DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, 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 1-6, 8, 11, 15-17, 19, 21, 31-33, 35 and 36 are pending in the instant invention. According to the Amendments to the Claims, filed December 27, 2024, claims 3, 4, 8, 11, 17, 19, 21, 31-33, 35 and 36 were amended and claims 7, 9, 10, 12-14, 18, 20, 22-30, 34 and 37-40 were cancelled.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2022/0052331, filed December 9, 2022, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/287,552, filed December 9, 2021.
Restrictions / Election of Species
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The forthcoming first Office action and prosecution on the merits includes (1) claims 1-4, 11 and 36, drawn to a method of treating Alzheimer’s disease in a subject… comprising… administering… at least about 700 mg/day of ALZ-801, shown to the right above; (2) claims 5, 6, 8 and 11, drawn to a method of treating Alzheimer’s disease in a subject… comprising… administering… (a) about 400 mg/day to about 600 mg/day of ALZ-801, shown to the right above,… for a first period of 50 weeks or more; and (b) at least about 700 mg/day of ALZ-801, shown to the right above, thereafter; and (3) claims 15-17, 19, 21, 31-33, 35 and 36, drawn to a method of treating Alzheimer’s disease in a subject… comprising… administering… (a) a first dosage of about 400 mg/day to about 600 mg/day of ALZ-801, shown to the right above,… for a first period of time…; and (b) a second dosage of ALZ-801, shown to the right above, that is at least 1.5 times higher than the first dosage for a second period of time, respectively.
Thus, a first Office action and prosecution on the merits of claims 1-6, 8, 11, 15-17, 19, 21, 31-33, 35 and 36 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of ALZ-801 into the abstract, to overcome this objection.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A method for treating Alzheimer’s disease in a subject, wherein the method comprises administering to the subject in need thereof at least 700 mg/day of ALZ-801 of the following formula:
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ALZ-801.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method of Claim 1, wherein the method further comprises administering to the subject in need thereof an amount of ALZ-801 in the range of at least 700 mg/day to 1.0 g/day.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method of Claim 1, wherein the method further comprises administering to the subject in need thereof 795 mg/day of ALZ-801.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method of Claim 1, wherein the method further comprises administering three times daily (TID) to the subject in need thereof 265 mg of ALZ-801.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A method for treating Alzheimer’s disease in a subject, wherein the method comprises administering to the subject in need thereof an amount of ALZ-801 of the following formula:
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ALZ-801
(a) in the range of 400 mg/day to 600 mg/day for a first period of at least 50 weeks; and
(b) at least 700 mg/day thereafter.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method of Claim 5, wherein the method further comprises administering to the subject in need thereof an amount of ALZ-801 of:
(a) 530 mg/day for a first period in the range of 52 weeks to 65 weeks; and
(b) 795 mg/day thereafter.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method of Claim 5, wherein the method further comprises administering to the subject in need thereof an amount of ALZ-801 of:
(a) 265 mg twice daily (BID) for a first period of at least 50 weeks; and
(b) 265 mg three times daily (TID) thereafter.
Appropriate correction is required. See MPEP § 2173.02.
Claim 15 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A method for treating Alzheimer’s disease in a subject, wherein the method comprises administering to the subject in need thereof an amount of ALZ-801 of the following formula:
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ALZ-801
(a) in a first dosage in the range of 400 mg/day to 600 mg/day for a first period of time until the subject demonstrates a decreased therapeutic response to the first dosage; and
(b) in a second dosage that is at least 1.5 times higher than the first dosage for a second period of time.
Appropriate correction is required. See MPEP § 2173.02.
Claim 16 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of Claim 15, wherein the method further comprises administering to the subject in need thereof a second dosage of ALZ-801 in an amount in the range of 1.5 times higher than the first dosage to less than 2 times higher than the first dosage.
Appropriate correction is required. See MPEP § 2173.02.
Claim 17 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of Claim 16, wherein the method further comprises administering to the subject in need thereof an amount of ALZ-801:
(a) for a second period of time until the subject demonstrates a decreased therapeutic response to the second dosage; and
(b) in a third dosage that is at least 2 times higher than the first dosage for a third period of time; or
(c) in a third dosage that is in the range of 2 times higher than the first dosage to less than 2.5 times higher than the first dosage for a third period of time.
Appropriate correction is required. See MPEP § 2173.02.
Claim 19 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of Claim 17, wherein the method further comprises administering to the subject in need thereof an amount of ALZ-801:
(a) for a third period of time until the subject demonstrates a decreased therapeutic response to the third dosage; and
(b) in a fourth dosage that is 2.5 times higher than the first dosage for a fourth period of time; or
(c) in a fourth dosage that is in the range of 2.5 times higher than the first dosage to less than 3 times higher than the first dosage for a fourth period of time.
Appropriate correction is required. See MPEP § 2173.02.
Claim 21 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method of Claim 15, wherein the method further comprises administering to the subject in need thereof an amount of ALZ-801:
(a) in a second dosage that is 700 mg/day; or
(b) in a second dosage that is 795 mg/day; or
(c) in a third dosage that is 1000 mg/day; or
(d) in a third dosage that is 1060 mg/day; or
(e) in a fourth dosage that is 1300 mg/day; or
(f) in a fourth dosage that is in the range of 1325 mg/day to 1590 mg/day.
Appropriate correction is required. See MPEP § 2173.02.
Claim 31 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method of Claim 15, wherein the method further comprises administering to the subject in need thereof an amount of ALZ-801 in a first dosage for a first period:
(a) of at least two weeks; or
(b) in the range of two weeks to three weeks; or
(c) of 6 months; or
(d) in the range of 6 months to 1 year.
Appropriate correction is required. See MPEP § 2173.02.
Claim 32 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of Claim 15, wherein the method further comprises the subject demonstrating at least one decreased therapeutic response selected from the group consisting of (a), (b), (c), (d), (e), (f), (g), (h), (i), (j), (k), and (l):
(a) increased aberrant motor behavior;
(b) increased agitation;
(c) increased depression;
(d) increased repetitive movement;
(e) reduced appetite;
(f) reduced comprehension;
(g) reduced conversation;
(h) reduced cooperation with caretakers;
(i) reduced mobility;
(j) reduced motor skills;
(k) reduced self-feeding; and
(l) reduced verbalizations,
or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 33 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The method of Claim 15, wherein the method further comprises the subject demonstrating at least one decreased therapeutic response illustrated by at least one cognitive test selected from the group consisting of (a), (b), and (c):
(a) the Clinical Dementia Rating Scale-sum of Boxes (CDR-SB);
(b) the Mini-Cog test; and
(c) the Mini-Mental State Examination (MMSE),
or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 35 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method of Claim 33, wherein the method further comprises the subject demonstrating at least one decreased therapeutic response illustrated by at least one cognitive test selected from the group consisting of (a) and (b):
(a) an increase in the score of the Clinical Dementia Rating Scale-sum of Boxes (CDR-SB) in the range of 0.5 to 1 over a period in the range of 6 months to 1 year; and
(b) a decrease in the score of the Mini-Mental State Examination (MMSE) in the range of 4 to 5 over a period in the range of 6 months to 1 year,
or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 1-4, 11 and 36 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 1 recites the physical characteristic, A method of treating Alzheimer’s disease in a subject having a MMSE score of 21 or less, comprising the step of administering to the subject at least about 700 mg/day of ALZ-801, in lines 1-3 of the claim.
Similarly, the inventor or joint inventor should further note that the aforementioned physical characteristic renders the instant invention ambiguous, vague, incoherent, opaque and/or otherwise unclear to the examiner and fails to meet the statutory requirements of 35 U.S.C. § 112(b), since the limitation merely states a physical characteristic (i.e. having a MMSE score of 21 or less) without providing any clarity regarding how the physical characteristic is imparted.
Likewise, the inventor or joint inventor should further note that the instantly recited having a MMSE score of 21 or less physical characteristic does not appear to emanate from and/or does not appear to be an inherent or salient property of the subject administered thereto in the instantly recited method of treating Alzheimer’s disease in a subject.
Next, the inventor or joint inventor should further note that the examiner is uncertain whether the instantly recited method of treating Alzheimer’s disease in a subject requires an additional unrecited component to impart the having a MMSE score of 21 or less physical characteristic to the subject administered thereto in the instantly recited method of treating Alzheimer’s disease in a subject.
Consequently, the inventor or joint inventor should further note that since the instantly recited method of treating Alzheimer’s disease in a subject incorporates the aforementioned ambiguous, vague, incoherent, opaque and/or otherwise unclear having a MMSE score of 21 or less physical characteristic, the instantly recited method of treating Alzheimer’s disease in a subject is rendered indefinite under 35 U.S.C. § 112(b), since one of ordinary skill in the art may not reasonably determine the metes and bounds of the instantly recited subject administered thereto in the instantly recited method of treating Alzheimer’s disease in a subject, due to an inability to establish the metes and bounds encompassed by the having a MMSE score of 21 or less physical characteristic.
Then, the inventor or joint inventor should further note that [A] claim which omits matter disclosed to be essential to the invention, as described in the specification or in other statements of record, may also be rejected under 35 U.S.C. § 112(a), as not enabling. {See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); and MPEP § 2164.08(c)}.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 1, 11 and 36 are further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the phrase, at least about, in claim 1, is a relative phrase which renders the claim indefinite. The phrase, at least about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the phrase, at least about. Similarly, the meaning of a phrase cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… at least about 700 mg/day of ALZ-801 has been rendered indefinite by the use of the phrase, at least about. {See Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 2 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… at least about 700 mg/day of ALZ-801 has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 3 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… at least about 700 mg/day of ALZ-801 has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 4 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… at least about 700 mg/day of ALZ-801 has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 5, 6, 8 and 11 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, in claim 5, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Likewise, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of 50 weeks or more; and (b) at least about 700 mg/day of ALZ-801 has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Next, the inventor or joint inventor should further note that the phrase, at least about, is a relative phrase which renders the claim indefinite. The phrase, at least about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the phrase, at least about. Then, the meaning of a phrase cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of 50 weeks or more; and (b) at least about 700 mg/day of ALZ-801 has been rendered indefinite by the use of the phrase, at least about. {See Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
Also, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Claim 6 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Likewise, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of 50 weeks or more; and (b) at least about 700 mg/day of ALZ-801 has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 8 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 8 recites the limitation, The method of claim 7,…, in line 1 of the claim. There is insufficient antecedent basis, in claim 7, for this limitation, with respect to the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of 50 weeks or more; and (b) at least about 700 mg/day of ALZ-801. According to the Amendments to the Claims, filed December 27, 2024, claim 7 was cancelled by the inventor or joint inventor.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Similarly, the inventor or joint inventor should further note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Likewise, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Next, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of 50 weeks or more; and (b) at least about 700 mg/day of ALZ-801 has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Claims 15-17, 19, 21, 31-33, 35 and 36 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the term, about, in claim 15, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Similarly, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Likewise, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) a first dosage of about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of time…; and (b) a second dosage of ALZ-801 that is at least 1.5 times higher than the first dosage for a second period of time has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim 21 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the phrase, at least about, is a relative phrase which renders the claim indefinite. The phrase, at least about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the phrase, at least about. Similarly, the meaning of a phrase cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Likewise, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) a first dosage of about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of time…; and (b) a second dosage of ALZ-801 that is at least 1.5 times higher than the first dosage for a second period of time has been rendered indefinite by the use of the phrase, at least about. {See Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Next, the inventor or joint inventor should further note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Then, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) a first dosage of about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of time…; and (b) a second dosage of ALZ-801 that is at least 1.5 times higher than the first dosage for a second period of time has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Claim 31 is further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the phrase, at least about, is a relative phrase which renders the claim indefinite. The phrase, at least about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the phrase, at least about. Similarly, the meaning of a phrase cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Likewise, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) a first dosage of about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of time…; and (b) a second dosage of ALZ-801 that is at least 1.5 times higher than the first dosage for a second period of time has been rendered indefinite by the use of the phrase, at least about. {See Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Next, the inventor or joint inventor should further note that the term, about, is a relative term which renders the claim indefinite. The term, about, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification fails to adequately define the term, about. Then, the meaning of a term cannot depend on the unrestrained, subjective opinion of the inventor or joint inventor practicing the invention. Moreover, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) a first dosage of about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of time…; and (b) a second dosage of ALZ-801 that is at least 1.5 times higher than the first dosage for a second period of time has been rendered indefinite by the use of the term, about. {See Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir.2007); W. L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991); and MPEP § 2173.05(b)}.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Claim Rejections - 35 U.S.C. § 112(d)
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
(d) REFERENCE IN DEPENDENT FORMS. Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 11 recites the limitation, The method of Claim 1, wherein the subject has an MMSE score of 21 or less,…, in lines 1-2 of the claim. According to claim 1, the subject has an MMSE score of 21 or less, with respect to the method of treating Alzheimer’s disease in a subject. Consequently, since The method of Claim 1, wherein the subject has an MMSE score of 21 or less,…, fails to specify a further limitation to the method of treating Alzheimer’s disease in a subject, as recited in claim 1, and/or fails to include all the limitations of the method of treating Alzheimer’s disease in a subject, as recited in claim 1, the instant dependent claim is rendered improperly dependent under 35 U.S.C. § 112(d).
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 11 is further rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 11 is rejected under 35 U.S.C. § 112(d) because the recitation of a physical characteristic of a subject administered thereto in a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, the subject administered thereto in the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of 50 weeks or more; and (b) at least about 700 mg/day of ALZ-801, as recited in claim 5, has an MMSE score of 21 or less, and MMSE score of 16 or less, or an MMSE score of 16 to 21. Consequently, since the physical characteristic of the subject administered thereto in the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of 50 weeks or more; and (b) at least about 700 mg/day of ALZ-801, whereby the subject administered thereto in the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of 50 weeks or more; and (b) at least about 700 mg/day of ALZ-801 has an MMSE score of 21 or less, and MMSE score of 16 or less, or an MMSE score of 16 to 21, fails to result in a further patentably distinct methodical step in the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of 50 weeks or more; and (b) at least about 700 mg/day of ALZ-801, as recited in claim 5, and/or fails to include all the limitations of the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of 50 weeks or more; and (b) at least about 700 mg/day of ALZ-801, as recited in claim 5, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claims to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim 36 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 36 is rejected under 35 U.S.C. § 112(d) because the recitation of a physical characteristic of a subject administered thereto in a method from which the claim depends, must result in a patentably distinct methodical step in the recited method, in order to be further limiting. In the instant dependent claim, the subject administered thereto in (1) the method of treating Alzheimer’s disease in a subject… comprising… administering… at least about 700 mg/day of ALZ-801, as recited in claim 1; or (2) the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) a first dosage of about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of time…; and (b) a second dosage of ALZ-801 that is at least 1.5 times higher than the first dosage for a second period of time, as recited in claim 15, respectively, is APOE4 homozygous. Consequently, since the physical characteristic of the subject administered thereto in (1) the method of treating Alzheimer’s disease in a subject… comprising… administering… at least about 700 mg/day of ALZ-801, as recited in claim 1; or (2) the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) a first dosage of about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of time…; and (b) a second dosage of ALZ-801 that is at least 1.5 times higher than the first dosage for a second period of time, as recited in claim 15, respectively, whereby the subject administered thereto in (1) the method of treating Alzheimer’s disease in a subject… comprising… administering… at least about 700 mg/day of ALZ-801; or (2) the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) a first dosage of about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of time…; and (b) a second dosage of ALZ-801 that is at least 1.5 times higher than the first dosage for a second period of time, is APOE4 homozygous, fails to result in a further patentably distinct methodical step in (1) the method of treating Alzheimer’s disease in a subject… comprising… administering… at least about 700 mg/day of ALZ-801, as recited in claim 1; or (2) the method of treating Alzheimer’s disease in a subject… comprising… administering… (a) a first dosage of about 400 mg/day to about 600 mg/day of ALZ-801,… for a first period of time…; and (b) a second dosage of ALZ-801 that is at least 1.5 times higher than the first dosage for a second period of time, as recited in claim 15, respectively, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claims to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 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.
Claims 1-6, 8, 11, 15-17, 19, 21, 31-33, 35 and 36 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Kong, et al. in US 8,748,656.
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The inventor or joint inventor should note that the instant invention recites a method of treating Alzheimer’s disease in a subject having a Mini-Mental State Examination (MMSE) score of 21 or less, comprising… administering… at least about 700 mg/day of ALZ-801, shown to the left above.
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Similarly, the inventor or joint inventor should further note that Kong, et al. (US 8,748,656) teaches a method of treating Alzheimer’s disease in a subject… comprising… administering… ALZ-801, shown to the right [mot (Alzheimer’s) - column 116, claim 11; and compound - column 116, claim 3, compound 1].
Likewise, the inventor or joint inventor should further note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Next, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Then, the inventor or joint inventor should further note that [M]erely modifying process conditions, such as temperature and concentration, is not a patentable modification, absent a showing of criticality. {See In re Aller, Lacey and Hall, 220 F.2d 454, 105 USPQ 233 (CCPA 1955)}.
Moreover, the inventor or joint inventor should further note that in the event the determination of the status of the invention as subject to AIA 35 U.S.C. § 102 (or as subject to pre-AIA 35 U.S.C. § 102) is incorrect, any correction of the statutory basis for the instant 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 - Obviousness-type 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 obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined invention claim is not patentably distinct from the reference claims because the examined invention claim is either anticipated by, or would have been obvious over, the reference claims. {See 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969)}.
US Application No. 17/877,380
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Consequently, claims 1-6, 8, 11, 15-17, 19, 21, 31-33, 35 and 36 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 18-29 and 42-53 of copending US Application No. 17/877,380. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 18 in the copending invention recites a method of treating Alzheimer’s disease in an ApoE4-positive patient… comprising… administering… L-valyl-3-amino-1-propanesulfonic acid (Val-APS), shown to the left above, respectively, which provide overlapping subject matter with respect to the instantly recited method of treating Alzheimer’s disease in a subject having a Mini-Mental State Examination (MMSE) score of 21 or less… comprising… administering… at least about 700 mg/day of ALZ-801, shown to the right above.
The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Moreover, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
US Application No. 18/462,238
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Claims 1-6, 8, 11, 15-17, 19, 21, 31-33, 35 and 36 are further rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 18, 19 and 24-35 of copending US Application No. 18/462,238. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 18 in the copending invention recites a method of treating Alzheimer’s disease in a subject… being APOE4-positive and having a baseline MMSE score of 16-19… comprising… administering… a pharmaceutical composition comprising valyl-3-amino-1-propanesulfonic acid (ALZ-801), shown to the left above, which provide overlapping subject matter with respect to the instantly recited method of treating Alzheimer’s disease in a subject
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having a Mini-Mental State Examination (MMSE) score of 21 or less… comprising… administering… at least about 700 mg/day of ALZ-801, shown to the right.
The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Next, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Moreover, the inventor or joint inventor should further note that [I]t is obvious to add a carrier or solvent to an unpatentable compound. {See Ex parte Douros and Vanderweff, 163 USPQ 667, (BPAI 1968)}.
US Patent No. 11,191,742
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Claims 1-6, 8, 11, 15-17, 19, 21, 31-33, 35 and 36 are further rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US Patent No. 11,191,742. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in US 11,191,742 recites a method of treating Alzheimer’s disease in a subject… being APOE4/4 homozygous and having a baseline MMSE score of ≥22… comprising… administering… a pharmaceutical composition comprising valyl-3-amino-1-propanesulfonic acid (ALZ-801), shown to the left above, which provides overlapping subject matter with respect to the instantly recited method of treating Alzheimer’s disease in a subject
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having a Mini-Mental State Examination (MMSE) score of 21 or less… comprising… administering… at least about 700 mg/day of ALZ-801, shown to the right above.
The inventor or joint inventor should note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Similarly, the inventor or joint inventor should further note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Likewise, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Next, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Then, the inventor or joint inventor should further note that [I]t is obvious to add a carrier or solvent to an unpatentable compound. {See Ex parte Douros and Vanderweff, 163 USPQ 667, (BPAI 1968)}.
Moreover, the inventor or joint inventor should further note that a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 37 CFR 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground, provided the conflicting invention or patent either is shown to be commonly owned with this invention, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Furthermore, the inventor or joint inventor should also note that the USPTO internet Web site contains terminal disclaimer forms which may be used, and the inventor or joint inventor is encouraged to visit http://www.uspto.gov/forms/, where (i) the filing date of the invention will determine what form should be used, and (ii) a web-based eTerminal Disclaimer may be filled out completely online using web-screens, respectively.
Also, the inventor or joint inventor should further note that an eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
Finally, for more information about eTerminal Disclaimers, the inventor or joint inventor should refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
Prosecution Insights