DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1, 2, and 5-19 are pending. Claims 3 and 4 are cancelled.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/CA2022/000057, filed on November 28, 2022. This application also claims the benefits of foreign priority to CA3157880, filed on May 6, 2022 and CA3157907, filed on May 6, 2022.
Specification - Abstract
The abstract of the disclosure is objected to because it is not in compliance with 37 C.F.R. 1.72 (b). Specifically, the sheet presenting the abstract includes other parts of the application or other material. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Written Description
Claims 1 and 2 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.
Specification relies on predictive extrapolation rather than demonstrating possession
Currently, claims 1 and 2 are extremely broad insofar as the instant claims recite any glycine transporter-1 antagonist compound being used in:
a method of treating or prophylactic treatment of vascular dementia in a subject or
a method of treating or prophylactic treatment of stroke in a subject.
Although the instant claims are extremely broad, the instant specification provides very limited working examples.
The instant specification does not appear to provide direct experimental evidence of a glycine transporter-1 antagonist as a vascular dementia prophylactic or treatment agent. However, the instant specification does state that the “mechanisms of stroke and vascular dementia are similar, with the mechanism of vascular dementia resulting in a series of more frequently occurring ‘smaller strokes’” (see pg. 10, lines 16-17).
The instant specification then teaches:
“it has been demonstrated, in vivo, that elevation of extracellular glycine by administering a GlyT-1 antagonist compound resulted in a decreased stroke volume and an attenuation of motor deficits in mice following ischemic stroke induced by PT or ET-1. This was observed when the GlyT-1 antagonist compound was administered pre-stroke, or post-stroke, thus demonstrating efficacy of the GlyT-1 antagonist compound as a stroke prophylactic agent as well as a stroke treatment agent” (pg. 51, lines 30-32 and pg. 52, lines 1-3).
Note: the information from the excerpt above is also reiterated in the instant specification on pg. 20, lines 18-25 (wherein the GlyT-1 antagonist compound used is NFPS)
The information from the excerpt above is pulled from Cappelli (citation below); see pg. 10, 2nd to last paragraph.
Cappelli, J. et al. Glycine-induced NMDA receptor internalization provides neuroprotection and preserves vasculature following ischemic stroke. iScience 2022, 25, 103539.; published January 21, 2022
The instant specification also discusses prior preclinical and clinical studies involving glycine transporter-1 antagonists (starts on pg. 47, line 28) before concluding that “[i]n light of the above it is soundly predicted that administering a therapeutically effective amount of a glycine transporter-1 antagonist compound to a patient as vascular dementia and/or stroke prophylactic/treatment agent according to the invention will effect neuro protection in a human patient's brain by sufficiently increasing the level of glycine in the brain for blocking the NDMA receptors” (pg. 51, lines 24-28).
Accordingly, the specification appears to infer utility for vascular dementia from the disclosed stroke data (taught in the prior art) and the asserted mechanistic relationship between stroke and vascular dementia, rather than providing direct experimental evidence demonstrating efficacy of a glycine transporter-1 antagonist in a vascular dementia model.
Therefore, the instant specification appears to set forth a research hypothesis supported by mechanistic reasoning and predictive extrapolation from prior-art studies, rather than demonstrating possession of a specific and/or novel glycine transporter-1 antagonist compound genus having the claimed prophylactic and therapeutic utility for vascular dementia and stroke.
The specification does not adequately describe the structural diversity of the claimed genus
Furthermore, according to MPEP § 2163:
“Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’ See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014).
Here, the instant specification discusses several glycine transporter-1 antagonist compounds identified in the prior art including NFPS (pg. 14, line 11), Bitopertin, BI 425809, Sarcosine, and PF-03463275 (see pg. 47, lines 29-30). However, merely identifying a limited number of prior-art glycine transporter-1 antagonists does not adequately describe the structural diversity encompassed by the claimed genus of “glycine transporter-1 antagonist.” The claims are not limited to compounds sharing a common chemical scaffold or structural motif, but instead encompass the entire class of glycine transporter-1 antagonist compounds without identifying structural characteristics representative of that genus or otherwise demonstrating possession of its full scope.
Moreover, the prior art itself recognizes that membership in a pharmacological class does not establish that all compounds within that class possess the same therapeutic properties. As explained by Furberg (Furberg, C. D. Class Effects and Evidence-Based Medicine. Clin. Cardiol. 2000, 23, pg. IV-15 to IV-19.):
“Drugs grouped into a therapeutic class on the basis of a common mechanism of action often have considerably different pharmacodynamic and pharmacokinetic properties” (abstract, 1st sentence);
“Equipotency in terms of clinical efficacy is difficult to determine. Since the concept of “class effect” is a term of convenience that has no universally accepted definition and subsequently should not form the basis for the practice of evidence-based medicine, untested drugs of a “class” should be considered to be unproven drugs” (abstract, last two sentences).
Accordingly, a POSITA would have understood that evidence relating to one or a very limited number of glycine transporter-1 antagonists do not establish that all compounds within the class possess the same prophylactic or therapeutic utility for vascular dementia or stroke. Although the instant specification discusses prior art studies involving several glycine transporter-1 antagonist compounds including NFPS, Bitopertin, BI 425809, Sarcosine, and PF-03463275, the specification does not reasonably convey that the inventor was in possession of the full claimed genus of a method of treating or prophylactic treatment of vascular dementia or stroke in a subject, the method comprising administering an effective amount of any glycine transporter-1 antagonist to said subject. Rather, the disclosure relies on the common functional characteristic of glycine transporter-1 antagonism and extrapolates the asserted therapeutic/prophylactic utility to the entire class without identifying other distinguishing characteristics demonstrating possession of the full scope of the claimed genus.
Functional definition of the claimed compound genus does not demonstrate possession
Additionally, the recitation of “glycine transporter-1 antagonist” creates a “reach-through” aspect to the claim. Specifically, the claims are not limited to compounds presently recognized as being glycine transporter-1 antagonists, but, instead, potentially reaches through to novel compounds that may later be discovered to function as a glycine transporter-1 antagonist. Thus, the scope of the claims is not confined to the few specific compounds described in the instant specification (i.e., NFPS, Bitopertin, BI 425809, Sarcosine, and PF-03463275), but extends to novel glycine transporter-1 antagonist identified only through future scientific investigation. However, the instant specification does not reasonably convey possession of such a broad genus. The limited number of specific glycine transporter-1 antagonist compounds referenced in the instant specification does not provide a representative disclosure or identify structural features common to the claimed compound genus sufficient to demonstrate possession of the full scope of “glycine transporter-1 antagonist.” Accordingly, the “reach-through” scope of the claim further demonstrates that the instant specification does not reasonably convey possession of the full scope of “a compound of the class of glycine transporter-1 antagonist compounds” as presently claimed.
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 6, 7, and 9-11 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.
The term “high dose” in claims 6, 7, 9, and 10 is a relative term which renders the claim indefinite. The term “high dose” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the amount of D-serine and glycine concurrently administered to the subject along with the glycine transporter-1 antagonist is rendered indefinite by the use of the term “high dose.”
The term “at least” in claim 11 is a relative term which renders the claim indefinite. The term “at least” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the number of hours before ischemic stroke as recited in instant claim 11 is rendered indefinite by the use of the term “at least.”
Note on 35 USC § 102 and § 103 Rejections
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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2, 8, 11, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Cappelli et al. (Cappelli) (Cappelli, J. et al. Glycine-induced NMDA receptor internalization provides neuroprotection and preserves vasculature following ischemic stroke. iScience 2022, 25, 103539.; published January 21, 2022) and
Cappelli teaches that “[m]ice pretreated with a GlyT1-A [i.e., glycine transporter-1 antagonist], which increases synaptic glycine levels, exhibited smaller stroke volume, reduced cell death, and minimized behavioral deficits following stroke induction by either photothrombosis or endothelin-1” (abstract). The GlyT1-A administered to the mice is NFPS (see pg. 10, 2nd to last paragraph, 2nd sentence). The NFPS dose administered was 5 mg/kg and the NFPS was injected intraperitoneally into the mice either 24 hours prior to stroke or 10 mins post-stroke (pg. 20, “Surgical procedures” section, 1st paragraph, 1st sentence). According to Cappelli, a decrease in stoke volume was maintained when NFPS was administered up to 10 minutes post-stroke (pg. 6, “pharmacological elevation of brain glycine reduces infarct size following photothrombosis” section, last sentence).
In other words, Cappelli discloses a method of treating and prophylactic treatment of stroke in mice by administering to the mice a dose of NFPS (i.e., 5 mg/kg) 24 hours before stroke induction or 10 minutes post-stroke. Therefore, Cappelli anticipates instant claims 2, 8, 11, and 17.
Claim Rejections - 35 USC § 103
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.
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.
Rejection Part 1:
Claims 1, 2, 5, 8, 11, 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over:
Cappelli et al. (Cappelli) (Cappelli, J. et al. Glycine-induced NMDA receptor internalization provides neuroprotection and preserves vasculature following ischemic stroke. iScience 2022, 25, 103539.; published January 21, 2022) in view of
Moltzen et al. (Moltzen) (WO 02/08216 A1; published January 31, 2002),
Venkat et al. (Venkat) (Venkat, P. et al. Models and mechanisms of vascular dementia. Experimental Neurology 2015, 272, 97-108.),
Kalaria et al. (Kalaria) (Kalaria, R. N. et al. Stroke injury, cognitive impairment and vascular dementia. Biochimica et Biophysica Acta 2016, 1862, 915-925.), and
McKay et al. (McKay) (McKay, E. et al. Multi-Infarct Dementia: A Historical Perspective. Dement Geriatr Cogn Disord Extra 2017, 7, 160-171.)
According to the “Claim Rejections - 35 USC § 102” section above, the prior art discloses a glycine transporter-1 antagonist (i.e., NFPS) capable of preventing and treating stroke (see Cappelli). Given that the claimed invention, as recited in claims 2, 8, 11, and 17, is anticipated by the prior art, a POSITA would have found it obvious to reproduce the subject matter disclosed. Therefore claims 2, 8, 11, and 17 are also rendered obvious.
Cappelli does not expressly disclose a method of treating or prophylactic treatment of vascular dementia, the method comprising administering an effective amount of a glycine transporter-1 antagonist to said subject.
However, the prior art does teach the following:
According to Moltzen:
“glycine transporter antago[nists] or inhibitors are believed to be highly beneficial in the treatment of… multi-infarct dementia…” (pg. 1, lines 29-32).
According to Venkat:
vascular dementia includes multi-infarct dementia which is characterized by multiple small strokes (pg. 98, left col., introduction section, 2nd paragraph, 2nd sentence).
According to Kalaria:
“stroke is related to two- to nine fold increase in risks of dementia; therefore, adequate primary prevention and neuroprotective intervention after stroke occurrence or recurrent events will have enormous impact” (pg. 921, right col., last paragraph, 1st sentence).
According to McKay:
“prevention of strokes and management of risk factors are the only universally and medically accepted means of controlling the onset of MID [i.e., multi-infarct dementia]” (pg. 161, 1st paragraph, last sentence).
Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to use a glycine transporter-1 antagonist (such as NFPS as disclosed in Cappelli) for the prophylactic treatment or treatment of vascular dementia. Specifically, the prior art establishes that multi-infarct dementia is a form of vascular dementia characterized by multiple small strokes, that stroke and recurrent stroke are closely associated with the development of vascular dementia, and that preventing stroke and providing neuroprotective intervention following stroke are recognized strategies for reducing the onset and further progression of multi-infarct dementia. Because the prior art already demonstrates that the glycine transporter-1 antagonist, NFPS, provides neuroprotection when administered either before or after stroke (as discussed in Cappelli), one of ordinary skill in the art would have been motivated to apply the same glycine transporter-1 antagonism to vascular dementia, which encompasses multi-infarct dementia, in order to prevent or treat the neuronal injury associated with the multiple stroke events underlying multi-infarct dementia. This motivation is further strengthened by Moltzen’s explicit teaching that glycine transporter antagonists are believed to be highly beneficial for the treatment of multi-infarct dementia.
One of ordinary skill in the art would have had a reasonable expectation of success because the prior art collectively suggested that glycine transporter-1 antagonists were promising candidates for preventing or treating vascular dementia. In view of the demonstrated neuroprotective efficacy of glycine transporter-1 antagonists in stroke and the recognized pathological relationship between repeated strokes and multi-infarct dementia (i.e., a type of vascular dementia), it would have been obvious to apply the known glycine transporter-1 antagonist (i.e., NFPS) to vascular dementia and confirm the predicted therapeutic benefit through routine experimentation. Therefore, instant claims 1, 5, and 13 are rendered obvious.
Rejection Part 2:
Claims 6, 7, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over:
Cappelli et al. (Cappelli) (Cappelli, J. et al. Glycine-induced NMDA receptor internalization provides neuroprotection and preserves vasculature following ischemic stroke. iScience 2022, 25, 103539.; published January 21, 2022)
Recall that Cappelli discloses a glycine transporter-1 antagonist (i.e., NFPS) capable of preventing and treating stroke (see the “Claim Rejections - 35 USC § 102” section above for details).
Cappelli further teaches that GINI (glycine-induced NMDAR internalization; see pg. 3, results section, 1st paragraph) provides neuroprotection, and preserves brain vasculature (pg. 10, Discussion section, 1st paragraph, last sentence). When GINI is induced, there is a decrease in NMDAR-EPSC amplitude in the ex vivo brain slices tested (pg. 3, results section, 1st paragraph, last 3 sentences). When NFPS and D-serine was administered, it also resulted in a significant decrease in NMDAR-EPSC amplitude (pg. 4, “Role of glycine binding site occupancy”, 2nd paragraph, 2nd to last sentence). Therefore, Cappelli also implies that GINI is induced when NFPS and D-serine is concurrently administered and, therefore, neuroprotection can occur. Note: Cappelli explicitly states: “These findings suggest that there is a common mechanism of action for glycine or D-serine to trigger GINI” (pg. 4, “Role of glycine binding site occupancy”, 3rd paragraph, 2nd to last sentence).
Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to concurrently administer a glycine transporter-1 antagonist, such as NFPS, with D-serine or glycine for the prevention or treatment of stroke. Cappelli teaches that NFPS is neuroprotective in ischemic stroke and further teaches that D-serine and glycine promote the same GINI mechanism that Cappelli identifies as neuroprotective during an ischemic event. Accordingly, a POSITA would have been motivated to combine NFPS with D-serine or glycine in order to enhance or facilitate the same neuroprotective mechanism already disclosed by Cappelli, with a reasonable expectation that the combination would provide neuroprotection against a stroke. As such, instant claims 9 and 10 are rendered obvious.
Furthermore, it would have been prima facie obvious to employ the same combination for the prevention or treatment of vascular dementia. As discussed above in Rejection Part 1 of this 103 rejection, the prior art teaches that vascular dementia includes multi-infarct dementia (which is characterized by multiple small strokes), that stroke increases the risks of dementia, and that prevention of strokes and management of risk factors are the only universally and medically accepted means of controlling the onset of multi-infarct dementia. Accordingly, one of ordinary skill in the art would have reasonably expected that a therapeutic strategy directed toward preventing or treating a stroke would likewise be applicable to preventing or treating vascular dementia which arises from multiple small strokes.
Rejection Part 3:
Claims 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over:
Cappelli et al. (Cappelli) (Cappelli, J. et al. Glycine-induced NMDA receptor internalization provides neuroprotection and preserves vasculature following ischemic stroke. iScience 2022, 25, 103539.; published January 21, 2022) in view of
Harsing et al. (Harsing) (Harsing, L. G. et al. The glycine transporter-1 inhibitors NFPS and Org 24461: a pharmacological study. Pharmacology, Biochemistry and Behavior 2003, 74, 811-825.)
Recall that Cappelli discloses a glycine transporter-1 antagonist (i.e., NFPS) capable of preventing and treating stroke (see the “Claim Rejections - 35 USC § 102” section above for details).
Cappelli does not disclose the oral administration of NFPS. Harsing is relied upon for this disclosure.
Harsing discloses the oral administration of NFPS to mice (see pg. 814, section, 2.4.1, 2nd sentence and Table 3 caption).
Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to orally administer NFPS in the method of Cappelli (which anticipates instant claims 2, 8, 11, and 17; see “Claim Rejections - 35 USC § 102” section above for details). A person of ordinary skill in the art would have been motivated to replace intraperitoneal administration with oral administration because Harsing teaches that oral administration of NFPS was known in the art, and the selection of a known route of administration for a known therapeutic compound constitutes no more than routine optimization. In view of Harsing’s disclosure, a POSITA would have had a reasonable expectation of success that orally administered NFPS would provide the neuroprotective effects disclosed by Cappelli. Therefore, instant claim 16 is rendered obvious.
Furthermore, for the reasons discussed above in Rejection part 1 of this 103 rejection, a POSITA would likewise have found it prima facie obvious to orally administer NFPS for the prevention or treatment of vascular dementia. The prior art teaches that vascular dementia includes multi-infarct dementia (which is characterized by repeated small strokes), and that prevention of stroke is an accepted strategy for preventing the onset of multi-infarct dementia. Accordingly, applying the known oral route of administration of NFPS to the prevention or treatment of vascular dementia (which is caused by multiple smaller strokes) would have been a predictable application of the prior art teachings with a reasonable expectation of success. Therefore, instant claim 12 is rendered obvious.
Allowable Subject Matter
Claims 14, 15, 18, and 19 are objected to as being dependent upon a rejected base claim.
Conclusion
Claims 1, 2, 5-13, 16, and 17 are rejected. Claims 14, 15, 18, and 19 are objected to. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY H. MURRAY can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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