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 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: “electroanatomical mapping system defining…” in claims 1 and 19.
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.
The “electroanatomical mapping system” has been interpreted as corresponding to an electronic control unit and a display, as set forth in paragraph [0037] of Applicant’s PG-Pub, 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 and12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bustan et al. (US Pub No. 2015/0342662).
With regards to claims 1 and 12, Bustan et al. disclose an electroanatomical mapping system and method of identifying optimized interconnections between ablation lesion segments, comprising:
receiving, at an electroanatomical mapping system, a plurality of lesion markers (100), each lesion marker of the plurality of lesion markers representing an ablation lesion segment in a tissue (paragraphs [0022], [0032]-[0033], referring to the system comprising an electro-physiological (EP) cardiac signal mapping, wherein the catheter (22) may comprise one or more mapping electrodes near the catheter distal end to measure electro-cardiac signals at one or more respective contact points with the heart tissue, wherein electrical potential measurements of the map points are combined with the simulated surface to produce a map of the potentials overlaid on the simulated surface and the system may synchronize images of the heart with the EP mapping in the catheter position sensing system [i.e. electroanatomical mapping system]; paragraphs [0037], [0051] referring to the processor recording the positions of multiple ablation sites (100, i.e. “plurality of lesion markers”) as cardiologist (30) forms the multiple lesions on the surface of the heart cavity with the ablation electrode); Figures 1-3);
the electroanatomical mapping system defining one or more disjoint subsets (140 and/or 130, 160) of the plurality of lesion markers (100) (paragraphs [0046]-[0049], referring to producing multiple clusters (140; “one or more disjoint subsets”) that are separated from one another by at least the adjacent distance threshold (ADT), and/or referring to the determination of the two regions (130, 160); Figures 2-4);
for each disjoint subset, the electroanatomical mapping system defining one or more optimized interconnections (i.e. 120 and/or 155) between lesion markers included within the respective disjoint subset (paragraphs [0046]-[0048], referring to marking of the distances between two ablations sites that are smaller than the adjacent distance threshold (ADT) [and thus optimized] with lines 120 and/or referring to the distances (155) that are closer to one another than the ADT threshold; Figures 2-4); and
outputting on a display (46) of the electroanatomical mapping system a graphical representation of the one or more disjoint sets and the one or more optimized interconnections between lesion markers on a graphical representation (i.e. “simulated surface”) of the tissue (paragraph [0029], referring to the processor (42) displaying an image (44) of the heart (26) with the recorded positions of the multiple ablation sites, possibly overlaid with local electro-cardiac signal measurements on the simulated surface, to cardiologist (30) on the display (46); paragraph [0052], referring to the site displaying step (208) in which the processor (42) displays the clustered ablation sites on display (46); paragraphs [0032]-[0033], referring to the processor (42) combining the electrical potential measurements of the map points with the simulated surface to produce a map of the potentials overlaid on the simulated surface, wherein images of the heart may be synchronized with the EP mapping; Figures 1-4).
Further, with regards to claim 12, Bustan et al. disclose that the system further comprise a display (46) and a lesion segment analysis processor (42) (Abstract; paragraph [0029]; Figure 1).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 2-9 and 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bustan et al., as applied to claim 1 above, and further in view of Grygorash et al. (“Minimum Spanning Tree Based Clustering Algorithms”, 2006).
With regards to claims 2 and 13, as discussed above, Bustan et al. meet the limitations of claim 1. Further, with regards to claim 19, Bustan et al. meet most of the limitations of claim 19 [see rejection of claim 1]. However, though Bustan et al. do disclose the use of a clustering process for defining the one or more disjoint subsets of the plurality of lesion markers (paragraphs [0046]-[0049]), Bustan et al. do not specifically disclose that the clustering process further comprises the electromechanical mapping system defining a minimum cost spanning tree for each of the one or more disjoint subsets of the plurality of lesion markers.
Grygorash et al. disclose a minimum spanning tree clustering algorithm that is capable of detecting clusters with irregular boundaries, wherein the clusters are detected to achieve some measure of optimality, such as minimum intercluster distance or maximum intercluster distance, thus clearly differentiating objects of interest in an image (pg. 1, Abstract; Section 1. Introduction).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the clustering process of Bustan et al. with a clustering process/algorithm comprising defining a minimum cost spanning tree for each of the one or more disjoint subsets of the plurality of lesion markers, as taught by Grygorash et al., as the substitution of one known clustering process/algorithm for another yields predictable results (i.e. clustering the plurality of lesion markers) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
With regards to claims 3 and 14, Grygorash et al. disclose that the electroanatomical mapping system defining the minimum cost spanning tree for each of the one or more disjoint subsets of the plurality of lesion markers comprises the electroanatomical mapping system: defining a weighted, undirected graph including a plurality of vertices and a plurality of weighted edges, wherein the plurality of vertices correspond to the plurality of lesion markers and each weighted edge of the plurality of weighted edges connects a pair of vertices of the plurality of vertices (pg. 1, Section 1, Introduction, referring to the minimum spanning tree (MST) of a weighted graph is the minimum weight spanning tree of that graph, wherein the cost of constructing a minimum spanning tree takes into account the number of edges of the graph and the number of vertices, wherein, once the MST is built for a given input, one way to produce a group of clusters is by sorting the edges of the minimum spanning tree in descending order of their weights; pg. 3-4, Sections 2-3.1, referring to the weighted edges of the tree; Figure 1-2); sorting the plurality of weighted edges by descending weight (pg. 1, right column, 2nd paragraph, referring to obtaining the k clusters by sorting the edges of the minimum spanning tree in descending order of their weights); and iteratively analyzing each weighted edge of the sorted plurality of weighted edges, at each iteration merging a first disjoint subset containing a first vertex of the pair of vertices connected by the respective weighted edge and a second disjoint subset containing a second vertex of the pair of vertices connected by the respective weighted edge into a combined disjoint subset and adding the respective weighted edge to a minimum spanning tree of the combined disjoint subset when the weight of the respective weighted edge is below a maximum weight threshold and the first vertex and the second vertex are not in a common disjoint subset prior to being merged into the combined disjoint subset (pg. 1, right column, second-third paragraphs, referring to removing the edges with the first k-1 heaviest weights, which is equivalent to keeping the edges when the weight of the respective weighted edge is below a maximum weight threshold and further referring to repeating the process to create a hierarchy of clusters until k clusters are obtained; pgs. 3-4, Section 3.1, see Table 1, wherein the HEMST clustering algorithm comprises removing a weighted edge (w_e) when the weighted edge is greater than weight threshold equivalent to the average weight of all the edges, which is equivalent to adding/keeping the weighted edges when the weight of the respective weighted edge is below a maximum weight threshold). Though Grygorash do not specifically disclose that the sorting of the plurality of weighted edges is by “ascending” weight, it would have been an obvious matter of design choice to rearrange the sorting from descending order to ascending order as it has been held that a rearrangement is an obvious matter of design choice when such a rearrangement does not modify the operation of the device. In this case, changing from descending sorting to ascending sorting as claimed would not modify the operation of the minimum cost spanning tree as weighted edges being ultimately below a maximum weight threshold could still be found whether the sorting is in a descending order or ascending order.
With regards to claims 4, Grygorash et al. disclose that the method further comprises, prior to iteratively analyzing the sorted plurality of weighted edges, defining a plurality of initial disjoint subsets, each initial disjoint subset including exactly one of the plurality of vertices of the graph (see Figure 1, wherein the depiction of the points in the left side of the figure represents, prior to the iterative analysis, defining a plurality if initial disjoint subsets, wherein each point corresponds to such “disjoint” subsets and includes exactly one of the plurality of vertices as it is defined by a single point).
With regards to claims 5 and 15, Grygorash et al. disclose that the weight of each weighted edge comprises a distance between the respective pair of vertices connected by the respective weighted edge (pg. 1, left column, Section 1, first paragraph, referring to the length of an edge is the Euclidean distance between a pair of points/vertices in the point set; pg. 3-4, Section 3.1, Figures 1-2).
With regards to claim 6, Grygorash et al. disclose that the distance comprises a Euclidean distance (pg. 1, left column, Section 1, first paragraph, referring to the length of an edge is the Euclidean distance between a pair of points/vertices in the point set; pg. 3-4, Section 3.1, Figures 1-2).
With regards to claims 7, 16 and 19, Grygorash et al. disclose that the one or more optimized interconnections between lesion markers included within the respective disjoint subset comprises a plurality of edges within the minimum cost spanning tree for the respective disjoint subset (pg. 4, left column, first paragraph; see Figure 2, wherein the points represent the lesion markers in the above combined references and the edges/lines between the points represent the interconnections that are depicted as comprising a plurality of edges). Bustan et al. further disclose this limitation (see Figure 3, wherein the one or more optimized interconnections (120, 150) comprise a plurality of edges within the minimum cost spanning tree for the respective disjoint subset/cluster).
With regards to claims 8, 17 and 19, Grygorash et al. disclose that the one or more optimized interconnections between lesion markers included within the respective disjoint subset further comprise one or more cycle-closing edges not included within the minimum cost spanning tree for the respective disjoint subset (pgs 3-4, Section 3.1, Table 1, referring to after an initial set of disjoint subtrees St are formed, each subtree is treated as a cluster and additional longest edges are removed from the entire edge set, and thus the removed longest edges correspond to the “one or more cycle-closing edges not included within the minimum cost spanning tree for the respective disjoint subset”).
With regards to claims 9 and 18, Grygorash et al. disclose the electroanatomical mapping system identifies the one or more cycle-closing edges not included within the minimum cost spanning tree for the respective disjoint subset according to a series of steps comprising: defining a plurality of leaf edges of the minimum cost spanning tree for the respective disjoint subset (pgs. 3-4, Section 3.1; see Table 1, referring to the initial set of disjoint subtrees St); and identifying a subset of the plurality of leaf edges that satisfy one or more cycle-closing criteria (pgs. 3-4, Section 3.1; Table 1, referring to finding the longest edges which are ultimately removed from the spanning tree); and defining the subset of the plurality of leaf edges that satisfy the one or more cycle-closing criteria as the one or more cycle-closing edges not included within the minimum cost spanning tree (pgs. 3-4, Section 3.1; Table 1, referring to finding the longest edges which are ultimately removed from the spanning tree, wherein such longest edges correspond to the one or more cycle-closing edges)
With regards to claims 11, 18 and 20, Grygorash et al. disclose that the one or more cycle-closing criteria comprises one or more of a cycle presence criterion (i.e. pgs. 3-4, Section 3.1; Table 1, wherein the finding the longest edges if the number of the subtrees is less than k corresponds to a “cycle presence criterion” as it is a criteria that is met to determine when to continue and/or finish the cycle).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bustan et al. in view of Grygorash et al. as applied to claim 9 above, and further in view of Gansner et al. (US Patent No. 4,953,106).
With regards to claim 10, as discussed above, the above combined references meet the limitations of claim 9. However, the above combined references do not specifically disclose that identifying the subset of the plurality of leaf edges that satisfy the one or more cycle-closing criteria comprises: assigning a weight to each leaf edge of the plurality of leaf edges; sorting the plurality of leaf edges by ascending weight; and iteratively analyzing each leaf edge of the sorted plurality of leaf edges with respect to each of the one or more cycle-closing criteria, at each iteration culling the respective leaf edge from the plurality of leaf edges when the respective leaf edge does not satisfy a cycle-closing criterion of the one or more cycle-closing criteria, thereby identifying the subset of the plurality of leaf edges that satisfy the one or more cycle-closing criteria.
Ganser et al. disclose making a layout of a graph from a list of the nodes and edges of the graph, wherein a feasible spanning forest is computed for each connected component of an underlying undirected graph and, for the given feasible spanning forest of the graph, each edge can be assigned a value (Abstract; column 5, lines 15-37; Figures 7-8). If an edge “e” is not in the forest, the value is defined to be 0, if the edge is in the forest, its removal splits the tree containing it into two places, wherein the value of “e” is defined by the sum of the weights of all edges going from the piece of the tree containing e’s tail to the piece containing e’s head, minus the sum of the weights of all the edges going in the opposite direction (column 5, lines 15-37, note that the edges are assigned weights and each edge (i.e. leaf edge of spanning tree) is iteratively analyzed with respect to cycle-closing criteria (i.e. value < 0; see Figure 7). Though Ganser et al. do not specifically disclose that the plurality of leaf edges (i.e. edges in the spanning forest) are sorted in ascending weight, Ganser et al. do disclose in other methods that an initial ordering is given in ascending order (i.e. “starting from nodes of minimum ranks”)in order to further optimize solutions (column 6, lines 34-63). Therefore, it would have been obvious to one of ordinary skill in the art to have the plurality of leaf edges of the above combined references be sorted in ascending weight, as taught by Ganser et al., in order to further optimize solutions (column 6, lines 34-63).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the identifying the subset of the plurality of leaf edges that satisfy the one or more cycle-closing criteria of the above combined references comprise: assigning a weight to each leaf edge of the plurality of leaf edges; sorting the plurality of leaf edges by ascending weight; and iteratively analyzing each leaf edge of the sorted plurality of leaf edges with respect to each of the one or more cycle-closing criteria, at each iteration culling the respective leaf edge from the plurality of leaf edges when the respective leaf edge does not satisfy a cycle-closing criterion of the one or more cycle-closing criteria, thereby identifying the subset of the plurality of leaf edges that satisfy the one or more cycle-closing criteria, as taught by Gansner et al., in order to improve the final placement of nodes/lesion markers after edge crossings are minimized (column 1, lines 49-55).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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