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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/5/2025 has been entered.
Response to Amendment
In response to the amendment filed on 12/5/2025, claims 4 and 15 have been cancelled, and claims 1-3, 5-14 are pending, while newly added claims 32-34 are withdrawn. Claims 32-34 are directed to an embolic protection device system which was previously withdrawn as a result of the Restriction Requirement dated 9/9/2024. The common technical features between the two groups are taught and made obvious by Yair et al (US 2019/0021836) as detailed below in the rejection of independent claim 1. Therefore, these features cannot be considered a special technical feature. If and when claim 1 is determined to be allowable, Applicant may request for a rejoinder of claims 32-34 if claim 32 includes the special technical feature of claim 1 at the time.
Response to Arguments
Applicant's arguments filed 12/5/2025 have been fully considered but they are not persuasive.
Applicant argues on pages 8-9 Yair et al fails to disclose the claims as amended, specifically regarding the second support portion includes a diameter of between 0.1-2mm less than the diameter of the first supporting portion. However, the Examiner respectfully disagrees. Arguments directed to the claims as amended are addressed and cited in the body of the rejections below. The rejection below, as a result of the claim amendments, have been changed from a 35 U.S.C. 102 rejection to a 35 U.S.C. 103 rejection. It is the Examiner’s position that the claimed invention is now made obvious by Yair et al.
Claim Objections
Claim 1 is objected to because of the following informalities:
In the last line of claim 1, “the diameter of the first supporting portion” should recite - - a diameter of the first support[[ing]] portion - -.
Appropriate correction is required.
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 1-3, 5-14 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 has been amended to recite “a filter portion comprising a plurality of immediately adjacent turns of the helix”. The term “immediately adjacent” would require the turns of the helix to be immediately next to one another, with no intervening element or space. However, as seen in Figs. 1A and 1B of Applicant’s drawings, the turns of the helix of filtering portion 203 are axially spaced from one another and therefore not immediately adjacent to one another. Therefore, this feature is considered new matter and for examination purposes the Examiner will interpret claim 1 as requiring the turns to be next to one another, without an intervening structure in between the turns.
Claim(s) 2, 3, 5-14 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
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 1-3, 5-14 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 1 recites the limitation "the axis" in line 6 of page 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear which axis is being referred to.
Claim(s) 2, 3, 5-14 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yair et al (US 2019/0021836).
Applicant is reminded claims 1-3, 5-14 are directed to an apparatus claim and not a method of use. Therefore, the prior art only needs to be capable of placing and positioning the medical device/embolic protection device as claimed and does not necessarily need to disclose the active step of placing and positioning the medical device/embolic protection device as claimed.
Yair et al discloses the following limitations:
Claim 1. An embolic protection device (EPD) (27) configured for arrangement within a carotid artery (5) ([0005]-[0006], [0093]; “Body vessel 5 may be an artery, such as a carotid artery”), the EPD comprising:
a filament (28) configured to include:
a first posterior device end (right side in Fig. 6B) and a second anterior device end (left side in Fig. 6B);
an un-deployed state (Fig. 5) including at least a portion configured to fit within a lumen of a needle (4); [0090], [0091], [0113]); and
a deployed state (Figs. 6A-6D) wherein the filament automatically forms (due to the shape memory nature of the filament; [0090]) a linearly arranged helix (linearly arranged along axis 34 in Fig. 6B; [0121]) comprising a plurality of turns wound in a first direction ([0029], [0094], [0095], [0098], [0114]-[0116]), the helix including:
a first support portion (see annotated figure below),
a second support portion (see annotated figure below) ([0095], [0096], [0115], [0118], [0119), and
a filter portion (30) comprising a plurality of immediately adjacent turns of the helix (Fig. 6B; i.e. there are no intervening structures between the turns of the filtering portion; [0094], [0098], [0115], [0120]),
wherein:
the device is configured for deploying within a carotid artery (5) of a subject in an implantation direction (Figures 2A-C, 6A-6D; [0093]-[0095]), such that the first posterior device end points towards a subject first end (right side as seen in the cited figures, and the second anterior device end points towards a subject second end (left side as seen in the cited figures),
the first direction of the helix corresponds to one of a clockwise or a counterclockwise direction upon the device being deployed in a carotid artery on a first side of the body of the subject (Figs. 2A-C, 6A-6D; [0093]-[0094], [0115]; “the deployed shape of filament 2 may be that of a wound wire comprising turns of varying sizes. In some embodiments, all turns may be wound in the same direction, for example, the clockwise direction or the counter clockwise direction.” Therefore, the filament is capable of being deployed within a carotid artery of a subject in an implantation direction wherein the first direction of the filament corresponds to one of a clockwise or a counterclockwise direction upon the device being deployed in a carotid artery arranged on a first side of the body of the subject depending on the orientation the user decides to deploy the medical device),
the first direction of the helix corresponds to the other of the clockwise or counterclockwise direction upon the device being deployed in a carotid artery on a second side of the body of the subject (Figs. 2A-C, 6A-6D; [0093]-[0094], [0115]; “the deployed shape of filament 2 may be that of a wound wire comprising turns of varying sizes. In some embodiments, all turns may be wound in the same direction, for example, the clockwise direction or the counter clockwise direction.” Therefore, the filament is capable of being deployed within a carotid artery of a subject in an implantation direction wherein the first direction of the filament corresponds to one of a clockwise or a counterclockwise direction upon the device being deployed in a carotid artery arranged on a first side of the body of the subject depending on the orientation the user decides to deploy the medical device); and
the filter portion (30) is arranged between the first support portion and the second support portion linearly along the axis (34).
Yair et al further discloses the diameter of the EPD being of varying sizes ([0094], [0115]) and specifically shows a diameter of the second support portion (as annotated below) being smaller than a diameter of the first support portion ([0120]; “coil diameter may decrease in diameter towards the distal end 22 of filament 28”). Yair et al fails to disclose the diameter of the second support portion is specifically between 0.1-2mm less than the diameter of the first supporting portion. However, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the difference in diameter of the first and second support portions of the EPD to be within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the first and second support portions to have a difference within the claimed range as a matter of routine optimization, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
It is noted Applicant has provided on page 9 of the remarks filed 12/5/2025 the importance of this feature, indicating it enables proper fitting of the EPD with the carotid artery since the carotid artery is naturally tapered. The second supporting portion is smaller in diameter by 0.1-2mm than the diameter of the first support portion, since the second support portion is arranged within a narrower portion of the carotid artery and the first support portion is arranged within a wider portion of the carotid artery.
However, Applicant has not provided evidence, such as how the claimed range have unexpected results in the fitting of the EPD within the carotid artery over the prior art. It is the Examiner's position that one of ordinary skill in the art at the time the invention was made would have known the approximate the approximate dimensions of the carotid artery to be treated and determined the necessary difference in diameters of the first and second support portions of the EPD to fit and anchor the EPD within the natural shape of the carotid artery since Yair et al explicitly discloses the EPD is for the carotid artery ([0093]) and that the second support portion has a diameter smaller than the diameter of the first support portion (Fig. 6B; [0120]). Therefore, the claimed range is merely a range discoverable by routine skill in the art and fails to patentably distinct the claimed invention of claim 1from the prior art.
PNG
media_image1.png
696
619
media_image1.png
Greyscale
Claim 2. The device of claim 1, wherein the first side can be the left side of the body of the subject, and the second side can be the right side of the body of the subject as the user can deploy the medical device in any side and direction as desired.
Claim 3. The device of claims 1, wherein the carotid artery on the left side of the body can be the left carotid artery, and the carotid artery on the right side of the body can be a right carotid artery as the device is disclosed and sized for implantation in the carotid arteries ([0093], [0151]) and can be deployed in any side and direction as desired.
Claim 5. The device of claim 1, the medical device is capable for use with a distal end of the needle that includes an opening and a bevel along a bevel plane. The needle is not positively recited as an element of the medical device. The device is sized for use with a needle (4) (Fig. 1; [0183]) and therefore, a needle with an opening and a bevel along a bevel plane can be used.
Claim 6. The device of claim 1, the medical device is capable for use with a distal end of the needle including an opening and a bevel along a bevel plane. The needle is not positively recited as an element of the medical device. The device is sized for use with a needle (4) (Fig. 1; [0183]) and therefore, a needle with an opening and a bevel along a bevel plane can be used.
Claim 7. The device of claim 1, the medical device is capable for use with the bevel plane arranged during implantation such that it faces the midline of the subject. The user can position the bevel plane in any desired manner during implantation.
Claim 8. The device of claim 1, the medical device is capable for use with the bevel plane arranged during implantation such that it faces the lateral direction of the subject. The user can position the bevel plane in any desired manner during implantation.
Claim 9. The device of claim 1, the medical device is capable for use with the bevel plane arranged during implantation such that it faces the caudal direction of the subject. The user can position the bevel plane in any desired manner during implantation.
Claim 10. The device of claim 1, the medical device is capable for use with the bevel plane arranged during implantation such that it faces the cranial direction of the subject. The user can position the bevel plane in any desired manner during implantation.
Claim 11. The device of claim 1, the medical device is capable for use with the bevel plane arranged during implantation such that it faces the midline of the subject and faces the caudal direction of the subject. The user can position the bevel plane in any desired manner during implantation.
Claim 12. The device of claim 1, the medical device is capable for use with the bevel plane arranged during implantation such that it faces the midline of the subject and faces the cranial direction of the subject. The user can position the bevel plane in any desired manner during implantation.
Claim 13. The device of claim 1, the medical device is capable for use with the bevel plane arranged during implantation such that it faces the lateral direction of the subject and faces the caudal direction of the subject. The user can position the bevel plane in any desired manner during implantation.
Claim 14. The device of claim 1, the medical device is capable for use with the bevel plane arranged during implantation such that if faces the lateral direction of the subject and faces the cranial direction of the subject. The user can position the bevel plane in any desired manner during implantation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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 on (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.
/KATHERINE M SHI/ Primary Examiner, Art Unit 3771