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 .
Detailed Action
This is in response to the non-provisional application filed 06/12/2024
Claim Interpretation - 35 USC § 112(f)
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.
Allowable Subject Matter
Claims 10-18 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: claim 10 recites said proximal element further adapted to rotate and move axially with respect to said distal element, said handle comprising a plurality of physically manipulable interfaces adapted to induce said first radial expansion and said first contraction of said distal element, said second radial expansion and said second contraction of said proximal element, said rotation of said proximal element and said axial movement of said proximal element.
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, 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication Number 2015/0250497 (Marks)
Regarding claim 1, Marks discloses as shown in Figures 1A, 1B, a recanalization system, comprising: a handle (handle 110, see paragraph [0133]); and an elongate member (central wire 10, see paragraph [0132]) in communication with said handle, said elongate member comprising an occlusion dislodging member (engaging elements 67, see paragraph [0132]) adapted to dislodge an occlusion in a vessel, said occlusion dislodging member coupled to said elongate member, said occlusion dislodging member adapted to axially move, radially expand and contract, and rotate, said handle capable of selectively induce said axial movement, radial expansion and contraction, and said rotation of said occlusion dislodging member (by extending or retracting it through tubing compartment 27, see paragraph [0132]).
Regarding claim 3, Marks discloses as shown in Figures 1A, 1B a recanalization system, comprising: a handle (handle 110, see paragraph [0133]); and an elongate member (central wire 10, see paragraph [0132]) in communication with said handle, said elongate member comprising a distal element (engaging element 90, see paragraph [0132]) and a proximal element (one of engaging elements 67, see paragraph [0132]), said distal element and said proximal element coupled to said elongate member, said distal element capable of first radially expand from a first pre-expansion configuration to a first expanded configuration, said proximal element capable of rotating and second radially expand from a second pre-expansion configuration to a second expanded configuration, said proximal element further capable of moving axially relative to said distal element, said handle capable of selectively inducing said first radial expansion of said distal element, said second radial expansion of said proximal element, said axial movement of said proximal element and said rotation of said proximal element (by extending or retracting it through tubing compartment 27, see paragraph [0132]).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0250497 (Marks) in view of U.S. Patent Publication Number 2002/0016564 (Courtney et al.)
Regarding claim 2, Marks fails to disclose wherein said system further comprises aspiration means for removing at least a first portion of said occlusion said dislodged by said occlusion dislodging member from said vessel.
Courtney et al., from the same field of endeavor teaches a similar system as shown in Figure 1, where the system includes an aspiration means (rising catheter, see paragraph [0120]) for removing at least a first portion of said occlusion said dislodged by said occlusion dislodging member from said vessel.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Marks to include the aspiration mean taught by Courtney et al. such that said system further comprises aspiration means for removing at least a first portion of said occlusion said dislodged by said occlusion dislodging member from said vessel in order to configure the system to clean the occlusion dislodging member after the procedure is finished.
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0250497 (Marks) in view of U.S. Patent Publication Number 2008/0183143 (Palasis et al.)
Regarding claims 4-6 Marks fails to disclose wherein said distal element comprises an outer coating comprising a biodegradable polymeric composition, wherein said biodegradable polymeric composition comprises a biodegradable polymer selected from the group consisting of poly(glycerol sebacate) (PGS), poly(glycerol-co-sebacate acrylate) (PGSA), poly(lactic-co-glycolic) acid (PLGA), poly(ε-caprolactone-co-L-lactic) acid (PCL-LA), poly(polyol sebacate) (PPS), poly(xylitol sebacate) (PXS) and poly(xylitol glutamate sebacate) (PXGS).
Palasis et al., from the same field of endeavor teaches a similar structure to the distal element disclosed by Marks (treatment system intended to be used in the vasculature) as shown in Figure 1, where distal element comprises an outer coating comprising a biodegradable polymeric composition in the form of poly(lactic-co-glycolic) acid (PLGA), wherein said biodegradable polymeric composition comprises at least one pharmacological agent, for the purpose of configuring the distal element to have a vascularly compatible material which contains therapeutic agent.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Marks to include the outer coating comprising a biodegradable polymeric composition in the form of PLGA taught by Palasis et al. in order to configure the distal element to have a vascularly compatible material which contains therapeutic agent.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0250497 (Marks) in view of U.S. Patent Publication Number 2008/0183143 (Palasis et al.) as applied to claim 6 above, and further in view of U.S. Patent Publication Number 2004/0138733 (Weber et al.)
Regarding claim 7, Marks fails to disclose wherein said at least one pharmacological agent comprises an anti-inflammatory selected from the group consisting of an alkaloid, a 5-lipoxygenase (5-LO) inhibitor, a phospholipase A2 (PLA2) inhibitor, a non-steroidal anti-inflammatory and a steroidal anti-inflammatory.
Weber, from a related field of endeavor teaches a similar system with a pharmacological agent comprises an anti-inflammatory selected from the group consisting of an alkaloid, a 5-lipoxygenase (5-LO) inhibitor, a phospholipase A2 (PLA2) inhibitor, a non-steroidal anti-inflammatory and a steroidal anti-inflammatory. See paragraph [0153].
It would have been obvious to one of roidnary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Marks in view of Palasis et al. by substituting the at least one pharmacological agent for the lipoxygenase inhibitor disclosed by Weber because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0250497 (Marks) in view of U.S. Patent Publication Number 2008/0183143 (Palasis et al.) as applied to claim 6 above, and further in view of U.S. Patent Publication Number 2003/0220660 (Kortenbach et al.)
Regarding claim 8, Marks fails to disclose wherein said at least one pharmacological agent comprises an antibiotic selected from the group consisting of an aminoglycoside, a cephalosporin, a penicillin, a macrolide and a tetracycline.
Kortenbach et al., from a related field of endeavor teaches a similar system with a pharmacological agent comprises an antibiotic selected from the group consisting of an aminoglycoside, a cephalosporin, a penicillin, a macrolide and a tetracycline. See paragraph [0073].
It would have been obvious to one of roidnary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Marks in view of Palasis et al. by substituting the at least one pharmacological agent for the tetracycline disclosed by Kortenbach because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2015/0250497 (Marks) in view of U.S. Patent Publication Number 2008/0183143 (Palasis et al.) as applied to claim 6 above, and further in view of U.S. Patent Publication Number 2003/0093111 (Ken et al.)
Regarding claim 9, Marks fails to disclose wherein said at least one pharmacological agent comprises an anti-neoplastic selected from the group consisting of a nucleoside analogue, an antifolate, an anthracycline, a taxane, a monoclonal antibody, a retinoid and an immunomodulatory agent (IMiD).
Ken et al., from a related field of endeavor teaches a similar system with a pharmacological agent comprises an anti-neoplastic selected from the group consisting of a nucleoside analogue, an antifolate, an anthracycline, a taxane, a monoclonal antibody, a retinoid and an immunomodulatory agent (IMiD). See paragraph [0047].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Marks in view of Palasis et al. by substituting the at least one pharmacological agent for the monoclonal antibody by Ken et al. because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771