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 Amendment
Claims 1, 2, 4-8 and 25 are pending. Claims 3, 9-24 have been canceled.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 and 25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Specification and Drawing objections are withdrawn in light of the Specification amendment submitted 10/09/2025. However a new Drawing objection is set forth as noted below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "164" and "162" have both been used to designate the smooth surface as well as the rough surface (Figs. 11 and 12). 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.
Specification
The amendment to the Specification submitted 10/09/2025 is accepted.
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.
Claims 1-8 and 25 are 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 1 recites structure to four different embodiments: an occluder comprising a primer has first thickness along a first longitudinal portion of the tubular construct, and a second thickness along a second longitudinal portion of the tubular construct separate from the first longitudinal portion; where
A. the second thickness being thinner than the first thickness
OR
B. second thickness not present
AND
X. polymeric filter coating applied over at least a portion of the primer
OR
Y. polymeric filter coating applied over the braided strands.
There is no support for an embodiment indicated by AX, i.e an occluder having a primer having a first thickness along a first portion, a separate second thinner thickness along a second portion AND a polymeric coating applied over the braided strand (interpreted as the coating not over the primer).
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.
Claim 7 and 8 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 7 appears to be claiming the structure of the therapeutic by a manner in which it is manufactured with both an intermediate product (tubular construct with inner and outer surface) and a final product (everted back such that the inner surface forms an exterior of the occluder) where there is nothing specifically distinguishing the inner surface from the outer surface. It is unclear if the intermediate product is positively required as a claimed structure. The claim will be interpreted with respect to the final structure that is claimed such that the occluder is coupled to the catheter and flares outward in a proximal to distal direction.
Claim 8 recites the limitation that the “polymeric filter coating is removed from a distal potion of the tubular construct”. It is unclear what structure is encompassed by the coating is removed. For example, does the claim require that a coating previously existed and then was removed (which would be considered a manner of manufacturing) or is the distal portion merely free of coating.
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 5 is 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. Claim 5 recites that the primer is unevenly distributed but claim 1 from which it depends claims that the primer is unevenly distributed.
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.
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.
Claim(s) 1, 2, 4 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clubb et al. (US 2004/0153117)
Clubb discloses: a therapeutic device (Fig. 9a, 9b) for delivery of a therapeutic agent within a vessel of a patient during a vascular procedure, comprising:
a) a catheter having a proximal end and a distal end with a distal tip, and an infusion lumen extending from the proximal end to the distal tip ([0029] describes a catheter is part of the system and has a lumen for receiving guidewire or elongate support where the lumen is capable of being an infusion lumen); and
b) an occluder (90) coupled to the distal end of the catheter ([0029] filter is preloaded in catheter and therefore coupled to the catheter), comprising
i) a tubular construct (90) formed from a plurality of braided elastic strands ([0034] and [0076]), the tubular construct extending from a proximal end to a distal end,
ii) a primer unevenly distributed to the plurality of braided elastic strands ([0074-0075] primer is applied and filter is masked where coating is not desired), wherein the primer has a first thickness along a first longitudinal portion of the tubular construct (where coating is applied), and a second thickness along a second longitudinal portion of the tubular construct separate from the first longitudinal portion, the second thickness being not present, and
iii) a polymeric filter coating applied over at least a portion of the primer
Claim 2. wherein: the plurality of braided elastic strands define diamond-shaped interstices in spaces between the braided elastic strands (see Fig. 9b, [0079]).
Claim 4. wherein the primer is completely absent from the second longitudinal portion of the tubular construct, and the polymeric filter coating is applied over the first longitudinal portion (Fig. 9A, coating 91 on proximal side of filter and no coating on distal side, [0074]).
Claim 5. wherein: primer is unevenly distributed to the plurality of braided elastic strands between the proximal and distal ends of the tubular construct ([0074-0075] primer is applied, and filter is masked where coating is not desired)
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(s) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Clubb et al. (US 2004/0153117) in view of Pinchuk (US 2018/0263752).
Clubb discloses the claimed structure as noted above.
Regarding Clubb does not disclose having the primer distributed as in claim 6 the filter particularly shaped as in claim 7. Clubb does discloses various embodiments to which the teachings can apply and further in any filter where control of pore size is desirable ([0052]).
However, Pinchik discloses a filter see for example Fig. 5 where the tubular construct is fixed to a catheter (306/308) at a first location 340b proximally adjacent the distal tip and is coupled to the catheter at a second location 342b proximally displaced from the first location to define a shape that flares outward in a proximal to distal direction [0059]. Pinchuk further discloses the desire to adjust pore size to adapt to its intended use [0075].
It would have been obvious to one of ordinary skill at the filing date of the invention to substitute the structure of Pinchuk into for the structure of Clubb since doing so would have been merely constituted substituting one know structure for another and would have yielded predictable results, namely a filter where adjusting pore sizes is preferable for the intended use of the device. KSR, 550 U.S. at, 82 USPQ2d at 1396. As to claim 6 and 8, Clubb teaches [0074] the coating (and primer) would be applied to the larger diameter portion where the pores are larger (including between the proximal end and the maximum diameter) in order to make the pores smaller and not to the ends where the pores are already small in order to create more uniform pore size across the length.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Clubb et al. (US 2004/0153117) in view of Hossainy et al. 20050238686).
Clubb discloses all the claimed features as noted above but does not disclose a primer has a second thickness on a second portion of the tubular construct being thinner than the first thickness on a first portion of the tubular construct.
However In the same manner as Clubb, Hossainy teaches a using primer layer for improving adhesion of a coating onto a an implantable device. Hossainy further discloses forming asperities or areas of roughness in the primer layer [0019], [0021] which is understood to enhance adherence of the coating. The asperities create an unevenness in thickness such that it meets limitation of the primer having two portions with two different thickness.
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to incorporate asperities into the primer layer in order to enhance the retainability of the coating applied to the primer
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 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 ELIZABETH HOUSTON whose telephone number is (571)272-7134. The examiner can normally be reached generally M-F 8:00-4:30.
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, Edward Lefkowitz can be reached at 571-272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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