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 .
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 03/19/2024, has been considered by the examiner.
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: “feedback structure” and “counter feedback structure” in claims 14 and 23.
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 § 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 14-26 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.
[Claim 14] The clam recites the limitation of “the feedback structure” in the 8th line of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, as it is unclear if “the feedback structure” refers to the previously recited “radially resilient feedback structure,” or if an additional structure is being introduced into the claim limitations. For purposes of examination, it is interpreted that “the feedback structure” refers to the previously recited “radially resilient feedback structure.”
[Claim 16] The claim recites the limitation of “the first step” in the 3rd and 4th lines of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, as it is unclear if “the first step” refers to the previously recited “radial first step,” or if an additional structure is being introduced into the claim language. For purposes of examination, it is interpreted that “the first step” refers to the previously recited “radial first step.”
[Claim 16] The claim recites the limitation of “the circumferential direction” in the 4th line of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, as it is unclear if “the circumferential direction” refers to a direction of how the feedback mechanism is to be rotated around a longitudinal axis of the medicament delivery device, or if another orientation is implied. For purposes of examination, it is interpreted that either scenario meets the limitations of the claim.
[Claims 15-26] The claims are rejected based upon their dependency from independent claim 14.
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.
Claims 14-20 and 24-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marsh et al. (WO 2016/001304 A1).
[Claims 14, 15, and 25] Marsh teaches a medicament delivery device (figure 1, item 10) comprising a feedback mechanism (figure 2, items 70/120), the feedback mechanism (figure 2, items 70/120) comprising:
a rotator (figure 2, item 70); and
a ring member (figure 2, item 120) arranged coaxially (figures 2 and 3) with the rotator (figure 2, item 70),
wherein the rotator (figure 2, item 70) and the ring member (figure 2, item 120) are configured to be rotatable relative to each other (page 31, lines 16-22),
wherein one of the rotator (figure 2, item 70) and the ring member (figure 2, item 120) has a radially resilient feedback structure (arm) (figure 9, item 123; page 26, lines 9-10) and the other one of the rotator (figure 2, item 70) and the ring member (figure 2, item 120) has a first counter feedback structure (figure 9, item 75; page 26, lines 9-10) configured to interact with the feedback structure (see 112b interpretation above) (figure 9, item 123) when one of the rotator (figure 2, item 70) and the ring member (figure 2, item 120) is rotated relative to the other one of the rotator (figure 2, item 70) and the ring member (figure 2, item 120) (page 31, lines 16-22),
wherein when the feedback structure (figure 9, item 123) interacts with the first counter feedback structure (figure 9, item 75) the feedback structure (figure 9, item 123) is configured to relax and hit the first counter feedback structure (figure 9, item 75) to thereby provide a first feedback sound (page 31, lines 16-22).
[Claim 16] Marsh teaches the limitations of claim 14, upon which claim 16 depends. In addition, Marsh discloses the first counter feedback structure (figure 9, item 75) comprises a radial first step (one of “ring of ratchet teeth”; page 24, lines 29-30) which when interacting with the feedback structure (figure 9, item 123) causes the feedback structure (figure 9, item 123) to become radially biased (page 26, lines 9-10), and a radial first step-back (adjacent “tooth” to radial first step) following the first step (see 112b interpretation above) (one of “ring of ratchet teeth”) in the circumferential direction (see 112b interpretation above) of the feedback mechanism (figure 2, items 70/120) configured to be hit by the feedback structure (figure 9, item 123) when the feedback structure (figure 9, item 123) is relaxed to provide the first feedback sound (page 31, lines 16-22).
[Claim 17] Marsh teaches the limitations of claim 16, upon which claim 17 depends. Marsh also discloses initial rotation of the rotator (figure 2, item 70) relative to the ring member (figure 2, item 120) causes the feedback structure (figure 9, item 123) to become radially biased by the first step (one of “ring of ratchet teeth”) (page 31, lines 16-22).
[Claim 18] Marsh teaches the limitations of claim 17, upon which claim 18 depends. Marsh also teaches further relative rotation between the rotator (figure 2, item 70) and the ring member (figure 2, item 120) causes the feedback structure (figure 9, item 123) to relax by the first step-back (adjacent “tooth” to radial first step) (page 31, lines 16-22).
[Claim 19] Marsh teaches the limitations of claim 14, upon which claim 19 depends. Marsh further discloses the rotator (figure 2, item 70) is configured to be rotated in a first direction (page 31, lines 16-22) and the ring member (figure 2, item 120) is configured to be rotated in a second direction opposite to the first direction (the examiner notes the ring member “is configured” to be rotated in a opposite second direction simply by rotating the entire medicament device by hand).
[Claim 20] Marsh teaches the limitations of claim 17, upon which claim 20 depends. In addition, Marsh teaches the rotator (figure 2, item 70) is configured to be rotated first causing interaction of the feedback structure (figure 9, item 123) with the first step (one of “ring of ratchet teeth”), and the ring member (figure 2, item 120) is configured to be rotated second causing interaction of the feedback structure (figure 9, item 123) with the first step-back (adjacent “tooth” to radial first step) (page 31, lines 16-22).
[Claim 24] Marsh teaches the limitations of claim 14, upon which claim 24 depends. Marsh further discloses the first feedback sound is a first click indicative of a start of medicament delivery or a second click indicative of an end of medicament delivery (page 31, lines 19-22).
Allowable Subject Matter
Claims 21-23 and 26, would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/
Primary Examiner, Art Unit 3783 06/10/2026
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