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 .
Claims 1-13 are currently pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference signs mentioned in the description: 12, 105, 109, 112, 113, 114, 235 and 260. 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. 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.
The drawings are objected to because there are lead lines or arrows in the following figures that lack reference numbers: Figures 11-20. Reference number 205 on the lower side of Fig. 19 should be corrected to 235. 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
The disclosure is objected to because of the following informalities: Paragraphs 72-77 are a repeat of paragraphs 95-100 and should be removed. Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1, line 12 recites “tapered waists either side” suggested to be changed to --tapered waists on either side-- for grammatical reasons. Appropriate correction is required.
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 3, 5-8 and 11 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 3 recites “it” however it is unclear what this language is referring to.
Claim 5 recites “the secondary stimulus element,” which lacks proper antecedent basis.
Claim 11 recites “the padding,” which lacks proper antecedent basis.
Any remaining claims are rejected as being dependent on a rejected base claim.
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.
Claims 1-4, 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Baxter et al. (2018/0369064) in view of Sealfon et al. (2016/0067424).
Regarding claim 1, in fig. 3 Baxter discloses a device for reducing the pain associated with an injection [0010], the device comprising: a body 12 in the form of an elongate tab (Fig. 3) having an operative face (face contacting the user’s skin) and a backing face (opposite face to the operative face), the operative face configured in use to be positioned on a patient's skin ([0010] see also fig. 1A), allowing a user to select an injection site near the body [0010] and view the injection site while performing the injection [0010], but is silent regarding that the body has a stimulus element in the form of a plurality of protrusions configured to extend beyond the operative face to contact the skin of the patient around or proximal to the injection site and stimulate the skin of the patient. However, 4A-4B and 4D Sealfon teaches a body 1 that has a stimulus element in the form of a plurality of protrusions 12 configured to extend beyond the operative face (face from which 12 protrude) to contact the skin of the patient around or proximal to the injection site and stimulate the skin of the patient [0037]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Baxter’s operative face with the addition of protrusions, as taught by Sealfon, for the purpose of anesthetizing the surface of the skin and/or distract the patient from discomfort associated with the injection ([0037] Sealfon). The modified Baxter discloses that the elongate tab may be any shape [0018], but does not explicitly recite that the elongate tab having two profiled edges such that the tab comprises a central expanded region, tapered waists either side of the central expanded region and flared ends. It would have been an obvious matter of design choice to modify the shape of Baxter’s elongate tab with an elongate tab having two profiled edges such that the tab comprises a central expanded region, tapered waists on either side of the central expanded region and flared ends, since such a modification would have involved a mere change in the form or shape of a component and it appears that an elongate tab having two profiled edges such that the tab comprises a central expanded region, tapered waists either side of the central expanded region and flared ends would perform equally as well as anesthetizing and distracting the user from an injection. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 2, the modified Baxter discloses a second stimulus element (vibrational source 32, Baxter).
Regarding claim 3, the modified Baxter discloses the body is configured to be secured to the patient such that it is retained in position proximal to the injection site (by strap 14, see fig. 1A Baxter).
Regarding claim 4, the modified Baxter discloses that at least a portion of the plurality of protrusions (12 Sealfon) is in the form of bumps, spikes or barbs extending from or through the operative face (12 Sealfon).
Regarding claim 9, the modified Baxter discloses a cover adapted to cover the operative face of the body ([0018] “covering” Baxter).
Regarding claim 13, the modified Baxter discloses that in use the injection site is located external to an outer edge of the body of the device and adjacent the body ([0010] Baxter).
Claims 5-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Baxter and Sealfon, as applied to claims 4, 5, 5, 5 and 9 above, respectively, in further view of Gillespie et al. (2013/0085556).
Regarding claim 5, the modified Baxter is silent regarding a secondary stimulus element is in the form of an active substance. However, Gillespie teaches a secondary stimulus element that is in the form of an active substance (supplemental body-care component 46 includes active substance [0057][0061] and protrusions [0060]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Baxter’s operative face protrusions with a pad including protrusions and an active substance, as taught by Gillspie, for the purpose of further enhancing the user’s skin surface as desired ([0061] Gillespie).
Regarding claim 6, the modified Baxter discloses that the active substance comprises a composition having a stimulating effect on the skin ([0061] Gillespie).
Regarding claim 7, the modified Baxter discloses that the active substance is a topical analgesic, anaesthetic or a natural or herbal product ([0061] Gillespie).
Regarding claim 8, the modified Baxter discloses that the active substance is stored in padding located on the operative face of the body ([0059][0061] Gillespie).
Regarding claim 10, the modified Baxter is silent regarding that the operative face of the body has padding attached thereto. However, Gillespie teaches padding attached to an operative face of a body (supplemental body-care component 46 includes active substance [0057][0061] and protrusions [0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Baxter’s operative face protrusions with a pad including protrusions and an active substance, as taught by Gillspie, for the purpose of further enhancing the user’s skin surface as desired ([0061] Gillespie). The modified Baxter discloses that the cover is shaped to cover the padding ([0018] “covering” disclosed by Baxter covers the entire body).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Baxter and Sealfon, as applied to claim 9 above, in further view of Gillespie et al. (2013/0085556) and Adams et al. (2019/0224461).
Regarding claim 11, the modified Baxter is silent regarding that a padding retains an active substance in use. However, Gillespie teaches padding attached to an operative face of a body (supplemental body-care component 46 includes active substance [0057][0061] and protrusions [0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Baxter’s operative face protrusions with a pad including protrusions and an active substance, as taught by Gillspie, for the purpose of further enhancing the user’s skin surface as desired ([0061] Gillespie). The modified Baxter discloses that the cover is shaped to cover the padding ([0018] “covering” disclosed by Baxter covers the entire body). The modified Baxter is silent regarding that the cover is designed to prevent compression of the padding. However, Adams teaches a cover 62 that is designed to prevent compression of the padding [0042]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Baxter’s cover with a removable rigid cap, as taught by Adams, for the purpose of preventing movement from an uncompressed state ([0042] Adams).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Baxter and Sealfon, as applied to claim 11 above, in further view of Vallero (2011/0288456).
Regarding claim 12, the modified Baxter is silent regarding an adhesive bandage that extends from the body and can be moved into position to cover the injection site. However, in fig. 1 Vallero teaches an adhesive bandage that extends from the body and can be moved into position to cover the injection site (110 [0054]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Baxter’s body with the addition of an adhesive bandage, as taught by Vallero, for the purpose of covering the injection site.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kravitz '209 discloses a device for reducing pain of injection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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