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.
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 Kang and Tallarida references to teach the limitations presented in the newly amended claims.
Response to Amendment
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, 3, 5-6, 9, 12-13, 21, and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2020/0061337) in view of Kang (US 2020/0168312).
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.
Kang teaches a computing device communicatively coupled to the pump, the computing device configured to control the pump to automatically draw the patient fluid via the catheter into the port (Figure 1; Figure 5; Paragraph 0047).
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 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 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 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.
Kang teaches a computing device communicatively coupled to the pump, the computing device configured to control the pump to automatically draw the cerebrospinal fluid via the catheter into the septum of the port for sampling (Figure 1; Figure 5; Paragraph 0047).
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 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. Kang 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 0018, 0020, 0024, and 0049).
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 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. 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 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. Kang 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 0018, 0020, 0024, and 0049; Examiner notes Singh specifically is used to teach the cerebrospinal fluid such that in combination Singh in view of Kang teaches this claim).
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. 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).
Claim(s) 2, 4, 11, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2020/0061337) in view of Kang (US 2020/0168312) 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 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, Stewart 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 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 (Paragraph 0271 of Stewart) thus choosing the specific sampling region would be obvious to one of ordinary skill in the art and would yield predictable results.
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, Stewart 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 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 (Paragraph 0271 of Stewart) thus choosing the specific sampling region 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) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2020/0061337) in view of Kang (US 2020/0168312) and in further view of Imran et al. (US 2022/0296868).
Regarding claim 8, Singh is silent on the pump being implanted. Imran teaches wherein the pump is configured to be implanted in the patient (Paragraphs 0157-0162). It would have been obvious to one of ordinary skill in the art to have modified Singh with Imran because Imran teaches the implementation of the pump as being a design choice (Paragraph 0157) which would be obvious to one of ordinary skill in the art and yield predictable results of a more integrated system.
Regarding claim 10, Singh is silent on the pump being implanted. Imran teaches wherein the pump is configured to be implanted in the patient (Paragraphs 0157-0162). It would have been obvious to one of ordinary skill in the art to have modified Singh with Imran because Imran teaches the implementation of the pump as being a design choice (Paragraph 0157) which would be obvious to one of ordinary skill in the art and yield predictable results of a more integrated system.
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 Kang (US 2020/0168312) 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).
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 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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