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 .
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 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, 2, 9, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9 of U.S. Patent No. 12,059 550 in view of Srisathapat et al (US 8,460,422).
Regarding claim 1 of the application, claim 8 of the patent, which includes claims 1 and 7, recites, a safety quick-refill compact pump for administering drugs (claim 1, lines 55-56), comprising: a motor-driven electromechanical actuator electronically controlled by a programmable electronic unit and adapted to cause bi-directional axial sliding of an extendable sliding rod which at least partially protrudes from a casing enclosing said actuator and carries at its head a pusher adapted to cause axial sliding of a plunger of a cylindrical reservoir or container containing a liquid drug and equipped, at an end thereof, with a pierceable membrane (claims 1, lines 57-66), said actuator being further externally provided with a first connecting portion of a male-female connecting joint at least partially surrounding said sliding rod (claim 1, lines 66-2); a bell-like shape container provided with a second connecting portion of said male-female connecting joint and firmly associable to the actuator by means of said second, complementary connecting portion, and defining, at its inside, a cylindrical chamber axially extending about the sliding axis of the sliding rod when said actuator and container are associated with each other, and arranged to receive within it said cylindrical reservoir (claim 1, lines 3-13), said container being provided, at a first end thereof, with an opening as inlet for the reservoir and, at its opposite end, with a duct for transporting the drug contained within the reservoir to the outside of the container (claim 1, lines 12-17); and a hollow piercing element oriented towards the inside of the chamber and defining said duct so that, when the reservoir is housed within the chamber and the container is firmly associated with the actuator by means of the male-female joint (claim 1, lines 18-24), said piercing element is in fluid communication with the inside of the reservoir (claim 1, lines 24-26); wherein said piercing element ,said container and said second connecting portion constitute a single inseparable body so that, when the body of the container is firmly associated with the body of the actuator and the reservoir is housed within the container, the piercing element communicates, through the duct ,the volume inside the reservoir and the environment outside the container (claim 1, lines 26-35); wherein an adapter is provided between the actuator and the container (claim 7); and wherein said adapter comprises a hollow body in which connecting portions are provided complementary to the connecting portions provided on the body of the actuator and on the body of the container, respectively (claim 8).
Claim 1 of the application further calls for the adapter thereby allowing mounting the container on a pump provided with a connecting portion which, because of its type and/or size, would not allow to receive the corresponding connecting portion provided in the body of the container. Srisathapat teaches an infusion device having an adapter that allows mounting of the container onto a pump provided with a connecting portion which, because of its shape and/or size, would not allow to receive the corresponding connection portion provided on the body of the container so that the user may be relieved from the burden of carrying a different delivery device to accommodate reservoirs filled with different drug dosages (abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 1 of the patent such that the adapter thereby allowing mounting the container on a pump provided with a connecting portion which, because of its type and/or size, would not allow to receive the corresponding connecting portion provided in the body of the container as taught by Srisathapat so that the same drug delivery device can be used with various sized reservoirs thereby reducing the burden on the user.
Regarding claim 2 of the application, claim 9 of the patent recites, wherein the adapter comprises a pair of screws or threaded pins radially or transversely passing through the body of the adapter and engaging in corresponding seats provided in the body of the actuator (claim 9).
Claim 9 of the application calls for the body of the container to be made of plastics by means of the molding or co-molding technique. This is interpreted to be a product by process claim wherein the scope of the claim is not limited to the recited manufacturing step, but rather to the structure implied by the recited step.
Regarding claim 10 of the application, claim 1 of the patent recites, the piercing element comprises, at an end thereof, a piercing tip and, at its opposite end, a luer lock connector or Enfit and an axial channel for transferring the drug to the outside of the reservoir to a cannula connected to the piercing element by means of said connector (claim 1, lines 36-42).
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 6 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 6 calls for “the container comprises a bell-shaped cylindrical body”. Claim 1, from which claim 6 depends, recites “a bell-like shape container”. It appears that these claims refer to the same container and therefore claim 6 should properly refer back to the ball-like shape container recited in claim 1.
Claim Rejections - 35 USC § 103
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, 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takatsuka et al (US 7,476,216) in view of Srisathapat et al (US 8,460,422).
Regarding claim 1, the preamble “a safety quick-refill compact pump” is interpreted to be an intended use limitation. Takatsuka discloses a pump capable of being refilled and having safety features and therefore meets this intended use. Takatsuka discloses a pump comprising a motor-driven electrical mechanical actuator 100 electronically controlled by a programmable electronic unit 8 (col. 3, line 63 – col. 4, line 3) and adapted to cause bi-directional axial sliding of an extendable sliding rod 21 which at least partially protrudes from a casing 1/2 enclosing said actuator (col. 5, lines 19-21; fig. 3: the sliding rod 21 extends out of the casing when it is in the fully extended position) and carries at its head a pusher adapted to cause axial sliding of a plunger 501 of a cylindrical reservoir 500 containing a liquid drug (col. 7, lines 3-6; fig. 3) and equipped, at an end thereof, with a pierceable membrane (fig. 3: pierced by needle 400), said actuator being further externally provided with a first connection portion 200 of a male-female connecting joint at least partially surrounding the sliding rod (fig. 3; col. 6, lines 26-31),
a bell-like shape container 300 provided with a second connecting portion 45
(fig. 6B) of said male-female connection joining and firmly associable to the actuator by means of said second complementary connection portion (fig. 6B; col. 6, lines 26-31), and defining , at its inside , a cylindrical chamber axially extending about the sliding axis of the sliding rod when said actuator and container are associated with each other (fig. 3) and, arranged to receive within it said cylindrical reservoir (fig. 3), and container being provided, at a first end thereof, with an opening as inlet for the reservoir (fig. 3), and, at its opposite end, with a duct 400 for transporting the drug contained within the reservoir to the outside of the container (fig. 3; col. 9, lines 12-14), and
a hollow piercing element 400 oriented toward the inside of the chamber and provided with a piercing tip oriented towards the inside of the chamber (fig. 5: proximal end of the needle has pierced the closure of the reservoir and therefore forms a piercing tip) and defining said duct (fig. 3) so that, when the reservoir is housed within the chamber and the container is firmly associated with the actuator by means of the male-female joint, said piercing element is in fluid communication with the inside of the reservoir (fig. 3) so that when the body of the container is firmly associated with the body of the actuator and the reservoir is housed within the container, the piercing element communicates through the duct with the volume inside the reservoir and the environment outside the container (fig. 3),
and an adaptor 200 is provided between the actuator and the container (fig. 3), and wherein the adapter comprises a hollow body in which the connecting portion are provided complementary to the connecting portions of the body and the actuator (figs. 3, 6B).
Claim 1 further calls for said piercing element and container and said second connecting portion to constitute a single inseparable body. Takatsuka discloses that these are separable elements. However, the courts have held that the use of a one piece construction instead of multiple pieces would be merely a matter of obvious design choice. See MPEP 2144.01(V)(B). Additionally, as is well known in the medical arts, joints between components provide an opportunity for contaminants to enter the system and therefore are undesirable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective fling date of the claimed invention to modify the piercing element, container, and second connecting portion of Takatsuka to be a single inseparable body because doing so would have been a matter of obvious engineering choice that makes the device easier to sterilize.
Claim 1 further calls for the adapter thereby allowing mounting the container on a pump provided with a connecting portion which, because of its type and/or size, would not allow to receive the corresponding connecting portion provided in the body of the container. Srisathapat teaches an infusion device having an adapter that allows mounting of the container onto a pump provided with a connecting portion which, because of its shape and/or size, would not allow to receive the corresponding connection portion provided on the body of the container so that the user may be relieved from the burden of carrying a different delivery device to accommodate reservoirs filled with different drug dosages (abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Takatsuka such that the adapter thereby allowing mounting the container on a pump provided with a connecting portion which, because of its type and/or size, would not allow to receive the corresponding connecting portion provided in the body of the container as taught by Srisathapat so that the same drug delivery device can be used with various sized reservoirs thereby reducing the burden on the user.
Regarding claim 6, Takatsuka discloses that the container comprises a bell-shaped cylindrical body further provided with a frustoconical portion at the piercing element (fig. 3: distal end connected to needle), wherein said portion acts as an abutment surface, in the chamber, for the reservoir 500 containing the drug to be injected (fig. 3).
Regarding claim 7, the limitation “made as a single piece” is interpreted to be a product by process limitation. The scope of such limitations is not limited to the recited steps, but rather the structure implied by the recited step. See MPEP 2113. In this case, the structure implied by the steps is a single inseparable body. This is the structure taught with regard to claim 1 above.
Regarding claim 8, the limitation “made as a single piece” and “co-molded” are interpreted to be a product by process limitation. The scope of such limitations is not limited to the recited steps, but rather the structure implied by the recited step. See MPEP 2113. In this case, the structure implied by the steps is a single inseparable body. This is the structure taught with regard to claim 1 above.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takatsuka in view of Srisathapat as applied to claim 1 above, and further in view of Lazzaro et al (US 7,192,416).
Claim 9 calls for the body of the container to be made of plastics. Takatsuka is silent as to the material of the container. Lazzaro teaches an injector including a container 26 formed form a plastic material that allows the reservoir inside to be viewed during injection (col. 5, line 66 – col. 6, line 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container of Takatsuka to be formed from a plastic material as taught by Lazzaro so that the reservoir inside could be viewed during use.
Claim 9 further calls for the body of the container to be made by means of molding or co-molding. This limitation is interpreted to be a product by process limitation. The scope of such limitations is not limited to the recited steps, but rather the structure implied by the recited step. See MPEP 2113. In this case, the structure implied by the steps is a single inseparable body. This is the structure taught with regard to claim 1 above.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takatsuka in view of Srisathapat as applied to claim 1 above, and further in view of Hodosh (US 6,159,161).
Regarding claim 11, Takatsuka discloses that the actuator is housed within a housing but fails to disclose the material of the housing. Hodosh teaches an injector including a housing made of plastic (col. 3, lines 35-36). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the housing of Takatsuka to be formed from plastic as taught by Hodosh because plastic is rigid, sterilizable, and easily formed into the desired shape.
Claim 11 further calls for the housing to be substantially parallelepiped shaped. Takatsuka fails to disclose this shape. However, it would have been a matter of obvious design choice to shape the housing, particularly the lower portion housing the actuator, in a parallelepiped shape. Applicant has not described any benefit arising from this shape. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the housing of Takatsuka to have a parallelepiped shape because doing so would have been a matter of obvious design choice.
Allowable Subject Matter
Claims 2-5, 10, 12-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 10 calls for the piercing element to comprise a piecing tip at one end and a luer lock or enfit at the opposite end. This type of connector is known in the art but cannot be found in conjunction with the elements of the invention, substantially as claimed. The device of Takatsuka requires a piercing member at both ends to operate as desired and therefore, there is no motivation to modify this element.
The adapter described in claim 2 could not be found in combination with the features of the invention, substantially as claimed.
Claims 11-13 including limitations similar to claim 10 discussed above and therefore are allowable for similar reasons.
Claims 3-5 are allowable at least for their dependence on claim 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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