DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 3, 2026 has been entered.
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 elastomeric needle shield positioned within the skin facing protrusion outwardly of the circumferential base portion 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.
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 1-5 and 7-11 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 is not clear where the specification discloses an elastomeric needle shield positioned within the skin facing protrusion outwardly of the circumferential base portion. Applicant has not indicated in the remarks where support for the amendments can be found and it is not immediately evident from the disclosure.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wall (US 2004/0116847 A1) in view of Gross et al. (US 5,527,288), Hadvary et al. (US 2013/0324884 A1), and Hessel (US 4,769,008).
With regard to claim 1, Wall teaches a medical fluid injection device that may be adhered to the skin of a patient, the device including: a housing including a skin-facing surface and upper and lower housing portions with the lower housing portion including the skin-facing surface (Fig. 1d member 10, the lower housing is taken as the lower half of the housing and the upper housing is the upper half of the housing); a medical fluid reservoir defined by an expandable elastomeric bladder having a fixed proximal end, a distal end and a bladder wall extending between the proximal and the distal end where the bladder is elongated between the proximal and distal ends and is expandable upon the pressurized introduction of medical fluid thereinto, an elastic force in the bladder wall of the elastomeric bladder solely, when the elastomeric bladder is expanded solely exerting a uniform pressure force on the medical fluid there within as the distal end of the bladder moves towards the proximal end (Figs. 1b-1d member 60, the proximal end facing the skin is fixed the opposing distal end 61 moves toward the proximal end [0061], the bladder is elongated between the proximal and distal ends as it extends the length between these ends, [0068] details the reservoir can be made of a material which contracts to reduce the volume, [0084] discloses that if a spring is used a constant force is applied for a constant rate which is interpreted as uniform pressure force, [0104] discloses various force means may be used/combined, the bladder is in contract with the fluid and is what is solely transferring pressure); an injection needle including an injection end movable between a retracted position within the housing and an injection position extending through the skin facing surface of the housing for injection into a patient, the needle being in fluid communication with the bladder in the injection position (Figs. 2a and 2e member 40).
Wall does not disclose a protrusion surrounded by a remaining portion of the skin-facing surface and including a circumferential base portion tapering away from the remaining portion of the skin-facing surface in a direction radially inwards towards the injection needle. However, Gross et al. teach a protrusion as recited (see Reference Figure 1 below), on an adhesively attached surface, which is beneficial for counter-acting the natural resilience of the skin to allow for better penetration (abstract, Col. 10 lines 42-46). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a protrusion with a circumferential base in Wall as Gross et al. teach this is beneficial for stretching the skin to aid in penetration.
Wall does not disclose the remaining portion of the skin-facing surface includes a circumferential edge that is tapered or curved toward the upper housing. However, Gross et al. teach the remainder of the skin-facing surface may be curved toward the upper housing for counter-acting the natural resilience of the skin to allow for better penetration (Fig. 10, surface 104, Col. 10 lines 42-46). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a curved skin-facing surface in Wall as Gross et al. teach this is beneficial for enhancing penetration. Further, one of ordinary skill would combine both the embodiments of Figs. 10 and 11 since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. This would enhance penetration further by enhancing the stretching.
Wall does not disclose an elastomeric needle shield. However, Hadvary et al. teach an elastomeric seal within a skin facing protrusion within which an injection needle is embedded prior to use which would prevent leaking and accidental needle sticks (Fig. 3 member 18, [0046], [0049]). Such a seal would also necessarily enhance sterility. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a shield in Wall as in Hadvary et al. as this would close the end of the needle to prevent leakage and would necessarily enhance sterility. As combined the protrusion extends from the skin-facing surface of the wall, a septum seal as in Hadvary et al. is placed within the opening of the protrusion and extends into the opening above the wall, this places it outward of the circumferential base as it is above the base. The device would still be able to operate to provide delivery.
Wall does not disclose an inner plug in the expandable blader with a larger diameter to pre-stress the blader. However, Hessel teaches pressurized fluid dispensing with a bladder which pre-stresses the bladder so that constant pressure is provided during delivery to reliably delivery contents at a substantially constant flow rate (Col. 1 lines 10-26, 48-60, Fig. 2 plug 4 bladder 2). Additionally, Gross et al. teach using just a pre-stressed bladder in place of a bladder and spring (Col. 9 lines 1-10). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a pre-stressed bladder in place of the bladder and spring of Wall as Hessel teaches this is beneficial for providing constant pressure for a constant flow rate and Gross et al. teach such to be equivalent. This would yield the same predictable result of delivery.
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With regard to claims 2-5, see Fig. 1b and exemplary Fig. 5 releasable member 120, adhesive portions 122 and 127, cover 129, 122 is pierced by the needle and remains on the skin ([0131], [0143], [0144]). This would be placed over the protrusion provided by the combination above.
Claims 7-11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wall (US 2004/0116847 A1) in view of Gross et al. (US 5,527,288), and Hadvary et al. (US 2013/0324884 A1).
With regard to claim 7, Wall teaches a medical fluid injection device that may be adhered to the skin of a patient, the device including: a housing including a skin-facing surface and upper and lower housing portions with the lower housing portion including the skin-facing surface (Fig. 1d member 10, the lower housing is taken as the lower half of the housing and the upper housing is the upper half of the housing); a medical fluid reservoir defined by an expandable elastomeric bladder having a fixed proximal end, a distal end and a bladder wall extending between the proximal and the distal end where the bladder is elongated between the proximal and distal ends and is expandable upon the pressurized introduction of medical fluid thereinto, an elastic force in the bladder wall of the elastomeric bladder solely, when the elastomeric bladder is expanded solely exerting a uniform pressure force on the medical fluid there within as the distal end of the bladder moves towards the proximal end (Figs. 1b-1d member 60, the proximal end facing the skin is fixed the opposing distal end 61 moves toward the proximal end [0061], the bladder is elongated between the proximal and distal ends as it extends the length between these ends, [0068] details the reservoir can be made of a material which contracts to reduce the volume, [0084] discloses that if a spring is used a constant force is applied for a constant rate which is interpreted as uniform pressure force, [0104] discloses various force means may be used/combined, the bladder is in contract with the fluid and is what is solely transferring pressure); an injection needle including an injection end movable between a retracted position within the housing and an injection position extending through the skin facing surface of the housing for injection into a patient, the needle being in fluid communication with the bladder in the injection position (Figs. 2a and 2e member 40).
Wall does not disclose a protrusion surrounded by a remaining portion of the skin-facing surface and including a circumferential base portion tapering away from the remaining portion of the skin-facing surface in a direction radially inwards towards the injection needle. However, Gross et al. teach a protrusion as recited (see Reference Figure 1 above), on an adhesively attached surface, which is beneficial for counter-acting the natural resilience of the skin to allow for better penetration (abstract, Col. 10 lines 42-46). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a protrusion with a circumferential base in Wall as Gross et al. teach this is beneficial for stretching the skin to aid in penetration.
Wall does not disclose the remaining portion of the skin-facing surface includes a circumferential edge that is tapered or curved toward the upper housing. However, Gross et al. teach the remainder of the skin-facing surface may be curved toward the upper housing for counter-acting the natural resilience of the skin to allow for better penetration (Fig. 10, surface 104, Col. 10 lines 42-46). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a curved skin-facing surface in Wall as Gross et al. teach this is beneficial for enhancing penetration. Further, one of ordinary skill would combine both the embodiments of Figs. 10 and 11 since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. This would enhance penetration further by enhancing the stretching.
Wall does not disclose an elastomeric needle shield. However, Hadvary et al. teach an elastomeric seal within a skin facing protrusion within which an injection needle is embedded prior to use which would prevent leaking and accidental needle sticks (Fig. 3 member 18, [0046], [0049]). Such a seal would also necessarily enhance sterility. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a shield in Wall as in Hadvary et al. as this would close the end of the needle to prevent leakage and would necessarily enhance sterility. As combined the protrusion extends from the skin-facing surface of the wall, a septum seal as in Hadvary et al. is placed within the opening of the protrusion and extends into the opening above the wall, this places it outward of the circumferential base as it is above the base. The device would still be able to operate to provide delivery.
If Wall is not found to teach the expandable elastomeric bladder to provide force as claimed, additionally, Gross et al. teach using just a pre-stressed bladder in place of a bladder and spring (Col. 9 lines 1-10). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a pre-stressed bladder in place of the bladder and spring of Wall as Gross et al. teach such to be equivalent. This would yield the same predictable result of delivery.
With regard to claims 8-11, see Fig. 1b and exemplary Fig. 5 releasable member 120, adhesive portions 122 and 127, cover 129, 122 is pierced by the needle and remains on the skin ([0131], [0143], [0144]). This would be placed over the protrusion provided by the combination above.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The references of record are relied upon to teach the new limitations as rejected above. The Examiner notes previously the bladder of Wall was combined with Hessel and the spring was substituted out. As noted in the 112 rejection it is not clear how the shield extends outwardly of the base. As combined and rejected above the seal would extend into the housing and is thus outward of the base.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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