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 Objections
Claim 1 objected to because of the following informalities: The Office believes that the text “1. A computer program product for identifying candidate target cells within a” in the beginning of claim 1 is a typographical or editing error. Subsequent to the aforementioned text, the claim recites: “1. A method for identifying candidate target cells within a biological fluid specimen, comprising:”, which the Office believes was the intended beginning of claim 1 since dependent claims 2-4 are all drawn to a method. Appropriate correction is required. Note that the recommended correction will lead to a statutory DP rejection with US 9,738,937 (15/476,848) parent claim 1.
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 1-22 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. Independent claims 1, 5, and 21 explain that the first and second connected regions come from first and second channels, respectively. However, the claims do not explain where the third connected region comes from. Thus, a person having ordinary skill in the art (PHOSITA) cannot know whether the third connected component comes from a third channel or also from one of the first or second channels. If the third connected region comes from one of the first or second channels, PHOSITA cannot know how to distinguish the third connected components from either the first or second connected components, respectively. Thus, the metes and bounds of the claims cannot be ascertained. The dependent claims do not remedy this deficiency.
Claims 3 and 4 contain the trademark/trade name ALEXA568®, anti-CD45-ALEXA488®, and ALEXA488®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe dyes used in cell analysis and, accordingly, the identification/description is indefinite.
35 USC 101 – Claim Rejection
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 1-4 are 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 claim 1 recites a “computer program product”, which can be reasonably be interpreted as a program per se, which does not fall into any statutory category. Dependent claims 2-4 do not remedy this deficiency.
Claims 5-7 and 9-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to mental process and recited math abstract ideas without significantly more.
Claim(s) 5 recite(s):
“identify first connected regions of pixels of a minimum first intensity in a first channel of the plurality of color channels”, which can be reasonably be interpreted as a human observer viewing a displayed image channel and mentally identifying objects with intensity range above or below that of the background via visual perception;
“identify second connected regions of pixels of a minimum second intensity in a second channel of the plurality of color channels”, which can be reasonably be interpreted as a human observer viewing a displayed image channel and mentally identifying objects with intensity range above or below that of the background via visual perception;
“determine first connected regions and second connected regions that spatially overlap”, which can be reasonably be interpreted as a human observer viewing displayed first and second image channels and mentally ascertaining which objects are collocated via visual perception;
“determine an aspect ratio of the spatially overlapping first connected regions and second connected regions based on a color channel of the plurality of color channels”, which is recited math of a mathematical relationship of width to height ratio;
“identify a spatially overlapping first connected regions and second connected regions for which the aspect ratio meets an aspect ratio threshold”, which can be reasonably be interpreted as a human observer mentally selecting overlapping first and second objects that have aspect ratios that fall within a certain range;
“determine a second connected region and a third connected region that spatially overlap”, which can be reasonably be interpreted as a human observer viewing displayed image channels and mentally ascertaining which objects are collocated via visual perception;
“determine an intensity ratio of the spatially overlapping second connected region and third connected region based on two color channels of the plurality of color channels”, which is recited math of a mathematical relationship that is a ratio calculated between intensities of overlapping second and third objects based on two color channels;
“eliminate as a candidate a spatially overlapping first connected region and second connected region corresponding to a spatially overlapping second connected region and third connected region for which the intensity ratio does not meet an intensity ratio threshold”, which can be reasonably be interpreted as a human observer viewing displayed channel images and intensity ratio pseudo-color colormaps and mentally rejecting any overlapping first and second objects where corresponding overlapping second and third objects are below or above an intensity ratio threshold.
This judicial exception is not integrated into a practical application because additional elements:
“A computer program product for identifying candidate target cells within a biological fluid specimen, the computer program product tangibly embodied in a non-transitory computer readable medium, comprising instructions to cause a processor to” are generically recited computer elements that do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer;
“receive a digital image of the biological fluid specimen, the digital image having a plurality of color channels” are generically recited insignificant extra-solution activity of data gathering; and
“provide a portion of the image corresponding to a remaining identified spatially overlapping first connected region and second connected region to a classifier as a candidate for classification” are generically recited insignificant extra-solution activity of data outputting.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because additional elements:
“A computer program product for identifying candidate target cells within a biological fluid specimen, the computer program product tangibly embodied in a non-transitory computer readable medium, comprising instructions to cause a processor to” are mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f);
“receive a digital image of the biological fluid specimen, the digital image having a plurality of color channels” are insignificant extra-solution activity of data gathering; and
“provide a portion of the image corresponding to a remaining identified spatially overlapping first connected region and second connected region to a classifier as a candidate for classification” are insignificant extra-solution activity of data outputting.
Listed dependent claims do not remedy these deficiencies:
Claims 6, 7, and 9-11 further recite limitations that can reasonably be interpreted as being mentally performed by a human observer via visual perception.
Claims 12-19 further recite math.
Claim 20 further recites limitations that are insignificant extra-solution activity of data gathering.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 5-18 and 21-22 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 5-18 and 21-22, respectively, of prior U.S. Patent No. 9,738,937. This is a statutory double patenting rejection.
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 1, 2, 3, 4, 19, and 20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 19, and 20, respectively, of U.S. Patent No. 9,738,937. Although the claims at issue are not identical, they are not patentably distinct from each other because limitations of the Application claims are present in the corresponding patent claims.
Allowable Subject Matter
Claims 1-22 would be allowable if rewritten or amended to overcome the rejection(s) under double patenting and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Also, claims 1-7 and 9-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: Limitations pertaining to “eliminate as a candidate a spatially overlapping first connected region and second connected region corresponding to a spatially overlapping second connected region and third connected region for which the intensity ratio does not meet an intensity ratio threshold”, in conjunction with other limitations present in the independent claims, distinguish over the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Atiba Fitzpatrick whose telephone number is (571) 270-5255. The examiner can normally be reached on M-F 10:00am-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Bee can be reached on (571) 270-5183. The fax phone number for Atiba Fitzpatrick is (571) 270-6255.
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Atiba Fitzpatrick
/ATIBA O FITZPATRICK/
Primary Examiner, Art Unit 2677
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