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 .
Response to Arguments
Claim Objections
Applicant’s arguments, see remarks and amended claims, filed 9/9/25, with respect to the objection to claim 9 have been fully considered and are persuasive. The objection to claim 9 has been withdrawn.
112(f) Interpretation
Applicant’s arguments, see remarks and amended claim set, filed 9/9/25, with respect to the interpretation of claim 14 under 35 U.S.C. 112(f) have been fully considered. Applicant’s amendment of “means” to “a processor unit” in claim 14, line 6 is sufficient to obviate interpretation under 35 U.S.C. 112(f) as a processor provides structure within the claim. However, applicant’s amendment of “means for acquiring” to “a receiving unit” in claim 14, line 4 is not sufficient to obviate interpretation under 35 U.S.C. 112(f) as unit is a nonce term for which “receiving” provides functionality without structure within the claim. As detailed infra, “a receiving unit” as claimed appears to correspond to a component of a computer device as disclosed in applicant’s specification.
112(b) Rejections
Applicant’s arguments, see remarks and amended claim set, filed 9/9/25, with respect to the rejection of claim 14 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejection of claim 14 under 35 U.S.C. 112(a) has been withdrawn.
Applicant’s arguments, see remarks and amended claim set, filed 9/9/25, with respect to the rejection of claim 2 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claim 2 under 35 U.S.C. 112(b) has been withdrawn.
101 Rejections
Applicant's arguments filed 9/9/2025 have been fully considered but they are not persuasive.
The ineligibility of amended independent claim 1 is illustrated by analogy to Example 49, claim 1 of the “July 2024 Subject Matter Eligibility Examples.”
The acquiring and receiving steps of claim 1, lines 3-5 are analogous to the sample collection/genotyping of Example 49 step (a) that are insignificant extra-solution activity that amounts to mere data gathering incidental to the identifying and generation of Example 49 step (b). See MPEP 2106.05(g). It is necessary to acquire and receive the 3D water and fat separated image of the muscle (e.g., a 3D Dixon MRI, noting that the applicant’s specification does not provide written description of the MRI scan type or apparatus) the data being a 3D MRI image dataset that comprises voxel volume elements, in order to use the recited judicial exception to perform the determining and calculating steps. The acquiring and receiving steps do not impose any other meaningful limits on the claim.
The determining and calculating steps of claim 1, lines 6-15 are analogous to the identifying and generation of Example 49 step (b) which recites a judicial exception of a mathematical calculation and/or mental process. See MPEP 2106.04(a)(2). The claim recites the mathematical calculation of a muscle fat fraction level (note that applicant’s specification fails to disclose any written description of how the muscle fat fraction level is determined) for each voxel of the image. The claim further recites the mathematical calculation of comparing the muscle fat fraction level of a muscle region (i.e., one or more voxels) of the image to a predetermined threshold. The claim further recites the mathematical calculation of the effective volume by multiplying the volume of the muscle region by a weighting function that is a function of the predetermined function (note that applicant’s specification fails to disclose any written description of how the muscle volume is determined). Furthermore, the claim does not impose any image size constraints upon the image, the image merely “comprising volume elements.” Under the BRI, “volume elements” appears to require the dataset comprise at least two voxels. A physician, with the aid of pen and paper, can readily perform each of the two determining steps and calculating step for each of the two voxels in the acquired and received image.
A specific treatment or prophylaxis is not recited in claim 1, and, therefore, similar to Example 49 step (c) the recited claim language fails to meaningfully limit the claim because it does not require any particular application of the abstract idea. See MPEP 2106.05(h).
Applicant has further amended the claim to add that the method is “computer-implemented,” “receiving the acquire image at a computer device comprising a processor unit,” and performing the determining and calculating steps using “the processor unit.” The computer device and processor unit as disclosed in applicant’s specification P.7, lines 29 – P.8, line 7 are generic computer/processor components disclosed at a high level of generality, i.e., as a generic computer performing generic computer functions such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.06(f) (see also Example 47, claim 2 at Step 2A, Prong Two).
Applicant has further amended the claim to specify “acquiring, by an imaging apparatus.” The claim does not restrict how the 3D water and fat separated image of the muscle is acquired. Applicant’s specification merely provides that that “[t]he three-dimensional water fat separated image may in one embodiment be determined using an MRI scan.” P.3, lines 6-7. Thus, applicant’s specification explains that this step may be carried out by any conventional method known in the art including MRI scans. See MPEP 2106.05 (see also Example 49, claim 1 at Step 2A, Prong 2 and Step 2B).
Consequently, for the reasons discussed above, the additional elements individually or in combination with the judicial exception do not provide an inventive concept; so, the claim as a whole does not amount to significantly more than a generic instruction to “apply” the judicial exception.
Further, as found in Example 49, at best, the claimed combination amounts to an improvement to the abstract idea of calculating an effective volume representation of the muscle rather than to any technology. See MPEP 2106.05(a). Thus, even when considering the elements in combination, the claim as a whole does not integrate the recited exception into a practical application.
Therefore, contrary to applicant’s assertions and arguments, claim 1 is not patent eligible. Furthermore, as detailed in the Non-Final Rejection of 6/16/25 and infra rejections, claims 2-13 are also not patent eligible.
Further, independent claim 14, has been amended to recite a computer device, receiving unit, and a processor unit. Applicant’s specification P.7, lines 29 – P.8, line 7 sets forth that the receiving unit and processor units are components of the computer device. As discussed above regarding independent claim 1, The computer device, receiving unit, and processor unit as disclosed in applicant’s specification P.7, lines 29 – P.8, line 7 are generic computer/processor components disclosed at a high level of generality, i.e., as a generic computer performing generic computer functions such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.06(f) (see also Example 47, claim 2 at Step 2A, Prong Two).
103 Rejections
Applicant’s arguments, see remarks and amended claim set, filed 9/9/25, with respect to claims 1-2 and 4-19 have been fully considered and are persuasive. The rejection under 35 U.S.C. 103 of claims 1-2 and 4-14 has been withdrawn.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, EP21173319.1 and PCT/EP2022/062032 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) for one or more claims of this application. Claims 1-2 and 4-19 recite subject matter not disclosed in the applications from which priority is claimed. Specifically:
Claim 1, line 3 recites “an imaging apparatus.” There does not appear to be written description in the priority applications for this limitation.
Claim 17, lines 1-2 recites “the imaging apparatus comprises a magnetic resonance imaging (MRI) system.” There does not appear to be written description in the priority applications for this limitation.
Claim 18, lines 1-2 recites “the imaging apparatus further comprises a computed tomography (CT) system.” There does not appear to be written description in the priority applications for this limitation.
Claims 2, 4-16 and 19 lack written description as being dependent upon or incorporating claim 1, line 3.
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 receiving unit” in claim 14, line 4.
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. “[A] receiving unit” appears to correspond to a component of a computer device as disclosed in applicant’s specification P.7, lines 29 – P.8, line 7.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 and 4-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, line 3 recites “an imaging apparatus.” There does not appear to be written description in the applicant’s originally filed specification or drawings for this limitation.
Claim 17, lines 1-2 recites “the imaging apparatus comprises a magnetic resonance imaging (MRI) system.” There does not appear to be written description in the applicant’s originally filed specification or drawings for this limitation.
Claim 18, lines 1-2 recites “the imagining apparatus further comprises a computed tomography (CT) system.” There does not appear to be written description in the applicant’s originally filed specification or drawings for this limitation.
Claims 2, 4-16 and 19 are rejected as being dependent upon or incorporating claim 1, line 3.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2 and 4-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
Claim 1 is illustrative:
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. The claim recites at least one step or act of determining the patient’s risk for a condition. Thus, the claim is a process, which is a statutory category of invention. (Step 1: YES).
Step 2A, Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04, subsection II, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
The determining and calculating steps of claim 1, lines 6-15 are analogous to the identifying and generation of Example 49 step (b) which recites a judicial exception of a mathematical calculation and/or mental process. See MPEP 2106.04(a)(2). The claim recites the mathematical calculation of a muscle fat fraction level (note that applicant’s specification fails to disclose any written description of how the muscle fat fraction level is determined) for each voxel of the image. The claim further recites the mathematical calculation of comparing the muscle fat fraction level of a muscle region (i.e., one or more voxels) of the image to a predetermined threshold. The claim further recites the mathematical calculation of the effective volume by multiplying the volume of the muscle region by a weighting function that is a function of the predetermined function (note that applicant’s specification fails to disclose any written description of how the muscle volume is determined). Furthermore, the claim does not impose any image size constraints upon the image, the image merely “comprising volume elements.” Under the BRI, “volume elements” appears to require the dataset comprise at least two voxels. A physician, with the aid of pen and paper, can readily perform each of the two determining steps and calculating step for each of the two voxels in the acquired and received image.
As there are no bright lines between the types of judicial exceptions, and many of the concepts identified by the courts as exceptions can fall under several exceptions, MPEP 2106.04, subsection I instructs examiners to “identify . . . the claimed concept (the specific claim limitation(s) that the examiner believes may recite an exception) [that] aligns with at least one judicial exception.” The determining and calculating steps of claim 1, lines 6-15 can be categorized under several exceptions (a mathematical concept-type abstract idea and a mental process-type abstract idea). See MPEP 2106.04, subsection II.B. (Step 2A, Prong One: YES).
Step 2A, Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
The acquiring and receiving steps of claim 1, lines 3-5 are analogous to the sample collection/genotyping of Example 49 step (a) that are insignificant extra-solution activity that amounts to mere data gathering incidental to the identifying and generation of Example 49 step (b). See MPEP 2106.05(g). It is necessary to acquire and receive the 3D water and fat separated image of the muscle (e.g., a 3D Dixon MRI, noting that the applicant’s specification does not provide written description of the MRI scan type or apparatus) the data being a 3D MRI image dataset that comprises voxel volume elements, in order to use the recited judicial exception to perform the determining and calculating steps. The acquiring and receiving steps do not impose any other meaningful limits on the claim.
A specific treatment or prophylaxis is not recited in claim 1, and, therefore, similar to Example 49 step (c) the recited claim language fails to meaningfully limit the claim because it does not require any particular application of the abstract idea. See MPEP 2106.05(h).
Furthermore, the preamble in claim 1, lines 1-2 does not add a meaningful limitation as it merely restates the abstract idea that the effective volume of the muscle is calculated/quantified.
Applicant has further amended the claim to add that the method is “computer-implemented,” “receiving the acquire image at a computer device comprising a processor unit,” and performing the determining and calculating steps using “the processor unit.” The computer device and processor unit as disclosed in applicant’s specification P.7, lines 29 – P.8, line 7 are generic computer/processor components disclosed at a high level of generality, i.e., as a generic computer performing generic computer functions such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.06(f) (see also Example 47, claim 2 at Step 2A, Prong Two).
Applicant has further amended the claim to specify “acquiring, by an imaging apparatus.” The claim does not restrict how the 3D water and fat separated image of the muscle is acquired. Applicant’s specification merely provides that that “[t]he three-dimensional water fat separated image may in one embodiment be determined using an MRI scan.” P.3, lines 6-7. Thus, applicant’s specification explains that this step may be carried out by any conventional method known in the art including MRI scans. See MPEP 2106.05 (see also Example 49, claim 1 at Step 2A, Prong 2 and Step 2B).
Consequently, for the reasons discussed above, the additional elements individually or in combination with the judicial exception do not provide an inventive concept; so, the claim as a whole does not amount to significantly more than a generic instruction to “apply” the judicial exception.
Further, as found in Example 49, at best, the claimed combination amounts to an improvement to the abstract idea of calculating an effective volume representation of the muscle rather than to any technology. See MPEP 2106.05(a). Thus, even when considering the elements in combination, the claim as a whole does not integrate the recited exception into a practical application. (Step 2A, Prong Two: NO). Thus, claim 1 is directed to a judicial exception. (Step 2A: YES).
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. Additional elements in claim 1, lines 3-5 were considered insignificant extra-solution activities (mere data gathering) in Step 2A, Prong Two. No specific treatment or prophylaxis is recited in the claim, therefore, claim 1 does not require any particular application of the calculated effective volume and lacks even an instruction to “apply” the abstract idea.
These additional elements should be re-evaluated in Step 2B, in which the extra-solution activity consideration takes into account whether or not an extra-solution activity is well-known. The data gathering activities in claim 1, lines 3-5 are recited at a high level of generality. The specification otherwise only describes carrying out acquiring and receiving the 3D water and fat separated image by any conventional method known in the art including MRI scans. See applicant’s specification P.3, lines 6-7. Further, the specification otherwise only describes receiving the acquired image and performing the determining and calculating steps using generic computer components. See applicant’s specification P.7, lines 29 – P.8, line 7.
Consequently, for the reasons discussed above, the additional elements individually or in combination with the judicial exception do not provide an inventive concept; so, the claim as a whole does not amount to significantly more than a generic instruction to “apply” the judicial exception and insignificant extra-solution activity. (Step 2B: NO). Claim 1 is not eligible.
Independent claim 14 incorporates the method of claim 1 and has been amended to recite a computer device, receiving unit, and a processor unit. Applicant’s specification P.7, lines 29 – P.8, line 7 sets forth that the receiving unit and processor units are components of the computer device. As discussed above regarding independent claim 1, The computer device, receiving unit, and processor unit as disclosed in applicant’s specification P.7, lines 29 – P.8, line 7 are generic computer/processor components disclosed at a high level of generality, i.e., as a generic computer performing generic computer functions such that it amounts to no more than mere instructions to apply the exception using a generic computer. See MPEP 2106.06(f) (see also Example 47, claim 2 at Step 2A, Prong Two). Therefore, independent claim 14 is not eligible.
Turning to the dependent claims:
Dependent claim 2 merely specifies the value of the predetermined threshold level, T1.
Dependent claim 4 merely specifies that the weighting function equals 1 when MFF1 is zero and decreases towards zero when MFF1 increases towards T1, and, thus, recites a mathematical concept and mental process.
Dependent claim 5 merely specifies that the weighting function is a linear function of MFF1, and, thus, recites a mathematical concept and mental process.
Dependent claim 6 merely specifies that the weighting function is 1-(MFF1/T1), and, thus, recites a mathematical concept and mental process.
Dependent claim 7 merely specifies that the weighting function is a non-linear function of MFF1, and, thus, recites a mathematical concept and mental process.
Dependent claim 8 merely specifies that the weighting function is exp(-k*(MGG1/T1), where k is a positive integer, and, thus, recites a mathematical concept and mental process.
Dependent claim 9 merely specifies that the weighting function is (1-MFF1/T1)^2, and, thus, recites a mathematical concept and mental process.
Dependent claim 10 merely specifies that the muscle fat fraction level is determined based on the water and fat level values, and, thus, recites a mathematical concept and mental process.
Dependent claim 11 merely specifies that the first volume region is formed by the voxels having a muscle fat fraction below the threshold, and, thus, recites a mathematical concept and mental process.
Dependent claim 12 merely specifies that the effective volume provides a quantification of the part of the muscle having a functional level at a predetermined rate, and, thus, recites a mathematical concept and mental process.
Dependent claim 13 merely specifies that the 3D water fat separated image is an MRI image. This recites necessary data gathering steps required to acquire the 3D MRI water and fat images of the muscle and do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
Dependent claim 15 merely specifies the value of the predetermined threshold level, T1.
Dependent claim 16 merely specifies the value of the predetermined threshold level, T1.
Dependent claim 17 merely specifies that the imaging apparatus comprises an MRI system. This merely recites a category of conventional imaging systems used to perform the necessary data gathering steps to acquire the 3D MRI water and fat images of the muscle and do not add a meaningful limitation to the method as they are insignificant extra-solution activity and/or generally link the use of the judicial exception to a particular field of use or a technological environment (MRI).
Dependent claim 18 merely specifies that the imaging apparatus comprises a CT system. This merely recites a category of conventional imaging systems used to perform the necessary data gathering steps to acquire the 3D MRI water and fat images of the muscle and do not add a meaningful limitation to the method as they are insignificant extra-solution activity and/or generally link the use of the judicial exception to a particular field of use or a technological environment (CT imaging).
Dependent claim 19 merely specifies that the volume elements are voxels.
Thus, claims 1-2 and 4-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
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 1, 4-6, 10-13, and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 17/428,524 (the ‘524 Application) in view of Heskamp.
Regarding claim 1, claim 4 of the ‘524 Application discloses a computer-implemented method (claim 1, lines 1-2) of quantifying an effective volume, VE, of a muscle of a subject (claim 4, lines 1-6), the method comprising the steps of:
acquiring, by an imaging apparatus, images of the muscle (claim 1, lines 4-9),
receiving the acquired image at a computer device comprising a processor unit (claim 1, lines 2-17),
determining, by the processor unit (claim 1, lines 2-3), a muscle fat fraction level, MFF1, for each volume element in the acquired image of the muscle (claim 1, lines 15-17),
determining, by the processor unit (claim 1, lines 2-3), a first volume region of the muscle in said image in which the muscle fat fraction level, MFF1, is below a predetermined threshold level, T1 (claim 1, lines 21-23, 35-37; claim 4, lines 1-6),
calculating, by the processor unit (claim 1, lines 2-3), an effective volume, VE, representation of the muscle representing a quantification of muscle function by multiplying the volume of the first volume region with WF(MFF1), wherein WF(MFF1) is a weighting function of the muscle fat fraction, MFF1, in said first volume region (claim 4, lines 1-6), wherein the weighting function, WF(MFF1), is a function of the predetermined threshold level, T1 (claim 4, lines 1-6), and decreases as the muscle fat fraction level, MFF1, approaches the predetermined threshold level, T1 (claim 4, lines 1-6).
However, while claim 4 of the ‘524 Application discloses acquiring a magnetic resonance image, claim 4 of the ‘524 Application does not disclose the magnetic resonance image is a three-dimensional water and fat separated image of the muscle, said image comprising volume elements each having water and fat level values.
However, in the same field of endeavor of quantitative MRI of muscle tissue, Heskamp teaches acquiring a three-dimensional water and fat separated image of the muscle, said image comprising volume elements each having water and fat level values (3D MRI Dixon sequences to obtain water and fat separated images and voxel volumes of the muscle, Abstract, P.e2804, ¶7 – P.e2805, ¶1, P.e2805, ¶3 - P.e2806, ¶1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Heskamp’s known technique of using 3D MRI Dixon sequences to obtain water and fat separated images of the muscle and voxel volumes of the muscle to claim 4 of the ‘524 Application’s known process for obtaining the muscle fat infiltration level to achieve the predictable result that MRI is well suited to study neuromuscular disorders as it is a noninvasive, quantitative method that can provide relevant biomarkers such as muscle volume and fat fraction. See, e.g., Heskamp, P.e2804, ¶2.
Regarding claim 4, claim 4 of the ‘524 Application discloses the weighting function, WF(MFF1), equals 1 when MFF1 is zero and decreases towards 0 when MFF1 increases towards T1 (claim 4, lines 1-6).
Regarding claim 5, claim 4 of the ‘524 Application discloses the weighting function, WF(MFF1), is a linear function of MFF1 (claim 4, lines 1-6).
Regarding claim 6, claim 4 of the ‘524 Application discloses the weighting function, WF(MFF1), is 1-(MFF1/T1) (claim 4, lines 1-6).
Regarding claim 10, while claim 4 of the ‘524 Application discloses a muscle fat fraction level, MFF1, for each volume element in the acquired image of the muscle (claim 1, lines 15-17), claim 4 of the ‘524 Application does not disclose the muscle fat fraction level is determined for each volume element based on the water and fat level values for the respective element.
However, in the same field of endeavor of quantitative MRI of muscle tissue, Heskamp teaches the muscle fat fraction level, MFF1, is determined for each volume element based on the water and fat level values for the respective element (fat fraction map is obtained for each voxel volume based on the water and fat signal intensity values for the voxel volume in the images, Abstract, P.e2805, ¶3 - P.e2806, ¶1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Heskamp’s known technique of using 3D MRI Dixon sequences to obtain water and fat separated images of the muscle and voxel volumes of the muscle such that the fat fraction map can be obtained for each voxel volume to claim 4 of the ‘524 Application’s known process for obtaining the muscle fat infiltration level to achieve the predictable result that MRI is well suited to study neuromuscular disorders as it is a noninvasive, quantitative method that can provide relevant biomarkers such as muscle volume and fat fraction. See, e.g., Heskamp, P.e2804, ¶2.
Regarding claim 11, claim 4 of the ‘524 Application discloses the first volume region is provided by the volume elements of the muscle in the image having a muscle fat faction level, MFF1, below the predetermined threshold level, T1 (claim 1, lines 21-23, 35-37; claim 4, lines 1-6).
Regarding claim 12, claim 4 of the ‘524 Application discloses the effective volume, VE, of the muscle provides a quantification of the part of the muscle having a functional level at a predetermined rate (claim 1, lines 21-23, 35-37; claim 4, lines 1-6).
Regarding claim 13, while claim 4 of the ‘524 Application discloses the image is an MRI image (claim 1, lines 4-7), claim 4 of the ‘524 Application does not appear to disclose the three-dimensional water fat separated image is an MRI image.
However, in the same field of endeavor of quantitative MRI of muscle tissue, Heskamp teaches the three-dimensional water fat separated image is an MRI image (3D MRI Dixon sequences to obtain water and fat separated images and voxel volumes of the muscle, Abstract, P.e2804, ¶7 – P.e2805, ¶1, P.e2805, ¶3 - P.e2806, ¶1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Heskamp’s known technique of using 3D MRI Dixon sequences to obtain water and fat separated images of the muscle and voxel volumes of the muscle to claim 4 of the ‘524 Application’s known process for obtaining the muscle fat infiltration level to achieve the predictable result that MRI is well suited to study neuromuscular disorders as it is a noninvasive, quantitative method that can provide relevant biomarkers such as muscle volume and fat fraction. See, e.g., Heskamp, P.e2804, ¶2.
Regarding claim 17, claim 4 of the ‘524 Application discloses the imaging apparatus comprises a magnetic resonance imaging (MRI) system (claim 1, lines 4-5).
Regarding claim 18, claim 4 of the ‘524 Application discloses the imaging apparatus comprises a computed tomography (CT) system (claim 1, lines 4-7).
Regarding claim 19, while claim 4 of the ‘524 Application does not appear to disclose the volume elements comprise voxels, in the same field of endeavor of quantitative MRI of muscle tissue, Heskamp teaches the volume elements comprise voxels (3D MRI Dixon sequences to obtain water and fat separated images and voxel volumes of the muscle, Abstract, P.e2804, ¶7 – P.e2805, ¶1, P.e2805, ¶3 - P.e2806, ¶1).
This is a provisional nonstatutory double patenting rejection.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of copending Application No. 17/428,524 (the ‘524 Application) in view of Heskamp.
Regarding claim 2, claim 5 of the ‘524 Application discloses the predetermined threshold level, T1, of muscle fat fraction is between 30-80% (claim 5, lines 1-2).
This is a provisional nonstatutory double patenting rejection.
Claim 15 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of copending Application No. 17/428,524 (the ‘524 Application) in view of Heskamp.
Regarding claim 15, claim 18 of the ‘524 Application discloses the predetermined threshold level, T1, of muscle fat fraction level, MFF1, is between 45-55% (claim 18, lines 1-2).
This is a provisional nonstatutory double patenting rejection.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. 17/428,524 (the ‘524 Application) in view of Heskamp.
Regarding claim 16, claim 19 of the ‘524 Application discloses the predetermined threshold level, T1, of muscle fat fraction level, MFF1, is 50% (claim 19, lines 1-2).
This is a provisional nonstatutory double patenting rejection.
Claim 14 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 17/428,524 (the ‘524 Application) in view of Heskamp.
Regarding claim 14, claim 4 of the ‘524 Application discloses a system configured to determine an effective volume of a muscle of a subject (method is performed by a computer with a processing unit, scanning is using a magnetic resonance imaging scanning device, claim 1, lines 1-7) according to the method of claim 1 (see rejection of claim 1 over claim 4 of the ‘524 Application in further view of Heskamp above), the system comprising
means for acquiring the image (image acquired using a magnetic resonance imaging scanning device, claim 1, lines 1-7), and
means configured to determine the muscle fat fraction level in the muscle, determine the first volume region, and calculate the effective volume (method is performed by a computer with a processing unit, claim 1, lines 1-7; muscle fat infiltration level, claim 1, lines 15-17; volume of first part of the first muscle, claim 4, lines 1-6; effective volume, claim 4, lines 1-6).
However, while claim 4 of the ‘524 Application discloses acquiring a magnetic resonance image, claim 4 of the ‘524 Application does not disclose acquiring the three-dimensional water and fat separated image.
However, in the same field of endeavor of quantitative MRI of muscle tissue, Heskamp teaches acquiring the three-dimensional water and fat separated image (3T MRI system and Matlab computer software environment on a personal computer to obtain 3D water and fat separated images, P.e2804, ¶7 – P.e2806, ¶1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Heskamp’s known technique of using 3D MRI Dixon sequences to obtain water and fat separated images of the muscle and voxel volumes of the muscle to claim 4 of the ‘524 Application’s known system for obtaining the muscle fat infiltration level to achieve the predictable result that MRI is well suited to study neuromuscular disorders as it is a noninvasive, quantitative method that can provide relevant biomarkers such as muscle volume and fat fraction. See, e.g., Heskamp, P.e2804, ¶2.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 7-9 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 101, 112(a), and 112(b) of claims 7-9, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Vidt et al. (“Assessments of fatty infiltration and muscle atrophy from a single magnetic resonance image slice are not predictive of three-dimensional measurements” 2016) discloses 3D MRI fat-water separated imaging to calculate the fat fraction, muscle volume, and fat free muscle volume including a 50% fat fraction percentage threshold where FFMV = MV-FIV = MV – (%fat)(MV) = MV(1-%fat).
Leinhard (U.S. Pub. No. 2020/0174090 sharing the same disclosure as EP3432018 published 01/23/2019) discloses 3D MRI fat-water separated imaging to calculate the fat fraction, muscle volume, and fat free muscle volume.
Leinhard et al. (U.S. Pub. No. 2017/0046837) discloses 3D MRI fat-water separated imaging to calculate the muscle volume, and lean tissue volume.
Leinhard et al. (U.S. Pub. No. 2015/0125056) discloses 3D MRI fat-water separated imaging to calculate the muscle volume and the fat fraction/ratio.
Karlsson et al. (“Automatic and quantitative assessment of total and regional muscle tissue volume using multi-atlas segmentation” 2014) discloses using 3D MRI fat-water separated imaging to calculate the muscle volume using a fat content ratio threshold to remove voxels larger than 50% fat.
Karlsson et al. (“The relation between local and distal muscle fat infiltration in chronic whiplash using magnetic resonance imaging” 2019) discloses using 3D MRI fat-water separated imaging to calculate the muscle volume using a fat content ratio threshold to remove voxels larger than 50% fat.
West et al. (“Precision of MRI-based body composition measurements of postmenopausal women” 2018) discloses using 3D MRI fat-water separated imaging to calculate the muscle volume using a fat content ratio threshold to remove voxels larger than 50% fat.
Linge et al. (“On the definition of sarcopenia in the presence of aging and obesity – initial results from UK Biobank” 2019) discloses using 3D MRI fat-water separated imaging to calculate the muscle volume using a fat content ratio threshold to remove voxels larger than 50% fat.
Linge et al. (“Adverse muscle composition is linked to poor functional performance and metabolic comorbidities in NAFLD” 2020) discloses using 3D MRI fat-water separated imaging to calculate the muscle volume using a fat content ratio threshold to remove voxels larger than 50% fat.
Thomas et al. (“Test-retest reliability of automated whole body and compartmental muscle volume measurements on a wide bore 3T MR system” 2013) discloses using 3D MRI fat-water separated imaging to calculate the muscle volume using a fat content ratio threshold to remove voxels larger than 50% fat.
Dahlqvist et al. (“MRI in neuromuscular diseases: an emerging diagnostic tool and biomarker for prognosis and efficacy” 2020) discloses using 3D MRI fat-water separated imaging to calculate the muscle fat infiltration, muscle volume, lean muscle volume, and lean muscle cross-sectional area.
Gidaro et al. (“Quantitative nuclear magnetic resonance imaging detects subclinical changes over 1 year in skeletal muscle of GNE myopathy” 2020) discloses using 3D MRI fat-water separated imaging to calculate the fat fraction, muscle volume, and lean muscle cross-sectional area.
Steenkjaer et al. (“Isokinetic strength and degeneration of lower extremity muscles in patients with myotonic dystrophy; an MRI study” 2020) discloses using 3D MRI fat-water separated imaging to calculate the fat fraction, muscle volume, and lean muscle cross-sectional area.
Marra et al. (“Specific muscle strength is reduced in facioscapulohumeral dystrophy: an MRI based musculoskeletal analysis” 2017) discloses using 3D MRI fat-water separated imaging to calculate the fat fraction, muscle volume, and lean muscle cross-sectional area.
Carlier et al. (“Skeletal muscle quantitative nuclear magnetic resonance imaging and spectroscopy as an outcome measure for clinical trials” 2016) discloses using 3D MRI fat-water separated imaging to calculate the fat fraction, muscle volume, and lean muscle cross-sectional area.
Bachasson et al. (“Lean regional muscle volume estimates using explanatory bioelectrical models in healthy subjects and patients with muscle wasting” 2020) discloses using 3D MRI fat-water separated imaging to calculate the fat fraction, muscle volume, and lean muscle cross-sectional area.
Azzabou et al. (“Validation of a generic approach to muscle water T2 determination at 3T in fat-infiltrated skeletal muscle” 2014) discloses using 3D MRI fat-water separated imaging to calculate the fat fraction.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Johnathan Maynard whose telephone number is (571)272-7977. The examiner can normally be reached 10 AM - 6 PM.
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