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 without traverse of Species II in the reply filed on 06/23/2026 is acknowledged.
Claims 6-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/23/2026.
Information Disclosure Statement
The Examiner notes that the Information Disclosure Statement (IDS) submissions (see attachments) are extremely long, citing over 300 references for consideration. The Examiner has considered all of the references submitted as part of the Information Disclosure Statements, but has not found any to be of particular relevance. If Applicant is aware of pertinent material in the references, it should be stated in a response to this Office action. Applicant is reminded of MPEP § 2004, paragraph 13:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Moreover, an IDS should comply with 37 CFR 1.56 (b) which states that "information is material to patentability which is not cumulative to information already of record or being made of record in the application …" [emphasis added]. The cited references, in addition to being extensive in volume, also appear to be largely cumulative, therefore, based upon the large number of references cited, the initialed references have been considered in a cumulative manner. Examiner further notes that numerous cited references appear to have little or no relevance at all to the disclosed/claimed invention, many of which do not even mention a drape and/or a valve.
Double Patenting
Claims 1-2 & 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1 & 7-8 of copending Application No. 18/289,531 (Prior – 11/03/2023 Claim set), in view of 2017/0000946 (Boyle).
As to Claim 1, Prior teaches a surgical fluid management system comprising:
a surgical instrument (Claim 1, Line 2);
a collection container (Claim 1, Line 3);
a fluid outflow tube coupled to the surgical drape and the collection container for withdrawal of exudate from the surgical instrument into the collection container (Claim 1, Lines 4-6); and
a valve disposed within the fluid outflow tube (Claim 7), the valve having a closed position for preventing flow into the collection container from the surgical instrument and an open position for enabling flow through the surgical instrument into the collection container (Claim 8).
Prior does not teach the surgical instrument is a surgical drape.
Boyle describes a similar surgical fluid management system with an exudate management system, and teaches the surgical instrument is a surgical drape (170).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the surgical instrument, as taught by Prior, a surgical drape, as taught by Boyle, since “to draw waste fluid into a collection container (Paragraph 0088).
As to Claim 2, Prior, as modified, teaches each limitation of Claim 1, and continues to teach the valve is a stopcock valve (Claim 17).
As to Claim 5, Prior, as modified, teaches each limitation of Claim 1, and continues to teach the surgical drape (Boyle 170) includes a body (Boyle 170) defining a cavity therein (one of ordinary skill in the art would conclude Boyle drape 170 must have a cavity in order to collect fluid, as described in Boyle Paragraph 0091), and a second end (the bottom of Boyle 170, as viewed in Boyle Figure 12) of the body (Boyle 170) is coupled to (as shown in Boyle Figure 12) the fluid outflow tube (Prior Claim 1, Lines 4-6).
This is a provisional nonstatutory double patenting rejection.
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.
Claims 1-3 & 5 are rejected under 35 U.S.C. 103 as being unpatentable over Boyle (U.S. PGPub 2017/0000946), in view of Chin (U.S. PGPub 2009/0270898).
As to Claim 1, Boyle teaches a surgical fluid management system (Figure 12) comprising:
a surgical drape (170);
a collection container (175);
a fluid outflow tube (see Figure 12 below) coupled to (as shown in Figure 12) the surgical drape (170) and the collection container (175) for withdrawal of exudate (the waste fluid, as described in Paragraph 0088) from (Paragraph 0088) the surgical drape (170) into (Paragraph 0088) the collection container (175); and
a valve (166) disposed within (as shown in Figure 12) the fluid outflow tube (see Figure 12 below), the valve…an open position (one of ordinary skill in the art would conclude valve 166 is open if fluid is flowing from drape 170 to container 175, as described in Paragraph 0088) for enabling flow through (Paragraph 0088) the surgical drape (170) into the collection container (175).
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Boyle Figure 12, Modified by Examiner
Boyle only teaches valve 166 controls the flow of waste fluid, but does not explicitly teach the valve having a closed position for preventing flow into the collection container from the surgical drape.
Chin describes a similar surgical fluid management system with an exudate management system, and teaches the valve (228) having a closed position for preventing flow into (Paragraph 0094).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the valve, as taught by Chin, in place of the valve, as taught by Boyle, since stopcock valves are well-known valves, and yield predictable results, i.e., regulate fluid flow.
As to Claim 2, Boyle, as modified, teaches all the limitations of Claim 1, and continues to teach the valve (Chin 228) is a stopcock valve (Chin Paragraph 0081).
As to Claim 3, Boyle, as modified, teaches all the limitations of Claim 1, and continues to teach a control console (Boyle 200) including (Boyle Paragraph 0088) a vacuum pump assembly (Boyle 420); and
a vacuum line (the line between Boyle port 427 and Boyle collection container 175, as described in Boyle Paragraph 0088) coupled to (Boyle Paragraph 0088) the vacuum pump assembly (Boyle 420) and the collection container (Boyle 175) for providing suction through (Boyle Paragraph 0088) the fluid outflow tube (see Boyle Figure 12 in the Claim 1 rejection above).
As to Claim 5, Boyle, as modified, teaches all the limitations of Claim 1, and continues to teach the surgical drape (Boyle 170) includes a body (Boyle 170) defining a cavity therein (one of ordinary skill in the art would conclude Boyle drape 170 must have a cavity in order to collect fluid, as described in Boyle Paragraph 0091), and a second end (the bottom of Boyle 170, as viewed in Boyle Figure 12) of the body (Boyle 170) is coupled to (as shown in Boyle Figure 12) the fluid outflow tube (see Boyle Figure 12 in the Claim 1 rejection above).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Boyle, in view of Chin, further in view of Roberts (U.S. PGPub 2008/0082084).
As to Claim 4, Boyle, as modified, teaches all the limitations of Claim 1, and continues to teach the use of Boyle control console 200 controlling valves (Paragraph 0048), but is silent on controlling Boyle valve 166, specifically. As such, Boyle, as modified, is silent on how the vale is controlled, so does not explicitly teach the control console controls the valve.
Roberts describes a waste management system, and teaches the use of an electromechanical (Paragraph 0018) valve (20).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to control, as taught by Roberts, the valve, as taught by Boyle, as modified, to automate the valve.
Modifying Roberts into Boyle, as modified, results in the control console (Boyle 200 and the Roberts electromechanical portion, as described in Roberts Paragraph 0018) controls (Roberts Paragraph 0018) the valve (Chin 228).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shener-Irmakoglu (2018/0014842 – see Figure 1) describes a similar surgical fluid management system.
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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