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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 9, 2025 has been entered.
Priority
The present Application, filed January 11, 2022, is a divisional of U.S. Patent Application No. 17/102,759, filed November 24, 2020, which claims priority to International Patent Application Publication No. PCT/US2020/041736 filed July 12, 2020, which claims the benefit of U.S. Provisional Patent Application No. 62/873,813, filed July 12, 2019.
Status of the Claims
In the amendment filed October 9, 2025, claims 2-3 and 11 are canceled and new claims 14-22 are added. Claims 1, 4-10, and 12-22 are currently pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 9, 2025 is acknowledged
Previous Rejections and/or Objections
Any objections and/or rejections raised in the previous Office Action but not reiterated below are considered to have been withdrawn.
Claim Rejections - 35 USC § 112(b) – Maintained -Slightly Modified in View of Amendment
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.
Response to Applicant’s Remarks on Previous Rejections for Indefiniteness:
The cancelation of claims 2-3 obviate the previous rejections of these claims under 35 U.S.C. § 112(b) for indefiniteness.
With respect to the rejection of claim 1 for indefiniteness, the amendment to claim 1 changes the terms of the rejection somewhat, but the rejection remains largely intact. Applicant has replaced the indefinite phrase “cholinergic neuronal loss” with the nearly equivalent “loss of choline acetyltransferase (ChAT)-positive neurons, and cites paragraphs [0014] and [0041]-[0042] and Figures 2A-2B of the instant specification as exemplifying identification of inhibition of loss of ChAT-positive neurons (see pg. 6, final paragraph of Applicant’s Remarks of October 9, 2025).
Paragraph [0014] references stereological quantification of ChAT+ neurons, and Figure 2A appears to show representative histological images from mice brains on which the stereological quantification was based (although the images could be derived from an alternative modality, such as MRI; this is not elaborated). Presumably claim 1 does not require histological examination of the brains of subjects of the claimed method. Indeed, it is unclear whether the claim requires any specific examination or confirmation of the extent of inhibition of loss of ChAT+ neurons. Claim 1 is indefinite at least because this question is unclear.
And if claim 1 does not require any such examination or confirmation, then “inhibiting loss of ChAT+ neurons” would seem to simply mean the method is believed, in general, to have this effect, although not necessarily on the subject at hand. In that case, “loss of ChAT+ neurons” would seems to be essentially equivalent to the previous “cholinergic neuronal loss,” as a functional descriptor that is ultimately qualitative and indefinite. Thus, while the precise reasoning for finding claim 1 indefinite is somewhat altered, claim 1 remains indefinite, as described further, below.
With respect to the rejection of claim 4, Applicant notes that the claim was incorrectly cited in the Office Action of December 9, 2024 as reciting that cholinergic neuronal loss is “detectable by clinical expression of pathology,” whereas it actually recites that “administration results in improvement of clinical expression of pathology.” While a valid correction, this does not fundamentally change the rejection, because claim 4, correctly cited, is of the same form as claims 5-10, which were rejected in the Office Action of December 9, 2024 as being “indefinite for reciting ‘wherein the administration results in’ various specified symptomatic improvements,” (pg. 4 of the Office Action of December 9, 2024, final paragraph). Applicant’s Remarks do not appear to directly address these rejections, and they remain reiterated, below.
Applicant’s Remarks do address the rejection of claim 11, made on substantially the same grounds, for being indefinite by virtue of reciting an intended result, devoid of patentable weight. Applicant asserts that, “[c]laim 11, as presently amended, requires that "loss of ChAT-positive neurons in the medial septum is inhibited," (pg. 7 of Applicant’s Remarks, second paragraph). However, claim 11 is canceled in Applicant’s most recent amendment.
To the extent that the arguments seemingly applied to canceled claim 11 are meant to be applicable to rejected claims 4-10, Applicant’s arguments here (pg. 7, second paragraph through pg. 8, second full paragraph of Applicant’s Remarks of October 9, 2025) largely echo those made in Applicant’s Remarks of August 26, 2024 pertaining to rejections of claims 2-10 (as pending at that time) for indefiniteness (see pgs. 6-7 of Applicant’s response of August 26, 2024). In short, Applicant reasserts that the alleged intended result must be given patentable weight according to the ruling of L'Oreal USA, Inc. v. Olaplex, Inc., 844 Fed. App'x 308 (Fed. Cir. 2021). As with the Final Rejection of December 9, 2024, This argument has been fully considered but is found unpersuasive.
As Applicant notes, the court in L’Oreal described two factors that caused the claims at issue to carry patentable weight, and to not describe mere intended results. These were that the alleged intended results (i) require specific, quantitative outcomes, i.e. they “state specific requirements rather than a general purpose or aspirational result for the claimed method; and (ii) are the only limitations in dependent claims, such that if they are not given patentable weight, entire claims are nullified. While the instant claims at issue arguably meet the second of these criteria, they do not meet the first.
For example, whereas the claims at issue in L’Oreal recite e.g. that breakage of hair is decreased by at least 5%, etc., the instant claims at issue recite that administration results in improvement in various symptoms or indicia of disease progression (e.g. improvement in clinical expression of pathology – claim 4). These do not appear to be specific quantitative outcomes, as required in L’Oreal, but rather general purposes.
Further to this point, claims 4-10 provide no threshold of what constitutes a genuine improvement beyond random variation nor, in several cases, how such improvement is defined or detected. For the reasons above, claims 4-10 are regarded as reciting intended purposes, without patentable weight.
Claims 1, 4-10, and 15-20 are indefinite:
Claims 1, 4-10, and 15-20 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 is indefinite for reciting “administering to the human an effective amount of neflamapimod to inhibit loss of ChAT-positive neurons,” because one of ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. As a first matter, it would be unclear whether this outcome must be achieved in the subject being treated, or whether administration must be shown to be effective to achieve this result in some subjects.
As noted above, these portions of the specification appear to describe a histological examination that cannot plausibly be individually applied to subjects of the instant method. In short, it would be unclear (i) whether claim 1 requires some determination for the individual patient that the administration actually resulted in inhibition of loss of ChAT+ neurons, (ii) if so, how such determination would be made, including what would be the baseline for evaluating inhibition, or (iii) alternatively whether the claim merely refers to a general belief, based on previous studies, that the method should, will, or might result in the claimed inhibition. For all of these reasons, this element of claim 1 is indefinite. Claims 4-10 and 12 are indefinite for depending from claim 1 without curing this indefiniteness.
Claims 4-10 are further indefinite, and claims 15-20 are indefinite, for reciting “wherein the administration results in” various specified symptomatic improvements. “A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Minton v. Nat'l Ass'n. of Sec. Dealers, 336 F.3d 1373, 1381 (Fed. Cir. 2003 – emphasis added to quotation). See also MPEP § 2111.04(I), further explaining that this ruling is not limited to the term “whereby” but applies to functionally equivalent clauses with terms such as “adapted to” or “wherein.”
Claim Rejections-- 35 USC § 102 – Modified in View of Amendments
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 and 14 are anticipated by Alam1:
Claims 1 and 14 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by International Patent Application Publication No. WO2016/007616 to Alam (hereinafter, “Alam1”).
Response to Applicant’s Remarks on Previous Rejections for Anticipation:
With respect to the claim construction and rejections for obviousness in the previous Office Action, Applicant presents arguments in the Remarks of October 9, 2025 that are highly similar to previous arguments (e.g. in Applicant’s Remarks of August 26, 2024). Applicant first argues that the asserted intentional purpose of amended claim 1 of “inhibiting loss of ChAT-positive neurons” must be given patentable weight and that none of the cited references teach this intentional purpose, in part because the claim has a “call back” to the element in the form of reciting “treating the subject in need thereof” (pg. 9 of Applicant’s remarks, section A.). To this point, Applicant cites a trio of cases: Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003); Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001); and Eli Lilly & Co. v. Teva Pharms. Int'l GmbH, 8 F.4th 1331, 1337 (Fed. Cir. 2021) – see the entirety of section A of Applicant’s remarks. These arguments have been fully considered, but are not found persuasive.
As pointed out in the Final Office Action of December 9, 2024, the present claims are regarded as being more analogous to Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368. Applicant asserts that the analysis in the Final Office Action of December 9, 2024 is in error, in part because “Jansen requires, as a matter of claim construction, that the preamble be construed as ‘a statement of the intentional purpose for which the method must be performed,’” (emphasis in Applicant’s Remarks). This is understood as suggesting that the question whether an intended result/purposeful intent carries patentable weight is fundamentally a question of form, and not of substance. According to this view, seemingly, as long as the form follows a prescribed setup, it does not matter whether intended result/purposeful intent that is recited in a method claim has any effect on the manner in which the method is performed.
To this point, Applicant asserts that the Final Office Action incorrectly relied on Bristol-Myers because the claim in Bristol-Myers does not recite “a subject in need thereof,” or equivalent. Inversely, Applicant appears to assert that the element at issue in the claim of Rapoport does not alter the patient population. However, as noted in the Final Office Action, the Court in Bristol-Myers explicitly held that the functional language at issue “is only a statement of purpose and intended result. The expression does not result in a manipulative difference in the steps of the claim,” thus emphasizing this absence of effect on the manner in which the method is performed as the critical factor in finding absence of patentable weight.
In Rapoport, contrary to Applicant’s suggestion, the Court did find that the element at issue in the contested claim limited the patient population to those experiencing sleep apnea. For example, the Court noted that such treatment is consistent with treatment of “the underlying sleep apnea disorder, which by definition manifests itself during sleep, and inconsistent with treatment of anxiety [treatment of which is taught by the prior art] and other symptoms commonly associated with sleep apnea, which would obviously manifest themselves while a patient is awake.” While somewhat overlapping, sleep apnea and anxiety are indisputably not the same condition and do not imply identical patient populations. In contrast, in the present case, loss of ChAT+ neurons is a fundamental manifestation of DLB (see, for example, the non-patent publication, Depletion of cholinergic neurons in the nucleus of the medial septum and the vertical limb of the diagonal band in dementia with Lewy bodies, Acta Neuropathol., 111, pgs. 109-114 (2006) by Fujishiro et al.), and there is no evidence of record to suggest that there is any difference between the patient populations of: (i) subjects having DLB generally, and (ii) subjects having DLB who would benefit from inhibition of loss of ChAT+ neurons. As such, the patient population in instant claim 1 is defined by those having Dementia with Lewy Bodies, and the recited treatment is in no way different from the treatment of the same patient population as taught by Alam1.
As such, as in Bristol-Myers, and unlike Rapoport et al., the recitation at issue (inhibiting loss of ChAT+ neurons) does not result in a manipulative difference in the steps of the method, whether in selection of patient population or in any other respect. For this reason, patentable weight is not afforded to the intended result of the method that is recited in the preamble and repeated in the claim body.
In section B., Applicant asserts that the Final Office Action did not identify anything in the cited art that expressly teaches an expectation that neflamapimod administration would ameliorate loss of ChAT+ neurons. To this point, Applicant further notes that the practice of finding inherency in obviousness analyses is circumscribed by the courts. This point has been fully considered, but is not found persuasive with respect to overcoming the prior art rejections. Given that patentable weight is not afforded to the element of inhibiting loss of ChAT+ neurons, as discussed above, it is not necessary to find this element in the art. Moreover, claim 1 is rejected for anticipation, not for obviousness, claim 1 being most relevant to the inherency of inhibiting loss of ChAT+ neurons.
Applicant then notes that the Declaration of Dr. Kjell Svensson, filed December 27, 2022 notes that DLB was recognized as particularly difficult to treat. This note is seemingly directed to questioning the conclusion that the teaching in Alam1 of a method to treat Lewy Body Dementia (LBD) is a teaching of a method to treat Dementia with Lewy Bodies (DLB). However, Dr. Svensson’s observation regarding the difficulty of treating DLB, as noted in the Final Office Action, does not overcome the fact that LDB is an umbrella term consisting of precisely two conditions and DLB is one of them.
Finally, in section B, Applicant asserts that the interpretation of Alam1 in the Final Office Action is flawed, because the second Declaration of Dr. Svensson, filed August 26, 2024 indicates that Alam1 teaches administering neflamapimod at a dose insufficient to product an anti-inflammatory effect. It is true that Alam1 teaches administration of neflamapimod at doses insufficient to induce an anti-inflammatory effect, in some embodiments. However, as noted at paragraph [0049], Alam1 also teaches embodiments in which neflamapimod is administered in an amount “sufficient” to inhibit cytokine signaling. Applicant misstates that the Final Office Action relies on paragraph [0023] for this. The Final Office Action relies on paragraph [0049], which expressly teaches it. Paragraph [0023] is merely cited in support of the tautology that, because cytokines are inflammatory, inhibition of cytokine signaling is intrinsically anti-inflammatory.
In short, there is no need for Alam1 to expressly create an expectation that neflamapimod would inhibit loss of ChAT+ neurons, because there is no manipulative difference, including patient population selection, between the method expressly taught by Alam1 and the method recited in instant claim 1.
In section C., Applicant argues that the cited art does not teach or suggest the goal of inhibiting loss of cholinergic (ChAT+) neurons, because it was not known as an obvious therapeutic goal in the treatment of DLB. This is highly similar to the point of section B., and it has been fully considered but is not found persuasive. It can be acknowledged that Applicant has made a novel discovery in the mechanism by which DLB pathology progresses, but such as discovery, by itself, does not equate to a novel invention. Applicant quotes MPEP § 2101.2(III) as stating that a patentable invention may lie in the discovery of the source of a problem even though the remedy may be obvious once the source of the problem is identified. This is true, but a patentable invention is not necessarily found in the discovery of a problem when the solution to the problem was already known. In the present case, the claimed method of inhibiting loss of ChAT+ cells in a subject having DLB is precisely the same as the already-known method of treating DLB. The fact that the practitioner of the method may have a newly-acquired understanding that the method inhibits neuronal loss does not, in and of itself, make the method new.
In section D., Applicant notes that the instant claims require a step of identifying a human having Dementia with Lewy Bodies as the subject for treatment with neflamapimod in order to inhibit loss of ChAT-positive neurons. Applicant asserts that the cited prior art, particularly Alam1, fails to teach this feature. This argument has been fully considered, but is not found persuasive.
Applicant repeats here the argument that Alam1 teaches treatment of LBD, but not treatment of DLB. That argument has been discussed above, and previously in the prosecution of this case (see, for example, the Final Office Action of December 9, 2024). Applicant appears to further argue that Alam1, in particular, does not teach the step of “identifying a human having Dementia with Lewy Bodies” as the subject to whom neflamapimod is administered. It is true that Alam1 does not expressly discuss a step of “identifying a human having Dementia with Lewy Bodies,” however such a step is inherently present in the step of administering neflamapimod to a human having DLB.
To that point, the instant specification, including the originally filed claims, makes no reference to a step of “identifying a human having Dementia with Lewy Bodies” The specification discusses inclusion criteria applied to a clinical study, but it does not address a specific step of “identifying a human having DLB” as part of a claimed method. In both cases (the instant specification and Alam1), such a step is inherently present in the method, and one of skill in the art would understand how to identify/provide a person having DLB for administration. For this reason, the absence of an explicit reference to “identifying a human having Dementia with Lewy Bodies” is not regarded as undermining the anticipation rejection.
Applicant further discusses Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368 (Fed. Cir. 2005), asserting that Perricone, stands for the proposition that disclosure of a genus (treatment of Lewy Body dementia) does not disclose a species within that genus (treatment of DLB). This is an overly broad reading of Perricone, and it stands in contravention of established law. ‘Whether a generic disclosure necessarily anticipates everything within the genus … depends on the factual aspects of the specific disclosure and the particular products at issue.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1083, 89 USPQ2d 1370, 1375 (Fed. Cir. 2008). See also Osram Sylvania Inc. v. American Induction Tech. Inc., 701 F.3d 698, 706, 105 USPQ2d 1368, 1374 (Fed. Cir. 2012) (“how one of ordinary skill in the art would understand the relative size of a genus or species in a particular technology is of critical importance”).
In the present case, the expressly disclosed genus to be treated in Alam1, Lewy Body Dementia, has precisely two species: (i) Dementia with Lewy Bodies, and (ii) Parkinson’s Disease Dementia (PDD). From the disclosure of LBD, one of skill in the art would of course “at once envisage” (In re Petering, 301 F.2d 676 (CCPA 1962)) each of the sole two species that the term encompasses. In short, because the genus of LDB disclosed by Alam1 is, essentially, the smallest possible genus (consisting of two and only two species) its disclosure amounts to a disclosure of each of its species.
The rejection, while slightly modified in view of the amendment, is maintained.
Reiterated rejection:
Claim 1 recites a method of inhibiting loss of ChAT+ neurons in a subject having Dementia with Lewy Bodies, the method comprising treating the subject in need thereof with neflamapimod, wherein said treating comprises (a) identifying a human having Dementia with Lewy Bodies and (b) administering to the human an effective amount of neflamapimod to inhibit loss of ChAT+ neurons.
Claim 14 recites a method of slowing progression of Dementia with Lewy Bodies (DLB) in a subject, the method comprising treating the subject in need thereof with neflamapimod, wherein said treating comprises identifying a human having DLB and (b) administering to the human an effective amount of neflamapimod to slow progression of DLB. Of note, new claim 14 is nearly identical to claim 1 as amended on September 29, 2023, until its reamendment of December 22, 2023.
Alam1 teaches a method of treating a neurologic disorder, the method comprising administering to a patient (i.e. a subject) in need thereof a dose of VX-745 (Abstract), and specifies that the patient can be a human (paragraph [0013]). VX-745 is neflamapimod (see, e.g. the non-patent publication, Neflamapimod: Clinical Phase 2b-Ready Oral Small Molecule Inhibitor Of P38α To Reverse Synaptic Dysfunction In Early Alzheimer’s Disease, J. Prev. Alz. Dis., 4, pgs. 273-278 (2017) by Alam et al. Alam1 also teaches that the method can include administering to a patient/subject a therapeutically effective amount of VX-745 sufficient to inhibit cytokine signaling (paragraph [0049]), and that, because cytokines are pro-inflammatory, this inhibition is an anti-inflammatory effect (paragraph [0023]). Alam1 further teaches that the neurological disorder can be Lewy Body Dementia (paragraph [0030]). As discussed above in the response to Applicant’s arguments, the neurological disorder/category of Lewy Body Dementia as taught by Alam1 intrinsically includes the specific disease, Dementia with Lewy Bodies, as recited by instant claim 1.
Alam1 thus teaches treating a subject having Dementia with Lewy Bodies, the treating the subject with neflamapimod, wherein the treatment comprises administering to a human an effective amount of neflamapimod. While Alam1 does not explicitly teach that the method is performed for the intended purpose of inhibiting loss of ChAT+ neurons in the subject having DLB, the method as taught by Alam1 inherently would achieve this purpose and, for the reasons discussed above, the intention of inhibiting loss of ChAT+ neurons by itself does not distinguish from the method of Alam1 since it does not tangibly affect the manner of performing the method, including the patient population.
Similarly, while Alam1 does not explicitly teach that the method is performed for the intended purpose of slowing progression of DLB, the method as taught by Alam1 inherently would achieve this purpose and, for the reasons discussed above, the intention of slowing progression of DLB by itself does not distinguish from the method of Alam1 since it does not tangibly affect the manner of performing the method, including the patient population.
Furthermore, Alam1 does not explicitly teach a separate step of identifying a human having DLB. Because no particular means of identifying such a human is recited in the instant claims, or described in the instant specification, the identifying step is construed generally as equivalent to “providing” a human having DLB. Such an act of identifying or providing a human having DLB is inherently present in the method of Alam1, because the human having DLB must be provided in order to be administered the neflamapimod.
Claim Rejections - 35 USC § 103 – Modified in View of Amendments
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.
Claims 6 and 17 are unpatentable over Alam1 and Fritz:
Claims 6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Alam1, in view of the non-patent publication, Motor performance differentiates individuals with Lewy body dementia, Parkinson’s and Alzheimer’s disease, Gait & Posture, 50, pgs. 1-7 (2016) by Fritz et al. (hereinafter, “Fritz”).
Claim 6, depending from claim 1, recites wherein mobility is assessed by the Timed Up and Go (TUG) Test and, as noted above with respect to the rejections under 35 U.S.C. 112b, is construed for examination purposes as reciting a step of assessing mobility by the TUG Test. Claim 17, depending from claim 14, recites the same additional feature
Alam1 is applied to claims 6 and 17 as to claims 1 and 14, above, but these references do not explicitly teach assessing mobility in a DLB patient by the TUG Test. It would have been obvious to one of ordinary skill in the art to assess mobility in a DLB patient by the TUG Test, because it was well-known in the art that the TUG test was useful for evaluating physical ability/deterioration in Dementia with Lewy Bodies. See, for example, Fritz.
Fritz teaches evaluation of motor ability in patients having various neurological disorders, including DLB (Abstract). Fritz teaches twenty-one patients having DLB (Table 1) were evaluated by the TUG test, as well as a combined TUG-cognitive test and shown to have inferior scores in comparison to patients with non-Lewy Body Dementias (pg. 4, left column, first paragraph). It would have been obvious to use the TUG test, as taught by Fritz, to evaluate mobility in DLB patients in the method of Alam1.
Claims 9 and 20 are unpatentable over Alam1 and Kung:
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Alam1, in view of the non-patent publication, Behavioural and Cognitive Changes in Lewy Body Dementias, Behav. Neurobiol., 2018, Article ID 2404191 (2018) by Kung et al. (hereinafter, “Kung”).
Claim 9, depending from claim 8, recites wherein dementia is assessed by Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) and, as noted above with respect to the rejections under 35 U.S.C. 112b, is construed for examination purposes as reciting a step of assessing dementia by the CDR-SB Test. Claim 20, depending from claim 14, recites the same additional element.
Alam1 is applied to claims 9 and 20 as to claim 1 and 14, above, but these references do not explicitly teach assessing dementia in a DLB patient by CDR-SB. It would have been obvious to one of ordinary skill in the art to assess dementia in a DLB patient by the CDR-SB, because it was well-known in the art that CDR-SB was useful for evaluating dementia in Dementia with Lewy Bodies. See, for example, Kung.
Kung reviews various aspects in the state-of-the-art in DLB research, and teaches, inter alia, that higher Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) are an associated risk factor of progression (first page, left column, fourth paragraph). It would have been obvious to use CDR-SB, as taught by Kung, to evaluate progression of dementia in DLB patients in the method of Alam1.
Claims 12-13 and 21-22 are unpatentable over Alam1 and Alam2:
Claims 12-13 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Alam1, in view of the non-patent publication, Neflamapimod: Clinical Phase 2b-Ready Oral Small Molecule Inhibitor Of P38α To Reverse Synaptic Dysfunction In Early Alzheimer’s Disease, J. Prev. Alz. Dis., 4, pgs. 273-278 (2017) by Alam et al. (hereinafter, “Alam2”).
Claim 12, depending from claim 1, recites wherein at least 120 mg per day of neflamapimod is administered, while claim 13, depending from claim 12, recites wherein neflamapimod is administered as a unit dose of 40 mg three times per day. Claims 21 and 22, depending from claim 14, recite the same elements as claims 12 and 13, respectively.
Alam1 is applied to claims 12 and 21 as to claims 1 and 14 above, but these references do not explicitly teach the dosing regimens recited in claims 12-13 and 21-22. It would have been obvious to one of ordinary skill in the art to assess dementia in a DLB patient by the CDR-SB, because these dosing regimens for neflamapimod were known in the art to be safe and effective. See, for example, Alam2.
Alam2 reports a clinical trial of neflamapimod on Alzheimer’s disease (Abstract). With respect to claim 12, Alam2 teaches 125 mg doses twice daily. With respect to claim 13, Alam2 teaches a 40 mg dose twice daily (pg. 275, right column, first paragraph). While Alam2 teaches these doses for treatment of Alzheimer’s disease and not explicitly for DLB, Alam2 teaches that these doses are safe and effective. Any modifications useful for treating DLB as opposed to Alzheimer’s would be a matter of routine optimization. Similarly, while claim 13 recites three daily doses of 40 mg and Alam2 explicitly teaches two doses of 40 mg, this would likewise be a matter of routine optimization, particularly as in the instant case where there is no showing that the recited dose is critical for the recited function. As such, it would have been obvious to use the safe and effective dosages taught by Alam2, or routine variations thereof, for administering neflamapimod to DLB patients in the method of Alam1.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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 mailing date of this final action.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629