DETAILED ACTION
The following Office Action is in response to the Non-Provisional Patent Application filed on September 17, 2024. Claims 1-20 are currently pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claims 3, 9, and 17 are objected to because of the following informalities:
Concerning claim 3, line 2 of the claim recites the phrase “cardiac monitoring and and/or pacing”, wherein the word “and” appears to be mistakenly added.
Concerning claim 9, the claim recites “the first and second anchors are generally annular shape”, wherein the word “shape” appears to be a misspelling of the word “shaped”.
Concerning claim 17, line 2 of the claim recites the phrase “at least first or second anchor”, wherein “first and second anchor” should be preceded by the article “the”.
Appropriate correction is required.
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.
Claims 1-20 are 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). Claims 1, 12, and 19 recite the limitation of “a first anchor positioned on a proximal side of the ostium in the left atrium” and “a second anchor positioned on the distal side of the ostium in the left atrium”. The limitations are written in such a way as to encompass a human organism in its recitation of a first anchor position on a proximal side of “the ostium in the left atrium” and the second anchor positioned on the distal side of “the ostium in the left atrium”. The limitation should instead be worded to have the first and second anchors be “configured to be positioned” on a proximal and distal side of “the ostium of in the left atrial appendage”. Claims 2-11, 13-18, and 20 are further rejected for being dependent on a claim that encompasses a human organism.
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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Concerning claims 1, 12, and 19, the claims recite the limitation of “the ostium in the left atrium”. There is a lack of antecedent basis for this limitation in the claims. For the purposes of compact prosecution, the limitation will be interpreted as being “an ostium in a left atrium”.
Concerning claim 6, line 2 of the claim recites the limitation of “actuation element”. There is a lack of antecedent basis for this limitation in the claims. For the purposes of compact prosecution, the limitation will be interpreted as being “the ratcheting element”.
Claims 2-11, 13-18, and 20 are further rejected for being dependent on an indefinite claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-20 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by VanTassel et al. (US 2003/0120337, hereinafter VanTassel).
Concerning claim 1, the VanTassel et al. prior art reference teaches a left atrial appendage occlusion implant (Figures 14-24), comprising: a first anchor configured to be positioned on a proximal side of an ostium in a left atrium having one or more barrier elements (Figure 15; 40) adapted to engage the atrial tissue around the ostium (Figure 16; 13); a second anchor configured to be positioned on the distal side of the ostium in the left atrial appendage (Figure 15; 130), and one or more elements coupled to the first and second anchors (Figure 15; 90), the one or more elements configured to securely clamp tissue on opposite sides of the ostium and seal the ostium with the first anchor (Figure 17; 13).
Concerning claim 2, the VanTassel reference teaches the device of claim 1, wherein the one or more barrier elements include a barrier element configured to prevent flow of blood into the LAA ([¶ 0067]).
Concerning claim 3, the VanTassel reference teaches the device of claim 1, wherein the first anchor may include an uncovered portion for use in cardiac monitoring and/or pacing (Figure 5; 300 | [¶ 0072]).
Concerning claim 4, the VanTassel reference teaches the device of claim 1, wherein the one or more elements are a ratcheting element coupled to the first and second anchors ([¶ 0085]), the ratcheting element configured to adjust a distance between the first and second anchors to securely clamp tissue on opposite sides of the ostium (Figure 17).
Concerning claim 5, the VanTassel reference teaches the device of claim 4, wherein the distance between first and second anchors can be adjusted by actuation of a delivery device releasably coupled to the ratcheting element (Figures 20-22; 170).
Concerning claim 6, the VanTassel reference teaches the device of claim 5, wherein once the tissue at the ostium is sufficiently clamped between the anchors, the delivery device can be released from the ratcheting element (Figure 21-22; 170).
Concerning claim 7, the VanTassel reference teaches the device of claim 4, wherein the ratcheting element includes a shaft with teeth slidably coupled to the first anchor and fixedly coupled to the second anchor ([¶ 0089]), the ratcheting element being configured to retract proximally causing the teeth on the ratcheting element to ratchet with respect to the first anchor while moving the first anchor toward the second anchor the clamp the tissue (Figures 12-21 | [¶ 0089]).
Concerning claim 8, the VanTassel reference teaches the device of claim 7, wherein the teeth of the ratcheting element are configured to lock the first anchor on the shaft (Figure 21 | [¶ 0089]).
Concerning claim 9, the VanTassel reference teaches the device of claim 1, wherein the first and second anchors are generally annular shaped (Figure 15; 40, 130).
Concerning claim 10, the VanTassel reference teaches the device of claim 1, wherein the first and second anchors are self-expanding ([¶ 0084]).
Concerning claim 11, the VanTassel reference teaches the device of claim 10, wherein the self-expanding first and second anchors are configured to collapse or compress into a delivery configuration for delivery of the implant to the LAA (Figure 14), and then self-expand after delivery (Figure 15).
Concerning claim 12, the VanTassel et al. prior art reference teaches a left atrial appendage occlusion implant (Figures 14-24), comprising: a first anchor configured to be positioned on a proximal side of an ostium in a left atrium having one or more barrier elements (Figure 15; 40) adapted to engage the atrial tissue around the ostium (Figure 16; 13) and prevent blood flow into the LAA ([¶ 0067]); a second anchor configured to be positioned on the distal side of the ostium in the left atrial appendage (Figure 15; 130), and a ratcheting element coupled to the first and second anchors ([¶ 0085]), the ratcheting element configured to adjust a distance between the first and second anchors to securely clamp tissue on opposite sides of the ostium (Figure 17).
Concerning claim 13, the VanTassel reference teaches the device of claim 12, wherein the ratcheting element includes a shaft with teeth slidably coupled to the first anchor and fixedly coupled to the second anchor ([¶ 0089]), the ratcheting element being configured to retract proximally causing the teeth on the ratcheting element to ratchet with respect to the first anchor while moving the first anchor toward the second anchor the clamp the tissue (Figures 12-21 | [¶ 0089]).
Concerning claim 14, the VanTassel reference teaches the device of claim 13, wherein the teeth of the ratcheting element are configured to lock the first anchor on the shaft (Figure 21 | [¶ 0089]).
Concerning claim 15, the VanTassel reference teaches the device of claim 12, wherein the first and second anchors are self-expanding ([¶ 0084]).
Concerning claim 16, the VanTassel reference teaches the device of claim 15, wherein the self-expanding first and second anchors are configured to collapse or compress into a delivery configuration for delivery of the implant to the LAA (Figure 14), and then self-expand after delivery (Figure 15).
Concerning claim 17, the VanTassel reference teaches the device of claim 12, further comprising a cardiac monitoring element and/or treatment element secured to at least the first or second anchor ([¶ 0072]).
Concerning claim 18, the VanTassel reference teaches the device of claim 12, wherein the first anchor includes sensing and/or stimulating electrodes in contact with the LAA tissue (Figure 5; 300 | [¶ 0072]).
Concerning claim 19, the VanTassel et al. prior art reference teaches a left atrial appendage occlusion implant (Figures 14-24), comprising: a first anchor configured to be positioned on a proximal side of an ostium in a left atrium having one or more barrier elements (Figure 15; 40) adapted to engage the atrial tissue around the ostium (Figure 16; 13) and prevent blood flow into the LAA ([¶ 0067]); a second anchor configured to be positioned on the distal side of the ostium in the left atrial appendage (Figure 15; 130), and a ratcheting element coupled to the first and second anchors ([¶ 0085]), the ratcheting element configured to adjust a distance between the first and second anchors to securely clamp tissue on opposite sides of the ostium (Figure 17), wherein the self-expanding first and second anchors are configured to collapse or compress into a delivery configuration for delivery of the implant to the LAA (Figure 14), and then self-expand after delivery (Figure 15).
Concerning claim 20, the VanTassel reference teaches the device of claim 19, wherein the ratcheting element includes a shaft with teeth slidably coupled to the first anchor and fixedly coupled to the second anchor ([¶ 0089]), the ratcheting element being configured to retract proximally causing the teeth on the ratcheting element to ratchet with respect to the first anchor while moving the first anchor toward the second anchor the clamp the tissue (Figures 12-21 | [¶ 0089]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Oral et al. reference (US 2013/0018413) and the Vijay reference (US 7,320,665) both teach left atrial appendage occlusion implants having first and second implants that may include ratcheting mechanisms; and the Braido reference (US 2010/0168778) also teaches a cardiac implant including having a first and second implant and a ratcheting mechanism.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN T TON/Examiner, Art Unit 3771 12/22/2025