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
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/14/2026.
Additionally, claims 2, 4, 8-9, and 13-19 are withdrawn as being drawn to nonelected species.
Claim 2 is directed to species A (Figs. 5A-5B), directed to a biodegradable capsule that completely covers the foam member, due to the limitation “wherein the biodegradable capsule covers an entirety of an outer surface of the expandable foam member”, as shown in Fig. 5A.
Claim 4, relates to species B (Figs. 6A-6B), directed to a biodegradable capsule with an open end due to limitation “wherein the biodegradable capsule covers all but the second end of the expandable foam member”.
Claims 8-9 and 17-19 are directed to species A (Figs. 5A-5B), directed to a biodegradable capsule that completely covers the foam member, due to the limitation “wherein when the expandable foam member is the in expanded configuration, the first dimension is shorter than the second dimension”, as shown in Fig. 5B.
Claims 9 and 18-19 are withdrawn as being dependent on a claims 8 and 17, respectively, as directed to species A.
Claim 13 is directed to species D, directed to a biodegradable capsule with two sections fixed together at a join, due to the limitation “includes a first section and a second section sealed to the first section”.
Claims 14-16 are directed to species E, directed to a biodegradable capsule within an expandable framework, due to the limitation “further comprising an expandable framework… the expandable framework defining an interior, wherein the expandable foam member is disposed within the interior”.
Claims 15-16 are withdrawn as being dependent on a claim 14 as directed to species A.
As such, claims 2, 4, 8-9, and 13-20 are withdrawn.
Applicant’s election without traverse of invention I, drawn to an occlusive implant, and species C (Figs. 7A-7C) drawn to a biodegradable capsule with a plurality of spaced apart apertures in the reply filed on 05/14/2026. is acknowledged.
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, 5-7, and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Studdert et al (US 20190275194 A1), herein referenced to as “Studdert” in view of Ortega et al (US 20140277057 A1), herein referenced to as “Ortega”.
Claim 1
Studdert discloses: An occlusive implant 10 (see Figs. 1A, 2A-4B, [0048]) comprising: an expandable foam member 118 (see Figs. 1A, 2A-4B, [0051]) in a compressed configuration (see Figs. 1A, 2A-4B, [0051], 118 is compressed until 124 is dissolved); and a biodegradable capsule 124 + 150 (see Figs. 1A, 2A-4B, [0051] and [0052]) disposed over the expandable foam member 118, the biodegradable capsule 124 holding the expandable foam member 118 in the compressed configuration for a first time period (see [0051], 118 is compressed until 124 is dissolved, [0089]), after which the biodegradable capsule degrades (see [0051] and [0118]), allowing the expandable foam member 118 to expand into an expanded configuration (see Figs. 3B and 4B, [0089]).
Studdert does not explicitly disclose: the expandable foam member made of a shape memory polymer.
However, Ortega in a similar field of invention teaches an occlusive implant 800 (see Figs. 8-10) with an expandable foam member 804 (see Figs. 8-10). Ortega further teaches: the expandable foam member 804 made of a shape memory polymer (see [0049], SMP foam, shape memory polymer).
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 the expandable foam member of Studdert to incorporate the teachings of Ortega and teach an occlusive implant with the expandable foam member made of a shape memory polymer. Motivation for such can be found in Ortega as shape memory polymers are able to activate via numerous pathways (see [0008]) and they can be placed more precisely within the geometry of the vascular disorder, and there is a higher degree of control over the expansion process while the device is held in the desired position (see [0009]).
Claim 3
The combination of Studdert and Ortega teaches: The occlusive implant of claim 1, see 103 rejection above. Studdert further discloses: wherein the biodegradable capsule 124 includes at least one aperture 157 + openings of 82 (see Fig. 4B, [0091], 124 can also including openings, [0100], pores or openings) extending through a wall 150 (see Figs. 1A, 2A-4B, [0052]) of the biodegradable capsule 124 + 150.
Claim 5
The combination of Studdert and Ortega teaches: The occlusive implant of claim 3, see 103 rejection above. Studdert further discloses: wherein when in the compressed configuration (see Fig. 4A), the expandable foam member 118 and the biodegradable capsule 124 + 150 are elongate (see Fig. 4A, 124 + 150 is elongate) with first distal end of 10 (see Fig. 4A) and second opposing ends proximal end at 25 (see Fig. 4A), wherein the biodegradable capsule 124 + 150 includes a plurality of spaced apart apertures 157 + openings of 82 (see Figs. 2A and 4B, [0065] and [0052] at least 2, hence a plurality) disposed adjacent the first end the distal end (see Fig. 4B, 82 is adjacent the distal end of 10, see also Fig. 1A, and there is at least one 157).
Claim 6
The combination of Studdert and Ortega teaches: The occlusive implant of claim 1, see 103 rejection above. Studdert further discloses: wherein the first time period (see [0051], 118 is compressed until 124 is dissolved, [0089]) is a preset time period (see [0089], at a preferred time).
Claim 7
The combination of Studdert and Ortega teaches: The occlusive implant of claim 6, see 103 rejection above. The combination of Studdert and Ortega does not explicitly teach: wherein the preset time period is 30 seconds to 4 minutes.
As noted in Studdert it is necessary for the soluble compound/biodegradable capsule to degrade at an appropriate time in order to avoid premature expansion of the expandable foam member/liquid-expandable article (see [0089]) to avoid preventing the impediment of the insertion of the device into deeper, more distal regions. This correlates to the preset time period of the biodegradable capsule before it degrades and as such the preset time period is 30 seconds to 4 minutes is considered to be a result effective variable since that the preset time determines how far the occlusion device can progress before it begins to expand. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Studdert by causing the preset time period is 30 seconds to 4 minutes 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, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235, (CCPA 1955).
Claim 10
The combination of Studdert and Ortega teaches: The occlusive implant of claim 1, see 103 rejection above. Studdert further discloses: wherein the biodegradable capsule 124 + 150 is made of one or more materials selected from the group consisting of poly(ethylene glycol) (see [0090], polyethylene glycol), polyvinyl alcohol (see [0090]), polyurethane (other alternatives will not be examined due to being optional claim limitations), polylactic acid, poly(lactide-co-glycolide), poly(s-caprolactone), sugar derivatives, salt, high surface area electrospun materials, and hydrogels (see [0090]).
Claim 11
The combination of Studdert and Ortega teaches: The occlusive implant of claim 1, see 103 rejection above. Studdert further discloses: wherein the biodegradable capsule 124 + 150 is made of a copolymer (see [0090], copolymer) of a hydrophobic component (see [0090], hydrophobic) and a hydrophilic component (see [0090], hydrophilic).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Studdert in view of Ortega as applied to claim 1 above, and further in view of Burnett et al (US 20060020278 A1), herein referenced to as “Burnett”.
Claim 12
The combination of Studdert and Ortega teaches: The occlusive implant of claim 11, see 103 rejection above. Studdert further discloses: wherein the copolymer (see [0090], copolymer) includes poly(ethylene glycol) (see [0090], polyethylene glycol).
The combination of Studdert and Ortega does not explicitly teach: and polylactic acid.
However, Burnett in a similar field of invention teaches an occlusive implant 4 (see Figs. 1A-1C) with a biodegradable material (see [0026]). Burnett further teaches: and polylactic acid (see [0026], polylactic acid).
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 the biodegradable copolymer of Studdert to incorporate the teachings of Burnett and have an occlusive with a copolymer with polylactic acid. This is due to polylactic acid being used as a biodegradable material for occlusion devices (see [0026]) is common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Morita et al (US 20180317926 A1), teaches an occlusive device with a plurality of cells through which the expansile materials expands out of a shell
Anderson et al (US 20190374230 A1), teaches an occlusive device where inflation fluid causes elements to expand out through apertures
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.
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 at 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.
RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
Prosecution Insights