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 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.
In claims 2 and 12, “means for limiting an amount that the actuator lever can move” is an abutment (which the actuator leave may contact and not pass).
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 5 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.
In claim 5, “the pair of pins” lacks antecedent basis. The claim is treated as if it depends on claim 3.
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, 2, 4, 10-12, 15 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garribotto et al (US 2004/0153032).
Regarding claim 1, Garribotto discloses an ambulatory infusion pump, comprising: a reservoir 30 configured to contain a medicament (¶40); a syringe assembly including a plunger (fig 40 configured to dispense medicament from the reservoir (¶40); a ratchet wheel 610 configured to rotate the syringe assembly (¶95); a pawl 602 configured to engage with the ratchet wheel (fig 26); an actuator lever 606 mechanically linked to the pawl (fig 26, ¶98); and a shape memory wire 646 mechanically linked with the actuator lever (fig 27), wherein actuation of the shape memory wire shortens the shape memory wire (¶98) to cause the shape memory wire to move the actuator lever such that the actuator lever moves the pawl to rotate the ratchet wheel and syringe assembly to cause the plunger to dispense a predetermined amount of medicament from the reservoir (¶s 94-98).
Regarding claim 2, further comprising means 648 for limiting an amount that the actuator lever can move (fig 27, either the resiliency of the spring or if the spring is fully compressed, it becomes a mechanical stop).
Regarding claim 4, wherein the amount that the actuator lever can move corresponds to how much the ratchet wheel is rotated (¶98).
Regarding claim 10, wherein the shape memory wire is configured as a spring (contracts and expands depending on if electricity is being applied).
Regarding claim 11, Garriboto discloses an ambulatory infusion pump, comprising: a reservoir 30 configured to contain a medicament (¶40); a syringe assembly including a plunger (fig 4) configured to dispense medicament from the reservoir (¶40); a ratchet wheel 610 and pawl mechanism 602 mechanically linked to the syringe assembly (¶95); and a shape memory wire 646 mechanically linked with the ratchet and pawl mechanism (via lever 606, fig 26; ¶98), wherein actuation of the shape memory wire shortens the shape memory wire (¶98) to cause the shape memory wire to move the pawl to rotate the ratchet wheel and syringe assembly to cause the plunger to dispense a predetermined amount of medicament from the reservoir (¶s 94-98).
Regarding claim 12, further comprising means 648 for limiting an amount that the pawl can move (fig 27, either the resiliency of the spring or if the spring is fully compressed, it becomes a mechanical stop).
Regarding claim 15, further comprising an actuator lever 606 mechanically linked to the pawl (fig 26, ¶98).
Regarding claim 20, wherein the shape memory wire is configured as a spring (contracts and expands depending on if electricity is being applied).
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.
Claim(s) 3, 5-8, 13, 14 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garribotto et al (US 2004/0153032) in view of Mernoe (US 2007/0276329).
Regarding claims 3 and 13, while Garribotto substantially discloses the invention as claimed, it does not disclose wherein the means for limiting the amount that the actuator lever can move comprises a pair of pins.
Mernoe discloses a shape memory actuator (¶91) which can drive a ratchet wheel and pawl system (figs 5a-5c). The actuator level 78a is limited by pints 85a and 85b (figs 5a-5c; ¶102).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Garriboto such that the means for limiting the amount that the actuator lever can move comprises a pair of pins as taught by Mernoe to more precisely and clearly delineate the range of motion of the actuator lever.
Regarding claims 5 and 14, wherein the pair of pins are located on opposing sides of an end of the actuator lever (see combination in claim 3; modifying Garriboto as taught by Mernoe will result in the pins being arranged as in claim 5a of Mernoe and thus as claimed by Applicant).
Regarding claims 6-8 and 16-18, while Garribotto substantially discloses the invention as claimed, it does not disclose a pin about which the actuator lever rotates, a mounting pin connecting the actuator level to the pawl, nor the actuator lever moves the pawl by pulling on the pawl away from the ratchet wheel with the mounting pin.
In Garribotto it is unclear how actuator lever 606 is linked with pawl 602.
Mernoe discloses use of pins (fig 3) as means of affixing structures together. Thus Mernoe suggests using a pin as a means to link the actuator level and pawl of Garribotto.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Garribotto such that it includes a mounting pin connecting the actuator level to the pawl and about which the actuator level rotates, and the actuator lever moves the pawl by pulling on the pawl away from the ratchet wheel with the mounting pin as suggested by Mernoe as it is a known means by which to connect structures in a shape memory wire and pawl and ratchet operated pump.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-18 and 20-22 of copending Application No. 18/090,788 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of each other and any differences are obvious to one of ordinary skill in the art and/or in view of the references used in the art rejections.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented (although Applicant has paid the issue fee for the copending application).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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