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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
This Action is responsive to the Reply filed on 26 November 2025 (“Reply”). As directed in the Reply:
Claims 1 and 16 have been amended;
no claims have been and/or remain cancelled; and
Claims 21 and 22 have been added.
Thus, Claims 1-22 are presently pending in this application, with Claims 17-20 having been previously withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to claims 1-16, 21, and 22 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.
Specification
The Abstract of the Disclosure (“Abstract”) is objected to because, while its text is now acceptable, it does not commence on a separate sheet, apart from any other text, 37 C.F.R. §§ 1.52(b)(4), 1.72(b).
Claim Rejections - 35 USC § 112
Claims 21 and 22 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 21, line 3, recites “can be avoided” and Claim 22, line 3, recites “can be stripped;” neither of these functions are associated with a particular structure; therefore, the scopes of the claims are indefinite, because it is unclear which structure performs each function. The Examiner suggests rewriting both claims, with the following suggestion for Claim 21 (which is how the claims are being treated; Claim 22 can be amended similarly):
21. The implantation needle according to claim 1, [[wherein]] further comprising:
an adhesive [[is]] arranged between the exterior surface and the covering at a tip portion of the implantation needle, wherein the adhesive inhibits delamination of the covering from the implantation needle [[can be avoided]] during insertion of the implantation needle.
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 and 21 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).
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.
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 Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 01/08/2026