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 .
Response to Amendment
The amendment filed on 08/28/25 has been entered in the case. Claims 1, 17-18 are pending for examination and claims 2-15 are cancelled.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitation “a second zone detachable from the planar portion of the skin-facing surface” in claim 1; the limitation “a device interface adhesive” in claim 1; the limitation “mechanical means” and “chemical means” in claims 16-17 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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
This disclosure is objected to because of the following informalities: It is the Examiner's position that Applicant has invoked sixth paragraph, means-plus-function language to define Applicant's invention. Therefore, the Examiner requires the Applicant to amend the specification pursuant to 37 CFR1.75(d) and MPEP 608.01 (o) to explicitly state, with reference to the terms and phrases of the claim element, what structure, materials, and acts perform the function recited in the claim element, what structure, materials, and acts perform the function recited in the claim element. Please not that the MPEP clearly states “Even if the disclosure implicitly sets forth the structure, materials, or acts corresponding to the means-(or step-) plus-function claim element in compliance with 35 U.S.C. 112, first and second paragraphs, the PTO may still require the applicant to amend the specification pursuant to 37 CFR 1.75(d) and MPEP 608.01(o)…”. (Also see MPEP 2181 (Rev. 1, Feb. 2000)).
Appropriate correction is required.
Claim Objections
Claims 16 & 16 are objected to because of the following informalities: It is the Examiner’s position that Applicant has evoked sixth paragraph, means-plus-function language to define Applicant’s invention. Therefore, the Examiner has objected to the claims for the reason set forth above in the objection to the specification. Appropriate correction is required.
112 6th Acknowledgement
With regard to Applicant’s “mechanical means” and “chemical means” of claims 16-17, the language appears to be an attempt to invoke 35 USC 112, 6th paragraph interpretation of the claims. A claim limitation will be interpreted to invoke 35 U.S.C. 112, sixth paragraph, if it meets the following 3-prong analysis:
(A) the claim limitations must use the phrase “means for ” or “step for; ”
(B) the “means for ” or “step for ” must be modified by functional language;
and
(C) the phrase “means for ” or “step for ” must not be modified by sufficient structure, material or acts for achieving the specified function.
In the instant case, applicant appears to have met the limitations set forth in MPEP § 2181, and examiner has turned to the specification for clarification.
In the specification, applicant does not define the meaning or structure of the “mechanical means” & “chemical means”. Therefore, Examiner cannot determine what elements are equivalent to “mechanical means” & “chemical means”. Therefore, claims 16-17 involves 112, 2nd paragraph issue.
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1, 16-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
It appears to Examiner that the limitation “skin-facing surface” and the limitation “adhesive tape” are designated in one element.
In Fig. 66 below, it shows that a skin-facing surface contains adhesive layer (but not adhesive tape). It is noted that the term “layer” is different with the term “tape”. Based on the Fig. 66, where is the adhesive tape that being extends beyond the skin facing surface?
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In Fig. 67, the adhesive layer is located right below a bottom surface of the device 7 or maybe right below the skin-facing surface. The Fig. 67 shows the adhesive layer 88 is located outside of the housing, however, it does not show that the adhesive layer 88 being connected to the 1st and 2nd zone of the adhesive tape.
Applicant is requested to clarify that: is the skin-facing surface and the adhesive tape are two separate components? Or the skin-facing surface includes the adhesive layer and located right below the skin-facing surface?
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Nowhere in the original specification has described that a second zone detachable from the planar portion of the skin-facing surface using a device interface adhesive. The Fig. 67 shows that the first zone 175 and the second zone 176 are attached to each other. Meanwhile, the claim 1 states that the adhesive tape attached to the planar portion of the skin facing surface in a first zone 175. In other words, the second zone 176 is also attaching to the first zone and the planar portion of the skin-facing surface. Oppositely, the claim requires the second zone detachable from the planar portion of the skin facing surface. Therefore, Applicant is requested to point out where is the location of the second zone being detached from the planar portion of the skin-facing surface by using interface adhesive.
Nowhere in the original specification has described that: the adhesive tape attached to the planar portion of the skin-facing surface… using a device interface adhesive? What is “a device interface adhesive”? where is the “device interface adhesive” is located in the medication injection device?
In Fig. 66, It appears to Examiner that the adhesive layer is located right below the skin-facing surface; wherein the adhesive layer does not extend beyond the planar portion perimeter of the skin-facing surface. Meanwhile, the adhesive 88 in Fig. 67 that does not attach to the first and second zone.
In claim 17, nowhere in the original specification has described the limitation “the permanent zone of the second zone includes a chemical means”. The para [0250] in the original specification describes that the first zone 175 includes mechanical means or chemical means. The original specification does not describe that the permanent zone of the second zone includes a chemical means.
[0205] Referring to FIG. 67, the adhesive 88 could be configured on the injection device 7 with at least two zones. The first zone 175 may include a permanent bond using mechanical or chemical means between the adhesive 88 and the injection device 7 and preferably be positioned within the perimeter of the injection device 7. The second zone 176 may be configured to be detachable or unattached from the injection device 7 and preferably be adjacent and on the outside (e.g., radially outward) of zone 1.
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 1, 16-18 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 limitation “said second zone positioned radially outward of the second zone” is vague. It is unclear to Examiner that how is the second zone is being extended outwardly by itself?
Can Applicant provide an example or point out in the drawings?
In claim 16, the limitation “the permanent bon of the first zone includes a mechanical means” is vague. The “mechanical means” has no structure, and therefore, it is unclear to Examiner that which element is considered as “mechanical means”?
In claim 17, the limitation “the permanent bon of the second zone includes a chemical means” is vague. The original species does not provide what kind of material is equivalent to the “chemical means”. Therefore, it is unclear to Examiner that which element/material is considered as “chemical means”?
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Kornerup et al. (US 7,985,199) in view of Wall et al. (US 7,670,314)
Regarding claim 1, Kornerup discloses a medication injection device comprising:
a housing 1 having a housing outer edge 1a (or A- as shown in the marked-up Fig. 2) defining a periphery of the housing, said housing further including a skin-facing surface (a bottom surface of the housing 1 that interact with a mounting pad 2) that includes an injection needle aperture (wherein a needle extends out) through which an injection needle 3 extends from the housing;
a skin displacement structure (a nose located at bottom portion of the housing 1, see marked-up Fig. 2 below) extending from the skin-facing surface around the injection needle aperture, (see marked-up Fig. 2 below), said skin-facing surface having a planer portion (a bottom portion of the housing 1) extending radially outwards from the skin displacement structure and terminating at a planar portion perimeter (at outer surface of the housing)
adhesive tape 2 (a whole unit tap 2) attached to the planar portion of the skin facing surface and configured to allow for attachment of the skin-facing surface of the housing of the medication injection device to a patient's skin, said adhesive tape 2 including skin interface adhesive (see marked-up figure) for adhering to the patient’s skin and an adhesive tape flange that is radially extends beyond the planar portion perimeter of the skin-facing surface; the adhesive tap attached to the planar portion of the skin facing surface in a first zone; a second zone detachable form the planar portion of the skin-facing surface using a device interface adhesive (release liner, col. 8, lines 57-58);
It is noted that the release liner must be removed before used. Therefore, said skin interface adhesive and said device interface adhesive (release liner) configured so that the device interface adhesive in the second zone detaches from the planar portion of the skin-facing surface while the skin interface adhesive remains firmly attached to the patient’s skin.
said adhesive tape further including a skin displacement structure opening (an opening formed at central area of the adhesive tap 2, see Fig 1) having a skin displacement structure opening edge surrounding the skin displacement structure.
Kornerup does not disclose that a permanent bond being provided in a first zone of the adhesive tape.
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Wall discloses an injection device comprising: a housing; an adhesive tape for securing the device directly to the skin is a pressure sensitive adhesive (PSA). The direct-attaching PSA and the base where the PSA is affixed are typically configured whereby the PSA adheres to the device more strongly than the PSA adheres to the skin. The PSA is typically permanently affixed to the device, col. 5, lines 34-39.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the adhesive tape of the device of Kornerup with providing a permanent bond at below the injection device (e.g. in this case, the permanent bond is affixed at first zone of the adhesive tape), as taught by Wall, in order to provide a permanently affixed to the device and the skin to avoid dislodge of the injection device during use.
Regarding claim 16, as best as understood, the permanent bond of the first zone includes a mechanical means (e.g. adhesive tape is attaching to the bottom of the device).
Regarding claim 17, as best as understood, the permanent bond of the first zone or second zone includes a chemical means (e.g., the adhesive layer is formed by chemical material).
Regarding claim 18, wherein the second zone is adjacent to the first zone.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 16-18 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
The newly added limitations have been disclosed in the new prior art of Wall et al. (US 7,670,314). Please see the rejection above for more details.
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 QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783