DETAILED ACTION
All references to Applicant’s specification are made using the paragraph numbers assigned in the US Publication of the present application US 2023/0355164 A1.
Claims 1-12 are hereby the present claims under consideration.
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 .
Drawings
The subject matter of this application admits of illustration by a drawing to facilitate understanding of the invention. Applicant is required to furnish a drawing under 37 CFR 1.81(c). No new matter may be introduced in the required drawing. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). In particular, the particular movements and placement of the stimulator with respect to the subject’s mouth and gums may be illustrated and would serve to facilitate understanding of the invention.
Claim Rejections - 35 USC § 112(b)
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 1-12 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 and its dependents are rejected as claim 1 recites “any diagnosed oral dysfunction” in line 5 but it is unclear if this limitation is referring to the diagnosed oral dysfunction of line 4, and/or any other diagnosed oral dysfunction that was not determined through the previously present method steps. For the purposes of this examination, the limitation will be interpreted as referring to the oral dysfunction diagnosed through the score analysis.
Claim 2 recites “treating the subject to reduce the symptoms of oral dysfunction” but it is unclear if the treatment provided by this step is the same as, related to, or different from, the “treatment protocol” provided in claim 1. For the purposes of this examination, the limitations will be interpreted as the same treatment provided by the treatment protocol.
Claim 5 recites “evaluating the subject’s oral posture” but it is unclear how this method step relates to the method of claim 1. In particular, it is unclear how this evaluation relates to the treatment protocol provided or any of the other recited method steps. For the purposes of this examination, this limitation will be interpreted as part of the stimulating step.
Claim 6 recites “evaluating the subject’s oral tolerance to touch” but it is unclear how this method step relates to the method of claim 1. In particular, it is unclear how this evaluation relates to the treatment protocol provided or any of the other recited method steps. For the purposes of this examination, this limitation will be interpreted as part of the stimulating step.
Claim 11 recites “proving one to ten cues in a treatment session” but it is unclear what “cues” entail. The meets and bounds of the “cue” being provided are unclear. For the purposes of this examination, the limitation will be interpreted as a physical therapy action.
Claim Rejections - 35 USC § 112(a)
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, 5-6, and 9 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 recites “stimulating an oral reflex response in the subject” but the specification describes specific oral reflexes to be tested and their respective tests in paragraphs 0030-0035 and 0045-0056 recite that the oral reflexes being tested are gape, thrust, left and right lateralization, left and right phasic bite, and suck and each of these reflexes corresponds to a particular method of stimulating said reflex. Thus it would seem that the specification does not support any method of stimulation being utilized to stimulate any possible oral reflex.
Claim 1 recites “scoring the oral reflex response to produce a score” but tables 6-10 and paragraphs 0047-0056 of the specification recite that the scoring follows a specific scoring method and various different types of scoring are performed for the different reflexes. Furthermore, each reflex for each scoring type corresponds specific ranges and/or responses. Thus is would seem that the generation of any type of score for the oral reflex is not fully supported.
Claim 1 recites “analyzing the score to diagnose an oral dysfunction” however the specification does not appear to describe how the scores are analyzed to diagnose an oral dysfunction. In particular, paragraphs 0026, 0057, 0059-0061, and 0065-0067 each refer to the diagnosis of oral dysfunction but do not appear to detail how a user can take the provided scores and generate a diagnosis from them. Rather it would seem that, as recited in paragraph 0061, the scores are used to identify particular areas that require treatment rather than diagnosing the oral dysfunction itself. The above paragraphs merely recite this step in functional language and do not describe the particular steps taken to “analyze” the score and produce an oral dysfunction diagnosis. Moreover, the specification does not appear to explicitly describe how the different scores relate to different oral dysfunctions.
Claim 1 recites “providing a treatment protocol based on any diagnosed oral dysfunction” but the specification paragraphs 0061-0071 describes several physical therapy treatments which appear to be repeatedly trying to stimulate the reflex, and the treatment of Frenotomy. The specification does not provide sufficient support for the claimed score of providing any type of “treatment protocol” based on any diagnosed oral dysfunction.
Claim 2 recites “treating the subject to reduce the symptoms of oral dysfunction” but the specification paragraphs 0061-0071 describe particular physical therapy treatments and frenotomy. The specification does not support the claimed scope of any type of treatment to reduce oral dysfunction.
Claim 5 recites “evaluating the subject's oral posture” but the specification does not fully support the evaluation of oral posture using any technique. Rather the specification described a particular technique for evaluating the subject’s oral posture in paragraphs 0042-0044.
Claim 6 recites “evaluating the subject's oral tolerance to touch” but the specification does not fully support the evaluation of oral tolerance to touch using any technique. Rather the specification described a particular technique for evaluating the subject’s oral tolerance to touch in paragraphs 0037-0041.
Claim 9 recites “wherein the treatment protocol includes physical therapy before and after the frenotomy” but the specification does not fully support the use of any and all physical therapy exercises in combination with the frenotomy. In particular, the physical therapy exercises describe in the specification are limited to the oral muscles.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites “wherein the oral reflex score is less than 3” which is a limitation drawn to the outcome of the scoring step but the score being a particular value does not further limit the method itself as no explanation as to what this score value means or how it alters the later steps of the method.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-12 are directed to a method of evaluating and treating oral dysfunction using a computational algorithm, which is an abstract idea. Claims 1-12 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] stimulating an oral reflex response in the subject;
[B1] scoring the oral reflex response to produce a score
[C1] analyzing the score to diagnose an oral dysfunction
[D1] providing a treatment protocol based on any diagnosed oral dysfunction
These elements [A1]-[D1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper; and/or they involve methods of organizing human activity such as managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
Step 2A – Prong Two: Claim 1 recites no additional limitations beyond the abstract idea
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention are directed towards the testing, decision making, and treatment performed by a trained physician evaluating a patient.
Claims 2-12 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exception:
Claim 2: treating the subject to reduce the symptoms of oral dysfunction.
Claim 2 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “treating the subject to reduce the symptoms of oral dysfunction” is merely adding the words “apply it” to the judicial exception because the type of treatment being provided and how it relates to the diagnosed oral function is not particularly limited. Thus the limitation is merely stating that a diagnosed patient is then treated through any means.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) 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, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention are directed towards the testing, decision making, and treatment performed by a trained physician evaluating a patient.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 7, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barlow US Patent Application Publication Number US 2012/0209148 A1 hereinafter Barlow.
Regarding claim 1, Barlow discloses a method of treating an oral dysfunction in a subject, the method comprising:
a. stimulating an oral reflex response in the subject (Paragraphs 0041 and 0071: the orofacial stimulator inserted into the patient’s mouth);
b. scoring the oral reflex response to produce a score (Paragraph 0049: the spatiotemporal index (STI) value);
c. analyzing the score to diagnose an oral dysfunction (Paragraph 0050 and 0053: the STI value may be used to evaluate the non-nutritive suckling (NNS) pattern for organization); and
d. providing a treatment protocol based on any diagnosed oral dysfunction (Paragraph 0050 and 0053: determine the best course of therapy to treat the patient).
Regarding claim 2, Barlow discloses the method of claim 1. Barlow further discloses the method further comprising treating the subject to reduce the symptoms of oral dysfunction (Paragraphs 0050 and 0073: the therapy is intended to entrain the patient to generate organized NNS patterns).
Regarding claim 3, Barlow discloses the method of claim 1. Barlow further discloses the method, wherein the oral reflex is selected from gape, suck, thrust, right phasic bite, left phasic bite, left lateralization, and right lateralization (Paragraph 0008: the reflex of suck is being assessed).
Regarding claim 4, Barlow discloses the method of claim 1. Barlow further discloses the method wherein the stimulating is performed by an evaluator (Paragraph 0071: the user of the system inserts the stimulator device into the patient’s mouth and thus “performs” the stimulating by introducing the pacified into the user’s mouth).
Regarding claim 7, Barlow discloses the method of claim 1. Barlow further discloses the method wherein the treatment protocol includes physical therapy to strengthen the neural connection between the subject's brain and oral muscles (Paragraphs 0031, 0053, and 0057: the tactile stimulus therapy stimulates and entrains the suck central pattern generator and trigeminal nerve).
Regarding claim 11, Barlow discloses the method of claim 1. Barlow further discloses the method wherein the treatment protocol includes providing one to ten cues in a treatment session (Paragraph 0059: the nominal number of pulses in a desired therapeutic burst is six but the number is configurable)
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 nonobviousness.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow US Patent Application Publication Number US 2012/0209148 A1 hereinafter Barlow as applied to claim 1 above and further in view of Patterson US Patent Application Publication Number US 2020/0229750 A1 hereinafter Patterson.
Regarding claim 5, Barlow discloses the method of claim 1. Barlow fails to further disclose the method further comprising evaluating the subject's oral posture.
Patterson teaches an intraoral apparatus for evaluating oral function of a patient. The intraoral apparatus comprises a dental-engagement element configured to engage with one or more teeth of the patient. The intraoral apparatus additionally comprises an oral media configured to be positioned adjacent to a palate of the patient. The intraoral apparatus further comprises a plurality of sensors associated with the oral media (Abstract). Thus, Patterson falls within the same field of endeavor as Applicant’s invention.
Patterson teaches a device for evaluating the tongue of the patient including a tongue position (Paragraph 0029 the tongue position measurement of Patterson is considered analogous to oral posture).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the tongue measurement device of Patterson into the method of Barlow because the tongue measurement device of Patterson may provide Barlow with additional metrics with which to calculate disorganized NNS patterns and may provide useful metrics for evaluating treatment.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow US Patent Application Publication Number US 2012/0209148 A1 hereinafter Barlow as applied to claim 1 above and further in view of Thach et. al. “Quantitative Assessment of Oral Tactile Sensitivity in Pre-term and Term Neonates, and Comparison with Adults”, Published April 1976, retrieved from Wiley Online Library hereinafter Thach.
Regarding claim 6, Barlow discloses the method of claim 1. Barlow fails to further disclose the method further comprising evaluating the subject's oral tolerance to touch.
Thach teaches a tactile sensitivity test to stimulate ipsilateral movements of the tongue in infants (Abstract). Thus, Thach is reasonably pertinent to the problem at hand.
Thach teaches a tactile sensitivity test for infants (Abstract the tactile sensitivity test of Thach is considered analogous to an oral tolerance to touch).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the tactile sensitivity test of Thach into the method of Barlow because the tactile sensitivity test of Thach is useful for testing certain reflexes of the infant and such reflex tests may provide useful information for diagnosing and/or monitoring the treatment of disorganized NNS
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Barlow US Patent Application Publication Number US 2012/0209148 A1 hereinafter Barlow as applied to claim 1 above and further in view of Hill et. al. “A pilot study of non-nutritive suck measures immediately pre- and post-frenotomy in full term infants with problematic feeding”, published December 2022, retrieved from ScienceDirect, hereinafter Hill.
Regarding claim 8, Barlow discloses the method of claim 1. Barlow fails to further disclose the method wherein the treatment protocol includes a frenotomy.
Hill teaches a study to describe symptoms of problematic feeding in infants with tongue-tie, evaluate changes in non-nutritive suck measures before and after frenotomy, and examine tongue-tie severity with changes in non-nutritive suck patterning (Abstract: Introduction). Thus, Hill is reasonably pertinent to the problem at hand.
Hill teaches that NNS amplitude and burst duration decreased significantly post-frenotomy (Section 3.3 NNS dynamics). Thus Hill teaches that frenotomies may be an effective way to reduce certain NNS parameters.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to utilize the frenotomy taught by Hill as a treatment for NNS because Hill teaches that frenotomies can have a reducing effect for certain NNS parameters (Section 3.3 NNS dynamics) which may be desirable for certain NNS patients and thus may be an effective treatment option.
Regarding claim 9, Barlow in view of Hill teaches the method of claim 8. Barlow further discloses the method wherein the treatment protocol includes physical therapy (Paragraphs 0031, 0053, and 0057: the tactile stimulus therapy stimulates and entrains the suck central pattern generator and trigeminal nerve)
Barlow fails to further disclose the treatment protocol including physical therapy before and after the frenotomy.
An obvious variation of Barlow in view of Hill would be to utilize both physical therapy and frenotomy treatments for a patient. Such a variation would be obvious to try because there are a finite number of treatment options presented in Barlow in view of Hill. Barlow in view of Hill teaches or suggests treatment including physical therapy and frenotomy and there is no indication or teaching that would indicate that the use of both treatment types would cause an adverse effect on the patient. One of ordinary skill in the art would have a reasonable expectation of success when combining the treatments because they each target different sources of potential NNS. The physical therapy targets training the brain, nerve, and muscles while the frenotomy serves to free the tongue from tissue that is potentially restricting its movement. Thus, it would be obvious to try utilizing both treatments in any order including the use of physical therapy before and after a frenotomy.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow US Patent Application Publication Number US 2012/0209148 A1 hereinafter Barlow
Regarding claim 12, Barlow discloses the method of claim 11. Barlow further suggests the method wherein the treatment session is provided one to fifteen times per day.
Barlow at least suggests this limitation in paragraph 0074 which indicates that after a therapy session is complete the user may initiate another therapy session for the same patient. Thus Barlow contemplate repeated therapy sessions for a single patient. It is asserted that the exact number of therapy sessions provided per day is subject to routine optimization and experimentation and one of ordinary skill in the art would recognize that the particular number and frequency of therapy session is dependent upon a number of patient factors including severity of the condition and other existing conditions of the patient. The particular number, duration, and frequency of therapy sessions would be determined by a clinician or user based on the particular circumstances of the patient.
Claim 10 is not presently rejected over the prior art. None of the prior art teaches or reasonably suggests an oral reflex score of less than 3.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791