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
Claim Status
Claims 1-7 are pending.
Priority
This application is filed 10/23/2024 and claims the benefit of domestic priority as below:
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Information Disclosure Statements
One IDS(s) received on 10/23/2024 have been considered unless marked with a strikethrough.
Claim interpretation
Claims are interpreted in accordance with the broadest reasonable interpretation (BRI) standard
consistent with the specification (See MPEP 2111).
With respect to claims 1-7, the phrases “the antithrombotic agent or thrombolysis agent” and “An anti-inflammatory agent……capable of inhibiting thrombus or capable of thrombolysis” are interpreted as intended use because they identify the purpose of the claimed compounds without requiring a structural distinction. (see MPEP 2144.07)
Claim Objections
Claims 1, 2, and 5-7 are objected to because of the following informalities:
Claim 5 is objected to because the term “ATP (Adenosine triphosphate)” should be “Adenosine triphosphate (ATP)”.
Claims 1, 2, 6 and 7 are objected to because claims 2 and 7 depend from claims 1 and 6, respectively, and Formula 1 and Formula 2 shows different coordination between “Gd” and the “carboxyl groups”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-6 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by applicants. (see MPEP 2163.02)
An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. (Emphasis added)
Further, the MPEP states that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. (see MPEP 2161.01)
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.") (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that "only similar language in the specification or original claims is necessary to satisfy the written description requirement").
As set forth in the en banc decision in Ariad Pharmaceuticals Inc. v. Eli Lilly and Company, 94 USPQ2d 1161 (Fed. Cir. 2010) at 1171, the court stated as follows:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. At 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. At 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 [25 USPQ2d 1601] (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
With respect to claims 1 and 6, the claims are drawn to a broad genus of compounds of Formula 1. The genus defines numerous alternatives for A, A1, the linker, L1, L2, R1-R3, and n. Moreover, claims 3-5 define functional subgenera inhibits platelet aggregation induced by thrombin, integrin αIIbβ3 activation in a concentration-dependent manner, and secretion of ATP (Adenosine triphosphate).
However, current specification provides evaluating antiplatelet drug efficacy, specifically testing how well a compound (i.e., MBP-11902, Formula 2) inhibits human platelet activation, clumping, and related cellular signaling. The specification does not disclose a representative number of Formula 1 compounds exhibiting the claimed activities or identify structural features common to the Formula 1 genus that correlate with or predict antithrombotic activity, inhibition of thrombin induced platelet aggregation, inhibition of integrin αIIbβ3 activation, inhibition of ATP secretion, or thrombolytic activity.
Kim et al. (Gadolinium-Based Neuroprognostic Magnetic Resonance Imaging Agents Suppress COX-2 for Prevention of Reperfusion Injury after Stroke, J. Med. Chem., 63(13), 6909-6923, pub’d 06/25/2020) discloses that the individual synthesis, characterization, and biological evaluation of multiple NSAID-DO3A-Gd (abstract, and results and discussion section). Huang et al (Platelet integrin αIIbβ3: signal transduction, regulation, and its therapeutic targeting, J. Hematol. Oncol., 12(1), 26, pub’d 03/07/2019) discloses that platelet integrin αIIbβ3 activation is controlled through complex inside-out and outside-in signaling mechanisms (abstract, Fig 2 and 3). Thus, inhibition of integrin αIIbβ3 activation, thrombin induced platelet aggregation, and ATP secretion involves specific molecular and signaling interaction and would not necessarily have been predictable for every compound encompassed by the broad Formula 1 genus. In addition, varying lengths of L1 and L2 (i.e., C1-C30 alkyl), along with their different linkers (i.e., amide, ether/acetal, methylene, carboxylate or ester carbonyl groups) affect binding affinity by changing molecular flexibility, spatial orientation, and structural stability.
Accordingly, the disclosure of biological results for MBP-11902 alone does not demonstrate possession of the full Formula 1 genus or of the functionally limited subject matter recited in claims 3-5. The specification lacks a representative number of species across the structural breadth of Formula 1 and lacks a disclosed or the structural function correlation that would permit a person of ordinary skill to recognize which compounds throughout the claimed genus possess the recited activities. (see MPEP 2163)
As set forth in the en banc decision in Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010), to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. Specifically, the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art in a way that shows that the inventor actually invented the claimed invention at the time of filing. Id.; Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172. (see MPEP 2161.01).
Accordingly, in view of the breadth of the claimed genus, the lack of representative examples, and the unpredictability of the relationship between the structures encompassed by Formula 1 and the claimed biological functions as discussed above, the specification does not reasonably convey to those skilled in the art that the invention is in possession of the full scope of the inventions in claims 1, and 3-6 at the time of filing.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (Gadolinium-Based Neuroprognostic Magnetic Resonance Imaging Agents Suppress COX-2 for Prevention of Reperfusion Injury after Stroke, J. Med. Chem., 63(13), 6909-6923, pub’d 06/25/2020).
Claim 1 recites an antithrombotic agent or thrombolysis agent having a structure represented by a following Chemical Formula 1, and claim 2 recites a specific compound as a Chemical Formula 2. Claim 6 recites an anti-inflammatory agent having a structure represented by a following Chemical Formula 1 and capable of inhibiting thrombus or capable of thrombolysis, and claim 6 recites a specific compound as a Chemical Formula 2.
Kim discloses the compound 4a (i.e., Gd-DO3A-Dif) that has A is –(CH2)n-A1- wherein n=1, A1 is -CONH-, linker is -L1NHCO-L2- wherein L1 is C2 alkyl and L2 is a single bond, and B is diflunisal moiety of the instant Chemical Formula 1. The compound 4a is structurally identical to the compound of Chemical Formula 2 recited in claims 2 and 7, and thus, fall within the genus of Chemical Formula 1 recited in claims 1 and 6 (scheme 1). Kim further discloses the compound is neuroprognostic agents, which combine molecular diagnostic imaging and targeted neuroprotection for treatment of reperfusion injury after stroke (abstract).
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Instant Chemical Formula 2 Kim’s compound
As discussed in the claim interpretation, Examiner wants to also point out that phrase "the phrases “the antithrombotic agent or thrombolysis agent” and “An anti-inflammatory agent……capable of inhibiting thrombus or capable of thrombolysis” are considered intended use language. During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).
Claims 3-5 recite the functional properties of the compound, and Kim discloses a compound structurally identical to the claimed compound. As discussed above, although the prior art reference does not explicitly disclose the functional property for the instant application, the prior art compound is structurally identical to the claimed compound. A prior art compound that is structurally identical to the claimed compound is presumed to possess the same inherent properties as the claimed compound. The discovery of a previously unrecognized property of a prior art compound does not render the old compound patentable. (See MPEP 2112)
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Chang (WO 2019/182393 A1, pub’d 09/26/2019).
Chang discloses the compound 10 that has A is –(CH2)n-A1- wherein n=1, A1 is -CONH-, linker is -L1NHCO-L2- wherein L1 is C2 alkyl and L2 is a single bond, and B is diflunisal moiety of the instant Chemical Formula 1. The compound 10 is structurally identical to the compound of Chemical Formula 2 recited in claims 2 and 7, and thus, fall within the genus of Chemical Formula 1 recited in claims 1 and 6 (paragraph [75]). Chang further discloses compounds may use an anti-inflammatory agent and a matrix metalloprotease-9 inhibitor (abstract).
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Claims 3-5 recite the functional properties of the compound, and Chang discloses a compound structurally identical to the claimed compound. As discussed above, although the prior art reference does not explicitly disclose the functional property for the instant application, the prior art compound is structurally identical to the claimed compound. A prior art compound that is structurally identical to the claimed compound is presumed to possess the same inherent properties as the claimed compound. The discovery of a previously unrecognized property of a prior art compound does not render the old compound patentable. (See MPEP 2112)
In view of Chang, and the treatment of intended use language and functional language under the MPEP 2144.07 and 2112, claims 1-7 are anticipated by Chang.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are anticipated by Kim and Chang, separately (see above). The present rejection under 35 U.S.C. 103 (below) is made under a claim interpretation where patentable weight is given to the claimed intended use limitations.
Claim(s) 1 and 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Gadolinium-Based Neuroprognostic Magnetic Resonance Imaging Agents Suppress COX-2 for Prevention of Reperfusion Injury after Stroke, J. Med. Chem., 63(13), 6909-6923, pub’d 06/25/2020), in view of Stone et al. (Pharmacology and toxicology of diflunisal, Br. J. Clin. Pharmacol., 4, 19S-29S, pub’d 02/01/1977)
With respect to independent claim 1, the claim recites that an antithrombotic agent or thrombolysis agent having a structure represented by a following Chemical Formula 1.
Kim teaches a biologically active diflunisal conjugated DO3A-Gd compound falling within Chemical Formula 1 (scheme 1). Kim further teaches that the conjugated compound is useful as an MRI contrast agent and exhibits anti-inflammatory and neuroprotective activity (abstract and results and discussion section).
Kim fails to teach that the Formula 1 compound is used as an antithrombotic agent or thrombolysis agent.
Stone teaches that diflunisal inhibits platelet aggregation induced by ADP, adrenaline, and thrombin (abstract). In particular, Stone states that “Diflunisal inhibited adenosine diphosphate, adrenaline and thrombin-induced aggregation of human platelets in vitro.“
It would have been obvious to a PHOSITA at the time of the invention to apply Stone’s known antiplatelet teaching concerning diflunisal to Kim’s biological active, diflunisal containing DO3A-tBu-NH2, and Gd conjugates disclosed in scheme 1 as below.
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Kim teaches that the diflunisal conjugated compound retains biologically relevant anti-inflammatory activity and also exhibits neuroprotective and MRI contrast enhancing properties. Stone teaches that diflunisal additionally inhibits platelet aggregation induced by multiple platelet agonists, including thrombin. Therefore, a person of ordinary skill would have been motivated to use or evaluate Kim’s diflunisal containing conjugate for platelet aggregation inhibitory and antithrombotic activity because the conjugate contain the same pharmacologically active diflunisal moiety evaluated by Stone. Although, the precise degree of antiplatelet activity would have required routine verification, a person of ordinary skill would have had a reasonable expectation that evaluating Kim’s compound for thrombin induced platelet aggregation inhibition would identify an additional therapeutic utility of the compound. Accordingly, combining the teachings would have suggested Kim’s Formula 1 compound as an antithrombotic agent based on Stone’s disclosure that diflunisal inhibits thrombin induced platelet aggregation, and predictably resulted in inhibition of multiple platelet activation pathways to the anti-inflammatory and neuroprotective compound.
The references is directed to the same field of endeavor and address related to the application. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Consistently, applying KSR example rationale (G) in the independent claim 1, it would have been prima facie obvious to apply the antiplatelet use of diflunisal to inhibit thrombin induced platelet aggregation taught by Stone to a biologically active DO3A-Gd conjugate containing a diflunisal moiety taught by Kim would have suggested and/or motivated Kim’s Formula 1 compound as an antithrombotic agent based on Stone’s teachings, and a reasonable expectation that such use or evaluation would successfully identity at least some diflunisal associated antiplatelet activity. (see MPEP 2141)
With respect to claim 3, the claim recites that the antithrombotic agent or thrombolysis agent inhibits platelet aggregation induced by thrombin.
Stone teaches that diflunisal inhibits thrombin induced aggregation of human platelets in vitro (abstract and Platelet aggregation studies section).
Therefore, claim 3 would have been obvious for the reason stated above with respect to claim 1.
With respect to claim 4, the claim recites that the antithrombotic agent or thrombolysis agent inhibits integrin αIIBβ3 activation in a concentration-dependent manner.
The combination teachings of Kim and Stone fail to teach that the agent inhibits integrin αIIBβ3 activation in a concentration-dependent manner.
However, the function of "agent inhibits platelet aggregation induced by thrombin" in claim 3 and "agent inhibits integrin αIIBβ3 activation in a concentration-dependent manner." In claim 4 are a direct cause-and-effect relationship where blocking the activation of a specific cell receptor prevents blood cells from clumping together. Blocking the activation of the integrin αIIBβ3 receptor stops platelets from clumping together. This specific receptor step lets thrombin cause platelet aggregation. Specifically, integrin αIIBβ3 activation is the necessary functional step that allows thrombin to induce platelet aggregation. Thus, inhibition of αIIBβ3 activation is a well-known mechanism for inhibiting platelet aggregation in the field.
Once a person of ordinary skill has been led to use or evaluate Kim’s compound for inhibition of thrombin-induced platelet aggregation, the person would have been motivated to measure αIIBβ3 activation over a range of compound concentrations. Such testing would determine whether the expected aggregation inhibition involved reduced activation of the principal platelet fibrinogen receptor and would identify concentrations producing the desired antiplatelet response.
Therefore, claim 4 would have been obvious for the reason stated above with respect claim 1. Additionally, applying KSR example rationale (D), it would have been prima facie obvious to apply conventional αIIBβ3 activation and concentration response assays to Kim’s known compound would predictably characterize the mechanism and extent of its expected platelet inhibitory activity.
With respect to claim 5, the claim recites that the antithrombotic agent or thrombolysis agent inhibits secretion of ATP (Adenosine triphosphate).
The combination teachings of Kim and Stone fail to teach that the antithrombotic agent or thrombolysis agent inhibits secretion of ATP.
However, ATP secretion is a known measure of thrombin induced platelet activation and aggregation. Thus, a person of ordinary skill had been led to use or evaluate Kim’s diflunisal containing compound for inhibition of thrombin induced platelet aggregation, motivated to measure ATP secretion using conventional platelet activity assays to characterize the mechanism and extent of the expected antiplatelet activity, and would have been expected that inhibition of thrombin-induced platelet activation and aggregation by Kim’s diflunisal containing compound would also reduce or inhibit ATP secretion.
Therefore, claim 5 would have been obvious for the reason stated above with respect claims 1 and 3, because inhibition of ATP secretion would have been a predictable result of the expected antiplatelet activity of Kim’s compound.
With respect to claim 6, the claim recites that an anti-inflammatory agent having a structure represented by a following Chemical Formula 1 and capable of inhibiting thrombus or capable of thrombolysis.
Kim teaches a biologically active diflunisal conjugated DO3A-Gd compound falling within Chemical Formula 1 (scheme 1). Kim further teaches that the conjugated compound is useful as an MRI contrast agent and exhibits anti-inflammatory and neuroprotective activity (abstract and results and discussion section).
Kim fails to teach an anti-inflammatory agent having capable of inhibiting thrombus or capable of thrombolysis.
Stone teaches that diflunisal inhibits thrombin induced aggregation of human platelets in vitro (abstract and Platelet aggregation studies section). It would have been obvious to a person of ordinary skill in the art to apply Stone’s teaching concerning the antiplatelet activity of diflunisal to Kim’s anti- inflammatory DO3A-GD conjugate containing the same pharmacologically active diflunisal moiety. A person of ordinary skill would have had reason to use of evaluate Kim’s compound for thrombus inhibitory activity, with a reasonable expectation that the diflunisal containing conjugate world retain at least some diflunisal associated antiplatelet activity.
Therefore, claim 6 would have been obvious for the reason stated above with respect to claim 1.
Conclusion
Claims 1-7 are rejected.
Claim 1, 2 and 5-7 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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