DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 27-31 are under examination.
Claim Rejections - 35 USC § 112
2. 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 27-31 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 recites the limitation "said executing instructions" in lines 10 and 14. There is insufficient antecedent basis for this limitation in the claim. This term was not mentioned previously in the instant claim. It is unclear to what it refers. Instant claims 28 and 29 are also rejected for depending from claim 27.
The term “high probability” in claim 27 is a relative term which renders the claim indefinite. The term “high probability” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims 28 and 29 are also rejected for depending from claim 27.
Claim 28 recites the limitation "said executing instructions" in line 7.. There is insufficient antecedent basis for this limitation in the claim. This term was not mentioned previously in the instant claim. It is unclear to what it refers. Instant claims 28 and 29 are also rejected for depending from claim 27.
Claim 30 recites the limitation "said executing instructions" in line 17. There is insufficient antecedent basis for this limitation in the claim. This term was not mentioned previously in the instant claim. It is unclear to what it refers. Instant claims 28 and 29 are also rejected for depending from claim 27.
The term “high probability” in claim 30 is a relative term which renders the claim indefinite. The term “high probability” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “high probability” in claim 31 is a relative term which renders the claim indefinite. The term “high probability” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 101
3. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 27-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 27-30 are directed to system and method of determining the presence of Systematic Inflammatory Response Syndrome. As described in Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S._, 134 S. Cr. 2347, 110 U.S.P.Q.2d 1976 (2014), a two-step analysis is required in considering the patent eligibility of the claimed subject matter. The first step requires determining if the claimed subject matter is directed to a judicial exception. The instant claims require the steps of comparing user selected patient related conditions with a screening criteria and comparing user selected clinical judgment based parameters with a screening criteria. These steps are drawn to mental steps or a mathematical algorithm. Dependent claims 28 and 29 recite additional mental steps. The courts have found mathematical algorithms to be drawn to the judicial exception of an abstract idea (In re Grams, 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). Thus, the instant claims are drawn to a judicial exception.
This judicial exception is not integrated into a practical application. The instant claims do not recite an element that reflects an improvement in the functioning of a computer or other technology, an element that applies the judicial exception to effect a particular treatment, an element that implements the judicial exception with a particular machine, or an element that effects a transformation of a particular article to a different state or thing. The instant claims recite additional elements of a processor, display, memory, programmable instructions, a graphical user interface, and a non-transitory computer-accessible storage medium.. However, the instant claims do not recite the structural limitations of these elements, and they are not drawn to a particular machine. The instant claims do not integrate the judicial exception into a practical application.
The second part of the analysis requires determining if the claims include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant claims recite the additional elements of a processor, display, memory, programmable instructions, a graphical user interface, and a non-transitory computer-accessible storage medium. However, these elements are well-understood, conventional and routine components of a general computer (Specifications, pages 17 and 18, paragraphs [00080] and [00081]). Reciting such well-understood, routine, and conventional data gathering steps do not transform a judicial exception into patent eligible subject matter. In addition, the recitation of the specific types of data, to be used in the judicial exception, does not transform the abstract idea into a non-abstract idea. (See buySAFE, Inc. v Google, Inc. 765 F.3d 1350, 112 U.S.P.Q.2d 1093 (Fed.Cir.2014)). Furthermore, the elements taken as a combination are also well-understood, routine, and conventional, since the elements are merely specifying a general purpose computer for implementing the judicial exception. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
4. 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.
Claims 27 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garrett et al. (US 2006/0246495 A1).
Regarding claims 27, Garrett et al. teach a system that includes a processor and a memory that stores programmable instructions executable by the processor to present a plurality of graphical interfaces (paragraphs [0030] and [0031]) including a first and second graphical user interface (paragraphs [0201] and [0709]) where the programmable instruction are executable to determine the presence of a medical conditions based on the patient information received on the graphical user interface (paragraphs [0030] and [0031]); where the first user interface present user selection options patient related conditions and comparing the conditions to a criteria to indicate the presence of Systematic Inflammatory Response Syndrome {paragraphs [0024], [0030] and [0031]); wherein the second graphical user interface presents, as user selection option, a plurality of clinical judgement-based parameters with a criteria (paragraphs [0472] and [0473]) to indicates a high probability of end organ damage due to infection (paragraphs [0111], [0472], and [0473]), wherein the second user interface is executed upon indication of the presence of Systematic Inflammatory Response Syndrome (paragraphs [0111], [0472], and [0473]).
Regarding claim 31, Garrett et al. teach a method that includes measuring vitals for a patient (paragraphs [0472] and [0473]); inputting patient vitals as patient information into a computing device (paragraphs [0030] and [0031]); executing the programmable instructions to determine the presence of systematic inflammatory response syndrome based on the inputted patient information (paragraphs [0030] and [0031]), prompting input into the computing device the clinical judgement information to determine the condition of the high probability sepsis (paragraphs [0472] and [0473]); presenting menu of clinical parameters selections (paragraphs [0472] and [0473]) and executing the instructions to determine the condition of severe sepsis based on the parameters (paragraphs [0367]. [0472] and [0473]).
Double Patenting
5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 27-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 19, 23, and 27 of U.S. Patent No. US 11,705,246 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 27-31 recite similar limitations to the claims in the U.S. Patent. The claims differ in that the claims in the U.S. Patent require the limitations of the instant claims with additional limitations. The instant claims encompass the subject matter of the U.S. Patent. The claims are not patentably distinct from each other.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERRY LIN whose telephone number is (571)272-2561. The examiner can normally be reached T-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JERRY LIN/Primary Examiner, Art Unit 1685
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