DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed
Notice of 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 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
In the response filed 4 May 2026, Applicant argues Carbunaru’518 in view of Neilson’922 fail to teach a vacuum tap “being adapted for application of a vacuum from an external vacuum source within the vacuum chamber”, as required by claim 1. Applicant argues that Carbunaru’518 teaches the component 202 is a suction cup ring that is adhered to tissue by pressing the suction cup ring onto the surface of the tissue (paragraph [0048]) or via an adhesive (paragraph [0048]).
This argument is not persuasive. At paragraph [0048], cited the last rejection, Carbunaru’518 discloses “Alternatively, the suction cup ring 202 may include a one-way valve for removing air from the cavity 216, a needle for applying negative pressure, or other such mechanism for removing air from the cavity 216 to form the vacuum seal.” The disclosed valve functions as a vacuum tap that places the vacuum chamber in fluid communication with an environment external to the vacuum tap. This valve is adapted for the application of vacuum from an external source within the vacuum chamber based on the above cited disclosure from paragraph [0048].
For these reasons, the rejection is maintained.
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.
Claims 1-20 are 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 pre-AIA the applicant regards as the invention.
Claim 1 the limitation "the tap" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Any claim not specifically addressed is rejected based on its dependency from a base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9, 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Carbunaru et al. (US Patent Publication 2011/0054518) in view of Neilson et al. (US Patent 7,717,922).
Claim 1: Carbunaru’518 teaches a component (200), comprising:
an upper surface (upper surface of 202),
a bottom surface (lower surface of 202),
a vacuum chamber (216);
a vacuum tap (“one-way valve”, paragraph [0048]) that places the vacuum chamber into fluid communication with the environment exterior to the vacuum tap (paragraph [0048],
the vacuum tap being adapted for application of vacuum from an external source within the vacuum chamber (paragraph [0048]),
the at least one vacuum chamber opening being adapted to, upon application of sufficient vacuum from the tap, securably engage with tissue proximate to the bottom surface by drawing at least some of the tissue toward the vacuum chamber so as to stably affix the component to the tissue (paragraph [0048]), and
one or more of:
(i) a sealer portion (204), the sealer portion configured such that application of vacuum to draw tissue toward the vacuum chamber exerts the sealer against the tissue so as to seal an opening present in the tissue (paragraph [0045]),
(ii) a projection (100) configured to extend into a wound when the component is engaged with a subject's tissue, the component optionally configured such that application of vacuum to draw tissue toward the vacuum chamber exerts the sealer against the tissue such that the projection extends into an opening of the tissue.
Carbunaru’518 does not teach the vacuum chamber is defined between the upper and lower surface of the component such that the bottom surface defines a vacuum chamber opening.
Like Carbunari’518, Neilson’922 teaches a component (10) for sealing placement against tissue. As in Carbunari’518, the component (10) includes an upper surface and a bottom surface that rests directly against tissue such that the vacuum chamber (18) is not defined between the upper and lower surfaces (see annotated copy of Figure 1 below).
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However, Neilson’922 teaches an alternate arrangement (Figure 13) in which the component (10) can have an upper surface (223) and a bottom surface (250) which defines the vacuum chamber (222) and has a vacuum chamber opening (251).
Neilson’922 teaches the arrangement of Figure 13 aids in preventing debris from entering the vacuum chamber (column 6, lines 30-38).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Carbunari’518 such that the upper and bottom surfaces of the component define a vacuum chamber having a vacuum chamber opening, as taught by Neilson’922, in order to prevent debris from entering the vacuum chamber when a vacuum is applied.
Claim 2: Carbunaru’518 teaches the component defines an inner wall (Figure 2a shows 200 is ring-shaped) and a component opening (210) at least partially bounded by the inner wall, the sealer portion (204) comprising a member affixed so as to seal the component opening (paragraph [0045]).
Claim 3: Carbunaru’518 teaches the member (204) is a resilient member (paragraph [0045]).
Claim 5: Carbunaru’518 teaches the member (204) defines an opening therethrough, the opening being configured to communicate a material to a tissue contacted by the member (Figure 2b show an opening through which element 100 passes; paragraph [0045] describes the member as configured for puncturing to create an opening).
Claim 6: Carbunaru’518 teaches the member (204) is flush relative to the bottom surface of the component (200) (Figure 3a).
Claim 7: Carbunaru’518 teaches the sealer portion (204) comprises a medicament (paragraph [0042] teaches drugs may be delivered through the drug delivery catheters passing through the sealer portion; when the drug delivery catheter is passing through the sealer portion, it is considered part of the sealer portion).
Claim 8: Carbunaru’518 does not specifically teach the drug delivery catheter delivers a clotting promoter but states the device can be used for any diagnostic or therapeutic purpose (paragraph [0042]). In light of this, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Carbunaru’518 such that it is used to deliver a particular drug, including a clotting promoter, depending on the type of procedure being performed and the needs of the surgeon/patient because Carbunaru’518 teaches the device can be used for any diagnostic or therapeutic purpose.
Claim 9: Neilson’922 teaches a vacuum chamber edge of the component defines a thickened end (Figure 16 shows thickened end 291) in order to enhance the rigidity of the component (column 6, lines 64-67).
Claim 12: Carbunaru’518 teaches a vacuum source in fluid communication with the vacuum tap (paragraph [0048]).
Claim 13: Carbunaru’518 teaches the vacuum source is manually operated (paragraph [0048]).
Claim 14: Carbunaru’518 does not explicitly teach the vacuum source is automated. However, Examiner takes OFFICIAL NOTICE that automatic vacuum sources are exceedingly well known in the art and additionally that it is exceedingly well known to substitute automatic and manual vacuum sources. In this case, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute a manual vacuum source, as in Carbunaru’518 for an automatic vacuum source in order to provide control over the amount of suction provided and to avoid providing too much suction against the tissue.
Claim 15: Carbunari’518 does not teach the component (200) defines a maximum cross-sectional dimension in the range of about 0.05 cm to about 10 cm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the component of Carbunari’518, as modified, to have a maximum cross-sectional dimension in the range of about 0.05 cm to about 10 cm since 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Carbunari’518, as modified, would not operate differently with the claimed dimensions.
Claim 16: Carbunari’518 does not teach the sealer portion (204) defines a maximum cross-sectional dimension in the range of about 0.05 cm to about 10 cm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the sealer portion of Carbunari’518, as modified, to have a maximum cross-sectional dimension in the range of about 0.05 cm to about 10 cm since 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Carbunari’518, as modified, would not operate differently with the claimed dimensions.
Claim 17: Carbunari’518 in view of Neilson’922 teach the device of claim 1, as outlined above. Carbunari’518 teaches a step of applying a vacuum via a vacuum tap to sealably affixing the component (200) to tissue (paragraph [0048]).
Claim 1, alternate interpretation: Carbunaru’518 teaches a component (500), comprising:
an upper surface (upper surface of 502),
a bottom surface (lower surface of 502),
a vacuum chamber (216; paragraph [0050] states 502 is substantially similar to element 202);
a vacuum tap (“one-way valve”, paragraph [0048], [0050]) that places the vacuum chamber into fluid communication with the environment exterior to the vacuum tap (paragraph [0048], [0050]),
the vacuum tap being adapted for application of vacuum within the vacuum chamber (paragraph [0048], [0050]),
the at least one vacuum chamber opening being adapted to, upon application of sufficient vacuum from the tap, securably engage with tissue proximate to the bottom surface by drawing at least some of the tissue toward (or even into) the vacuum chamber so as to stably affix the component to the tissue (paragraph [0048], [0050]), and
one or more of:
(i) a sealer portion (520, 527), the sealer portion configured such that application of vacuum to draw tissue toward the vacuum chamber exerts the sealer against the tissue so as to seal an opening present in the tissue (paragraph [0050], [0051]);
(ii) a projection (100) configured to extend into a wound when the component is engaged with a subject's tissue, the component optionally configured such that application of vacuum to draw tissue toward the vacuum chamber exerts the sealer against the tissue such that the projection extends into an opening of the tissue.
Carbunaru’518 does not teach the vacuum chamber is defined between the upper and lower surface of the component such that the bottom surface defines a vacuum chamber opening.
Like Carbunari’518, Neilson’922 teaches a component (10) for sealing placement against tissue. As in Carbunari’518, the component (10) includes an upper surface and a bottom surface that rests directly against tissue such that the vacuum chamber (18) is not defined between the upper and lower surfaces (see annotated copy of Figure 1 below).
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However, Neilson’922 teaches an alternate arrangement (Figure 13) in which the component (10) can have an upper surface (223) and a bottom surface (250) which defines the vacuum chamber (222) and has a vacuum chamber opening (251).
Neilson’922 teaches the arrangement of Figure 13 aids in preventing debris from entering the vacuum chamber (column 6, lines 30-38).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Carbunari’518 such that the upper and bottom surfaces of the component define a vacuum chamber having a vacuum chamber opening, as taught by Neilson’922, in order to prevent debris from entering the vacuum chamber when a vacuum is applied.
Claim 2, alternate interpretation: Carbunaru’518 teaches the component defines an inner wall (Figure 5e shows 502 is ring-shaped) and a component opening (510) at least partially bounded by the inner wall, the sealer portion (520, 527) comprising a member affixed so as to seal the component opening (Figures 5a-5e).
Claim 3, alternate interpretation: Carbunaru’518 teaches the member (520, 527) is a resilient member (membrane 504).
Claim 4, alternate interpretation: Carbunaru’518 teaches the member (520, 527) is a rigid member.
Claim 5, alternate interpretation: Carbunaru’518 teaches the member (520, 527) comprises an opening therethrough (526), the opening being configured to communicate a material to a tissue contacted by the member.
Claim 6, alternate interpretation: Carbunaru’518 teaches the member (520, 527) is flush relative to the bottom of the component (Figure 5d, 5e).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Carbunaru’518 in view of Neilson’922, as applied to claim 1, further in view of Albert et al. (US Patent Publication 2012/0116334).
Claims 10: Carbunari’518, as modified, does not teach the component comprises multiple vacuum chamber openings.
Like Carbunari’518, Albert’334 teaches a component (5009, Figures 50a-50c) in communication with a vacuum source (paragraph [0213]) for attaching the ring to tissue (paragraph [0213]). The component (5009) has an upper surface (top of 5009), a bottom surface (bottom of 509) and a vacuum chamber (internal chamber within ring that is visible in Figure 50c). The bottom surface has a vacuum chamber opening (visible in Figure 50c). Albert’334 teaches this vacuum chamber opening can be in the form of a single slot (“slot 5011” in paragraph [0213]) or a series of apertures in order to seal the component against the patient’s tissue (paragraph [0213]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Carbunari’518 by substituting one element (a single vacuum chamber opening) for another (a series of vacuum chamber openings), as taught by Albert’334, because Albert’334 teaches both types of openings function to hold the component against tissue when a vacuum is applied. One of ordinary skill in the art would have expected either arrangement to perform equally well at holding the component against tissue because Albert’334 teaches they can be interchanged and still achieve similar results.
Claims 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Carbunaru’518 in view of Neilson’922, as applied to claims 1 and 17, respectively, further in view of Bagwell et al. (US Patent Publication 2020/0368524).
Claim 11: Carbunari’518, as modified, does not teach the component comprises multiple vacuum chambers.
Like Carbunari’518, Bagwell’524 teaches a component (156’’, Figures 7-9) having a single vacuum chamber in communication with a vacuum source (paragraph [0067]) for stabilizing tissue in the skull (paragraph [0022]) in order to advance an instrument (122) into the tissue. Alternately, Carbunari’518 teaches the component (Figure 9b) has a plurality of vacuum chambers (156’’, 158’’) in order to allow movement between the two chambers and increase the tension on the tissue in to further reduce tissue movement during instrument insertion (paragraph [0067]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Carbunari’518, such that there are multiple vacuum chambers, as taught by Bagwell’524, in order to allow movement between the chambers and increase tension on tissue to reduce tissue movement during instrument insertion (paragraph [0067]).
Claim 18: Carbunari’518, as modified, does not teach the vacuum draws some tissue into the vacuum chamber to stably affix the component to the tissue.
Like Carbunari’518, Bagwell’524 teaches a component (156’’, Figures 7-9) in communication with a vacuum source (paragraph [0067]) for stabilizing tissue in the skull (paragraph [0022]) in order to advance an instrument (122) into the tissue. The component (156’’) has vacuum chamber openings (162) on the bottom surface of the component. Tissue is drawn into the vacuum chamber openings (162) (Figure 8, paragraph [0067]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Carbunari’518 such that tissue is drawn into the vacuum chamber opening, as taught by Bagwell’524, in order to enhance the stabilization of the component in order to increase accuracy when inserting a needle into tissue (paragraph [0067]).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Carbunaru’518 in view of Neilson’922, as applied to claim 1, further in view of Mark et al. (US Patent 2014/0187922).
Claim 19, 20: Carbunari’518, as modified, teaches the device of claim 1, but does not teach providing a second component having different dimensions in a kit.
Providing different sized components in a single kit is old and well known. For example,
Mark’922 teaches a component (“surgical access assembly 100”) provided in the form of a kit having multiple components having different sizes to provide the surgeon flexibility in choosing the right size for the particular procedure (paragraph [0102]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Carbunari’518, by providing multiple components having different dimensions in the form of a kit, as taught by Mark’922, in order to provide the surgeon with flexibility in choosing the right sized component for a particular procedure.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Friday 9am-5pm and alternating Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 11 May 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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