DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
2. This communication is in response to the communication filed 7/29/2022. Claims 1-20 are currently pending.
Claim Rejections - 35 USC § 101
3. 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.
3.1. Claims 1-5 and 7-20 are rejected under 35 U.S.C. § 101 because while the claims (1) are to a statutory category (i.e., process, machine, manufacture or composition of matter, the claims (2A1) recite an abstract idea (i.e., a law of nature, a natural phenomenon); (2A2) do not recite additional elements that integrate the abstract idea into a practical application; and (2B) are not directed to significantly more than the abstract idea itself.
In regards to (1), the claims are to a statutory category (i.e., statutory categories including a process, machine, manufacture or composition of matter). In particular, independent claims 1, 13 and 19, and their respective dependent claims are directed, in part, to systems and methods for estimating a reservoir volume of an infusate within an implantable medical device.
In regards to (2A1), the claims, as a whole, recite and are directed to an abstract idea because the claims include one or more limitations that correspond to an abstract idea including mathematical concepts and mental processes. For example, independent claims 1, 13 and 19, as a whole, are directed to systems configured to estimate and a method for estimating a volume of infusate within an implantable medical device by estimating a distribution of refill intervals based on the actual infusion data; and estimating a probability of an expected residual volume of infusate within the fluid reservoir differing from an actual residual volume of infusate within the fluid reservoir by greater than or equal to a determined percentage. Estimating volumes and probabilities are mathematical concepts and thus, abstract. The dependent claims include all of the limitations of their respective independent claims and thus are directed to the same abstract idea identified for the independent claims but further describe the elements and/or recite field of use limitations.
Furthermore, the claims are also directed to a mental process because the claims, except for certain limitations (* identified below in bold), under the broadest reasonable interpretation, can be reasonably and practically performed in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion. That is, other than reciting the certain additional elements, nothing in the claims precludes the limitations from being practically performed in the mind and/or with pen and paper. For example, estimating refill volume intervals and probabilities of an expected residual fluid volume are limitations that can be reasonably and practically performed in the human mind and/or with pen and paper.
CLAIM 1:
A medical system configured to estimate a volume of infusate within an implantable medical device, the system comprising:
an implantable medical device comprising a fluid reservoir; and
an external programmer in communication with the implantable medical device, the external programmer comprising a processor configured to estimate a distribution of refill intervals based on actual infusion data including patient initiated infusions.
CLAIM 2
The system of claim 1, wherein the distribution of refill intervals is determined by a random probability distribution model.
CLAIM 3
The system of claim 1, wherein the random probability distribution model is at least one of a stochastic model, Markov chain or Monte Carlo simulation.
CLAIM 4
The system of claim 1, wherein the distribution of refill intervals is used to determine a scheduled refill date based on a probability that the scheduled refill date will occur after a termination date of a majority of the distribution of refill intervals.
CLAIM 5
The system of claim 4, wherein at least 95% of the distribution of refill intervals end before the scheduled refill date.
CLAIM 6
The system of claim 1, wherein the system implements one or more controls to inhibit premature exhaustion of infusate, when an estimated fluid reservoir volume decreases below a threshold limit.
CLAIM 7
The system of claim 6, wherein the actual infusion data including patient initiated infusions is used to establish an upper control limit.
CLAIM 8
The system of claim 7, wherein patient initiated infusions are limited when the actual infusion data including patient initiated infusions at least one of approaches or is greater than or equal to the upper control limit.
CLAIM 9
The system of claim 1, wherein at least one condition having a potential to impact an actual residual volume of infusate delivered by the implantable medical device is considered in the estimation of the distribution of refill intervals.
CLAIM 10
The system of claim 9, wherein the at least one condition includes a measured actual residual volume, drug type, off-label usage, infusion rate, concentration, implant duration, manufacturing tolerance, or combination thereof.
CLAIM 11
The system of claim 1, wherein the processor is further configured to estimate a probability of an expected residual volume of infusate within the fluid reservoir differing from an actual residual volume of infusate within the fluid reservoir by greater than or equal to a determined percentage, based on an occurrence of at least one condition.
CLAIM 12
The system of claim 11, wherein the probability of an expected residual volume differing from an actual residual volume is determined by at least one of a Baysian network or other statistical model.
CLAIM 13
A medical system configured to estimate a volume of infusate within an implantable medical device, the system comprising:
an implantable medical device comprising a fluid reservoir; and
an external programmer in communication with the implantable medical device, the external programmer comprising a processor configured to estimate a probability of an expected residual volume of infusate within the fluid reservoir differing from an actual residual volume of infusate within the fluid reservoir by greater than or equal to a determined percentage, based on an occurance of at least one condition.
CLAIM 14
The system of claim 13, wherein the at least one condition includes a measured actual residual volume, drug type, off-label usage, infusion rate, concentration, implant duration, manufacturing tolerance, or combination thereof.
CLAIM 15
The system of claim 13, wherein the probability of an expected residual volume differing from an actual residual volume is determined by a at least one of a Baysian network or other statistical model.
CLAIM 16
The system of claim 13, wherein the probability of an expected residual volume differing from an actual residual volume is determined as a distribution of values, each value representing a possible difference between an expected residual volume and an actual residual volume.
CLAIM 17
The system of claim 16, wherein the distribution of values is determined by a random probability distribution model.
CLAIM 18
The system of claim 17, wherein the random probability distribution model is at least one of a stochastic model, Markov chain or Monte Carlo simulation.
CLAIM 19
A method of estimating a volume of infusate within an implantable medical device, the method comprising:
collecting actual infusion data including patient initiated infusions from an implantable medical device including a fluid reservoir;
estimating a distribution of refill intervals based on the actual infusion data.
CLAIM 20
The method of claim 19, wherein the distribution of refill interval is based on controlled data gathered from a sampling of implantable medical devices.
* The limitations that are in bold are considered “additional elements” that are further analyzed below in subsequent steps of the 101 analysis. The limitations that are not in bold are abstract and/or can be reasonably and practically performed in the human mind and/or with pen paper.
In regards to (2A2), the claims do not recite additional elements that integrate the abstract idea into a practical application. The additional elements in the claims (i.e., * identified above in bold) do not integrate the abstract idea into a practical application because the additional elements merely add insignificant extra-solution activity to the abstract idea; merely link the use of the judicial exception to a particular technological environment or field of use; and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea (i.e., the additional elements do not amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer).
Here, the additional elements (e.g., implantable medical device, external programmer, processor, etc.) are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies. Moreover, the claims recite “a medical system configured to”, “a processor configured to”, etc. devoid of any meaningful technological improvement details and thus, further evidence the additional elements are merely being used to leverage generic technologies to automate what otherwise could be done manually. Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Furthermore, the additional elements do not recite improvements to the functioning of a computer, or to any other technology or technical field—the additional elements merely recite general purpose computer technology; the additional elements do not recite applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition—there is no actual administration of a particular treatment; the additional elements do not recite applying the judicial exception with, or by use of, a particular machine—the additional elements merely recite general purpose computer technology; the additional elements do not recite limitations effecting a transformation or reduction of a particular article to a different state or thing—the additional elements do not recite transformation such as a rubber mold process; the additional elements do not recite 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—the additional elements merely leverage general purpose computer technology to link the abstract idea to a technological environment.
In regards to (2B), the claims, individually, as a whole and in combination with one another, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of (A) a generic computer structure(s) that serves to perform computer functions that serve to merely link the abstract idea to a particular technological environment (i.e., computers); and/or (B) functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Here, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer technologies. Mere instructions to apply an exception using generic computer technologies cannot provide an inventive concept.
Moreover, paragraphs [0037]-[0039] of applicant's specification (US 2023/0032068) recites that the system/method is implemented using a computing platform, such as a mobile phone, tablet or personal computer which are well-known general purpose or generic-type computers and/or technologies. The use of generic computer components recited at a high level of generality to process information through an unspecified processor/computer does not impose any meaningful limit on the computer implementation of the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Furthermore, the additional elements are merely well-known general purpose computers, components and/or technologies that receive, transmit, store, display, generate and otherwise process information which are akin to functions that courts consider well-understood, routine, and conventional activities previously known to the pertinent industry, such as, performing repetitive calculations; receiving or transmitting data over a network; electronic recordkeeping; retrieving and storing information in memory; and sorting information (See, for example, MPEP § 2106).
Therefore, the claims are not patent-eligible under 35 U.S.C. § 101.
Allowable Subject Matter
4. The prior art does not appear to reasonably teach all of the limitations of the claims. For example, the prior art does not appear to teach “an external programmer in communication with the implantable medical device, the external programmer comprising a processor configured to estimate a distribution of refill intervals based on actual infusion data including patient initiated infusions,” as recited in independent claim 1; “an external programmer in communication with the implantable medical device, the external programmer comprising a processor configured to estimate a probability of an expected residual volume of infusate within the fluid reservoir differing from an actual residual volume of infusate within the fluid reservoir by greater than or equal to a determined percentage, based on an occurance of at least one condition,” as recited in independent claim 13; and “collecting actual infusion data including patient initiated infusions from an implantable medical device including a fluid reservoir; estimating a distribution of refill intervals based on the actual infusion data,” as recited in independent claim 19.
Conclusion
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
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, Peter H Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681
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