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 .
Status of the Application
The amendment of 26 February 2024 is entered.
Claims 1-29 are pending and are being examined on the merits.
Claim Objections
Claims 2, 4, 6, 7, and 15 are objected to because of the following informalities: each of claim 2, 4, 6, and 7 utilize the term “GLP-1r” instead of the proper “GLP-1R” as found in other claims such as claim 1. In claim 15, the claim recites “none” instead of “nine”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for inhibiting the secretion of inflammatory and/or neurotoxic mediators from activated microglial cells and astrocytes by administering a pharmaceutically effective amount of a composition comprising a long-active GLP-1R agonist, does not reasonably provide enablement for a method for treating or preventing neurological impairment induced by, or resulting from, infection with a virus in a subject by administering a pharmaceutically effective amount of a composition comprising a long-active GLP-1R agonist to reduce microglial activation. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997); In re Wright 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); See also Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir. 1991); In re Fisher 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Further, in In re Wands 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the court stated:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman [230 USPQ 546, 547 (BdPatAppInt 1986)]. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredict-ability of the art, and (8) the breadth of the claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Nature of the Invention
The invention is drawn to administration of a GLP-1R agonist to a subject, where the administration reduces microglial activation and as a result treats or prevents neurological impairment induced by or resulting from infection with a virus.
Breadth of the Claims
The claims are broad with respect to the viral infection and the GLP-1R agonist. The broadest interpretation of the infection is that it can be from any virus, and similarly the GLP-1R agonist can take the form of any long-acting construct. With the exception of claims 2 and 3, the GLP-1R agonist is defined largely by function rather than by a particular structure.
State of the Prior Art
The prior art recognizes that GLP-1R agonists can be utilized to impact microglial activation, including production of inflammatory or neurotoxic mediators (see e.g. WO 2017/112889 A1).
Balcom et al. Brain 144:3576-3588 (published 16 August 2021) recites a variety of potential neurological impairments resulting from COVID-19 infection, but does not indicate that the neurological impairment was predictable or commonplace among those infected with SARS-CoV-2.
Relative Skill of those in the Art
The relative skill of those in the art is high.
Predictability or Unpredictability of the Art
There is a general lack of predictability in the pharmaceutical art. In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970).
It is generally not predictable whether a given viral infection will result in neurological impairment. See the above cited Balcom et al. art.
The specification indicates that only 1-2% of COVID patients suffer from persistent cognitive dysfunction after infection, indicating that the predictability of such neurological impairment is highly unpredictable (see e.g. p.44).
Amount of Direction or Guidance Given
The specification guides that many patients suffering from long-term COVID suffer from cognitive deficits, and argues that microglial reactivity in the CNS outlasts the active viral infection. The specification specifically states that microglial dysregulation is the target for GLP-1R agonist therapy in COVID-19 infections, noting that other viral infections can cause brain inflammation. The specification also notes that in certain COVID-19 patients any symptoms resolve without treatment, while others persist in neurological deficits, i.e. the effects are unpredictable. The long-acting GLP-1R agonist is defined as one that is effective for one hour and up to two months. The NLY01 composition as used in the examples is defined as a PEGylated exenatide having a 50 kDa PEG moiety attached to the exenatide peptide, with a half-life of 12±4 days in humans and the ability to cross the blood-brain barrier.
With respect to treatment of neurological impairment from COVID-19 infection, the specification suggests prophetic trials using NLY01 (see e.g. p.44-45). Treatment of neurological impairment from Japanese encephalitis virus, Dengue virus, West Nile virus, and viral encephalitis (Venezuelan, Wester, Equine) is also suggested but no specific protocols are prescribed.
Presence/Absence of Working Examples
Three working examples are present. In the first, it is shown that microglial cells express GLP-1R. In the second, pro-inflammatory cytokine expression in microglial cells is reduced when in the presence of the GLP-1R agonist NLY01. In the final example, NLY01 is shown to inhibit microglial activation in a mouse model. The activation of microglia in COVID-19 is discussed as leading to cognitive defects, but there is no evidence presented that any long-acting GLP-1R treats or prevents neurological impairment induced by or resulting from any viral infection.
Quantity of Experimentation Necessary
In this instance, the skilled artisan is presented with a limited amount of experimental data suggesting action of a particular GLP-1R agonist on microglial cell activation and production of inflammatory and neurotoxic mediators. The specification offers prophetic studies for determining if NLY01 might serve as a therapeutic in the context of COVID-19, but also makes clear that only a limited subset of patients actually suffer from neurological deficits. Accordingly, the artisan must make do with limited in vitro and in vivo data that is unrelated to neurological impairment due to viral infection and conduct the clinical trials on their own. In this case there is a lack of laboratory or clinical evidence that any GLP-1R agonist will work to treat neurological impairment from any viral infection, let alone COVID-19. The skilled artisan is required to conduct both the in vitro and in vivo experimentation and conduct clinical trials across a wide range of GLP-1R agonists and viral infections, with no assurance of success. The prior art did not recognize GLP-1R agonists as being useful for treating any neurological disorders associated with any viral infection. Having to conduct such experimentation poses an undue burden.
In view of the Wands factors as discussed above, it is the Examiner’s opinion that the claims are not fully enabled and one of skill in the art would have to engage in undue experimentation to practice the invention as claimed herein, without a reasonable assurance of success.
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, 10, and 15 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 “appropriate control” in claim 6 is a relative term which renders the claim indefinite. The term “appropriate control” 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.
Regarding claim 10, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In claim 15, the indefinite language is “one, two, three, four, five, six, seven, eight, none, ten or more than ten days, weeks, or months prior to the onset of one or more symptom of neurological impairment”. The claim is indefinite because it is amenable to multiple plausible interpretations: (1) the infection could have occurred 1-10 or more than ten days prior or any number of weeks or months prior, or (2) the infection could have occurred 1-10 or more than 10 days, weeks, or months prior (i.e. 1-10 days, 1-10 weeks, 1-10 months). Ex parte Kenichi Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (precedential) “hold[s] that if a claim is amenable to two or more plausible constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite.”
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
1. Claims 1-10, 16-26, and 28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al. (US 11,123,405 B2, published 21 September 2021, priority to 23 December 2015, hereafter referred to as ‘405).
The applied reference has a common inventor (Seulki Lee) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The ’405 patent claims a method of treating a neurodegenerative disease or disorder associated with innate immune cell activation by administering a PEGylated exenatide analog to block or reduce activation of said immune cells and alleviate symptoms to improve motor, memory, or cognitive skills (see e.g. claim 1). The cells are microglia cells (see e.g. claim 5). This anticipates claim 1.
With respect to claims 2 and 3, as noted above ‘405 claims a PEGylated exenatide.
With respect to claims 4 and 5, ‘405 claims inhibition of secretion of inflammatory and/or neurotoxic mediators including from microglia and astrocytes (see e.g. claims 4 and 5).
With respect to claim 6, ‘405 claims reduction of the same inflammatory or neurotoxic mediators (see e.g. claim 7).
With respect to claim 7, ‘405 claims reduction of cell populations of activated microglia (see e.g. claim 8).
With respect to claim 8, as noted above ‘405 claims improvement of cognitive skills.
With respect to claim 9, as noted above ‘405 claims improvement of motor skills and memory.
With respect to claim 10, as noted above ‘405 claims improvement of cognitive skills and memory.
With respect to claim 16, ‘405 claims overlapping administration routes (see e.g. claim 10).
With respect to claim 17, ‘405 claims overlapping dosage forms (see e.g. claim 12).
With respect to claim 18, ‘405 claims administration from 1-4 times a month (see e.g. claim 13).
With respect to claim 19, ‘405 claims overlapping administration periods (see e.g. claims 14-18).
With respect to claim 20, ‘405 claims sufficient dosing protocols as set forth above that the weekly dosage for 12 weeks would be a matter of routine experimentation.
With respect to claim 21, ‘405 claims a half-life of 12-200 hours in non-human primates and humans (see e.g. claim 19).
With respect to claim 22, ‘405 claims dosages of 0.001-100 mg/kg (see e.g. claim 20).
With respect to claims 23-24, the dosage ranges as claimed by ‘405 and average human weight of 100 kg for a male would lead to overlapping total doses.
With respect to claim 25, as noted above ‘405 claims sufficient different dosing regimens that the weekly dosing for up to 6 months would be a matter of routine optimization.
With respect to claim 26, ‘405 claims treatment of under a year and up to 10 years (see e.g. claims 22 and 23).
With respect to claim 28, ‘405 claims patients with Alzheimer’s or Parkinson’s disease (see e.g. claim 1).
2. Claims 1-7, 16-25, and 28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al. (US 12,233,109 B2, published 25 February 2025, priority to 23 December 2015, hereafter referred to as ‘109).
The applied reference has a common inventor (Seulki Lee) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The ’109 patent claims a method of treating a subject with Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, ALS, spinocerebellar ataxia type 1, and MS by administering a PEGylated GLP-1R agonist (see e.g. claim 1). This is claimed to block activation of resident innate immune cells, including microglia cells and astrocytes (see e.g. claims 2 and 5). This anticipates claim 1.
With respect to claims 2 and 3, ‘109 claims a PEGylated exenatide (see e.g. claim 8).
With respect to claims 4 and 5, ‘109 claims inhibition of secretion of inflammatory and/or neurotoxic mediators including from microglia and astrocytes (see e.g. claims 4 and 5).
With respect to claim 6, ‘109 claims measuring changes of the same inflammatory or neurotoxic mediators (see e.g. claim 32).
With respect to claim 7, ‘109 claims reduction of cell populations of activated microglia (see e.g. claim 7).
With respect to claim 16, ‘109 claims overlapping administration routes (see e.g. claim 9).
With respect to claim 17, ‘109 claims overlapping dosage forms (see e.g. claim 11).
With respect to claim 18, ‘109 claims administration once per month (see e.g. claim 14).
With respect to claim 19, ‘109 claims overlapping administration periods (see e.g. claims 12-16).
With respect to claim 20, ‘109 claims sufficient dosing protocols as set forth above that the weekly dosage for 12 weeks would be a matter of routine experimentation.
With respect to claim 21, ‘109 claims a half-life of 12-200 hours in non-human primates and humans (see e.g. claim 17).
With respect to claim 22, ‘109 claims dosages of 0.001-100 mg/kg (see e.g. claim 18).
With respect to claims 23-24, the dosage ranges as claimed by ‘109 and average human weight of 100 kg for a male would lead to overlapping total doses.
With respect to claim 25, as noted above ‘109 claims sufficient different dosing regimens that the weekly dosing for up to 6 months would be a matter of routine optimization.
With respect to claim 28, ‘109 claims patients with Alzheimer’s or Parkinson’s disease (see e.g. claim 1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-10, 16-26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (WO 2017/112889 A1, published 29 June 2017, hereafter referred to as ‘889).
The ‘889 application discloses a method of treating a neurodegenerative disease or disorder by administering a long-acting GLP-1R in an amount to alleviate one or more symptom of the disease or disorder (see e.g. claim 1). ‘899 further discloses that the long-acting GLP-1R agonist blocks activation of innate immune cells to inhibit secretion of inflammatory and/or neurotoxic mediators, including cells selected from microglia or astrocytes (see e.g. claims 2, 4, and 5).
The difference between ‘889 and the claimed invention is that ‘889 does not explicitly claim a method of treating neurological impairment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of ‘889 would also encompass treatment of neurological impairment, since that is a common feature of neurological diseases or disorders. The rationale comes from ‘889 also claiming that the administration improves motor, memory, or cognitive skills (see e.g. claim 31). There would have been a reasonable expectation of success because the same composition is administered and ‘889 offers overlapping treatment as compared to the instant claims. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 2, ‘889 provides for PEGylated GLP-1R agonists, Fc fusion GLP-1 agonists, albumin fusion GLP-1, or derivatives thereof (see e.g. claim 13).
With respect to claim 3, ‘889 provides for a PEGylated exenatide analog (see e.g. claim 14).
With respect to claims 4 and 5, as noted above ‘889 discloses inhibition of secretion of inflammatory and/or neurotoxic mediators including microglia and astrocytes.
With respect to claim 6, ‘889 claims reduction of the same inflammatory or neurotoxic mediators (see e.g. claim 7).
With respect to claim 7, ‘889 claims reduction of cell populations of activated microglia (see e.g. claim 8).
With respect to claim 8, as noted above ‘889 discloses reduction in cognitive impairment and neurological problems.
With respect to claim 9, as noted above ‘889 discloses improvement in motor and memory skills.
With respect to claim 10, as noted above ‘889 discloses improvement in memory skills, i.e. memory loss.
With respect to claim 16, ‘889 discloses the same routes of administration (see e.g. claim 15).
With respect to claim 17, ‘889 discloses the same dosage forms (see e.g. claim 17).
With respect to claim 18, ‘889 discloses dosing between 1-4 times a month, within the range as claimed (see e.g. claim 18).
With respect to claim 19, ‘889 discloses dosing once a week, every two weeks, approximately once a month, once every two months, and between 1-3 times every 6 months (see e.g. claims 19-23).
With respect to claim 20, as noted above ‘889 discloses weekly dosing, and also discloses treatment for a year overlapping with the 12-week period as claimed (see e.g. claim 28).
With respect to claim 21, ‘889 discloses a half-life between 12-200 hours in non-human primates or humans (see e.g. claim 24).
With respect to claim 22, ‘889 discloses dosing at 0.001 mg/kg to 100 mg/kg (see e.g. claim 25).
With respect to claims 23 and 24, given the range of dosing and average weight of 100 kg for a human male, the total dose would overlap with that instantly claimed.
With respect to claim 25, given the dosing periods as disclosed by ‘889 the weekly dosing for up to 6 months would be a routinely optimizable parameter.
With respect to claim 26, as noted above ‘889 discloses a variety of dosing periods, including up to 10 years (see e.g. claims 27 and 28).
With respect to claim 28, ‘889 discloses treating patients with Alzheimer’s disease and Parkinson’s disease (see e.g. claims 9 and 10).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1. Claims 1-10, 16-26, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7, 8, 10, 12-19, 22, and 23 of U.S. Patent No. 11,123,405 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘405 patent claims an overlapping method.
The ’405 patent claims a method of treating a neurodegenerative disease or disorder associated with innate immune cell activation by administering a PEGylated exenatide analog to block or reduce activation of said immune cells and alleviate symptoms to improve motor, memory, or cognitive skills (see e.g. claim 1). The cells are microglia cells (see e.g. claim 5). This overlaps with instant claim 1.
With respect to claims 2 and 3, as noted above ‘405 claims a PEGylated exenatide.
With respect to claims 4 and 5, ‘405 claims inhibition of secretion of inflammatory and/or neurotoxic mediators including from microglia and astrocytes (see e.g. claims 4 and 5).
With respect to claim 6, ‘405 claims reduction of the same inflammatory or neurotoxic mediators (see e.g. claim 7).
With respect to claim 7, ‘405 claims reduction of cell populations of activated microglia (see e.g. claim 8).
With respect to claim 8, as noted above ‘405 claims improvement of cognitive skills.
With respect to claim 9, as noted above ‘405 claims improvement of motor skills and memory.
With respect to claim 10, as noted above ‘405 claims improvement of cognitive skills and memory.
With respect to claim 16, ‘405 claims overlapping administration routes (see e.g. claim 10).
With respect to claim 17, ‘405 claims overlapping dosage forms (see e.g. claim 12).
With respect to claim 18, ‘405 claims administration from 1-4 times a month (see e.g. claim 13).
With respect to claim 19, ‘405 claims overlapping administration periods (see e.g. claims 14-18).
With respect to claim 20, ‘405 claims sufficient dosing protocols as set forth above that the weekly dosage for 12 weeks would be a matter of routine experimentation.
With respect to claim 21, ‘405 claims a half-life of 12-200 hours in non-human primates and humans (see e.g. claim 19).
With respect to claim 22, ‘405 claims dosages of 0.001-100 mg/kg (see e.g. claim 20).
With respect to claims 23-24, the dosage ranges as claimed by ‘405 and average human weight of 100 kg for a male would lead to overlapping total doses.
With respect to claim 25, as noted above ‘405 claims sufficient different dosing regimens that the weekly dosing for up to 6 months would be a matter of routine optimization.
With respect to claim 26, ‘405 claims treatment of under a year and up to 10 years (see e.g. claims 22 and 23).
With respect to claim 28, ‘405 claims patients with Alzheimer’s or Parkinson’s disease (see e.g. claim 1).
2. Claims 1-7, 16-25, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 7-9, 11-18, and 32 of U.S. Patent No. 12,233109 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘109 patent claims an overlapping method.
The ’109 patent claims a method of treating a subject with Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, ALS, spinocerebellar ataxia type 1, and MS by administering a PEGylated GLP-1R agonist (see e.g. claim 1). This is claimed to block activation of resident innate immune cells, including microglia cells and astrocytes (see e.g. claims 2 and 5). This overlaps with instant claim 1.
With respect to claims 2 and 3, ‘109 claims a PEGylated exenatide (see e.g. claim 8).
With respect to claims 4 and 5, ‘109 claims inhibition of secretion of inflammatory and/or neurotoxic mediators including from microglia and astrocytes (see e.g. claims 4 and 5).
With respect to claim 6, ‘109 claims measuring changes of the same inflammatory or neurotoxic mediators (see e.g. claim 32).
With respect to claim 7, ‘109 claims reduction of cell populations of activated microglia (see e.g. claim 7).
With respect to claim 16, ‘109 claims overlapping administration routes (see e.g. claim 9).
With respect to claim 17, ‘109 claims overlapping dosage forms (see e.g. claim 11).
With respect to claim 18, ‘109 claims administration once per month (see e.g. claim 14).
With respect to claim 19, ‘109 claims overlapping administration periods (see e.g. claims 12-16).
With respect to claim 20, ‘109 claims sufficient dosing protocols as set forth above that the weekly dosage for 12 weeks would be a matter of routine experimentation.
With respect to claim 21, ‘109 claims a half-life of 12-200 hours in non-human primates and humans (see e.g. claim 17).
With respect to claim 22, ‘109 claims dosages of 0.001-100 mg/kg (see e.g. claim 18).
With respect to claims 23-24, the dosage ranges as claimed by ‘109 and average human weight of 100 kg for a male would lead to overlapping total doses.
With respect to claim 25, as noted above ‘109 claims sufficient different dosing regimens that the weekly dosing for up to 6 months would be a matter of routine optimization.
With respect to claim 28, ‘109 claims patients with Alzheimer’s or Parkinson’s disease (see e.g. claim 1).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
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