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 .
Election/Restrictions
Claims 12-13 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/21/2026.
The following claims are additionally withdrawn: 5-6, 8-11, and 14.
Claim 5 is directed to unelected Group 1, species A (Fig. 6) elongate strand anchors to distal hub.
Claim 6 is directed to unelected Group 1, species C (Fig. 8) elongate strand remains anchored while core wire disengages.
Claim 8 is directed to unelected Group 2, species A (Figs. 9-10) because of the limitation “at least one piece of expandable foam configured to slide over the elongate strand into the interior of the expand framework”.
Independent claim 9 is directed to unelected Group 2, species A and B (Figs. 9-10) because of the limitation “at least one piece of expandable foam configured to slide in a compressed configuration over the elongate strand into the interior of the expand framework”.
As such claims 5-6 and 8-14 are withdrawn.
Applicant's election with traverse of Group 1, Species B (Fig. 7) and Group 2, species D (Figs. 13-15 and 21-22) in the reply filed on 05/21/2026 is acknowledged. The traversal is on the ground(s) that the Examiner did not establish a serious search or examination burden.
The applicant argues that the Group 1 species are not mutually exclusive, in that the differences relate to where an elongate strand is anchored and whether the strand remains coupled after core-wire disengagement.
This is not found persuasive because the elongate strand cannot simultaneously remain coupled and be uncoupled after core-wire disengagement. And furthermore, the strand cannot be anchored both at the distal end of the frame and proximal end of the frame as required by the disclosure.
The applicant argues that Fig. 8 shows the same embodiment as in Fig. 7. However, the specification makes no indication that this is case. In [0078], it is stated that “In some embodiments, the distal end 152 of the elongate strand 150 may be secured to, coupled to, and/or attached to a proximal portion of the expandable framework 22 and/or the occlusive implant 20, as seen in FIG. 7. In some embodiments, the distal end 152 of the elongate strand 150 may be fixedly attached to the proximal portion of the expandable framework 22 and/or the occlusive implant 20. In some embodiments, the elongate strand 150 may be configured to remain coupled to the expandable framework 22 after the core wire 130 has been decoupled from the expandable framework 22, as seen in FIG. 8.”
There is no clear delineation that this is the same embodiment, in fact, remaining coupled is separate from not remaining coupled.
The applicant further argues that the species in Group 2 are not mutually exclusive. The examiner again disagrees, as the structure in Figs. 13-15 is different from Figs. 16-18, as the capsule is attached to the elongate strand in Figs. 13-15 while it is attached to the framework in Figs. 16-18, and both cannot exist in the same device at the same time, hence they are mutually exclusive.
The requirement is still deemed proper and is therefore made FINAL.
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 retaining structure in claims 15-17.
The limitation “a retaining structure” invokes 35 U.S.C. 112(f) because the term “structure” is a generic placeholder with not specific structural definition modified by the functional language “retaining” or “to retain” without being further modified by sufficient structure. As such this limitation will be interpreted as “a plurality of elongate fingers” or “a capsule” (see [0099] of patent application publication).
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 § 102
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ginn et al (US 20050267528 A1), herein referenced to as “Ginn”.
Claim 1
Ginn discloses: An occlusive implant system 20 (see Figs 9H-9I, [0089]), comprising: a core wire delivery device 100 (see Fig. 3A, [0088]-[0089], 9H and 9I is similar to 9F and 9G, which deploys via an appropriate delivery, such as the delivery devices described previously herein, see [0066] also) having a lumen 102 (see Fig. 3A, [0066]) extending therethrough; an occlusive implant 20 releasably coupled to a distal end (see Figs. 3A-3C and 9H-9I, 20 is releasably coupled to the distal end of 100, see Fig. 3C, [0066]) of the core wire 100, the occlusive implant 20 comprising an expandable framework 40 (see Figs. 9H-9I, [0089], see also [0080], a restraining member is a knit or woven fabric that encapsulates 22, and can expand as shown in Fig. 9I) configured to shift between a collapsed configuration (see Fig. 9H) and a deployed configuration (see Fig. 9I); and an elongate strand 24 (see Figs. 3A-3C and 9H-9I, [0089]) extending along the core wire 100 to the expandable framework 40; wherein the elongate strand 24 extends into an interior 41 (see Fig. 9H-9I, [0089]) of the expandable framework 40 in the deployed configuration (see Fig. 9I).
Claim 2
Ginn discloses: The occlusive implant system of claim 1, see 102 rejection above. Ginn further discloses: wherein the elongate strand 24 extends within the lumen 101 (see Figs. 3A-3C) of the core wire 100 to the expandable framework 40 (see Figs. 3A-3C and 9I-9H).
Claim 3
Ginn discloses: The occlusive implant system of claim 1, see 102 rejection above. Ginn further discloses: wherein a distal end distal end of 24 (see Figs. 9I-9H) of the elongate strand 24 is secured to the expandable framework 40 (see Figs. 9H-9I, 24 is secured to 22, hence it is secured to 40 by also being within 41).
Claim 4
Ginn discloses: The occlusive implant system of claim 3, see 102 rejection above. Ginn further discloses: wherein the distal end distal end of 24 of the elongate strand 24 is secured to a proximal portion 41 (see Figs. 9H-9I, [0089]) of the expandable framework 40 (see Figs. 9H-9I, the distal end of 24 is secured to the proximal portion 41, by being within it).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ginn in view of van der Burg et al (US 20050177182 A1), herein referenced to as “van der Burg”.
Claim 7
Ginn discloses: The occlusive implant system of claim 1, see 102 rejection above. Ginn does not explicitly disclose: further comprising an occlusive covering disposed on a proximal portion of the expandable framework.
However, van der Burg in a similar field of invention teaches an occlusive implant (see Fig. 10) with an expandable framework 17 (see Fig. 10). van der Burg further teaches: further comprising an occlusive covering 15 (see Fig. 10, [0137]) disposed on a proximal portion 216 (see Fig. 10, [0137]) of the expandable framework 17.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ginn to incorporate the teachings of van der Burg and teach an occlusive implant system with an occlusive covering disposed on a proximal portion of the expandable framework. Motivation for such can be found in van der Burg as it can retain a sufficient porosity to facilitate cellular ingrowth and/or attachment (see [0108]).
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ginn in view of Burnett et al (US 20060089627 A1), herein referenced to as “Burnett”.
Claim 15
Ginn discloses: An occlusive implant system 20 (see Figs 9H-9I, [0089]), comprising: a core wire delivery device 100 (see Fig. 3A, [0088]-[0089], 9H and 9I is similar to 9F and 9G, which deploys via an appropriate delivery, such as the delivery devices described previously herein, see [0066] also) having a lumen 102 (see Fig. 3A, [0066]) extending therethrough; an occlusive implant 20 releasably coupled to a distal end (see Figs. 3A-3C and 9H-9I, 20 is releasably coupled to the distal end of 100, see Fig. 3C, [0066]) of the core wire 100, the occlusive implant 20 comprising an expandable framework 40 (see Figs. 9H-9I, [0089], see also [0080], a restraining member is a knit or woven fabric that encapsulates 22, and can expand as shown in Fig. 9I) configured to shift between a collapsed configuration (see Fig. 9H) and a deployed configuration (see Fig. 9I); at least one piece of expandable foam 22 (see Figs. 9H-9I, [0089], see also [0056], foam) disposed in a compressed configuration (see Fig. 9H, compressed 22) within an interior the interior of 40 (see Fig. 9H) of the expandable framework 40 in the collapsed configuration (see Fig. 9H); a retaining element the portion of 24 attached to 22 (see Figs. 9H-9I, [0089]) holding the at least one piece of expandable foam 22 in the compressed configuration (see Figs. 9H-9I, [0089], while attached the connection of 24 causes 22 to remain compressed), wherein the retaining element the portion of 24 attached to 22 is engaged with the expandable framework 40 in a retaining configuration (see Fig. 9H, 24 is engaged with 40 through 22); and an elongate strand 24 (see Figs. 3A-3C and 9H-9I, [0089]) extending along the core wire 100 to the expandable framework 40, wherein the elongate strand 24 extends into the interior 41 (see Fig. 9H-9I, [0089]) of the expandable framework 40 and is coupled to the retaining element the portion of 24 attached to 22 (see Figs. 9H-9I).
Ginn does not explicitly disclose: the retaining structure (see 112(f) interpretation above, which is interpreted as a capsule or a plurality of elongate fingers).
However, Burnett in a similar field of invention teaches an occlusive implant system 10 (see Figs. 1-2B) with an occlusive device 17 (see Figs. 1-2B) and a retaining element 40 (see Figs. 2A-2B) which is engaged with the occlusive device 17 in a retaining configuration (see Fig. 2A) and an elongate strand 50 (see Figs. 2A-2B) coupled to the retaining element 40 (see Figs. 2A-2B). Burnett further teaches: the retaining element 40 is a retaining structure 42 + 44 (see Figs. 2A-2B, [0040], meets the definition of a plurality of elongate fingers and a capsule).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified retaining element of Ginn to incorporate the teachings of Burnett and teach an occlusive implant system with the retaining element is a retraining structure (a capsule/a plurality of elongate fingers). Motivation for such ca be found in Burnett as this capsule/pod shape assists in navigating the overall device through a tortuous anatomical path by providing a blunt yet structured tip (see [0039]).
Claim 16
The combination of Ginn and Burnett teaches: The occlusive implant system of claim 15, see 103 rejection above. Ginn further discloses: wherein proximal translation of the elongate strand 24 (see Figs. 9H-9I, [0089], proximal translation of 24 causes the point between 24 and 22 to disengage and then allows 22 to expand as shown in Fig. 9I) is configured to shift the retaining element from the retaining configuration (see Fig. 9H) to a release configuration (see Fig. 9I), thereby releasing the at least one piece of expandable foam 22 within the interior (see Fig. 9I, 22 expands within the interior of 40) of the expandable framework 40.
The language, " wherein proximal translation of the elongate strand is configured to shift the retaining structure from the retaining configuration to a release configuration, thereby releasing the at least one piece of expandable foam within the interior of the expandable framework," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Ginn and Burnett meets the structural limitations of the claim, and is capable of modified retaining structure, to withdraw the elongate strand (see Figs. 2A to 2B, in Burnett) in a similar fashion as disclosed in Ginn (Figs. 9H to 9I) to cause a release of the expandable foam which would be within the retaining structure.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Claim 17
The combination of Ginn and Burnett teaches: The occlusive implant system of claim 16, see 103 rejection above.
The language, " wherein at least a portion of the retaining structure is configured to be removed from the interior of the expandable framework after releasing the at least one piece of expandable foam within the interior of the expandable framework," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Ginn meets the structural limitations of the claim, and is of the elongate strand 24, from being removed from 40, as seen in Fig. 9I, the strand is no longer attached to 22, as the removable attachment is disengaged, thus 24 can be removed from the interior of 40.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Claim 18
The combination of Ginn and Burnett teaches: The occlusive implant system of claim 15, see 103 rejection above. Burnett further teaches: wherein the retaining structure 40 comprises a plurality of elongate fingers 41 + 42 (see Figs. 2A-2B, [0040]) fixedly secured 56 (see Figs. 2A-2B, [0040], 41 +42 are fixedly attached to each other at their proximal end, such that they can hinge at the proximal end) to each other proximate a first end 56 (see Figs. 2A-2B, [0040]) of the plurality of elongate fingers 41 + 42 and biased apart from each other proximate a second end the distal end of 41 + 42 (see Figs. 2A-2B, [0040]-[0042] especially 2B, where 41 and 42 can be biased apart) of the plurality of elongate fingers 41 + 42 opposite the first end the distal end is opposite of the proximal end at 56.
Claim 19
The combination of Ginn and Burnett teaches: The occlusive implant system of claim 18, see 103 rejection above. Burnett further teaches: wherein the retaining structure 40 comprises a coupling element 48 (see Figs. 2A-2B, [0040]) configured to prevent the plurality of elongate fingers 41 + 42 from moving apart from each other (see [0040]-[0042], while 48 is at the distal end, it prevents 41 + 42 from separating) proximate the second end the distal end of 41 + 42 of the plurality of elongate fingers 41 + 42.
Claim 20
The combination of Ginn and Burnett teaches: The occlusive implant system of claim 19, see 103 rejection above. Burnett further teaches: wherein proximal translation (see Figs. 2A-2B, [0040]-[0042]) of the elongate strand 50 is configured to disengage the coupling element 48 and the plurality of elongate fingers 41 + 42 (see Figs. 2A-2B, [0040]-[0042], retraction of 48 via 50 away from 41 + 42 allows for 41 + 42 to separate) from each other.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bates et al (US 20060052816 A1) teaches an occlusive implant system with a core wire and elongate strand and expandable foam
Glaser et al (US 20050234543 A1) teaches an occlusive implant system with a capsule/a plurality of elongate fingers
Wallace et al (US 9060777 B1) teaches an occlusive implant system (Fig. 39) with an elongate strand attached to the expandable frame at a proximal portion
Green (US 6485501 B1) teaches a temporary occlusive implant system with a plurality of elongate fingers and a coupling element
Gilson (US 6514280 B1) teaches an occlusive implant system with a plurality of elongate fingers
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 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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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
Prosecution Insights