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 . Claims 1-20 are currently pending.
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.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 5 recites that the querying (which roughly includes requesting data from a database or computer system to ultimately retrieve, filter, or manipulate stored information) is further based on an instruction from a healthcare provider for the expectant mother. There were no examples of what was meant in the original disclosure regarding what those instructions could possibly be. Healthcare providers giving instructions to the patients is a very well-known practice in the medical arts, and of course in the field of delivery. However, what those actual instructions could entail are not disclosed in the original disclosure..
This also appears to be something that is beyond the scope of the actual device/processor itself, as the “based on” language suggests it is not performed by the device/processor and could simply be the healthcare provider verbally describing the filter or input to the user. This of course is acceptable in a method type claim but given this is a system type claim where that step is not tied to the processor, it would reasonably fall under fully capable of being performed by the combination with no additional modifications. The processor itself is not providing the instruction, and if the querying that is claimed is simply the queried information from claim 1 (fetal alignment recommendations, health parameters of the expectant mother, fetus, etc.) then that is already met by claim 1 and claim 5 does not add anything structurally or to the methodology performed by the processor. What those choices are “based on” is not performed by the processor itself which is what the querying step is tied to from claim 1.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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.
Claim 1, 9, and 16 in lines 11-12 (depending on the independent claim) details that the system is to “present the recommendation in view of a user interface of a fetal monitoring application”, it’s unclear what “in view” means. It reads like the fetal monitoring application on a user interface somehow views said recommendation and is not actually positively claimed as part of the system. The language is ultimately ambiguous and should be clarified in order to overcome the rejection.
Claims 8, 15, and 20 also include the ambiguous “in view” language in lines 7-8. If the Applicant means that the recommendation or visual representation is to be displayed using the fetal monitoring application, then it should be reworded to reflect that.
Claim 1 recites the limitation "the plurality of fetal alignment recommendations" in line nine. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1, 5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Principe et al. US Publication 2012/0238894 (hereinafter Principe) in view of James et al. US Publication 2007/0213627 (hereinafter James) in view of Lavonne (YouTube video “Motion - Birth Tracker and Labor Algorithm App is LIVE”) and in further view of Miller US Publication 2021/0390129 (hereinafter Miller).
Regarding claim 1, Principe discloses a system (Figures 11-12), comprising: a processor ([0081]-[0086]); and a memory device ([0086]-[0088]) comprising instructions that are executable by the processor ([0087]) that includes database and accessing/inputting information on said database including a plurality of maternal health parameters for an expectant mother in labor, a plurality of fetal health parameters for a fetus of the expectant mother, a presentation of the fetus, and a descent of the fetus ([0061] which details a computing system that allows for accessing prior data along with user inputs, see also [0129]-[0134] which details the information stored in a database).
Principe is silent on the position of the fetus being a monitored/inputted piece of information for the database. James teaches a fetal monitoring system that includes a database with various templates that correspond the sensing to a fetal presentation/position (Figures 1-2, [0040]-[0073], claims 8, 48, 54, and also includes a processor and memory at 50, 60), where a comparator 51 that can choose the template for presentation/position from the data pool. It would have been obvious to the skilled artisan before the effective filing date to utilize the additional data as taught by James with the system of Principe as predictable results would have ensued (utilizing additional pertinent fetal information to aid in assessment/diagnosis).
Principe is silent on the user interface being on a fetal monitoring app, as well as the recommendation generation. Lavonne teaches a fetal monitoring application (an actual app, see link to video above, specifically at 0-5 seconds, 27-30 seconds, 40-45 seconds, which details accessing a database of recommendations, positions for the expectant mother to lay in, then based on the inputs of the fetus/mother, provides a generated recommendation, allowing for the ability to refresh for more options, as well as update which positions/recommendations did not work for them to update the list). The query is considered accessing the database, inputting additional criteria, and requesting a position to aid in natural birth/fetal positioning. The second set of recommendations is considered the master list of possible positions, and the first set being what is actually provided for the user to try out. Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the app functionality as taught by Lavonne with the device of Principe in order to aid the health care provider (or expecting mother) in finding comfortable positions to rest/sleep in as well as prep for labor for a natural birth.
Neither Principe, James, nor Lavonne explicitly detail a random selection. The refresh option shown in Lavonne’s app at the 40-42 second mark does not have to be random as it could be based on the most basic machine learning. Miller teaches a content optimization system used in applications that details that the content or categories can be randomly provided ([0022][0034][0037][0075]). Given that the pool of recommendations of Lavonne are finite, and that the number of options a dataset or set of recommendations can be chosen is limited to random, a pre-chosen order, or adjusted and selected by a machine learning technique, it would have been obvious to the skilled artisan before the effective filing date to utilize the random selection process as taught by Miller with the combination of Principe, James, and Lavonne as predictable results would have ensued (utilizing a finite selection process on a known data set).
Regarding claim 5, the resultant combination of claim 1 above already provides the querying step (by the processor/memory) and as this is not a method claim, and as this step of the querying being “based on an instruction from a healthcare provider” is also not physically performed by the processor which would require those steps to be directly met by the prior art, the combination above is fully capable of having the querying based on what a healthcare provider suggests as is further well-known in the medical field. Lavonne further does mention that the app inputs are all performed by a healthcare provider for the expectant mother (32 seconds in, which shows that the app is actually used by medical staff for their patients). Lavonne is combinable for the reasons mentioned above in rejected claim 1.
Regarding claim 7, Principe discloses the overall system as modified by James, Lavonne, Miller, where Lavonne already mentions utilizing an app (above). Principe further discloses determining maternal and fetal parameters ([0070][0090][0097] which includes maternal ECG, fetal ECG, uterine EHG, EMG, ultrasound fetal heart rate). The determining step is broad in nature and can also be read as the user simply inputting the data (mentioned above in claim 1) into the app, as is shown at the 27-30 second marks of the video. The combination for combining Lavonne remains unchanged.
Regarding claim 8, Principe discloses the instructions being executable by the processor (above) to: identify a media source that provides a visual representation of the recommendation (Figure 12 shows the computing setup, which includes a monitor; connecting a generic monitor to a computer to be identified to be used has been common practice for Linux since 2005/2008, Windows 1995, 1998 when it became standard, and macOS 2001); and provide the visual representation by: accessing the media source; and displaying the visual representation in view of the user interface of the fetal monitoring application (the monitor of Principe would have reasonably be able to display the results from an app taught above by Lavonne). Lavonne teaches the use of the fetal monitoring application (as mentioned above) and is combinable for the previously mentioned rationale.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Principe in view of James, Lavonne, Miller and in further view of Malvasi et al. “Dystocia, Delivery, and Artificial Intelligence in Labor Management: Perspectives and Future Directions” Oct 25, 2024.
Regarding claims 2, Principe is silent on the machine learning aspect. Malvasi teaches using a machine learning model trained to provide the first plurality of fetal alignment recommendations based on the plurality of maternal/fetal parameters (see sections 3, paragraphs 1-2, sections 3.1 and 3.3 which detail utilizing machine learning to predict labor/delivery outcomes utilizing the fetal/maternal health/conditions to recommend cesarean delivery or not faster). The factors listed were already disclosed above in rejected claim 1. It would have been obvious to the skilled artisan before the effective filing date to utilize the machine learning as taught by Malvasi with the system of Principe in order to provide better recommendations faster. If applied to Lavonne (of the above combination), machine learning would simply aid in the recommendation process based on the inputs the suer has in the app.
Claims 3-4, 9, 11, 13-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Principe in view of James, Lavonne, Miller and in further view of Collado et al. US Publication 2017/0053519 (hereinafter Collado).
Regarding claim 3, Principe is silent on the removal of previous fetal alignment recommendations. Lavonne teaches that the information of which positions were uncomfortable is input into the recommendation generator (2 second mark), even though it would be incredibly unlikely to provide a choice that the expectant mother already found to be uncomfortable, there is not explicit mention of the removal step. Miller teaches a reward system for prioritizing data sets that are preferred while deprioritizing those that are not ([0027], but is also silent on the actual removal of the data from the database.
Collado teaches an infant monitoring system that includes a processor/memory to provide recommendations based on removing the previous positions while providing options for other positions ([0019]-[0020]). The randomization is detailed above via Miller above, while the fetal alignment options are already detailed above as well. It would have been obvious to the skilled artisan before the effective filing date to aid in choosing a recommendation as taught by Collado with the combination of Principe, James, Lavonne, and Miller so as to provide better overall care/comfort as would be expected.
Regarding claim 4, Principe is silent regarding the removal then continued implantation of the recommendations. Lavonne teaches that the user can refresh the recommendations are uncomfortable (as mentioned above, see also at the 25, 27, 30 second marks), but is also silent on the formal removal of those recommendations from the database’s pool. Miller again teaches the recall value where the selection of upcoming recommendations is a function of the outcome of the prior presentation ([0028]), but also does not explicitly disclose the claimed limitation.
Collado teaches querying that is further based on a result of implementing the one or more previous recommendations ([0019]-[0020]) to better aid in recommending new positions that were not recently tried. The fetal alignment of course is described above (see contents of rejected claim 1). It would have been obvious to the skilled artisan before the effective filing date to utilize the additional steps as taught by Collado with the combination of Principe, James, Lavonne, and Miller so as to provide better overall care/comfort as would be expected.
Regarding claim 9, see the contents of rejected claims 1, 3 above.
Regarding claim 11, see the contents of rejected claim 5 above.
Regarding claim 13, see the contents of rejected claim 4 above.
Regarding claim 14, see the contents of rejected claim 7 above.
Regarding claim 15, see the contents of rejected claim 8 above.
Regarding claim 16, see contents of rejected claims 1, 3, 9 above.
Regarding claim 18, see the contents of rejected claim 4 above.
Regarding claim 19, see the contents of rejected claim 7 above.
Regarding claim 20, see the contents of rejected claim 8 above.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Principe in view of James, Lavonne, Miller, and in further view of Gomes et al. US Publication 2022/0354466 (hereinafter Gomes).
Regarding claim 6, Principe discloses the other factors including maternal and fetal health but is silent on the placenta’s location as being part of the dataset. Gomes teaches a prenatal health monitoring system that includes a database the has maternal and fetal health data, and specifically placenta location ([0055][0068]). It would have been obvious to the skilled artisan before the effective filing date to utilize the additional fetal information as taught by Gomers with the system of Principe in order to aid in the overall monitoring of fetal health during the pregnancy/labor, and for the same reasons all of the other metrics are in the database of Principe.
Claims 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Principe in view of James, Lavonne, Miller, and Collado, and in further view of Malvasi.
Regarding claims 10 and 17, see contents of rejected claim 2 above.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Principe in view of James, Lavonne, Miller, and Collado, and in further view of Gomes.
Regarding claim 12, see contents of rejected claim 6 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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