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 .
Election/Restriction
This application contains claims directed to the following patentably distinct species:
Figures 2A-2B – claims 1-11
Figures 9A-9D and 11A – claims 1-9, 12-13, and 18
Figures 10A-10D – claims 1-9 and 19-20
Figure 11B – claims 1-9, 12, and 14-15
Figure 11C – claims 1-9, 12, 14, and 16
Figure 11D – claims 1-9, 12, 14, and 17
The species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species, such as different cross-sectional profiles of the spiral ligation element in figures 2A-2B, the insertion of stiff wire in figures 9A-9D, the second spiral element in figures 10A-10D, and the different atraumatic tips/elements in each of the figures 11B-11D. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 1-9 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Glenn Seager on 09/15/2025, a provisional election was made without traverse to prosecute the invention of Species 2, claims 1-9, 12-13, and 18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 10-11, 14-17, and 19-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “54” has been used to designate both the first locking feature and the second locking feature. 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. 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 Objections
Claims 1 and 12 are objected to because of the following informalities:
Claims 1 and 12 each recite in line 1 “the LAA” and is suggested to read “a LAA” for better antecedent basis.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “delivery device” in claims 1 and 12, “first releasable locking feature” and “second releasable locking feature” in claim 5, and “penetration element” in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-9, 12, and 18 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 1 recites the limitation "the spiral ligation device" in line 8. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant meant to recite the LAA ligation device, the delivery device, or the spiral ligation element. For the purposes of examination, the Office will interpret the claim to mean the spiral ligation element. Claims 2-9 are rejected based on their dependency to claim 1.
Claim 3 recites the limitation "the spiral ligation device" in lines 1 and 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant meant to recite the LAA ligation device, the delivery device, or the spiral ligation element. For the purposes of examination, the Office will interpret the both recitations of “the spiral ligation device” to mean the spiral ligation element.
Claim 12 recites the limitation "the spiral ligation device" in line 10. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant meant to recite the LAA ligation device, the delivery device, or the spiral ligation element. For the purposes of examination, the Office will interpret the claim to mean the spiral ligation element. Claim 18 is rejected based on its dependency to claim 1.
Claim Rejections - 35 USC § 102
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 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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rothstein et al. (US PGPub 2009/0222026), hereinafter known as “Rothstein.”
With regards to claim 1, Rothstein discloses (Figures 1-12) a left atrial appendage (LAA) ligation device 200 adapted for ligating the LAA via a trans-septal approach, the LAA including an ostium (paragraphs 7 and 45 – although the device is not explicitly for ligating the LAA, paragraph 7 discloses the device for closing tissue defects such as a PFO or other internal tissue defect, and therefore is capable of also ligating the LAA via a trans-septal approach), the LAA ligation device 200 comprising:
a spiral ligation element 20 extending from an end point 32 disposed at a periphery 32 of the spiral ligation element 20 (paragraph 30) to a center point 60 of the spiral ligation element 20 (paragraph 38; figures 1A-1B), the spiral ligation element 20 having a diameter defined by the periphery 32 and a length defined between the periphery 32 and the center point 60 (figures 1A-1B); and
a delivery device 202 (see Note below) adapted to releasably secure the spiral ligation element 20 and to enable rotation of the spiral ligation device 20 (see 112(b) rejection above; paragraphs 46 and 61 – via tether 214).
Note – 112(f) interpretation – Applicant’s delivery device includes a sheath and a delivery shaft used to deliver the LAA ligation device (spec. [0066]); Rothstein’s delivery device is a catheter-type device used to deliver the clip 20 (paragraph 45; figure 6A); therefore both delivery devices are equivalent in delivering the device.
With regards to claim 2, Rothstein discloses wherein the end point 32 of the spiral ligation element 20 is adapted to penetrate through the ostium of the LAA (paragraph 39 – functional language – piercing tissue is interpreted to mean penetrating through the ostium of the LAA).
With regards to claim 3, Rothstein discloses wherein rotation of the spiral ligation device 20 (see 112(b) rejection above) after the end point 32 of the spiral ligation element 20 has penetrated through the ostium of the LAA causes the spiral ligation device 20 (see 112(b) rejection above) to wrap around an exterior of the LAA, thereby cinching down onto the LAA (paragraph 60; figures 10A-10D).
With regards to claim 4, Rothstein discloses wherein the delivery device 202 is adapted to releasably secure the center point 60 of the spiral ligation element 20 (paragraphs 53, 56, and 61 – via tether 214).
With regards to claim 5, Rothstein discloses wherein the center point 60 of the spiral ligation element 20 comprises a first releasable locking feature (see Note below’ position on the cross-member 60 where tether 214 is wrapped around to form 248) and the delivery device 202 includes a second releasable locking feature 214 (see Note below) complementary to the first releasable locking feature (figure 6B; paragraphs 53, 56, and 61 – tether 214 is removed from engagement (unwrapped) with the clip 20, more specifically the position on the cross-member 60 of the clip 20 where the tether 214 is wrapped around).
Note – 112(f) interpretation – Applicant’s first releasable locking feature and second releasable locking features are complimentary components that releasably engage with one another (figures 4 and 7; paragraphs 63 and 67); Rothstein’s first and second releasable locking features are a center portion of a rod and a tether that releasably engage with one another (figure 6B; paragraphs 53, 56, and 61); therefore both first and second releasable locking features are equivalent in releasably engaging with one another to release the spiral ligation element.
With regards to claim 6, Rothstein discloses further comprising a removable sheath 218 that holds the first releasable locking feature engaged with the second releasable locking feature 214 until the removable sheath 214 is removed (figures 8A-9B; paragraphs 46 and 60-61)
With regards to claim 7, Rothstein discloses wherein the spiral ligation element 20 is held to the delivery device 202 via a weakened spot 248 that is adapted to break upon application of sufficient torque (paragraphs 53, 56, and 61 – functional limitation – wrapped portion 248 is capable of breaking, or unwrapping, upon application of pull forces from the proximal portions of the tether 246a/246b).
Claims 12-13 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jimenez et al. (US PGPub 2013/0338706), hereinafter known as “Jimenez.”
With regards to claim 12, Jimenez discloses (Figures 1 and 11A-11B) a left atrial appendage (LAA) ligation device (figure 1) adapted for ligating the LAA via a trans-septal approach (paragraphs 39 and 93 - although the device is not explicitly for ligating the LAA, paragraph 39 discloses the device for closing cardiac tissue puncture, and therefore is capable of also ligating the LAA via a trans-septal approach), the LAA including an ostium, the LAA ligation device comprising:
a spiral ligation element 790 extending from an endpoint disposed at a periphery of the spiral ligation element 790 to a center point of the spiral ligation element 790 (see annotated figure 11B below), the spiral ligation element 790 having a diameter defined by the periphery and a length defined between the periphery and the center point (figure 11B; paragraph 93), the spiral ligation element 790 defining a lumen extending through the spiral ligation element 790 (paragraph 93);
a penetration element 795 (see Note below) slidingly disposed within the lumen, the penetration element 795 adapted for penetrating through an ostium of the LAA (paragraph 93 – functional limitation – 795 is capable of penetrating through an ostium of the LAA as the device is sued to close cardiac tissue puncture); and
a delivery device 130 (see Note below) adapted to releasably secure the spiral ligation element 790 and to enable rotation of the spiral ligation device 790 (see 112(b) rejection above; paragraphs 46 and 93 – “It is appreciated that these elastic coiled member 790 and coiled guide 795 aspects can apply to an outer coil, an inner coil, or both, as are described with reference to FIG. 1”).
Note – 112(f) interpretation – Applicant’s penetration element is similar to the stiff wire that alters an overall configuration of the spiral ligation device (paragraph 73; figures 9A-9D and 11A); Jimenez’s penetration element is a coiled guide that is inserted into the spiral ligation element to increase the diameter (figures 11A-11B; paragraph 93); therefore both penetration elements are equivalent in altering the configuration of the spiral ligation device.
Note – 112(f) interpretation – Applicant’s delivery device includes a sheath and a delivery shaft used to deliver the LAA ligation device (spec. [0066]); Jimenez’s delivery device is a catheter/shaft used to deliver the coil 790 (paragraphs 46 and 93; figure 1); therefore both delivery devices are equivalent in delivering the device.
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With regards to claim 13, Jimenez discloses wherein the endpoint (of 790) is adapted to curl into an atraumatic tip when the penetration element 795 is withdrawn from the lumen (functional limitation - paragraph 93 – when penetration element 795 is removed, spiral ligation element 790 retracts to its smaller diameter and cases an inward force on the tissue, therefore the endpoint of spiral ligation element 790 is capable of curling into an atraumatic tip when retracting to the smaller diameter).
With regards to claim 18, Jimenez discloses wherein the spiral ligation element 790 is biased to a first configuration (figure 11B) in which the spiral ligation element 790 has a first overall diameter and the spiral ligation element 790 is adapted to be expanded to a second configuration (figure 11A) having a second overall diameter greater than the first overall diameter (790 in figure 11A has a greater diameter than 790 in figure 11B as also disclosed in paragraph 93) by extending a stiff wire through the lumen (functional limitation – paragraph 93 discloses the penetration element 795 extending through the spiral ligation element 790 to expand the diameter, therefore a stiff wire is capable of extending through the hollow lumen of the spiral ligation element 790 to also expand the diameter).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rothstein in view of Montidoro et al. (US PGPub 2021/0219981), hereinafter known as “Montidoro.”
With regards to claim 8, Rothstein discloses the device as claimed in claim 1. Rothstein is silent wherein the delivery device comprises a dual-wound coil or a slotted laser-cut hypotube.
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to deliver the spiral ligation element, Montidoro teaches (Figures 1-3D) wherein the delivery device comprises a slotted laser-cut hypotube (paragraph 41).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery device of Rothstein to include comprising a slotted laser-cut hypotube as taught by Montidoro for the purpose of having greater flexibility and greater stability (paragraph 41 of Montidoro).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Rothstein in view of Van Tassel et al. (US Patent 6,551,303), hereinafter known as “Van Tassel.”
With regards to claim 9, Rothstein discloses the device as claimed in claim 1. Rothstein is silent to further comprising a polymeric sealing member disposed relative to the spiral ligation element.
However, in a similar field of endeavor of treating the LAA, Van Tassel teaches (Figure 10) further comprising a polymeric sealing member 270 disposed relative to the ligation element 40 (Col 7 line 63 – Col 8 line 18).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the LAA ligation device of Rothstein to include the polymeric sealing member as taught by Van Tassel for the purpose of sealing the membrane against leakage from the atrial appendage (Col 8 lines 14-16 of Van Tassel).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 09/16/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771