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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/9/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 2-10, 12-14, and 16-22 are objected to because of the following informalities:
The preamble of the dependent claims should read “The drug delivery device according to claim..” instead of “Drug delivery device according to claim…”
The preamble of claim 22 should read “A pharmaceutical composition…” instead of “Pharmaceutical composition…”
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:
“actuator mechanism configured to move the first distal end towards the second distal end” in claim 1
“locking mechanism configured to lock the first body part in relation to the second body part in a first state of the drug delivery device” in claim 18
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.
See par. [0093]-[0096], [0165], and [0172]-[0173] for the actuator mechanism
See par. [0204] for the locking mechanism
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(s) 1, 5, 10, 12, 16, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanaka et al. (US 8,202,247; hereafter Tanaka).
In regard to claim 1, Tanaka discloses a drug delivery device (1) for oral administration and having a central axis (the horizontal axis of 1), the drug delivery device comprising: a first body part (left-hand side of the housing); a first attachment part (left-hand side roller 11) attached to the first body part and having a first distal end (one of claws 23 of left-hand side roller 11) provided with a tip (tip of claw 23) configured to penetrate a biological tissue (see col. 4, line 59- col. 5, line 18); a second attachment part (right-hand side roller 11) having a second distal end (one of claws 23 of right-hand side roller 11); and an actuator mechanism (20) configured to move the first distal end towards the second distal end (see col. 4, line 59- col. 5, line 18; the rotation of the claws 23 upward to grip tissue brings the tips of the claws from opposing rollers closer; see Figs 2 and 4).
In regard to claim 5, Tanaka discloses wherein the first attachment part (left-hand side roller 11) extends in a direction away from the first body part (see at least Fig. 1; the roller 11 extends at least in a direction away from the left-hand side of the housing).
In regard to claim 10, Tanaka discloses wherein the second distal end (right-hand roller 11) of the second attachment part (right-hand side of the housing) is provided with a tip (tip of claw 23) configured to penetrate a biological tissue or the second distal end (right-hand roller 11) of the second attachment part (right-hand side of the housing) is provided with a gripping part (tip of claw 23) configured to grip a biological tissue.
In regard to claim 12, Tanaka discloses wherein the drug delivery device comprises a first compartment (17), the drug delivery device being configured to deliver an active drug substance (18) from the first compartment to the surroundings of the drug delivery device (via ejection port 12a).
In regard to claim 16, Tanaka discloses wherein the actuator mechanism (20) is configured to move the first distal end (one of claws 23 of left-hand side roller 11) from a first primary position (see Fig. 2-4) with a first primary radial distance from the central axis of the delivery device to a first secondary position with a first secondary radial distance from the central axis, wherein the first secondary radial distance is larger than the first primary radial distance (the actuator 20 rotates the claws 23 towards the central axis to grip the tissue for piercing; see Figs. 2 and 4 and rotates away from the central axis to release the tissue; the released position would be the first secondary radial distance which is larger or farther away from the central axis than the gripped first primary position which is closer to the central axis).
In regard to claim 22, Tanaka discloses a pharmaceutical composition comprising a drug delivery device according to claim 1 (see rejection of claim 1) and an active drug substance (18).
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.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tanaka.
In regard to claim 17, Tanaka discloses wherein the actuator mechanism (20) is configured to move the first distal end from a first primary angular position of first primary position to a first secondary angular position of first secondary position in relation to a first proximal end of the first attachment part (the actuator 20 rotates the claws 23 towards the central axis to grip the tissue for piercing; see Figs. 2 and 4 and rotates away from the central axis to release the tissue; the released position would be the first secondary radial distance which is larger or farther away from the central axis than the gripped position which is closer to the central axis) but Tanaka fails to expressly disclose wherein an angle between the first primary angular position and the first secondary angular position is larger than 10 degrees.
However, the applicant has not disclosed that the specific angle of larger than 10 degrees solves a particular problem or works to the exclusion of other angles. For this reason, the limitation is deemed to be a design consideration which fails to patentably distinguish over the cited art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the recited angle if the patient and/or tissue being treated required such an angle and/or the size and amount of claws 23 present dictated that such an angle be used.
Allowable Subject Matter
Claims 2-4, 6-9, 13-14, and 18-21 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.
In regard to claim 2, Tanaka does disclose a second body part (right-hand side of the housing), wherein the second attachment part (right-hand side roller 11) is attached to the second body part, and the actuator mechanism is configured to rotate the first and second attachment parts (the rollers 11 are rotated) but the actuator mechanism (20) does not rotate the first and second body parts about a primary axis of the drug delivery device as is recited.
The remaining claims are dependent on claim 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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