DETAILED ACTION
This office action is responsive to the amendment filed December 17, 2025. By that amendment, claims 1-3, 6-8, and 12 were amended. Claims 1-15 are pending.
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 Arguments
The objection to claim 12 was overcome by the amendment to the claim of December 17, 2025.
It is now stated on the record that applicant did not intend to invoke 35 USC 112(f) in his claims. The terms cooling agent and collecting agent have been amended to second agent and first agent, respectively. Examiner will treat these limitations as broadly as is reasonable in light of the instant disclosure.
Applicant's arguments filed December 17, 2025, related to the rejections of claims 1-12 under 35 USC 102(a)(1) in view of Rivat et al. (US 2018/0021859 A1) and claims 13-15 under 35 USC 103 in view of Rivat have been fully considered but they are not persuasive.
The arguments have been carefully considered.
At p. 6, it is argued that Rivat is not a medical kit or medical debris collector because Rivat is disclosed for use in the construction field, rather than the medical field.
At pp. 6-7, it is argued that gel which passes from the first chamber to the second chamber will not inherently function as cooling agent.
At pp. 7-8, it is argued that Rivat fails to teach certain claimed features of claim 6.
Finally, at p. 8, it is argued that the rejection under 35 USC 103 does nothing to resolve the alleged deficiencies of the rejection under 35 USC 102; and further that since Rivat is not in analogous art to the instant invention, that the rejection is improper.
Regarding the argument that Rivat is not disclosed for the medical field, examiner agrees. However, Examiner takes the position that Rivat meets each claimed structural limitation as identified in the rejections of record, and is fully capable of achieving each claimed function, as identified in the rejections. Initially, examiner notes that the construction field disclosure appears to be a narrower teaching than entirely what is encompassed by Rivat – Rivat further teaches use in “drilling of any material with a hand tool”; and teaches that not only can the tool be used on walls but “surfaces”.
MPEP 2131.05 states in relevant parts “Arguments that the alleged anticipatory prior art is ‘nonanalogous art’ … [are] not ‘germane’ to a rejection under section 102.” “The question of whether a reference is analogous art is not relevant to whether that reference anticipates. A reference may be directed to an entirely different problem than the one addressed by the inventor, or may be from an entirely different field of endeavor than that of the claimed invention, yet the reference is still anticipatory if it explicitly or inherently discloses every limitation recited in the claims.”
The argument states that no evidence is provided that Rivat could be used in a medical setting, and that it is not inherent that one could do so “because some devices for the construction field are not suitable for use in a medical setting”. Examiner disagrees that there is any reason that the Rivat one could not place the Rivat device into a medical field, pass a drill bit therethrough, and collect debris from drilling within the Rivat device in the medical field, in the same manner as the claimed device is claimed to be capable of doing. Examiner takes the position that there is nothing about the Rivat device that makes it not suitable for use in a medical setting, or incapable of performing each claimed functional limitation.
It is then suggested that there is no suggestion that Rivat is capable of collecting medical debris. Examiner disagrees. Rivat specifically teaches collection of dust residues “or any other debris created by a drilling operation”. [0002] It is examiner’s position that bone chips or any other incidental debris (e.g. metal fragments from a bone plate) are debris created by a drilling operation. Such debris becoming loose in a field which are then carried away by a drill bit will interact with the collection materials of Rivat.
Even more, the instant invention has taught use of gel as its collecting agent. It is this gel which is capable of collecting drilling debris or medical debris. Rivat discloses gel as his collecting agent. It is therefore clear that Rivat’s disclosed gel is capable of collecting drilling debris or medical debris as claimed, based on the instant disclosure. Examiner therefore maintains his position that it is, indeed, inherent that Rivat’s gel is capable of collecting surgical debris.
Therefore this argument is not found persuasive.
Regarding the argument that Rivat’s gel will not function as a cooling agent, examiner disagrees. It is initially noted that the claim language does not require cooling agent actually be present in the second compartment – only the capability of the second compartment to be able to provide such an agent. Examiner takes the position that the Rivet second compartment is capable of retaining gel, whether or not it actually does. Examiner cited the gel reaching this second compartment in Rivat only as evidence that the second compartment can actually contain a cooling agent (e.g. gel).
As to the argument that Rivat’s gel will not inherently function as a cooling agent – examiner disagrees. However, rather than discussing the laws of thermodynamics here to prove inherency (since examiner will be ‘over his skis’ very quickly), examiner will instead point to applicant’s own disclosure which teaches that the cooling agent can be gel. “The material of the cooling agent may be the same as the material of the collecting agent” ([0023], published application, instant). The collecting agent has been specifically taught as a gel ([0022, [0032], published application, instant). It is therefore examiner’s position that applicant’s own disclosure has taught that gel is properly a cooling agent.
The combination of Rivat’s teaching of a second chamber clearly capable of carrying gel (and actually doing so); and the instant disclosure of the cooling agent being the same as the collecting agent (and the collecting agent in the instant application being gel), it is not proper to state that disclosure of gel in the second chamber in Rivat does not read on the claimed limitations.
The argument is not found persuasive.
Regarding claim 6, it is specifically argued that the drill bit carrying gel to the second chamber does not read on the claimed “collector being configured to provide the cooling agent to a drilling zone of a workpiece during a drilling process via the at least one outlet”. Applicant’s argument clarifies that a ‘drilling zone’ is ‘e.g. at a screw to be drilled out’.
Examiner now understand what the claim is intended to require, based on this argument, and agrees that this intended meaning is not taught by Rivat. However, this is not what examiner understood the claim to require, and maintains his position that Rivat reads on the words of the claim.
The claimed ‘drilling zone of a workpiece’ is not required to be treated as narrowly as applicant apparently wishes the limitation to be interpreted based on the argument. Rather, examiner read the claim and understood differently:
This is the first instance of the term “a drilling zone of a workpiece” in this claim (this claim depending from claims 2 and 1, originally, and now only claim 1).
Examiner understood a workpiece to be a working tool for purposes of making the rejection. While examiner now understands that the workpiece was intended to be the structure which the drill acts, he sees no reason his original understanding of the claim was improper. The drill bit, itself is not required to be passed through the collector in the claims (only capable of passing therethrough), and nothing clarifies what the workpiece is in this claim
A drilling zone of a workpiece can be considered to be the entirety of the flutes on the drill, in view of the words of the claim
Examiner maintains his positions that the Rivat device includes an outlet once a drill bit (or another workpiece) is passed therethrough. The workpiece punctures the membrane to cause the two compartments to be in fluid communication. Any of the second agent which is present in the second compartment can be carried by the drilling zone of the workpiece (flutes of the drill bit) during a drilling process via the punctured outlet. The region where the puncture occurs can be considered to be a distal region of the container, as presently claimed.
Ultimately, this argument is not found persuasive. Examiner recommends clarification as to what the workpiece is, or else positive requirement of the drill bit, or else further narrowing of what the distal region is intended to encompass, to exclude examiner’s broad understanding and to overcome this rejection.
Regarding the arguments related to the rejection under 35 USC 103, since the arguments related to the rejections under 35 USC 102 have not been found persuasive, examiner does not agree that there are any deficiencies which the 103 rejection is required to cure – therefore this portion of the argument is not found persuasive.
Regarding the statement that Rivat is not to analogous art since it relates to the construction field, examiner disagrees. Examiner is in agreement that Rivat is for the construction field, but this is not the endeavor that examiner intended to rely upon Rivat for. Rather, examiner was relying upon the fact that Rivat is a debris collector for use in a drilling operation as his basis for stating that Rivat is analogous art. As already discussed, the material used in Rivat (gel) is the same as that disclosed in the instant disclosure as being capable of both collecting medical debris and use as a cooling material. Therefore examiner does not find this to be a persuasive argument.
The rejections of record are maintained, below, as modified only to correlate to the amended claim language.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rivat et al. (US 2018/0021859 A1).
Regarding claim 1, Rivat teaches a kit as at fig. 4 capable of use in a medical setting for use with a drilling device (not shown), the kit comprising a drill (not shown, [0001]) and a medical debris collector 1, the medical debris collector 1 comprising a container 2a/2b, wherein the container comprises a first compartment 2a at least partially filled with a collecting agent 7 (gel) , the first compartment 2a and the first agent 7 being configured for at least partially enclosing the drill to thereby collect drilling debris in the container and the collecting agent during a drilling process [0047-8]. The container comprises a second compartment 2b, wherein the second compartment 2b is capable of providing a second agent for the drilling process (e.g. see gel which passes through from chamber 2a as described at [0061]; it is considered inherent that gel which passes from chamber 2a to chamber 2b will function to cool a portion of the drill passing therethrough: see applicant’s own disclosure of use of gel as the cooling agent: [0023], [0032] of the published instant application).
Regarding claim 2, the second compartment 2b is a lumen having a length, such that it is considered an elongate lumen. See fig. 4.
Regarding claim 3, the container 2a/2b and the first agent 7 are configured for enclosing at least a portion of a working section of the drill (as the drill passes through the device, through 6, and into a workpiece blow).
The and/or clause is treated as optional, and not considered required by the claim.
Regarding claim 4, the first compartment 2a includes a distal portion capable of being drilled through by the drill.
The “or” clause means that the second alternative need not be considered to the claimed limitations to be met.
Regarding claim 5, the container 2a/2b includes a proximal opening that is located at a proximal portion of the first compartment 2a when a drill is drilled therethrough. The container 2a/2b is configured to house at least the portion of the working section of the drill (e.g. the tip thereof) within the first compartment 2a such that a proximal portion of the drill extends proximally from the proximal opening when the drill is driven therethrough. The proximal opening is proximal of the working section of the drill.
Regarding claim 6, the container 2a/2b comprises at least one outlet in fluid communication with the second compartment 2b and an exterior of the medical debris collector of fig. 4 (when drilled through by the drill, the outlet is formed), the medical debris collector of fig. 4 being configured to provide the second agent to a drilling zone of a workpiece during a drilling process via the at least one outlet (the second agent being carried by the drill bit); wherein the at least one outlet is located in a distal region of the container (the outlet formed by the drill can be considered to be in a distal region – essentially everything past a proximal tip can be considered a distal region; as compared to a fig. 2 embodiment, the chamber in the fig. 4 embodiment is more distal such that this can be considered a ‘distal region’).
Regarding claim 7, the first agent 7 is ultrasound gel. [0048]
The and/or clauses are treated as optional and not required by the claim. Once the first option (ultrasound gel) is met, the other options need not be further evaluated.
Regarding claim 8, at least 1/4 a volume of the first compartment 2a is filled with the first agent 7 as seen at fig. 4.
The and/or clause is treated as optional and not required by the claim.
Regarding claim 9, the medical debris collector of fig. 4 is adapted for relative rotation between the container 2a/2b and the drill (the drill rotates therein as it pierces the container 2a/2b).
The and/or clauses are treated as optional and not required by the claim.
Regarding claim 10, the container is intrinsically and/or extrinsically rigid (formed of plastic [0004], [0043]).
Regarding claim 11, the drill comprises a non-working section (considered inherent in drill bits – the portion which is retained by and adjacent to the chuck or the like of a driver is considered to be “non-working” since they do not cut the target material) and wherein the container includes a drill guide 6, wherein the drill guide 6 is configured to be located at the non-working section (when the drill is driven through 6, the non-working portion can come into contact with 6).
Regarding claim 12, there is no disclosure of particulars of the drill. However, examiner takes the position that typical drill bits are capable of use in surgical screw removal (from some substance) of at least some types of surgical screws.
The and/or clauses are treated as optional and not required by the claim.
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(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rivat.
Regarding claim 13, Rivat teaches the limitations of claim 1, as above, but fails to specify size of the container.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Rivat device in the claimed sizes as a matter of forming the device for use in particular situations and particularly sized workpieces.
The and/or clauses are treated as optional and not required by the claim.
Regarding claim 14, wherein the device is taught being tapered [0025], [0043], etc.
The taper demonstrated in the figures is not “distally tapering”. Examiner is of the position that the disclosure of “generally tapered shape” will permit other tapers than the one demonstrated in the figure to be part of what is disclosed.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Rivat device in the claimed taper. One would have done so as a matter of forming the device for use in particular situations and particularly sized workpieces.
Regarding claim 15, the container is formed of a plastic material. “Plastic” is understood include “thermoplastic” materials. The instant disclosure teaches that thermoplastics meet the claimed limitation of particular temperature ranges of shape adaption.
It would have been obvious to one with ordinary skill in the art at the time of the invention to choose a thermoplastic material for the container since thermoplastics fall within the disclosure of “plastic”, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Conclusion
THIS ACTION IS MADE FINAL. 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 Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799