DETAILED ACTION
Brief Summary
This is a non-final Office action addressing reissue U.S. Application 15/835,948 (hereafter the ‘948 Application”).
A request for continued examination (“RCE”) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 10, 2022 has been entered.
Upon review of the ‘948 Application, the application was filed on December 8, 2017. The ‘948 Application is a reissue of U.S. Patent No. 9,208,557 (hereafter “the ’557 Patent”), which originally issued on December 8, 2015 with patented claims 1-14, being filed as U.S. Application 13/878,623 having the 371 (c)(1),(2), (4) date of June 17, 2013, being originally filed as PCT/FR2011/052374 on October 11, 2011, whereby the PCT application claims foreign priority to the French Patent Application 10-52851, dated October 11, 2010.
As noted above, the ‘557 Patent issued with claims 1-14. Previously, during this reissue prosecution, various claims were amended, claims 15-17 were added, and claim 1 was canceled. A final Office action was mailed on January 10, 2022, which indicated that claims 2-17 were rejected.
Subsequently, the Applicant filed the instant amendment and remarks with the RCE on May 10, 2022, whereby the amendment dated May 10, 2022 amends claims 2, 3, 11, 15, and 17, and adds new claims 18-20. Thus, with the amendment dated May 10, 2022, claims 2-20 are currently pending, with claims 2, 11, 15, 18, 19, and 20 are now independent.
The present application is being examined under the pre-AIA first to invent provisions.
Reissue
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 9,208,557 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Non-Compliant Amendment
The amendment dated May 10, 2022 does not comply with 37 CFR 1.173. In this regard, 37 CFR 1.173(c) and (d) state:
(c) Status of claims and support for claim changes. Whenever there is an amendment to the claims pursuant to paragraph (b) of this section, there must also be supplied, on pages separate from the pages containing the changes, the status (i.e., pending or canceled), as of the date of the amendment, of all patent claims and of all added claims, and an explanation of the support in the disclosure of the patent for the changes made to the claims.
(d) Changes shown by markings. Any changes relative to the patent being reissued which are made to the specification, including the claims, upon filing, or by an amendment paper in the reissue application, must include the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets; and
(2) The matter to be added by reissue must be underlined, except for amendments submitted on compact discs (§§ 1.96 and 1.821(c))….
With this, the submitted amendment dated May 10, 2022 is not seen to include any explanation of support in the disclosure of the patent for the changes made in the claims. Particularly, there is not seen to be an explanation of support for features in new claims 18-20 in the amendment dated May 10, 2022.
Further, the submitted amendment dated May 10, 2022 includes markings to claims that are not shown relative to the patent being reissued. For example, in claim 11, lines 1 and 2, the phrase “among a plurality of quantities of interest” is shown in brackets, as well as also being underlined. Additionally, in claim 11, lines 24 and 26, the word “quantities” is shown lined out, and also is shown as underlined. Here, with respect to both of these elements, because the above noted phrase and words are not to be within the newly added limitations, these elements should not be included in the underlined claim language. Only the features that are to be added should be underlined, relative to the patent being reissued.
Similarly, in claim 15, lines 1 and 2, the phrase “among a plurality of quantities” is shown lined out, and is also shown as underlined. Additionally, in claim 15, line 19, the word “quantities” is lined out, and in claim 15, line 20, the phrase “an impulse response of said dynamical system” is shown in brackets, and also is underlined. Here, with respect to each of these elements, because the above noted phrases and words are not to be within the newly added limitations, these elements should not be included in the underlined claim language. Only the features that are to be added should be underlined, relative to the patent being reissued.
Therefore, for the above reasons, the amendment dated May 10, 2022 does not comply with 37 CFR 1.173, which sets forth the manner of making amendments in reissue applications. A supplemental paper correctly amending the reissue application is required.
Claim Objections
Claim 15 is objected to because of the following informalities:
In claim 15, lines 1 and 2, with the amended changes, the claim currently reads “estimating a quantity of interest of interest of an…”. One of the instances that recite “of interest” should be removed.
Appropriate correction is required.
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 17-20 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.
Regarding dependent claim 17, in lines 1-3, the claim now recites “A perfusion-weighted imaging analysis system comprising: said apparatus for estimating a quantity of interest according to claim 15, and a hardware interface device configured to render the estimated quantity to a user.”
In reviewing independent claim 15, for which claim 17 depends on, claim 15 already recites “a hardware interface device” having the claimed function “for displaying the estimated quantity to a user” in line 23 of the claim. This creates confusion in claim 17, as claim 17 is unclear if there is a second hardware interface device, with the second one performing a different function than the previous recited “hardware interface device”. If the Applicant’s intention for claim 17 is to have two separate and distinct hardware interface devices, than the specification of the ‘557 Patent is not seen to sufficiently describe these features. Here, the Examiner suggests amending line 3 of claim 17 to read “said [a] hardware interface device further configured to…”
Regarding claims 18-20, each of these new claims include the equation, described as the relationship of:
PNG
media_image1.png
49
266
media_image1.png
Greyscale
But in explaining the variable of this equation, these claims each state “h(t) is the impulse response at measurement time points tj, j=1,N of the artery/tissue/vein dynamical system, and wherein h(t) is the quantity of interest to be estimated”. With this, claims 18-20 are unclear as to what is being defined. Particularly, is the recited “h(t)” in the claims referring to “h(τ)” in the equation? While the formula is clear that the integration of h(τ) is over the range of 0 to the value t, the claimed function of “h(t)” is not expressly recited in the equation. Additionally, the claims recite that the function h(t) is “the impulse response at measurement time points tj, j=1,N”. But the upper limits of the claimed integration in the equation are “t”. With the current claim language, the claims are not clear of what the variable “tj” are referring to. Are the points of time “t” different than the points of time “tj”? If the function h(t) is to be the impulse response at measurement time points tj, wouldn’t the function be written as “h(tj)”?
Along this vein, the equation in claims 18-20 appear to be described in col. 8, line 34-col. 9, line 4 of the ‘557 Patent. Here, the ‘557 Patent defines “tj” with a subsequent equation in col. 8, line 60, that being:
PNG
media_image2.png
83
193
media_image2.png
Greyscale
Thus, without this further context, the claims as written are unclear of what this variable of “tj” in the equation represents.
Allowable Subject Matter
Claims 2-14 and 16 is seen to be allowable over the art of record.
Additionally, claims 15 and 17-20 would also appear to be patentable over the art of record, and would be deemed patentable if the objection and rejection under 35 U.S.C. 112 were to be overcome.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding independent claim 2, as well as independent claims 11, and 15, upon review of the prior art references and the current claims, as amended, in the Examiner’s opinion, it would not be obvious to one of ordinary skill in the art to have the method, as claimed, with the dynamical system being (i) linear, (ii) time-invariant and (iii) formally determined by the relationship C(t) = BF · Ca(t) * R(t), and with the quantity of interest being R(t), such that the evaluation of a posterior marginal probability distribution for said quantity of interest includes “assigning a direct probability distribution for the experimental perfusion data given parameters involved in the estimation of the quantity of interest of the artery/tissue/vein dynamical system in said voxel, and assigning a joint prior probability distribution for said quantity by introducing purely soft information on the quantity of interest R(t) in said voxel and applying the Principle of Maximum Entropy”, as required in independent claim 1, and similarly in claims 11 and 16. The closest prior art, being the references of Shimony (Joshua S. Shimony, et al., “Estimation of Cerebral Blood Flow from Dynamic Susceptibility Contrast MRI Using a Tissue Model”, AIP Conference Proceedings, American Institute of Physics, New York, Vol. 803, 7 August 2005, pp. 535-542), Kao (U.S. Patent Application Publication 2004/0218794), and Bretthorst (G. Larry Bretthorst, “The Near-irrelevance of Sampling Frequency Distributions”, in Maximum Entropy and Bayesian Methods, 1999, pages 21-46 (hereafter “Bretthorst”, being cited in the previous Office action dated May 24, 2021) fall short of expressly disclosing the combination of these features.
Particularly, the reference of Shimony discloses a method that estimates cerebral blood flow from a contrast MRI using a tissue model. However, Shimony lacks the specific teaching that requires “assigning a joint prior probability distribution for said quantity by introducing purely soft information on the quantity of interest R(t) in said voxel and applying the Principle of Maximum Entropy.” Additionally, the reference of Kao discloses a system and method processes perfusion images using dynamic susceptibility contrast magnetic resonance imaging. But Kao also lacks the specific teaching that requires “assigning a joint prior probability distribution for said quantity by introducing purely soft information on the quantity of interest R(t) in said voxel and applying the Principle of Maximum Entropy.” Finally, the reference of Bretthorst discloses a method of assigning joint probability by using the principle of maximum entropy. However, Bretthorst lacks any specific teaching of “assigning a joint prior probability distribution for said quantity by introducing purely soft information on the quantity of interest R(t) in said voxel”. Thus, with these specific features, which were included in the amendment dated May 10, 2022, these claims, when viewed as a whole, are rendered as patentable over the art of record.
Additionally, with respect to independent claims 18, 19, and 20, these claims recite similar limitations noted above, but instead recite the quantity of interest as “the impulse response h(t)”. Here, for similar reasons discussed above, the references of Shimony, Kao, and Bretthorst also fall short of teaching the limitations in these claims, when viewing the claim as a whole. But again, claims 18-20 currently stand rejected under 35 U.S.C. 112.
Conclusion
The following prior art made of record and not relied upon, is considered pertinent to Applicant’s disclosure:
WIPO Publication WO 2009/017746, with the inventor of Shinagawa et al., discloses a method and apparatus for pharmacokinetic analysis in measured breast MRI images; and
WIPO Publication WO2006/118549, with the inventor of Nowinski et al., discloses a method and apparatus for registering a measured MRI volume image with appropriate anatomical and blood supply territory.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Joseph R. Pokrzywa, whose telephone number is (571) 272-7410. The Examiner can normally be reached on Monday-Friday, 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Michael Fuelling can be reached on (571) 270-1367. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Signed:
/JOSEPH R POKRZYWA/ Primary Examiner, Art Unit 3992
Conferees:
/ROBERT J HANCE/Primary Examiner, Art Unit 3992 /M.F/Supervisory Patent Examiner, Art Unit 3992