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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 19-23 and 25-39) in the reply filed on 3/2/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/8/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “rotating assembly” of claim 39 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 31, 34, and 39 are objected to because of the following informalities:
On line 3 of claim 31, “a septum” should read “the septum” because there is already antecedent basis for the term in claim 19.
On line 7 of claim 34, “and movable” should read “the needle mechanism movable” to provide a clearer statement.
On line 4 of claim 39, “each of the needle mechanisms” should read “each of the plurality of needle mechanisms”.
On line 8 of claim 39, “the first needle support” should read “the second needle support” to correct an obvious typo.
On lines 11-12 of claim 39, “the needle mechanisms” should read “the plurality of needle mechanisms”.
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:
“driving member…configured to engage with the first needle support… in claim 19 and 36
“driving mechanism…configured to drive mechanism… in claim 30 and 37
“rotating assembly configured to rotate the needle mechanisms” in claim 39
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.
The driving member is interpreted as the structure disclosed in par. [0056] and [0058] of the pg-publication
The driving mechanism is interpreted as the structure disclosed in par. [0048]
The rotating assembly is interpreted as the structure disclosed in par. [0065]
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 § 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 39 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 regard to claim 39, there is no antecedent basis for “the first needle and the second needle” on lines 9-10. It appears that the applicant is trying to positively recite the needles as part of the needle mechanisms but the introduction in lines 9-10 makes it unclear. The examiner suggests amending the claim so that the first and second needle are positively recited and associated with the respective needle support. For the purposes of this action, the examiner is interpreting the first and second needle as structural requirements and being associated with the respective needle supports.
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) 19-22, 25-28, and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cowe et al. (US 2019/0328973; hereafter Cowe).
In regard to claim 19, Cowe discloses a drug delivery device (100) comprising: a cartridge (10) having a septum (16) sealing a reservoir (14) configured to hold a medication (see at least par. [0090]); and a needle assembly comprising: a housing (144) configured to interface with a surface (144 interacts with many surfaces); a first needle (134) supported by a first needle support (132) positioned at least partially within the housing (see at least Fig. 6b); a second needle (172) supported by a second needle support (170) positioned at least partially within the housing (see at least Fig. 6b); a driving member (150, 184) supported by the housing and configured to engage with the first needle support and the second needle support and to move the first and second needle supports relative to the housing (see par. [0098], [0103], [0105], [0122]; spring 150 moves first needle support and spring 184 via pushing 144 moves 170); a first fluid coupler (158, 160) in fluid communication with the first needle; and a second fluid coupler (164) in fluid communication with the second needle (see at least Fig. 6b), wherein the first and second fluid couplers fluidly couple the first and second needles when the first and second fluid couplers are aligned (the fluid couplers are always fluidly coupled to the needles).
In regard to claim 20, Cowe discloses wherein the first needle (134) and the second needle (172) are oriented in approximately opposite directions along a central axis (see Fig. 6b; 172 is oriented to move side to side and 134 is oriented to move up and down).
In regard to claim 21, Cowe discloses wherein the driving member is configured to move the first needle (134) in a first direction (134 moves from up to down position), and to move the second needle (172) in a second direction (172 moves in side-to-side position), the second direction being approximately opposite the first direction.
In regard to claim 22, Cowe discloses further comprising a first seal (“suitable sealing material” at par. [0138]) at a first end of the housing, and a second seal (176) at the second end of the housing (see at least Fig. 6b).
In regard to claim 25, Cowe discloses a cassette (114) configured to hold the cartridge (see par. [0094]).
In regard to claim 26, Cowe discloses wherein the cassette (114) is decouplable from the needle assembly (via the coupling element 22; decoupling 10 from 22 would decouple 114 from the needle assembly).
In regard to claim 27, Cowe discloses wherein the driving member (150, 184) is configured to drive the first and second needle supports to move from a first configuration to a second configuration (the first configuration is the unactuated configuration and the second configuration is the actuated configuration).
In regard to claim 28, Cowe discloses wherein the driving member (150, 184) (150, 184) is additionally configured to drive the first and second needle supports to move from the second configuration and to the first configuration (the driving member is a spring and therefore can move from the second to the first configuration as well).
In regard to claim 30, Cowe discloses, further comprising a driving mechanism (200) coupled to the cartridge and configured to drive the medication from the cartridge through the needle assembly (see at least par. [0110]-[0111]).
In regard to claim 31, Cowe discloses wherein the housing of the needle assembly comprises a first end and a second end (see at least Fig. 6b), wherein the cartridge (10) comprises the septum (16) proximate the second end of the housing, and when movement of the first and second fluid couplers to align the second needle (172) pierces the septum (16) (see at least Fig. 7b).
Allowable Subject Matter
Claims 23, 29, 32-33 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 23, while Cowe can broadly be interpreted to include the recited seals of claim 22, these seals are not configured to be pierced by the first and second needles.
In regard to claim 29, Cowe discloses springs as driving members and not pinion gears and does not disclose racks for the supports.
In regard to claims 32-33, Cowe discloses springs as driving members and therefore there is no need for an electric motor as is recited.
Claims 34-38 are allowed.
In regard to claim 34, Cowe fails to disclose or suggest the combination of limitations recited in claim 34. Specifically, Cowe fails to teach or suggest “a needle mechanism supported by the housing, comprising a first needle and a second needle, and movable from a first configuration to a second configuration, wherein in the first configuration the needle mechanism is positioned at least partially within the housing and in the second configuration at least one of the first needle and the second needle extends beyond the first end and the second end, respectively; and a first fluid coupler and a second fluid coupler within the needle mechanism and fluidly coupled to the first needle and the second needle respectively, wherein the first and second fluid couplers fluidly disconnect the first and second needles when the needle mechanism is in the first configuration and fluidly couple the first and second needles when the needle mechanism is in the second configuration.” Cowe discloses fluid couplers (see rejection above) but the fluid couplers are always in fluid communication via flexible tube (162) so there is no disconnection in the first configuration as is recited in claim 34. There is no teaching reference and/or motivation to modify Cowe to meet the claimed limitations of claim 34.
Claim 39 will be considered allowable upon resolution of the 112 rejection above. In regard to claim 39, Cowe only discloses one needle mechanism and not a plurality of needle mechanisms as is recited. Furthermore, Cowe fails to disclose or suggest the recited rotating assembly of claim 39. There is no teaching reference and/or motivation to modify Cowe to meet the claimed limitations of claim 34.
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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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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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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