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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the system and controllable injection pump of claim 47 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
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.
Claim 48 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because a computer program is not one of the four statutory categories of invention. Software per se is not patent eligible subject matter.
Claim 49 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) continuously measuring a fluorescent output signal correlated with an input signal defined by a series of boluses of said fluorescent imaging agent, and wherein the series of boluses is administered with a predefined and/or controlled duration between subsequent boluses, and defining the subject specific time domain perfusion reference as the fluorescent output signal vs. time. This could all be performed as a mental process. This judicial exception is not integrated into a practical application because it does not represent an improvement in the functioning of a computer or an improvement to a technical field, there is no application of a particular treatment or prophylaxis, it is not implemented by a particular machine or manufacture, and the result is not applied to a particular task in any meaningful way. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim presents only elements which could be practically performed in the human mind, or by a human using a pen and paper.
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.
Claim 29-31 and 41 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 29, and all dependent claims thereof, recites the limitation “[t]he method of claim 28, wherein the normal perfusion pattern is determined by a device using means other than image acquisition.” However, claim 28 sets forth “…analyzing the fluorescence images, obtaining, defining and/or determining a normal perfusion pattern, at least in an intensity domain and/or in a time domain… .” Claim 28 uses only commas, which gives the appearance that the above cited limitation is part of a single clause. If this is the case, then it appears that claim 28 sets forth that “analyzing the fluorescence images” and “determining a normal perfusion pattern” as being linked actions which renders the limitations of claim 29 indefinite because it is unclear what “determined…using means other than image acquisition” is meant to convey when it appears that this function does “use” image acquisition. It is not clear if the device of claim 29 is meant to augment the analysis/determination of claim 28 or if this is meant to be an alternative means of determining the normal perfusion pattern. However, claim 28 also provides “analyzing the fluorescence images” and “determining a normal perfusion pattern” in separate indents which could mean that they are meant to be separate clauses and that the actions are not linked. This ambiguity further renders the limitations of claim 29 indefinite. Applicant is respectfully encouraged to amend the claims to clearly and distinctly recite exactly which actions are to be performed using the images of claim 28 and which actions are to be performed without using the images of claim 28.
The term “substantially similar” in claim 41 is a relative term which renders the claim indefinite. The term “substantially similar” 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 § 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) 28, 32-36, and 40-49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lund et al. (US 2020/0146564 A1, May 14, 2020) (hereinafter “Lund”).
Regarding claim 28: Lund discloses a computer implemented method for detecting one or more areas having an abnormal perfusion pattern in tissue of a subject during a medical procedure, the method comprising: continuously acquiring fluorescence images of the tissue, wherein the fluorescence images are associated with a fluorescent output signal correlated with an input signal defined by a series of boluses of at least one fluorescent imaging agent ([0070]-[0071] - video is considered to be "continous" acquisition; [0093]; [0099] - video sequences; [0101] - the description of the behavior of time-intensity curves implicitly discloses continous acquisition, since this would be necessary to capture the dynamic behavior of the curve; [0128]; [0146]), and wherein the series of boluses is administered with a predefined and controlled duration between subsequent boluses ([0087], [0089], [0146]), analyzing the fluorescence images, obtaining, defining and/or determining a normal perfusion pattern, at least in an intensity domain and/or in a time domain ([0099]-[0101], [0124]-[0128], [0145]; the disclosed curves are time-intensity curves which are by definition "in an intensity domain and/or in a time domain"), and detecting, in the fluorescence images, possible tissue areas with an abnormal perfusion pattern based on the normal perfusion pattern and the fluorescent output signal ([0148]-[0151]).
Regarding claim 32: Lund discloses the method of claim 28, comprising the step of identifying at least one tissue area with normal perfusion and determining the normal perfusion pattern there from ([0124]-[0126], [0189]-[0190], [0193]-[0194]).
Regarding claim 33: Lund discloses the method of claim 28, wherein at least one tissue area with normal perfusion is identified manually ([0052], [0100]).
Regarding claim 34: Lund discloses the method of claim 28, wherein the normal perfusion pattern is defined based on a surgeon selecting a tissue area to have normal perfusion ([0100], [0126]-[0127]).
Regarding claim 35: Lund discloses the method of claim 28, further comprising obtaining an expected signal based on the normal perfusion pattern, wherein the possible tissue areas with an abnormal perfusion pattern are detected based on a comparison of the expected signal and the fluorescent output signal ([0124]-[0126]).
Regarding claim 36: Lund discloses the method of claim 28, wherein the normal perfusion pattern is selected from historical data ([0142]-[0143] - post- or intra-operative comparison to data acquired before surgery is “historical data”; [0189] - “used for comparison with later perfusion measurements” is “historical data”).
Regarding claim 40: Lund discloses the method of claim 28, comprising the step of classifying a tissue area detected as having an abnormal perfusion pattern by utilizing a plurality of labelled body kernels ([0117]-[0121] - predefined objects are “labeled body kernels”).
Regarding claim 41: Lund discloses the method of claim 28, comprising the step of analysing a plurality of regions of interest (ROI) in the fluorescence images, the ROIs distributed over different tissue areas, and if the fluorescent output signals of a plurality of these ROIs are substantially similar and/or if associated body kernels of a plurality of these ROIs are substantially similar, one or more of these ROIs are defined as having normal perfusion patterns ([0110], [0117]-[0121], [0125]).
Regarding claim 42: Lund discloses the method of claim 28, wherein the at least one fluorescence imaging agent is selected from the group of: indocyanine green (ICG), infracyanine green (IfCG), brilliant blue green (BBG), and bromophenol blue (BPB), fluorescein isothiocyanate, rhodamine, phycoerythrin, phycocyanin, allophycocyanin, ophthaldehyde, fluorescamine, rose Bengal, trypan blue, fluoro-gold, green fluorescence protein, a flavin, methylene blue, porphysomes, cyanine dye, IRDDye800CW, CLR 1502 combined with a targeting ligand, OTL38 combined with a targeting ligand, or a combination thereof ([0082]).
Regarding claim 43: Lund discloses the method of claim 28, wherein the fluorescence agent is ICG and wherein the amount of ICG in a predefined bolus is less than 0.01 mg/kg body weight ([0087]).
Regarding claim 44: Lund discloses the method of claim 28, wherein the series of boluses are injected with an interval of between 5 and 600 seconds between boluses ([0057]).
Regarding claim 45: Lund discloses the method of claim 28, wherein the fluorescence agent is ICG and wherein the amount of ICG in a predefined bolus is less than 0.005 mg/kg body weight and wherein boluses are injected with an interval of between 5 seconds and 5 minutes ([0090] - between 0.0001 and 0.01 includes “less than 0.005”).
Regarding claim 46: Lund discloses the method of claim 28, wherein the duration between subsequent boluses is between 5 seconds and 5 minutes, or up to 10 minutes, over a time period of at least 2, or at least 3, or at least 5 minutes and wherein the input signal is defined in terms of volume of fluorescent imaging agent vs. time ([0089], [0097]).
Regarding claim 47: Lund discloses a system for identifying an abnormal perfusion pattern in tissue of a subject, during a medical procedure, comprising a controllable injection pump for holding at least one first fluorescence imaging agent, the injection pump being configured for injecting a series of predefined boluses of said first fluorescence imaging agent into a vein of the subject, thereby generating an input signal, the system configured for executing the method of claim 28 ([0068]).
Regarding claim 48: Lund discloses a computer program having instructions which, when executed by a computing device or computing system, cause the computing device or computing system to carry out the method according to claim 28 ([0027]).
Regarding claim 49: Lund discloses a computer implemented method for establishing a time domain perfusion reference of a subject, comprising the steps of: continuously measuring a fluorescent output signal correlated with an input signal defined by a series of boluses of said fluorescent imaging agent, and wherein the series of boluses is administered with a predefined and/or controlled duration between subsequent boluses, and defining the subject specific time domain perfusion reference as the fluorescent output signal vs. time ([0020], [0099], [0152]).
Double Patenting
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 28-30, 32-35, and 37-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-11, 14-16, 19, and 22 of U.S. Patent No. 12,440,115. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims anticipate every limitation of the instant claims by virtue of being a narrower version of the same subject matter.
Allowable Subject Matter
Claim 31 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
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