DETAILED ACTION
Election/Restrictions
Applicant’s election of Group 2, claims 2-15 in the reply filed on 12/19/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1, 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/19/2025.
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
Claim 2 is objected to because of the following informalities: Claim 2 recites in part “,the lighting mechanism cures the embolic material.” In lines 8-9 should be “,the lighting mechanism is configured to cure the embolic material.” Appropriate correction is required.
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) 2-5, 7-11, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kassab et al U.S 2016/0192912.
Claim 2: Kassab et al disclose a delivery system as best seen in figure 5d, comprising: a catheter 16; a lighting mechanism (it is noted that a light source for producing light having a desired wavelength range (not shown). Furthermore, the optical fiber 60 may additionally comprise a control mechanism (not shown) that permits the measured application of the desired light wavelengths. Each optical fiber 60 may be any standard optical fiber or fiber light known in the art and is configured to transmit the light produced by the light source through its distal end 62 in a therapeutically effective pattern or as otherwise may be desired, see paragraph 71); a delivery lumen 44/46 extending through a length of the catheter; and a light source (it is noted that a light source for producing light having a desired wavelength range (not shown). Furthermore, the optical fiber 60 may additionally comprise a control mechanism (not shown) that permits the measured application of the desired light wavelengths. Each optical fiber 60 may be any standard optical fiber or fiber light known in the art and is configured to transmit the light produced by the light source through its distal end 62 in a therapeutically effective pattern or as otherwise may be desired, see paragraph 71) in communication with the lighting mechanism; wherein, in a delivery configuration, an embolic material (see paragraph 78) is delivered through the delivery lumen; and, wherein, in a curing configuration, the lighting mechanism is configured to cure the embolic material (see paragraphs 83,89).
Claims 3-4: Kassab et al disclose wherein the lighting mechanism is comprised of an optical fiber 60., wherein the lighting mechanism is comprised of a fiber optic cable (see paragraph 71).
Claims 5, 7: Kassab et al disclose wherein the lighting mechanism is fixed to an outer surface of the catheter (it is noted that “light” as indicated in fig. 5d does locate outside the catheter 16); wherein the lighting mechanism is in communication with a lens at a distal end of the catheter (it is noted that the catheter 16 can also be configured to emit light having a desired lens range through the opening(s) 36. Such function can be exceedingly useful, especially where a light-cured adhesive 47 is being used to seal the LAA cavity, see paragraph 73).
Claims 8-11: Kassab et al disclose wherein the catheter 16 includes a light delivery lumen, and wherein the lighting mechanism (it is noted that a light source for producing light having a desired wavelength range (not shown). Furthermore, the optical fiber 60 may additionally comprise a control mechanism (not shown) that permits the measured application of the desired light wavelengths. Each optical fiber 60 may be any standard optical fiber or fiber light known in the art and is configured to transmit the light produced by the light source through its distal end 62 in a therapeutically effective pattern or as otherwise may be desired, see paragraph 71); extends through the light delivery lumen., wherein the lighting mechanism is shielded and the embolic material is comprised of a light curable adhesive (it is noted that light cure adhesive 47 is being used to seal the LAA cavity, see fig. 5c, paragraph 73).
Claim 13: Kassab et al disclose wherein the catheter is comprised of a balloon catheter, and wherein the lighting mechanism (it is noted that a light source for producing light having a desired wavelength range (not shown). Furthermore, the optical fiber 60 may additionally comprise a control mechanism (not shown) that permits the measured application of the desired light wavelengths. Each optical fiber 60 may be any standard optical fiber or fiber light known in the art and is configured to transmit the light produced by the light source through its distal end 62 in a therapeutically effective pattern or as otherwise may be desired, see paragraph 71) is attached to a distal tip of the balloon catheter (it is noted that a ballon catheter tip is known in the art at 14a,b, in fig. 3a, see paragraph 74).
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kassab et al.
Claim 6: Kassab et al disclose the invention substantially as claimed but is silent regarding the lighting mechanism is wound around an outer surface of a catheter. It would have been to one ordinary skilled in the art at the time the invention was made to construct the device with the lighting mechanism is wound around an outer surface of a catheter, since the applicant has not disclosed that doing so solves any stated problem (It is noted in applicant’s disclosure in paragraph 71, a cable 112, in one example a fiber optic cable and in another example an optical fiber, is wound and fixed to an outside surface of the catheter 110) or is anything more than selecting one of numerous shapes or configurations a person ordinary skill in the art would find available to substitute with the device with the lighting mechanism is wound around an outer surface of a catheter that is known in the medical art.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kassab et al in view of Wilson et al U.S Pat 9,078,738.
Claim 6: Kassab et al disclose the invention substantially as claimed but is silent regarding the lighting mechanism is comprised of a pusher having a distal light. However, Wilson et al teach the lighting mechanism is comprised of a pusher having a distal light (it is noted that in fig, 4, a fiber pusher 405 with the SMP actuator 406 at the distal tip of the central tube and inner catheter 410. Separate fibers are used to actuate the central tube tip and the inner catheter tip for independent control. A small amount of laser light is reflected from the fiber-coil interface back through the coupler 403 into the photodetector 407. Source fluctuations may be monitored by the source photodetector 408. As the laser light heats the SMP 406 in the distal tip of the catheter, the umbrella deploys. As an optional design feature, detection of the actuation can be fed back to the operator (or computer) 409. The SMP 406 movement causes the reflected signal to decrease. The changes in the reflected signal can be used to control the driving current of the laser 401 or to alert an operator of the status of the actuator 406 (e.g., open or closed). The light can be absorbed by a suitable dye, which is incorporated into the SMP actuator uniformly, or in a gradient engineered to provide for even heating throughout the actuator geometry (see col 11, lines 52-65). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Kassab with the lighting mechanism is comprised of a pusher having a distal light as taught by Wilson et al in order to transport light to the smp actuator 406 at the distal tip of the tube and an inner catheter 410(see col. 11, lines 52-65).
Allowable Subject Matter
Claims 14-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 14: the prior arts fail to disclose or reasonably suggest the claimed including the lighting mechanism that has an optical fiber that forms a structural reinforcement layer of a balloon catheter. Claim 15 is also allowed by virtue of it dependency from claim 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VI X NGUYEN whose telephone number is (571)272-4699. The examiner can normally be reached Monday-Friday (6:30-4:30).
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, 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.
/VI X NGUYEN/Primary Examiner, Art Unit 3771