DETAILED ACTION
This office action is responsive to the amendment filed 5/20/2026. Claims 8-15 and 17-20 remain pending and under prosecution.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
No claim elements are interpreted under 112 sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
It is noted that while Claim 8 recites steps of selecting the patient's name from a displayed list of patients at a user interface generated by the non-nutritive suck application system, selecting a therapy mode of the non-nutritive suck application, selecting a displayed “new therapy” control button; and, configuring a therapy protocol to be performed as steps that can fall into the abstract idea of a mental concept, the claims also includes concrete steps. These include: positioning the patient to encourage a rooting response to the orofacial stimulator appliance; inserting the orofacial stimulator appliance into the patient's mouth; holding the orofacial stimulator appliance to maintain contact with the patient's mouth during the therapy protocol; removing the orofacial stimulator appliance from the patient's mouth at the conclusion of the therapy protocol, which would amount to the claim as a whole being significantly more than a mental concept. Therefore, no 101 rejection is set forth.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 8-9, 11, 14-15, and 19-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barlow et al (US Pub No. 20060074354, referred to as "A") in view of Barlow et al (US Pub No. 20060079814, referred to as “B”), Goodman et al (US Pub No. 20040128163), Snell et al (US Pat No. 5309919), and Campbell et al (US Pat No. 6208974).
In regard to Claim 8, Barlow et al “A” disclose a method for using a non-nutritive suck appliance assembly in communication with a non-nutritive suck application system 600 (Figure 1-2), the method comprising:
a user interface 128, a display device 136 of the non-nutritive suck application system;
the non-nutritive suck application system having memory 126, 130 and executing a non-nutritive suck application on at least one processor 122 seen in Figure 1;
providing a therapy protocol – stimulus – of the non-nutritive suck application (0035);
configuring the selected therapy protocol to be performed using as a suck profile, (0038), and which is based on patient data, e.g. the size of the infant – “various embodiments use pacifiers available in at least three sizes: micro-premature infants, premature infants, and term infants” (0030);
calibrating an orofacial stimulator appliance 106 of the non-nutritive suck appliance 500 assembly to perform the selected therapy protocol using the configuration described, best seen in Figure 1 and Figure 3C (0054, 0056-0057);
positioning the patient to encourage a rooting response to the orofacial stimulator appliance, i.e. positioning patient upright;
starting the selected therapy protocol, best seen in Figure 7;
inserting the orofacial stimulator appliance into the patient's mouth which occurs in step 162, seen in Figure 7 (0012);
holding the orofacial stimulator appliance to maintain contact with the patient's mouth during the therapy protocol, best seen in Figure 1 (0050);
necessarily removing the orofacial stimulator appliance from the patient's mouth at the conclusion of the therapy protocol; and,
providing summary remarks regarding the therapy protocol at the user interface (0069).
However, Barlow et al “A” do not expressly disclose selecting the patient's name from a displayed list of patients at a user interface generated by the non-nutritive suck application system,
selecting a therapy protocol of the non-nutritive suck application;
selecting a displayed “new therapy” control button,
and configuring the selected therapy protocol based on patient data of the patient selected from the displayed list of patients, the patient data comprising at least one of age, an injury or data regarding assessment history of the patient.
Barlow et al “B” teaches that it is well known in the art to provide an analogous NNS application system with a client database as well as storing multiple data sets (0041, 0047). Barlow et al “B” also discloses selecting a therapy protocol of the NNS application from a user-selectable waveform library to apply the appropriate stimulus to the patient (0047) as well as providing an assessment and then later therapy, i.e. predetermined suck regimen (0053).
Snell et al teach that it is well known in the art to provide an analogous medical application with a user interface that is generated for display on the display device 80, i.e. a touch screen 78, seen in Figure 3 and 12-18, that effectively enables all types of mode and functionality particular to the desired procedure. Goodman et al teach that it is well known in the art to provide a touch screen interface that enables creation, modification, and ease of use of different patient profiles for the desired medical application including selecting the patient's name from a displayed list of patients and providing buttons named after the desired function that the user will select to perform said function (0047, 0061, 0076, 0077, 0079, 0080, 0081, 0094).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have Barlow et al "A" be modified such that the user interface is generated for display on the display device, as taught by Snell et al, to effectively provide a touch screen for ease of use, and to perform the steps of selecting a patient's name from a displayed list of patients generated by the non-nutritive suck application system by providing buttons for said functions such as “new therapy” as suggested by Goodman et al; selecting a therapy protocol of the non-nutritive suck application (taught by Barlow et al “B”); selecting a displayed "new therapy" control button, as suggested by Goodman et al and Barlow et al “B” when combined with Barlow et al “A” since Barlow et al “B” teach multiple modes of the device, i.e. assessment or therapy, to effectively enable a convenient and effective touch screen functionality to the method already taught by Barlow et al “A” by switching between multiple patients and functions of the device.
Cambell et al, similarly to Goodman et al and Snell et al, teach that it is well-known in the art to provide a digital interface for a medical system comprising configuring a selected therapy protocol based on patient data of the patient selected from the displayed list of patients, the patient data comprising at least one of data regarding assessment history of the patient – “the initial status of a selected diagnosis is "Needs Protocol." When the doctor places the cursor over a diagnosis in the tentative diagnosis box, it becomes highlighted. The doctor can then launch a protocol by clicking on the protocol button… To generate a protocol, the server looks up the protocol in a protocol table using the selected diagnosis as a key. The protocol for a tentative diagnosis includes one or more (typically several) recommended therapy items, each having a status. When the user clicks on the protocol button, the server generates the protocol and sends the protocol items and status to the client. In turn, the client displays a diagnostic protocol screen” (Col.17: 35-50).
Figure 10 shows the digital interface for the selected patient 1002 and includes assessment history of the patient, i.e. tentative diagnosis 1004 and diagnosis status 1008, which enables the selected therapy protocol to be configured in the manner above by presenting the associated protocol and recommended therapy items (Col.17: 51-Col.18: 14). Campbell et al thus advantageously enables personalization of the selected therapy protocol to be configured for the individual patient based on their specific assessment history.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Barlow et al “A” as modified such that it includes configuring a selected therapy protocol based on patient data of the patient selected from the displayed list of patients, the patient data comprising at least one of data regarding assessment history of the patient to effectively provide personalization of the selected therapy protocol to be configured for the individual patient based on their specific assessment history.
9. Barlow et al “A" disclose the method of claim 8, wherein calibrating the orofacial stimulator appliance comprises: inserting a therapy insert 105 into a receiver tube 110 of the orofacial stimulator appliance, best seen in Figure 3C (0054, 0056-0057); and, mounting a pacifier 110 onto an end of the orofacial stimulator appliance 106, best seen in Figure 3C.
11. Barlow et al “A” in combination with Barlow et al “B”, Goodman et al, and Snell et al disclose the therapy protocol is started by selecting a "start therapy" control button at the user interface, wherein it would be obvious to provide a functional start button for the functions already disclosed by Barlow et al “A” as suggested by Goodman et al for the reasons elaborated above.
14. Barlow et al “A” discloses providing power to the non-nutritive suck application system 600 (0039); providing power to the non-nutritive suck appliance assembly 500 (0039). Goodman et al disclose logging in to the application as part of selecting the proper mode for reasons elaborated above (0047, 0061, 0076, 0077, 0079, 0080, 0081, 0094).
Claim 15. Barlow et al “A” as modified do not expressly disclose the steps of adding a new patient to the displayed list of patients, wherein adding a new patient comprises:
selecting an “add new patient” control button at the user interface;
entering new patient data at the user interface; and
selected a “save” control button to save the new patient data in the memory of the application.
Goodman et al teach the steps of adding a new patient to the displayed list of patients, wherein adding a new patient comprises:
selecting an “add new patient” control button at the user interface – “provision of active buttons to manually add a new patient 613, delete” (0077);
entering new patient data at the user interface – “An additional interface component is a selectable menu… which may be manually edited as well… displaying a listing patients 609 which the user can select” (0076);
to necessarily save the new patient data in the memory of the application as would be well-known in the art (0047, 0061, 0076, 0077, 0079, 0080, 0081, 0094).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al such that the steps of adding a new patient to the displayed list of patients, wherein adding a new patient comprises: selecting an “add new patient” control button at the user interface; entering new patient data at the user interface; and saving the new patient data in the memory of the application as taught by Goodman et al an effective way to provide the digital interface for said functions as desired, wherein it would have been obvious to a skilled artisan to also include a “save” control button to save the new patient data in the memory of the application, since Goodman et al already disclose control buttons for the other functions and the saving function is a known a critical digital function.
19. Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al disclose the invention above but do not expressly disclose the selected therapy protocol to be performed is based on patient data and non-nutritive suck (NNS) assessment data.
Barlow et al “B” also teach that the therapy protocol – entrainment signal – to be performed is based on NNS assessment data – “performing a suck assessment at a time after subjecting the infant to the stimulus. In one such example, the method may further include adjusting the entrainment signal, and accordingly the stimulus, based on this later suck assessment” (0058) to effectively update the therapy protocol based on the infant’s assessment data.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al such that the selected therapy protocol to be performed is based on patient data and non-nutritive suck (NNS) assessment data as taught by Barlow et al “B” to effectively update the therapy protocol based on the infant’s assessment data.
20. Campell et al teach the patient data of the patient selected from the displayed list of patients further comprises assessment history of the patient stored in the memory of the non-nutritive suck application system, as is typical in the art – “the client maintains the patient's exam file in memory and issues context sensitive additional questions that are generated based on observations entered during the exam. As observations are made during the physical exam, the client executing the physical exam software determines when to present additional screens. The conditions that need to be satisfied to trigger additional exam screens are maintained in memory variables which control the operation and behavior of the exam as a whole, and the operation and behavior of individual sub-exam screens” (Col.15: 20-33).
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al, further in view of Kennish et al (US Pub No. 20070182571).
Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al disclose the invention above including measuring a frequency (0010, 0057, 0062-0063) and an amplitude (0047) of at least one pacifier displacement as taught by Barlow et al “A.”
However, the references do not expressly disclose measuring with a laser micrometer. Kennish et al teach that it is well-known in the art to use a laser micrometer to measure changes in linear position as occurs in Barlow et al “A” (0030). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al to measure with a laser micrometer as taught by Kennish et al as an effective means for such.
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al, further in view of Standley (US Pat No. 5830235)
Barlow et al “A” in combination with Barlow et al “B”, Goodman et al, Snell et al, and Campbell et al disclose the therapy protocol is started but do not expressly disclose depressing a button on the orofacial stimulator appliance.
Standley teach that an analogous orofacial stimulator appliance can have a button on the orofacial stimulator appliance to effectively enable functioning (claim 7). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Barlow et al “A” in combination with Barlow et al “B”, Goodman et al, Snell et al, and Campbell et al such that the orofacial stimulator appliance can have a button on the orofacial stimulator appliance to effectively enable functioning.
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al, further in view of Cohen (US Pub No. 20100016675).
Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al disclose the invention above but not disclose the summary remarks comprise data regarding a state of alertness for the patient. Cohen teaches that it is well known in the art to diagnose the level of alertness for a patient in an analogous sucking pattern diagnosis method to effectively diagnose NNS patterns (abst, 0005, 0011). Therefore, it would have been obvious to modify the invention of Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al to have the summary remarks comprise data regarding a state of alertness for the patient as taught by Cohen to more effectively assess and provide therapy for desired the NNS pattern.
Claim 17-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al, further in view of Oppelt et al (US Pat No. 5435304).
In regard to Claim 17, Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al disclose the invention above but do not expressly disclose generating a therapeutic pressure pulse profile signal comprising a base frequency signal further comprising two or more pressure pulses, wherein each pressure pulse causes a displacement of a pacifier surface contacted by the lip and the mouth of the patient, each of the two or more pressure pulses has a square wave profile and are separated by an interval between 500 milliseconds and 650 milliseconds in duration.
Barlow et al "B” teach that it is well known in the art to provide therapeutic pressure pulse profile signal comprising a base frequency signal further comprising two or more pressure pulses, wherein each pressure pulse causes a displacement of a pacifier surface contacted by the lip and the mouth of the patient to the patient's mouth to effectively treat an orofacial deficiency (0013, 0045, 0064 of Barlow et al “B”). It is noted that applicant does not appear to disclose any criticality towards the specific interval as solving a particular problem, conferring a specific advantage, or providing a desired result. Oppelt et al teach that it is well known in the art to have square wave profile pressure pulses as an effective form of therapy for a patient (Col.6-7).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the invention of Barlow et al “A” as modified by Barlow et al “B”, Snell et al, Goodman et al, and Campbell et al such that there is generating a therapeutic pressure pulse profile signal comprising a base frequency signal further comprising two or more pressure pulses, wherein each pressure pulse causes a displacement of a pacifier surface contacted by the lip and the mouth of the patient, each of the two or more pressure pulses has a square wave profile and are separated by an interval between 500 milliseconds and 650 milliseconds in duration, as taught by Barlow “B” and Oppelt et al, respectively, to effectively provide therapy for the patient for a orofacial deficiency.
Claim 18: Barlow et al “B” discloses the therapeutic pressure pulse profile signal comprises at least six pressure pulses in succession contacted with the patient for at least two minutes, at least twice a day (0064), wherein it would have been obvious to have the therapy be at least six pressure pulses in succession contacted with the patient for at least two minutes, at least twice a day as taught by Barlow et al “B” to provide an effective therapy to produce the desired NNS pattern.
Response to Arguments
Applicant's arguments filed with respect to the use of Barlow et al “A” in regard to the configuring of the selected therapy in the new amendment are moot as Campbell et al has been set forth to teach configuring a selected therapy protocol based on patient data of the patient selected from the displayed list of patients, the patient data comprising at least one of data regarding assessment history of the patient.
It is noted that while applicant contends that “configuring a therapy protocol” is different than configuration of memory to store data (Remarks pg. 8), it is noted that the claims do not specify what is meant by said configuring of the therapy protocol. As such, it is submitted that Campbell et al teach the digital interface for the selected patient 1002 and includes assessment history of the patient, i.e. tentative diagnosis 1004 and diagnosis status 1008, which enables the selected therapy protocol to be configured by presenting the associated protocol and recommended therapy items, best seen in Figure 9-10 (Col.17: 51-Col.18: 14). Campbell et al establish a direct functional connection between the step of selecting the patient from the displayed list and configuring the therapy protocol by using patient-specific data, i.e. assessment history, as claimed (Remarks pg. 9).
Regarding the combination of references, applicant contends that a skilled artisan would not look to Snell and Goodman because they are not drawn to non-nutritive suck therapy systems (Remarks pg. 10-11). As previously noted, the invention appears drawn to the digital interface method of using the invention already disclosed by Barlow et al “A” and Barlow et al “B.” The teachings of Snell et al and Goodman et al despite not being drawn to a NNS appliance are clearly drawn toward digital interface methods of other medical applications. It would have been obvious to a skilled artisan to apply said known digital interface method to Barlow et al “A” and Barlow et al “B” to precisely provide “ease of use” as stated. This would be a particular technological advantage.
It is also noted that MPEP 2141 states that “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396.” Thus, the skilled artisan would clearly understand how to apply the digital interface method of Snell et al and Goodman et al (and Campbell et al) to that of Barlow et al “A” and Barlow et al “B.”
Lastly, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Therefore, the overall rejection is maintained.
Conclusion
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 Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
