, Kohlbrenner teaches the invention as claimed and as discussed above for claim 1, and Kohlbrenner further teaches (Fig. 10) the driver is rotationally fixed with respect to the dosing member, or
the driver (for this claim only, the driver shall comprise of 120 and 220 – see *Note below) is coupled to the housing (for this claim only, in addition to 10, 20, and 150, the housing shall also comprise of 210) via a threaded connection (shown by threads 221 and 222, which are formed between 210 and 220 – see ¶ [0088], ll. 9-11) configured to translate rotational movement of the driver (120, 220) into axial movement (¶ [0088], ll. 18-21: “A rotation of the coupling sleeve 120 with respect to the transmission sleeve 210 therefore leads to a rotation and axial displacement of the dose limiting ring 220”).
*Note: Per ¶ [0088], ll. 11-17, “In the interior of the dose limiting ring 220, longitudinal grooves 222 are present which can be seen in FIGS. 12A and 12B, into which the longitudinal ribs 122 of the coupling sleeve 120 (cf. FIG. 6) engage. Thereby, the dose limiting ring 220 is movable on the one hand so as to be secure with regard to rotation in the axial direction on the coupling sleeve” – therefore, 220 is rotatably driven by 120.
Overall, elements 120 and 220 are connected to each other and may collectively be considered “the driver”.
Regarding claim 21, Kohlbrenner teaches (Figs. 2-4) a drug delivery device, comprising:
a housing (comprising 10, 20, and 150), configured to connect to a dispensing unit (40 – Fig. 2) comprising a compartment (40) containing a fluid (¶ [0065], ll. 8-9);
a piston rod (90 – Figs. 2-3) configured to move in a proximal direction (to the left) to eject the fluid; and
a dosing mechanism (Fig. 3),
the dosing mechanism comprising an actuation member (80 – Figs. 2-3) to be actuated by a user to advance the piston rod (90) and to thereby eject a set dose out of the compartment (40) and a conversion mechanism configured to convert movement of the actuation member (80) to a movement of the piston rod (90),
the conversion mechanism comprising a nut (110 – Figs. 3-4) and a driver (120 – Figs. 3-4),
the nut (110) is threadedly engaged (via cams 91 – see also ¶ [0072]) with the piston rod (90 – Fig. 3) and rotationally fixed to the housing (10, 20, 150) during delivery of the set dose (¶ [0086] discusses that “The thrust sleeve 90 is locked against relative rotation with respect to the guide sleeve 110” and “the thrust sleeve 90 is advanced axially on a rotation of the external threaded rod 180”. Therefore, both 90 and 110 do not rotate with respect to the housing),
the driver (120) is rotatable (¶ [0086], ll. 19-21: “a rotary movement of the coupling sleeve 120 is converted into an axial displacement of the thrust sleeve 90”) and axially movable with respect to the housing (10, 20, 150) during dose delivery and configured to axially advance the nut (110) during dose delivery (¶ [0081], ll. 18-20: “the unit of guide sleeve 110, bearing holder 130 and coupling sleeve 120 is moved in the proximal direction”), and
the conversion mechanism comprises a friction reduction mechanism (ball bearing ring 140 on the left – Fig. 4),
the further friction reduction mechanism (140) disposed between the nut (110) and the driver (120) – (as shown in Fig. 4) to reduce friction (inherent function of a ball bearing ring) therebetween during dose delivery.
Regarding claim 22, Kohlbrenner teaches the invention as claimed and as discussed above for claim 21, and Kohlbrenner further teaches (Fig. 4) the friction reduction mechanism (140) comprises a bearing element (¶ [0075], ll. 3-4: “a first ball bearing ring 140”).
Regarding claim 23, Kohlbrenner teaches the invention as claimed and as discussed above for claim 22, and Kohlbrenner further teaches (Fig. 4) the bearing element (140) is configured to rotate with respect to the nut (110) or the driver (120) – (per ¶ [0086], ll. 19-21, driver 120 is rotatably relative to bearing 140, which is fixed. Thus, this is equivalent to bearing ring 140 rotating with respect to driver 120).
Regarding claim 24, Kohlbrenner teaches the invention as claimed and as discussed above for claim 22, and Kohlbrenner further teaches (Fig. 4) the bearing element (140) is axially restrained between the nut (110) and the driver (120) – (as shown in Fig. 4).
Regarding claim 25, Kohlbrenner teaches the invention as claimed and as discussed above for claim 24, and Kohlbrenner further teaches (Fig. 4) the nut (110) is connected to the driver (120) by a connection (bearing holder 130) configured to restrict relative movement between the nut (110) and the driver (120) in an axial direction – (as shown in Fig. 4, 130 locks 120 in place relative to 110. Additionally, ¶ [0081], ll. 18-20 teaches “the unit of guide sleeve 110, bearing holder 130 and coupling sleeve 120 is moved in the proximal direction”).
Regarding claim 26, Kohlbrenner teaches the invention as claimed and as discussed above for claim 21, and Kohlbrenner further teaches (Fig. 4) the friction reduction mechanism (140) is disposed at a proximal end (left end) of the driver (120) – (as shown in Fig. 4).
Regarding claim 27, Kohlbrenner teaches the invention as claimed and as discussed above for claim 21, and Kohlbrenner further teaches (Fig. 4) the friction reduction mechanism (140) is disposed in a proximal end region (left end region) of the nut (110) – (as shown in Fig. 4).
Regarding claim 28, Kohlbrenner teaches the invention as claimed and as discussed above for claim 21, and Kohlbrenner further teaches (Fig. 4) the driver (120) is connected to the nut (110) via a connection (bearing holder 130) configured to limit axial movement between the driver (120) and the nut (110) – (as shown in Fig. 4, 130 locks 120 in place relative to 110. Additionally, ¶ [0081], ll. 18-20 teaches “the unit of guide sleeve 110, bearing holder 130 and coupling sleeve 120 is moved in the proximal direction”).
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.
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kohlbrenner (US 2009/0247960 A1), in view of Grimoldby (US 2018/0250471 A1).
Regarding claim 9, Kohlbrenner teaches the invention as claimed and as discussed above for claim 8, except for the intermediate part is connected to the dosing member by a connector configured to restrict relative movement between the intermediate part and the dosing member in an axial direction and enables relative rotational movement between the intermediate part and the dosing member.
Grimoldby teaches (Figs. 10, 13, 27, and 30) a similar drug delivery device (100 – Fig. 30) comprising a conversion mechanism comprising a dosing member (380 – Figs. 13, 27, and 30) and an intermediate part (drive spring 330 – Fig. 30); and further teaches:
the intermediate part (330) is connected to the dosing member (380) by a connector (spring seat 310 – Figs. 10 and 27) configured to restrict relative movement between the intermediate part (330) and the dosing member (380) in an axial direction (in Fig. 27, connector 310 makes contact with dosing member 380; thereby restricting relative movement between 330 and 380) and enables relative rotational movement between the intermediate part (330) and the dosing member (380) – (in Fig. 27, 330 and 380 are free to rotate with respect to each other).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kohlbrenner by including a connector (in this case, a spring seat) for connecting the intermediate part to the dosing member such that the connector is configured to restrict relative movement between the intermediate part and the dosing member in an axial direction and to enable relative rotational movement between the intermediate part and the dosing member, in order to provide a spring seat, which helps to retain the intermediate part (spring), as taught by Grimoldby (¶ [0159], ll. 6-8).
Claims 19 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Kohlbrenner (US 2009/0247960 A1), in view of Chanoch (US 5,582,598).
Regarding claim 19, Kohlbrenner teaches the invention as claimed and as discussed above for claim 18, except for the connection is a snap connector.
Chanoch teaches (Figs. 1-2) a similar drug delivery device (10 – Fig. 1) comprising a conversion mechanism comprising a nut (34 – Fig. 2) and a driver (50 – Fig. 2);
wherein the driver (50) is connected to the nut (34) via a connection (40 – Fig. 2) which limits axial movement between the driver (50) and the nut (34), wherein the connection is a snap connector (col. 4, ll. 64-67: “Driver 50 is slidably inserted into housing 22 of pen body assembly 12 such that distal end 54 of driver 50 is snap fit over the enlarged ends of resilient fingers 40 at proximal end 36 of nut 34”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kohlbrenner by additionally including a snap connector between the driver and the nut, in order to prevent axial movement between the nut and the driver, but permit free relative rotational movement within the housing, as taught by Chanoch (col. 4, l. 67 – col. 5, l. 2).
Regarding claim 29, Kohlbrenner teaches the invention as claimed and as discussed above for claim 21, except for the connection is a snap fit connector.
Chanoch teaches (Figs. 1-2) a similar drug delivery device (10 – Fig. 1) comprising a conversion mechanism comprising a nut (34 – Fig. 2) and a driver (50 – Fig. 2);
wherein the driver (50) is connected to the nut (34) via a connection (40 – Fig. 2) which limits axial movement between the driver (50) and the nut (34), wherein the connection is a snap fit connector (col. 4, ll. 64-67: “Driver 50 is slidably inserted into housing 22 of pen body assembly 12 such that distal end 54 of driver 50 is snap fit over the enlarged ends of resilient fingers 40 at proximal end 36 of nut 34”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kohlbrenner by including a snap fit connector between the driver and the nut, in order to prevent axial movement between the nut and the driver, but permit free relative rotational movement within the housing, as taught by Chanoch (col. 4, l. 67 – col. 5, l. 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see attached form PTO-892 “Notice of References Cited”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY NG whose telephone number is (571)272-2318. The examiner can normally be reached M-F 9:30 AM - 6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at 571-272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY NG/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
Prosecution Insights