DETAILED ACTION
Notice of AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-3 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 2 is rejected under 35 U.S.C. 101 for the following reason:
Claim 2 recites “[u]se of a compound of formula (I)… for use in the treatment of canine cognitive dysfunction or other form of dementia in dog”.
The claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-3 are rejected under 35 U.S.C. 112(b) for the following reason:
Claims 1-3 recite a “compound of formula (I)… optionally in the form of a stereoisomer, such as enantiomer, or a mixture of at least two stereoisomers, such as at least two enantiomers”.
The phrase “such as” renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention (see MPEP § 2173.05(d)).
Claim 2 is ADDITIONALLY rejected under 35 U.S.C. 112(b) for the following reason:
Claim 2 recites “[u]se of a compound of formula (I)… for use in the treatment of canine cognitive dysfunction or other form of dementia in dog”.
As drafted, the claim does not properly set forth any steps involved in the “u]se of a compound of formula (I)” and, as such, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brus et al (WO 2016/151484).
Claim 1 is drawn to a compound of formula (I):
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for use in the treatment of canine cognitive dysfunction or other form of dementia in dog.
Brus et al teach “inhibitors of butyrylcholinesterase… for the treatment of Alzheimer’s disease and other forms of dementia” (Abstract), wherein the inhibitor is instantly claimed formula (I) (Page 13, final compound; see also Paragraph 0235, Example 2).
As to the recitation that the compound of formula (I) is “for use in the treatment of canine cognitive dysfunction or other form of dementia in dog”, Applicant is reminded that product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (MPEP 2113). As stated by the court in In re Thorpe (777 F.2d 695 (Fed. Cir. 1985), “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claims is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process”.
In the instant case, the compound of formula (I) taught by Brus et al would be capable of use in the treatment of canine cognitive dysfunction or other form of dementia in dog.
Accordingly, claim 1 is anticipated.
Claim 3 is drawn to a pharmaceutical composition for use in the treatment of canine cognitive dysfunction or other form of dementia in dog, comprising a therapeutically effective amount of a compound of formula (I).
As discussed above, Brus et al teach “inhibitors of butyrylcholinesterase… for the treatment of Alzheimer’s disease and other forms of dementia” (Abstract), wherein the inhibitor is instantly claimed formula (I) (Page 13, final compound; see also Paragraph 0235, Example 2). Brus et al further teach pharmaceutical compositions thereof (Paragraphs 0026-0028), and specifically disclose “[s]tock solutions of compounds were prepared in DMSO in a concentration of 10 mM” and “further diluted” (Paragraph 0044), which entails a pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I).
Accordingly, claim 3 is also anticipated.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19 of U.S. Patent No. 10,071,964.
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a compound of formula (I):
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and compositions thereof, as well as the use of said compound.
The ‘964 claims recite the instantly claimed compound (claim 3) and a composition thereof (claim 7).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611