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 .
Specification
Paragraph 001 needs to be updated to remove the attorney docket numbers while including properly identified earlier applications (see 37 CFR 1.78).
Paragraph 0046 states “apposition”, this should likely read “a position”.
Specification/Drawings
The following explanation and objections are made in reference to both the drawings and the specification, an in particular, to the reference numbers within the drawings and specification.
In figure 6A there is reference number 27. Paragraph 0051 states that reference number 27 is a “mandrel”, however this is a component within the handle assembly and it is not clear how this can be a mandrel. Paragraph 0046 identifies element 22 (also in figures 6A and 6B) as a mandrel. It is believed that element 22 is the mandrel, however it is unclear what element 27 is. Also in figure 6A there are two figure numbers 30 which do not appear to be the same structure. Paragraph 0051 states that element 30 is “batteries”, which seems unlikely due to the placement of figure number 30.
In figure 7 element 40 is labeled as a connector (see paragraph 0052), element 41 is a generator (see paragraph 0052), element 42 is a grounding pad (paragraph 0052), element 39 is a button switch (see paragraph 0052); all of these elements based on the specification and drawings are mislabeled.
It is requested that the drawings as well as the specification are reviewed and updated to reflect the specific feature in the drawings related to the figure number.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the air pump (claim 21) and “needle penetrated through the patient’s skin” (claim 21) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 21 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 21 recites “the patient’s skin”, although “a patient’s pericardium” has previously been recited, skin of the patient has not been previously recited. It is suggested that the language within the preamble of claim 9 is amended to read “a pericardial space beneath a pericardium of a patient”; with this amendment claim 21 would be proper as currently written.
Claim Objections
Claim 23 recites the limitation “wherein advancing”, in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested that the claim is amended to recite “wherein the advancing”.
Claim 24 recites the limitation “wherein advancing”, in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested that the claim is amended to recite “wherein the advancing”.
Claim 25 recites the limitation “wherein penetrating”, in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested that the claim is amended to recite “wherein the penetrating”.
Claim 27 recites the limitation “wherein advancing”, in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested that the claim is amended to recite “wherein the advancing”.
Claim 28 recites the limitation “wherein advancing”, in line 1. There is insufficient antecedent basis for this limitation in the claim. It is suggested that the claim is amended to recite “wherein the advancing”.
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 9-36 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9, line 7 recites “advancing a catheter into the pericardial space beneath the patient’s pericardium”. The pericardium is considered to be the fluid-filled sac surround a heart; this fluid filled sac has two layers with the fluid contained within the two layers i. The pericardial space is the fluid filled space between the layers of the pericardium. Therefore this language is unclear because the catheter is advanced into the pericardial space (the area between the two layers of the pericardium) beneath the pericardium. It is therefore unclear if the catheter is advanced into the fluid filled space or if the catheter is advanced to the side of the pericardial space closest to the heart; penetrating both layers of the pericardial sac. In this case it is believed that the intent is to advance the catheter entirely through the pericardial sac to the area between the heart wall and the pericardial sac. If this interpretation is correct it is suggested that the claim language is amended to recite “advancing a catheter through the pericardial space to a position beneath the patient’s pericardium, which is adjacent to a heart wall”.
Claim 21 recites “wherein the fluid tight reservoir is configured to be inflated via an air pump using a needle penetrated through the patient’s skin into the fluid tight reservoir”. This language is unclear, the fluid tight reservoir is operably connected to a balloon 119 (figure 11A) however it is not clear how the reservoir itself is inflated. It is also noted that the language “the patient’s skin” lacks proper antecedent basis and is also rejected under 35 USC § 101. It has been suggested that the preamble of claim 9 is amended to read “a pericardial space beneath a pericardium of a patient”; with this amendment claim 21 would be proper as currently written.
There are currently two claims which are labeled claim 28, one of these claims should be cancelled and added as a “new” claim after claim number 36.
The remainder of the claims are also rejected in that they depend from claim 9 which is the only independent claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 19-23 and 33-36 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Each of the claims are directed towards structure of a device to perform the method, stated another way each claim is directed towards a device. However, independent claim 9 is directed towards a method. In this case the claims properly refer to a previously presented claim (claim 9) however they do not appear to further limit the method steps of claim 9.
Claim 19 recites “wherein the interventional tool comprises a fluid tight reservoir”. The method step in claim 9 recites “advancing an interventional tool through the lumen of the catheter into the pericardial space”. In this case, based on figures 11A-12B the fluid tight reservoir 122 is joined to the balloon cannula 118, however there is no mention of the fluid tight reservoir being advanced in any manner. It is suggested that the language is amended to specify that the balloon catheter/interventional tool is advanced and then joined to a fluid tight reservoir.
Claim 20 recites “wherein the fluid tight reservoir comprises an expandable balloon”. It is unclear which method step this is tied to. . It is suggested that the language is amended to specify that the fluid tight reservoir is operable attached to an expandable balloon.
Claim 21 recites “wherein the fluid tight reservoir is configured to be inflated via an air pump using a needle penetrated through the patient’s skin into the fluid tight reservoir”; it is not clear which method step this is tied to. It is suggested that this language is amended to recite a method step which is carried out by the specific components of the device. This amendment could read “inserting a needle to penetrate through the patient’s skin into the fluid tight reservoir and inflating a balloon”.
Claim 22 recites “wherein the interventional tool comprises a ventricular assist balloon cannula”; it is not clear which method step this is tied to. It is suggested that the claim is amended to include the method step associated with the ventricular assist balloon cannula is advanced through the lumen of the catheter. This could read “wherein the step of advancing an interventional tool includes advancing a ventricular assist balloon cannula”.
Claim 23 is rejected in that they depends from claim 22 which is previously rejected.
Claim 33 recites “wherein the fluid tight reservoir is positioned subcutaneously in a subxiphoid region of the patient”. It is not clear which method step this is tied to. It is suggested that the language is amended to recite “positioning the fluid tight reservoir subcutaneously in a subxiphoid region of the patient”.
Claims 34-36 are rejected in that they depend from claim 20 which is also rejected.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claims rejections of claims 19-23 and 33-36 are based on the dependency rule as being improper dependents; therefore they are no longer subject to examination and will not be rejected under prior art.
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.
Claims 9, 24-25, 27, 29 and 31-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toy et al. US 2012/0238968.
Regarding claim 9: Toy discloses a method for accessing a pericardial space (figures 9-16) comprising;
inserting a needle 125 (figure 10) beneath the patient’s xiphoid process (needle 125 “sharpened distal tip” is inserted within device 10 through a sub-xiphoid access point 202);
penetrating the pericardial space with the needle (figure 14 shows the pericardial sac 208 pulled away from the heart wall 210; figure 15 demonstrates that the pericardial sac is penetrated and figure 16 shows the sharpened tip 125 penetrating the pericardial space, paragraphs 0053-54)
advancing a guidewire 216 (figure 16) inside the needle into the pericardial space (figure 16, paragraphs 0053-54);
removing the needle from the xiphoid process (paragraph 0054);
advancing a catheter into the pericardial space (paragraph 0054) and
advancing an interventional tool (“introducer sheaths, catheters or other devices”, paragraph 0054).
Regarding claim 24: Toy discloses using fluoroscopic guidance to advance the catheter (paragraph 0024).
Regarding claim 25: Toy discloses that the penetrating step includes penetrating the pericardial space with the needle 125 (figure 16) and advancing the needle though a sub-xyphoid approach anterior to the diaphragm (figure 9, paragraphs 0023, 0047-48).
Regarding claim 27: Toy discloses advancing the catheter over the guidewire into the pericardial space (paragraphs 0053-54).
Regarding claim 29: Toy discloses withdrawing the catheter from the pericardial space after delivery of the interventional tool (paragraph 0054).
Regarding claim 31: Toy discloses removing the needle while leaving the guidewire in place (paragraphs 0053-54).
Regarding claim 32: Toy discloses advancing a sheath into the pericardial space over the guidewire prior to advancing the interventional tool (paragraphs 0053-54).
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 26 is rejected under 35 U.S.C. 103 as being unpatentable over Toy et al. US 2012/0238968 in view of Morgan US 2013/0274782.
Regarding claim 26: Toy discloses the claimed invention however Toy does not specifically disclose confirming entry of the guidewire into the pericardial space. Morgan however teaches of positioning a guidewire intra-pericardially and confirming it has been placed (paragraph 0037). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Toy to include confirming guidewire placement, as taught by Morgan, in order to leave a guidewire in place for further procedures.
Claims 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Toy et al. US 2012/0238968 in view of Morgan US 2013/0274782 and further in view of Urbanski et al. US 2021/0137584.
Regarding claims 28 and 30: Toy discloses the claimed invention however toy does not disclose removing the guidewire prior to advancing the interventional tool. Urbanski however teaches of advancing a sheath and dilator and then removing the sheath and dilator to provide access for advancement and placement of devices (paragraph 0142). It therefore would have been obvious to one of ordinary skill in the art to use a dilator and to remove the dilator and guidewire, as taught by Urbanski, in order to provide an access port for placement of devices.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i https://www.kenhub.com/en/library/anatomy/pericardial-cavity
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