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 Objections
Claim 10 is objected to because of the following informalities: Claim 10 should be amended to recite: “…in response to movement of the plunger.”. 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.
Claims 7 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 7, line 2 ends with “…and the plunger….” From this language, it is unclear how the plunger was intended to be further limited. The claim will be interpreted to only require the first limitation wherein the plunger and the cylindrical housing are of the same shape until further clarification is made.
Regarding claim 12, the claim sets forth “the base washer” and there is insufficient antecedent basis for this limitation as it is not set forth in claim 1. In addition, claim 12 sets forth “the elastic member”, however, it is unclear whether or not this is the “elastic sleeve” set forth in claim 1. For the purposes of examination, it will be considered as the elastic sleeve and the base washer will be considered as a surface of the elastic sleeve which secures the plunger.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claim(s) 1-8, 10-12, and 14-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jolly (US 4,122,983).
Regarding claim 1, Jolly discloses a drug delivery system (it’s fully capable of delivering any fluid which would include drugs or the like) comprising: a reservoir (10) having a housing (portion of barrel 9 for retaining medicament and the plunger assembly therein); a plunger (12) configured to fit within the housing (Figure 1); an elastic sleeve (13; it’s made of plastic as per Col. 8, lines 61-68, and therefore has some elasticity, as no claimed value or physical function which requires a specific function of elasticity is explicitly claimed) within the housing and coupled to a surface of the plunger (it can be seen in Figure 2, that the connection of 11 and 13 locates the plunger within a recess in the elastic sleeve and it is therefore engaging a surface thereof), wherein the elastic sleeve is leakproof (the sleeve prevents liquid from passing distal to the sleeve as it abuts the barrel wall to form a fluid-tight seal in the barrel; e.g., Col. 9, lines 12-38 disclose forming the seal by connecting 11 and 13 to force the edge of sleeve 12 to abut the barrel wall; this connection forces the plunger outward and therefore forms a leakproof seal proximal of the plunger and therefore the elastic sleeve as claimed); a lead screw (14) passing through a center of the elastic sleeve and a center of the plunger (Figure 2, it passes through all components of the plunger); and a reservoir cap (6, 7) coupled to the housing (Figures 1-2).
Regarding claim 2, Jolly further discloses wherein the plunger (12) further comprises a fluid stop perimeter (outer edge of sleeve 12 which abuts the inner surface of the barrel to form the fluid-tight plunger assembly) having a leakproof sealing component, wherein the leakproof sealing component engages an internal wall of the cylindrical housing (the surface of the plunger which contacts the barrel is the leakproof sealing component forming the fluid stop perimeter).
Regarding claim 3, Jolly further discloses wherein rotation of the lead screw (14) is operable to move the plunger within the cylindrical housing (Col. 8, lines 39-48).
Regarding claim 4, Jolly further discloses wherein the reservoir cap (6,7) is stationary (it doesn’t move after being installed to the front of the device).
Regarding claim 5, Jolly further discloses wherein the reservoir cap includes a sealed port (Figure 1, opening 5 is sealed via 33) coupled through the reservoir cap (Figure 1)that enables a void between the plunger and the reservoir cap to be filled with a liquid drug (the valve seat 33 can be moved to open or close orifice 5 to allow for dispensing or filling of the chamber as desired via distal or proximal movement of the plunger assembly).
Regarding claim 6, Jolly further discloses wherein the lead screw has a length greater than the cylindrical housing (it can be seen in Figure 1 that the lead screw 14 extends beyond the terminal proximal end of the chamber as well as extending distal of the terminal distal edge of the reservoir chamber making up the housing).
Regarding claim 7, Jolly further discloses wherein the plunger and the cylindrical housing are of the same shape (e.g., Figure 5, they’re both cylindrical).
Regarding claim 8, Jolly further discloses wherein the cylindrical housing is a rigid structure (Col. 6, lines 47-49 disclose the barrel as being formed from a diaphanous material; the barrel is rigid enough to absorb the force of expelling a viscous fluid and therefore will have some rigidity as claimed; known diaphanous materials for similar devices include glass and plastics).
Regarding claim 10, Jolly further discloses an exit port (orifice 5) operable to enable the liquid drug to be expelled from the elastic sleeve in response to movement of the plunger (Col. 9, lines 39-56).
Regarding claim 11, Jolly further discloses wherein movement of the plunger is in response to rotation of the lead screw (the threaded rod 14 is connected to piston actuating knob 19 to advance the plunger as claimed; Col. 9, lines 40-45).
Regarding claim 12, Jolly further discloses wherein the elastic member (13) engages the plunger between two surfaces and extends radially through a center opening of the plunger (12) and is sealed to a surface of the plunger facing the elastic member (it can be seen that the plunger is secured within a recess between the proximal and distal ends of the elastic member 13 which is considered to meet the engagement of the elements as set forth).
Regarding claim 14, Jolly further discloses wherein the reservoir (within barrel 9) has an initial fill position when the plunger is located at a location nearest to the reservoir cap within the cylindrical housing; and the reservoir has a filled position when the plunger is located at a location farthest away from the reservoir cap within the cylindrical housing (for this claim, the initial fill position can be considered as when the plunger is at its distal-most point and wherein rearward movement will allow some fluid to flow back through orifice 5 to fill the barrel; it is fully capable of filling to some extent; the filled position is when the piston is in its most proximal position when filled so as to dispense the maximum volume of fluid from the reservoir).
Regarding claim 15, Jolly further discloses wherein the reservoir cap (6,7) is coupled to an end of the cylindrical housing by bonding, welding, friction, snaps, or threads (Figure 1; Col. 8, lines 1-4).
Allowable Subject Matter
Claims 9 and 13 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.
Claims 16-20 are allowed.
The following is an examiner’s statement of reasons for allowance: the prior art made of record and relied upon does not anticipate or render obvious, alone or in combination, the features of the cited claims. The closest prior art is considered to be Jolly which teaches the known use of a lead-screw based plunger drive with elastic components separate from the plunger. Claim 9 requires the elastic sleeve to expand and contract to either be filled or emptied of fluid during movement of the plunger assembly which cannot be reasonably taught by Jolly as the seal does not expand or contract at all during use. Similarly, claim 13 requires the elastic sleeve to expand and contract as the plunger is moved along the body of the device. Jolly cannot be considered to teach such a feature as it is a static plastic coupling for retaining the plunger on the lead screw via a drive nut which provides the outward force to fluidly seal the chamber. There would be no motivation to make the elastic sleeve of Jolly expand or contract as the plunger moved along the length of the barrel or to fill with fluid during use. Regarding claim 16, the elastic sleeve is required to surround the lead screw and to couple to a surface of the plunger as well as to a second end of the housing. There would be no reasonable motivation for one of ordinary skill in the art to make such a coupling in the device of Jolly. This coupling allows the lead screw to maintain its non-wetted function throughout use of the device which is not known from Jolly or from other relevant prior art. For at least these reasons, along with the totality of structure claimed, render claim 16 as patentable over the prior art made of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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