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 .
Acknowledgment
Claims 1, 3-4 are amended and filed on 9/9/2025.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The newly added limitation to claim 1, “a first layer of the flexible polymer….but not in the first layer” in the last 6 lines was not found in the specification.
Note: the applicant in the remark filed on 9/9/2025 pointed that ¶0019, ¶0028, ¶0029 and Fig. 1b of the current application are the disclosure for such amendment. However, Fig. 1b show that the nanoneedles are embedded in a layer of PMDS (PMDS is the substrate see ¶0028 of the current application ). Also, in ¶0028 show that PMDS was coated by a thin layer with unclear location and thickness..etc. Therefore, as disclosed, there is no support to limitation “ nanoneedles are placed on a surface of a first layer and …are embedded within the second layer but not in the first layer”.
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, “a first layer” and/or “a second layer” and “wherein the first ends of the nanoneedles are embedded with the second layer but not in the first layer “as claimed in claim 1 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.
Note: the applicant in the remark filed on 9/9/2025 that the Fig. 1b show upper layer as a first layer, but the upper layer (as shown in middle process of Fig. 1b) is not in the final product as in the right.
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 1-9 and 21 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.
In the last 6 line of claim 1, “a first layer of the flexible polymer material… the first ends of the nanoneedles are placed on a surface of a first layer and … the first ends of the nanoneedles are embedded within the second layer but not in the first layer” 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.
the applicant in the remark filed on 9/9/2025 argues that ¶0019, ¶0028, ¶0029 and Fig. 1b of the current application are the disclosure for such amendment. However, Fig. 1b show that the nanoneedles are embedded in a layer of PMDS (PMDS is the substrate see ¶0028 of the current application ). Also, in ¶0028 show that PMDS was coated by a thin layer with unclear location and thickness...etc. Therefore, as disclosed, there is no support to limitation “ nanoneedles are placed on a surface of a first layer and …are embedded within the second layer but not in the first layer”.
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 1-9 and 21 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 the limitation “a first layer of the flexible polymer material… the first ends of the nanoneedles are placed on a surface of a first layer and … the first ends of the nanoneedles are embedded within the second layer but not in the first layer” in the last 6 lines. It unclear if the first ends of the nanoneedles are placed and contact/attached to above
For the purpose of examination, the examiner will interpret the limitation as “the first ends of the nanoneedles are placed and a above
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 4, 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prace (US. 20060240218A1) in view of Chang et al. (US. 20140295558A1) (“Chang”).
Re Claim 1, Prace discloses a device for intracellular and intratissue nanoinjection of biomolecules into a living body (Fig. 1-6b, ¶0106 ), the device comprising: a flexible substrate (100, 110, ¶0102, ¶0105) formed of a flexible material (¶0019, ¶0105); and nanoneedles (120, Fig. 1) partly embedded in and extending (as 120b is inside 110) outwardly from a surface of the flexible substrate (top surface of 110, ¶0026), wherein the nanoneedles are rigid (¶0060, ¶0077), and wherein each nanoneedle has a first end (12b) that is completely embedded within the flexible substrate (110) and a tip end (120a) opposite the first end that extends out of the flexible substrate (Fig. 1) and further discloses that the nanoneedle can be in a cone shape (¶0054, the nanofibers), wherein the flexible substrate comprises: a first layer of the flexible polymer material (100), wherein the first ends of the nanoneedles are placed on a surface of the first layer (Fig.1);.and a second layer of the flexible polymer material coated on the surface of the first layer (110, ¶0026) wherein the second layer is physically bonded to the surface the first layer (¶0026), and wherein the first ends of the nanoneedles are embedded within the second layer but not in the first layer (Fig. 1), but it fails to discloses that each nanoneedle has a tapered diameter that increases in a direction from the tip end to the first end such that the diameter of the tip end is smaller than the diameter of the first end.
However, Chang discloses a device (Figs. 1-11) capable to be used for intracellular and intratissue nanoinjection of biomolecules into a living body (¶0046), the device comprising: a flexible substrate formed of a flexible material (¶0090); and wherein each nanoneedle (Fig. 2, Fig, 11) has a tapered diameter (¶0078) that increases in a direction from the tip end (top end with diameter around 528 nanometer) to the first end (lower end around 1.6 micrometer) that has the diameter around such that the diameter of the tip end is smaller than the diameter of the first end (¶0078).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the shape of nanoneedles of Prace so that each nanoneedle has a tapered diameter that increases in a direction from the tip end to the first end such that the diameter of the tip end is smaller than the diameter of the first end as taught by Chang for the purpose of using a shape that allow for safe use in biological and medical application and providing a very simple robust approach to achieve delivery of molecules effectively and efficiently (Chang, ¶0078, ¶0090).
Re claim 4, Prace discloses wherein the flexible substrate is optically transparent (¶0022).
Re claim 6, Prace discloses wherein the nanoneedles have heights (length that can be vary, ¶0099), but it is silent with regards that the heights is about 8 micrometers to about 70 micrometers.
However, Chang discloses a device (Fig. 1-11) and wherein the heights is about 8 micrometers to about 70 micrometers (around 8 micrometer 7.42±1.35 micrometer).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the length of the nanoneedles of Prace so that the nanoneedles has heights of about 8 micrometers to about 70 micrometers as taught by Chang for the purpose of using a shape that allow for safe use in biological and medical application and providing a very simple robust approach to achieve delivery of molecules effectively and efficiently (Chang, ¶0078, ¶0090
Re claim 7, Prace discloses wherein the nanoneedles have tip diameters of about 80 nm to about 3 micrometers (¶0033, greater than 100 nm)
Re claim 8, Prace discloses wherein each of the nanoneedles has an aspect ratio of about 2:1 to 125:1 ( the ratio of the height to the base diameter can be 10:1, 50:1, ¶0035).
Claim(s) 2-3, 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prace in view Cheng and further in view of Chang et al. (US. 20040260251A1) (“Chang II”).
Re claim 2, Prace discloses that the substrate is made from a flexible material, but it is silent that it is an elastomer material.
However, Chang II discloses a device (Fig. 3a-b) capable to be used for intracellular and intratissue nanoinjection of biomolecules into a living body (¶0019), the device comprising: a flexible substrate formed of a flexible material (310, PDMS ¶0033 similar to the material of the current case see ¶0022); and wherein the flexible material is an elastomer material (PDMS ¶0033 similar to the material of the current case see ¶0022).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the material of substrate of Prace so that it is made from an elastomer material as taught by Chang II for the purpose of using an art recognized material that used in substrate (Chang II, ¶0033).
Re claim 3, Prace discloses wherein the nanoneedles are formed of monocrystalline or silicon (¶0033 monocrystalline, ¶0052 silicon), but it is silent with regards that that nanoneedle is made from monocrystalline silicon.
However, Chang II discloses a device (Fig. 3a-b) capable to be used intratissue nanoinjection of biomolecules into a living body (¶0019), the device comprising: a flexible substrate formed of a flexible material (310, PDMS ¶0033 similar to the material of the current case see ¶0022); and wherein the nanoneedle (310) is made from monocrystalline silicon ((PDMS monomer ¶0033, ¶0032).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the material of nanoneedle made of Prace so that it is made from monocrystalline silicon as taught by Chang II for the purpose of using an art recognized material that used in nanoneedle (Chang II, ¶0033).
Re claim 5, Prace discloses wherein the flexible substrate has a thickness (thickness can be vary, ¶0055), but it is silent with regards that the thickness is about 80 micrometers to about 280 micrometers.
However, Chang II discloses a device (Fig. 3a-b) capable to be used for intracellular and intratissue nanoinjection of biomolecules into a living body (¶0019), the device comprising: a flexible substrate formed of a flexible material (310, PDMS ¶0033 similar to the material of the current case see ¶0022); and the flexible substrate has a thickness of about 80 micrometers to about 280 micrometers (¶0004).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the thickness of substrate of Prace so that thickness is about 80 micrometers to about 280 micrometers as taught by Chang II for the purpose of using an art recognized size of substrate (Chang II, ¶0004).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prace in view of Chang and further in view of Butte et al. (US. 20160058377A1) (“Butte”).
Re claim 9, Prace discloses a method of using the device of claim 1 (see rejection of claim 1), but it fails to disclose the method comprising: applying a composition comprising the biomolecules to the surface of the flexible substrate from which the nanoneedles extend; and then contacting a surface of a living body with the device such that tips of the nanoneedles extending away from the flexible substrate pierce the surface of the living body and the composition enters the living body.
However, Butte discloses a method of using a device (Fig. 1) and wherein the method comprising: applying a composition comprising the biomolecules to the surface of the flexible substrate from which the nanoneedles extend (¶0126, the needles and top surface of 111 coated with biomolecule such as sucrose); and then contacting a surface of a living body with the device such that tips of the nanoneedles extending away from the flexible substrate pierce the surface of the living body and the composition enters the living body ( then penetrate the skin, ¶00125).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the method of Prace so that the method comprising: applying a composition comprising the biomolecules to the surface of the flexible substrate from which the nanoneedles extend; and then contacting a surface of a living body with the device such that tips of the nanoneedles extending away from the flexible substrate pierce the surface of the living body and the composition enters the living body.as taught by Butte for the purpose of improving the penetration of the needles within the tissue (Butte, ¶0139).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prace in view of Chang and further in view Chiang et al. (US. 20070014981A1) (“Chiang”).
Re claim 21, Prace fails to disclose wherein the nanoneedles have nanoporous surfaces comprising nanoscale pores.
However, Chiang discloses a device (Fig. 1) and wherein the nanoneedles have nanoporous surfaces comprising nanoscale pores. (¶0018).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the nanoneedle of Prace so that the nanoneedles have nanoporous surfaces comprising nanoscale pores as taught by Chiang for the purpose of reducing the refractive index due to destructive interference and enhancing the visibility image (Chiang, ¶0018, ¶0002).
Response to Arguments
Applicant’s arguments, see remarks filed 9/9/2025, with respect to the rejection(s) of claim(s) 1 under 103 and with regards newly added limitation. This is found not persuasive as Prace has a first layer 100 and a second layer 110 and nanoneedles are embedded within second layer, but not the first layer see ¶0026 and Fig. 1 of Prace.
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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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.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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