DETAILED ACTION
This action is in response to applicant's amendments filed 01/23/26.
The examiner acknowledges the amendments to the claims.
Claims 1-20 are pending in this application.
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 Amendment
The declaration under 37 CFR 1.132 filed 01/23/2026 is insufficient to overcome the rejection of claims 11-12 based upon 35 U.S.C. 103 as set forth in the last Office action because:
The declaration fails to set forth facts, and rather only sets forth expert opinion evidence and conclusions without any objective factual evidence supporting the statements.
Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) ("It is well settled that unexpected results must be established by factual evidence." "[A]ppellants have not presented any experimental data showing that prior heat-shrinkable articles split. Due to the absence of tests comparing appellant’s heat shrinkable articles with those of the closest prior art, we conclude that appellant’s assertions of unexpected results constitute mere argument."). See also In re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972); Ex parte George, 21 USPQ2d 1058 (Bd. Pat. App. & Inter. 1991).
The statements regarding the Maini-Mangosong combination being based on a lack of guidance on integration and after-the-fact reconstruction rather than a routine modification only sets forth opinion evidence without factual evidence. Similarly, the statements regarding the Maini-Van Bladel combination being based on a lack of guidance on implementation and hindsight reconstruction without a reason for modification are also insufficient for the lack of factual evidence.
The expert opinion statements regarding non-obviousness were considered but were not found to be of substantial evidentiary value to rebut a prima facie case of obviousness. See MPEP 716.01(c) I-III.
Response to Arguments
Applicant's arguments filed 01/23/2026 have been fully considered but they are not persuasive.
Applicant generally argues that modifying Maini with Mangosong (previously claim 11 and now amended claim 1) is non-obvious to one of ordinary skill in the art, since the prior art does not describe how a hemostatic valve would be implemented in a balloon-assisted access and controlled needle-advancement sheath architecture of the type disclosed in Maini, considering tactile feedback and balloon inflation pathways or sheath-adjacent dynamic structures in Maini.
However, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the references must provide specific guidance on how to combine the physical components. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981) and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”). In this case, the combined teachings suggest that one of ordinary skill in the art would be motivated to modify the percutaneous sheath of Maini with a hemostatic valve, as taught by Mangosong, for the advantage of preventing leakage of blood out of the patient from the sheath during a procedure. For instance, hemostasis could be maintained when tools are introduced through the sheath (for example, a transseptal wire 519 is shown being introduced through sheath 514; Maini, Figures 23A-23D, col. 16, lines 56-60).
Applicant further generally argues that modifying Maini with Van Bladel (claim 12) is non-obvious to one of ordinary skill in the art, since the prior art does not describe how a radiopaque feature would be implemented without altering the needle mechanics or operation, and does not provide guidance for implementing the radiopaque feature.
Again, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the references must provide specific guidance on how to combine the physical components. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981) and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”). In this case, the combined teachings suggest that one of ordinary skill in the art would be motivated to modify the needle of Maini such that it has a contrasting tip, as taught by Van Bladel, for the benefit of enhanced visualization of the system and identification of the distal tip position during a procedure.
In response to applicant's arguments that the examiner's conclusions of obviousness are based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill before the effective filing date, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, the examiner submits that the conclusions of obviousness are based upon knowledge that was within the level of a skilled artisan.
Claim Objections
Claim 11 is objected to because of the following informalities: “a hemostatic valve (1104) on the sheath (1101)” is already recited in Claim 1, upon which Claim 11 depends. Appropriate correction is required.
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 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 1-11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Maini (U.S. Pat. No. 11,707,321) in view of Mangosong et al., hereinafter “Mangosong” (U.S. Patent No. 6,129,713).
Regarding claims 1 and 11, Maini discloses a percutaneous system (it is noted that “percutaneous” is a recitation of the intended use of the claimed invention, which must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art; if the prior art structure is capable of performing the intended use, then it meets the claim, and the system of Maini is capable of being used through the skin) comprising:
a sheath 514 (Figures 21B, 22B).
However, Maini does not disclose a hemostatic valve on the sheath.
In Figures 5-6, Mangosong teaches a sheath comprising a hemostatic valve 70 on the sheath (col. 4, lines 63-65).
It would have been obvious to one of ordinary skill before the effective filing date to modify Maini with a hemostatic valve as claimed, as taught by Mangosong, in order to prevent blood loss during a procedure.
Regarding claim 2, Maini discloses a spacer 510 is placed upon the sheath (Figures 21B, 22B).
Regarding claim 3, Maini discloses a needle 515 is parallel within the sheath 514 (Id.).
Regarding claim 4, Maini discloses the needle 515 is sheathed so the needle is not exposed beyond the spacer (Id.).
Regarding claim 5, Maini discloses a passthrough (lumen 517 within 514) wherein the needle 515 is retractable within the passthrough (Figures 21B, 23A-C; col. 16, lines 45-47).
Regarding claim 6, Maini discloses the needle 515 is not exposed beyond the spacer 510 while retracted (Id.).
Regarding claim 7, Maini discloses the needle 515 is extendable beyond the spacer 510 to suitably acquire a target (Figure 22B, col. 17, lines 23-30).
Regarding claim 8, Maini discloses wherein the spacer 510 comprises a balloon (col. 16, lines 9-13).
Regarding claim 9, Maini discloses an at least one insufflation port 512 on the sheath 514 to insufflate the balloon of the spacer 510 (col. 16, lines 10-13, Figure 21B).
Regarding claim 10, Maini discloses a passthrough (lumen 517 within 514) comprises a coaxial capable inner diameter (can be coaxial with instruments accommodated through lumen 517).
Regarding claim 18, Maini discloses a method for commencing an interventional radiology procedure (see abstract; transeptal puncture procedure using imaging such as ultrasound/MRI; col. 6, lines 21-46, col. 15, lines 3-26), comprising: inserting a needle 515 a balloon spacer 510, and a sheath 514 percutaneously (delivered through the skin and into patient’s blood vessel to access the patient’s septum; col. 1, lines 27-58) without initially extending the needle (col. 17, lines 7-30, Figures 21B and 24); and subsequently extending the needle through the sheath (Id. and Figures 22B, 23D).
However, Maini does not disclose a hemostatic valve on the sheath.
In Figures 5-6, Mangosong teaches a sheath comprising a hemostatic valve 70 on the sheath (col. 4, lines 63-65).
It would have been obvious to one of ordinary skill before the effective filing date to modify Maini with a hemostatic valve as claimed, as taught by Mangosong, in order to prevent blood loss during a procedure when tools are introduced through the sheath (for example, a transseptal wire 519 is shown being introduced through sheath 514; Maini, Figures 23A-23D, col. 16, lines 56-60).
Regarding claim 19, Maini discloses expanding the balloon spacer 510 while simultaneously maintaining the needle 515 in sheathed position within the sheath 514 (Id. and Figure 23C; inflated balloons 510 overhang and extend past the distal end of the sheath).
Regarding claim 20, Maini discloses subsequently unsheathing the needle 515 through the sheath 514 percutaneously (while the needle/sheath are still positioned through the skin and within the vasculature, the needle 515 is moved forward and extends past the balloons 510; Id. and Figure 23D)
Claims 1-3 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenbaum et al., hereinafter “Rosenbaum” (U.S. Pat. No. 9,468,462) in view of Mangosong (U.S. Patent No. 6,129,713).
Regarding claims 1-3, 14-17, Rosenbaum discloses a percutaneous system (Figure 1; it is noted that “percutaneous” is a recitation of the intended use of the claimed invention, which must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art; if the prior art structure is capable of performing the intended use, then it meets the claim, and the system of Rosenbaum is capable of being used through the skin) comprising:
a sheath 200, a spacer 204 placed upon the sheath (Figures 1, 3, 4; 204 spaces 200 longitudinally apart from 304), a needle 300 parallel with the sheath (Figure 1), a catheter 100 parallel with the sheath (Id.), wherein the sheath is coaxial around a passthrough (lumen of tubular member 202) which is capable of serving as an access tube, a retention suture 199 within the catheter (Figure 1) which is capable of curling the catheter (col. 6, lines 39-59), wherein the retention suture facilitates formation of a pigtail loop (Figure 2) to drain via a side hole 116 of catheter (col. 6, lines 1-15).
However, Rosenbaum does not disclose a hemostatic valve on the sheath.
In Figures 5-6, Mangosong teaches a sheath comprising a hemostatic valve 70 on the sheath (col. 4, lines 63-65).
It would have been obvious to one of ordinary skill before the effective filing date to modify Rosenbaum with a hemostatic valve as claimed, as taught by Mangosong, in order to prevent blood loss during a procedure when tools are introduced through the sheath (for example, a guide wire may be introduced through sheath 200; Rosenbaum, col. 14, lines 46-60).
Claims 1-3 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (U.S. Pub. No. 2007/0112302) in view of Mangosong (U.S. Patent No. 6,129,713).
Regarding claims 1 and 13, Yu discloses a percutaneous system (Figures 1A-2; it is noted that “percutaneous” is a recitation of the intended use of the claimed invention, which must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art; if the prior art structure is capable of performing the intended use, then it meets the claim, and the system of Yu is capable of being used through the skin) comprising:
a sheath 24 and a trocar 22 (Figures 1A-2).
However, Yu does not disclose a hemostatic valve on the sheath.
In Figures 5-6, Mangosong teaches a sheath comprising a hemostatic valve 70 on the sheath (col. 4, lines 63-65).
It would have been obvious to one of ordinary skill before the effective filing date to modify Yu with a hemostatic valve as claimed, as taught by Mangosong, in order to prevent blood loss during a procedure when tools are introduced through the sheath (for example when trocar 22 or a guide wire 78 is introduced through sheath 24; Yu, [0069], Figures 1A, 7B-7C).
Regarding claims 1-3 and 13-15, in an alternative interpretation, Yu discloses a sheath 26, a spacer 99 or 58 placed upon the sheath (99/52 spaces 54 longitudinally apart from 46; Figures 1A, 3-4A), a needle 22 parallel within the sheath (via 24), a trocar 24, a catheter 28 parallel with the sheath, wherein the sheath is coaxial around the passthrough (lumen of sheath 26; Figure 4A) which serves as an access tube
However, Yu does not disclose a hemostatic valve on the sheath.
In Figures 5-6, Mangosong teaches a sheath comprising a hemostatic valve 70 on the sheath (col. 4, lines 63-65).
It would have been obvious to one of ordinary skill before the effective filing date to modify Yu with a hemostatic valve as claimed, as taught by Mangosong, in order to prevent blood loss during a procedure when tools are introduced through the sheath (for example when cannula 24 or a guide wire is introduced through sheath 26; Yu, [0069], Figures 1A, 7B-7C).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Maini (U.S. Pat. No. 11,707,321) in view of Mangosong (U.S. Patent No. 6,129,713), as applied to claim 3 above, and further in view of Van Bladel et al., hereinafter “Van Bladel” (U.S. Pub. No. 2014/0350417).
Regarding claim 12, Maini as modified teaches the claimed invention, as discussed above, except for a contrasting tip formed on the needle, which is suitably configured for image-guided surgical procedures, although Maini discloses a sheath marker 513 (col. 16, lines 6-9, Figure 21B) that may be radiopaque/contrasting (col. 10, lines 16-24).
Van Bladel teaches in [0057] a needle 122 having a contrasting (radiopaque) tip, suitably configured for image-guided surgical procedures.
It would have been obvious to one of ordinary skill before the effective filing date to modify the needle of Maini as modified with a contrasting tip, as taught by Van Bladel, in order to make the distal tip easily identifiable during a procedure (Id.) which facilitates advancing and positioning within the body.
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 DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771