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
This office action is responsive to the amendment filed on 11/20/2025. As directed by the amendment: claims 1, 6, 10, and 17-18 have been amended; claims 8-9, 13, and 15 have been cancelled; and no claims have been added. Thus, claims 1-7, 10-12, 14, and 16-20 are presently pending in this application.
Examiner notes that the Applicant has failed to identify (underline and strikethrough) all amended limitations (see for example, claim 1, line 6 previously recited “the top surface” and now recites “a top surface”).
Claim Objections
Claims 1 and 19-20 are objected to because of the following informalities:
Claim 1, lines 1-2 recite “A needle holding unit including for injection…, comprising:” however the language does not make sense because it is unclear what the unit includes. The examiner suggests removing the word “including”.
Claim 19, line 1 recites “The needle holding unit of claim 1 wherein the dead space volume is either, 28 μl, 29 μl, 30…” but should read “The needle holding unit of claim 1 wherein the dead space volume is either 28 μl, 29 μl, 30…”.
Claim 20, line 1 recites “each needle holding unit” but should read “the needle holding unit” in order to be consistent with the language recited in claim 1.
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 1 and 18-19 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 1 recites “(e) wherein, the needle comprises a low dead space design that reduces an amount of drug product required to treat a patient by more than 40% and provides low drug product reflux as compared to a needle that does not have the low dead space design” however it is unclear what structure is required for the claim limitation above. For purposes of examination, the examiner will interpret the required structure to perform the claimed limitation is a smaller diameter needle (for example, 30G, 31G, 32G, 33G, 34G, 35G, 36G, 37G, 38G or smaller), see Paragraph [0082].
Claim 18 recites the limitation "the backwall" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the dead space volume" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 7, 10-12, 14, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noronha et al. (US 20180042765 A1) (as evidenced by Prausnitz et al. (WO 2014036009 A1)).
Regarding claim 1, Noronha discloses a needle holding unit (Figs. 11-13) including for injection of a drug product into the suprachoroidal space of a patient’s eye, comprising:
(a) a needle (166) with a length of 700 to 1100 μm (Paragraph [0096]);
(b) a needle base (165) attached to the needle (Figs. 11-13);
(c) a needle hub (160) attached to the needle base (Figs. 11-13) that is made of a suitably rigid material (Paragraph [0072]), wherein;
(d) a top surface of the needle is a contoured surface extending from a high point to a low point with an angle theta θ between 30 degrees and 45 degrees (Examiner notes that WO2014/179698 has been incorporated by reference, see Paragraph [0096]. Prausnitz discloses a top surface of the needle 610 having a contoured surface extending from a high point 617 and a low point X3, see Fig. 13. Prausnitz also discloses that an angle theta θ θ1 being between 30 degrees and 45 degrees, see Paragraphs [1109] and [1121]);
(e) wherein, the needle comprises a low dead space design that reduces an amount of drug product required to treat a patient by more than 40% and provides low drug product reflux as compared to a needle that does not have the low dead space design (As noted above, the examiner is interpreting a smaller diameter needle as providing structure to a low dead space design. Noronha teaches that the microneedle 166 can be 30G, 32G, or 34G, see Paragraph [0096]), thus teaching a smaller diameter needle as evidenced by the disclosure of the present application, see Paragraph [0082]). The language “that reduces an amount of drug product required to treat a patient by more than 40% and provides low drug product reflux as compared to a needle that does not have the low dead space design” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The microneedle of Noronha can be 30G, 32G, or 34G, therefore it is capable of reducing an amount of drug product required to treat a patient by more than 40% and providing low drug product reflux as compared to a needle that does not have the low dead space design).
Regarding claim 2, Noronha discloses the needle holding unit of claim 1 wherein the needle has a length of 900 to 1000 μm (Paragraph [0096]).
Regarding claim 3, Noronha discloses the needle holding unit of claim 1, wherein the needle has a length of 925±30μm (Paragraph [0096]).
Regarding claim 4, Noronha discloses the needle holding unit of claim 1, wherein the needle is 29 to 33 gauge (Paragraph [0096]).
Regarding claim 7, Noronha discloses the needle holding unit of claim 1, wherein the needle hub is made of a metal (Paragraph [0072]) or a plastic.
Regarding claim 10, Noronha discloses the needle holding unit of claim 1, wherein an opening of the needle is circular, oval or oblong (Fig. 19 of Noronha and Fig. 7 of Prausnitz).
Regarding claim 11, Noronha discloses the needle holding unit of claim 1, wherein the needle is made of one or more of stainless steel (Paragraph [0072]), tungsten or silicon.
Regarding claim 12, Noronha discloses the needle holding unit of claim 1 wherein the needle hub includes a locking unit (163) to lock the needle hub to a syringe (Fig. 16).
Regarding claim 14, Noronha discloses the needle holding unit of claim 12 wherein the locking unit is configured to engage a Luer lock (163) on the syringe (Paragraph [0092]).
Regarding claim 16, Noronha discloses the needle holding unit of claim 1 wherein the needle includes an opening in the contoured cutting surface with the opening connecting to a channel in the needle that allows fluid to flow (Prausnitz discloses an opening connecting to a channel 614 in the needle 610 to allow fluid to flow, see Fig. 13 and Paragraphs [1117]-[1118]).
Regarding claim 17, Noronha discloses the needle holding unit of claim 1 wherein a lower point of the contoured cutting surface is connected to a lower portion (See 613 in Prausnitz) by an offset (See X4, Fig. 13, Paragraph [1119] in Prausnitz).
Regarding claim 18, Noronha discloses the needle holding unit of claim 1 wherein an offset is angled towards the backwall and connects to the low point of the contoured cutting surface (Prausnitz discloses the offset X4 being angled at θ2 towards a backwall 611 and connects to the low point X3, see Fig. 13).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Noronha et al. (US 20180042765 A1).
Regarding claim 5, Noronha discloses the needle holding unit of claim 1, wherein the needle base has can be any suitable shape, size, and/or configuration (Paragraph [0093]).
Noronha is silent regarding wherein the needle base has a height of 4 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the needle base of Noronha to a height of 4 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the needle base of Noronha would not operate differently with the claimed height. Further, applicant places no criticality on the height claimed.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Noronha et al. (US 20180042765 A1) in view of Kodama (US 20190381256 A1).
Regarding claim 6, Noronha discloses the needle holding unit of claim 1, wherein the needle base is made of a material or combination of materials that is/are relatively flexible and/or that has/have a relatively low durometer (Paragraph [0094]).
Noronha is silent regarding wherein the needle base is made of a metal, silicone, or a plastic.
In analogous art, Kodama teaches wherein a needle base (21) is made of silicone (Paragraph [0092]).
it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the needle base of Noronha to incorporate the teachings of Kodama to incorporate being made of silicone because it is a well-known material in the medical art/field.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Noronha et al. (US 20180042765 A1) in view of Bley et al. (US 20200261266 A1).
Regarding claim 19, Noronha discloses the needle holding unit of claim 1 but is silent regarding wherein the dead space volume is either, 28 μl, 29 μl, 30 μl, 31 μl, 32 μl, 33 μl, 34 μl, 35 μl, 36 μl, 37 μl, 38 μl, 39 μl, 40 μl, 41 μl, 42 μl or 43 μl.
In analogous art, Bley teaches a dead space volume is either, 28 μl, 29 μl, 30 μl, 31 μl, 32 μl, 33 μl, 34 μl, 35 μl, 36 μl, 37 μl, 38 μl, 39 μl, 40 μl, 41 μl, 42 μl or 43 μl (Paragraph [0093]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified a dead space volume of Noronha to incorporate the teachings of Bley to incorporate being either, 28 μl, 29 μl, 30 μl, 31 μl, 32 μl, 33 μl, 34 μl, 35 μl, 36 μl, 37 μl, 38 μl, 39 μl, 40 μl, 41 μl, 42 μl or 43 μl in order to deliver small volumes (Paragraph [0093]) and reduce medication waste.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Noronha et al. (US 20180042765 A1) in view of Bruehwiler et al. (US 20120041385 A1).
Regarding claim 20, Noronha discloses the needle holding unit of claim 1, but is silent regarding wherein each needle holding unit is individually packaged and labeled.
In analogous art, Bruehwiler teaches wherein each needle holding unit is individually packaged and labeled (Paragraph [0009]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified each needle holding unit of Noronha to incorporate the teachings of Bruehwiler to incorporate being individually packaged and labeled in order to identify the needle and provide a sterility barrier (Paragraph [0009]).
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive.
The claim objection made to claim 19 is being maintained because the claim was not amended to overcome the objection.
The 112(b) rejections made to claims 18-19 are also being maintained because the claims were not amended to overcome the rejections.
In response to applicant's arguments, on page 5, that Noronha (as evidenced by Prausnitz) does not teach “a top surface of the needle is a contoured surface extending from a high point to a low point with an angle theta θ between 30 degrees and 45 degrees”, the Examiner respectfully disagrees. Prausnitz discloses a top surface of the needle 610 having a contoured surface extending from a high point 617 and a low point X3, see Fig. 13. Prausnitz also discloses that an angle theta θ θ1 being between 30 degrees and 45 degrees, see Paragraphs [1109] and [1121].
In response to applicant's arguments, on page 5, that Noronha (as evidenced by Prausnitz) does not teach “wherein, the needle comprises a low dead space design that reduces an amount of drug product required to treat a patient by more than 40% and provides low drug product reflux as compared to a needle that does not have the low dead space design”, the Examiner respectfully disagrees, see rejection above.
Conclusion
THIS ACTION IS MADE FINAL. 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 HONG-VAN N TRINH whose telephone number is (571)272-8039. The examiner can normally be reached Monday-Friday 9:15-5:45 ET.
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, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783