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 .
Election/Restrictions
Applicant’s election of Invention I in the reply filed on 01/06/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant cancelled each of the unelected Invention II claims.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claim 1 is 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.
As to Claim 1, the preamble should read --A system for injecting materials into a patient and for monitoring and controlling an injection process in real-time—to overcome antecedent basis issues.
The limitation “a positioning element that is designed to stabilize the needle in relation to the skin of the patient”, in Lines 5-6 should read --a positioning element that is designed to stabilize the needle in relation to a patient—to overcome antecedent basis issues.
The limitation “a controller that is designed to receive from the force sensor data measurement on said resistance force” should read --a controller that is designed to receive measurement data of said resistance force from the force sensor
The limitation “the controller is designed to detect in real-time penetration of the tip of the needle into the tissue of the patient, and to identify the kind of tissue layer that the tip of the needle is positioned, based on said data measurement on said resistance force and/or analysis made by the controller” should read -- wherein the controller is designed to detect in real-time penetration of a tip of the needle into the tissues of the patient, and to identify the kind of tissue layer of the tissues that the tip of the needle is positioned, based on said data of said resistance force and/or analysis made by the controller—to overcome antecedent basis issues, and correct grammatically confusing language.
The limitation “enabling to inject the materials in an upper part, a middle part or a lower part of a dermis layer or in another kind of tissue layer, depending on the specific treatment, and/or enabling to stop the movement of the needle in order to prevent penetration into blood vessels or directing the tip into the blood vessel in order to inject the material into the blood vessel”, in Lines 21-25, is indefinite.
It is not clear what structure is being enabled to either inject the material or stop the movement of the needle, rendering the claim indefinite.
It is not clear if the respective parts of the dermis layer and the another kind of tissue layer are part of the previously defined tissue layer, or if the parts are separate from the tissue layer. For the purpose of examination, each of the parts and the another kind of tissue layer will be interpreted as components of the tissue layer.
Additionally, the limitation in Lines 17-19, describes preventing the tip of the needle from piercing the blood vessel. The limitation in Lines 21-25 describes inserting the tip into the blood vessel. As such, the two limitations conflict with each other, since it is not clear how the tip can both avoid piercing the blood vessel and be placed within the blood vessel at the same time.
For the purpose of examination, the limitation in Lines 17-19 will be interpreted as the controller is designed to detect in real time a contact of the tip of the needle with a blood vessel data of said resistance force received in real-time from the force sensor.
The limitation in Lines 21-25 will be interpreted as are injected in an upper part of the tissue layers, a middle part of the tissue layers, or a lower part of a dermis layer of the tissue layers, or in another kind of tissue layer of the tissue layers, depending on a specific treatment[[,]]; and/or stopping the movement of the needle in order to prevent penetration into the blood vessel, or directing the tip into the blood vessel in order to inject the materials into the blood vessel.--
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Brodsky (U.S. PGPub 2016/0058957), in view of Bartlett (U.S. PGPub 2011/0202012).
As to Claim 1, Brodsky teaches a system (Figure 6) for injecting materials into a patient (Abstract) and for monitoring and controlling the injection process in real-time (at least Paragraph 0081), comprising:
a syringe (8),
a needle (7) that is connected or designed to be connected to (as shown in Figure 6) the syringe (8),
a positioning element (1) that is designed to stabilize (Paragraph 0080) the needle (7) in relation to the skin of the patient (the skin described in Paragraph 0080),
a force sensor (9) that is designed to measure resistance force (the insertion force described in Paragraph 0081) exerted on the needle (Paragraph 0084) during penetration (insertion; Paragraph 0084) of the needle (7) within (as shown in Figure 5) tissues (4/19/20) of the patient, and
a controller (21) that is designed to receive from (Paragraph 0081) the force sensor (9) data measurement (the output signal described in Paragraph 0081) on said resistance force (the insertion force described in Paragraph 0081);
wherein the controller (21) is designed to detect (Paragraph 0090) in real-time penetration of (18 in Figure 7) the tip (the tip of needle 7 described in Paragraph 0090) of the needle (7) into (as shown in Figure 5d) the tissue (4/19/20) of the patient…
wherein the controller (21) is designed to detect (Paragraph 0094) in real time a contact (23/24 in Figure 7) of the tip (the tip of needle 7 described in Paragraph 0090) of the needle (7) with a blood vessel (22) for avoiding blood vessel piercing or injuring (Paragraph 0095), based on the data measurement (the output signal described in Paragraph 0081reflecting the raise in the force between points 23/24 in Paragraph 0095) on said resistance force (the force measured by force sensor 9, as described in Paragraph 0095) received in real-time from (Paragraph 0095; Figure 7) the force sensor (9); and
wherein enabling to inject the materials in an upper part, a middle part or a lower part of a dermis layer or in another kind of tissue layer, depending on the specific treatment, and/or enabling to stop the movement (via stopping linear motor 12, as described in Paragraph 0095) of the needle (7) in order to prevent penetration (Paragraph 0095) into blood vessels (22) or directing the tip into the blood vessel in order to inject the material into the blood vessel. Multiple enablement options were provided as alternatives to each other. Since Brodsky teaches one of the options, the remaining options do not need to be taught.
Brodsky does not teach to identify the kind of tissue layer that the tip of the needle is positioned, based on said data measurement on said resistance force and/or analysis made by the controller.
Bartlett describes a similar injection system, and teaches to identify (via the tissue impedance reading described in Paragraphs 0040/0051) the kind of tissue layer (T1/T2/T3) that the tip (the tip of needle 25 described in Paragraph 0057) of the needle (25) is positioned (the location based on tissue impedance described in Paragraph 0051; as shown in Figures 1/9/10), based on said data measurement (the pressure/force reading described in Paragraph 0051) on said resistance force (Figures 9/10) and/or analysis made by (Paragraph 0051) the controller (23).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to identify the type of tissue, as taught by Bartlett, of the tissues, as taught by Brodsky, " to indicate when the desired insertion location has been reached (Paragraph 0040).”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Iwase (2011/0275994) and Riordan (2020/0086066) describe blood vessel avoidance methods based on pressure/force.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783