DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election without traverse of Group/Invention I – claims 1-14 and 20 (drawn to an endovascular treatment system) in the reply filed on 22 May 2026 is acknowledged.
3. Applicant’s election without traverse of Endovascular Treatment System – Species A (embodied in Figures 1-6) in the reply filed on 22 May 2026 is acknowledged.
According to Applicant’s response – “Applicant elects to proceed with examination of the invention and species identified as Invention I, Species A, directed to claims 1-6, 8-14 and 20, without traverse”.
4. Claim 8 is drawn to non-elected Species B (Figures 7-10), which embodiment shows “the main body has an outer surface that projects radially outward proximate the external opening at locations corresponding to an outer profile of each of the internal tubes such that the external openings are longitudinally-oriented”.
Figure 2 of the elected embodiment clearly shows (i) “outer surface” 124 of “main body component” 102a as non-protruding (i.e., the opposite from “an outer surface that projects radially outward proximate the external opening”), and (ii) “external opening” 162 as flush with “outer surface” 124 of “main body component” 102a, and not as “longitudinally-oriented” (since the elected embodiment clearly shows “external opening” 162 as extending traverse to longitudinal axis of “main lumen” 128).
5. Claim 9 is drawn to a non-elected embodiment that is NOT shown in the drawings, i.e., “and further wherein the external openings of each of the first and second internal tubes are longitudinally aligned to the inner lumen”. Figure 2 of the elected embodiment clearly shows “external opening” 162 as flush with “outer surface” 124 of “main body component” 102a, or as extending transverse (i.e., not longitudinally aligned) to “inner lumen” 128. Further, compare claim 9 to claim 11.
6. Claim 20 is drawn to non-elected Species B (Figures 7-10), which embodiment shows “the main body has an outer surface that projects radially outward proximate the external opening at locations corresponding to an outer profile of each of the internal tubes such that the external openings are longitudinally-oriented”.
Figure 2 of the elected embodiment clearly shows (i) “outer surface” 124 of “main body component” 102a as non-protruding (i.e., the opposite from “an outer surface that projects radially outward proximate the external opening”), and (ii) “external opening” 162 as flush with “outer surface” 124 of “main body component” 102a, and not as “longitudinally-oriented” (since the elected embodiment clearly shows “external opening” 162 as extending traverse to longitudinal axis of “main lumen” 128).
7. Therefore, claims 7-9 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 May 2026.
Drawings
8. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
a. Therefore, the “and further wherein the external openings of each of the first and second internal tubes are longitudinally aligned to the inner lumen” (claim 9) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Objections
9. Claims 8-12 and 14 are objected to because of the following informalities:
a. Each of claims 8-12 and 14 recites “the main body” rather than “the main body component” (as introduced in independent claim 1). Appropriate correction is required.
Claim Rejections - 35 USC § 112
10. 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.
11. Claims 8, 10, and 20 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.
a. Regarding claim 8, the recitation “wherein the main body has an outer surface” (preamble) is NOT further limiting independent claim 1 (which claim 1 recites “and an external opening in an outer surface of the main body component” in line 6).
b. Regarding claim 10, the recitation “wherein the main body has an outer surface” (preamble) is NOT further limiting independent claim 1 (which claim 1 recites “and an external opening in an outer surface of the main body component” in line 6).
b. Regarding independent claim 20, the recitation “the main body having an outer surface” (line 9) is NOT further limiting independent claim 20 (reciting “and an external opening in an outer surface of the main body component” in line 6).
Claim Rejections - 35 USC § 103
12. 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 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.
13. Claims 1-6 and 10-14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Lostetter (US PG Pub No. 2019/0336269 A1) or, in the alternative, under 35 U.S.C. 103 as obvious over Lostetter (US PG Pub No. 2019/0336269 A1) in view of Skender (US PG Pub No. 2016/0296353 A1).
Referring to Figures 1-3, Lostetter ‘6269 discloses an endovascular treatment system comprising:
a main body component (12) having a first end (16), a second end (18), and an inner lumen (20), the main body including a first internal tube (24) and a second internal tube (50, 52, or 54) located within the inner lumen (clearly shown in the figures, and disclosed in [0022] and [0023]), each of the first and second internal tubes having an origin oriented toward the first end of the main body component (the origin of internal tube 24 is 28; the origin of internal tube 50 is 53) and an external opening (22/34 and 59/34) in an outer surface (14) of the main body component; and
a plurality of side branch components (Figure 3 - side branch components 46), including a first side branch component and a second side branch component, each configured to be received in one of the first and second internal tubes and to extend from the external openings in the outer surface of the main body component ([0006], [0028], [0029]),
wherein the system is configured to be endovascularly implanted in, and to treat the abdominal aorta ([0002], [0006], [0028], [0029]), the main body component being configured to be anchored in the abdominal aorta ([0002], [0006], [0028], [0029]) at a location that is superior of a location of renal arteries of the patient such that the plurality of side branch components are anchorable (capable of) in renal arteries of the patient for perfusion thereof ([0002], [0006], [0028], [0029]).
Notice, Figures 4A, 4B, and 5 also shows the claimed “first and second internal tubes” (116) each having an external opening (112) in an outer surface of the main body component (100), and branch prostheses 108, 110 configured to extend from the external openings in the outer surface of the main body component.
With regards to statements of intended use and other functional statements (e.g., wherein the system is configured to be endovascularly implanted in, and to treat the abdominal aorta, the main body component being configured to be anchored in the abdominal aorta at a location that is superior of a location of renal arteries of the patient such that the plurality of side branch components are anchorable in renal arteries of the patient for perfusion thereof), they do not impose any structural limitations on the claims distinguishable over the device of Lostetter ‘6269, which is capable of being used as claimed if one so desires to do so. In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Claims directed to apparatus must be distinguished from the prior art in terms of structure rather than function. In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA1959). “[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). Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim. Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969).
Regarding recitation “the main body component including at least one of a fenestration feature and a scallop feature”, Figure 1 clearly shows the main body component as including “a fenestration feature” ([0023] - “wherein wall apertures 56,58 are aligned with wall apertures defined by stent graft component 12”).
Lostetter ‘6269 discloses the invention as claimed, except for particularly disclosing the main body component as including a scallop feature. However, this is already known in the art. For example, Skender ‘6353 teaches (Figure 1) a main body component (10) including at least one of a fenestration feature (fenestration 38, or any of fenestrations 12) and a scallop feature (40) for the well-known advantage of prevention of occluding a blood vessel and to facilitate perfusion thereof and/or receipt of an additional side branch component or other feature if needed (depending on particular condition of the patient). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of the main body component including at least one of a fenestration feature and a scallop feature, as taught by Skender ‘6353, with the invention of Lostetter ‘6269, in order to prevent occluding a blood vessel and to facilitate perfusion thereof and/or receipt of an additional side branch component or other feature if needed (depending on particular condition of the patient).
As noted by the United States Supreme Court, if a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. KSR, 127 S. Ct. at 1740. "When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82USPQ2d 1385, 1396 (2007).
Regarding claim 2, Lostetter ‘6269 teaches wherein the first and second internal tubes are circumferentially offset by approximately 180 degrees ([0023] – “graft prosthesis 10 includes three tunnel graft components 50,52,54, wherein tunnel graft components 50,54 are located essentially opposite each other within main lumen 20 of main graft component 12”, wherein “opposite each other” means circumferentially offset by approximately 180 degrees, as shown in Figures 1-3).
Regarding claim 3, Lostetter ‘6269 teaches wherein the first and second internal tubes are circumferentially offset by approximately 160 degrees. Paragraph [0023] states “graft prosthesis 10 includes three tunnel graft components 50,52,54, wherein tunnel graft components 50,54 are located essentially opposite each other within main lumen 20 of main graft component 12”. Based on this teaching, 50 and 52 are not circumferentially offset by approximately 180 degrees, but less.
Further, looking to Applicant’s specification, there is no criticality in the use of a “wherein the first and second internal tubes are circumferentially offset by approximately 160 degree”.
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have modified Lostetter ‘6269 invention wherein the first and second internal tubes are circumferentially offset by approximately 160 degrees, since optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results.
Regarding claim 4, Lostetter ‘6269 teaches wherein the first and second internal tubes are circumferentially offset by approximately 140 degrees. Paragraph [0023] states “graft prosthesis 10 includes three tunnel graft components 50,52,54, wherein tunnel graft components 50,54 are located essentially opposite each other within main lumen 20 of main graft component 12”. Based on this teaching, 50 and 52 are not circumferentially offset by approximately 180 degrees, but less.
Further, looking to Applicant’s specification, there is no criticality in the use of a “wherein the first and second internal tubes are circumferentially offset by approximately 140 degree”.
Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have modified Lostetter ‘6269 invention wherein the first and second internal tubes are circumferentially offset by approximately 140 degrees, since optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results.
Regarding claim 5, Lostetter ‘6269 wherein the main body component has a larger, proximal inlet (open proximal end 16) and two smaller, distal outlets defined by two legs (Figures 1-3 clearly show smaller short leg and long leg as the distal outlets).
Regarding claim 6, Lostetter ‘6269 wherein the two legs include a short leg and a long leg (Figures 1-3 clearly show a short leg and a long leg).
Regarding claim 10, Lostetter ‘6269 wherein the main body has an outer surface (14) and further wherein the external openings of the first and second internal tubes are flush (clearly shown in Figure 1 and Figures 4A, 4B) with the outer surface of the main body such that the external openings are radially-oriented (clearly shown in Figures 1-3 and Figures 4A, 4B).
Regarding claim 11, Lostetter ‘6269 wherein the origins of each of the first and second internal tubes are oriented toward the first end of the main body and are longitudinally aligned with the inner lumen of the main body (clearly shown in Figures 1-3 and Figures 4A, 4B), and further wherein the external openings of each of the first and second internal tubes extend transverse to the inner lumen (clearly shown in Figures 1-3 and Figures 4A, 4B).
Regarding claim 12, Lostetter ‘6269 teaches wherein the origin of at least one of the first and second internal tubes are inset (e.g., distal offset from edge of proximal end) from the first end of the main body by an inset distance (clearly show in Figures 1-3; further, see [0023]).
Regarding claim 13, Lostetter ‘6269 discloses the invention as claimed, except for particularly disclosing the wherein the inset distance is from 5mm to 10mm.
Applicant appears to have placed no criticality on the claimed range (see [0053] of the instant application, indicating “as shown, the origins 160 are longitudinally aligned, or substantially longitudinally aligned, although they may be offset from one another as desired. In some examples, the origins 160 are inset from the first end 120 of the main body component 102a from 5mm to 10mm, for example, although a variety of offsets are contemplated. In various examples, the external openings 162 are offset from the first end 120 of the main body 102a by no more than 40mm, for example, although a variety of offsets are contemplated”.
It would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have manufactured Lostetter ‘6269 invention to have wherein the inset distance is from 5mm to 10mm, 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.
Regarding claim 14, Lostetter ‘6269 teaches wherein the external opening of at least one of the first and second internal tubes are offset from the first end of the main body by an offset distance (clearly show in Figures 1-3; further, see [0023]). Lostetter ‘6269 discloses the invention as claimed, except for particularly disclosing wherein the external opening of at least one of the first and second internal tubes are offset from the first end of the main body by an offset distance of no more than 40mm.
Applicant appears to have placed no criticality on the claimed range (see [0053] of the instant application, indicating “as shown, the origins 160 are longitudinally aligned, or substantially longitudinally aligned, although they may be offset from one another as desired. In some examples, the origins 160 are inset from the first end 120 of the main body component 102a from 5mm to 10mm, for example, although a variety of offsets are contemplated. In various examples, the external openings 162 are offset from the first end 120 of the main body 102a by no more than 40mm, for example, although a variety of offsets are contemplated”.
It would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have manufactured Lostetter ‘6269 invention to have wherein the external opening of at least one of the first and second internal tubes are offset from the first end of the main body by an offset distance of no more than 40mm, 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.
Conclusion
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US PG Pub No. 2003/0199967 A1
US PG Pub No. 2018/0042739 A1
US PG Pub No. 2021/0068992 A1
US PG Pub No. 2006/0184228 A1
US PG Pub No. 2012/0130472 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774
Prosecution Insights