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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Species A, claims 1-8 in the reply filed on 6/29/26 is acknowledged.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/29/26.
Claim Objections
Claim 8 is objected to because of the following informalities:
In claim 8, line 1, “(Withdrawn)” should be --(Original)--. Appropriate correction is required.
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: “drive mechanism” in claim 1.
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 § 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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kazuhiro et al. (20100228121). Regarding claim 1, Kazuhiro et al. discloses a pumping mechanism for a drug delivery device comprising: an outer reservoir 11; an inner reservoir 30 configured to linearly translate into the outer reservoir; a drive mechanism for linearly translating the inner reservoir into the outer reservoir (fig. 4, 105, paragraph [0043]); and a clutch mechanism for coupling the outer reservoir or the inner reservoir to a housing of the drug delivery device (fig. 3a, 90 & 92, paragraph [0041]).
Prior Art
Prior art made of record but not relied upon is considered pertinent to Applicant's disclosure for showing other pumping mechanisms.
Allowable Subject Matter
Claims 2-8 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 improvements comprise the clutch mechanism comprising (claim 2) a brake pad; and a lever for forcing the brake pad into engagement with an outer surface of the outer reservoir, (claim 3) a first piece of hook and loop fasteners attached to housing of the drug delivery device; a second piece of mating hook and loop fasteners attached to an outer surface of the outer reservoir; and a sheath disposed between the first and second pieces of hook and loop fasteners to prevent engagement of the first and second pieces of hook and loop fasteners; wherein the sheath is removed after the filling of the pumping mechanism to allow engagement of the first and second pieces of mating hook and loop fasteners to prevent further movement of the outer reservoir, (claim 4) a first adhesive pad attached to a housing of the drug delivery device; a second adhesive pad attached to an outer surface of the outer reservoir; and a liner disposed between the first adhesive pad and the second adhesive pad; wherein the liner is removed after the filling of the pumping mechanism and further wherein an adhesive on the first and second adhesive pads is activated when the first and second adhesive pads contact each other (claim 5) a spring clamp attached to a housing of the drug delivery device and disposed around an outer surface of the outer reservoir; wherein the spring clamp, in a tensioned state, allows linear translation of the outer reservoir and, in an un-tensioned state, engages the outer reservoir to prevent further translation of the outer reservoir, (claim 6) a guy line attached to a housing of the drug delivery device and to the outer reservoir, the outer reservoir moving along the guy line as the pumping mechanism is being filled; and a spring mechanism which, when un-tensioned, tensions the guy line to prevent further movement of the outer reservoir, (claim 7) a guy line attached to a housing of the drug delivery device and to the outer reservoir, the outer reservoir pulling the guy line as the pumping mechanism is being filled; and a clamp mechanism which, when un-tensioned, clamps the guy line to prevent further movement of the outer reservoir, and (claim 8) one or more bi-stable mechanisms rigidly attached to housing of the drug delivery device which, in a first stable state, are disengaged from the outer reservoir so as to allow translation of the outer reservoir and, in a second stable state, are engaged with the outer reservoir to prevent further movement of the outer reservoir.
Contact Information
Any inquiry concerning this communication or earlier communication from the examiner should be directed to Thomas Lazo whose telephone number is (571) 272-4818. The examiner can normally be reached on Monday-Friday from 8:00 am to 4:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor Nathaniel Wiehe, can be reached on (571) 272-8648. The fax phone number for this Group is (571) 273-8300.
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/THOMAS E LAZO/Primary Examiner,
Art Unit 3745
July 11, 2026
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