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 .
DETAILED ACTION
This office action is in response to applicant's reply filed on April 22, 2026.
Status of Claims
Amendment of claims 22, 36, 39, 44 and 52, cancellation of claims 35, 45-46 and 53, and addition of claims 55-59 is acknowledged.
Claims 22, 36-37, 39-44, 47-52 and 54-59 are currently pending and are the subject of this office action.
Claims 37 and 49-50 were withdrawn since do not encompass the elected species: Dravet Syndrome.
New claim 58 is withdrawn, since it does not encompass the elected species: Dravet Syndrome
Claims 22, 36, 39-44, 47-48, 51-52, 54-57 and 59 are presently under examination as they relate to Dravet Syndrome.
Priority
PNG
media_image1.png
196
348
media_image1.png
Greyscale
Rejections and/or Objections and Response to Arguments.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 103 (Modified Rejection Necessitated by Amendment).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1) Claims 22, 36, 39-44, 47-48 and 51-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ceulemens et. al. (US 2014/0329908) and Ceulemens et. al. (Poster presented at the 69th Annual Meeting of the American Epilepsy Society (December 2015), Philadelphia), in view of Wirrell; et. al. (Pediatric Neurology (March 2017) 68:18-34), Gioia et. al. (Child Neuropsychology (2002) 8:249-257), LeJune et. al. (Child Neuropsychology (2010) 16:182-201) and Slick et. al. (Child Neuropsychology (2006) 12:181-189). All references were cited in previous office actions.
For claims 22, 36, 39-41 and 51 Ceulemens (US publication) teaches a method of treating Dravet Syndrome (DS) comprising the administration of a composition comprising a therapeutically effective amount of fenfluramine or a pharmaceutically acceptable salt thereof over a period of time (see abstract and entire document), wherein the therapeutically effective amount is about 0.5 mg/kg/day (see [0053]) which anticipates the instantly required dose.
Ceulemens does not teach that the above “therapeutically effective amount” of fenfluramine necessary for the treatment of DS (about 0.5 mg/kg/day) also improves cognitive function in a patient suffering from DS. However, as mentioned above, the therapeutically effective amounts of fenfluramine disclosed by Ceulemens for the treatment of DS (about 0.5 mg/kg/day) anticipates the therapeutically effective amounts of fenfluramine required to improve cognitive function in the same patient population (patients with DS). The same amount (about 0.5 mg/kg/day) of the same drug (fenfluramine) administered to the same patients (Dravet syndrome patients) should have the same effects, whether the prior art was aware of it or not.
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the “therapeutically effective amounts” of fenfluramine disclosed in the method of the prior art (Ceulemens) are not the same as the “therapeutically effective amounts” of fenfluramine claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the “therapeutically effective amounts” of fenfluramine in the claimed method are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Ceulemens does not teach assessing cognitive function of the patient before and after treatment, wherein assessing is performed by performing at least one test of a cognitive function selected from the group consisting of BRIEF, GEC, etc.
However, Ceulemens (US publication) further teaches that Dravet syndrome patients are typically children under the age of 18 (see abstract). Dravet syndrome is a rare and catastrophic form of intractable epilepsy that begins in infancy. Initially the patient experiences prolonged seizures. In their second year, additional types of seizures begin to occur, and this typically coincides with a developmental decline, possible due to repeated cerebral hypoxia. This leads to poor development of language and motor skills (see [0033]).
Ceulemens (poster) also teaches a method of treating DS comprising the administration of a composition comprising fenfluramine. Ceulemens (poster) also teaches that DS is a therapy-resistant epilepsy syndrome that mainly affects children and also results in developmental delay and cognitive and behavioral problems.
None of the above references teaches “assessing cognitive function of the patient before the administration and assessing cognitive function of the patient after administration, wherein the assessments of cognitive function are performed by measuring at least one cognitive score of the patient with a test of cognitive function, wherein the test of cognitive function selected from the group consisting of: BRIEF GEC, etc.”
However, Wirrell teaches that DS is a distinctive, early-life epilepsy (see page 19, left column, first paragraph). Further, almost all DS patients develop intellectual disability. Abnormalities on the neurological examination are seen in most patients with time (i.e., a neurological function, see Table 2 on page 23). There was a strong consensus regarding the need for a formal developmental assessment just before starting school (see page 28 under comorbidities). They recommend routine survey development and behavior at clinic visits by a neurologist/epileptologist. Children should undergo formal developmental or cognitive assessment before starting school. Children should be assessed by speech, physiotherapy, and occupational therapy before school entry, etc. (see Table 4 on page 29). Routine questions regarding the development, behavior and gait concerns should be a part of the functional inquiry, starting at diagnosis. More formal developmental assessment before school entry can help in documenting areas that may require additional services and therapies to maximize their educational experience (see page 31, right column under comorbidities).
Further, Gioia teaches that the Behavior Rating Inventory of Executive Function (BRIEF) is a parent- and teacher-completed rating scale, developed to assess the everyday behavioral manifestations of children’s executive control functions (see page 249, left column).
LeJeune teaches that: the term “executive functioning” refers to a set of interrelated cognitive abilities and behaviors sub served by the prefrontal cortex and its extensive connections that allow individuals to purposefully identify goals to develop a plan toward obtaining goals, and to regulate behaviors, emotions and cognitions in the service of progressing toward these goals. Dysfunction of this system has been documented among children with a variety of neurodevelopmental conditions such as ADHD, autism spectrum disorders, as well as acquired neurologic insults such as traumatic brain injury (see page 182 and 183).
Finally, Slick teaches applying a BRIEF test to be completed by parents of children with intractable epilepsy (Dravet syndrome is a rare and catastrophic form of intractable epilepsy that begins in infancy, see Ceulemens US 2014/0329908 paragraph [0033]).
Before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to treat a child patient suffering from DS by first: administering a BRIEF test to the child patient and obtaining a first set of BRIEF scores as done by Slick, and as suggested by: Wirrell, wherein the cognitive and behavioral assessment consist of administering a BRIEF test, which according to Gioia and LeJune was specifically developed for children with cognitive/behavioral problems due to a variety of neurological diseases; then administering fenfluramine in order to treat the epileptic seizures of DS patient as taught by Ceulemens, and then further assess with a second BRIEF test and compare the cognitive/behavioral status of the patient during treatment as suggested by Wirrell and because Ceulemens teaches that there is a developmental decline, which means that there is a cognitive deterioration through time.
The prior art is silent regarding “improving cognitive function”. However: “improving cognitive function” will naturally flow from the method made obvious by the prior art (see above rejection), since the same compound (fenfluramine) is being administered to the same subjects (patients suffering from Dravet Syndrome that have been diagnosed with cognitive impairment). In other words, products of identical composition cannot exert mutually exclusive properties when administered under the same circumstances.
In other words, even though the prior art is silent regarding “improving cognitive function”, by practicing the method made obvious by the prior art: “the administration of fenfluramine to patients suffering from Dravet Syndrome (that have been diagnosed with cognitive impairment)", one will also be “improving cognitive function”, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("improving cognitive function”) of the method made obvious by the prior art (“the administration of fenfluramine to patients suffering from Dravet Syndrome that have been diagnosed with cognitive impairment)”.
MPEP 2145 II states: “The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious”. Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
The prior art is silent regarding the statement in claim 39: “wherein at least one cognitive score increased by 10% or more between the assessing before administration and the assessing after administration”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “the administration of fenfluramine to patients suffering from Dravet Syndrome (that have been diagnosed with cognitive impairment), further comprising assessing cognitive function of the patient before the administration and assessing cognitive function of the patient after administration, wherein the assessments of cognitive function are performed with a test of cognitive function selected from the group consisting of: Brief, GEC, etc.”
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”
In the instant case ““wherein at least one cognitive score increased by 10% or more between the assessing before administration and the assessing after administration,” appears to be the result of the process made obvious by the prior art: “the administration of fenfluramine to patients suffering from Dravet Syndrome (that have been diagnosed with Cognitive impairment), further comprising assessing cognitive function of the patient before the administration and assessing cognitive function of the patient after administration, wherein the assessments of cognitive function are performed with a test of cognitive function selected from the group consisting of: Brief, GEC, etc.", e. g. the intended result of a process step positively recited.
All this will result in the practice of claims 22, 36, 39-41 and 51 with a reasonable expectation of success.
Ceulemens teaches all the limitations of claim 42-43, except for the treatment lasting at least 3 months or at least 14 weeks.
However, Ceulemens (Poster) teaches that patients suffering from DS have been treated with fenfluramine from 1 to 19 years (i.e., at least 3 months or at least 14 weeks, see introduction), further Ceulemens (Poster) teaches that the median duration of dosing fenfluramine was 0.9 years (i.e., 10.8 months, see under “Details of FFA dosing are presented in Table 2).
The prior art is silent regarding the statement in claims 42 and 43: “wherein increase by 10% or more in at least one cognitive score is an increase in at least one BRIEF score of 25% or more”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “the administration of fenfluramine to patients suffering from Dravet Syndrome that have been diagnosed with Dravet Syndrome, further comprising assessing cognitive function of the patient before the administration and assessing cognitive function of the patient after administration, wherein the assessments of cognitive function are performed with a test of cognitive function selected from the group consisting of: Brief, GEC, etc., wherein the treatment lasts for a period of at least 3 months or 14 weeks”
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”
In the instant case “wherein increase by 10% or more in at least one cognitive score is an increase in at least one BRIEF score of 25% or more,” appears to be the result of the process made obvious by the prior art: “the administration of fenfluramine to patients suffering from Dravet Syndrome (that have been diagnosed with Dravet Syndrome), further comprising assessing cognitive function of the patient before the administration and assessing cognitive function of the patient after administration, wherein the assessments of cognitive function are performed with a test of cognitive function selected from the group consisting of: Brief, GEC, etc., wherein the treatment lasts for a period of at least 3 months or 14 weeks", e. g. the intended result of a process step positively recited.
All this will result in the practice of claims 42-43 with a reasonable expectation of success.
For claim 44, Ceulemens teaches the administration of about 0.5 mg/kg/day (See [0053]), wherein fenfluramine is formulated with a pharmaceutically acceptable carrier (See [0055]), thus resulting in the practice of claim 44 with a reasonable expectation of success.
For claims 47-48, Ceulemens further teaches the administration of a co-therapeutic like: Stiripentol (See [0056]), thus resulting in the practice of claims 47-48 with a reasonable expectation of success.
For claim 52, Ceulemens teaches the administration of about 0.5 mg/kg/day (See [0053]), wherein fenfluramine is formulated with a pharmaceutically acceptable carrier (See [0055]), thus resulting in the practice of claim 52 with a reasonable expectation of success.
For claim 59, Ceulemens (Poster) teaches that patients suffering from DS have been treated with fenfluramine from 1 to 19 years (see introduction), further Ceulemens (Poster) teaches that the median duration of dosing fenfluramine was 0.9 years (i.e., 10.8 months, see under “Details of FFA dosing are presented in Table 2).
As such, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to continue the treatment by continuing the administration of fenfluramine until it was determined that the treatment of DS was successful and assessing cognitive function all along the treatment, since as explained above, cognitive measurements of DS patients is common practice in the pharmaceutical/medicinal art.
The phrase: “whether the increased score increased by more than 10% due to continuing treatment” does not require any active steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “the administration of fenfluramine to patients suffering from Dravet Syndrome that have been diagnosed with Dravet Syndrome, further comprising assessing cognitive function of the patient before the administration and assessing cognitive function of the patient after administration, wherein the assessments of cognitive function are performed with a test of cognitive function selected from the group consisting of: Brief, GEC, etc.”
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”
In the instant case “whether the increased score increased by more than 10% due to continuing treatment,” appears to be the result of the process made obvious by the prior art: “the administration of fenfluramine to patients suffering from Dravet Syndrome (that have been diagnosed with Dravet Syndrome), further comprising assessing cognitive function of the patient before the administration and assessing cognitive function of the patient after administration, wherein the assessments of cognitive function are performed with a test of cognitive function selected from the group consisting of: Brief, GEC, etc.", e. g. the intended result of a process step positively recited.
All this will result in the practice of claim 59 with a reasonable expectation of success.
2) Claims 54-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ceulemens et. al. (US 2014/0329908) and Ceulemens et. al. (Poster presented at the 69th Annual Meeting of the American Epilepsy Society (December 2015), Philadelphia), in view of Wirrell; et. al. (Pediatric Neurology (March 2017) 68:18-34), Gioia et. al. (Child Neuropsychology (2002) 8:249-257), LeJune et. al. (Child Neuropsychology (2010) 16:182-201) and Slick et. al. (Child Neuropsychology (2006) 12:181-189) as applied to claims 22, 36, 39-44, 47-48 and 51-52 above, further in view of Busner et. al. (Psychiatry (July 2007) 29-37), Jonas et. al. (WO 2006/034465, March 2006), Miller et. al. (WO 2013/112363, August 2013), Glass et. al. (WO 2015/013397, January 2015) and During (US 2018/0221319). All references were cited in previous office actions.
The prior art teaches all the limitations of claims 54-57, except for the test of cognitive function being Clinical Global Impression (CGI).
However, Busner teaches that CGI is a well-established research training tool applicable to all psychiatric disorders that can easily be used by the practicing clinician to meet this need (See under introduction). The CGI scale can track patient progress and treatment response over time (See abstract). The CGI provides an overall clinician-determined summary measure that considers all available information, including a knowledge of the patient’s history, psychological circumstances, symptoms, behavior, and the impact of the symptoms on the patient’s ability to function. The CGI has two components: the CGI-severity which rates illness severity and the CGI-improvement, which rates change from the initiation of treatment. For the past 30 years, the CGI has been shown to correlate well with standard, well-known research drug efficacy scales across a wide range of psychiatric indications (See under What is the CGI?). For researchers the CGI has extraordinary utility. It is applicable across all CNS studies, no matter the population, drug, or other main measures. It provides ready recognizable and universally known efficacy measure that distinguishes it from the more complex, lengthier, and sometimes difficult to administer efficacy scales (see under Can the CGI be used in Clinical Practice?)
Further, CGI has been extensively used in cases where children or adults were suffering from diseases that cause development disorders, behavioral disorders, learning disabilities, etc. For example: Jonas teaches that CGI scale was used to evaluate children with behavioral disorders that include among others: learning disabilities and pervasive developmental disorders (see page 1 under Childhood Disorders, and see page 15, Second paragraph).
Miller teaches a method of assessing the progress of patients being treated for Tourette’s Disorder (TD), which is a childhood neuropsychiatric disorder characterized by multiple motor and vocal ties that is associated with considerable disability and reduction in quality of life (See [06]). The progress of the treatment was assessed using the CGI scale (see for example page 13 d), see also page 32 d).
Glass teaches a method of assessing the progress of patients being treated for Autism Spectrum Disorders, which are a collection of linked developmental disorders, and for neurodevelopmental disorders (See pages 1 and 2, under background). The progress of the treatment was assessed using the CGI scale (see page 10, lines 20-24).
Finally, During teaches a method of assessing the progress of patients being treated with seizure disorders. Cognitive function may be measured by the CGI of change scale (see [0051]).
Before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to treat a child patient suffering from DS by first: assessing a CGI of the patient and obtaining an initial set of scores as suggested by: Busner, Jonas, Miller, Glass and During for children with similar developmental/cognitive/behavioral issues; then administering fenfluramine in order to treat the epileptic seizures of DS patient, as taught by Ceulemans, and then further assess with a second CGI test and compare the cognitive/behavioral status of the patient during treatment as suggested by Busner and continue the treatment until the patient shows an improvement in the CGI score.
The statement: “wherein the assessing after the treating shows a clinically meaningful improvement comprising an improvement of Much Improved or Very Much Improved in at least one Clinical Global Impression of Improvement (CGI-I) score compared to the assessment before the treating” does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “the administration of fenfluramine to children suffering from DS and that are being assessed by a CGI test".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein the assessing after the treating shows a clinically meaningful improvement comprising an improvement of Much Improved or Very Much Improved in at least one Clinical Global Impression of Improvement (CGI-I) score compared to the assessment before the treating” appears to be the result of the process made obvious by the prior art: ““the administration of fenfluramine to children suffering from DS and that are being assessed by a CGI test", e. g. the intended result of a process step positively recited. As such, this limitation in the instantly claimed method has not been given any weight.
All this will result in the practice of claims 54-57 with a reasonable expectation of success.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Applicant argues that:
The Office has not articulated a negative effect that was caused by lack of a cognitive assessment after the treating. Stated in another manner, even if a skilled artisan performed both cognitive assessments, the Office has not articulated what value that knowledge would produce. Applicant contends that simply such gaining knowledge by itself cannot be reasonably interpreted as a benefit to the skilled artisan. For example, the Office did not name any treatment decision that would be influenced by knowledge regarding cognitive function progress.
Examiner’s response:
Performing a cognitive test in an individual suffering from DS is invaluable since according to Wirrell more formal developmental assessment before school entry can help in documenting areas that may require additional services and therapies to maximize their educational experience (see page 31, right column under comorbidities). So, the lack of a cognitive assessment will prevent adjusting additional services and therapies that could improve the educational experience of a DS patient.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached on Flexing M-F 7 AM-7 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, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
April 28, 2026.
Prosecution Insights