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 for Election/Restrictions
Applicant’s election without traverse of Group I (claims 2-16) in the reply filed on 5/11/2026 is acknowledged. Applicant states that claims 2-16 read on the elected invention.
Election was made without traverse in the reply filed on 5/11/2026.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a user-operated control mechanism configured to transition a distance between the first arm distal portion and the second arm distal portion” in claim 7 and “a biasing element coupled with one or the first arm or the second arm, the biasing element configured to urge expandable cage toward an expanded configuration” in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
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 2-7 and 15 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation of “wherein in the collapsed configuration a first distance between the first arm distal portion and the second arm distal portion includes a first length and in the expanded configuration a second distance between the first arm distal portion and the second arm distal portion includes a second length greater than the first length” in claim 2 is not disclosed in the applicant’s specification. The applicant’s specification does not explicitly disclose this limitation. It is clear from the applicant’s specification and also in Figures 11A-11B that the second length should be less than the first length and not greater than since in the collapsed configuration, the first arm is in an extended position (greater distance from the second arm distal portion) and in the expanded configuration, the first arm is in a retracted position (less distance from the second arm distal portion).
The limitation of “wherein the cage includes the biasing element configured to control the diameter of the cage” in claim 15 is not disclosed in the applicant’s specification. The applicant’s specification does not explicitly disclose this limitation.
Claims 3-7 are rejected due to being dependent on rejected claim 2.
Claims 2-7, 9 and 15 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 pre-AIA the applicant regards as the invention.
Regarding claim 2, the claim recites the limitation “wherein in the collapsed configuration a first distance between the first arm distal portion and the second arm distal portion includes a first length and in the expanded configuration a second distance between the first arm distal portion and the second arm distal portion includes a second length greater than the first length”. It is not clear to the examiner how the second length can be greater than the first length if in the collapsed configuration, the first arm is in an extended position resulting in a greater distance from the second arm distal portion and if in the expanded configuration, the first arm is in a retracted position resulting in less distance from the second arm distal portion. Therefore, the scope of the claim is unclear. For examination purposes, the limitation “wherein in the collapsed configuration a first distance between the first arm distal portion and the second arm distal portion includes a first length and in the expanded configuration a second distance between the first arm distal portion and the second arm distal portion includes a second length greater than the first length” will be interpreted as “wherein in the collapsed configuration a first distance between the first arm distal portion and the second arm distal portion includes a first length and in the expanded configuration a second distance between the first arm distal portion and the second arm distal portion includes a second length less than the first length”. Appropriate correction is required.
Regarding claim 9, the claim recites the limitation “wherein the user-operated control mechanism includes the biasing element configured to resist movement of the first arm relative to the second arm”. It is not clear to the examiner how the user-operated control mechanism includes the biasing element if claim 8 recites that the connector includes the biasing element. Therefore, the scope of the claim is unclear. Appropriate correction is required.
Regarding claim 15, the claim recites the limitation “wherein the cage includes the biasing element configured to control the diameter of the cage”. It is not clear to the examiner how the cage includes the biasing element if claim 8 recites that the connector includes the biasing element. Therefore, the scope of the claim is unclear. Appropriate correction is required.
Claim 3-7 are rejected due to being dependent on rejected claim 2.
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 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.
Claims 2, 5-9, 11-14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bilitz (US Patent No. 5,817,104).
Regarding claim 2 as best understood, Bilitz discloses (Figures 1-12C) a device (10) fully capable in being used as a thrombectomy device comprising: a handle (12); a cage (70) including a proximal end portion and a distal end portion (Figures 3A-3B), the cage having a reduced configuration (Figure 3A) and an expanded configuration (Figure 3B); wherein in the reduced configuration the cage is configured to have a collapsed configuration relative to the expanded configuration (Figures 3A-3B); a first arm (72) including: a first arm distal portion coupled with the distal end portion of the cage (Figures 3A-3B); and a first arm proximal portion operatively coupled with the handle (Figure 11C); and a second arm (62) including: a second arm distal portion coupled with the proximal end portion of the cage (Figures 3A-3C); and a second arm proximal portion coupled with the handle (Figures 11A-11C); wherein the first arm is axially movable relative to the second arm (Figures 11B-11C) (Col. 6, lines 62-67 and Col. 7, lines 1-22); wherein in the collapsed configuration a first distance between the first arm distal portion and the second arm distal portion includes a first length (Figure 3A) and in the expanded configuration a second distance between the first arm distal portion and the second arm distal portion includes a second length (Figure 3B) less than the first length (clearly shown in Figures 3A-3B) (Col. 6, lines 62-67 and Col. 7, lines 1-22).
Regarding claim 5, wherein the handle includes a control mechanism (18) coupled with the first arm proximal portion (Figures 11A-11C).
Regarding claim 6, wherein in the reduced configuration, a diameter of the cage is less than the diameter of the cage in the expanded configuration (clearly shown in Figures 3A-3B).
Regarding claim 7, including a user-operated control mechanism (18) configured to transition a distance between the first arm distal portion and the second arm distal portion (Figures 11A-11C) (Col. 6, lines 62-67 and Col. 7, lines 1-22); wherein the distance is proportionate to a diameter of the cage (Col. 6, lines 62-67 and Col. 7, lines 1-22).
Regarding claim 8, Bilitz discloses (Figures 1-12C) a device (10) fully capable in being used as a thrombectomy device comprising: a handle (12) including a user-operated control mechanism (18); a connector (62, 72) coupled with the user-operated control mechanism (Figures 11A-11C), the connector distally extending from the handle (Figures 11A-11C); a user-adjustable radially expandable cage (70) coupled with a distal portion of the connector; wherein the connector extends through the cage from a proximal portion of the cage to a distal portion of the cage (Figures 11A-11C), the connector including: a first arm (72) coupled with the distal portion of the cage (Figures 3A-3B) and the first arm configured to control a movement of the distal portion of the cage (Col. 6, lines 62-67 and Col. 7, lines 1-22); a second arm (62) coupled to the proximal portion of the cage and configured to control a movement of the proximal portion of the cage (Figures 3A-3B and 11B-11C); and a biasing element (26) coupled with the first arm [Operatively coupled with the first arm to bias the cage in the collapsed configuration as shown in Figure 11B], the biasing element configured to urge expandable cage toward an expanded configuration (Figure 11C) [Urge the cage toward an expanded configuration by having the biasing element to be compressed as shown in Figures 11B-11C]; wherein in the expanded configuration, a diameter of the cage is greater than the diameter of the cage in a contracted configuration (Figure 11B); wherein the user-operated control mechanism is configured to transfer movement from the user-operated control mechanism to move the first arm relative to the second arm to adjust the diameter of the cage (Figures 11A-11C) (Col. 6, lines 62-67 and Col. 7, lines 1-22).
Regarding claim 9, wherein the user-operated control mechanism includes the biasing element configured to resist movement of the first arm relative to the second arm (Figures 11A-11C) (Col. 6, lines 62-67 and Col. 7, lines 1-22).
Regarding claim 11, wherein the biasing element includes a resiliently deformable member (Figures 11A-11C) (Col. 6, lines 62-67 and Col. 7, lines 1-22).
Regarding claim 12, wherein increasing a distance between a distal portion of the first arm and a distal portion of the second arm reduces the diameter of the cage (Figure 3A).
Regarding claim 13, wherein a distal portion of the second arm is statically positioned relative to the cage (Figures 11B-11C).
Regarding claim 14, wherein the user-operated control mechanism is configured to reposition a distal portion of the first arm relative to the distal portion of the second arm (Figures 11A-11C) (Col. 6, lines 62-67 and Col. 7, lines 1-22).
Regarding claim 16, including a sheath (60) configured to cover the cage in the contracted configuration (Figures 3C and 11A).
Claims 2-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Demarais (US Patent No. 6,454,775).
Regarding claim 2 as best understood, Demarais discloses (Figures 4-5B) a device (100) fully capable in being used as a thrombectomy device comprising: a handle (14); a cage (108) including a proximal end portion and a distal end portion (Figures 5A-5B), the cage having a reduced configuration (Figure 5A) and an expanded configuration (Figure 5B); wherein in the reduced configuration the cage is configured to have a collapsed configuration relative to the expanded configuration (Figures 5A-5B); a first arm (104) including: a first arm distal portion coupled with the distal end portion of the cage (Figures 5A-5B); and a first arm proximal portion operatively coupled with the handle (Figure 1); and a second arm (102) including: a second arm distal portion coupled with the proximal end portion of the cage (Figures 5A-5B); and a second arm proximal portion coupled with the handle (Figure 1); wherein the first arm is axially movable relative to the second arm (Figures 5A-5B) (Col. 9, lines 13-53); wherein in the collapsed configuration a first distance between the first arm distal portion and the second arm distal portion includes a first length (Figure 5A) and in the expanded configuration a second distance between the first arm distal portion and the second arm distal portion includes a second length (Figure 5B) less than the first length (clearly shown in Figures 5A-5B) (Col. 9, lines 13-53).
Regarding claim 3, including an extraction mechanism (110) located within the cage (Figures 5A-5B).
Claim Rejections - 35 USC § 103
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 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 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 of this title, 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.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Demarais (US Patent No. 6,454,775) in view of Bilitz (US Patent No. 5,817,104).
Regarding claim 8, Demarais discloses (Figures 4-5B) a device (100) fully capable in being used as a thrombectomy device comprising: a handle (14) including a user-operated control mechanism (24); a connector (102, 104) coupled with the user-operated control mechanism (Figure 1), the connector distally extending from the handle (Figure 1); a user-adjustable radially expandable cage (108) coupled with a distal portion of the connector; wherein the connector extends through the cage from a proximal portion of the cage to a distal portion of the cage (Figures 5A-5B), the connector including: a first arm (104) coupled with the distal portion of the cage (Figures 5A-5B) and the first arm configured to control a movement of the distal portion of the cage (Figures 5A-5B) (Col. 9, lines 13-53); a second arm (102) coupled to the proximal portion of the cage and configured to control a movement of the proximal portion of the cage (Figures 5A-5B); wherein in the expanded configuration, a diameter of the cage is greater than the diameter of the cage in a contracted configuration (Figure 5B); wherein the user-operated control mechanism is configured to transfer movement from the user-operated control mechanism to move the first arm relative to the second arm to adjust the diameter of the cage (Figures 5A-5B) (Col. 7, lines 9-26 and Col. 9, lines 13-53).
Demarais fails to disclose and a biasing element coupled with the first arm, the biasing element configured to urge expandable cage toward an expanded configuration.
Bilitz, in the analogues art of expandable baskets used for surgery, teaches (Figures 1-11C) a stone basket (10) that includes a biasing element (26) coupled with a first arm (72) [Operatively coupled with the first arm to bias the cage in the collapsed configuration as shown in Figure 11B], the biasing element configured to urge the expandable cage (70) toward an expanded configuration (Figure 11C) [Urge the cage toward an expanded configuration by having the biasing element to be compressed as shown in Figures 11B-11C]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Demarais to have included a biasing element coupled with the first arm, the biasing element configured to urge expandable cage toward an expanded configuration as taught by Bilitz, in order facilitate the medical procedure by having the basket to automatically collapse when the user-operated control mechanism is released (Bilitz, Col. 7, lines 9-22).
Regarding claim 10, Demarais modified by Bilitz further discloses wherein the cage includes a thrombus extractor (110) [Fully capable in being used as a thrombus extractor] positioned within the cage (Figures 5A-5B).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2, 3, 8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, 13 and 21 of U.S. Patent No. 10,779,852. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims
18/955,362
2
3
8
10
Claims
Patent 10,779,852
1, 6,13, 21
9
1, 6, 13, 21
9
Claims 2 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,813,663. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims
18/955,362
2
8
Claims
Patent 10,813,663
1
1
Claims 2, 3, 8 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 13 and 16 of U.S. Patent No. 11,406,418. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are fully contained within the claim of the patent application.
Claims
18/955,362
2
3
8
10
Claims
Patent 11,406,418
1, 7, 16
13
1, 7, 16
13
Allowable Subject Matter
Claim 4 is 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 and also, if they overcome the double patenting rejection and if claim 2 overcomes the 112 rejections set forth in this Office Action.
The following is an examiner’s statement of reasons for indicating allowable subject matter in the dependent claims:
The prior art of record fails to disclose or render obvious the combination of features as claimed. In particular, the prior art of record fails to disclose wherein the extraction mechanism includes a longitudinally extending tube and a rotating macerator located within the longitudinally extending tube (claim 4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771
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