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 to Amendment
This office action is responsive to the amendment filed on April 23, 2024. As directed by the amendment: no claims have been amended, claims 1-21 have been cancelled, and claims 22-71 have been added. Thus, claims 22-71 are presently pending in this application.
Claim Objections
Claim 46 is objected to because of the following informalities: please remove the space between the words “where in”. Appropriate correction is required.
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 22-71 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 22 recites the limitation "the at least first and second infusion spines" in 4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the at least first and second expandable infusion spines”. Lines 8, 13, 16, 17, 19, 20-21, 24, 25, and 27 also lack antecedent basis. Claims 23-34 are rejected at least because they depend from claim 22.
Claim 22 recites the limitation "the plurality of movable assemblies" in lines 11-12. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the plurality of movable needles assemblies”. Lines 13-14 also lack antecedent basis. Claims 23-34 are rejected at least because they depend from claim 22.
Claim 22 recites the limitation "the corresponding infusion spine" in line 16. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “a corresponding infusion spine”. Claims 23-34 are rejected at least because they depend from claim 22.
Claim 35 recites the limitation "the plurality of movable assemblies" in 11-12. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the plurality of movable needles assemblies”. Lines 13-14 also lack antecedent basis. Claims 36-55 are rejected at least because the depend from claim 35.
Claim 35 recites the limitation "the at least first and second infusion spines" in 4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the at least first and second expandable infusion spines”. Lines 8, 13, 16, 17, 19, 20-21 and 27-28 also lack antecedent basis. Claims 36-55 are rejected at least because the depend from claim 35.
Claim 35 recites the limitation "the corresponding infusion spine" in line 16. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “a corresponding infusion spine”. Claims 36-55 are rejected at least because the depend from claim 35.
Claim 44 recites in lines 1-2, the first material is a different durometer than the second material, which conflicts with claim 43 from which claim 44 depends because claim 43 recites that the first material is the same as the second material.
Regarding claim 46, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “low durometer” in claim 46 is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the limitation “low durometer polyurethane” has been rendered indefinite by the use of the term “low”.
Regarding claim 52, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 49 and 52 contain the trademark/trade name PEBAX. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a polymeric material and, accordingly, the identification/description is indefinite.
Claim 56 recites the limitation "the at least one infusion spine" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the at least one expandable infusion spine”. Lines 8, 14, 15, 16, 18 and 21 also lack antecedent basis. Claims 57-71 are rejected at least because they depend from claim 56.
Claim 56 recites the limitation "the movable assembly" in lines 11-12. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the movable needle assembly”. Claims 57-71 are rejected at least because they depend from claim 56.
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.
Claims 22, 30-32, 35, 56 and 64-71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7 and 14-21 of U.S. Patent No. 11,918,768, see table below. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that all of the elements of the application claims can be found in the patent claims. With regard to claim 22 of the application, claim 1 of the patent discloses an inflatable balloon having an inflated cylindrical configuration (c 28 ln 64-65); an expandable infusion scaffold comprising at least first and second expandable infusion spines (c 28 ln 66-67), each of the at least first and second infusion spines defining a lumen therein and each including two or more spaced apart radial openings therethrough c 28 ln 67 to c 29 ln 3), wherein the expandable infusion scaffold is adapted and positioned about the inflatable balloon such that inflation of the balloon causes the scaffold to radially expand (c 29 ln 4-7), the at least first and second infusion spines extending about an outer cylindrical surface of the inflatable balloon when the inflatable balloon is in an inflated state (c 29 ln 7-10); a plurality of movable needles assemblies (c 29 ln 11), each one of the plurality of movable assemblies disposed in one of the at least first and second expandable infusion spines and movable within and relative to the infusion spine (c 29 ln 11-14), each of the plurality of movable assemblies comprising an elongate body (rail, c 29 ln 17) coupled to a plurality of needles such that movement of the elongate body within the corresponding infusion spine moves the plurality of the needles as a group relative to the infusion spine between undeployed configurations in which each of the plurality of needles are housed within the infusion spine and deployed configurations in which each of the plurality of needles extends generally radially out of one of the radial openings in the infusion spine for delivery of an agent into at least one of a wall of a target vessel or perivascular tissue (c 29 ln 22-31); and a first spine securing member (c 29 ln 32) that is disposed radially outside of a radially outermost surface of at least one of the first and second spines in a location where the at least first and second spines extend about the outer cylindrical surface of the inflatable balloon (c 29 ln 32-39), and a second spine securing member (c 29 ln 39-40) that is disposed within a distal end of at least one of the first and second spine lumens (c 29 ln 40-42).
Application
11,918,768
citation
22
1
23
-
24
-
25
-
26
-
27
-
28
-
29
-
30
2
31
4
32
3
33
-
34
-
35
4, 7
36
-
37
-
38
-
39
-
40
-
41
-
42
-
43
-
44
-
45
-
46
-
47
-
48
-
49
-
50
-
51
-
52
-
53
-
54
-
55
-
56
1, 14
57
-
58
-
59
-
60
-
61
-
62
-
63
-
64
15
65
15
66
16
67
17
68
18
69
19
70
20
71
21
Potentially Allowable Subject Matter
Claims 22-71 are potentially allowed, subject to the claim objections, 112(b) and double patenting rejections above.
Reasons for Potential Allowance
The following is an Examiner's statement of reasons for potential allowance: the claims in this application are potentially allowed because the prior art of record fails to disclose either singularly or in combination the claimed intravascular apparatus.
The closest prior art is Rajagopalan et al. (Rajagopalan) US 2020/0060942.
Regarding claim 22, Rajagopalan fails to teach among all the limitations or render obvious an intravascular apparatus as claimed, which includes the at least first and second infusion spines including two or more spaced apart radial openings therethrough, each of the plurality of movable assemblies comprising a plurality of needles such that movement of the elongate body within the corresponding infusion spine moves the plurality of the needles as a group relative to the infusion spine between undeployed configurations in which each of the plurality of needles are housed within the infusion spine and deployed configurations in which each of the plurality of needles extends generally radially out of one of the radial openings in the infusion spine for delivery of an agent into at least one of a wall of a target vessel or perivascular tissue; and a first spine securing member that is disposed radially outside of a radially outermost surface of at least one of the first and second spines in a location where the at least first and second spines extend about the outer cylindrical surface of the inflatable balloon, and a second spine securing member that is disposed within a distal end of at least one of the first and second spine lumens, in combination with the total structure and function of the intravascular apparatus as claimed.
Regarding claim 35, Rajagopalan fails to teach among all the limitations or render obvious an intravascular apparatus as claimed, which includes each of the at least first and second infusion spines including two or more spaced apart radial openings therethrough; each of the plurality of movable assemblies comprising a plurality of needles such that movement of the elongate body within the corresponding infusion spine moves the plurality of the needles as a group relative to the infusion spine between undeployed configurations in which each of the plurality of needles are housed within the infusion spine and deployed configurations in which each of the plurality of needles extends generally radially out of one of the radial openings in the infusion spine for delivery of an agent into at least one of a wall of a target vessel or perivascular tissue; and at least first and second sleeves extending about the outer cylindrical surface of the inflatable balloon and bonded to at least a portion of the outer cylindrical surface of the inflatable balloon, each of the at least first and second expandable infusion spines disposed within one of the at least first and second sleeves where the at least first and second spines extend about the outer cylindrical surface of the inflatable balloon, in combination with the total structure and function of the intravascular apparatus as claimed.
Regarding claim 56, Rajagopalan fails to teach among all the limitations or render obvious an intravascular apparatus as claimed, which includes the at least one infusion spine including two or more spaced apart radial openings therethrough, the movable assembly comprising a plurality of needles such that movement of the elongate body within the infusion spine moves the plurality of the needles as a group relative to the infusion spine between undeployed configurations in which each of the plurality of needles are housed within the infusion spine and deployed configurations in which each of the plurality of needles extends generally radially out of one of the radial openings in the infusion spine for delivery of an agent into a wall of a target vessel; and at least one spine securing member disposed within a distal end of the lumen of the at least one spine, in combination with the total structure and function of the intravascular apparatus as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783