DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “calculating, by technical means, at least one texture score B . . . and “applying, by the technical means, robustness improvement step that . . .” in claim 37, and “means arranged to and/or programmed to calculate at least one texture . . .” and “means arranged to and/or programmed to apply robustness improvement step that . . .”, in claim 54.
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 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.
35 U.S.C. 101 requires that a claimed invention must fall within one of the four eligible categories of invention (i.e. process, machine, manufacture, or composition of matter) and must not be directed to subject matter encompassing a judicially recognized exception as interpreted by the courts. MPEP 2106. The four eligible categories of invention include: (1) process which is an act, or a series of acts or steps, (2) machine which is an concrete thing, consisting of parts, or of certain devices and combination of devices, (3) manufacture which is an article produced from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand labor or by machinery, and (4) composition of matter which is all compositions of two or more substances and all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids. MPEP 2106(I).
Claim 71 is rejected under 35 U.S.C. 101 as not falling within one of the four statutory categories of invention because the claimed invention is directed to computer program per se. See MPEP 2106(I). A claim directed toward a non-transitory computer-readable medium having the program encoded thereon establishes a sufficient functional relationship between the program and a computer so as to remove it from the realm of “program per se”. MPEP 2111.05(III). Hence, adding the limitation of “stored on a non-transitory computer-readable medium” would resolve this issue.
Claim 72 is rejected under 35 U.S.C. 101 as not falling within one of the four statutory categories of invention because the broadest reasonable interpretation of the instant claims in light of the specification encompasses transitory signals. But, transitory signals are not within one of the four statutory categories (i.e. non-statutory subject matter). See MPEP 2106(I). However, claims directed toward a non-transitory computer readable medium may qualify as a manufacture and make the claim patent-eligible subject matter. MPEP 2106(I). Therefore, amending the claims to recite a “non-transitory computer-readable medium” would resolve this issue.
35 U.S.C. 101 requires that a claimed invention must fall within one of the four eligible categories of invention (i.e. process, machine, manufacture, or composition of matter) and must not be directed to subject matter encompassing a judicially recognized exception as interpreted by the courts. MPEP 2106. Three categories of subject matter are found to be judicially recognized exceptions to 35 U.S.C. § 101 (i.e. patent ineligible) (1) laws of nature, (2) physical phenomena, and (3) abstract ideas. MPEP 2106(II). To be patent-eligible, a claim directed to a judicial exception must as whole be directed to significantly more than the exception itself. See 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 74618, 74624 (Dec. 16, 2014). Hence, the claim must describe a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception. Id
Claims 37-41, 53-58 and 70-72 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more. Claim 37 is directed to digitized image, obtained by X-Ray based imaging system, calculating, at least one texture score B for the image by applying an experimental variogram to the tissue texture, and applying a robustness improvement step that take into account, at least one patient factor and at least one technical factor. Specifically, the obtained digitized image, refers to gathering data under insignificant Extra-solution activity e.g. pre-solution activity (MPEP 2106.05(g)), calculating, at least one texture score B for the image by applying an experimental variogram to the tissue texture, is referring to abstract idea of Mathematical concepts e.g. a Mathematical formula or equation, (MPEP 2106.04(a)(2)(I)(B)) and applying a robustness improvement step that take into account, at least one patient factor and at least one technical factor, is referring to abstract idea of applying the gathered factors as an insignificant Extra-solution activity of gathering data and further applying the data into the Mathematical formula or equation of the texture score calculation. Therefore, claim 37, meets the requirement of the step 2A, prong one of the guidelines for including an abstract idea.
The claim is then considered under step 2A, prong two, for integrating the judicial exception into a practical application. Limitations that the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
• An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
• Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The courts have also identified limitations that did not integrate a judicial exception into a practical application:
• Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
• Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
• Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
Based on the above conditions, Examiner does not believe that the limitations of claim 37 qualifies the claim under any of the qualifying conditions above. In fact, the limitations of claim 37 tends to lean more toward conditions that are not qualified i.e. “ Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g)” and /or the step of the robust improvement referring to “Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h). Therefore claim 37 fails step 2A, prong two for conveying a qualified practical application.
Additionally, claim 37 is further considered under step 2B to include additional elements that amount to significantly more than the judicial exception. Limitations that the courts have found to qualify as "significantly more" when recited in a claim with a judicial exception include:
i. Improvements to the functioning of a computer, e.g., a modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, as discussed in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see MPEP § 2106.05(a));
ii. Improvements to any other technology or technical field, e.g., a modification of conventional rubber-molding processes to utilize a thermocouple inside the mold to constantly monitor the temperature and thus reduce under- and over-curing problems common in the art, as discussed in Diamond v. Diehr, 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see MPEP § 2106.05(a));
iii. Applying the judicial exception with, or by use of, a particular machine, e.g., a Fourdrinier machine (which is understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) that is arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web, as discussed in Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923) (see MPEP § 2106.05(b));
iv. Effecting a transformation or reduction of a particular article to a different state or thing, e.g., a process that transforms raw, uncured synthetic rubber into precision-molded synthetic rubber products, as discussed in Diehr, 450 U.S. at 184, 209 USPQ at 21 (see MPEP § 2106.05(c));
v. Adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016) (see MPEP § 2106.05(d)); or
vi. Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment, e.g., an immunization step that integrates an abstract idea of data comparison into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases, as discussed in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see MPEP § 2106.05(e)).
Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include:
i. Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f));
ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
iii. Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)); or
iv. Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
Based on the above conditions, Examiner is unable to identify any one or more claimed elements that amount to significantly more than the judicial exception. Therefore claim 37 also fails step 2B as well, and is not eligible under 101.
Similar assessments are applied to the corresponding device claim 54. The claim is also reciting means for applying the steps of the claimed process. Referring to Applicant’s specifications, the means are merely applying a mathematical formula/function in order to get the outcome, i.e. the score B, and further apply the gathered factors to apply robustness to the formula. It is important to note that a general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine (MPEP 2106.05(b)(I)). Therefore, claim 54 is also ineligible under 101.
Regarding claims 38 and 39, the claims recite obtaining particular factors which are regarded as gathering data under insignificant extra solution activities. Therefore, the claims are ineligible under 101.
Regarding claim 40, the claim refers to further gathering certain tissue data i.e. a bone tissue, as insignificant extra solution activity, and the abstract idea of applying a mathematical formula to get texture score B. The claim is therefore ineligible under 101.
Regarding claim 41, the claim refers to digitized bi-dimensional image, that is chosen in a region having a trabecular structure, as further gathered data under insignificant extra solution activity. The claim is therefore ineligible under 101.
Regarding claim 53, the claim refers to the texture score B being unitless, as further product of the mathematical formula, and the claim is therefore not eligible under 101.
Regarding device claims 55-58 and 70, the claims refer to the corresponding process claims 38-41 and 53 and do not further add additional elements for considerations. Therefore, the claims are not eligible under 101
Regarding claims 71 and 72, claims refer to computer program and/or a computer-readable storage medium comprising instructions which, when executed by a computer, cause the computer to carry out the steps of the process according to the claim 37 above. Examiner further refers the Applicant to MPEP 2106.05(b), wherein it recites, if applicant add a generic computer or generic computer components and asserts that the claim recites significantly more because the generic computer is 'specially programmed' (as in Alappat, now considered superseded) or is a 'particular machine' (as in Bilski), the Examiner should look at whether the added elements, i.e. the program, integrate the exception into a practical application or provide significantly more than the judicial exception. Based on the findings, Examiner does not believe the program to run the steps of the claim 37 adds significantly more than the judicial exception. Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 223-24, 110 USPQ2d 1976, 1983-84 (2014). See In re Alappat, 33 F.3d 1526, 1545, 31 USPQ2d 1545, 1558 (Fed. Cir. 1994); In re Bilski, 545 F.3d 943, 88 USPQ2d 1385 (Fed. Cir. 2008). In the instant case, the claims 71 and 72 only adds a programmed instructions to perform the judicial exception of claim 37 and therefore, do not add significantly more to the claim. Therefore, the claims are ineligible under 101.
Allowable Subject Matter
Claims 42-52 and 59-69 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: the prior art or the prior art of record specifically, Silva et al (PTOL-892, Item U) and Silva et al (PTOL-892, Item V), does not disclose:
. . . . combining: the parameter(s) obtained for each pixel into a texture score B for each pixel, . . . . this step further comprising applying the robustness improvement step related to the at least one patient factor and/or the at least one technical factor into the texture score B: . . . at least one parameter used for calculating or determining score B, preferably: at least one parameter among Ro, a, b, c, d, and/or at least one parameter (a,p,y,6,s) used for giving respective weights between a, b, c, d, and/or e for calculating the texture score B and/or by correcting, as a function of patient and/or technical factor(s), score B, of claims 42 and 59 combined with other features and elements of the claims;
Claims 43-52 and 60-69 depend from an allowable base claim and are thus allowable themselves.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHERVIN K NAKHJAVAN whose telephone number is (571)272-5731. The examiner can normally be reached Monday-Friday 9:00-12:00 PST.
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/SHERVIN K NAKHJAVAN/Primary Examiner, Art Unit 2672