Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
2. Applicant’s amendment filed August 7, 2025 is acknowledged. Claims 2, 8-11, 13-16 and 18-19 are cancelled. Claims 1, 12, 17, 22-26 and 34 are amended. Claims 1, 3-7, 12, 17 and 20-35 are pending in this application and under examination in this office action.
3. Applicant’s arguments filed on August 7, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Specification
4. The objection to the specification is withdrawn in response to Applicant’s amendment to the specification.
Claim Rejections/Objections Withdrawn
5. The rejection of claims 1-7, 12, 17 and 20-35 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in response to Applicant’s amendment to the claims.
The rejection of claims 1-7, 12, 17, 20-29 and 34 are rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Culp et al. (US2019/0040131, published Feb 7, 2019, priority May 4, 2018, as in IDS)
Claim Rejections/Objections Maintained
In view of the amendment filed on August 7, 2025, the following rejections are maintained.
Claim Rejections - 35 USC § 102
6. 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 1, 3-7, 12, 17, 20-29 and 34 stand rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Culp et al. (US2019/0040131). The rejection is maintained for the reasons of record and the reasons set forth below.
Claims 1, 3-7, 12, 17, 20-29 and 34 as amended are drawn to a method of treating and/or delaying progression of a disease or injury in an individual, comprising administering to the individual an anti-CD33 antibody intravenously at a dose of between 1.6 mg/kg and 15 mg/kg, wherein the antibody is administered about once every twelve weeks or more frequently; and wherein the antibody comprises: a heavy chain variable region (VH) that comprises an HVR-H1 comprising the amino acid sequence SEQ ID NO: 105, an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 119, and an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 122; and a light chain variable region (VL) that comprises an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 127, an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 135, and an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 146.
Response to Arguments
On p. 8 of the response, Applicant argues that the rejection has been overcome in view of amendment to claim 1 by reciting “between 1.6 mg/kg and 15 mg/kg”. Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2131, Culp et al. (US2019/0040131) does teach the claimed method because:
i. The method disclosed by Culp uses the same material (i.e. an anti-CD33 antibody having recited SEQ ID NOs: for HCDRs1-3 and LCDRs or VH and VL or heavy chanin and light chain; see the sequence alignment; [0030]-[0034]; [0040]) and the same active step (i.e. intravenously administering to an individual in need thereof; see [00380]) in the same patient population (i.e. dementia, frontotemporal dementia (FTD), Alzheimer’s disease (AD), vascular dementia, mixed dementia, tauopathy disease, infections and cancer in claims 27-28 or diagnosed with AD or probable AD dementia with different clinical assessments including MMSE of 16-28 points, CDR-GS of 0.5,1 or 2 or positive-amyloid-PET scan in claims 28-33 and 35; see [0047]; [0141]; [0146]; [0210]; [0257]; [0261]; 384]; [0387]-[0389]; [0403]-[0414]; [0427]-[0429]; [0434]-[0440]; [0446]; claims 62-64). Culp teaches intravenously administering (see [00380]) to the individual an anti-CD33 antibody at a dose of about 2mg/kg (see [0383]), which is within the claimed range of “1.6-15mg/kg” recited in claim 1, and thus anticipate instant claims.
Culp also teaches a dose range including 10ng/kg up to 100mg/kg, 1-10mg/kg or 3ug/kg-2mg/kg (see [0382]-[0383]), which is overlapping with the claimed range of “1.6-15mg/kg”.
ii. The limitations “wherein the surface level of CD33 is reduced by at least 70% compared to prior to administration” in claim 12, “wherein the reduction of surface level of CD33 is present for at least 17 days or 56 days” in claims 17 and 20, “wherein the reduction of CD33 is on peripheral blood monocytes” in claim 21, “wherein the terminal half-life of the anti-CD33 in plasma is about 4,5, 6…12 days or about 10 days” in claims 25-26 (see para [0393]-[0394]) are inherent results/features of administration of the claimed anti-CD33 antibody because the Culp’s method uses the same active step (intravenous administration), the same anti-CD33 antibody having the same sequences for HCDRs1-3 and LCDRs1-3 or VH and VL or HC and LC in the same patient populations including dementia, FTD, AD, vascular dementia, mixed dementia, tauopathy disease, infections and cancer and as also evidenced by Monroe et al. (WO2016/201388; see para. [0175]-[0177]). Thus, claims 1-7, 12, 17, 20-29 and 34 are anticipated by Culp.
Accordingly, the rejection of claims 1, 3-7, 12, 17, 20-29 and 34 under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Culp (US2019/0040131) is maintained.
Claim Rejections - 35 USC § 103
7. 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-7, 12, 17, 20-29 and 34 stand rejected under 35 U.S.C. 103 as being unpatentable over Culp et al. (US2019/0040131) in view of Monroe et al. (WO2016/201388). The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Arguments
On p. 9-10 of the response, Applicant argues that i) Culp is discussed up and Monroe does not cure the deficiencies of Culp because Monroe teaches dose ranges of 10ng/kg to 100mg/kg/day or 1-10mg/kg/day, about 2mg/kg followed by weekly 1mg/kg every other week, 3ug/kg-2mg/kg and different dosing frequencies ([0403]) and 1.6mg/kg ([0056] and [523]) and does not teach the claimed dose range of 1.6-15mg/kg or once every twelve weeks; ii) the claimed methods demonstrate unexpected results of decreasing CD33 levels at a dose of 1.6mg/kg or 15mg/kg below and remaining approximately 70-75% below baseline levels for at least 17 days or 80-90% below baseline levels for at least 56 days post administration as shown in Example 2 and Figure 1.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. For the reasons set forth above, Culp does teach the method of claims 1, 3-7, 12, 17, 20-29 and 34 and the use of a dose within the claimed dose range of 1.6mg/kg and 15mg/kg.
ii. While Culp does not explicitly teach a dose range that is exactly identical to the claimed range, Monroe (WO2016/201388) teaches this limitation and provides motivation and an expectation of success because Monroe teaches treatment of different diseases including dementia, FTD, AD, vascular dementia, mixed dementia, tauopathy disease, infections and cancer by an anti-CD33 antibody at the claimed dose ranges and regimens recited in claims 1-3 and 5-7.
Monroe teaches different doses including 1.6 mg/kg, or 8 mg/kg ([0056]; [0176]; [0523], claims 6, 91),10ng/kg-100mg/kg or 1-10mg/kg or about 2mg/kg ([0402]-[0403]); that EC50 of anti-CD33 antibody to decrease cellular levels of CD33 in a subject in vivo is at 2-8 mg/kg, less than 15 mg/kg, less than 10 mg/kg, less than 9 mg/kg, less than 8 mg/kg…less than 2 mg/kg…or less than 1.8 mg/kg ([0020]-[0023]; [0123]; [0168]; [0176]), which is within or overlapping with the claimed dose range of 1.6mg/kg-15mg/kg in claim 1, 1.6mg/kg, 10mg/kg, or 15mg/kg...recited in claims 3-7. Monroe also teaches that dosing frequency is three times per day, twice per day, once per day, once every other day, once weekly, once every two weeks, once every four weeks….once monthly, once every two months…longer ([0403]), which is within or overlapping with the claimed dose range of 1.6mg/kg-15mg/kg in claim 1, 1.6mg/kg, 10mg/kg, or 15mg/kg...and frequencies of once every two weeks, once every four weeks…or once every twelve weeks recited in claims 3-7.
The claimed method requires an anti-CD33 antibody at a dose of 1.6mg/kg-15mg/kg in claim 1, 1.6mg/kg, 10mg/kg, or 15mg/kg, which overlaps with the range of Culp or Monroe because Culp teaches about 2mg/kg, which is within the claimed range of “1.6-15mg/kg”; or a dose range including 10ng/kg up to 100mg/kg, 1-10mg/kg or 3ug/kg-2mg/kg (see [0382]-[0383]), which is overlapping with the claimed range of “1.6-15mg/kg”; and Monroe teaches different doses including 1.6 mg/kg, or 8 mg/kg, or 10ng/kg-100mg/kg or 1-10mg/kg or about 2mg/kg or EC50 of decreasing cellular levels of CD33 in a subject in vivo at 2-8 mg/kg, less than 15 mg/kg, less than 10 mg/kg, less than 9 mg/kg, less than 8 mg/kg…less than 2 mg/kg…or less than 1.8 mg/kg. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists. Note that
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima faciecase of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”, See MPEP §2144.05-I.
“a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)” See MPEP §2144.05-I.
Further, routine optimization of the range of Culp or Monroe would have led to the claimed range of 1.6-15mg/kg because Culp teaches about 2mg/kg, which is within the claimed range of “1.6-15mg/kg”; or a dose range including 10ng/kg up to 100mg/kg, 1-10mg/kg or 3ug/kg-2mg/kg, which is overlapping with the claimed range of “1.6-15mg/kg”; and Monroe teaches different doses including 1.6 mg/kg, or 8 mg/kg, or 10ng/kg-100mg/kg or 1-10mg/kg or about 2mg/kg or EC50 of decreasing cellular levels of CD33 in a subject in vivo at 2-8 mg/kg, less than 15 mg/kg, less than 10 mg/kg, less than 9 mg/kg, less than 8 mg/kg…less than 2 mg/kg…or less than 1.8 mg/kg. The person of ordinary skill in the art would have found it obvious to optimize within the range taught by Culp and Monroe because Culp and Monroe teach that this entire range reduces cellular levels of CD33 in a subject in vivo, and also teaches how to optimize the dose range of anti-CD33 in decreasing cellular levels of CD33 in a subject in vivo. Note that
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”; “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert.denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP § 2144.05.
A person of ordinary skill in the art would have recognized that selecting and applying the known dose ranges including between 1.6mg/kg and 15mg/kg, about 1.6mg/kg, 5mg/kg, 7.5mg/kg, 10mg/kg or 15mg/kg, or once every two weeks at a dose of about 1.6mg/kg or once every four weeks at a dose of 1.6 mg/kg or 15mg/kg for an anti-CD33 antibody in treatment of different diseases including dementia, FTD, AD, vascular dementia, mixed dementia, tauopathy disease, infections and cancer and the known method disclosed by Monroe to the Culp’s method would have yielded the predictable result of treating different diseases including dementia, FTD, AD, vascular dementia, mixed dementia, tauopathy disease, infections and cancer, and resulted in an improved method for treating different diseases including dementia, FTD, AD, vascular dementia, mixed dementia, tauopathy disease, infections and cancer using an anti-CD33 antibody.
Using the known dose ranges including between about 1.6-15mg/kg, about 1.6mg/kg, 5mg/kg, 7.5mg/kg, 10mg/kg or 15mg/kg, or once every two weeks at a dose of about 1.6mg/kg or once every four weeks at a dose of 1.6 mg/kg or 15mg/kg for an anti-CD33 antibody in treatment of different diseases including dementia, FTD, AD, vascular dementia, mixed dementia, tauopathy disease, infections and cancer in the Culp’s method would treat the recited diseases and expand application of the Culp’s method, and would increase patient’s satisfaction with treatment of different diseases including dementia, FTD, AD, vascular dementia, mixed dementia, tauopathy disease, infections and cancer using an anti-CD33 antibody.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known dose ranges including between about 1.6-15mg/kg, about 1.6mg/kg, 5mg/kg, 7.5mg/kg, 10mg/kg or 15mg/kg, or once every two weeks at a dose of about 1.6mg/kg or once every four weeks at a dose of 1.6mg/kg or 15mg/kg for an anti-CD33 antibody in treatment of different diseases including dementia, FTD, AD, vascular dementia, mixed dementia, tauopathy disease, infections and cancer and the known method disclosed by Monroe to the Culp’s method, and yield the predictable result of treating different diseases including dementia, FTD, AD, vascular dementia, mixed dementia, tauopathy disease, infections and cancer.
iii. In response to Applicant’s arguments related to unexpected results, note that evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978). See MPEP 716.02(c)-I. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. See: MPEP §716.02. In addition, “A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue.” In re Corkill, 711 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). See MPEP 716.02(a)-I. Further, evidence of unexpected results is frequently in the form of a direct comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See: e.g., In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
In this case, Applicants fails to provide evidence of side-by-side comparisons to demonstrate unexpected results as claimed because the claimed method and the claimed dose ranges are disclosed in the prior art references of Culp and Monroe as set forth above. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). See MPEP 716.02(d)-II. Since Applicant fails to provide any evidence as discussed above to support any unexpected results as claimed, the claimed method is anticipated and/or obvious over the prior art, absent evidence to the contrary.
Accordingly, the rejection of claims 1-7, 12, 17, 20-29 and 34 under 35 U.S.C. 103 as being unpatentable over Culp et al. (US2019/0040131) in view of Monroe et al. (WO2016/201388) is maintained.
Claim Rejections - 35 USC § 103
8. Claims 30-33 and 35 stand rejected under 35 U.S.C. 103 as being unpatentable over Culp et al. (US2019/0040131) in view of Monroe et al. (WO2016/201388) as applied to claims 1-7, 12, 17, 20-29 and 34 above, and further in view of Novak et al. (US2018/0142007), Perneczky et al. (Am J. Geri. Psy, 2006; 14:139-144) and Hoover (Neurology, 2010; 82:1146-1147). The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Arguments
On p. 11 of the response, Applicant argues that Culp and Monroe are discussed above and Novak, Perneczky and Hoover do not cure the deficiencies of Culp and Monroe because none of Novak, Perneczky and Hoover teach administering the claimed anti-CD33 antibodies to an individual at a dose of between 1.6mg/kg and 15mg/kg once very twelve week or more frequently.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. For the reasons set forth above, Culp and Monroe do teach the method of claims 1-7, 12, 17, 20-29 and 34 and the use of a dose of between 1.6mg/kg and 15mg/kg.
ii. Applicant cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, Novak, Perneczky and Hoover are cited to support the limitations “wherein the individual has a MMSE score of between about 16-28 points” in claim 30, “a CDR-GS of about 0.5, 1, or 2” in claim 31, “a positive amyloid-PET scan” in claim 32, “taking a stable dose of a cholinesterase inhibitor and/or a memantine therapy for AD” in claim 33, “AD assessed using one or more clinical assessment including BRANS, CDR, PE, TSPO-PET imaging or any combination thereof” in claim 35.
iii. While Culp and Monroe do not explicitly teach that the individual has a MMSE score of between about 16-28 points as in claim 30, a CDR-GS of about 0.5, 1, or 2 as in claim 31, a positive amyloid-PET scan as in claim 32, taking a stable dose of a cholinesterase inhibitor and/or a memantine therapy for AD as in claim 33, or AD assessed using one or more clinical assessment including BRANS, CDR, PE, TSPO-PET imaging or any combination thereof as in claim 35, Novak, Perneczky and Hoover teach these limitations and provide motivation and an expectation of success because Novak, Perneczky and Hoover teach treating patients with dementia or AD, and wherein the dementia or AD patient is evaluated as having a MMSE score of 15-26 or 26-29 as in claim 30 or is evaluated with a CDR-GS of about 0.5, 1 or 2 as in claim 31, a positive amyloid-PET scan as in claim 32, or AD is assessed using one or more clinical assessment including BRANS, CDR, PE, TSPO-PET imaging or any combination thereof as in claim 35 (see para [0432] [0774]-[0776]) or taking a stable dose of a cholinesterase inhibitor and/or a memantine therapy for AD as in claim 33.
In particular, Novak teaches treating dementia or AD using an anti-tau antibody in a subject in need thereof, wherein the subject with dementia or AD is evaluated as having a MMSE score of 15-26 (see para [0772], which is within the claimed range of 16-28 points in claim 30) or evaluated with a CDR-GS as in claim 31, a positive amyloid-PET scan in claim 32 or AD assessed using one or more clinical assessment including BRANS, CDR, PE, TSPO-PET imaging or any combination thereof as in claim 35 (see para [0432] [0774]-[0776]) or taking a stable dose of a cholinesterase inhibitor and/or a memantine therapy for AD as in claim 33 (see para [0446]-[0447]; [0462]; [0469]; [0752]-[0754]). Perneczky teaches that patients with probable dementia or AD have a MMSE score of ranging from 26–29, patients with mild dementia or AD have a MMSE score of 21–25, patients with moderate dementia or AD have a MMSE score of 11–20 and patients with severe dementia or AD have a MMSE score of 0-10 (see p. 2). Hoover et al. teaches that patients with dementia or AD have a CDR-GS of about 0.5, 1, or 2 as in claim 31 (see p. 1146, table 1)
A person of ordinary skill in the art would have recognized that selecting and treating the AD/dementia patients who have the known MMSE score of between about 16-28 points, the known CDR-GS score of about 0.5, 1, or 2, the known positive amyloid-PET scan, and/or take a stable dose of a cholinesterase inhibitor and/or a memantine therapy for AD, or assessing AD/dementia patients using one or more clinical assessment including BRANS, CDR, PE, TSPO-PET imaging or any combination thereof to the Culp’s method would have yielded the predictable result of treating patients with different forms of dementia including FTD, AD, vascular dementia, mixed dementia, tauopathy disease, and resulted in an improved method for treating dementia, FTD, AD, vascular dementia, mixed dementia, tauopathy disease using an anti-CD33 antibody.
Selecting and treating the AD/dementia patients who have the known MMSE score of between about 16-28 points, the known CDR-GS score of about 0.5, 1, or 2, the known positive amyloid-PET scan, or take a stable dose of a cholinesterase inhibitor and/or a memantine therapy for AD, or assessing AD/dementia patients using one or more clinical assessment including BRANS, CDR, PE, TSPO-PET imaging or any combination thereof in the Culp’s method would treat different forms of dementia including FTD, AD, vascular dementia, mixed dementia, tauopathy disease and expand application of the Culp’s method, and would increase patient’s satisfaction with treatment of different diseases including dementia, FTD, AD, vascular dementia, mixed dementia, tauopathy disease using an anti-CD33 antibody because dementia or AD patients with different degrees or stages of severity can be diagnosed and evaluated or assessed by using a MMSE score of between about 16-28 points, having a CDR-GS score of about 0.5, 1, or 2, having a positive amyloid-PET scan, taking a stable dose of a cholinesterase inhibitor and/or a memantine therapy for AD or using one or more clinical assessment including BRANS, CDR, PE, TSPO-PET imaging or any combination thereof.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and treat the AD/dementia patients having the known MMSE score of between about 16-28 points, the known CDR-GS score of about 0.5, 1, or 2, the known positive amyloid-PET scan or take a stable dose of a cholinesterase inhibitor and/or a memantine therapy for AD, or assessing AD/dementia patients using one or more clinical assessment including BRANS, CDR, PE, TSPO-PET imaging or any combination thereof to the Culp’s method, and yield the predictable result of treating different forms of dementia at different stages including FTD, AD, vascular dementia, mixed dementia, tauopathy disease.
Accordingly, the rejection of claims 30-33 and 35 under 35 U.S.C. 103 as being unpatentable over Culp in view of Monroe as applied to claims 1-7, 12, 17, 20-29 and 34 above, and further in view of Novak, Perneczky and Hoover is maintained.
Double Patenting
9. 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.
Claims 1-7, 12, 17 and 20-35 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-34 and 36-77 of US10711062 or claims 1-17 and 19-20 of US11254743 in view of Culp et al. (US2019/0040131), Monroe et al. (WO2016/201388), Novak et al. (US2018/0142007), Perneczky et al. (2006) and Hoover (2010). The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Arguments
On p. 11 of the response, Applicant argues that for the reasons set forth above, none of the cited references disclose a method of treating and/or delaying progression of a disease or injury in an individual as recited in amended claim 1.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §804, §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. For the reasons set forth above under the 102 rejection, Culp does teach the method of claims 1, 3-7, 12, 17, 20-29 and 34 and the use of a dose within the claimed dose range of 1.6mg/kg and 15mg/kg.
ii. For the reasons set forth above under the 103 rejection, Culp and Monroe do teach the method of claims 1-7, 12, 17, 20-29 and 34 and the use of a dose of between 1.6mg/kg and 15mg/kg.
iii. For the reasons set forth above under 103 rejection, Culp and Monroe, Novak, Perneczky and Hoover do teach the method of claims 30-33 and 35.
iv. Claims 33-34 and 36-77 of US10711062 (the ‘062 patent) or claims 1-17 and 19-20 of US11254743 (the ‘743 patent) claim a method of treating different diseases including Alzheimer’s disease (AD) using an anti-CD33 antibody including the claimed anti-CD33 antibody having the recited SEQ ID NOs: for HCDRs1-3 and LCDRs1-3, VH and VL or HC and LC.
While the claims of the ‘062 patent) or the claims of the ‘743 patent do not recite a specific dose range of between 1.6mg/kg and 15mg/kg, about 1.6mg/kg, 5mg/kg, 7.5mg/kg, 10mg/kg or 15 mg/kg in claims 1 and 3 or once every two weeks at a dose of about 1.6mg/kg in claim 5 or once every four weeks at a dose of 1.6 mg/kg or 15mg/kg in claims 6-7, or wherein the AD has a MMSE score of between about 16-28 points in claim 30, a CDR-GS of about 0.5, 1, or 2 in claim 31, a positive amyloid-PET scan in claim 32, taking a stable dose of a cholinesterase inhibitor and/or a memantine therapy for AD as in claim 33, AD assessed using one or more clinical assessment including BRANS, CDR, PE, TSPO-PET imaging or any combination thereof in claim 35, Culp, Monroe, Novak, Perneczky and Hoover teach these limitations and provide motivation and an expectation of success for the reasons set forth above under the 103 rejections.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and treat the AD/dementia patients having the known MMSE score of between about 16-28 points, the AD/dementia patients having the known CDR-GS score of about 0.5, 1, or 2, the AD/dementia patients having the known positive amyloid-PET scan, the AD/dementia patients taking a stable dose of a cholinesterase inhibitor and/or a memantine therapy for AD or assessing AD/dementia patients using one or more clinical assessment including BRANS, CDR, PE, TSPO-PET imaging or any combination thereof by using the claimed dose range in the method of the ‘062 patent or the ‘743 patent, and yield the predictable result of treating different forms of dementia at different stages including FTD, AD, vascular dementia, mixed dementia, tauopathy disease.
Accordingly, the rejection of claims 1-7, 12, 17 and 20-35 on the ground of nonstatutory double patenting as being unpatentable over claims 33-34 and 36-77 of US10711062 or claims 1-17 and 19-20 of US11254743 in view of Culp, Monroe, Novak, Perneczky and Hoover is maintained.
Conclusion
10. NO CLAIM IS ALLOWED.
11. THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chang-Yu Wang whose telephone number is (571)272-4521. The examiner can normally be reached on Monday-Thursday, 7:00am-5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker, can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Chang-Yu Wang
December 18, 2025
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
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