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 .
Claim Objections
Claim 6 is objected to because of the following informalities: the claim appears to misspell the word “porous” as “porours”. 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 2-6 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.
Regarding claim 2, the claim recites “wherein at least one inflatable member” and depends from claim 1, which previously introduces “one or more inflatable members”. Therefore, it is unclear whether the recitation in claim 2 intends to refer to at least one of the one or more inflatable members introduced in claim 1, or to additional inflatable members introduced in claim 2, therefore rendering the claim indefinite. For examination purposes, it will presume to refer back to the one or more inflatable members introduced in claim 1.
Regarding claim 5, the claim recites “the inflatable members”, and depends from claim 1, which previously introduces “one or more inflatable members”. It is unclear whether claim 5 intends to further limit claim 1 by requiring a plurality of inflatable members (and thus excluding an embodiment having only one inflatable member), or whether claim 5 intends to recites “the one or more inflatable members”. For examination purposes, it will presume to read as “the one or more inflatable members”.
Claims 3-4 and 6 are indefinite by virtue of their dependency on indefinite base claims 2 and 5, respectively.
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: component that enables controlled deflation of at least one inflatable member in claims 1 and 14 and dependents therefrom (except for claim 8 – the claim recites sufficient structure to no longer invoke 112f). The equivalent structures for performing the claimed function are set forth at [026]/[027]/[030] of the specification as filed.
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
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 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 and 8-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0012980 A1 to Brister et al. (hereinafter “Brister”).
Regarding claim 1, Brister discloses (see abstract; Figs. 1A-28D; and [0072]-[0211]) a device (as shown in the Figures), comprising: an occluding segment (see [0074]/[0076]/[0097]), wherein the occluding segment contains one or more ([0136]/0157]) inflatable members (see [0074]/[0076]/[0097]), the occluding segment contains at least one component that enables controlled deflation of at least one inflatable member following permanent implantation of the device (see [0196]-[0210], a biodegradable barrier which degrades under physiological conditions to cause deflation and thus corresponds under 112f to the structure for performing the claimed function); and, a delivery segment wherein the delivery segment contains at least one lumen to accommodate inflation of at least one inflatable member and the delivery segment is detachably coupled to the occluding segment on at least one point (see [0075]/[0085]/[0086]/ [0134]-[0138]).
Brister further discloses (claim 2) wherein at least one inflatable member contains at least one valve (see [0122]); (claim 3) wherein the at least one inflatable member is attached to at least one stem-like member ("needle") on at least one point (see [0096]/[0141]); (claim 4) whereby each inflatable member can be inflated/deflated independently (see [0136]); (claim 8) wherein the component for controlled deflation takes a form of a biodegradable barrier (see [0196]-[0205]); (claim 9) wherein the component for controlled deflation is coated by an insulating material (see [0196]-[0205]); (claim 10) wherein the occluding segment and delivery segment maintain alignment throughout deployment (see [0134]-[0144]); (claim 11) wherein the delivery segment incorporates a steerable mechanism (see [0134]); (claim 12) wherein the delivery segment incorporates at least one pressure sensor (see [0155]); (claim 13) whereby the component for controlled deflation can be activated by an external controller (see [0072], light or radiation applied from external the body via a controller is disclosed as being within the scope of the degradable nature of the balloon to initiate controlled deflation).
Claim(s) 1, 5-7, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0338696 A1 to Sideris (hereinafter “Sideris”).
Regarding claim 1, Sideris discloses (see abstract; Figs. 1-10; and [0026]-[0038]) a device (Figs. 8-10, [0033]) comprising an occluding segment (see [0033] and Fig. 8, 9 + 13), wherein the occluding segment contains one or more inflatable members (13, see Fig. 8 and see [0033]), the occluding segment contains at least one component that enables controlled deflation (see [0033], bio-degradable barrier of the balloon which degrades under physiological conditions to cause deflation and thus corresponds under 112f to the structure for performing the claimed function) of at least one inflatable member following permanent implantation of the device (see [0033]); and, a delivery segment (11) wherein the delivery segment contains at least one lumen (an inflation lumen is inherent in the device of Fig. 8 in order to inflate balloon 13) to accommodate inflation of at least one inflatable member and the delivery segment is detachably coupled to the occluding segment on at least one point (see [0033]-[0035] and Fig. 9).
Sideris further discloses (claim 5) wherein the inflatable members are surrounded by a material (9) intended to achieve a result of accelerated permanent attachment to the surrounding tissue and/or accelerated endothelialization (see [0033]); (claim 6) wherein the material forms a patch, wherein the patch is attached to at least one inflatable member on at least one point, the patch is elastic; and the patch is porous (see Figs. 8-9 and [0033]); (claim 7) wherein the occluding segment accommodates a guide wire for 'over the wire' implantation (see Fig. 7).
Regarding claim 14, Sideris discloses (see abstract; Figs. 1-10; and [0026]-[0038]) a method of placing a device (Figs. 8-10, [0033]-[0035]) at the site of a physiological structure (ASD shown in Fig. 9) comprising: a. placing into a delivery sheath ("long sheath", [0035]) an occluding segment (see [0033] and Fig. 8, 9 + 13) that is detachably coupled to a delivery segment (11, see Figs. 8-9 and [0033]-[0035]), wherein said occluding segment contains at least one inflatable member (13, see Fig. 8 and [0033]) and at least one component that enables controlled deflation (see [0033], bio-degradable barrier of the balloon which degrades under physiological conditions to cause deflation and thus corresponds under 112f to the structure for performing the claimed function) of the at least one inflatable member following permanent implantation of the device (see [0033]) b. advancing the occluding segment through the delivery sheath to the physiological structure of interest via the delivery segment (see [0035]); c. inflating the at least one inflatable member of the occluding segment (see [0035]); d. detaching the occluding segment from the delivery segment (see [0033]/[0035]); and e. deflating the at least one member (see [0033]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art disclosing balloon devices which can occlude and which can be controllably deflated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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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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/SHAUN L DAVID/Primary Examiner, Art Unit 3771