DETAILED ACTION
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 “wherein the diameter of the radially expandable distal tip” in line 8 should be “wherein a diameter of the radially expandable distal tip’’. 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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vale et al U.S 2017/0105743.
Claim 2: Vale et al disclose an extension guide catheter as best seen in figures 66a-e comprising: a tubular catheter body (it is noted an aspiration catheter…(see paragraph 306) having a proximal end, a distal end, and a lumen extending therebetween: and a radially expandable distal tip (it is noted that an intermediate or aspiration catheter with an expansile tip that can be delivered in a constricted form. The side and end view of this device showing the tip in the collapsed configuration are shown in FIGS. 66a and b. The tip material 901 can be folded inside the lumen to facilitate expansion. The expanded tip configuration of the device is shown in FIGS. 66c and 66d (see paragraph 306) at the distal end of the tubular catheter body, said expandable distal tip having a central passage contiguous with the lumen of the tubular catheter body, wherein the expandable distal tip comprises a supporting structure (it is noted that frame 904 is equivalent as a supporting structure since it extends distally from a distal end of the catheter body and having a central clot receiving passage contiguous with the aspiration lumen of the catheter body) coupled to a membrane (it is noted that a membrane-thin polymer sleeve 909, (see paragraph 306); wherein a diameter of the radially expandable distal tip is less than that of the tubular catheter body. (It is the examiner position that such structures may find use as aspiration catheters as generally described herein for other uses, for example extension guide catheters where the distal tip is configured to seat deep inside the arteries to provide extra support for catheters, and other tools used during complex coronary interventions, or distal lesions).
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) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vale et al U.S 2017/0105743.
Claim 1: Vale et al disclose a method for aspirating clot from a patient’s vasculature as best seen in figures 66a-e, said method comprising: engaging an open distal end of an expandable distal tip structure (it is noted that an intermediate or aspiration catheter with an expansile tip that can be delivered in a constricted form. The side and end view of this device showing the tip in the collapsed configuration are shown in FIGS. 66a and b. The tip material 901 can be folded inside the lumen to facilitate expansion. The expanded tip configuration of the device is shown in FIGS. 66c and 66d (see paragraph 306) at the distal end of the tubular catheter body, said expandable distal tip having a central passage contiguous with the lumen of the tubular catheter body) of an aspiration catheter (it is noted an aspiration catheter…(see paragraph 306) against a region of clot in the patient’s vasculature; wherein a portion of the volume of clot is drawn into the central passage of the expandable distal tip and causes a circumference of the distal tip (it is noted that the tip material 901 can be folded inside the lumen to facilitate expansion. The expanded tip configuration of the device is shown in FIGS. 66c and 66d. This increased tip diameter facilitates the aspiration and removal of large clot volumes by increasing the area of the catheter tip that applies aspiration to the clot (see paragraph 306) to expand to accommodate the clot which has been drawn into the central passage; but is silent regarding applying a negative pressure to a proximal end of an aspiration lumen in the catheter to draw a volume of the clot into a central passage of the expandable distal tip; However, Vale et al, in another embodiment, figure 63 does teach applying a negative pressure to a proximal end of an aspiration lumen in the catheter (see paragraphs 291,292). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Vale et al-figures 66a-e with applying a negative pressure to a proximal end of an aspiration lumen in the catheter, in other embodiment, figure 63, in order to provide a better of aspiration of the clot into a central clot receiving passage. (see paragraph 291,292 it is noted that he combination of these two flow restrictors means that a vacuum or negative pressure can be applied to the proximal end of guide catheter 655 and transmitted to the distal end of Rx catheter 650 in such a way that any blood aspirated into the mouth of Rx catheter 650 is not supplied from the body of blood proximal to seal 652 in vessel 656. This system enables a physician to use a standard guide or sheath to rapidly create an access path to the region of the target occlusion, and then use the Rx catheter 650 to quickly access and aspirate the target clot from the vessel. This system provides a major advantage in the speed and ease with which a physician will be able to access and retrieve the clot. The provision of the distal vessel seal 652 on the Rx.)
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