DETAILED ACTION
This action is responsive to the Amendment filed on 03/27/2026. Claims 1-15 have been amended. Claims 1-15 are pending in the case. Claims 1, 13, and 15 are independent claims.
Examiner’s Note
These amendments do not comply with 37 CFR 1.121, which explicitly states that “All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of "currently amended," and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text.” In this case, Applicant has the “as output” limitation in line 12 of claim 1 without underlining the added text. Applicant is respectfully reminded to follow proper markup rules in order to avoid receiving a Notice of Non-Compliant Amendment in future rounds of prosecution.
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 text receiver” in claim 13.
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 Objections
Claims 5, 14, and 15 are objected to because of the following informalities:
Claim 5:
Line 4 improperly reintroduces the limitation “relationships” (antecedent basis for this limitation had already been established in line 9 of parent claim 1).
Claim 14:
Line 2 recites an “output configured to output” where it appears that a hardware device configured to output was apparently intended. The Office respectfully recommends claiming the hardware device (even if broadly) directly.
Line 2 also recites “a text input” where it appears that a hardware device configured to receive the text input was apparently intended. The Office respectfully recommends claiming the hardware device (even if broadly) directly.
Line 5 improperly reintroduces the limitation “a medical report” (antecedent basis for this limitation had already been established in line 6 of parent claim 13).
Line 8 improperly reintroduces the limitation “annotated data elements” (antecedent basis for this limitation had already been established in line 6 of parent claim 13).
Claim 15:
Lines 3-4 contain multiple formatting errors that do not accurately reflect the changes that have been made relative to the immediate prior version of the claims with proper markings (including leaving the characters “s-“ in line 3).
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 13 and 14 are 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 pre-AIA the applicant regards as the invention. The claim limitation “a text receiver” in claim 13 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed functions and to clearly link the structure, material, or acts to the respective functions. In other words, (i) the disclosure is devoid of any structure that performs the function in the claim, (ii) the structure described in the specification does not perform the entire function in the claim, or (iii) no association between the structure and the function can be found in the specification. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 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.
Claims 1-7, 9, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Pub. No. 2018/0108443 (hereinafter “Li”).
As to independent claims 1, 13, and 15, Li shows a computer-implemented method [¶ 02], a computer system [fig. 4], and a concomitant computer program product [¶ 65] for structuring a medical report text comprising:
receiving text to be included in a medical report and parsing the received text to obtain a plurality of data elements, connected by semantic connectors [text (which may have the intended use/result of ultimately being included in a medical report) is received and parsed to obtain a plurality of data elements (entities and/or attributes), connected by semantic connectors (relationships between entities/attributes) | ¶ 04];
generating a graph of annotated data elements [generating a medical knowledge graph of annotated/“validated” data elements (fig. 2)], the generating comprising:
annotating each of the obtained data elements using medical knowledge bases, each of the medical knowledge bases being indicative of medical vocabulary or medical ontology or medical statistics [annotating/validating each of the obtained data elements using medical knowledge bases/sources, each of the medical knowledge bases/sources being indicative of medical vocabulary or medical ontology or medical statistics (¶¶ 35-38 & 51)]; and
establishing relationships between the annotated data elements such that the graph is generated, the graph comprising the annotated data elements connected by the relationships [relationships between the annotated data elements are established such that a graph is generated, the graph comprising the annotated data elements connected by the relationships (¶¶ 35-38, 60, & 64)];
embedding the generated graph into one of a plurality of pre-stored target structures, each of the target structures having an order criterion, to provide as output a structured medical report text document comprising the annotated data elements sequentially ordered according to the order criterion of the one of the plurality of target structures, into which the generated graph has been embedded [the generated graph is embedded into one of a plurality of pre-stored target structures (like a graph (¶¶ 38 & 50) or tree (¶ 40) structure), each of the target structures having an order criterion (like the hierarchical/parent-child order of the tree/graph structure (¶¶ 11-12, 40, & 50)), with the possible intended result to provide a structured medical report text document comprising the annotated data elements sequentially ordered according to the order criterion of the one of the plurality of target structures, into which the generated graph has been embedded (¶¶ 38-41, 50, & 57-58)].
As to dependent claim 2, Li further shows:
outputting the structured medical report text document, wherein the outputting is to a human-readable output of an output device or to a database for machine-based data analysis [the outputting of the structured medical report text document may be to a human-readable output of an output device (¶¶ 57-58) or to a database for machine-based data analysis (¶¶ 34 & 38-40)].
As to dependent claim 3, Li further shows:
wherein the established relationships between data elements are represented as edges between nodes of the generated graph [the established relationships between data elements are represented as edges between nodes of the generated graph (fig. 2; ¶¶ 11-12 & 41)].
As to dependent claim 4, Li further shows:
wherein establishing the relationships between the annotated data elements is based at least on the medical knowledge bases, the established relationship being indicative at least of medical knowledge [establishing relationships between annotated data elements is based at least on the medical knowledge bases/“sources,” the established relationship being indicative at least of medical knowledge (¶¶ 35-38 & 51)].
As to dependent claim 5, Li further shows:
wherein, in the establishing the relationships between the annotated data elements, one or more of the data elements are matched to one or more nodes of the medical knowledge bases and edges relating to said one or more nodes are extracted and established as relationships of the one or more data elements [in the establishing relationships between annotated data elements, one or more of the data elements are matched to one or more nodes of the medical knowledge bases and edges relating to said one or more nodes are extracted and established as relationships of the one or more data elements (fig. 2; ¶¶ 11-12, 41, & 52-54)].
As to dependent claim 6, Li further shows:
wherein the establishing relationships between annotated data elements is based at least on the received text, the established relationship being indicative at least of semantic relationships between the data elements [the establishing relationships between annotated data elements is based at least on the received text, the established relationship being indicative at least of semantic relationships between the data elements (¶¶ 31-34)].
As to dependent claim 7, Li further shows:
wherein, in the establishing relationships between annotated data elements, one or more of the data elements are set as nodes and the semantic connectors, which connect the data elements in the parsed text, are set as edges and established as the relationships of the one or more data elements [in the establishing relationships between annotated data elements, one or more of the data elements are set as nodes and semantic connectors, which connect the data elements in the parsed text, are set as edges and established as relationships of the one or more data elements (fig. 2; ¶¶ 11-12, 41, & 52-54)].
As to dependent claim 9, Li further shows:
wherein the plurality of target structures are selected from one or more of decision trees, ordered graphs, or hierarchical graphs [the plurality of target structures are selected from one or more of decision trees, ordered graphs, or hierarchical graphs (fig. 2; ¶¶ 11-12, 40, & 50)].
As to dependent claim 12, Li further shows:
wherein the medical knowledge bases comprise semantic networks [the medical knowledge bases comprise semantic networks (¶¶ 35-38 & 51)].
As to dependent claim 14, Li further shows:
an output configured to output the structured medical report text document [the structured medical report text document may be output by an output (¶¶ 34, 38-40 & 57-58)], and a text input configured to receive user input [a text input may receive user input (¶¶ 55-57)], wherein the processor further configured to carry out a method including steps comprising: receiving the text and to be included in a medical report parsing the received medical report text to obtain the plurality of data elements, connected by the plurality of semantic connectors: generating the graph of annotated data elements, the generating comprising: annotating each of the obtained data elements using the medical knowledge bases, each of the medical knowledge bases being indicative of the medical vocabulary or the medical ontology or the medical statistic; and establishing the relationships between the annotated data elements such that the graph is generated, the graph comprising the annotated data elements connected by the relationships: embedding the generated graph into one of the plurality of target structures, each of the target structures having the order criterion, to provide the structured medical report text document comprising the annotated data elements sequentially ordered according to the order criterion of the one of the plurality of target structures, into which the generated graph has been embedded [See the steps above and corresponding mappings for claims 1, 13, and 15.].
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 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.
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.
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.
Claims 8, 10, and 11 are rejected under 35 U.S.C. § 103 as being unpatentable over Li in view of US Patent Application Pub. No. 2014/0052444 (hereinafter “Roberge”).
As to dependent claim 8, Li shows pre-processing text in general (see Li: ¶¶ 03-04), but it does not appear to explicitly recite doing so “such that text is received by: speech-recognizing audio data; image-processing picture data; or transcription-processing of video data” as apparently intended. In an analogous art, Roberge shows:
performing a pre-processing of at least one of the following, such that the text is received by: speech-recognizing audio data; image-processing picture data; or transcription-processing of video data [“The present invention pertains to a system and methods that include a set of template hierarchies used to match words of an utterance to terms of a template in order to select the best matching template corresponding to the utterance. This is referred generally herein as mapping an utterance to a template.” (¶ 44)
“{…} medical reports are used for most of the examples describing the present invention herein {…}” (¶ 46)
“For purposes of this application, the term “utterance” refers to a word or sequence of words spoken by a user. An utterance is usually spoken aloud and the spoken speech can be converted to text by speech recognition software. {…}” (¶ 48)].
One of ordinary skill in the art, having the teachings of Li and Roberge before them prior to the effective filing date of the claimed invention, would have been motivated to incorporate Roberge’s speech-recognizing techniques into Li. The rationale for doing so would have been “allowing the user to perform work without looking away from the subject to which the utterance may pertain” (Roberge: ¶ 45) and/or “to allow a user to easily verbalize information including data through utterances pertaining to a particular subject while maintaining visual focus on the subject or on another subject, for example, a radiologist can look away from the display device while utilizing the system. The user enters the spoken words or utterances into the system through an input device, upon which the system ultimately provides a narrative text or report layout and format in an efficient manner” (Roberge: ¶ 73). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Li and Roberge in order to obtain the invention as recited in claim 8.
As to dependent claim 10, Li generally shows matching the generated graph to a tree structure and/or directed/hierarchical graph structure (Li: ¶¶ 11-12, 40, & 50). However, Li does not appear to explicitly recite “matching the generated graph to each of the target structures and selecting one of the plurality of target structures based on the result of the matching” as apparently intended. In an analogous art, Roberge shows:
wherein embedding of the generated graph comprises matching the generated graph to each of the target structures and selecting one of the plurality of target structures based on a result of the matching [Roberge shows matching its generated graph equivalent (a hierarchical tree (¶¶ 51-52)) to each of the target structures (target template structures) and selecting one of the plurality of target/template structures based on a result of the matching (e.g. “a template is selected based on how well the words in the utterance match the structure, semantics and content of the template” (¶ 55)). | See ¶¶ 49-55.].
One of ordinary skill in the art, having the teachings of Li and Roberge before them prior to the effective filing date of the claimed invention, would have been motivated to incorporate Roberge’s structure matching techniques into Li. The rationale for doing so would have been “to match the words of a spoken utterance against the terms in a template hierarchy in such a way as to allow for normal variations in human expression such as differences in word order and grammatical form, incomplete phrasings, extraneous terms, synonymous terms, and multi-term phrasings” (Roberge: ¶ 74). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Li and Roberge (hereinafter, the “Li-Roberge” combination) in order to obtain the invention as recited in claim 10.
As to dependent claim 11, Li-Roberge further shows:
wherein the matching comprises exploring multiple paths or multiple hierarchy levels of a search space tree using a search tree algorithm [Both Li and Roberge show in their own way exploring multiple paths or multiple hierarchy levels of a search space tree using a search tree algorithm (Li: ¶¶ 22, 40, & 55-58 | Roberge: ¶¶ 58-59 & 71).].
Response to Arguments
Applicant’s arguments have been fully considered but they are not persuasive. Applicant argues:
“ Applicant respectfully asserts that Li fails to teach or suggest embedding a generated graph into one of a plurality of pre-stored target structures. For example, paragraph [0060]-[0070] of the as-filed specification describes embedding as the fitting of a generated graph into a pre-existing structural template that imposes a defined order criterion on the output, resulting in a sequentially ordered structured text document. Applicant respectfully asserts that Li's conversion step is a data transformation from one internal representation to another - it imposes no pre-defined order criterion, selects from no plurality of candidate structures, and produces no sequentially ordered text document. The two operations are conceptually and functionally distinct.
The Office Action maps the claimed "embedding the generated graph into one of a plurality of pre-stored target structures" to Li's conversion of extracted medical information into the Medical Knowledge Graph in paragraph [0038]-[0042] and [0050]. See Office Action, p. 11- 12. Upon closer analysis, however, Applicant respectfully asserts that no coherent mapping of Li's disclosed elements onto this limitation is possible - regardless of which of Li's structural representations is read as the "generated graph" and which as the "target structure." In particular, Li's processing pipeline proceeds as follows: medical source text is processed to extract entities, attribute values, and relationships, which are first stored in a two-dimensional table or, alternatively, in a tree or graph structure (See Li, par. [0038]-[0042]), and subsequently converted into the Medical Knowledge Graph as the final output (See Li, par. [0050]). Irrespective of which of Li's elements is mapped to the claimed "generated graph" and which to the claimed "target structures," either possible reading leads to a deficiency.
In particular, under the first reading - Li's Medical Knowledge Graph as the "generated graph" and Li's two-dimensional table or intermediate graph/tree structure as the "target structures" - it is required that Li's final output (the Knowledge Graph) be embedded into Li's intermediate product (the table or tree structure). This is a temporal and logical inversion of Li's own disclosed process. In Li, the intermediate representations - be it the two-dimensional table or any graph structure - are generated before the Knowledge Graph and serve as its precursors. Hence, they cannot simultaneously function as target structures into which the Knowledge Graph is subsequently embedded.
Moreover, under the second reading - Li's intermediate tree or graph structure as the "generated graph of annotated data elements" and Li's final Knowledge Graph as the "target structure" - the mapping fails for three independent reasons. First, Li's intermediate structure does not comprise "annotated data elements" in the sense of the claims. The claimed annotation is an enrichment process whereby each data element is associated with medical knowledge from structured ontological knowledge bases, including assignment of semantic types and linkage to synonyms and ontological relationships (See as-filed specification, par. [0036]-[0047]). Li's intermediate structure contains, at most, validated extracted data - entities, attribute values, and relationships drawn from medical reference sources and subjected to Li's iterative validation procedure (See Li, par. [0035]-[0038]). As will be further addressed below, Li's validation process is categorically distinct from the claimed annotation step: validation is a quality-assurance procedure, not an ontological enrichment operation. Accordingly, the elements populating Li's intermediate structure - even if validated - are not "annotated data elements" within the meaning of the claims. Second, Li's Medical Knowledge Graph is not a "pre-stored target structure." The claimed target structures are stored in memory prior to and independently of any input text processing, and one is selected from among a plurality based on the structural characteristics of the generated graph (See as-filed specification, par. [0014]-[0015], [0061]-[0071], [0080]). Li's Knowledge Graph, by contrast, is dynamically generated and continuously expanded during Li's processing pipeline - it does not pre-exist as a stored structural template awaiting selection. A dynamically generated output cannot constitute a pre-stored target structure. Third, Li discloses only a single Knowledge Graph - not a plurality of pre-stored target structures from which one is selected for embedding. The limitation "one of a plurality of pre-stored target structures" remains entirely unaddressed under any reading of Li.
Beyond these structural deficiencies, Li's conversion of its intermediate representation into the Knowledge Graph does not constitute "embedding" in the sense of the claims under either reading. Embedding as claimed is the fitting of a generated graph into a pre-existing structural template that imposes a defined order criterion on the output, resulting in a sequentially ordered structured text document (Specification, [0060]-[0070]). Li's conversion step is a data transformation from one internal representation to another - it imposes no pre-defined order criterion, selects from no plurality of candidate structures, and produces no sequentially ordered text document. The two operations are conceptually and functionally distinct.”
The Office respectfully disagrees. Applicant is respectfully reminded that “a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment” 1 and that during examination, the claims must be interpreted as broadly as their terms reasonably allow.2 In other words, the Office maintains that the many unclaimed features/passages from the Specification to which Applicant points are not read into the claims, especially when the limitation in question merely recites “embedding” per se without further specificity. The Office submits that even Applicant’s own estimation of Li’s teachings, wherein “medical source text is processed to extract entities, attribute values, and relationships, which are first stored in a two-dimensional table or, alternatively, in a tree or graph structure (See Li, par. [0038]-[0042]), and subsequently converted into the Medical Knowledge Graph as the final output (See Li, par. [0050])” reasonably reads on “embedding” as broadly recited, due at least to the fact the first/intermediate (table/tree/graph) target structure is “embedded” into the ultimate “Medical Knowledge Graph,” as Applicants themselves concede.
Moreover, as to Applicant’s argument alleging that the “claimed annotation is an enrichment process whereby each data element is associated with medical knowledge from structured ontological knowledge bases, including assignment of semantic types and linkage to synonyms and ontological relationships (See as-filed specification, par. [0036]-[0047]),” the Applicant is once again reminded that a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment and that during examination, the claims must be interpreted as broadly as their terms reasonably allow. In other words, all of the extra functionalities that Applicant attributes to the “annotating” step are not read into the claims when the limitation in question merely recites “annotating” without further specificity (which is reasonably covered by Li’s validation metadata-annotating teachings conceded by the Applicant).
Furthermore, as to Applicant’s “pre-stored” argument, the Office again respectfully reminds Applicant that a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment and that during examination, the claims must be interpreted as broadly as their terms reasonably allow. In other words, the Office emphasizes that Applicant’s allegation that the “claimed target structures are stored in memory prior to and independently of any input text processing, and one is selected from among a plurality based on the structural characteristics of the generated graph” is incorrect because these features are neither explicitly claimed nor implicitly necessitated by the mere addition of the word “pre-stored.” Moreover, Applicant’s own concession that Li’s Knowledge Graph is “continuously expanded during Li's processing pipeline” at the very least means that it was generated at a first time, and then based on this first time “pre-storing” step, it is subsequently “continuously expanded” upon.
Additionally, as to Applicant’s allegation that “Li discloses only a single Knowledge Graph - not a plurality of pre-stored target structures from which one is selected for embedding,” the Office again respectfully reminds Applicant that a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment and that during examination, the claims must be interpreted as broadly as their terms reasonably allow. In other words, the Office emphasizes that the active selection/filtering/discrimination process alleged by the Applicant is neither explicitly recited nor implicitly required by the claims, and that Li’s showing of at least one pre-stored target structure sufficiently reads on the limitation in question as actually recited.
Finally, the Office further submits that, even though the prior art rejection included above does not necessarily rely on the following technicality, the limitation reciting “to provide a structured medical report text document comprising the annotated data elements sequentially ordered according to the order criterion of the one of the plurality of target structures, into which the generated graph has been embedded” is currently drafted as a mere intended result (thus lacking patentable weight 3) of the “embedding the generated graph into one of a plurality of pre-stored target structures” limitation.
“ Applicant respectfully asserts that Li produces no such output under any reading of its disclosure. In particular, Li's end product is a queryable Medical Knowledge Graph, i.e. a non- sequential, graph-based data structure designed for multi-directional knowledge mining and keyword-based decision support (See Li, par. [0050], [0055]- [0059]). For example, the passages cited one page of 12 of the Office Action (i.e., Li, par. [0038]-[0041], [0050], and [0057]-[0058]) in support of this limitation confirm this characterization rather than contradict. In particular, paragraphs [0038]- [0041] of Li describe the internal conversion of a two-dimensional table into graph data, while paragraph [0050] of Li describes the Knowledge Graph as a reference tool for medical practitioners and paragraphs [0057]- [0058] of Li describe the display of query results returned in response to a user's keyword search. Applicant respectfully asserts that none of these passages discloses the generation of a structured medical report text.
Furthermore, this distinction is not merely formal but reflects a fundamental difference in technical purpose. Li is directed to constructing a reusable, institution-wide medical knowledge base from reference sources - a task performed once and queried repeatedly. The claimed invention is directed to structuring a patient-specific medical report text authored by a reporting physician - a task performed in real time, on a per-report basis, producing a document that flows directly back to the physician and into the patient record. These are categorically different technical problems with categorically different outputs. Even if one were to assume - contrary to the arguments above - that Li's mapping for the generated graph and the target structures were correct, Li would still fail to disclose the generation of a structured medical report text as the output of that process. The § 102 rejection must therefore fail on this independent ground.”
The Office respectfully disagrees with Applicant’s opinion and submits that even a “Medical Knowledge Graph” as characterized by the Applicant reasonably reads on a “a structured medical report text” document because all of its adjectives apply. In other words, the graph is: a) “structured” because it is comprised at least of a graph/node-edge structure (see Li: ¶ 52), and b) it comprises “medical report text” because its data comprises medical report text data (see Li: ¶ 51). Finally, even though Li does not need to rely on the following technicality (due at least to the evidence submitted in the preceding sentence and the fact that Li’s field of use happens, like the instant application, to also be medical in nature), whether or not Li’s data/text would have been “medical” or not would have amounted to a non-functional description/intended field of use qualifier, which would not have carried considerable patentable weight for purposes of prior art analysis.
“ Applicant further asserts that Li fails to teach or suggest receiving text to be included in a medical report, as required by amended independent claim 1. For example, as described in paragraphs [0028]-[0031] of the as-filed specification, the text to be included in a medical report encompasses text authored by a reporting physician - typed, dictated, handwritten, or transcribed from audio or video - in the context of drafting a medical report for a specific patient case.
Li, in contrast, processes text from structured medical knowledge sources - clinical practice guidelines, medical encyclopedias, and medical textbooks. See Li, par. [0051]. These are reference documents from which general medical knowledge is extracted to construct a reusable knowledge base. Applicant respectfully asserts that the reference documents of Li are fundamentally distinct from the free-form, patient-specific input text that the claimed invention receives and processes”
The Office respectfully disagrees and once again respectfully reminds Applicant that a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment and that during examination, the claims must be interpreted as broadly as their terms reasonably allow. In other words, as to Applicant’s allegation that “the text to be included in a medical report encompasses text authored by a reporting physician - typed, dictated, handwritten, or transcribed from audio or video - in the context of drafting a medical report for a specific patient case,” the Office asserts that these features are neither explicitly claimed nor implicitly required by a limitation that merely recites “receiving text” without further specificity. As admitted by the argument above, Li receives text, which is all that is required by the “receiving text” limitation.
“ Applicant further asserts that Li fails to teach or suggest annotating obtained data elements using medical knowledge bases, as required by amended independent claim 1. For example, as described in paragraphs [0036]-[0047] and illustrated in FIG. 2 of the as-filed specification, annotation is an enrichment process where each data element extracted from the physician's text is associated with medical knowledge from ontological knowledge bases: semantic types are assigned (e.g., "disorder," "finding," "organ"), synonyms are linked, and relationships from the knowledge base are transferred to the element. In particular, the specification explicitly references standardized medical ontologies such as SNOMED CT and ICD-10 as exemplary knowledge bases. See as-filed specification, par. [0043].
The Office Action maps the claimed annotation step to Li's validation process described in paragraphs [0035]-[0038] and [0051] of Li. See Office Action, p. 11. Applicant respectfully asserts that this mapping conflates two fundamentally distinct operations. In particular, Li's validation process, by contrast, is a quality-assurance procedure that checks extracted medical information for consistency, flags invalidated entries, and re-extracts them until all entries meet validation criteria. See Li, par. [0035]-[0038]. A POSITA would not understand this as annotation. Rather, it represents iterative error correction of an extraction pipeline.”
The Office respectfully disagrees. Applicant is once again reminded that a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment and that during examination, the claims must be interpreted as broadly as their terms reasonably allow. In other words, all of the extra functionalities that Applicant attributes to the “annotating” step are not read into the claims when the limitation in question merely recites “annotating” without further specificity (which is reasonably covered by Li’s validation teachings conceded by the Applicant, which at the very least annotate each of the data elements with validation-related metadata).
“Applicant further asserts that Li fails to teach or suggest the claimed semantic connectors, which connect the parsed data elements. For example, the present application expressly and consistently distinguishes between two different concepts: (i) semantic connectors being syntactic elements of the input text such as spaces, punctuation marks, and conjunctions, used in the parsing step to identify data element boundaries (See as-field specification, par. [0032]-[0033]); and (ii) relationships being semantic connections established between annotated data elements in the generated graph, which may be derived from the knowledge bases or from the text itself (See as- filed specification, par. [0048]-[0058]).
The Office Action maps the claimed semantic connectors (concept (i)) and the relationships between annotated data elements (concept (ii)) to Li's "relationships between entities/attributes" described in paragraph [0004] of Li. See Office Action, pp. 10-11. Applicant respectfully asserts that Li's "relationships between entities," at best, correspond to concept (ii), rather than concept (i). In doing so the Office Action maps a single element in Li to two structurally distinct limitations of the independent claims. Applicant respectfully notes that it is improper to rely on the same structure in Li to teach two different elements of the claim. Lantech, Inc. v. Keip Machine Co., 32 F.3d 542 (Fed. Cir. 1994); In re Robertson, 169 F.3d 743 (Fed. Cir. 1999); see also Ex parte Weideman, Appeal No. 2008-3454, decision of the Patent Trail and Appeal Board, Patent No. 7,597,395, p. 7 (holding that an Examiner's rejection was improper because "it is improper to rely on the same structure in [a prior art] reference as being responsive to two different elements"); Ex parte Koutsky, Appeal No. 2015-004218, decision of the Patent Trial and Appeal Board, Patent Application No. 13/557,595, p. 5 (holding that "when a claim requires two separate elements, one element having two separate functions will not suffice to meet the terms of the claim"); Ex parte Konstant, Appeal No. 2009-001901, decision of the Patent Trial and Appeal Board, Patent Application No. 10/858,242, p. 6 (also holding that an Examiner's rejection was improper because "it is improper to rely on the same structure in [a prior art] reference as being responsive to two different elements"). Therefore, the Office action's mapping of the claim to Li is improper, and the rejection must be withdrawn for at least this reason.”
The Office respectfully disagrees with their reasoning. Dependent claim 7 explicitly recites that “the semantic connectors{…} are set as edges and established as the relationships of the one or more data elements.” In other words, Applicants themselves (via the claims) explicitly redefine the semantic connectors as the relationships. Even if this were not the case, the Office mapped the underlying conceptual relationships between the data elements as “the semantic connectors,” and the graph’s edges (which represent these conceptual relationships) to the “relationships” as claimed, as taught by Li: fig. 2; ¶¶ 04, 11-12, 41, & 52-54. Furthermore, Applicant is once again reminded that a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment and that during examination, the claims must be interpreted as broadly as their terms reasonably allow. In other words, Applicant’s allegation of the “semantic connectors being syntactic elements of the input text such as spaces, punctuation marks, and conjunctions” is neither explicitly recited by the claims nor implicitly required from a limitation that merely recites “semantic connectors” as is without further specificity.
Therefore, the Office respectfully asserts that the cited art sufficiently teaches the limitations recited in the amended claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 C.F.R. § 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 C.F.R. § 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
It is noted that any citation to specific pages, columns, lines, or figures in the prior art references and any interpretation of the references should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. In re Heck, 699 F.2d 1331, 1332-33, 216 U.S.P.Q. 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 U.S.P.Q. 275, 277 (C.C.P.A. 1968)).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVARO R CALDERON IV whose telephone number is (571)272-1818. The examiner can normally be reached on Monday - Friday (8:30am - 5:00pm).
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/ALVARO R. CALDERON IV/
Examiner
Art Unit 2171
/KIEU D VU/Supervisory Patent Examiner, Art Unit 2171
1 See MPEP 2111.01(II) (citing Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004)).
2 In re American Academy of Science Tech Center, 367 F.3d 1359, 1369, 70 U.S.P.Q.2d 1827, 1834 (Fed. Cir. 2004).
3 See, e.g., MPEP §§ 2111.04 & 2114.
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