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 .
Response to Arguments
Applicant argues in the response filed 12/01/2025 that paragraph 87 of the specification as originally filed had a typo where the unit of measurement was supposed to be in “milligrams” and not micrograms. The examiner acknowledges it could have been a typo, but the applicant has not provided evidence for the certainty of the typo with respect to the change of magnitude of the weight. The statement by the applicant that there was a typo is not proof that there was a typo. Paragraph 87 of the specification and the claims used “micrograms” as well as using the symbol for micrograms. There does not seem to be any use of “milligrams” for the weight in the specification as originally filed and therefore it would not have been clear and obvious that the unit of measurement is supposed to be “milligrams” in paragraph 87. Further the applicant has not provided evidence on the weight of the device with respect how the weight is clearly in the ranges of milligrams, instead of micrograms, based on the material used and the volume of the device. Therefore the amendment changing micrograms to milligrams is considered to be new matter.
The applicant argues the claim amendments would overcome the previous claim objections. The objections have been withdrawn. The applicant agues the claim amendments with respect to the membrane encapsulating the device would overcome the 102 and 103 rejections. The rejections have been withdrawn. New rejections with respect to Bal-Boychuk in view of Myers (and McGoldrick) have been made below.
Specification
The amendment filed 12/01/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “the occluding device may weigh between 25 milligrams milligrams mg[[µg]] to 200 mg[[µg]], 50 [[µg]]mg to 150 [[µg]]mg, 75 [[µg]]mg to 125mg, values between the foregoing, etc.). In some cases, it may be preferable for the occluding device to weigh less than 50 milligrams .
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 116 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 116 is amended to state the device weighs between 25 milligrams and 200 milligrams. There does not seem to be support from the specification as originally filed for the new weight. Therefore, the limitation is considered to be new matter.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 101, 103, 105-114, 116-120, 122 are rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2018/0333150 to Bak-Boychuk in view of U.S. Patent Publication 2021/0059684 to Meyer.
As to claim 101, Bak-Boychuk discloses an interseptal occluding device configured to be positioned within an opening in a partition of a heart (paragraph 63), the interseptal occluding device comprising: a support structure (802) comprising: a central portion (812) defining a lumen (figure 31a,b); a first anchoring portion (804a, paragraph 133) extending from a first end of the central portion; a second anchoring portion (804b, paragraph 133, figure 32) extending from a second end of the central portion, the second anchoring portion opposite the first anchoring portion; and wherein the lumen extending through a center of the first anchoring portion and a center of the second anchoring portion (figure 31a,b,32,33), the lumen being unobstructed by the first anchoring portion and the second anchoring portion (figure 31a,b,32,33), wherein the support structure is configured to contract and expand between a compressed tubular configuration for insertion through a patient’s vasculature (paragraph 136), and an expanded configuration (paragraph 136), in which the first anchoring portion and the second anchoring portion extend radially outwards from the lumen to compress the partition therebetween (paragraph 136), with the lumen extending through the opening in the partition of the heart; and a membrane (“occluding member”, paragraph 132, such as 38 as disclosed in paragraph 81,82, or 504, paragraph 108) comprising a plurality of electrospun fibers (paragraph 81), the membrane coupled to the support structure (paragraph 85), the membrane extending across the lumen such that the membrane is configured to occlude the lumen when the support structure is expanded to prevent blood flow from passing through the opening in the partition of the heart (paragraph 81), the membrane configured to promote tissue growth across at least across a portion the membrane (paragraph 84) but is silent about the membrane coupled to and encapsulating the first anchoring portion, the second anchoring portion, and the central portion the first anchoring.
Myers teaches a similar device (occluder) having a membrane is coupled to and encapsulating a first anchoring portion, a second anchoring portion, and a central portion (paragraph 89, 91, 92) for the purpose of providing a buffer or cushioning the interaction between the device and the tissue. Having the membrane encapsulate the support structure can allow for a barrier between the entire frame and the tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the membrane of Bak-Boychuk be coupled to and encapsulate the first anchoring portion, the second anchoring portion, and the central portion in order for providing cushioning between the device and the tissue along the entire device.
As to claim 103, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the membrane comprises a radiopaque material (paragraph 32, 119, 83). If it would not be known that the radiopaque material can be used in the membrane 38 it would have been obvious in order to allow for fluoroscopic visualization (paragraph 119).
As to claim 105, with the device of Bak-Boychuk and Myers above, Myers further teaches the membrane is configured to prevent the support structure from directly contacting a patient’s blood when the interseptal occluding device is implanted in the patient (paragraph 91, 92).
As to claim 106, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the second anchoring portion comprises a plurality of loops located radially outward of the lumen and at or near an outer edge of the second anchoring portion, wherein the plurality of loops are configured to releasably couple the interseptal occluding device to a delivery device (figure 31a). The second anchoring portions do have loops that form petals that can be releasably coupled to a delivery device. Alternatively, Bak-Boychuk discloses eyelets (30, paragraph 73) which can read on the loops located radially outward of the lumen and at or near an outer edge of the second anchoring portion, wherein the plurality of loops are configured to releasably couple the interseptal occluding device to a delivery device (paragraph 73) for the purpose of attaching the device to a delivery apparatus. It would have been obvious to one of ordinary skill in the art before the effective filing date to use a plurality of loops located radially outward of the lumen and at or near an outer edge of the second anchoring portion, wherein the plurality of loops are configured to releasably couple the interseptal occluding device to a delivery device in the embodiment of figure 31a,b, 32, 33 in order for attaching the device to a delivery apparatus.
As to claim 107, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the membrane is configured to allow a medical instrument inserted in a first compartment of the heart to pass through the membrane and a tissue layer formed on the membrane through the lumen into a second compartment of the heart, wherein the partition divides the first compartment and the second compartment (paragraph 80, 81).
As to claim 108, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the membrane forms a continuous surface (paragraph 82, a sheet will read on a continuous surface).
As to claim 109, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the membrane is configured to lie flat against the partition once implanted (paragraph 82, figure 9). The membrane is a sheet which can be capable to lie flat, therefore the membrane can lie flat against the partition.
As to claim 110, Bak-Boychuk discloses an interseptal occluding device configured to be positioned within an opening in a partition of a heart (paragraph 63), the interseptal occluding device comprising: a support structure (12) comprising a lumen (lumen through central portion 14); and a membrane (38) comprising a plurality of electrospun fibers (paragraph 81), the membrane coupled to the support structure (paragraph 85), the membrane configured to occlude a majority of the lumen when the interseptal occluding device is implanted (paragraph 81,82), wherein the interseptal occluding device extends less than 0.2 mm into a left atrium of the heart once implanted and less than 1 mm into a right atrium of the heart one implanted (paragraph 82, 94, 78), wherein the membrane is configured to act as a tissue scaffold to promote growth of a layer of tissue across at least a portion of the membrane (paragraph 84). The claim is a device claim so therefore cannot positively recite the left/right atrium and/or the method step of placement. Therefore the device will be capable of being placed so that is extends less than 0.2 mm into a left atrium of the heart and less than 1 mm into a right atrium of the heart. Further, Bak-Boychuk disclose the device can be placed flush. Therefore the extension can be minimal. Additionally/alternatively Bak-Boychuk discloses the thickness of the frame can be 0.1-0.3 mm but can be varied as needed on the size of the orifice (paragraph 78). The specification of the application as originally filed supports that the occluding device will extend minimally into the right atrium and be substantially flush, as well as it being desirable to extend less than 0.2 mm into the left atrium. With the dimensions of Bak-Boychuk, the planar flush occluding device will be capable of extending less than 0.2 mm into a left atrium. If it would not be known, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount the device extends into the left atrium and right atrium as applicant appears to have placed no criticality on the claimed range (see paragraph 89 of the specification of the present invention indicating the range is desirable but not critical) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
However, Bak-Boychuk is silent about the membrane coupled to and encapsulating the support structure.
Myers teaches a similar device (occluder) having a membrane is coupled to and encapsulating the support structure of the occlusion device (paragraph 89, 91, 92) for the purpose of providing a buffer or cushioning the interaction between the device and the tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the membrane of Bak-Boychuk be coupled to and encapsulate the support structure for the purpose of providing cushioning between the device and the tissue along the entire device.
As to claim 111, Bak-Boychuk discloses the device above including the plurality of fibers have diameter between 0.05-1.5 microns (paragraph 82) but does not explicitly disclose the plurality of electrospun fibers have diameters between 0.5 microns and 5 microns. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of the fibers as applicant appears to have placed no criticality on the claimed range (see paragraph 84 of the specification of the present invention indicating the fiber diameter “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
As to claim 112, 113, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the invention essentially as claimed as discussed above. However, Bak-Boychuk does not expressly disclose the plurality of fibers are configured to deform with elongation of at least 400% and an ultimate strain between 350-400% as required by the claim. Bak-Boychuk discloses the fibers can be weaker and allow a device to be passed through which will would then read on elongation. The percent elongation and ultimate straight of the fibers will result in the ease of passing a medical instrument through the membrane. As seen in paragraphs 78, 85 the applications states the elongation and ultimate strain allows for the stretchability of the membrane before plastic deformation and as such the elongation and ultimate strain are disclosed to be a result effective variable in that they allow the membrane to stretch without plastically deforming to allow a device to pas therethrough. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Bak-Boychuk by making the plurality of fibers to deform with elongation of at least 400% and have an ultimate strain between 350-600% as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine. experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claim 114, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the interseptal occluding device has an overall thickness of less than 5 mm (paragraph 78, the thickness of the frame can read on the thickness of the device). Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the device as applicant appears to have placed no criticality on the claimed range (see paragraph 88 of the specification of the present invention indicating the thickness “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
As to claim 116, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the invention essentially as claimed as discussed above and an embodiment where the device can weigh 0.05 grams (50 milligrams), which is between 25 milligrams and 200 milligrams. If it would not be known that the weight of the device as disclosed can be applicable for the device as claimed in claim 110 with the amount the device can extend into the left and right atrium, it would have been obvious. The application states that the weight of the device may be attributed in part of the use of electrospun fibers and is dependent on the size of the device and the size of the defect. It is to be noted that Bak-Boychuk does use electrospun fibers (paragraph 81), have the dimensions of the device vary depending on the size of the orifice (paragraph 78) and can occlude a similar septum defect (paragraph 77). Further having the weigh less can allow for using less material to make the device. 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 device of Smith to weigh between 25 milligrams and 200 milligrams 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 Bak-Boychuk would not operate differently with the claimed weight and since device would function appropriately having the claimed weight. Further, applicant places no criticality on the range claimed, indicating simply that the device may weigh between 25-200 milligrams and the weight is dependent on the size of the device and the defect (paragraph 87).
As to claim 117, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the plurality of electrospun fibers are configured to promote tissue growth at least across the membrane (paragraph 81).
As to claim 118, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the device above including the membrane is 100-200 microns thick (paragraph 82) but does not explicitly disclose membrane is less than 100 microns thick. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size of the fibers as applicant appears to have placed no criticality on the claimed range (see paragraph 78 of the specification of the present invention indicating the membrane thickness can vary).
As to claim 119, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses a first anchoring portion (16); a second anchoring (18, paragraph 67) portion opposite the first anchoring portion; and an expandable central structure (14) coupled to the first anchoring portion and the second anchoring portion, the expandable central structure defining the lumen (figure 2).
As to claim 120, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the expandable central structure comprises a resilient member (paragraph 74, 115, the frame can have a resilient material).
As to claim 122, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the central portion is configured to be positioned in the opening in the partition of the hart such that the lumen is axially aligned with the opening in the partition of the heart (figure 32).
Claim 102 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2018/0333150 to Bak-Boychuk in view of U.S. Patent Publication 2021/0059684 to Meyer as applied to claims 101-103, 105-114, 116-120, 122 above, as further in view of and/or as evidenced by U.S. Patent Publication 2008/0077180 to Kladakis.
As to claim 102, with the device of Bak-Boychuk and Myers above, Bak-Boychuk discloses the membrane includes a plurality of perforations (paragraph 81, ). The membrane can be made from one more sheets comprises the electrospun fibers and also easily punctured with a medical instrument during subsequent recrossing. Therefore either where the multiple sheets are attached, the spacing between the fibers that are spun to form the membrane, and/or where the membrane is punctured can read on the plurality of perforations. Kladakis teaches a similar device (occluder, abstract) which can provide evidence on a plurality of perforations on an encapsulating membrane on where sheets of the membrane are attached and/or perforations on where a device can puncture through the membrane (figure 11,12). If it would not be known that Bak-Boychuk can read on the plurality of perforations, it would have been obvious for the membrane of Bak-Boychuk as modified by Meyer to have a plurality of perforations to attach the sheets of the membrane together and/or allow a device to pass through the membrane.
Claim 121 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2018/0333150 to Bak-Boychuk in view of U.S. Patent Publication 2021/0059684 to Meyer as applied to claims 101-103, 105-114, 116-120, 122 above, and further in view of U.S. Patent Publication 2016/0166241 to McGoldrick.
As to claim 121, Bak-Boychuk as modified by Meyer discloses the device above but is silent about the plurality of electrospun fibers of the membrane have a fiber architecture of random non-aligned fibers.
McGoldrick teaches a similar device (closure device) having plurality of electrospun fibers of the membrane having a fiber architecture of random non-aligned fibers (paragraph 25, 89). The random nature of fibers will have them be not aligned. McGoldrick teaches that a membrane can consist of electrospun fibers having a pattern or random orientation as desired. Using the random non-aligned pattern will yield the predictable result of still occluding the opening. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the membrane of Bak-Boychuk as modified by Meyer comprise electrospun fibers having a fiber architecture of random, non-aligned for a pattern of the fibers as desired.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2003/0139819 to Beer, U.S. Patent Publication 2015/0142049 to Delgado (as cited reference 9 in the IDS filed 12/01/2025), and U.S. Patent Publication 2016/0256141 to Mendez all disclose similar devices specifically with respect to encapsulating membranes capable of disclosing, rendering obvious, or providing evidence on the claims of record.
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771