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 .
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0062] of the specification recites “window 254”. This should likely say “window 224” as elsewhere the specification uses reference numeral 224 for the window and furthermore because the instant drawings do not use a reference numeral 254 anywhere. Since this appears to only be an issue with the specification, an objection to the drawings is not being given. However, in the event that applicant does intend to refer to “window 254”, the drawings will be objected to.
Appropriate correction is required.
Claim Objections
Claims 5 is/are objected to because of the following informalities:
As to claim 5, “comprise” in line 1 should read comprises.
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: “data collection device” in claim 5, claim 12, and claim 28, “a limit element to prohibit axial movement of the slide button” of claim 7, “an attachment element configured to couple to a portion of the user dose setter” of claim 8, and “a limit element” of claim 28.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claims 1-11, 13, 14, and 16 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.
Re claim 1, the final stanza appears to constitute a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(p)). The examiner recommends using “configured to” language, rather than recite a method step.
Claim 13 recites the limitation "the proximal surface of the activation button" in line 2. There is insufficient antecedent basis for both “the proximal surface of the activation button” (emphasis added) and “the activation button” itself in the claim.
Claim 14 recites the limitation "the proximal surface of the activation button" in line 2. There is insufficient antecedent basis for both “the proximal surface of the activation button” (emphasis added) and “the activation button” itself in the claim.
Claim 16 was amended to introduce a pair of receivers. However, claim 12 was also amended to introduce a pair of receivers. It is unclear if claim 16 is intended to introduce a second pair of receivers or refer to the pair already introduced in claim 12.
Claim 16 recites the limitation "the corresponding receiver of the guide body" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims inherit the deficiencies of the claims from which they depend.
Allowable Subject Matter
Claims 12, 15, 17-20, and 28 are allowed.
Claims 1, 3-11, 13, 14, and 16 would be allowable if rewritten or amended 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.
The following is an examiner’s statement of reasons for allowance:
As to claim 1, the closest prior art of record is Allerdings (WO 2014/037331 A1), provided by applicant on 4/5/24. Allerdings discloses:
An apparatus (2) for a medication delivery device (see Figs. 9a-9d), the medication delivery device having a body (201), a user dose setter (203, 204) coupled to a proximal end of the body, the user dose setter comprising a proximal surface (right-most/proximal surface of 204) facing away from a needle end of the body (see Fig. 1a showing needle 15 placed on opposite side) and a circumferential surface (radial outer surface of 203) extending from the proximal surface and defined about a longitudinal axis of the medication delivery device, the apparatus comprising:
a guide body (205) configured to be associated with the medication delivery device, the guide body having a receivers (portion of 205 that receives arm 207), the receiver having a pocket extending longitudinally along the longitudinal axis (see Figs. 9a-9d);
a slide button (209) axially movable relative to the guide body;
a rail (207) coupled between the guide body and the slide button, the rail slidably coupled within the pocket of the corresponding receiver (see Figs. 9b-9d);
wherein the slide button includes a shielding surface (left/distal surface of 209), the shielding surface at least partially covering the proximal surface of the user dose setter of the medication delivery device (Figs. 9b-9d), wherein during dose setting and delivery the slide button is rotationally free relative to the user dose setter and axially movable relative to the guide body; wherein during dose setting the user dose setter is rotated in a first direction, the user dose setter together with the slide button proximally move away from the body of the medication delivery device from a first position to a second position (see Figs. 9b-9d).
However, Allerdings is silent to the guide body having a pair of receivers, and thus a pair of rails coupled between the guide body and the slide button, each of the rails circumferentially spaced from one another to define a pair of opposite-facing windows therebetween, each of the opposite-facing windows sized to allow access for rotation of the user dose setter during dose setting, each of the rails slidably coupled within the pocket of a corresponding one of the receivers.
The examiner notes the corresponding Written Opinion Of The Internation Searching Authority for the corresponding PCT/US2022/045594, which states “A plurality of rails do not appear to have any additional/surprising effect over a single rail as in [Allerdrings].... The objective problem to be solved appears to be an alternative stabilizing apparatus for a medication delivery device. To add an extra arm or sliding member to the add-on module of [Allerdings] does not appear to take inventive skills to implement in the absence of an unexpected effect and is therefore seen as a trivial modification for the skilled person faced with the above formulated problem”. The examiner also however notes that the instant claim 1 contains limitations that are narrower than those discussed in the Written Opinion, which does not mention the limitations of each of the rails circumferentially spaced from one another to define a pair of opposite-facing windows therebetween, each of the opposite-facing windows sized to allow access for rotation of the user dose setter during dose setting. So, while the examiner does agree that adding additional rails to Allerdings would be within the level of ordinary skill in the art, the manner in which claim 1 requires adding an additional appears to be more than just a simple design choice and/or duplication of parts. Therefore, the instant claim 1 is considered non-obvious over Allerdings.
As to claims 12 and 28, neither Allerdings nor any of the other prior art of record teaches or makes obvious all the limitations of either claim in combination.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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