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 .
Claim Objections
Claims 16-23 and 26-30 are objected to because of the following informalities:
As to claim 16, the preamble, in particular the wording of “…is the end of the pad adjacent to an injection site when the pad is in use” could potentially be misleading as it would imply that no other “ends” of the pad could be adjacent the injection site. The examiner recommends amending claim 16 to move wording from the preamble into the body of the claim for the sake of clarity. See the Allowable Subject Matter section below for proposed amendments.
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.
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: “an insertion mechanism configured to insert the medicament delivery member into the injection site” in claim 20.
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 23, and 26-29 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 23 recites “the medicament delivery device”, which is unclear because claim 16 introduced two different medicament delivery devices.
Claim 26 recites “said medicament delivery device” which is unclear because claim 16 introduced two different medicament delivery devices.
Claim 27 recites “wherein the first attachment portion comprises an arm configured to engage a feature of a medicament delivery device” which has been made unclear because claim 16 has been amended to recite “the first attachment portion comprises a slider, the slider comprising a first arm and a second arm”. In other words, it is not clear if the arm introduced in claim 27 is the same as one of the arms introduced in claim 16 or a different arm.
Claim 28 recites “said medicament delivery device” which is unclear because claim 16 introduced two different medicament delivery devices and claim 27 also introduced a medicament delivery device.
Claim 29 recites “a longitudinal axis of the medicament delivery device extending perpendicular to the axis”. However, between claim 16 introducing two different medicament delivery devices, and claim 29 introducing a medicament delivery device, the wording of “the medicament delivery device” is unclear.
Allowable Subject Matter
Claims 16-22 and 30-32 are allowed.
Claims 23, and 26-29 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.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 16, the claim has been amended to include limitations from previous claims 24 and 25. It was noted in the previous office action that the prior art of record if silent to the limitations of wherein the slider comprises a first arm and a second arm, wherein the first arm and the second arm are spaced apart from one another and configured to grip a medicament delivery device between the first arm and the second arm in combination with the rest of the elements of claim 16. The examiner suggests the following amended claim 16 to obviate the objections above:
16. (Currently Amended): A pad
a distal end,
a proximal end configured to placed adjacent to an injection site when the pad is in use,
an axis extending from the proximal end to the distal end,
a first attachment portion configured to receive a medicament delivery device; and
a second attachment portion attached to the first attachment portion,
wherein the second attachment portion is arranged at the proximal end of the pad,
wherein the second attachment portion is configured to attach the pad to said injection site when the pad is in use, and
wherein the first attachment portion comprises a slider, the slider comprising a first arm and a second arm, wherein the first arm and the second arm are spaced apart from one another and configured to grip [[a]] the medicament delivery device between the first arm and the second arm.
As to claim 31, the claim has been amended to incorporate previous claim 33. It was noted in the previous office action that the prior art of record is silent to wherein the attachment portion comprises a slider having a first arm and a second arm, where the first arm and the second arm are spaced apart from one another and where movement of the first arm and the second arm relative to a base portion of the pad will grip the medicament delivery device between the first arm and the second arm in combination with the rest of the limitations of claim 31.
The remaining claims not specifically mentioned above depend from or require all the limitations of either claim 16 or claim 31.
Response to Arguments
Applicant’s Remarks submitted 12/16/25 have been considered.
With regard to the comments under the heading “2. Status of the Claims” (pages 6-7 of Remarks), the applicant states “Applicant has not amended the claims” but then later states “Claims 16 and 31 have been amended”. The examiner will assume that the Claims 12/16/25 are what the applicant intended to submit.
With regard to the comments under the headings “3. Response to the Claim Objections” (page 7 of Remarks) and “4. Response to the § 112(b) Rejections” (page 7 of Remarks), the arguments are moot/persuasive as the amendments have addressed and/or obviated the previous objections and rejections under § 112(b).
With regard to the comments under the heading “Response to the Statement About Claim Invoking 35 U.S.C § 112(f)” (pages 7-8 of Remarks), the arguments are not persuasive. The examiner notes however, that claim 20 was/is not rejected under 35 U.S.C. 112(b). The statements regarding 112(f) merely show that the term “an insertion mechanism configured to insert the medicament delivery member into the injection site” in claim 20 passes the three-prong analysis described in MPEP 2181, and therefore is being interpreted to invoke 35 U.S.C. § 112(f) . The examiner further notes that MPEP 2181 states “Application of 35 U.S.C. 112(f) is driven by the claim language, not by applicant’s intent or mere statements to the contrary included in the specification or made during prosecution”. The applicant argues that the claimed “insertion mechanism” is a definite structural component, but does not point out what type of structural component it embodies. MPEP 2181 states:
The following is a list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f): "mechanism for," "module for," "device for," "unit for," "component for," "element for," "member for," "apparatus for," "machine for," or "system for."
which shows how “mechanism” is known nonce term/generic placeholder.
With regard to the comments under the heading “6. Response the § 102 and § 103 Rejections” (page 8 or Remarks), the examiner agrees that the amendments have obviated the previous prior art rejections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/James D Ponton/Primary Examiner, Art Unit 3783