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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 14, 2026 has been entered.
Response to Arguments
The applicant's amendments and arguments/remarks have been fully considered but are moot in view of the new grounds of rejections presented herein. Specifically, the examiner has provided the Braig and Lenihan references to teach the limitations presented in the newly amended claims.
Response to Amendment
Election/Restrictions
Newly submitted claims 26-27 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The system is a system for sampling and delivery therapy to the user. The previous invention originally claimed was merely directed to sampling. As such these inventions appear distinct and would introduce a search burden as the delivery therapeutics is a new and distinct aspect.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 26-27 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 23 and 25 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.
Regarding claims 23 and 25: The term “machine learning model” is treated as a black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this model. For example, How many and what types of layers are there? How is the data propagated? What logics are programmed to help the machine learning model make a decision? Is the training supervised or unsupervised? What are the weightings? Are other training concepts used such as regression? It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
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.
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(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2020/0061337) in view of Braig et al. (US 2007/0179436).
Regarding claim 1, Singh teaches a system for sampling a patient fluid (Abstract; Paragraph 0140) comprising:
a port configured to be implanted in a patient (port 100, 200; Paragraphs 0139-0140);
a catheter in fluid communication with the port (Paragraphs 0139-0140), the catheter configured to be implanted in the patient (catheter 400; Paragraphs 0139-0140)
a pump in fluid communication with at least one of the port or the catheter (Paragraph 0140); and
Singh teaches the possibility of a processor being connected to the system (Paragraph 0106) but is silent on a computing device being able to control the pump.
Braig teaches at least one sensor configured to sense at least one parameter associated with one or more of the port, the pump, or the catheter (Paragraph 0139; pressure sensor 317, catheter 11); and
a computing device (210) communicatively coupled to the pump (203) and the at least one sensor (317), the computing device configured to control the pump based on the at least one parameter to automatically draw a target volume of the patient fluid via the catheter into the port (Paragraph 0139; “Thus, for example, with pump 203 operating to draw blood from patient P, if the pressure as measured by pressure sensor 317 is within a range of normal blood pressures, it may be assumed that blood is being drawn from the patient and pumping continues. However, if the pressure as measured by pressure sensor 317 falls below some level, then controller 210 instructs pump 203 to slow or to be operated in a forward direction to reopen the blood vessel.”).
It would have been obvious to one of ordinary skill in the art to have modified Singh with Braig because it can aids in determining whether the system is working properly or if there are potential complications with the patient thus allowing adjusting when needed (Paragraph 1039 of Braig).
Claim(s) 1, 3-6, 8-13, 21, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2020/0061337) in view of Lenihan et al. (US 2015/0094644).
Regarding claim 1, Singh teaches a system for sampling a patient fluid (Abstract; Paragraph 0140) comprising:
a port configured to be implanted in a patient (port 100, 200; Paragraphs 0139-0140);
a catheter in fluid communication with the port (Paragraphs 0139-0140), the catheter configured to be implanted in the patient (catheter 400; Paragraphs 0139-0140)
a pump in fluid communication with at least one of the port or the catheter (Paragraph 0140); and
Singh teaches the possibility of a processor being connected to the system (Paragraph 0106) but is silent on a computing device being able to control the pump.
Lenihan teaches at least one sensor configured to sense at least one parameter associated with one or more of the port, the pump, or the catheter (Paragraphs 0026 and 0056); and
a computing device communicatively coupled to the pump and the at least one sensor, the computing device configured to control the pump based on the at least one parameter to automatically draw a target volume of the patient fluid via the catheter into the port (Paragraphs 0026 and 0056-0057).
It would have been obvious to one of ordinary skill in the art to have modified Singh with Lenihan because it allows for the replenishing of fresh CSF to improve the status of the patient (Paragraphs 0039-0040 of Lenihan).
Regarding claim 3, Singh teaches wherein the patient fluid is cerebrospinal fluid (Paragraph 0140; ‘a clinician can utilize the fluid delivery system to sample cerebrospinal fluid for diagnostic purposes’).
Regarding claim 4, Singh teaches being able to sample fluid for diagnostic purposes (Paragraph 0140) which would mean that Singh is capable of sampling fluid from a spinal region or brain region as those are where CSF is collected. In the interest of compact prosecution, Lenihan teaches wherein the catheter is configured to be implanted in at least one of a spinal region or a brain region of the patient (Paragraph 0042; Figures 1A-1B). It would have been obvious to one of ordinary skill in the art to have modified Singh with Lenihan because Singh teaches the capability of this function (Paragraph 0140 of Singh) and it would enable treatment of various disorders (Paragraph 0021 of Lenihan) thus choosing the specific sampling region would be obvious to one of ordinary skill in the art and would yield predictable results.
Regarding claim 5, Singh teaches wherein the port is configured to be implanted subcutaneously (Paragraph 0139; ‘subcutaneously implanted port 100, 200’).
Regarding claim 6, Singh teaches wherein the port comprises a septum (106, 206) in fluid communication with the catheter, and the system further comprises a needle configured to pierce the septum to collect the patient fluid (Paragraph 0140).
Regarding claim 8, Singh is silent on the pump being implanted. Lenihan teaches wherein the pump is configured to be implanted in the patient (Paragraph 0022). It would have been obvious to one of ordinary skill in the art to have modified Singh with Lenihan because implanting the pump is a conventional in the art design choice which would be obvious to one of ordinary skill in the art and yield predictable results of a more integrated system.
Regarding claim 9, Singh teaches a system for sampling a cerebrospinal fluid (Abstract; Paragraph 0140), comprising:
a port having a septum, the port being configured to be implanted in a patient (port 100, 200; Paragraphs 0139-0140; septum 106, 206);
a catheter in fluid communication with the septum, the catheter configured to be implanted in the patients (catheter 400; Paragraphs 0139-0140); and
a pump in fluid communication with at least one of the port or the catheter (Paragraph 0140; ‘a clinician can utilize the fluid delivery system to sample cerebrospinal fluid for diagnostic purposes’); and
Singh teaches the possibility of a processor being connected to the system (Paragraph 0106) but is silent on a computing device being able to control the pump.
Lenihan teaches a computing device communicatively coupled to the pump, the computing device configured to control the pump to automatically draw, on a periodic basis, the cerebrospinal fluid via the catheter into the septum of the port for sampling (Paragraphs 0026 and 0056-0057).
It would have been obvious to one of ordinary skill in the art to have modified Singh with Lenihan because it allows for the replenishing of fresh CSF to improve the status of the patient (Paragraphs 0039-0040 of Lenihan).
Regarding claim 10, Singh is silent on the pump being implanted. Lenihan teaches wherein the pump is configured to be implanted in the patient (Paragraph 0022). It would have been obvious to one of ordinary skill in the art to have modified Singh with Lenihan because implanting the pump is a conventional in the art design choice which would be obvious to one of ordinary skill in the art and yield predictable results of a more integrated system.
Regarding claim 11, Singh teaches being able to sample fluid for diagnostic purposes (Paragraph 0140) which would mean that Singh is capable of sampling fluid from a spinal region or brain region as those are where CSF is collected. In the interest of compact prosecution, Lenihan teaches wherein the catheter is configured to be implanted in at least one of a spinal region or a brain region of the patient (Paragraph 0042; Figures 1A-1B). It would have been obvious to one of ordinary skill in the art to have modified Singh with Lenihan because Singh teaches the capability of this function (Paragraph 0140 of Singh) and it would enable treatment of various disorders (Paragraph 0021 of Lenihan) thus choosing the specific sampling region would be obvious to one of ordinary skill in the art and would yield predictable results.
Regarding claim 12, Singh teaches further comprising a needle configured to selectively couple to the port to collect the cerebrospinal fluid (Paragraph 0140).
Regarding claim 13, Singh teaches wherein the port is configured to be implanted subcutaneously (Paragraph 0139; ‘subcutaneously implanted port 100, 200’).
Regarding claim 21, Singh teaches the possibility of sensor and a processor being connected to the system (Paragraph 0106) but is silent on a computing device being able to control the pump. Lenihan teaches further comprising: at least one sensor communicatively coupled to the computing device, wherein the computing device is configured to control the pump to automatically draw the patient fluid into the port in response to receiving a signal from the at least one sensor (Paragraphs 0026 and 0056-0057).
It would have been obvious to one of ordinary skill in the art to have modified Singh with Lenihan because it allows for the replenishing of fresh CSF to improve the status of the patient (Paragraphs 0039-0040 of Lenihan).
Regarding claim 24, Singh teaches the possibility of sensor and a processor being connected to the system (Paragraph 0106) but is silent on a computing device being able to control the pump. Lenihan teaches further comprising: at least one sensor communicatively coupled to the computing device, wherein the computing device is configured to control the pump to automatically draw the cerebrospinal fluid into the septum in response to receiving a signal from the at least one sensor (Paragraphs 0026 and 0056-0057; examiner notes Singh in particular teaches the septum structure).
It would have been obvious to one of ordinary skill in the art to have modified Singh with Lenihan because it allows for the replenishing of fresh CSF to improve the status of the patient (Paragraphs 0039-0040 of Lenihan).
Claim(s) 2 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2020/0061337) in view of Lenihan et al. (US 2015/0094644) and in further view of Stewart et al. (US 2018/0021364).
Regarding claim 2, Singh teaches being able to sample fluid for diagnostic purposes (Paragraph 0140) which would mean that Singh is capable of sampling fluid from a patient with a diagnosis of at least one of glioma or ampotrophic lateral sclerosis (ALS). In the interest of compact prosecution, Stewart teaches wherein a diagnosis of the patient includes at least one of glioma or amyotrophic lateral sclerosis (ALS) (Paragraphs 0271 and 0424). It would have been obvious to one of ordinary skill in the art to have modified Singh with Stewart because Singh teaches the capability of this function (Paragraph 0140 of Singh) and it would enable treatment of various disorders/issues/tumors (Paragraph 0271 of Stewart) thus choosing the specific disorder/issue/tumor would be obvious to one of ordinary skill in the art and would yield predictable results.
Regarding claim 14, Singh teaches being able to sample fluid for diagnostic purposes (Paragraph 0140) which would mean that Singh is capable of sampling fluid from a patient with a diagnosis of at least one of glioma or ampotrophic lateral sclerosis (ALS). In the interest of compact prosecution, Stewart teaches wherein a diagnosis of the patient includes at least one of glioma or amyotrophic lateral sclerosis (ALS) (Paragraphs 0271 and 0424). It would have been obvious to one of ordinary skill in the art to have modified Singh with Stewart because Singh teaches the capability of this function (Paragraph 0140 of Singh) and it would enable treatment of various disorders/issues/tumors (Paragraph 0271 of Stewart) thus choosing the specific disorder/issue/tumor would be obvious to one of ordinary skill in the art and would yield predictable results.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2020/0061337) in view of Lenihan et al. (US 2015/0094644) and in further view of Tallarida et al. (US 2001/0056266).
Regarding claim 22, Singh is silent on the needle stop. Tallarida teaches wherein the port further comprises a needle stop positioned below the septum (Paragraph 0013). It would have been obvious to one of ordinary skill in the art to have modified Singh with Tallarida because it allows for less trauma and prevents potential penetration of the needle beyond where it is needed (Paragraph 0013 of Tallarida) and further the specific placement would be obvious to one of ordinary skill in the art since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C).
Claim(s) 23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2020/0061337) in view of Lenihan et al. (US 2015/0094644) and in further view of Kang (US 2020/0168312).
Regarding claim 23, Singh teaches the possibility of a processor being connected to the system (Paragraph 0106) but is silent on a computing device being able to control the pump. Lenihan teaches the use of a computing device to control a pump (Paragraphs 0026 and 0056-0057) but is silent on the use of a machine learning model. Kang teaches wherein the computing device implements a machine learning model, and wherein the computing device is configured to control the pump to automatically draw the patient fluid into the port in response to an output from the machine learning model (Paragraph 0007; see full disclosure).
It would have been obvious to one of ordinary skill in the art to have modified Singh with Kang because it can aid in preventing possibly situations that could being pain to a patient (Paragraphs 0002-0010 of Kang).
Regarding claim 25, Singh teaches the possibility of a processor being connected to the system (Paragraph 0106) but is silent on a computing device being able to control the pump. Lenihan teaches the use of a computing device to control a pump (Paragraphs 0026 and 0056-0057) but is silent on the use of a machine learning model. Kang teaches wherein the computing device implements a machine learning model, and wherein the computing device is configured to control the pump to automatically draw the cerebrospinal fluid into the septum in response to an output from the machine learning model (Paragraph 0007; see full disclosure).
It would have been obvious to one of ordinary skill in the art to have modified Singh with Kang because it can aid in preventing possibly situations that could being pain to a patient (Paragraphs 0002-0010 of Kang).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JASON SIMS can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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