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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/21/2023; 12/1/2023; 1/12/2024; 7/12/2024; 7/31/2024; 11/15/2024; 1/3/2025; 1/16/2025; 10/13/2025; 11/7/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group III (claims 10-16) directed to a self-expanding stent having more than one diameter in the reply filed on February 10, 2026 is acknowledged.
Claims 1-9 and 17-20 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 February 10, 2026.
Response to Amendment
Claims 1-20 are pending in the application. Claims 1-9 and 17-20 are withdrawn. Claims 10-12, 15-16 have been amended. Claims 10-16 are rejected.
Claim Objections
Claims 10-16 are objected to because of the following informalities: The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. Appropriate corrections are 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.
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 12-16 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 12 recites the limitation "the target occluded vessel" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation “the guidewire junction” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 is 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 15 recites “having at least one barrel stent section or a zone of different diameter and whereby the barrel stent section is more proximal to and adjacent to the guide wire junction and vice-versa with any number of sections and coverings to achieve desired blood baffling.” It is unclear what is meant be “the barrel stent section is more proximal to and adjacent to the guidewire junction and vice-versa with any number of sections and coverings to achieve desired blood baffling.” Since the claims do not require a guidewire or multiple coverings.
Claim 16 recites “whereby a distal tip may be configured with closed or porous end; a distal tip closed with a laser cut configuration” in lines 2-3 of the claims. This limitation is unclear. It is unclear if the distal tip having a closed or porous end is a positively required limitation in the claim. Additionally, it is unclear if the claim is attempting to define a single distal tip or multiple distal tips. For the purposes of examination, this limitation is being interpreted as “The system of claim 15, further including a distal tipa closed laser cut configuration or a porous end[[s]];
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.
Claim(s) 10-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cam et al (US PG Pub 2016/0302797).
Regarding claim 10, Cam teaches a novel enhanced system1, which comprises blood flow baffling2- means, including in combination:
at least a stent (53) capable of self-expansion (See paragraphs [0006], [0010], [0041], [0061] and [0067]) and having more than one diameter (note section 55 and 57 have different diameters. See Fig. 2C; paragraphs [0042], [0043] and [0058]).
Regarding claim 11, Cam teaches the stent as required by claim 10 above and further teaches wherein an at least two diameter version (see Fig. 2C, note there are at least two different diameters of the stent) is created for ease of use, in a neurovascular intervention3 (See abstract; paragraph [0069])
Regarding claim 12, Cam teaches the stent as required by claim 11 above and further teaches further comprising at least one of said diameters being sized for4 a target occluded vessel, and the second being a diameter close to a proximal main diameter that is sized for another secondary vessel. (See paragraphs [0038]-[0039])
Regarding claim 13, Cam teaches the stent as required by claim 12 above and further teaches the secondary vessel5 is at least one of the internal carotid, common carotid, Basilar and vertebral arteries. (See paragraphs [0134]-[0135] which lists the types of vessels the stent can be placed in including the internal carotid, common carotid, Basilar and vertebral arteries)
Regarding claim 14, Cam teaches the stent as required by claim 13 above and further teaches further comprised of covering (See paragraphs [0051]-[0054]), whereby the flow dynamics of blood are impacted. (Note paragraph [0054] states “In some embodiments, the portion of the protruding section 57 that includes a mesh or covering, such as a polymer covering, may also be configured to cause diversion of flow”)
Regarding claim 15, Cam teaches the stent as required by claim 14 above and further teaches the stent having a zone of different diameter6 (protruding section 57) (See Fig. 2C)
Regarding claim 16, Cam teaches the stent as required by claim 15 above and further teaches a distal tip (note the stent 53 has two ends either of which may be considered “distal”) may be configured with a closed laser cut7 configuration or a porous end (See paragraphs [0124]-[0130]); and the stent is covered or coated with a polymer (See paragraph [0054]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.S.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
1 MPEP §2111.02 states “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation");
2MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, “baffle” is defined by Merriam-Webster and generally understood to mean “ to check or break the force or flow of by or as if by a baffle” and “a device (such as a plate, wall, or screen) to deflect, check, or regulate flow or passage (as of a fluid, light, or sound)”. In the instant case, the stent as taught by Cam is a “blood flow baffling means” since it alters (deflects and regulates) the flow of blood. See paragraphs [0038]-[0039] and [0050]-[0054]
3 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, “for ease of use in a neurovascular intervention” is a recitation of intended use. So long as the prior art is capable of performing the recited function, it is deemed to meet the claimed limitation. In the instant case, Cam explicitly states the stent can be used in a neurovascular application (See abstract and paragraph [0069]).
4 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, the diameters being “sized for” a particular location or vessel is a recitation of intended use. So long as the prior art is capable of performing the recited function, it is deemed to meet the claimed limitation. In the instant case, Cam teaches the device is appropriately sized for placement at a bifurcation which is deemed to meet the claimed limitation. Additionally, it is clear the stent as taught by Cam has two separate diameter sections which is the only structural requirement of the claims. (See Fig. 2C; paragraphs [0005], [0012], [0036], [0038], etc.)
5 As stated in footnotes 3 and 4 above, this is a recitation of intended use and does not carry full patentable weight.
6 It is noted that the claim as presently presented is an alternative limitation “having at least one barrel stent section or a zone of a different diameter”. The remaining limitations are only applicable to the barrel stent section. See MPEP §2173.05(h)
7 It is noted that this is a product-by-process limitation, and as such only the product will be examined. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)); see MPEP 2113). The court further stated in Brown. “[w]e are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product by process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 173 USPQ 685, 688 (CCPA 1972)