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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 13. 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. 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.
Specification
The disclosure is objected to because of the following informalities: Pg. 23 line 7 25 should be 24. Pg. 26 line 2 recites “et thereby” which appears to contain a typographical error.
Appropriate correction is required.
Claim Objections
Claims 1-33 are objected to because of the following informalities: the claims should start with An or The.
In claim 1 line 8 “a pen injection system” is believed to be “the pen injection system.”
Claims 2 and 3 refer to “the other” for clarity the claim should recite which components optionally may be considered as the other.
Claim 8 refers to “the at least one portion” and “the reduced internal diameter” there is insufficient antecedent basis for these limitations in the claim.
Claim 11 refers to “the at least one portion” and “the reduced thickness” there is insufficient antecedent basis for these limitations in the claim.
Claim 13 refers to “the compressible membrane” there is insufficient antecedent basis for this limitation in the claim.
Claim 19 refers to “the first elongated outer body component” there is insufficient antecedent basis for this limitation in the claim.
Claim 24 refers to “the second elongated outer body component” there is insufficient antecedent basis for this limitation in the claim.
Claim 30 refers to “the first elongated outer body component” there is insufficient antecedent basis for this limitation in the claim.
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.
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 4-7, 9, 10, 26, and 27 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.
The term “nominal” in claims 4-7, 9 and 10 is a relative term which renders the claim indefinite. The term “nominal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the thickness and diameter recitations are indefinite. Claim 26 recites “the compression ring comprises at least one projecting contact member.” Previously, claim 19 recited the compression ring comprises a surface engagement means. It is not clear from the specification if the projecting contact member is the structure of the surface engagement means. For purposes of the rejection, it is considered as the same structure.
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) 1-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deroo et al. (FR 3079422 A1).
With regard to claim 1, Deroo et al. teach automatic needle inserter for a pen injection system comprising: an elongated inserter body having a proximal extremity and a distal extremity (Fig. 2 including at least 80 and 40), and a longitudinal bore extending through the elongate body from the proximal extremity to the distal extremity, the longitudinal bore having a central longitudinal axis (Fig. 3), wherein the elongated inserter body is dimensioned and configured to receive a pen injection system introduced into said bore via the proximal extremity of the inserter body, and is further configured and dimensioned to prevent the pen injection system from exiting the longitudinal bore via the distal extremity (Fig. 3 member 10); the elongated inserter body further comprising: a rotationally-activated locking means configured to lock the pen injection system in an axial position within the longitudinal bore through rotation of at least a part of the elongated inserter body about the central longitudinal axis from a first, non-locking position to at least one or more second, locking positions (Figs. 2 and 3 member 90 is locking through rotation of 80).
With regard to claims 2 and 3, 40 and 80 can rotate with respect to each other.
With regard to claim 4, end portion with 93 forms a compression ring (Fig. 2).
With regard to claims 5-8, members 93 hinge to compress around the instrument resulting in a gradual reduction in the internal diameter.
With regard to claims 9-11, members 93 taper towards 94 resulting in a gradual reduction in thickness.
With regard to claims 12-15 see Fig. 2 member 100.
With regard to claims 16-30, see carriage member 30, the surface engagement means is the projecting contacts formed by the threads on 90 and 80, the runnel is formed on each by the insertion space before the start of the threads and the space between the threads which allows initial axial movement for the two components to attach before rotation, the slider arm is 34 which engages runnel 44, the releasable trigger arm is 32, and the release button is 60. See Figs. 2-7, generally pgs. 36 and 37 of the translation portion of the provided reference.
With regard to claims 31-33 the selectively actionable member is formed by members 310 and 320 (Figs. 2 and 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783