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
Status of Claims
Claims 4-8, 14-20, and 24-31 are pending.
Election/Restrictions
Applicants’ election of Group II drawn to a compound of formula (I), (II) or (IV) and the following species:
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as a species from formula I, in the reply filed on 12/8/2025 is acknowledged. The election was made without traverse.
Accordingly, claims 5, 8, 14-17, 19-20, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 4, 6-7, 18, 24, and 26-31 are under examination in the instant office action.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 compound of claim 18 (elected compound) is not encompassed by the formula I as recited in claim 4 because the formula I requires the presence of both R4 and R5, but one of R4 and R5 is not present in the elected compound.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description Rejection
Claims 4, 6-7, 18, 24, and 26-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification fails to describe how to make and how to use the compounds claimed.
Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1st "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The Guidelines for Examination of Patent Applications Under 35 USC 112, ¶1, “Written Description” Requirement (Federal Register, Vol. 66, No. 4, pg. 1105, column 3), in accordance with MPEP § 2163, specifically state that for each claim drawn to a genus the written description requirement may be satisfied through sufficient description of a representative number of species by a) actual reduction to practice; b) reduction to drawings or structural chemical formulas; c) disclosure of relevant, identifying characteristics (i.e., structure) by functional characteristics coupled with a known or disclosed correlation between function and structure.
In the instant case, the specification does not contain a method for making the compounds recited in claim 4. Further, the broad variability in the structures of the genus will require distinct methods of making. In particular, when Y is O, the compounds of formula I contain a trivalent oxygen atom (carrying R4, R5, and the bond through which it is connected to C=O). Such compounds are known to be unstable. However, there is no disclosure or guidance how to make such unstable compounds. There is no example falling the genus defined by formula I as recited in claim 4 wherein both R4 and R5 are present when Y is O. Even the elected compound does not read on the claimed genus as stated above. On top of that, the variable “x” ranges from 0 to 20 and R1, R2, R3, R4, and R5 can be various different functional groups, thus the resulting compounds can be extremely large. In addition, there is no activity test for any of the compounds as recited in the claims. The compounds are disclosed to be a PGK1 inhibitor, but there is no test showing that the claimed genus will have such property.
The most of in vitro and in vivo test results in the specification are directed to CBR-470-1:
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([0007] and Examples 1-9). However, the compound is different from the claimed genus of formula I as it does not have -C(O)-Y-R4R5 moiety. While the specification discloses CBR-470-2:
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([0007] and Examples 1-9), this compound is also not a species of the claimed genus of formula I because one of R4 or R5 is absent. One of ordinary skill in the art would not be able to predict the property of the claimed genus based on the activities of CBR-470-1 which has different structure from the claimed genus. Thus, the specification does not provide any guidance or example as to which compounds of the claimed genus would do what is claimed.
The first paragraph of 35 U.S.C. 112 requires that the "specification shall contain a written description of the invention * * *" This requirement is separate and distinct from the enablement requirement. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991). The written description requirement has several policy objectives. "[T]he 'essential goal' of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470,473 n.4 (CCPA 1977). Another objective is to put the public in possession of what the applicant claims as the invention. See Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). *>"The 'written description' requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent's term.
Accordingly, the specification fails to comply with written description requirement as to how to make and use the claimed genus of compounds and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim Interpretation
The instant claims are drawn to a compound having a structure of:
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.
As stated above, the elected compound is not encompassed by the formula I as recited in claim 4 because one of R4 and R5 is not present in the elected compound while the formula I requires the presence of both R4 and R5. In view of the elected compound and the specification, claim 4 is treated as if it recites “when Y is O, one of R4 or R5 is not present” for prior art rejection.
The elected species appear to be free of prior art, thus search has been extended to a species defined by the above formula wherein R1 is chlorine, R2 is H, R3 is H, x is 1, Y is O, R4 is substituted or unsubstituted alkyl such as methyl and ethyl, and R5 is absent.
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 4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PubChem Record of CID 21006225 (Created date: 12/5/2007).
The PubChem Record discloses the following compounds:
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(p1), which is a species of the claimed genus recited in claim 4.
As to the preamble, “phosphoglycerate kinase 1 inhibitor”, it is an intended use. Since the instant claims are directed to a compound, such intended use does not have any patentable weight. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In this case, there is no structural difference between the compound of the prior art and the claimed invention, thus it would be capable of performing the intended use as claimed. In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is.
As such, the instant claims 4 and 6 are anticipated by the PubChem Record.
Claims 4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PubChem Record of CID 21006222 (Created date: 12/5/2007).
The PubChem Record discloses the following compounds:
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(p1), which is a species of the claimed genus recited in claim 4.
As to the preamble, “phosphoglycerate kinase 1 inhibitor”, it is an intended use. Since the instant claims are directed to a compound, such intended use does not have any patentable weight. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In this case, there is no structural difference between the compound of the prior art and the claimed invention, thus it would be capable of performing the intended use as claimed. In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is.
As such, the instant claims 4 and 6 are anticipated by the PubChem Record.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 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.
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.
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.
Claims 4, 6, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over PubChem Record of CID 21006225 (Created date: 12/5/2007) or CID 21006222 (Created date: 12/5/2007).
The teachings of the PubChem Record as applied supra are herein applied for the same teachings in their entirety.
The PubChem Record differs from the claim 26 as it does specifically disclose adding a pharmaceutically acceptable carrier such as water. However, it would have been prima facie obvious to one of ordinary skill in the art to prepare a composition by adding well-known pharmaceutical acceptable carriers such as water or ethanol for solubilizing or dispersing a compound in order to analyzing properties of the compound such as solubility. The result would have been predictable because the addition of water or ethanol would provide a composition suitable for such analysis.
Double Patenting Rejection
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 4, 6-7, 18, 24, and 26-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of US Patent 12048688.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the patent recite the elected species and the compounds of the instant claims 24 and 29 and their use for inhibiting phosphoglycerate kinase 1 (PGK1). Also, it would have been prima facie obvious to one of ordinary skill in the art to prepare a pharmaceutical composition by adding pharmaceutical acceptable carriers suitable for administering it to a subject depending on administration routes.
As such, the instant claims are anticipated by or would have been obvious over the claim of the patent.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611