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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/12/2025 has been entered.
Status of Claims
Claims 1-13 and 15-21 are pending and examined on the merits.
Claims 1, 15, and 18 are currently amended.
Claims 19-21 are new.
Claim 14 is cancelled.
Claim 5 is withdrawn for being drawn to a non-elected species.
Response to Amendment
Applicant’s amendments filed 08/12/2025 have been fully considered.
Claim Objections:
Applicant amended claim 15 to correct a dependency issue. Accordingly, the objection of claim 15 is withdrawn.
Claim rejections under 35 USC 112(b):
Applicant amended claim 1 to overcome an antecedent basis issue. Accordingly, the rejections of claims 1-18 under 35 U.S.C. 112(b) are withdrawn.
Response to Arguments
Applicant amended the independent claim which necessitates a new ground of rejection. Accordingly, Applicant's arguments filed 08/12/2025 have been fully considered but they are moot. Specifically, Li (U.S. Pre Grant Pub. No. 2014/0303579 A1) and Ross (U.S. Pre Grant Pub. No. 2010/0191178 A1) are introduced in the present rejection for disclosing and rendering obvious the limitations presented via the amendment. Minskoff (U.S. Pre Grant Pub. No. 2017/0224887 A1), Shevgoor (U.S. Pre Grant Pub. No. 2011/0130745 A1), Martsolf (U.S. Pre Grant Pub. No. 2020/0113672 A1), Yarger (U.S. Pre Grant Pub. No. 2016/0325026 A1), and Friedrich (U.S. Pre Grant Pub. No. 2012/0324954 A1) are introduced as secondary references in the present rejection for disclosing and rendering obvious some of the limitations of the claims.
Claim Rejections - 35 USC § 112
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 21 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.
Claim 21 recites the limitation "the switchover device" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of this Office Action, and in the interest in compact prosecution, Examiner will treat this claim as dependent on claim 19.
Claim Rejections - 35 USC § 103
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-4, 6, 9-10, 15, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Li (U.S. Pre Grant Pub. No. 2014/0303579 A1) in view of Ross (U.S. Pre Grant Pub. No. 2010/0191178 A1).
Regarding claim 1, Li teaches: A suction head (see apparatus 2 in Fig. 3) for suctioning a liquid containing organic components (see at least para. [0012]), the suction head comprising
an inner surface (at least inherent) defining a main channel of the suction head (main channel is at numeral 11 in Fig. 3), the main channel extending along a main axis of the suction head towards a suction connection of the suction head (see for example the line at numeral 6 which connects the suction head 2 to circulating pump 3),
suction holes (see for example numeral 114 in Fig. 3) entering into the suction head and extending through the inner surface to the main channel (at least inherent because the suction head 2 is an aspirator; see para. [0027]), so that each suction hole provides a passageway through which the liquid may be drawn into the main channel (see at least para. [0027]), and
flow-guiding devices (see helical blade 111 in Fig. 2) configured for imparting a rotational component about the main axis of a flow of the liquid through the main channel (due to the helical nature of blade 111, the flow of the liquid will necessarily have a rotational component), when the flow of the liquid, which enters the suction head through the suction holes, is brought about by a negative pressure in the dual suction connection (para. [0027] teaches that the pulverized hematoma lump is aspirated when negative pressure is introduced), wherein:
the suction connection comprises an inner vacuum outlet (see for example the line marked by numeral 6) that is adapted to connect a first vacuum source (see circulating pump 3) to the main channel at the main axis of the suction head (the line marked by numeral 6 connects the first vacuum source to the main channel at numeral 11) so that, when the inner vacuum outlet is connected to the first vacuum source and the first vacuum source is activated, the first vacuum source provides suction adjacent the main axis of the suction head (as shown in Fig. 3, suction is provided adjacent the main axis of the suction head).
However, Li fails to explicitly teach that the suction connection of the suction head is a dual suction connection or that the dual suction connection comprises two physically separate vacuum outlets including an outer vacuum outlet, as required by the claim.
Ross teaches an analogous suction device for suctioning an organic liquid (see at least Abstract and para. [0013]) comprising a dual suction connection (see vacuum pulsing device 156 in Fig. 1) comprising two physically separate vacuum outlets (see for example aspiration lines 152 and 164 in Fig. 1). Ross further teaches a vacuum pulsing device 156 that generates vacuum pulses of controlled frequency and duration (see para. [0062]) which is controlled by a control console 112 (see para. [0065]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li to incorporate the teachings of Ross by including a dual suction connection (such as vacuum pulsing device 156 of Ross) that comprises two physically separate vacuum outlets at least in order to break up target tissue prior to its aspiration, as taught by Ross (see para. [0063]). Additionally, one of ordinary skill in the art would have been motivated to combine the electronic controllers of Ross, such as control console 112, to the device of Li in order to make the device function by connecting one portion of the fluid suction pole 121 to the first vacuum source 3 of Li and connecting another portion of the fluid suction pole 121 to a second vacuum source (such as vacuum 168 of Ross). In addition, as broadly recited, the second vacuum source provides suction adjacent the inner surface of the suction head at least because the suction does not have to be directly adjacent the inner surface of the suction head.
Regarding claim 2, Li in view of Ross teaches the invention as discussed above in claim 1. Additionally, Li in view of Ross teaches wherein a path covered by the flow of the liquid through the main channel, due to the rotational component about the main axis, is at least 100 % longer than the extension of the main channel along the main axis (due to the helical blade 111 causing a rotational movement of the flow of liquid, the path is at least 100% longer than the extension of the main channel at least because liquid is forced to flow in a rotational direction rather than in a straight direction; therefore, the fluid path will necessarily be at least 100% longer because the fluid would be moving rotationally about an inner surface of the main channel and not straight through the main channel).
Regarding claim 3, Li in view of Ross teaches the invention as discussed above in claim 1. Additionally, Li in view of Ross teaches wherein the flow guiding devices comprise at least one of the following features: - helical flow guiding elements are arranged on the inner surface (see helical blade 111 on the inner surface of aspirator 1).
Regarding claim 4, Li in view of Ross teaches the invention as discussed above in claim 1. Additionally, Li in view of Ross teaches wherein a length of paths travelled by the flow of the liquid through the main channel due to the rotational component about the main axis per unit of extension of the main channel along the main axis increase towards the suction connection (as described on page 9, lines 14-23 of Applicant’s Specification, such an increase may be achieved by decreasing the pitch of the helical tracks; as shown in Fig. 3 of Li, the rotation component provided by helical blade 111 increases the length of paths travelled by the flow of the liquid through the main channel).
Regarding claim 6, Li in view of Ross teaches the invention as discussed above in claim 1. Additionally, Li in view of Ross teaches wherein a free flow cross-section of the suction head comprises a steady course along the flow of the liquid towards the suction connection (as shown in Fig. 3 of Li, a steady course of the flow of liquid exists from the suction holes marked by numeral 113 toward the connection marked adjacent numeral 6).
Regarding claim 9, Li in view of Ross teaches the invention as discussed above in claim 1. Additionally, Li in view of Ross teaches wherein one of the suction holes which enters into the suction head closer to the suction connection than other ones of the suction holes has a higher flow resistance for the liquid up to the main channel than the other ones of the suction holes (as shown in Fig. 3 of Li, the suction holes directly adjacent a center of the suction head have a longer flow path from the exterior of the device toward the vacuum source than suction holes located away from the center of the suction head; therefore, the suction holes located directly adjacent the center will necessarily have a higher flow resistance for liquid due to the liquid having to travel a longer distance).
Regarding claim 10, Li in view of Ross teaches the invention as discussed above in claim 9. However, while Li in view of Ross fails to teach wherein the higher flow resistance of a particular one of the suction holes which enters into the suction head closest to the suction connection is at least 100 % higher than a flow resistance of a particular one of the suction holes which enters into the suction head farthest away from the suction connection, it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” See In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); see also MPEP 2144.04(IV)(A). Therefore, one of ordinary skill in the art would have reasonably been motivated to make the flow resistance of a particular one of the suction holes which enters into the suction head closest to the suction connection at least 100 % higher than a flow resistance of a particular one of the suction holes which enters into the suction head farthest away from the suction connection, as required by the claim.
Regarding claim 15, Li in view of Ross teaches the invention as discussed above in claim 1. Additionally, Li in view of Ross teaches wherein a switchover device (see control console 112) which switches over between the two vacuum outlets is configured for opening the inner vacuum outlet and closing the outer vacuum outlet when air is removed via suction through the suction head (para. [0073] teaches that control console 112 is configured to decide when to activate and deactivate the vacuum pulsing device 156 by shutting down one or more vacuum pump 108, 168; see also para. [0065]).
Regarding claim 18, Li in view of Ross teaches the invention as discussed above in claim 1. Additionally, Li in view of Ross teaches wherein the first vacuum source is different from the second vacuum source (see for example vacuum pumps 108, 168 in Fig. 1).
Regarding claim 19, Li in view of Ross teaches the invention as discussed above in claim 1. Additionally, Ross teaches wherein the inner vacuum outlet and the outer vacuum outlet (see first and second aspiration lines 152, 164 in Fig. 1) are connected to a switchover device (see control console 112), which is adapted for sensing when air is being removed via suction through the suction head and, in response to determining that ambient air is being removed via suction through the suction head, closing the outer vacuum outlet so that the suction head provides suction primarily or exclusively through the inner vacuum outlet (para. [0073] teaches that control console 112 is configured to decide when to activate and deactivate the vacuum pulsing device 156 by shutting down one or more vacuum pump 108, 168; see also para. [0065]).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Li (U.S. Pre Grant Pub. No. 2014/0303579 A1) in view of Ross (U.S. Pre Grant Pub. No. 2010/0191178 A1), as applied above to claim 1, and further in view of Shevgoor (U.S. Pre Grant Pub. No. 2011/0130745 A1).
Regarding claims 7-8, Li in view of Ross teaches the invention as discussed above in claim 1. However, neither Li nor Ross explicitly teach wherein each of the suction holes comprises an open cross-sectional area that decreases towards the inner surface or wherein the open cross-sectional area of each of the suction holes decreases from an outer surface of the suction head up to the inner surface by at least 67 %, as required by the claims.
Shevgoor teaches an analogous suction device (see Abstract) comprising an inner surface defining a main channel (see for example Fig. 3B) and suction holes (see hole 812 at least in Figs. 29 and 30; para. [0099] teaches a plurality of holes 812). Shevgoor further teaches that the open cross-sectional area of each of the suction holes decreases from an outer surface of the suction head up to the inner surface (as applied to claim 7; as shown in at least Figs. 29 and 30, the suction holes taper from an outer surface to an inner surface; see also para. [0099]). Additionally, Shevgoor teaches that the relative shape and size of the hole with respect to other features of the catheter body can vary (see para. [0099]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li in view of Ross to incorporate the teachings of Shevgoor by making the open cross-sectional area of each of the suction holes decrease from an outer surface of the suction head up to the inner surface at least in order to prevent tissue snagging and shearing, as taught by Shevgoor (see para. [0109]).
Additionally, as applied to claim 8, while Li in view of Ross fails to explicitly teach at least 67% decrease of the open cross-sectional area of each of the suction holes from the outer surface of the suction head up to the inner surface, as required by the claim, it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” See In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); see also MPEP 2144.04(IV)(A). Therefore, one of ordinary skill in the art would have reasonably been motivated to decrease the suction holes’ open cross-sectional areas by at least 67 % from the outer surface of the suction head to the inner surface.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Li (U.S. Pre Grant Pub. No. 2014/0303579 A1) in view of Ross (U.S. Pre Grant Pub. No. 2010/0191178 A1), as applied above to claim 1, and further in view of Martsolf (U.S. Pre Grant Pub. No. 2020/0113672 A1).
Regarding claims 11 and 12, Li in view of Ross teaches the invention as discussed above in claim 1. However, Li in view of Ross fails to explicitly teach that the inner surface is at least partially covered with a slip-coating and/or that the suction holes are lined with a slip-coating, as required by the claims.
Martsolf teaches an analogous suction device for removing material from with a patient’s body (see at least Abstract) comprising a lubricious or lubricant coating 60 that can be applied to all or to various portions of the device 20 (see for example Fig. 5 and para. [0036]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li in view of Ross to incorporate the teachings of Martsolf by at least partially covering the inner surface with a slip-coating (as applied to claim 11) and/or to line the suction holes with a slip-coating (as applied to claim 12) at least because Martsolf teaches that such a lubricant coating prevents the material being removed from a patient’s body from sticking to the device (see para. [0036] of Martsolf). Therefore, one of ordinary skill in the art would have been reasonably included the lubricant on the inner surface of the device and on the suction holes, which would be beneficial as it would prevent material from sticking to the device, as taught by Martsolf.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Li (U.S. Pre Grant Pub. No. 2014/0303579 A1) in view of Ross (U.S. Pre Grant Pub. No. 2010/0191178 A1), as applied above to claim 1, further in view of Martsolf (U.S. Pre Grant Pub. No. 2020/0113672 A1), and further in view of Yarger (U.S. Pre Grant Pub. No. 2016/0325026 A1).
Regarding claim 13, Li in view of Ross teaches the invention as discussed above in claim 1. However, Li in view of Ross fails to explicitly teach wherein the suction head comprises a 3D-printed shaped body whose surfaces are provided with a continuous smooth coating, as required by the claim.
Yarger teaches an analogous aspirator comprising a suction connector and a suction head (see at least Abstract). Yarger further teaches that the suction head can be formed through various manufacturing processes, including 3D printing (see para. [0206]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li in view of Ross to incorporate the teachings of Yarger by 3D-printing the suction head at least because such a manufacturing process of medical devices is well known in the art, as evidenced by Yarger’s disclosure (see para. [0206]).
However, neither Li, Ross, nor Yarger explicitly teach that the suction head’s surfaces are provided with a continuous smooth coating, as required by the claim.
As discussed above in the rejection of claims 11 and 12, Martsolf teaches an analogous suction device for removing material from with a patient’s body (see at least Abstract) comprising a lubricious or lubricant coating 60 that can be applied to all or to various portions of the device 20 (see for example Fig. 5 and para. [0036]).
Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li in view of Ross in view of Yarger to incorporate the teachings of Martsolf by coating the surface of the suction head with a continuous smooth coating at least because Martsolf teaches that such a lubricant coating prevents the material being removed from a patient’s body from sticking to the device (see para. [0036] of Martsolf).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Li (U.S. Pre Grant Pub. No. 2014/0303579 A1) in view of Ross (U.S. Pre Grant Pub. No. 2010/0191178 A1), as applied above to claim 1, further in view of Minskoff (U.S. Pre Grant Pub. No. 2017/0224887 A1).
Regarding claim 16, Li in view of Ross teaches the invention as discussed above in claim 1. However, Li in view of Ross fails to explicitly teach wherein in front of its end facing the suction connection, the open cross sectional area of the main channel is reduced by the inner surface by at least 50 %, as required by the claim.
Minskoff teaches that the cross sectional area of the main channel is reduced at the suction port and at the collection port (see at least Fig. 9B).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li in view of Ross to incorporate the teachings of Minskoff by reducing the open cross sectional area of the main channel in front of its end facing the suction connection at least because Minskoff teaches that such narrowing allows for the separation of gasses, liquids, and solids (see at least para. [0207]).
Additionally, while neither Li, Ross, nor Minskoff explicitly teach at least 50% reduction of the inner surface of the open cross sectional area of the main channel in front of its end facing the suction connection, as required by the claim, it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” See In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); see also MPEP 2144.04(IV)(A). Therefore, one of ordinary skill in the art would have reasonably been motivated to reduce the inner surface of the open cross sectional area of the main channel in front of its end facing the suction connection by at least 50 %.
Regarding claim 17, Li in view of Ross teaches the invention as discussed above in claim 1. However, Li in view of Ross fails to explicitly teach wherein the main channel, at its end facing the suction connection, is completely closed by the inner surface, as required by the claim.
Minskoff teaches a check valve mechanism to prevent the flow of solids or liquids through the suction port (see at least para. [0119]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li in view of Ross to incorporate the teachings of Minskoff by including a check valve mechanism in the main channel at its end facing the suction connection at least in order to prevent the flow of solids or liquids through the suction port, as taught by Minskoff (see para. [0119]). Additionally, since the check valve is located on the interior of the main channel, the check valve is considered to be part of the inner surface. Therefore, the main channel is completely closed by the check valve, i.e., inner surface, when the check valve is activated (see at least para. [0332] and Fig. 18).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Li (U.S. Pre Grant Pub. No. 2014/0303579 A1) in view of Ross (U.S. Pre Grant Pub. No. 2010/0191178 A1), as applied above to claim 19, further in view of Friedrich (U.S. Pre Grant Pub. No. 2012/0324954 A1).
Regarding claim 20, Li in view of Ross teaches the invention as discussed above in claim 19. However, Li in view of Ross fails to explicitly teach wherein the switchover device comprises a soundwave sensor for determining, based on airborne or structure-borne sound waves, whether ambient air is being removed through the suction head, as required by the claim.
Friedrich teaches an analogous suction device (see Abstract) comprising an acoustic wave sensor that detects acoustic waves generated by the suction element during operation (see Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li in view of Ross to incorporate the teachings of Friedrich by including a soundwave sensor that determines whether ambient air is being removed through the suction head at least in order to detect whether air or fluid is being sucked by the device which would inform a user about the operating state of the suction element and decrease damage to blood cells, as taught by Friedrich (see at least para. [0009]).
Regarding claim 21, Li in view of Ross teaches the invention as discussed above in claim 19. However, Li in view of Ross fails to explicitly teach wherein the switchover device is configured so that, in response to determining that only liquid is being removed via suction through the suction head, closing the inner vacuum outlet so that the suction head provides suction primarily or exclusively through the outer vacuum outlet, as required by the claim.
Friedrich teaches that the control device and acoustic wave sensor are equipped to detect acoustic waves, and depending on the acoustic wave pattern detected, to change the suction power acting at the suction opening (see para. [0012]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Li in view of Ross to incorporate the teachings of Friedrich by configuring the control console 112 of Ross to provide suction primarily or exclusively through the outer vacuum outlet when detecting a predetermined acoustic wave at least because Friedrich teaches that when the acoustic wave sensor detects at least one predetermined characteristic acoustic wave pattern, suction power acting at the suction opening can be changed, as taught by Friedrich (see at least para. [0012]).
Conclusion
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/PHILIP R WIEST/ Primary Examiner, Art Unit 3781