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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/19/2025 has been entered.
Response to Amendment
The Amendment filed 5/19/2025 has been entered. Claims 2-21 remain pending in the application.
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: “driven by a separate, second drive element” in claims 13 and 21.
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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Daniel (WO 2011/123024 A1).
Regarding claim 13, Daniel teaches a method (page 9, lines 15-29) for releasing a substance (contents inside element 80) from a device (figure 7), comprising the steps of:
automatically releasing the substance from a syringe 80 held immovably within a housing 20 of the device (figure 7) in response to pressing the device (figure 7) onto an injection site, wherein the substance is released by means of a first drive element 105 (page 12, line 29-page 13, line 6, claim does not recite a structure of a first drive element and due to rotation of element 105, sequence of substance release is initiated therefore, element 105 meets the claimed first drive element); and
producing a feedback signal (page 13, line 29-page 14, line 2, page 11, lines 24-31) for signaling of a completed substance release by means of a feedback element 110 driven by a separate, second drive element 91.
Regarding claim 14, Daniel teaches wherein the first drive element 105 releases energy (page 12, line 29-page 13, line 6, the energy that element 105 holds to keep element 91 in the pre-tensioned state is released upon rotation of element 105 and thus releasing the energy upon element 91) to the second drive element 91 before, during or after the substance release.
Regarding claim 15, Daniel teaches wherein the pressing comprises pressing a needle protective sleeve 30 (page 9, line 31-page 10, line 9) of the device onto the injection site to displace the needle protective sleeve in a proximal direction to thereby cause the step of automatically releasing the substance, wherein the substance is automatically released from the syringe 80.
Regarding claim 16, Daniel teaches wherein the step of producing the feedback signal (page 11, lines 24-31) is by the feedback element 110 striking the housing or a stationary element 22 in the housing 20.
Regarding claim 17, Daniel teaches further comprising, prior to the step of producing the feedback signal, coupling the second drive element 91 to a piston rod 90 of the device, and upon dispensing a predefined quantity of the substance by the piston rod 90, releasing (page 11, lines 14-31, page 12, line 23-page 13, line 6, page 13, lines 29-33) the coupling to cause the step of producing the feedback signal.
Claim(s) 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bollenbach et al. (US 2008/0262438 A1).
Regarding claim 21, Bollenbach teaches a method (paragraph 0053) for releasing a substance from a device, comprising the steps of:
automatically releasing the substance (paragraph 0053, lines 1-7, paragraph 0056, paragraph 0057, paragraph 0060, lines 1-17) in response to pressing the device onto an injection site, wherein the substance is released by means of a first drive element 6; and
producing a feedback signal (paragraph 0060, lines 14-17, paragraph 0062, lines 1-8) for signaling of a completed substance release by means of a feedback element 17 driven by a separate, second drive element 7,
wherein the second drive element 7 is configured as a spring (paragraph 0046, lines 1-2, “retracting spring”) and is coupled with the needle protective sleeve 9 for displacing the needle protective sleeve in a distal direction in order to cover the needle (paragraph 0063, lines 16-23).
Allowable Subject Matter
Claims 18-20 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 following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Daniel (WO 2011/123024 A1), is silent regarding wherein the second drive element is coupled with the needle protective sleeve for displacing the needle protective sleeve in a distal direction in order to cover the needle in combination with other claimed limitations of claim 18.
Claims 19-20 being dependent on claim 18 are also indicated allowable.
Response to Arguments
Applicant’s arguments with respect to claim 13 have been considered but are moot because the arguments do not apply in view of the present rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783