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
The Amendment filed 06/04/2026 has been entered. Claim 3 is pending in the application. Claims 1-2 are cancelled. Claim 3 is entered as “New”.
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.
Claim 3 is 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.
As to Claim 3, applicant has failed to show possession of the claimed invention by failing to provide sufficient detail needed to understand what the invention is and how it works. Applicant claims the controller is further configured to detect in real time contact of the tip of the needle with a blood vessel based on the identified type of tissue layer in which the needle tip in positioned and based on a rate of change and a magnitude of variation in the real-time force measurement data. This raises questions to what applicant had possession of, in that neither the specification nor the drawings, or a combination thereof, adequately explain how the controller is capable of using 1) the identified tissue type, 2) rate of change, and 3) a magnitude of variation to determine if the needle tip has contacted the blood vessel.
The original disclosure only describes the use of change in magnitude to determine identify the type of tissue. The original disclosure does not describe using any of the three variable listed in the limitation. As such, the limitation is considered new matter.
The original disclosure does not disclose how to use the identified tissue type to identify the tissue type. This is a circular identification means.
The original disclosure does not disclose using a rate of change to identify the tissue type, only a magnitude change.
The original disclosure does not disclose a magnitude of variation, only a magnitude change. It should be noted –see attached Change vs. Variation - What's the Difference_ _ This vs. That pdf from the website thisvsthat.io describing the difference between the terms “change” and “variation”—the terms “change” and “variation” are not synonymous with each other. As such, Applicant does not have sufficient support for using the term “variation” in place of the term “change”.
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 3 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 3, the limitation “a controller configured to receive real-time force measurement data from the force sensor indicative of a resistance force”, in Lines 13-14, is indefinite. It is not clear if the “real-time force measurement data from the force sensor indicative of a resistance force” described in the limitation is the same data as the “resistance force exerted on the needle during penetration of the needle” described in Lines 7-8, or if the two data sets are different. For the purpose of examination, the two data sets will be interpreted as the same data set.
The term “the plunger”, in Line 11, lacks antecedent basis.
The limitation “wherein the controller is further configured to detect in real time contact of the tip of the needle with a blood vessel based on the identified type of tissue layer in which the needle tip in positioned and based on a rate of change and a magnitude of variation in the real-time force measurement data”, in Lines 19-22, is indefinite. The limitation is grammatically confusing. The phrase “in positioned”, in Line 21, should read –is positioned.
One of ordinary skill in the art would interpret a blood vessel as being comprised of tissue. As such, it is not clear if the blood vessel first described in Line 20 is part of the tissues described in Line 18, or if the blood vessel is separate from the tissues. For the purpose of examination, the blood vessel will be interpreted as part of the tissues.
As described in the 112(a) rejection above, the original disclosure does not provide sufficient support for identifying the tissue based on each of 1) the identified tissue type, 2) rate of change, and 3) a magnitude of variation. As such, it is not clear how the controller is capable of identifying the tissue based on each of the three variables. The first variable relies on the tissue to be identified before the tissue can be identified. The last two variables are not even mentioned in the disclosure.
The phrase “further penetration of the needle into the detected blood vessel”, in Lines 24-25, is indefinite. The phrase implies the needle has previously penetrated the blood vessel. However, this has not been claimed. The needle penetrates tissues in Lines 7-8, but this is not necessarily penetrating the blood vessel, since other tissues may be penetrated. The needle contacts a blood vessel in Lines 19-20, but this does not inherently mean the needle penetrated the blood vessel. As such, the phrase does not appear to have proper antecedent basis, since the needle has not previously penetrated the blood vessel. For the purpose of examination, the phrase will be interpreted as simply “penetration of the needle into the detected blood vessel”, where the term “further” is removed.
Response to Arguments
Applicant's arguments filed 06/04/2026 have been fully considered but they are not persuasive.
Regarding the 112 rejections, new Claim 3 has new 112(a) and 112(b) rejections.
Regarding the 103 rejection, Applicant argues Brodsky, in view of Bartlett, does not teach new Claim 3. Examiner disagrees.
In light of the 112 rejections above, Examiner is unable to determine if the application is in condition for allowance.
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 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
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