DETAILED ACTION
Response to Amendment
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/13/2026 has been entered.
Acknowledgements
The abstract submitted on 4/13/2026 is accepted.
The 112 rejections are withdrawn in light of the claim amendments filed on 4/13/2026.
Claim Rejections - 35 USC § 102
Claims 1, 2, 4-6, 8, 9, 11, 12, 15, 16, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. 2017/0251976, by Schouenborg (“Schouenborg”).
Schouenborg discloses an implantation needle as claimed by Applicant, as follows.
Claim 1: An implantation needle (70 in Figs. 7, 7a) for inserting a subcutaneously insertable element into a body tissue (70 is fully capable of performing as claimed), the implantation needle comprising:
a needle body (71) having an exterior surface (Fig. 7a, where it meets 72); and
a covering (coating 72) disposed on the exterior surface (Fig. 7a), the covering comprising a pharmaceutical compound ([0031]), wherein the pharmaceutical compound is configured to remain at least partially in the body tissue after retraction of the implantation needle (Figs. 12-12c and [0039], describing the hydrated gel remaining in the patient upon retraction of the “pin”), wherein delamination of the covering from the implantation needle takes place during the retraction of the implantation needle from the body tissue (the hydrated gel separates from the underlying pin upon retraction of the pin as a whole, which is delamination of the gel layer from the pin’s exterior surface).
Claim 2: (The implantation needle according to claim 1,) wherein the pharmaceutical compound is selected from the group consisting of an immunosuppressive, an anti-allergic and an anti-inflammatory agent (anti-inflammatory agent, [0031]).
Claim 4: (The implantation needle according to claim 1,) wherein the pharmaceutical compound comprises at least one compound configured to improve tolerance of the subcutaneously insertable element (anti-inflammatory agent, [0031]).
Claim 5: (The implantation needle according to claim 1,) wherein the pharmaceutical compound is configured to reduce at least one of an immune rejection, a scarring, a growth of infectious agents (antibiotic, [0031]).
Claim 6: (The implantation needle according to claim 1,) wherein the covering comprises at least one excipient (the gel).
Claim 8: (The implantation needle according to claim 1,) wherein the implantation needle comprises an outer surface facing an outer environment of the implantation needle (outer surface of 71 in Fig. 7a) and an inner surface facing an interior space of the implantation needle (inner surface of 74), wherein the covering at least partially covers the outer surface (Fig. 7a).
Claim 9: (The implantation needle according to claim 1,) wherein the implantation needle comprises a subcutaneously insertable element receiving portion (any portion proximal of the distalmost end) and a tip portion that is at least partially covered with the covering (distalmost tip; the coated pin is fully capable of receiving the unclaimed element).
Claim 11: (The implantation needle according to claim 1,) wherein the pharmaceutical compound is configured to be released via a mechanical stripping process during withdrawal of the implantation needle from the body tissue ([0039], hydrated gel is stripped off of the underlying pin upon its retraction).
Claim 12: (The implantation needle according to claim 1,) wherein the pharmaceutical compound is configured to be released via a dissolving process of the pharmaceutical compound ([0031], pharmaceutical agent dissolves into the body fluids).
Claim 15: A method of manufacturing the implantation needle according to claim 1, the method comprising:
a) providing at least one needle element (needle 70 exists and therefore has been provided); and
b) covering at least one surface of the needle element with a pharmaceutical compound by a covering process to form the implantation needle ([0094], covered by dispensing).
Claim 16: (The method according to claim 15,) wherein the covering process is selected from the group consisting of dip coating, powder coating, spray coating, printing, lamination, dispensing (id.), physical vapor deposition, chemical vapor deposition, electrospinning, electroplating, and chemical surface functionalizing.
Claim 22: (The implantation needle according to claim 1,) (see treatment above) wherein a non-stick coating ([0090], TEFLON®) is arranged between the exterior surface and the covering at a receiving portion of the implantation needle, wherein the covering can be stripped from the implantation needle during retraction of the implantation needle (hydrated gel is stripped from the underlying pin upon pin retraction).
Claim Rejections - 35 USC § 103
Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Schouenborg as applied to Claim 1 above, and further in view of U.S. Patent App. Pub. 2007/0299409, by Whitbourne et al. (“Whitbourne ‘409”).
Schouenborg describes a device substantially as claimed by Applicant; see above. It does not, however, describe that:
the pharmaceutical compound is selected from the group consisting of dexamethasone, a derivative of dexamethasone, betamethasone, and a derivative of betamethasone (Claim 3); and
the excipient is selected from the group consisting of a polylactide, a polyglycolide, and a polydioxanone (Claim 7).
Whitbourne ‘409 relates to coatings for implantation needles, which coatings remain in the patient after retraction of the needle, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Whitbourne ‘409 teaches that the pharmaceutical agent in the coating and released to the patient can be dexamethasone ([0020], for inhibiting inflammation), and that polylactic acid can be used as an excipient in the coating ([0057], to enhance eventual bioerosion of the coating).
It 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, to make Schouenborg’s device so that the pharmaceutical compound is dexamethasone and the excipient is polylactide, because Whitbourne ‘409 teaches doing so in a closely related needle, in order to inhibit inflammation and to increase eventual bioerosion of the coating.
Claims 10, 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Schouenborg as applied to Claim 1 above, and further in view of U.S. Patent No. 5,997,517, granted to Whitbourne (“Whitbourne ‘517”).
Schouenborg describes a device substantially as claimed by Applicant; see above. It does not, however, describe that:
the tip portion further comprises an adhesive coating arranged between a surface of the implantation needle and the covering (Claim 10); or
an adhesive is arranged between the exterior surface and the covering at a tip portion of the implantation needle, wherein delamination of the covering from the implantation needle can be avoided during insertion of the implantation needle (see treatment above; Claim 21); or both (Claim 23).
Whitbourne ‘517 relates to coatings for implantation needles, which coatings remain in the patient after retraction of the needle, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Whitbourne ‘517 teaches that such needles can be provided with an adhesive layer (passim; see, e.g., Abstract, describing epoxies, which are adhesives) between the medical device substrate and a top coat, to improve the integrity of the device as a whole (col. 3, lines 22-28).
It 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, to make Schouenborg’s device to include adhesive coating arranged between a surface of the implantation needle and the covering, inhibiting delamination, because Whitbourne ‘517 teaches doing so in a closely related coated needle, to improve the integrity of the device as a whole.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Schouenborg as applied to Claim 1 above, and further in view of U.S. Patent App. Pub. No. 2016/0361091, by Frey et al. (“Frey”).
Schouenborg describes a device substantially as claimed by Applicant; see above. In addition, it discloses that its device can be a needle for which extends below a cutaneous layer (see Figs. 1a-2), thus disclosing to the reader that its coated device is to be used subcutaneously. Schouenborg does not describe its implantation needle in combination with a subcutaneously insertable element (Claim 13), or that the needle comprises a receiving portion configured to house the insertable element (Claim 14).
Frey relates to implantation needles and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Frey teaches that a subcutaneous access needle (1; see [0039) can be used with a subcutaneously insertable element (Abstract; passim), and that the needle comprises a receiving portion (5) configured to house the insertable element ([0039]), so that the implant can be planted into a patient subcutaneously for, e.g., analyte measurement ([0046]).
It 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, to provide Schouenborg’s coated, subcutaneous access needle in a kit with a subcutaneously insertable element, and that the needle comprises a receiving portion configured to house the insertable element, because Frey teaches doing so in a closely-related device, in order to implant an analyte sensor.
Response to Arguments
Applicant's arguments filed 4/13/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Schouenbourg fails to disclose or suggest an implantation needle wherein delamination of the pharmaceutical covering occurs during the retraction of the implantation needle, the examiner respectfully disagrees. The applicant argues that Schouenbourg discloses a pin having a layer of dry gel forming agent, wherein the gel forming agent forms a gel upon meeting an aqueous body fluid after inserting into tissue. The applicant further argues that the pin is left in place until the gelatin layer 22 has been fully dissolved and a gelatin gel 23 has been formed around the pin. The applicant argues that the dry gel is not delaminated because it is dissolved in aqueous fluid and the pin is only removed one the gel has been dissolved. This argument is not persuasive. The limitation in question is largely a functional limitation that describes what happens to the covering (delamination) during a certain action (retraction of the needle). The structure described by Schouenbourg certainly can meet this limitation. Schouenbourg discloses in par. [0096] that “Insertion should be as fast as possible to avoid dissolution of gelatin in the layer 22 by aqueous body fluid during insertion.” The implication is that the aqueous body fluid has the ability to dissolve the gelatin layer rapidly and this dissolution could take place during a quick insertion and retraction of the needle.
The examiner finds the argument unpersuasive for another reason. Par. [0039] describes the gel forming agent and the aqueous gel as the same structure, wherein the agent forms into the gel upon contact with an aqueous solution. The pin is ultimately delaminated from this structure when the pin is removed from the body and the aqueous gel and the aqueous gel remains in the body. This action certainly fits within the scope of the limitation in question in claim 1.
In response to the applicant’s argument (see 3rd full paragraph on page 9) that the non-stick coating prevents delamination of the pin and the gel, the examiner respectfully disagrees. The examiner maintains that the non-stick coating makes it easier for the pin to separate from the gel.
In response to the applicant’s argument about claim 21, the examiner respectfully disagrees. The applicant argues that Schouenbourg teaches away from incorporating an adhesive because Schouenbourg teaches at par. [0090] that an easy release between the gel and the pin is attained via a Teflon covering between the two structures. The examiner largely agrees with this reasoning but notes that a portion of the gelatin layer, specifically portion 22’, does not get dissolved and is removed with the pin (see par. [0096] and Figs. 1d-1e). A good adherence between this portion and the pin would be optimal in ensuring the portion is removed with the pin. The portion 22’ can be considered the tip portion because it is adjacent an end of the device. The same rationale applies to claims 10 and 23.
Conclusion
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
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