DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/14/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. However, Examiner notes that the Non-Patent Literatures numbered as 26-28 in the information disclosure statement (IDS) submitted on 10/14/2024 were lined through and not considered because they failed to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Thus, the information referred to therein has not been considered. Further, minor typographical errors were found in the IDS and were addressed by annotating the IDS.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Figure 1, reference numbers: (0), (1), (2), (4), (5), (6), and (7). Further, Figure 16 also includes reference number (2).
Figure 16, reference number (28).
Figure 18B, reference number (26).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because:
Figure (3), reference number (11) appears to be pointing to the “left femoral,” even though paragraph [0025] of the specification clearly states that reference number (11) is to be directed to the “right femoral”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because:
It begins with the phrase “Disclosed is…”, which is an implied introductory expression discouraged by MPEP § 608.01(b). Further, the phrase, “the device described within,” is also an implied introductory expression discouraged by MPEP § 608.01(b).
It uses the word “novel,” which constitutes a statement of purported merit rather than a concise technical disclosure.
It includes the term “means”, which is a legal phraseology used in patent claims and should be avoided in the abstract.
It contains nontechnical statements describing compatibility with standard surgical tools and procedures, which are not part of the technical disclosure and improperly reference the invention’s advantages or context of use.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Paragraph [0022] refers to “FilterWire from Boston Scientific.” The use of the terms “FilterWire” and “Boston Scientific”, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following each term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The following portion of paragraph [0022] should be amended to the following, “These filters utilize a memory metal such as Nitinol to oppose the vascular wall tightly sealing any emboli from passage while a filter material such as a porous fabric material retains the emboli from passing distally from the device.”
Paragraph [0024] should be amended to the following, “FIG. 2 illustrates the common technique in carotid filter 9 insertion for carotid stenting 10 as delivered via femoral artery over a guidewire 8.” The reference numbers as clearly seen in Figure 2 are opposite the disclosure, clearly reference number (9) is pointing to the “filter,” while reference number (8) is clearly pointing to the “guidewire.”
The following portion of paragraph [0041] should be amended to the following, “Once the guide catheter is in place a filter may be advanced into the left carotid artery and deployed leaving this vessel protected from emboli.”
Appropriate correction is required.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 9,492,264 (‘264), claim 1 of U.S. Patent No. 10,130,458 (‘458), and claim 1 of U.S. Patent No. 11,191,631 (‘631), all of which issued to the same inventor and commonly assigned. The claims at issue are not patentably distinct from each other because they differ only in ways that would have been obvious to a person of ordinary skill in the art at the time the invention was made.
The ‘264 and ’458 patents claim an embolic protection device or filter device comprising first and second filter portions, where the first portion is positioned in the brachiocephalic artery and the second portion is positioned in the left common carotid artery. The ‘631 patent similarly claims a hinged frame with first and second filter portions configured to engage the wall of the aorta near the ostia of the brachiocephalic and left common carotid arteries. The purpose of these devices is to protect the cerebral vasculature from embolic debris.
The instant claim recites a filter system comprising a guide catheter and first and second filters, wherein the guide catheter is configured to deliver the first filter into a left common carotid artery and the second filter into a right common carotid artery to prevent foreign material from traveling into the carotid circulation.
A person of ordinary skill in the art, motivated by the known need for bilateral cerebral protection, would have found it obvious to modify the dual-filter systems of the cited patents, which protect the left common carotid artery and the brachiocephalic artery, to a system that instead protects the left and right common carotid arteries. This anatomical repositioning of known filter devices to a new, but also known, target location represents a predictable and non-inventive variation.
Furthermore, the specific mechanism for delivery and expansion of the filters as claimed in the instant application does not patentably distinguish the subject matter. The use of a guide catheter to "deliver" and "expand" multiple filters into branch vessels was a known method in the art, as demonstrated by the applicant’s own earlier patents, such as U.S. Patent No. 9,345,565 and U.S. Patent No. 9,326,843, which both disclose a catheter with a pull wire mechanism for articulating and deploying filters. The functional language of the instant claim merely describes a well-established mode of deployment and does not introduce a novel structural limitation.
Therefore, the differences between the claimed subject matter and the claims of the ‘264, ‘458, and ‘631 patents do not render the instant claim patentably distinct.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Don Michael (US PGPUB No. 20040243175 A1).
Regarding claim 1, Don Michael discloses, a filter system (system used in figure 9b) for preventing foreign material from traveling into carotid circulation (the system is structured to be able to perform this function), the system comprising: a guide catheter (68); a first filter (4a); and a second filter (4); wherein the guide catheter is configured to deliver the first filter into a left common carotid artery and expand the first filter (structured to be able to do this, see explanation below); wherein the guide catheter is configured to deliver the second filter into a right common carotid artery and expand the second filter (structured to be able to do this, see explanation below).
Examiner notes the limitations “wherein the guide catheter is configured to deliver the first filter into a left common carotid artery and expand the first filter” and “wherein the guide catheter is configured to deliver the second filter into a right common carotid artery and expand the second filter” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus 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)). Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Don Michael discloses all the structure as claimed, and is further used to expand multiple filters in different vessels of a patient. As such, it is capable of performing the functions as claimed (i.e. it is capable of delivering the first filter into a left common carotid artery and expand the first filter and configured to deliver the second filter into a right common carotid artery and expand the second filter).
Conclusion
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/O.N./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771